YEARBOOK 2008 / I - AIPPI

YEARBOOK 2008 / I 

XXXXI TH CONGRESS – BOSTON 2008 

(6 – 11 SEPTEMBER 2008) 

Q202: THE IMPACT OF PUBLIC HEALTH ISSUES ON 

EXCLUSIVE PATENT RIGHTS 

WORKING GUIDELINES, GROUP REPORTS, 

SUMMARY REPORTS, RESOLUTIONS 

ASSOCIATION INTERNATIONALE 

POUR LA PROTECTION 

DE LA PROPRIETE INTELLECTUELLE 

INTERNATIONAL ASSOCIATION 

FOR THE PROTECTION 

OF INTELLECTUAL PROPERTY 

INTERNATIONALE VEREINIGUNG 

FÜR DEN SCHUTZ DES 

GEISTIGEN EIGENTUMS 

001-010_Intro-book1.indd 1 17.07.2009 09:33:01

The reports and the summaries from the National and Regional Groups are normally reproduced 

without alteration in content, style and spelling. 

Dans le cas normal, les rapports et les résumés des Groupes nationaux et régionaux sont publiés 

sans corrections du contenu, du style et de l’orthographie. 

Die Berichte und Zusammenfassungen der Landes- und Regionalgruppen werden im Normalfall 

ohne Korrekturen von Inhalt, Stil und Orthographie wiedergegeben. 

AIPPI General Secretariat 

© AIPPI, Zurich 2008 

Edited in the name of AIPPI by the AIPPI General Secretariat, Zurich (Switzerland) 

Price CHF 30.–; for AIPPI members free of charge 

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XXXXI TH CONGRESS OF AIPPI 

BOSTON, 6 – 11 SEPTEMBER 2008 

THE QUESTIONS ON THE AGENDA 

QUESTION Q202 

WORKING GUIDELINES 

GROUP REPORTS 

SUMMARY REPORTS 

RESOLUTIONS 

XXXXI E CONGRES DE L’AIPPI 

BOSTON, 6 – 11 SEPTEMBRE 2008 

LES QUESTIONS A L’ORDRE DU JOUR 

QUESTION Q202 

ORIENTATIONS DE TRAVAIL 

RAPPORTS DES GROUPES 

RAPPORTS DE SYNTHESE 

RESOLUTIONS 

XXXXI. KONGRESS DER AIPPI 

BOSTON, 6. – 11. SEPTEMBER 2008 

DIE FRAGEN DER TAGESORDNUNG 

FRAGE Q202 

ARBEITSRICHTLINIEN 

BERICHTE DER LANDESGRUPPEN 

ZUSAMMENFASSENDE BERICHTE 

ENTSCHLIESSUNGEN 

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I. 

THE QUESTIONS ON THE AGENDA 

LES QUESTIONS A L’ORDRE DU JOUR 

DIE FRAGEN DER TAGESORDNUNG 


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The Questions on the Agenda 

On the basis of a proposal from the Programme Committee, the Executive Committee decided to 

put the following Questions on the Agenda for the Congress 2008 in Boston: 

Q202 The impact of public health issues on exclusive patent rights 

Q203 Damages for infringement, counterfeiting and piracy of trademarks 

Q204 Liability for contributory infringement of IPRs 

Q205 Exhaustion of IPRs in cases of recycling and repair of goods 

Les Questions à l’ordre du jour 

Le Comité exécutif a décidé, sur proposition de la Commission des Programmes, de mettre à l’ordre 

du jour pour le Congrès 2008 à Boston les questions suivantes: 

Q202 L’influence des questions de santé publique sur les droits exclusifs de brevet 

Q203 Les dommages et intérêts pour l’imitation, la contrefaçon et le piratage des marques 

Q204 La responsabilité pour contrefaçon par fourniture de moyen des droits de propriété 

intellectuelle 

Q205 L’épuisement des droits de propriété intellectuelle en cas de réparation ou de recyclage 

des produits 

Die Fragen der Tagesordnung 

Der Geschäftsführende Ausschuss hat auf Vorschlag des Programmausschusses beschlossen, die 

folgenden Fragen auf die Tagesordnung des Kongresses 2008 in Boston zu setzen: 

Q202 Auswirkungen von Fragen der Volksgesundheit auf exklusive Patentrechte 

Q203 Schadensersatz für Verletzung, Fälschung und Piraterie von Marken 

Q204 Verantwortlichkeit für die mittelbare Verletzung von Rechten des Geistigen Eigentums 

Q205 Die Erschöpfung von Rechten des Geistigen Eigentums in Fällen des Recyclings oder der 

Reparatur von Waren 


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II. 

QUESTION Q202 

THE IMPACT OF PUBLIC HEALTH ISSUES 

ON EXCLUSIVE PATENT RIGHTS 

QUESTION Q202 

L’INFLUENCE DES QUESTIONS DE SANTé PUBLIQUE 

SUR LES DROITS EXCLUSIFS DE BREVET 

FRAGE Q202 

AUSWIRKUNGEN VON FRAGEN DER VOLKSGESUNDHEIT 

AUF EXKLUSIVE PATENTRECHTE 


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Working Guidelines 

by Jochen E. BüHLING, Reporter General 

Dariusz SZLEPER and Thierry CALAME, Deputy Reporters General 

Nicolai LINDGREEN, Nicola DAGG and Shoichi OKUYAMA 

Assistants to the Reporter General 

Question Q202 

The impact of public health issues on exclusive patent rights 

Introduction 

1) The protection of public health is one of the most pressing issues in today’s world. The patent 

system is designed to promote scientific and technological innovation and, as a result, has 

contributed to significant improvements in the treatment of health conditions, as evidenced by 

the many medicines which have been invented and brought to the market. The patent system 

also contributes to public health and society at large by making available patent information 

which is freely available to other researchers to further improve existing technologies and 

products. Despite the public policy objectives inherent in the patent system, the relationship 

between patents and public health has been the subject of debate. Some consider that the 

current patent system does not adequately address public health issues. More specifically, 

there have been concerns about how patents may affect access to medicines, diagnostics, 

medical devices and medical treatment in view of possible future pandemics such as HIV/ 

AIDS, SARS or Avian flu. 

2) Access to patented medicines, diagnostics and the like is a complex issue and may be 

affected by different factors such as pricing, availability, stock, and speed of manufacturing 

and supply. The exclusionary nature of patent rights has the effect that third parties are 

excluded from manufacturing or offering for sale products which are covered by the scope 

of the patents without the authority of the patent owner. By way of example, this may result 

in a shortage of adequate supplies of drugs capable of treating pandemic diseases if the 

patentee lacks sufficient manufacturing capacities or maintains high pricing. For instance, in 

the recent cases of anthrax attacks in the United States, some voices raised concerns that 

German pharmaceutical company Bayer would not be able to meet all of the demand of its 

anthrax drug Ciprobay and moreover would not be willing to provide it at affordable rates. 

3) In general, the development of new drugs and medical devices requires substantial investment 

and long-term research, coupled with expensive clinical trials and regulatory approval 

procedures. The exclusive right conferred by a patent is one of the incentives for pharmaceutical 

companies to make the necessary investments into that research. To ensure access by third 

parties to patented technologies, the patent system is primarily based on a voluntary licensing 

mechanism. If the patent owner is not willing or able to provide access, this may be problematic. 

The patent system, therefore, provides for a number of limitations of the exclusive patent 

rights, such as, for example, provision for compulsory licensing in certain circumstances, 

recognition by some countries of the legality of parallel imports of patented medicines 

or – with a view to providing access on a longer term basis – research and Bolar exceptions. 

4) The purpose of this question is to examine national and international legislation and case 

law in respect of limitations which may play a role in providing access to patented medicines 

and other medical or biological products so as to facilitate health care, notably in the context 

of public health crises such as those which may occur in any country, also in developed 

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countries, but also those which are currently afflicting some developing and least developed 

countries. This question is only concerned with limitations of the exclusive nature of patents. It 

does not deal with issues of patentability, such as the exclusion of patentable subject matter 

on public policy or morality grounds. In addition, although certain aspects of trademark 

law, competition law, and medical and health care law may also be relevant in the context 

of public health crises, this question only addresses patents. Finally, this question does not 

specifically single out and refer to the issue of access to medicines in developing countries 

and least developed countries. While access to affordable medicines is undoubtedly a 

pressing issue and also relevant in the context of this question, this issue is not at the core of 

this question Q202. This question rather looks at limitations on patent protection applicable 

to medicines and other medical products at a general level, notably in cases of public health 

crises, without any particular focus on developing and least developed countries. It is taken 

into account that in the case of developing and least developed countries, other factors may 

play an even more important role in preventing medicines to reach those in need thereof, such 

as inadequacies in health care policy and in health care infrastructure. 

Previous work of AIPPI 

5) AIPPI has studied health-sensitive limitations of the patentee’s exclusive rights in previous 

questions. 

6) Already at the Congress of Washington in 1956 AIPPI studied restrictions of the rights of 

the patentee for reasons of public interest in the context of Article 5 (A) Paris Convention. 

In resolution Q3 AIPPI adopted the principle that measures, other than compulsory licenses, 

restricting the rights of the patentee should only be permitted if compelling requirements 

of public interest are not satisfied by the granting of a compulsory license. The Congress 

further recommended that compulsory licences and similar measures be subject to equitable 

compensation to the patentee. These principles were confirmed at subsequent meetings noting 

that any restriction of the exclusive right of the patentee would impair the success of the patent 

system as a means of encouraging invention and, accordingly, be detrimental to the general 

interest of the public. 

7) In 1966 the Congress of Tokyo adopted resolution Q39 (Reasons for which the rights of the 

patentee can be restricted) which mentions as reasons for restricting the rights of the patentee: 

abuse resulting from the exercise of the exclusive patent rights, dependent patents, failure to 

work or insufficient working (both subject to more stringent provisions). The resolution Q39 

further specifies that a compulsory license must not be granted until an agreement has proved 

to be impossible. 

8) In resolution Q101 (Parallel Import of Patented Products) adopted by the Executive Committee 

in Barcelona in 1990 AIPPI resolved that a patentee should be able to invoke its patent against 

parallel import of a patented product. This resolution was confirmed in resolution Q156 

(International Exhaustion of Industrial Property Rights) adopted at the Melbourne Congress in 

2001. The resolution Q156 rejects the notion of international exhaustion and notes that there 

should in any event be no international or regional exhaustion of an IPR where a product has 

been put on the market under a compulsory licence. 

9) The Executive Committee of Tokyo in 1992 adopted resolution Q105 regarding experimental 

use as a defence to a claim of patent infringement. The AIPPI resolution favours permitting 

experimental use of a patented invention for academic purposes, including testing of the 

invention to evaluate the teaching and validity of the patent, but not for commercial purposes. 

The resolution Q105 considers use of the invention during the lifetime of the patent for the 

purpose of obtaining regulatory approval (which uses are today exempted by the Bolar 

exception, where applicable) not to be experimental use. 

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10) At the Congress of Montreal in 1995, AIPPI resolved that compulsory licensing provisions 

should equally apply to patents related to the environment (Q128 - Patents and the Protection 

of the Environment). Similarly, the resolution Q150 (Patentability requirements and scope of 

protection of Expressed Sequence Tags (ESTs), Single Nucleotide Polymorphisms (SNPs) and 

entire genomes) adopted by the Executive Committee of Sorrento in 2000 notes that AIPPI is 

not in favour of special provisions for experimental use or compulsory licenses in the field of 

ESTs, SNPs and entire genomes. 

11) The summary report Q178 (Scope of Patent Protection) in 2004 notes that medical treatment, 

pharmaceutical inventions and the patentability of second medical use claims inevitably lead 

to questions of accessibility to new medicines and how doctors can avoid patent infringement 

in emergency situations. The report mentions the possibility of issuing compulsory licences for 

such patents. 

12) The summary report Q187 (Limitations on exclusive IP rights by competition law) in 2005 

confirms that all reporting countries provide for exceptions to the exclusive rights of the 

patentee, notably the possibility of issuing compulsory licenses (in the United States only in 

relation to nuclear energy and the environment). In their group reports some groups had noted 

the exceptional nature of the compulsory licensing provisions and the fact that in practice they 

were very rarely implemented, but had emphasised that their mere existence would force 

patentees to negotiate license agreements under more advantageous conditions for future 

licensees. The summary report Q187 further notes that some reporting countries provide for 

exceptions relating to tests and experiments. While the group reports Q187 touch on issues 

which are also relevant in the context of this question, they cannot be seen as comprehensive 

analysis of compulsory licensing and experimental use exception. 

13) Special Committee Q94 (GATT/WTO) which monitors and advises on developments of the 

GATT/WTO TRIPS Agreement has reported on public health issues in the context of TRIPS, 

notably on the decision of August 30, 2003 under paragraph 6 of the Doha declaration on 

the TRIPS Agreement and Public Health and the new Article 31bis TRIPS allowing generic 

copies of pharmaceuticals made under compulsory licences to be exported to (developing) 

countries that lack production capacity in the pharmaceutical sector. 

Discussion 

14) WTO member states retain a considerable degree of flexibility in addressing public health 

issues. 

15) According to Article 8 (1) TRIPS members may adopt measures necessary to protect public 

health and nutrition, and to promote the public interest in sectors of vital importance to 

their development, provided that such measures are consistent with the provisions of this 

Agreement. Article 8 (2) TRIPS notes that appropriate measures may be needed to prevent 

the abuse of intellectual property rights by right holders or the resort to practices which 

unreasonably restrain trade or adversely affect the international transfer of technology. 

16) According to Article 30 TRIPS members may provide limited exceptions to the exclusive rights 

conferred by a patent, provided that such exceptions do not unreasonably conflict with a 

normal exploitation of the patent and do not unreasonably prejudice the legitimate interests 

of the patent owner, taking account of the legitimate interests of third parties. Article 30 TRIPS 

leaves WTO member states with considerable freedom to define the nature and extent of 

exceptions to the exclusive rights of patent owners. There are different types of exceptions that 

may be provided for within the scope of Article 30 TRIPS and, at the same time, are relevant 

in connection with public health issues. 

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17) For instance, a research and experimental use exception permits use of pharmaceutical 

inventions without compensation to the owner for research and experimentation purposes. 

Application of the research exception may contribute to access to medicines on a long term 

basis to the extent that it may lead to improved products. While the research exception is 

rather narrow in the United States, many countries (notably in Europe) explicitly authorize 

research on an invention without the consent of the patent owner, for scientific and to some 

extent even mixed scientific and commercial purposes. 

18) Another exception specifically applicable to pharmaceutical patents is the Bolar exception. 

This exception relates to using an invention without the patentee’s consent for the purpose of 

obtaining approval of a generic product before the patent expiration date. This procedure 

may permit the marketing of a generic product promptly after the patent expires. Generic 

competition may in turn lead to lower prices and, as a result, improved affordability of 

drugs. Some countries have adopted a Bolar-type exception while simultaneously extending 

pharmaceutical patent terms by way of supplementary protection certificates (SPC) or the like 

to account for the long time needed to obtain regulatory approval. The scope of the Bolar 

exemption, however, differs among various jurisdictions. 

19) A further possibility of improving access to pharmaceuticals would be to admit parallel imports 

of a patented medicine from a country where it is sold by the patentee or with his consent at a 

lower price. Parallel importing is seen as one of the measures that member countries may take 

to protect public health under Article 8 (1) TRIPS. For instance, in South Africa the medicines 

law (The Medicines and Related Substances Act, 1965) and not the patent law provides for 

a parallel import exception but limited to medicines (and subject to the prior decision of the 

Ministry of Health). However, the doctrine of international exhaustion - the underlying concept 

for allowing parallel imports - remains controversial as far as patents are concerned. 

20) Some patent laws exempt from the effects of the patentee’s exclusive rights, medicines 

prepared for an individual case in a pharmacy or by a medical professional. This exception 

may also contribute to access to medicines in case of medical crises. 

21) Under the law of most jurisdictions methods of medical treatment are not patentable subject 

matter. If methods of medical treatment are patentable, issues of access to such medical 

treatment methods may arise. In other words, if methods of medical treatment are patentable, 

patent law may provide for a medical treatment defence or similar exception to the patentee’s 

exclusive rights to ensure access to medical treatment, notably in the context of public health 

crises. 

22) Compulsory licensing allows a government to licence to a company or other party the right 

to use a patented invention without the patent owner’s consent. The issuing of compulsory 

licences is seen by some as a crucial element in promoting access to medicines, diagnostics 

and the like, notably in developing countries. Most countries make available some form of 

compulsory licensing. Article 31 TRIPS specifically allows WTO members to grant compulsory 

licenses on grounds to be determined by each member. Compulsory licences are generally 

available for lack or insufficiency of working, to remedy anti-competitive practices, for cases of 

emergency (e.g. when urgent public health needs exist for example as a result of a pandemic) 

and government use, and for other public interest grounds. In Switzerland, for instance, the 

patent law was recently amended to include compulsory licensing provisions for research 

tools and diagnostic methods in addition to the traditional compulsory licensing provisions. 

23) According to Article 31 TRIPS, the conditions to be met should a compulsory license be 

granted include: the requirement that a licence be voluntarily requested before being granted 

on compulsory term, non-exclusivity, and an adequate remuneration to the patent owner. 

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The requirement that a licence be voluntarily requested before being granted on compulsory 

term may be waived in the case of a national emergency or other circumstances of extreme 

urgency. 

24) Article 31 (f) TRIPS provides that compulsory licences must be granted predominantly to supply 

the domestic market. The 2001 Doha Ministerial Conference decided that this should be 

changed so that countries unable to manufacture the pharmaceuticals could obtain cheaper 

copies elsewhere if necessary. The 2005 Hong Kong Ministerial Conference adopted new 

Article 31bis TRIPS making permanent the Doha decision of August 30, 2003 by setting aside 

Article 31 (f) TRIPS in the pharmaceutical sector. The TRIPS amendment will become effective 

when two thirds of the WTO’s members have ratified the change. In the interim, the decision 

of August 30, 2003 remains applicable. As per September 2007, ten WTO members have 

accepted the protocol amending the TRIPS agreement. In July 2007, Rwanda notified its 

decision to import a generic AIDS/HIV product from the Canadian manufacturer Apotex, Inc. 

and to renounce from enforcing patent rights that may have been granted within Rwanda’s 

territory with respect to the original product. The Commissioner of Patents in Canada has in 

the meantime granted a compulsory licence to Apotex, Inc. 

25) Despite the provisions for compulsory licences in many national laws, relatively few compulsory 

licenses have actually been granted. The practical value of the existence of compulsory 

license provisions is that the threat of it usually induces the grant of contractual licenses 

on reasonable terms. This is, however, not always the case. The Brazilian and Thailand 

governments recently issued compulsory licences to patents of Merck & Co., Inc. relating to 

the anti-retroviral drug Efavirenz for the treatment of HIV/AIDS after negotiations between 

Merck and the government had failed. In 2006 the Italian Competition Authority granted a 

compulsory licence to GSK’s patents relating to Sumatriptan succinate, used in the production 

of powerful migraine medicines, to a local chemical company after GSK had refused to grant 

a voluntary licence. 

26) In some countries, such as the UK, crown use is a further exemption from the exclusive rights 

of patentees. The British government may make or sanction use of a patented invention 

without previous licence, subject only to an obligation to pay compensation for doing so. The 

exemption covers for example the supply of scheduled drugs in the Health Service. 

27) In some countries, such as South Africa, Competition Authorities have relied on competition 

law principles to require some patentees of medical products to grant licences to competitors, 

including to generic manufacturers. 

28) Finally, some countries such as Switzerland even allow the government to expropriate a 

patent – as a whole or in part – for reasons of public interest, subject to an obligation to pay 

compensation for doing so. 

Questions 

I) Analysis of current law and case law 

The Groups are invited to answer the following questions under their national laws: 

1) Is a research or experimental use exception recognised under your patent law? If so, under 

which conditions? What is the scope of the research exception? Specifically, is research or 

experimental use permitted for commercial purposes? 

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2) Is a Bolar-type exception recognised under your patent law? If so, under which conditions? 

What is the scope of the Bolar exception? Specifically, is it limited to drugs or does it also 

apply to other products, including biological products, research tools, etc.? If your patent law 

does not provide for a Bolar exception, will using an invention without the patentee’s consent 

for the purpose of obtaining approval of a generic product be covered by the research 

exception? 

3) Are parallel imports of patented medicines, medical devices or similar permitted? If so, under 

which conditions? Do the same principles apply if the products originate from markets where 

they were made available under a compulsory license? 

4) Is an individual prescriptions exception recognised under your patent law? If so, under which 

conditions? 

5) Please answer this question only if in your country methods of medical treatment are patentable 

subject matter: Does your patent law provide for a medical treatment defence or similar 

exception to the patentee’s exclusive rights? 

6) Are compulsory licenses available under your patent law? If so, under which conditions and 

on which grounds (e.g. to remedy anticompetitive conduct, for cases of emergency, other 

public interest grounds, etc.)? Are you aware of any compulsory licenses granted in your 

country for the domestic manufacture and supply of pharmaceutical products? If so, please 

provide details, including the name of the licensor, the licensee and the product covered. 

7) Has new Article 31bis TRIPS been ratified in your country? Are you aware of any other 

legislative amendment in your country with a view to implementing the WTO decision of 

August 30, 2003? Are you aware of any compulsory licenses granted in your country for the 

importation or exportation of pharmaceutical products? If so, please provide details, including 

the name of the licensor, the licensee and the product, if they are publicly available. 

8) Is the government allowed to make use of a patented invention without previous license and 

if so, on what basis (e.g. crown use) and under which conditions? 

9) Is the government allowed to expropriate a patent and, if so, under which conditions? 

10) If your patent law recognises other means of facilitating access to medicines, medical devices, 

diagnostics and the like, notably in the context of public health crises (including, among 

others, information tools such as the Orange Book providing timely consumer information on 

generic drug approvals), which have not been discussed above, please explain. 

II) Proposals for adoption of uniform rules 

The Groups are invited to put forward proposals for adoption of uniform rules regarding 

health-sensitive limitations of patent rights with a view to protecting public health. More 

specifically, the Groups are invited to answer the following questions: 

1) Should patent law provide for 

– research and experimental use exception; 

– Bolar exception; 

– parallel import of patented medicines; 

– individual prescriptions exception; 

– medical treatment defence; 

– compulsory licensing; 

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– expropriation; 

– any other limitations of the exclusive patent rights to facilitate access to medicines, 

diagnostics, medical devices and the like? 

If so, under what circumstances? If not, why not? 

2) Do you see other ways than by limitations of patent rights in which patent law might facilitate 

access to medicines, diagnostics, medical devices and the like? 

3) Should any of the limitations of patent rights, specifically the research and experimental use 

exception, Bolar exception, and individual prescriptions exception be harmonised? If so, 

how? If not, why not? 

National Groups are invited to comment on any additional issue concerning the impact of public 

health issues on the patentee’s exclusive rights which they find relevant. 

Note: 

It will be helpful and appreciated if the Groups follow the order of the questions in their Reports and 

use the questions and numbers for each answer. 

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Orientation de Travail* 

par Jochen E. BüHLING, Rapporteur général 

Dariusz SZLEPER et Thierry CALAME, Suppléants du Rapporteur général 

Nicolai LINDGREEN, Nicola DAGG et Shoichi OKUYAMA 

Assistants du Rapporteur général 

Question Q202 

L’influence des questions de santé publique 

sur les droits exclusifs de brevet 

Introduction 

1) La protection de la santé publique est l’une des questions importantes du monde actuel. Le 

système des brevets a été conçu afin de promouvoir l’innovation scientifique et technologique 

et, en conséquence, a contribué à d’importantes améliorations dans la manière d’aborder 

les conditions de santé, comme le démontrent les nombreux médicaments inventés et mis 

sur le marché. Le système des brevets a également apporté une contribution à la santé 

publique et à la société dans son ensemble en rendant accessible l’information relative au 

brevet, information disponible gratuitement pour les autres chercheurs, ceci afin d’améliorer 

les technologies et produits existants. Malgré les objectifs de politique publique inhérents au 

système des brevets, la relation entre les brevets et la santé publique a fait l’objet de débats. 

Certains considèrent que le système des brevets actuel n’aborde pas de façon adéquate les 

questions de santé publique. Plus spécifiquement, certaines inquiétudes ont été formulées 

quant à la possible incidence des brevets sur l’accès aux médicaments, diagnostics, appareils 

médicaux et traitements médicaux au regard de probables pandémies futures telles que le 

VIH/SIDA, le SRAS ou la grippe aviaire. 

2) L’accès à des médicaments, diagnostics ou autres, brevetés, est un problème complexe sur 

lequel différents facteurs, tels que l’évaluation des prix, la disponibilité, le stock et la vitesse 

de fabrication et d’approvisionnement, peuvent avoir un effet. La nature exclusive des droits 

de brevet résulte, en cas de non autorisation émanant du titulaire du brevet, en l’exclusion des 

tiers de toute fabrication ou offre de vente des produits entrant dans le champ dudit brevet. 

A titre d’exemple, si le breveté venait à manquer de capacités suffisantes de fabrication ou 

qu’il décidait de maintenir des prix élevés, ceci pourrait entraîner une insuffisance dans 

l’approvisionnement adéquat de médicaments capables de traiter des maladies épidémiques. 

Par exemple, dans les récents cas de crises de maladie du charbon (anthrax) aux Etats-Unis, 

certaines voix exprimèrent leur inquiétude que l’entreprise pharmaceutique allemande Bayer 

ne soit pas capable de satisfaire à toutes les demandes relatives à son médicament antimaladie 

du charbon Ciprobay, et que de plus, elle n’accepte pas de le fournir à un prix 

abordable. 

3) En général, le développement de nouveaux médicaments et de nouveaux appareils médicaux 

requiert un investissement substantiel ainsi qu’une recherche à long terme, auxquels s’ajoutent 

d’onéreux essais cliniques et procédures d’approbation réglementaire. Le droit exclusif conféré 

par un brevet constitue l’un des encouragements poussant les entreprises pharmaceutiques à 

nécessairement investir dans cette recherche. Afin d’assurer l’accès des tiers aux technologies 

brevetées, le système des brevets est principalement basé sur un mécanisme de licence 

* Traduit par Michel MONCHENY (Cabinet Lavoix, FRANCE) 

019-026_WG_Q202_FR.indd 19 17.07.2009 09:34:16 

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volontaire. Si le titulaire du brevet n’est pas d’accord pour ou n’est pas capable d’autoriser 

l’accès, cela s’avère problématique. Le système des brevets, cependant, prévoit un grand 

nombre de limitations aux droits exclusifs du brevet, telles que, par exemple, les dispositions 

relatives au recours à des licences obligatoires dans certaines circonstances, la reconnaissance 

par certains pays de la légalité des importations parallèles de médicaments brevetés ou- dans 

l’optique de fournir un accès à long terme - l’exception de recherche et l’exception Bolar. 

4) Le but de cette question est d’analyser les législations et jurisprudences nationales et 

internationales relatives aux limitations susceptibles de jouer un rôle dans l’accès aux 

médicaments brevetés et autres produits médicaux ou biologiques, de manière à faciliter 

les soins médicaux, notamment en cas de crises de santé publique telles que celles qui 

peuvent se produire dans tout pays, dans les pays développés, mais aussi celles qui 

touchent actuellement les pays en voie de développement et les pays moins développés. 

Cette question traitera uniquement des limitations à la nature exclusive des brevets. Elle ne 

touchera pas aux questions de brevetabilité, telle que l’exclusion de sujets brevetables pour 

des raisons de politique publique ou de moralité. De plus, bien que certains aspects du 

droit des marques, du droit de la concurrence et du droit de la santé puissent également 

s’avérer pertinents dans le contexte des crises de santé publique, cette question ne concerne 

que les brevets. Finalement, cette question n’est pas particulièrement singulière et se réfère 

aux problèmes d’accès aux médicaments dans les pays en voie de développement et dans 

les pays moins développés. Alors que l’accès aux médicaments à un prix abordable 

est indubitablement une question importante et également pertinente dans le contexte de 

cette question, ce problème n’est pas le cœur de la question Q202. Cette question préfère 

s’intéresser aux limitations apportées à la protection par brevet applicable aux médicaments 

et autres produits médicaux d’un point de vue général, notamment en cas de crises de santé 

publique, sans se focaliser particulièrement sur les pays en voie de développement et pays 

moins développés. Il est à considérer que dans le cas des pays en voie de développement 

et pays moins développés, d’autres facteurs, tels que des insuffisances dans les politiques de 

soins médicaux et dans les infrastructures de santé, peuvent jouer un rôle parfois encore plus 

important dans l’échec de la distribution de médicaments à ceux qui en ont besoin. 

Travail précédent de l’AIPPI 

5) AIPPI a étudié dans des questions préalables les limitations de santé publique à l’exclusivité 

conférée au breveté. 

6) Déjà au Congrès de Washington en 1956, l’AIPPI a étudié les restrictions apportées aux 

droits du breveté pour des raisons d’intérêt général dans le contexte de l’Article 5 (A) de la 

Convention de Paris. Dans la résolution Q3, l’AIPPI a adopté pour principe que les mesures, 

autres que les licences obligatoires, restreignant les droits du breveté ne devraient être admises 

que dans les cas où les exigences impérieuses de l’intérêt général n’étaient pas satisfaites 

par l’octroi d’une licence obligatoire. Le Congrès a par la suite préconisé que l’exécution de 

licences obligatoires et mesures similaires donnent lieu à un dédommagement équitable pour 

le breveté. Ces principes ont été confirmés lors des assemblées suivantes constatant que toute 

restriction à l’exclusivité conférée au breveté affaiblirait le succès du système des brevets en 

tant que moyen d’encouragement de l’innovation et, en conséquence, serait préjudiciable à 

l’intérêt général du public. 

7) En 1966, le Congrès de Tokyo a adopté la résolution Q39 (Motifs pour lesquels les droits 

du breveté peuvent être restreints) qui mentionne à titre de motifs pour réduire les droits du 

breveté: l’abus découlant de l’usage des droits exclusifs de brevet, les brevets dépendants, 

les échecs de travail ou les exploitations insuffisantes (tous deux sujets à des dispositions plus 

rigoureuses). La résolution Q39 spécifie de plus qu’une licence obligatoire ne doit pas être 

accordée avant que tout accord n’ait été reconnu impossible. 

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8) Dans la résolution Q101 (Importation Parallèle de Produits Brevetés) adoptées par le Comité 

exécutif à Barcelone en 1990, l’AIPPI a adopté la résolution qu’un breveté devrait être capable 

d’invoquer son brevet pour s’opposer à l’importation parallèle d’un produit breveté. Cette 

résolution a été confirmée dans la résolution Q156 (L’épuisement International des Droits de 

Propriété Industrielle) adoptée au Congrès de Melbourne en 2001. La résolution Q156 rejette 

la notion d’épuisement international des droits et constate qu’il ne doit y avoir en aucun cas 

d’épuisement international ou régional des droits d’un IPR lorsqu’un produit a été mis sur le 

marché suite à une licence obligatoire. 

9) Le Comité exécutif de Tokyo en 1992 a adopté la résolution Q105 relative au recours à 

l’utilisation expérimentale comme moyen de défense à une réclamation pour atteinte à un brevet. 

La résolution de l’AIPPI est favorable à l’utilisation expérimentale d’une invention brevetée à 

des fins académiques, y compris à l’essai de l’invention afin d’évaluer l’enseignement et 

la validité du brevet, mais à des fins non commerciales. La résolution Q105 considère que 

l’utilisation de l’invention au cours de la durée de vie du brevet dans le but d’obtenir une 

autorisation réglementaire (de telles utilisations sont aujourd’hui exemptées par l’exception 

Bolar, quand elle est applicable) ne constitue pas une utilisation expérimentale. 

10) Au Congrès de Montréal en 1995, l’AIPPI a adopté la résolution que les dispositions 

relatives aux licences obligatoires devraient également s’appliquer aux brevets relatifs à 

l’environnement. (Q128 – Brevets et Protection de l’Environnement). De même, la résolution 

Q150 (Conditions de brevetabilité et champ de protection des Expressed Sequence Tags 

(ESTs), Single Nucleotide Polymorphims (SNPs) et de l’intégralité des génomes) adoptée par 

le Comité exécutif de Sorrento en 2000 constate que l’AIPPI n’est pas favorable au recours 

à des dispositions spéciales pour l’utilisation expérimentale ou les licences obligatoires en 

matière d’ESTs, de SNPs et d’intégralité des génomes. 

11) Le rapport Q178 (Champ de la Protection du Brevet) en 2004 constate que le traitement 

médical, les inventions pharmaceutiques et la brevetabilité des deuxièmes utilisations 

thérapeutiques conduisent inévitablement à des questions d’accessibilité des nouveaux 

médicaments et à s’interroger sur la manière dont les docteurs peuvent éviter les infractions 

au brevet dans les situations d’urgence. Le rapport mentionne la possibilité d’émettre des 

licences obligatoires pour de tels brevets. 

12) Le rapport Q187 (Limitations apportées par le droit de la concurrence à l’exclusivité des PI) 

en 2005 confirme que tous les pays rapporteurs prévoient des exceptions à l’exclusivité du 

breveté, notamment par la possibilité d’accorder des licences obligatoires (aux Etats-Unis, elles 

ne peuvent être en rapport qu’avec l’énergie nucléaire et l’environnement). Dans leurs rapports 

des groupes, certains groupes ont constaté la nature exceptionnelle des dispositions relatives 

aux licences obligatoires et le fait qu’en pratique, elles soient très rarement appliquées, mais 

ils ont également souligné le fait que leur simple existence amènerait les brevetés à négocier 

des accords à des conditions plus avantageuses pour les futurs licenciés. Le rapport Q187 

constate, de plus, que certains pays rapporteurs prévoient des exceptions relatives aux essais 

et expériences. Alors que les rapports des groupes Q187 touchent à des problèmes qui 

sont également pertinents dans le contexte de cette question, ils ne peuvent être considérés 

comme constitutifs d’une analyse complète des licences obligatoires et exception d’utilisation 

expérimentale. 

13) La Comité spécial Q94 (GATT/WTO) qui contrôle et conseille en matière de développements 

des Accords du GATT/WTO TRIPS a émis un rapport sur les questions de santé publique 

dans le contexte du TRIPS, notamment sur la décision du 30 Août 2003, sous le paragraphe 

6 de la déclaration Doha sur l’Accord TRIPS et Santé Publique et le nouvel article 31bis TRIPS 

autorisant les génériques de produits pharmaceutiques créés sous licence obligatoire en 

019-026_WG_Q202_FR.indd 21 17.07.2009 09:34:16 

21

vue d’être exportés vers les pays (en voie de développement) en manque de capacité de 

production dans le secteur pharmaceutique. 

Discussion 

14) Les Etats membres du WTO conservent un haut niveau de flexibilité dans la résolution des 

problèmes de santé publique. 

15) Selon l’article 8 (1), les membres du TRIPS peuvent adopter les mesures nécessaires afin de 

protéger la santé publique et la nutrition, et de promouvoir l’intérêt général dans les secteurs 

d’une importance vitale à leur développement, sous réserve que de telles mesures soient en 

accord avec les dispositions de cet Accord. L’article 8 (2) TRIPS constate que les mesures 

appropriées peuvent s’avérer nécessaires à l’empêchement d’abus dans l’exercice des droits 

de propriété intellectuelle par le titulaire des droits ou de recours à des pratiques restreignant 

le commerce d’une manière déraisonnable ou ayant des incidences défavorables sur le 

transfert international de technologie. 

16) Selon l’article 30 TRIPS, les membres peuvent prévoir des exceptions limitées à l’exclusivité 

conférée par un brevet, dans la mesure où de telles exceptions n’entrent pas déraisonnablement 

en conflit avec une exploitation normale du brevet et ne portent pas un préjudice injustifié 

aux intérêts légitimes du titulaire du brevet, tout en tenant compte des intérêts légitimes des 

tiers. L’Article 30 TRIPS laisse aux états membres du WTO une considérable liberté dans la 

définition de la nature et de l’étendue des exceptions à l’exclusivité des titulaires de brevet. 

Il existe plusieurs types d’exceptions qui peuvent être prévues dans le champ de l’article 30 

TRIPS et, en même temps, qui s’avèrent pertinentes en relation avec les questions de santé 

publique. 

17) Par exemple, une exception de recherche et d’utilisation expérimentale permet l’utilisation 

d’inventions pharmaceutiques sans dédommagement pour le titulaire lorsque le produit est 

utilisé à des fins de recherche et d’expérimentation. L’application de l’exception de recherche 

peut favoriser l’accès à des médicaments dans la mesure où cela peut amener, à long terme, 

des produits perfectionnés. Alors que l’exception de recherche est plutôt étroite aux Etats- 

Unis, de nombreux pays (notamment en Europe) autorisent explicitement la recherche sur 

une invention à des fins scientifiques et dans une certaine mesure même à des fins à la fois 

scientifiques et commerciales, sans le consentement du titulaire du brevet. 

18) Une autre exception spécifiquement applicable aux brevets pharmaceutiques est l’exception 

Bolar. Cette exception est relative à l’utilisation d’une invention sans le consentement du 

breveté aux fins d’obtenir une autorisation pour le produit générique avant la date d’expiration 

du brevet. Cette procédure peut permettre la commercialisation du produit générique aussitôt 

après l’expiration du brevet. La concurrence des génériques peut à son tour conduire à des 

prix plus bas et, par conséquent, à rendre plus abordable les médicaments. Certains pays ont 

adopté une exception du type Bolar tout en allongeant la durée du brevet pharmaceutique 

par le biais de certificats complémentaires de protection (CCP) ou autres afin de justifier 

de la longue durée requise pour l’obtention d’une autorisation réglementaire. La portée de 

l’exemption Bolar, cependant, diffère selon les juridictions. 

19) Une autre possibilité afin d’améliorer l’accès aux produits pharmaceutiques serait d’autoriser 

les importations parallèles d’un médicament breveté en provenance d’un pays où il serait 

vendu par le breveté ou bien avec son autorisation à un prix plus bas. Selon l’article 8 (1) 

TRIPS, l’importation parallèle est considérée comme l’une des mesures que les pays membres 

peuvent prendre afin de protéger la santé publique. Par exemple, en Afrique du Sud, c’est 

la loi sur les médicaments (Acte sur les Médicaments et Substances Apparentées, 1965) et 

non pas le droit des brevets qui prévoit une exception d’importation parallèle, mais qui reste 

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limitée aux médicaments (et soumise à une décision préalable du Ministère de la Santé). 

Cependant, la doctrine de l’épuisement international des droits – concept sous-jacent afin 

d’autoriser les importations parallèles – reste controversée en ce qui concerne les brevets. 

20) Certaines lois sur les brevets exemptent des effets des droits exclusifs conférés au breveté 

les médicaments préparés à titre individuel dans une pharmacie ou par un professionnel 

médical. Cette exception peut également favoriser l’accès aux médicaments en cas de crises 

médicales. 

21) Conformément aux lois de la plupart des juridictions, les méthodes de traitement médical ne 

sont pas brevetables. Si les méthodes de traitement médical étaient brevetables, les problèmes 

d’accès à de telles méthodes de traitement médical augmenteraient. En d’autres termes, 

si les méthodes de traitement médical s’avéraient brevetables, le droit des brevets devrait 

prévoir une défense pour les traitements médicaux ou une exception similaire à l’exclusivité 

du breveté afin d’assurer l’accès au traitement médical, notamment en cas de crises de santé 

publique. 

22) La licence obligatoire permet à un gouvernement d’octroyer par licence à une entreprise ou 

à un tiers le droit d’utiliser une invention brevetée sans le consentement du titulaire du brevet. 

L’octroi de licences obligatoires est considéré comme un élément crucial dans la promotion 

de l’accès aux médicaments, aux diagnostics et autres, notamment dans les pays en voie de 

développement. La plupart des pays rend disponible un certain type de licence obligatoire. 

L’article 31 TRIPS autorise spécifiquement les membres du WTO à accorder des licences 

obligatoires à des conditions qui doivent être déterminées par chacun des membres. Les 

licences obligatoires sont généralement mises à disposition pour manque ou insuffisance 

d’exploitation, pour remédier aux pratiques anticoncurrentielles, en cas d’urgence (ex. lorsque 

des besoins urgents de santé publique existent, par exemple suite à une pandémie), pour une 

utilisation gouvernementale, ainsi que pour d’autres fondements d’intérêt public. En Suisse, 

par exemple, le droit des brevets a récemment été modifié afin d’inclure les dispositions 

relatives aux licences obligatoires pour les outils de recherche et méthode de diagnostic qui 

viennent s’ajouter aux dispositions traditionnelles relatives aux licences obligatoires. 

23) Selon l’Article 31 TRIPS, les conditions nécessaires à l’octroi d’une licence obligatoire 

incluent: l’exigence qu’une licence soit demandée volontairement avant d’être accordée à 

titre obligatoire, sans exclusivité, et qu’une rémunération adéquate soit versée au titulaire du 

brevet. On peut renoncer à l’exigence que la licence soit demandée volontairement avant 

d’être accordée à titre obligatoire en cas d’urgence nationale ou dans d’autres circonstances 

d’extrême urgence. 

24) L’article 31 (f) TRIPS prévoit que les licences obligatoires doivent être octroyées principalement 

afin d’approvisionner le marché intérieur. La Conférence ministérielle Doha 2001 a décidé que 

ceci devait être modifié afin que les pays incapables de fabriquer les produits pharmaceutiques 

puissent en obtenir ailleurs des copies moins chères si nécessaire. La Conférence ministérielle 

d’Hong Kong 2005 a adopté le nouvel article 31 (f) TRIPS en rendant permanente la décision 

Doha du 30 Août 2003, en réservant l’article 31 (f) TRIPS au secteur pharmaceutique. 

L’amendement TRIPS deviendra effectif lorsque deux tiers des membres du WTO auront ratifié 

le changement. Entre-temps, la décision du 30 Août 2003 reste applicable. En Septembre 

2007, 10 membres WTO avaient accepté le protocole modifiant l’accord TRIPS. En juillet 

2007, le Rwanda a informé de sa décision d’importer un produit générique du produit SIDA/ 

HIV du fabricant canadien Apotex, Inc. et de renoncer au respect dû aux droits accordés par 

les brevets à l’intérieur du territoire rwandais par rapport au produit d’origine. Le Commissaire 

aux Brevets canadien a dans le même temps accordé une licence obligatoire à Apotex, Inc. 

019-026_WG_Q202_FR.indd 23 17.07.2009 09:34:17 

23

25) Malgré les dispositions relatives aux licences obligatoires dans beaucoup de droits nationaux, 

relativement peu de licences obligatoires ont en fait été accordées. La valeur pratique de 

l’existence de dispositions relatives aux licences obligatoires est que la menace perpétrée 

par elles entraîne souvent l’octroi de licences contractuelles en des termes raisonnables. 

Ceci, cependant, n’est pas toujours le cas. Les gouvernements brésilien et thaïlandais ont 

récemment octroyé des licences obligatoires sur les brevets Merck and Co., Inc. relatifs à une 

médicament antirétroviral Efavirenz pour le traitement du VIH/SIDA après que les négociations 

entre Merck et le gouvernement aient échoué. En 2006, l’autorité de concurrence italienne 

a accordé une licence obligatoire sur les brevets GSK relatifs au succinate de Sumatriptan, 

utilisé dans la production de médicaments pour les fortes migraines, à une entreprise de 

chimie locale après que GSK ait refusé d’accorder une licence volontaire. 

26) Dans certains pays, tels que le Royaume-Uni, la Couronne utilise une autre exemption à 

l’exclusivité des brevetés. Le gouvernement britannique peut procéder à ou autoriser l’utilisation, 

sans licence préalable, d’une invention brevetée, sous réserve de payer un dédommagement 

pour un tel usage. Cette exemption touche par exemple l’approvisionnement de médicaments 

prévus dans le Service de Santé. 

27) Dans certains pays, tel que l’Afrique du Sud, les autorités de concurrence se sont appuyées 

sur des principes de droit de la concurrence afin d’exiger de certains détenteurs de brevets 

sur des produits pharmaceutiques qu’ils accordent des licences à leurs concurrents, y compris 

aux fabricants de génériques. 

28) Finalement, certains pays, tels que la Suisse, autorisent même le gouvernement à exproprier 

un brevet – en tout ou en partie- pour des raisons d’intérêt général, sous réserve d’une 

obligation de payer un dédommagement pour un tel acte. 

Questions 

I) Analyse de la loi et de la jurisprudence actuelle 

Les Groupes sont invités à répondre aux questions suivantes conformément à leurs droits 

nationaux: 

1) Votre droit des brevets prévoit-il une exception d’utilisation à des fins de recherche ou 

d’expérimentation? Si oui, à quelles conditions? Quelle est la portée de l’exception 

de recherche? Plus particulièrement, est-ce que l’utilisation à des fins de recherche et 

d’expérimentation permet de poursuivre un but commercial? 

2) Votre droit des brevets prévoit-il une exception du type Bolar? Si oui, à quelles conditions? 

Quelle est la portée de l’exception Bolar? Spécifiquement, est-elle limitée aux médicaments 

ou s’applique-t-elle à d’autres produits, y compris aux produits biologiques, aux outils de 

recherche, etc? Si votre droit des brevets ne prévoit pas d’exception Bolar, est –ce que le 

fait d’utiliser une invention sans le consentement du breveté en vue d’obtenir une autorisation 

pour un produit générique serait couvert par l’exception de recherche? 

3) Les importations parallèles de médicaments, d’appareils médicaux ou autres sont-elles 

permises? Si oui, à quelles conditions? Est-ce que ces mêmes principes s’appliquent 

si les produits sont originaires de marchés où ils ont été rendus disponibles par licence 

obligatoire? 

4) Votre droit des brevets prévoit-il une exception de prescriptions individuelles? Si oui, à quelles 

conditions? 

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5) Prière de ne répondre à cette question que si dans votre pays les méthodes de traitement 

médical sont brevetables: votre droit des brevets prévoit-il une défense pour les traitements 

médicaux ou une exception similaire aux droits exclusifs du breveté? 

6) Les licences obligatoires sont-elles disponibles dans votre droit? Si oui, à quelles conditions 

et sur quels fondements (ex afin de remédier à des conduites anticoncurrentielles, en cas 

d’urgence, ou sur d’autres fondements d’intérêt général, etc.)? Avez-vous connaissance 

d’autres licences obligatoires octroyées dans votre pays pour les fabrications nationales et 

l’approvisionnement de produits pharmaceutiques? Si oui, prière de détailler, en incluant le 

nom du donneur de licence, du licencié et du produit couvert. 

7) L’article 31 bis TRIPS a-t-il été ratifié dans votre pays? Avez-vous connaissance de tout autre 

amendement législatif dans votre pays réalisé en vue d’appliquer la décision WTO du 30 

août 2003? Avez-vous connaissance d’une quelconque licence obligatoire accordée dans 

votre pays pour l’importation ou l’exportation de produits pharmaceutiques? Si oui, prière de 

détailler, en incluant, si publiquement disponibles, le nom du donneur de licence, du licencié 

et du produit. 

8) Votre gouvernement est-il autorisé à faire utiliser une invention brevetée sans licence préalable 

et si oui, sur quels fondements (ex. utilisation par la Couronne) et à quelles conditions? 

9) Votre gouvernement est-il autorisé à exproprier un brevet et, si oui, à quelles conditions? 

10) Si votre droit des brevets prévoit d’autres moyens pour faciliter l’accès aux médicaments, 

appareils médicaux, diagnostics et autres, notamment en cas de crises de santé publique 

(y compris, entre autres, des outils d’information tels que le Livre Orange fournissant dans 

les délais une information de consommateurs sur les autorisations de mise sur le marché de 

médicaments génériques) qui n’a pas été abordée ci-dessus, prière d’expliciter. 

II) Proposition pour l’adoption de règles uniformes 

Les Groupes sont invités à émettre des propositions pour l’adoption de règles uniformes relatives 

aux limitations à l’exclusivité en vue de protéger la santé publique. Plus spécifiquement, les 

Groupes sont invités à répondre aux questions suivantes: 

1) Le droit des brevets doit-il prévoir: 

– une exception d’utilisation de recherche et d’expérimentation; 

– une exception Bolar; 

– une importation parallèle de médicaments brevetés; 

– une exception de prescription individuelle; 

– une défense de traitement médical; 

– une licence obligatoire; 

– une expropriation; 

– toute autre limitation à l’exclusivité du brevet afin de faciliter l’accès à des médicaments, 

diagnostics, appareils médicaux et autres? 

Si oui, en quelles circonstances? Si non, pourquoi? 

2) Voyez-vous d’autres moyens que les limitations à l’exclusivité pour que le droit des brevets 

puisse faciliter l’accès aux médicaments, aux diagnostics, aux appareils médicaux et 

autres? 

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25

3) Les limitations à l’exclusivité, particulièrement l’exception d’utilisation à des fins de recherche 

et d’expérimentation, l’exception Bolar, et les exceptions de prescription individuelle doiventelles 

être harmonisées? Si oui, comment? Si non, pourquoi? 

Les Groupes Nationaux sont invités à commenter tout problème additionnel concernant l’impact 

des questions de santé publique sur l’exclusivité du breveté qui pourrait s’avérer pertinent. 

Note: 

Il serait utile et appréciable que les Groupes suivent l’ordre des questions dans leur Rapports et 

reportent la question et son numéro pour chaque réponse. 

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Arbeitsrichtlinien* 

von Jochen E. BüHLING, Generalberichterstatter 

Dariusz SZLEPER und Thierry CALAME, Stellvertreter des Generalberichterstatters 

Nicolai LINDGREEN, Nicola DAGG und Shoichi OKUYAMA 

Assistenten des Generalberichterstatters 

Frage Q202 

Der Einfluss von Themen der öffentlichen Gesundheitspflege 

auf exklusive Patentrechte 

Einleitung 

1) Der Schutz der öffentlichen Gesundheitspflege ist eines der dringendsten Themen in der 

heutigen Welt. Das Patentsystem ist konzipiert, wissenschaftliche und technologische 

Innovation zu fördern, und hat als Folge zu signifikanten Verbesserungen bei der Behandlung 

von Gesundheitszuständen beigetragen, wie durch viele Arzneimittel bewiesen, welche 

erfunden und auf den Markt gebracht wurden. Das Patentsystem trägt ebenfalls zur 

öffentlichen Gesundheitspflege und Gesellschaft insgesamt bei, indem es Patentinformationen 

verfügbar macht, welche für andere Forscher frei verfügbar sind, um bestehende Technologien 

und Produkte weiter zu verbessern. Trotz der im Patentsystem innewohnenden Ziele der 

öffentlichen Ordnung ist die Beziehung zwischen Patenten und öffentlicher Gesundheitspflege 

Diskussionsgegenstand gewesen. Einige sind der Ansicht, dass das gegenwärtige Patentsystem 

sich Themen der öffentlichen Gesundheitspflege nicht angemessen widmet. Insbesondere 

hat es Bedenken gegeben, wie Patente Zugang zu Arzneien, Diagnostik, medizinischen 

Vorrichtungen und medizinischer Behandlung im Hinblick auf mögliche zukünftige Pandemien 

wie HIV/AIDS, SARS oder Vogelgrippe beeinträchtigen können. 

2) Zugang zu patentierten Arzneien, Diagnostik und Ähnlichem ist ein komplexes Thema 

und kann durch unterschiedliche Faktoren wie Preisgestaltung, Verfügbarkeit, Bestand und 

Schnelligkeit der Herstellung und Bereitstellung beeinflusst sein. Die ausschliessende Natur 

von Patentrechten hat die Wirkung, dass Dritte ohne die Befugnis des Patentinhabers von 

Herstellung oder Verkaufsangebot von Produkten ausgeschlossen sind, welche durch den 

Umfang der Patente abgedeckt sind. Als Beispiel kann dies einen Bereitstellungsengpass 

für Arzneien ergeben, welche pandemische Krankheiten behandeln können, falls es dem 

Patentinhaber an ausreichenden Herstellungskapazitäten mangelt oder er hohe Preisgestaltung 

beibehält. Zum Beispiel erhoben im kürzlichen Fall von Anthrax-Angriffen in den Vereinigten 

Staaten einige Stimmen Bedenken, dass die deutsche pharmazeutische Firma Bayer nicht in 

der Lage wäre, alle Nachfragen nach seiner Anthrax-Arznei Ciprobay zu befriedigen und 

darüber hinaus nicht Willens wäre, sie zu erschwinglichen Preisen bereitzustellen. 

3) Im Allgemeinen erfordert die Entwicklung neuer Arzneien und medizinischer Vorrichtungen 

wesentliche Investitionen und langfristige Forschung, verbunden mit teuren klinischen 

Erprobungen und behördlichen Genehmigungsverfahren. Das durch ein Patent verliehene 

Exklusivrecht ist eines der Anreize für pharmazeutische Unternehmen, die notwendigen 

Investitionen in diese Forschung zu tätigen. Um Dritten den Zugaben zu patentierten 

Technologien sicherzustellen, basiert das Patentsystem primär auf einem freiwilligen 

Lizensierungsmechanismus. Falls der Patentinhaber nicht Willens oder in der Lage ist, 

Zugang zu gewähren, kann dies problematisch sein. Das Patentsystem sieht daher eine 

* Übersetzt von Peter PAWLOY (Sonn & Partner PAe., ÖSTERREICH) 

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27

Anzahl an Einschränkungen der exklusiven Patentrechte vor, wie zum Beispiel Verfügung 

von Zwangslizensierung unter bestimmten Umständen, Anerkennung der Legalität von 

Parallelimporten patentierter Arzneien durch einige Länder, oder – hinsichtlich der Gewährung 

von Zugang auf längerfristiger Basis – Forschungs- und Bolar-Ausnahmen. 

4) Der Zweck dieser Frage ist es, nationale und internationale Gesetzgebung und Fallrecht 

bezüglich der Einschränkungen zu untersuchen, welche eine Rolle beim Vorsehen von Zugang 

zu patentierten Arzneien und anderen medizinischen oder biologischen Produkten spielen 

können, um so öffentliche Gesundheitspflege zu erleichtern, insbesondere im Kontext von Krisen 

der öffentlichen Gesundheitspflege, wie jene, welche in jedem Land, auch in entwickelten 

Ländern auftreten können, aber auch jene, welche gegenwärtig einige Entwicklungsländer 

und weniger entwickelte Länder heimsuchen. Diese Frage betrifft nur Beschränkungen der 

exklusiven Natur von Patenten. Sie beschäftigt sich nicht mit Themen der Patentierbarkeit, wie 

dem Ausschluss von patentierbaren Gegenständen aus Gründen der öffentlichen Ordnung 

oder Moral. Obwohl bestimmte Aspekte des Markenrechts, Wettbewerbsrechts und Rechts 

der medizinischen und gesundheitlichen Versorgung im Zusammenhang von Krisen der 

öffentlichen Gesundheitspflege ebenfalls relevant sein können, richtet sich diese Frage nur 

an Patente. Schliesslich sondert diese Frage nicht spezifisch das Thema des Zugangs zu 

Arzneien in Entwicklungsländern oder weniger entwickelten Ländern aus oder bezieht sich 

darauf. Während Zugang zu erschwinglichen Arzneien ohne Zweifel ein drängendes 

Thema und im Kontext dieser Frage ebenfalls relevant ist, ist dieses Thema nicht der Kern 

dieser Frage Q202. Diese Frage betrachtet eher Beschränkungen von Patentschutz, welche 

auf Arzneien und andere medizinische Produkte auf allgemeiner Ebene anwendbar sind, 

besonders in Fällen von Krisen der öffentlichen Gesundheitspflege, ohne einen speziellen 

Fokus auf Entwicklungsländer und weniger entwickelte Länder. Es wird berücksichtigt, dass 

im Fall von Entwicklungsländern und weniger entwickelten Ländern andere Faktoren eine 

noch wichtigere Rolle dabei spielen können zu verhindern, dass Arzneien die Bedürftigen 

erreichen, wie Unzulänglichkeiten in der Gesundheitspolitik und in der Infrastruktur der 

Gesundheitsfürsorge. 

Vorherige Arbeit von AIPPI 

5) AIPPI hat gesundheitsempfindliche Einschränkungen der Exklusivrechte des Patentinhabers in 

vorhergehenden Fragen untersucht. 

6) Schon beim Kongress in Washington 1956 untersuchte AIPPI Restriktionen der Rechte des 

Patentinhabers aus Gründen des öffentlichen Interesses im Zusammenhang mit Artikel 5 (A) 

der Pariser Verbandsübereinkunft. In Entschliessung Q3 nahm AIPPI den Grundsatz an, dass 

Massnahmen, anders als Zwangslizenzen, welche die Rechte des Patentinhabers beschränken, 

nur erlaubt sein sollten, falls zwingende Erfordernisse des öffentlichen Interesses durch 

Gewähren einer Zwangslizenz nicht befriedigt werden. Der Kongress empfahl ferner, dass 

Zwangslizenzen und ähnliche Massnahmen gerechter Entschädigung für den Patentinhaber 

unterliegen sollten. Die Grundsätze wurden bei nachfolgenden Zusammenkünften bestätigt 

mit der Anmerkung, dass jede Einschränkung des Exklusivrechts des Patentinhabers den 

Erfolg des Patentsystems als ein Mittel zur Ermutigung von Erfindung beeinträchtigen würden 

und demgemäss für das allgemeine Interesse der Öffentlichkeit schädlich sei. 

7) 1966 nahm der Kongress von Tokio Entschliessung Q39 (Gründe, aus welchen die Rechte 

des Patentinhabers beschränkt werden können) an, welche als Gründe für die Beschränkung 

der Rechte des Patentinhabers nennt: Missbrauch als Folge des Ausübens der exklusiven 

Patentrechte, abhängige Patente, Funktionsversagen oder unzureichendes Funktionieren 

(welche beide strengeren Bestimmungen unterliegen). Die Resolution Q39 spezifiziert ferner, 

dass eine Zwangslizenz nicht gewährt werden darf, bis eine Übereinkunft sich als unmöglich 

erwiesen hat. 

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8) In Entschliessung Q101 (Parallelimport von patentierten Produkten), welche durch den 

geschäftsführenden Ausschuss in Barcelona 1990 angenommen wurde, beschloss AIPPI, dass 

ein Patentinhaber in der Lage sein sollte, sein Patent gegen Parallelimport eines patentierten 

Produkts anzuführen. Diese Entschliessung wurde in Entschliessung Q156 (Internationale 

Erschöpfung von gewerblichen Eigentumsrechten), angenommen beim Melbourne Kongress 

2001, bekräftigt. Entschliessung Q156 weist den Gedanken von internationaler Erschöpfung 

zurück und vermerkt, dass es auf keinen Fall internationale oder regionale Erschöpfung 

eines IPR geben sollte, wo ein Produkt unter einer Zwangslizenz auf den Markt gebracht 

worden ist. 

9) Der Geschäftsführende Ausschuss von Tokio 1992 nahm die Entschliessung Q105 

hinsichtlich Benutzung zu Versuchszwecken als Einwand gegenüber einem Anspruch wegen 

Patentverletzung an. Die AIPPI Entschliessung favorisiert das Erlauben von Benutzung zu 

Versuchszwecken einer patentierten Erfindung für akademische Zwecke, einschliesslich 

Testen der Erfindung, um die Lehre und Gültigkeit des Patents zu bewerten, aber nicht für 

kommerzielle Zwecke. Entschliessung Q105 erwägt die Verwendung der Erfindung während 

der Lebensdauer des Patents für den Zweck, behördliche Genehmigung zu erhalten (welche 

Verwendungen heutzutage durch die Bolar-Ausnahme, wo anwendbar, freigestellt sind), 

welche keine Benutzung zu Versuchszwecken ist. 

10) Beim Kongress von Montreal 1995 beschloss AIPPI, dass Zwangslizenz-Regelungen 

gleichermassen auf Patente bezogen auf die Umwelt Anwendung finden sollten 

(Q128 – Patente und der Schutz der Umwelt). Ähnlich vermerkt Entschliessung Q150 

(Patentierungsvoraussetzungen und Schutzumfang von Expressed Sequence Tags (ESTs), 

einzelner Polymorphismen von Nukleotid-Sequenzen (SNPs) und ganzer Genome), 

angenommen durch den Geschäftsführenden Ausschuss von Sorrento in 2000, dass AIPPI 

keine speziellen Regelungen für Benutzung zu Versuchszwecken oder Zwangslizenz im 

Bereich von ESTs, SNPs und ganzer Genome favorisiert. 

11) Der zusammenfassende Bericht Q178 (Umfang von Patentschutz) in 2004 vermerkt, dass 

medizinische Behandlung, pharmazeutische Erfindungen und die Patentierbarkeit zweiter 

medizinischer Verwendungsansprüche unvermeidlich zu Fragen der Zugänglichkeit zu neunen 

Arzneien führen und wie Ärzte Patentverletzung in Notfallsituationen vermeiden können. Der 

Bericht erwähnt die Möglichkeit, Zwangslizenzen für solche Patente auszugeben. 

12) Der zusammenfassende Bericht Q187 (Beschränkungen von exklusiven Rechten des geistigen 

Eigentums durch Wettbewerbsrecht) in 2005 bekräftigt, dass alle berichtenden Länder 

Ausnahmen für die exklusiven Rechte des Patentinhabers vorsehen, besonders die Möglichkeit, 

Zwangslizenzen herauszugeben (in den Vereinigten Staaten nur in Bezug auf Atomenergie und 

die Umwelt). In ihren Gruppenberichten hatten einige Gruppen die aussergewöhnliche Natur 

der Zwangslizenz-Regelungen und die Tatsache vermerkt, dass sie in der Praxis sehr selten 

implementiert wurden, aber betonten, dass allein ihre Existenz Patentinhaber dazu zwingen 

würde, Lizenzvereinbarungen unter vorteilhafteren Bedingungen für zukünftige Lizenznehmer 

zu verhandeln. Der zusammenfassende Bericht Q187 vermerkt ferner, dass einige berichtende 

Länder Ausnahmen bezogen auf Tests und Versuche vorsehen. Während die Gruppenberichte 

Q187 Themen berühren, welche im Kontext dieser Frage ebenfalls relevant sind, können sie 

nicht als umfassende Analyse von Zwangslizensierung und Ausnahmen für Benutzung zu 

Versuchszwecken angesehen werden. 

13) Sonderausschuss Q94 (GATT/WTO), welcher Entwicklungen der GATT/WTO TRIPS 

Abkommen überwacht und berät, hat von Themen der öffentlichen Gesundheitspflege 

im Kontext von TRIPS berichtet, besonders zur Entscheidung vom 30. August 2003 unter 

Absatz 6 der Doha-Erklärung zum TRIPS-Abkommen und der öffentlichen Gesundheitspflege 

unter dem neuen Artikel 31bis TRIPS, welcher erlaubt, unter Zwangslizenz hergestellte 

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29

generische Kopien von Pharmazeutika in (Eintwicklungs-) Länder zu exportieren, denen es an 

Produktionskapazität im pharmazeutischen Sektor mangelt. 

Diskussion 

14) WTO-Mitgliedsstaaten behalten einen beträchtlichen Flexibilitätsgrad beim Ansprechen von 

Themen der öffentlichen Gesundheitspflege. 

15) Gemäss Artikel 8 (1) TRIPS können Mitglieder Massnahmen ergreifen, welche notwendig sind, 

öffentliche Gesundheitspflege und Ernährung zu schützen und das öffentliche Interesse in 

Sektoren zu fördern, welche von grundlegender Wichtigkeit für ihre Entwicklung sind, mit der 

Massgabe, dass solche Massnahmen mit den Regelungen dieses Abkommens übereinstimmen. 

Artikel 8 (2) TRIPS vermerkt, dass angemessene Massnahmen benötigt werden können, um 

den Missbrauch von Rechten des geistigen Eigentums durch Rechtseigentümer oder das 

Greifen nach Praktiken verhindert, welche den Handel unverhältnismässig beschränken oder 

den internationalen Technologietransfer beeinträchtigen. 

16) Gemäss Artikel 30 TRIPS können Mitglieder begrenzte Ausnahmen zu den Exklusivrechten 

vorsehen, die durch ein Patent verliehen werden, mit der Massgabe, dass solche Ausnahmen 

nicht unverhältnismässig in Widerspruch zu einer normalen Ausbeute des Patents stehen und 

nicht unverhältnismässig die legitimen Interessen des Patentinhabers beeinträchtigen, unter 

Berücksichtigung der legitimen Interessen Dritter. Artikel 30 TRIPS lässt WTO-Mitgliedsstaaten 

beträchtliche Freiheit, die Art und das Ausmass von Ausnahmen für die Exklusivrechte von 

Patentinhabern zu definieren. Es gibt unterschiedliche Arten von Ausnahmen, die innerhalb 

des Umfangs von Artikel 30 TRIPS vorgesehen werden können und zur gleichen Zeit in 

Verbindung mit Themen der öffentlichen Gesundheitspflege relevant sind. 

17) Zum Beispiel erlaubt eine Ausnahme der Benutzung für Forschung und Versuch die Benutzung 

von pharmazeutischen Erfindungen ohne Kompensation an den Inhaber für Forschungs- und 

Versuchszwecke. Anwendung der Forschungsausnahme kann zum Zugang zu Arzneien auf 

einer längerfristigen Basis in dem Masse beitragen, dass sie zu verbesserten Produkten 

führen kann. Während die Forschungsausnahme in den Vereinigten Staaten eher eng ist, 

genehmigen viele Länder (besonders in Europa) explizit Forschung zu einer Erfindung ohne 

die Einwilligung des Patentinhabers zu wissenschaftlichen und in bestimmtem Umfang selbst 

gemischten wissenschaftlichen und kommerziellen Zwecken. 

18) Eine weitere Ausnahme, welche speziell für pharmazeutische Patente anwendbar ist, ist die 

Bolar-Ausnahme. Diese Ausnahme betrifft Verwenden einer Erfindung ohne Einverständnis des 

Patentinhabers für den Zweck, Genehmigung für ein generisches Produkt vor dem Fristablauf 

des Patents zu erhalten. Dieses Verfahren kann das Vermarkten eines generischen Produkts 

direkt nachdem das Patent abläuft erlauben. Generischer Wettbewerb kann seinerseits 

zu niedrigeren Preisen und als Folge verbesserter Erschwinglichkeit von Arzneien führen. 

Einige Länder haben eine Ausnahme vom Bolar-Typ angenommen, während sie gleichzeitig 

pharmazeutische Patentkonditionen durch ergänzende Schutzzertifikate (SPC) oder Ähnliches 

ausweiten, um die lange Zeit zu berücksichtigen, welche benötigt wird, um behördliche 

Genehmigung zu erhalten. Der Umfang der Bolar-Ausnahme unterscheidet sich jedoch 

zwischen verschiedenen Gerichtsbarkeiten. 

19) Eine weitere Möglichkeit, Zugang zu Pharmazeutika zu verbessern, wäre es, Parallelimporte 

einer patentierten Arznei aus einem Land zuzulassen, wo es durch den Patentinhaber oder 

mit seinem Einverständnis zu einem niedrigeren Preis verkauft wird. Parallelimport wird als 

eine der Massnahmen gesehen, die Mitgliedsländer ergreifen können, um die öffentliche 

Gesundheitspflege unter Artikel 8 (1) TRIPS zu schützen. Zum Beispiel sieht in Südafrika das 

Arzneimittelrecht (The Medicines and Related Substances Act, 1965) und nicht das Patentrecht 

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Parallelimport-Ausnahmen vor, jedoch begrenzt auf Arzneien (und der vorherigen Entscheidung 

des Gesundheitsministeriums unterworfen). Jedoch bleibt die Doktrin der internationalen 

Erschöpfung – dem zugrunde liegenden Konzept zum Erlauben von Parallelimporten – sofern 

es Patente betrifft kontrovers. 

20) Einige Patentrechte nehmen Arzneien von den Wirkungen der Exklusivrechte des 

Patentinhabers aus, welche für einen Einzellfall in einer Apotheke oder durch jemanden, der 

einen medizinischen Beruf ausübt, hergestellt werden. Diese Ausnahme kann ebenfalls zum 

Zugang zu Arzneien im Fall medizinischer Krisen beitragen. 

21) Nach dem Recht der meisten Gerichtsbarkeiten sind medizinische Behandlungsverfahren 

kein patentierbarer Gegenstand. Falls medizinische Behandlungsverfahren patentierbar 

sind, können Themen bezüglich Zugang zu solchen medizinischen Behandlungsverfahren 

entstehen. Mit anderen Worten: falls medizinische Behandlungsverfahren patentierbar sind, 

kann das Patentrecht einen Einwand der medizinischen Behandlung oder ähnliche Ausnahme 

der Exklusivrechte des Patentinhabers vorsehen, um Zugang zu medizinischer Behandlung 

sicherzustellen, besonders im Zusammenhang mit Krisen der öffentlichen Gesundheitspflege. 

22) Zwangslizensierung ermöglicht es einer Regierung, einer Firma oder anderen Partei das 

Recht zu genehmigen, eine patentierte Erfindung ohne die Zustimmung des Patentinhabers zu 

benutzen. Das Thema der Zwangslizenzen wird von einigen als ein entscheidendes Element 

beim Fördern von Zugang zu Arzneien, Diagnostik und Ähnlichem gesehen, besonders in 

Entwicklungsländern. Viele Länder machen eine Form der Zwangslizensierung verfügbar. 

Artikel 31 TRIPS erlaubt es speziell WTO-Mitgliedern, Zwangslizenzen aus Gründen zu 

verleihen, die durch jedes Mitglied bestimmt werden. Zwangslizenzen sind wegen Mangel oder 

Unzulänglichkeit der Funktion, um wettbewerbswidrige Praktiken zu beseitigen, in Notfällen 

(z.B. wenn es dringliche Fälle der öffentlichen Gesundheitspflege gibt, zum Beispiel als Folge 

einer Pandemie) und Regierungsverwendung und aus anderen Gründen des öffentlichen 

Interesses im Allgemeinen verfügbar. In der Schweiz wurde zum Beispiel das Patentrecht 

kürzlich geändert, um Zwangslizenz-Regelungen für Forschungswerkzeuge und diagnostische 

Verfahren zusätzlich zu den traditionellen Zwangslizenz-Regelungen einzuschliessen. 

23) Gemäss Artikel 31 TRIPS sollten die Bedingungen, die erfüllt werden müssen, sollte eine 

Zwangslizenz gewährt werden, einschliessen: Die Anforderung, dass eine Lizenz freiwillig 

erbeten wird, bevor sie aus Zwang gewährt wird, Nicht-Exklusivität und eine angemessene 

Entlohnung für den Patentinhaber. Auf die Anforderung, dass eine Lizenz freiwillig erbeten 

wird, bevor sie aus Zwang gewährt wird, kann im Fall eines nationalen Notfalls oder aus 

anderen Umständen extremer Dringlichkeit verzichtet werden. 

24) Artikel 31 (f) TRIPS sieht vor, dass Zwangslizenzen überwiegend gewährt werden müssen, 

um den heimischen Markt zu versorgen. Die 2001 Doha Ministerkonferenz entschied, 

dass dies geändert werden sollte, so dass Länder, welche nicht in der Lage sind, die 

Pharmazeutika herzustellen, preiswertere Kopien falls notwendig woanders erhalten könnten. 

Die 2005 Hongkong Ministerkonferenz nahm den neuen Artikel 31bis TRIPS an, was die 

Doha-Entscheidung vom 30. August 2003 dauerhaft macht, indem Artikel 31 (f) TRIPS im 

pharmazeutischen Sektor aufgehoben wird. Die TRIPS-Änderung wird wirksam werden, 

wenn zwei Drittel der WTO-Mitglieder die Veränderung ratifiziert haben. In der Zwischenzeit 

bleibt die Entscheidung vom 30. August 2003 anwendbar. Bis September 2007 haben zehn 

WTO-Mitglieder das Protokoll, welches das TRIPS-Abkommen verändert, angenommen. 

Im Juli 2007 gab Ruanda seine Entscheidung bekannt, ein generisches AIDS/HIV Produkt 

des kanadischen Herstellers Apotex, Inc. zu importieren, und auf das Durchsetzen von 

Patentrechten zu verzichten, die innerhalb des Territoriums von Ruanda bezüglich des 

Originalprodukts gewährt worden sein können. Der Bevollmächtigte für Patente in Kanada 

hat mittlerweile Apotex, Inc. eine Zwangslizenz gewährt. 

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31

25) Trotz der Vorkehrungen für Zwangslizenzen in vielen nationalen Gesetzen sind tatsächlich 

relativ wenige Zwangslizenzen gewährt worden. Der praktische Wert der Existenz von 

Vorkehrungen für Zwangslizenzen ist, dass deren Drohung üblicherweise die Verleihung von 

vertraglichen Lizenzen zu vernünftigen Bedingungen herbeiführt. Dies ist jedoch nicht immer 

der Fall. Die brasilianische und thailändische Regierung erliessen kürzlich Zwangslizenzen 

für Patente von Merck & Co., Inc., welche sich auf die Anti-Retrovirus Arznei Efavirenz für 

die Behandlung von HIV/AIDS beziehen, nachdem Verhandlungen zwischen Merck und der 

Regierung gescheitert waren. 2006 gewährte die italienische Wettbewerbsbehörde eine 

Zwangslizenz für GSK Patente bezogen auf Sumatriptansuccinat, welches in der Herstellung 

von leistungsstarken Migräne-Arzneien verendet wird, an eine lokale Chemiefirma, nachdem 

GSK sich geweigert hatte, eine freiwillige Lizenz zu gewähren. 

26) In einigen Ländern wie den UK ist crown use eine weitere Ausnahmeregelung von den 

Exklusivrechten von Patentinhabern. Die britische Regierung kann eine patentierte Erfindung 

ohne vorhergehende Lizenz benutzen oder die Benutzung bewilligen, nur unter der 

Verpflichtung, dafür Kompensation zu bezahlen. Die Ausnahme deckt zum Beispiel die 

Lieferung von eingeplanten Arzneien im Gesundheitsdienst ab. 

27) In einigen Ländern wie Südafrika haben sich Wettbewerbsbehörden auf Gründsätze des 

Wettbewerbsrechts gestützt, um von einigen Patentinhabern von medizinischen Produkten zu 

verlangen, Lizenzen an Wettbewerber zu verleihen, einschliesslich generische Hersteller. 

28) Schliesslich erlauben es einigen Länder wie die Schweiz sogar der Regierung, ein Patent – 

als Ganzes oder teilweise – aus Gründen des öffentlichen Interesses zu enteignen, was einer 

Verpflichtung unterliegt, dafür eine Kompensation zu bezahlen. 

Fragen 

I) Analyse des gegenwärtigen Rechts und Fallrechts 

Die Gruppen sind eingeladen, die folgenden Fragen unter ihren nationalen Gesetzen zu 

beantworten: 

1) Werden unter Ihrem Patenrecht Ausnahmen für Benutzung zu Forschungs- oder 

Versuchszwecken anerkannt? Falls ja, unter welchen Bedingungen? Wie ist der Umfang 

der Forschungsausnahme? Ist speziell Benutzung zu Forschungs- oder Versuchszwecken für 

kommerzielle Zwecke erlaubt? 

2) Ist unter Ihrem Patentrecht eine Ausnahme vom Bolar-Typ anerkannt? Falls ja, unter welchen 

Bedingungen? Wie ist der Umfang der Bolar-Ausnahme? Ist sie speziell auf Arzneien 

beschränkt oder trifft sie auch auf andere Produkte zu, einschliesslich biologischer Produkte, 

Forschungswerkzeuge usw.? Falls Ihr Patentrecht keine Bolar-Ausnahme vorsieht, wird das 

Benutzen einer Erfindung ohne Einwilligung des Patentinhabers für den Zweck, Genehmigung 

für ein generisches Produkt zu erhalten, durch die Forschungsausnahme gedeckt? 

3) Sind Parallelimporte von patentierten Arzneien, medizinischen Vorrichtungen oder Ähnlichem 

erlaubt? Falls ja, unter welchen Bedingungen? Finden die gleichen Prinzipien Anwendung, 

wenn die Produkte von Märkten stammen, wo sie unter einer Zwangslizenz verfügbar gemacht 

wurden? 

4) Ist in Ihrem Patentrecht eine Ausnahme für individuelle Verschreibungen anerkannt? Falls ja, 

unter welchen Bedingungen? 

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5) Bitte beantworten Sie diese Frage nur, wenn in Ihrem Land medizinische Behandlungsverfahren 

patentierbare Gegenstände sind: Sieht Ihr Patentrecht Einwand der medizinischen Behandlung 

oder ähnliche Ausnahme von den Exklusivrechten des Patentinhabers vor? 

6) Sind Zwangslizenzen unter Ihrem Patentrecht verfügbar? Falls ja, unter welchen Bedingungen 

und aus welchen Gründen (z.B. um wettbewerbsschädliches Verhalten zu beseitigen, für 

Notfälle, aus anderen Gründen des öffentlichen Interesses usw.)? Haben Sie Kenntnis von 

irgendwelchen Zwangslizenzen, welche in Ihrem Land für die heimische Herstellung und 

Versorgung von pharmazeutischen Produkten gewährt wurden? Falls ja, bitte geben Sie 

Details an, welche den Namen des Lizenzgebers, des Lizenznehmers und das abgedeckte 

Produkt einschliessen. 

7) Ist der neue Artikel 31bis TRIPS in Ihrem Land ratifiziert worden? Haben Sie Kenntnis von einer 

anderen legislativen Änderung in ihrem Land hinsichtlich der Implementierung der WTO- 

Entscheidung vom 30. August 2003? Haben Sie Kenntnis von irgendwelchen Zwangslizenzen, 

welche in Ihrem Land für den Import oder Export von pharmazeutischen Produkten gewährt 

wurden? Falls ja, bitte geben Sie Details an, welche den Namen des Lizenzgebers, des 

Lizenznehmers und das Produkt einschliessen, falls sie öffentlich verfügbar sind. 

8) Darf die Regierung eine patentierte Erfindung ohne vorherige Lizenz benutzen und falls ja, 

auf welcher Basis (z.B. crown use) und unter welchen Bedingungen? 

9) Darf die Regierung ein Patent enteignen und falls ja, unter welchen Bedingungen? 

10) Falls Ihr Patentrecht andere Mittel anerkennt, um Zugang zu Arzneien, medizinischen 

Vorrichtungen, Diagnostik und Ähnlichem zu erleichtern, besonders im Zusammenhang mit 

Krisen der öffentlichen Gesundheitspflege (einschliesslich unter anderem Informationswerkzeuge 

wie das Orange Book, welches rechtzeitige Verbraucherinformation zu Genehmigungen für 

generische Arzneien vorsieht), welche oben nicht diskutiert worden sind, erklären Sie bitte. 

II) Vorschläge zur Annahme von einheitlichen Regeln 

Die Gruppen sind eingeladen, Vorschläge für die Annahme von einheitlichen Regeln 

bezüglich gesundheitsempfindlicher Beschränkungen von Patentrechten hinsichtlich Schutz 

der öffentlichen Gesundheitspflege einzureichen. Spezieller sind die Gruppen eingeladen, 

die folgenden Fragen zu beantworten: 

1) Sollte Patentrecht 

– Ausnahmen zur Benutzung zu Forschungs- und Versuchszwecken; 

– Bolar-Ausnahmen; 

– Parallelimport von patentierten Arzneien; 

– Ausnahmen für individuelle Verschreibungen; 

– Einwand der medizinischen Behandlung; 

– Zwangslizensierung; 

– Enteignung; 

– Irgendwelche anderen Beschränkungen der exklusiven Patentrechte, um Zugang zu 

Arzneien, Diagnostik, medizinischen Vorrichtungen und Ähnlichem zu erleichtern 

vorsehen? 

Falls ja, unter welchen Umständen? Falls nein, warum nicht? 

2) Sehen Sie andere Wege als durch Beschränkung von Patentrechten auf welchen Patentrecht 

den Zugang zu Arzneien, Diagnostik, medizinischen Vorrichtungen und Ähnlichem erleichtern 

könnte? 

027-034_WG_Q202_DE.indd 33 17.07.2009 09:35:16 

33

3) Sollten irgendwelche Einschränkungen von Patentrechten, speziell die Ausnahme der 

Benutzung zu Forschungs- und Versuchszwecken, Bolar-Ausnahme und Ausnahme für 

individuelle Verschreibungen harmonisiert werden? Falls ja, wie? Falls nicht, warum nicht? 

Landesgruppen sind eingeladen, jedes zusätzliche Thema betreffend den Einfluss von Themen der 

öffentlichen Gesundheitspflege auf die Exklusivrechte von Patentinhabern zu kommentieren, welche 

sie relevant finden. 

Anmerkung: 

Es wird hilfreich sein und geschätzt werden, wenn die Gruppen in ihren Berichten der Reihenfolge 

der Fragen folgen und die Fragen und Nummern für jede Antwort verwenden. 

34 

027-034_WG_Q202_DE.indd 34 17.07.2009 09:35:16

Questions 

Argentina 

Argentine 

Argentinien 

Report Q202 

in the name of the Argentine Group 






Yes, an experimental use exception is recognised under the Argentine Patent Law. Section 

36 of the Patent Law provides that the right conferred by a patent shall have no effect 

against any third party who, within the private or academic field and with no commercial 

purposes, carries out activities of purely experimental scientific or technological research, 

testing or teaching, and for this purpose manufactures or employs a patented product or uses 

a patented process. Therefore, according to the Patent Law, experimental use is not permitted 

for commercial purposes. 






exception? 

Although the Patent Law does not contemplate a Bolar-type exception, said exception is 

recognised by the Confidentiality Law. According to this law, any third party may use a 

patented product or process before the expiration of the patent, with experimental purposes 

and to gather the information required for approval of a product or procedure by the pertinent 

authority, for its sale after the expiration of the patent. The exception is not limited to drugs, 

and it therefore applies to any other product requiring prior regulatory approval. 

Considering that the Confidentiality Law was enacted after the Patent Law, the former would 

be considered to prevail over the latter. The validity of the Confidentiality Law vis-à-vis the 

TRIPS Agreement has not been challenged so far at the Argentine Courts. 




Section 36 (c) of the Argentine Patent Law provides: 

“The right conferred by a patent shall have no effect against: ... (c) Any person or legal entity 

that ... imports, or in any other way markets the patented product or obtained by the patented 

process, once sue product is lawfully placed on the market in the country ...” 

035-040_Q202_Argentina.indd 35 17.07.2009 09:36:54 

35

Section 36 of the Regulatory Decree provides: 

“ ... it shall be understood that an imported product has been lawfully placed on the market 

when the licensee authorized to market it within the country, shows that it has been placed 

on the market by the patentee in the country where it was acquired, or by a third party 

authorized to market it.” 

One possible reading of Section 36 of the Argentine Patent Law is that if the product was 

lawfully placed on the world market by someone, there would be no further exclusive patent 

rights in Argentina. For instance, the product could be placed on the market in a country 

where there is no patent protection at all. 

However, we understand that such interpretation is not acceptable because it would contradict 

the exclusive right conferred by Article 17 of the Argentine Constitution, and more specifically 

by Section 8 of the Patent Law and Article 28 of the TRIPS Agreement since they both extend 

the right conferred by a patent to the prohibition of the imports of the concerned product. 

For that reason, we estimate that a reasonable interpretation of Section 36 of the Argentine 

Patent Law would be that “lawfully placed” means with the authorization of the patentee 

or its licensee or a party authorized by the patentee. In other words, that Section 36 of the 

Argentine Patent Law would refer to the “exhaustion of rights” situation and that accordingly 

the exclusive right of the patent holder is exhausted after the product is lawfully placed on the 

market, in Argentina or abroad. 

In addition, to support that interpretation, we would point out that the Supreme Court has 

accepted the validity of the so-called “parallel imports” in trademark cases as long as these 

imports are the consequence of an “exhaustion of rights” occurred in another jurisdiction. 

In any event, it is worth noting that our patent legislation is not particularly clear on this matter 

nor is there is any relevant case law. 


conditions? 

Yes, an individual prescriptions exception is recognised under the Patent Law, which provides 

that the rights conferred by a patent shall have no effect against: (i) the production of medical 

products habitually carried out by licensed professionals, and per unit, upon executing a 

medical prescription, nor (ii) any further acts related to such medical products. 




Methods of medical treatment are non patentable subject matter in Argentina. 

In this respect, Section 6.e) of the Argentine Patent Law does not consider methods of chirurgic, 

therapeutic or diagnostic treatment as inventions. 

A related issue is the patentability of second medical uses, which are not explicitly admitted 

or rejected under the Argentine statute. Few patents were granted that could qualify as 

focusing on second medical uses. However, afterwards, the Argentine Patent Office started 

rejecting patent applications for these inventions. Moreover, the Guidelines of the Argentine 

Patent Offices do not admit Swiss-type claims as main claims in a patent application. 






36 

035-040_Q202_Argentina.indd 36 17.07.2009 09:36:55

Yes, compulsory licenses are available under Argentine Patent Law. Patent Law provides 

that compulsory licenses may be granted due to: (i) lack of working, (ii) anticompetitive 

practices incurred by the patentee, (iii) sanitary emergency or national security reasons and 

(iv) dependency. However, no compulsory licenses have been granted in Argentina up to 

now. 

In line with Article 5 of the Paris Convention, the Patent Law provides that mandatory licenses 

for lack of working may be applied for after three years from grant of the patent, or four years 

as from application, whichever term is longer and also, if the use of the invention has been 

interrupted for more than one year after the above terms have expired. 

A Patent owner may invoke the following defenses in the case of lack of working: 

• that there were effective and serious preparatory measures to work the invention; or 

• that the inactivity derived from a force majeure event, including objective difficulties of 

a technical and legal character to obtain the registration before a public agency for 

marketing authorization, which made the use of the invention impossible. 

To obtain a mandatory license, a third party must also prove that he has the economic 

capacity to carry out an efficient use of the patented invention, and that he has a plant duly 

authorized by the competent authority. 

The decree regulating the Patent Law provides that importation of the product embodying 

the invention should be considered to be sufficient working of the patent. Some legal 

commentators have argued that the decree may not include such type of provision if it is 

not included in the Patent Law. In any event, Article 27 of the TRIPS Agreement provides 

that “patents shall be available and patent rights enjoyable without discrimination as to ... 

whether the products are imported or locally produced.” That, in the authors’ opinion, settles 

the matter that importation should be deemed as sufficient working, especially considering 

the higher hierarchy of treaties in Argentina. 

Furthermore, to obtain a mandatory license applicant must comply in general with the 

requirements set forth in Article 31 of the TRIPS Agreement. 

The Patent Office determines a reasonable compensation to be paid to the patentee by 

taking into account the economic value of the authorization being granted and the average 

royalties being paid within such commercial field of activities when similar license agreements 

between independent parties are executed. That decision may be appealed to the Federal 

Courts. 

There is a situation in which the patent may be declared to be cancelled as a consequence 

of lack of working. If a mandatory license is granted to a third party, and that party does not 

make use of the invention within a term of two years as from the grant of the license for causes 

attributable to the patentee, the patent may be canceled. 

Compulsory licenses may also be granted if patentee incurs in anti-competitive practices, or 

in cases of sanitary emergency, or for national security reasons. 






Argentina has not ratified new Article 31bis TRIPS so far, and we are not aware of any other 

legislative amendment with a view to implementing the WTO decision of August 30, 2003. 

We are not aware of any compulsory licenses granted for the importation or exportation of 

pharmaceutical products either. 


37



The Patent Law does not allow the government to make use of a patented invention without 

previous license. 


Although the Patent Law does not specifically provide for patent expropriations, the government 

could expropriate a patent on the grounds of the Argentine Constitution and the Expropriation 

Law. Expropriation is only allowed on the grounds of public interest, which must be declared 

by a law from the Congress, and the patentee must be previously compensated. 





Law 25.649 obliges doctors to prescribe medicines by their INN, and not by trademark. 

If a prescription wants to name the product by its trademark the doctor must state his/her 

reason. Pharmacists are also compelled to offer alternative medicines to the one prescribed 

by the doctor, focusing on those being sold at a lower price. However, these provisions are 

disregarded to a large extent. 

Furthermore, in few cases the courts decided that patients should be supplied the product 

designated by its trademark in the doctor’s prescription. 













We consider that all the exemptions previously mentioned should be provided for in the patent 

law, except for: (i) parallel import of patented medicines, and (ii) limitations to patent rights 

with the aim of facilitating access to medicines since we consider that said goal, unfortunately, 

can not be achieved by limiting patent rights. 

We consider that the research and experimental use exception should be strictly limited to 

cases involving non direct commercial purposes. 

Moreover, we consider that the compulsory licensing and expropriation exemptions should 

be narrowly construed so as to preserve the rights of the patent holder. 

On the other hand, we consider that parallel import of patented medicines should not be 

allowed since it produces an economic distortion of markets with the consequent increase 

of prices. Moreover, parallel imports negatively affect local production of medicines since it 

creates barriers from direct foreign investment. 

38 

035-040_Q202_Argentina.indd 38 17.07.2009 09:36:55



There exist indeed other ways than the limitations of patent rights which might facilitate access 

to medicines, diagnostics, medical devices and the like, particularly in the sense of making 

less expensive and/or more effective this access to the needy. The government may subsidize 

the selling prices of the original products still under patent protection and/or give tax benefits 

to manufacturers and importers of patented medicines and devices. 




It would be advisable to harmonise the limitations of patent rights since it would create 

certainty for patent holders over different national jurisdictions. In this respect, international 

organizations such as the WTO could be a suitable means for achieving that result. 

Summary 

The Group considers that limitations to patent rights should be provided for in the patent law, but 

not for parallel import of patented medicines nor with the aim of facilitating access to medicines. 

Research and experimental use exception should be strictly limited to cases involving non direct 

commercial purposes. Compulsory licensing and expropriation exemptions should be narrowly 

construed so as to preserve the rights of the patent holder. Parallel import of patented medicines 

should not be allowed since it produces an economic distortion of markets with the consequent 

increase of prices and it negatively affects local production of medicines creating barriers from 

direct foreign investment. There are ways other than limitation of patent rights which might facilitate 

access to medicines, diagnostics, medical devices and the like. It would be advisable to harmonise 

the limitations of patent rights since it would create certainty for patent holders over different 

national jurisdictions. 

Résumé 

Le Groupe considère que la loi des Brevets devrait spécifier des restrictions au droit des brevets, 

excepté ce qui concerne l’importation parallèle des médicaments brevetés et ce qui facilite l’accès 

aux médicaments. L’exemption pour la recherche ainsi que l’usage expérimental devraient être 

strictement limités pour usages à des fins non commerciales. Les exemptions concernant la licence 

obligatoire et l’expropriation devraient être rigoureusement étudiées dans le but de préserver les 

droits du porteur du brevet. L’importation parallèle de médicaments brevetés ne devrait pas être 

autorisée car elle provoque un déséquilibre économique des marchés ayant comme conséquence 

une hausse des prix et elle affecte négativement la production locale de médicaments créant des 

obstacles à l’investissement étranger. Parallèlement aux restrictions au droit des brevets, il existe 

d’autres moyens de faciliter l’accès aux médicaments, à l’examen médical, aux appareils médicaux 

et autres. Il serait souhaitable d’harmoniser les restrictions au droit des brevets afin d’offrir sécurité 

aux porteurs de titres de brevet dans les différentes juridictions nationales. 

Zusammenfassung 

Die Gruppe betrachtet dass Patentrechtsbeschränkungen sollten in dem Patent Gesetz erstellt 

werden, aber nicht für Parallelimport von patentierte Arzneimitteln, und auch nicht um die 

Medizinsbesorgung zu erleichtern. Die Forschung und Versuchsgebrauchausnahme sollte nur zu 


39

keine direkt geschäftliche Anwendungen begrenzt werden. Zwangsmässige Lizenzierung und 

Zwangsenteignung sollten eingeengt ausgelegt sein damit das Recht von den Patentbesitzern 

präserviert ist. Parallelimport von patentierte Arzneimitteln sollte nicht erlaubt sein, weil es eine 

Wirtschaftliche Marktverzerrung vorbringt, der dadurch die Preise steigen und der dadurch 

die lokale Produktion vom Medizinprodukte betroffen wird, und folglich für die direkt aus dem 

Ausland herstammte Investierung einen Hindemis schafft. Es gibt andere Arte die nicht Patentrechte 

beschränken, und mit dem die Besorgung von Medizin, Diagnose, Medizinsapparate, usw., 

kann erleichtet sein. Es würde sehr ratsam die Patentrechtsbeschränkungen in Übereinstimmung 

zu bringen weil damit würde Gewissheit für den Patentbesitzern in vielen verschiedene Ländern 

erschafft. 

40 

035-040_Q202_Argentina.indd 40 17.07.2009 09:36:55

Questions 

Australia 

Australie 

Australien 

Report Q202 

in the name of the Australian Group 

by Carolyn HARRIS, Sarah MATHESON, Wayne CONDON and Ben STRATE 



1) Is a research or experimental use exception recognised under your patent law? 

No express research or experimental use exception is available under the Patents Act 

1990 (Cth). Many believe that an implicit exception for experimental use would be found 

to exist were the question to come before an Australian court. This has not yet happened. 

Nevertheless, researchers tend to act on the assumption that an exception exists. 

Whether a research exception exists and what its scope might be has been discussed in 

detail in recent years. The Australian Law Reform Commission (ALRC) released a report in 

2004 recommending legislative clarification of the research exception. The Advisory Council 

on Intellectual Property (ACIP), an independent body established to provide policy advice 

to the Federal Government on issues relating to intellectual property, also recommended 

introduction of a statutory exception in 2005. Both groups discussed evidence supporting the 

existence of an experimental use exception, but in the absence of Australian court authority, 

neither could state with certainty whether the exception existed or what might be its scope. 

The Commonwealth Government released a response in August 2007 stating that it would 

amend the patent legislation to include an experimental use exception, reflecting Australia’s 

international obligations as closely as possible. The Government stated that the amendments 

will outline the research activities that can be done without infringing on a patent holder’s 

rights, including determining how an invention works, verifying the validity of patent claims, 

or improving the invention. No such legislation has been introduced into parliament as yet. 

Arguments supporting the exception tend to centre around definitions of the patentee’s 

exclusive right under the Commonwealth Patents Act 1990 (Patents Act) to ‘exploit’ their 

invention. The Explanatory Memorandum states that this exclusive right was not intended 

to ‘modify the present law relating to certain acts which have been held not to constitute 

infringement—for example, use of an invention for certain experimental or trial purposes’. 

ACIP supports this argument by observing that the fact that use for experimental or research 

purposes may not constitute an infringement is consistent with the scope and purpose of the 

Act as a whole. 

There is also an old line of English authority, beginning with the 19th century case of Frearson 

v Loe, 1 which has not been overturned in Australia. The decision in that case suggested that 

acts might not constitute ‘use’ of an invention where there is no commercial purpose. It is 

possible that this exception would continue to apply to allow experimental use of patented 

products and methods. 

1 (1878) 9 ChD 48. 

041-050_Q202_Australia.indd 41 17.07.2009 09:37:29 

41

If so, under which conditions? What is the scope of the research exception? Specifically, is 

research or experimental use permitted for commercial purposes? 

Given that the exception is not clearly defined, it is difficult to state precisely either the 

conditions in which the exception would operate or the scope of the exception. It seems that, 

whether the exception were found to be based on the definition of ‘exploit’ or on the principle 

in Frearson v Loe, use for commercial purposes would not be permitted. 

2) Is a Bolar-type exception recognised under your patent law? 

The Patents Act provides a Bolar-type exception for manufacturers of generic pharmaceutical 

products. 

If so, under which conditions? 

Rights in a ‘pharmaceutical patent’ are not infringed by a person exploiting an invention if the 

exploitation is solely for purposes connected with obtaining inclusion in the Australian Register 

of Therapeutic Goods or similar regulatory approval under a law of a foreign country. A 

‘pharmaceutical patent’ is defined as a patent claiming a pharmaceutical substance or a 

method, use or product relating to a pharmaceutical substance. A method, use or product 

relating to a pharmaceutical substance includes: 

– a method for producing a raw material needed to produce the substance; 

– a product that is a raw material needed to produce the substance; and 

– a product that is a pro-drug, metabolite or derivative of the substance. 

The exception only applies for those seeking foreign regulatory approval if the patent in 

question has been extended beyond the normal twenty year period. 


apply to other products, including biological products, research tools, etc.? 

According to the Explanatory Memorandum the definition of a ‘pharmaceutical patent’ is 

intended to cover ‘all patents that a generic pharmaceutical company would need to exploit 

in order to seek inclusion of a good other than a medical device or a therapeutic device 

on the Australian Register of Therapeutic Goods’. The exception is not intended to allow 

the stockpiling of quantities for later sale or manufacturing of quantities of the product for 

export. 

The scope of the exception is limited by the definition of a ‘pharmaceutical substance’. A 

‘pharmaceutical substance’ is defined as a substance, including a mixture or compound of 

substances, for therapeutic use: 

– whose application involves a chemical interaction, or physico-chemical interaction, with 

a human physiological system; or 

– action on an infectious agent, or on a toxin or other poison, in a human body. 

The exception does not extend to ‘medical devices’ or ‘therapeutic devices’. Accordingly, 

instruments, apparatus, appliances or materials used for medical or therapeutic purposes 

are not within the exception. In conjunction with the ‘chemical interaction’ requirement in the 

‘pharmaceutical substance’ definition, this appears to limit the exception to drug patents. 

If your patent law does not provide for a Bolar exception, will using an invention without the 

patentee’s consent for the purpose of obtaining approval of a generic product be covered by 

the research exception? 

42 

041-050_Q202_Australia.indd 42 17.07.2009 09:37:29


which conditions? 

Parallel imports of patented medicines or medical devices are not expressly permitted. The 

patentee’s exclusive right to ‘exploit’ their invention includes the exclusive right to import it. 

There is no suggestion of a statutory exception for parallel importation. The Australian courts 

have not been required to consider the legality of parallel importation for some years. 

However, the exhaustion of rights principle may prevent the patentee from claiming an 

exclusive right to import goods sold by the patentee to another party. Sale of patented goods 

without any restriction may give rise to an implied licence to do with imported goods as the 

purchaser wishes. 2 However, the patentee may use a licence agreement to impose conditions 

on what use may be made of patented goods after sale, 3 provided that the agreement does 

not prevent the purchaser from using or selling any product owned by any person other than 

the seller, or require the purchaser to acquire any product owned by any person other than 

the seller. Patentees who sell their products overseas may therefore make it a condition of sale 

that the purchaser may not import their goods into Australia. If they do not do so expressly, 

parallel importation may be permitted. 

Do the same principles apply if the products originate from markets where they were made 

available under a compulsory license? 

Apart from the limitations discussed in answer to Question 6, the Patents Act does not limit 

the conditions upon which a compulsory licence may be ordered. In general, a licensee is 

permitted to ‘exploit’ an invention, which includes the right to import it. 

The objects of the compulsory licensing provisions include ensuring that Australian demand 

for the patented article could be reasonably met, whether from local production or from 

imports (see further answer to question 6 below). However, it is not clear whether the same 

reasoning would apply to import of goods made available under compulsory licences made 

in other markets. 


conditions? 

No exception for individual prescriptions is recognised under Australian patent law. The 

definition of the patentee’s exclusive right to ‘exploit’ their invention includes the right to 

‘make’ the patented product, or use the patented process to make a product. There is nothing 

to suggest a broad exception for syntheses by pharmacists or medical professionals of 

medications prescribed for an individual. 




Since the Full Court of the Federal Court of Australia’s decisions in Bristol-Myers Squibb Co 

v FH Faulding & Co Ltd4 (Bristol-Myers) and Anaesthetic Supplies Pty Ltd v Rescare Ltd, 5 

methods of medical treatment have been considered patentable subject matter. However, 

Australian patent law does not provide for a medical treatment defence or similar exception 

to the patentee’s exclusive rights. Bristol-Myers suggested that medical practitioners who 

2 Interstate Parcel Express Co Pty Ltd (carrying on business as Angus & Robertson Bookshops) v Time-Life International 

(Nederlands) BV and Another (1977) 138 CLR 534; Avel Pty Ltd v Multicoin Amusements Pty Ltd (1990) 171 CLR 88. 

3 Interstate Parcel Express Co Pty Ltd v Time-Life International (Nederlands) BV (1977) 138 CLR 534, 549; Transfield Pty 

Ltd v Arlo International Ltd (1980) 144 CLR 83. 

4 (2000) 170 ALR 439. 

5 (1994) 50 FCR 1. 


43

wish to use patented methods of medical treatment should, although it is cumbersome and 

expensive, seek a compulsory licence (see further answer to question 6 below). Strong patent 

protection for methods of medical treatment, it is argued, encourages the great expense 

required to evaluate and investigate new medical processes and surgical methods. 

6) Are compulsory licenses available under your patent law? 

Compulsory licences are available under the Patents Act. An application for a compulsory 

licence may not be made until 3 years after the sealing of the relevant patent. 

If so, under which conditions and on which grounds (e.g. to remedy anticompetitive conduct, 

for cases of emergency, other public interest grounds, etc.)? 

The Federal Court may order a patentee to grant a licence to work a patented invention if: 

– the applicant (for the compulsory licence) has tried for a reasonable period, but without 

success, to obtain from the patentee an authorization to work the invention on reasonable 

terms and conditions; and 

– the reasonable requirements of the public with respect to the patented invention have not 

been satisfied; and 

– the patentee has given no satisfactory reason for failing to exploit the patent; or 

– the patentee has contravened or is contravening Part IV of the Trade Practices Act 1974 

in connection with the patent. This might include price-fixing, misuse of market power or 

exclusive dealing. 

Reasonable requirements of the public are taken not to have been satisfied if: 

– an existing trade or industry in Australia, or the establishment of a new trade or industry 

in Australia, is unfairly prejudiced, or the demand in Australia for the patented product, 

or for a product resulting from the patented process, in not reasonably met, because of 

the patentee’s failure: 

• to manufacture the patented product to an adequate extent, and supply it on 

reasonable terms; or 

• to manufacture, to an adequate extent, a part of the patented product that is 

necessary for the efficient working of the product, and supply the part on reasonable 

terms; or 

• to carry on the patented process to a reasonable extent; or 

• to grant licences on reasonable terms; or 

• a trade or industry in Australia is unfairly prejudiced by the conditions attached by 

the patentee to the purchase, hire or use of the patented product, the use or working 

of the patented process; or 

• if the patented invention is not being worked in Australia on a commercial scale, but 

is capable of being worked in Australia. 

A compulsory licence must not give the licensee the exclusive right to work the patented 

invention, and a licence is to be assignable only in connection with an enterprise or goodwill 

in connection with which the licence is used. 

Commentary on this aspect of Australian patent law reflects that the provisions of the legislation 

appear to provide significant opportunities for competitors adversely affected by the existence 

of all unworked patents to obtain relief. However, there are very few reported cases in 

which the provisions have been considered, and none that are directed to pharmaceutical 

inventions. 

44 

041-050_Q202_Australia.indd 44 17.07.2009 09:37:29

An examination of the circumstances set out [in the legislation] suggests that the objects of the 

compulsory licensing provision of the Act cover both (1) fostering Australian manufacturing 

industry to make the patented article or to use the patented process and (2) ensuring that the 

Australian demand for the patented article or articles made in accordance with the patented 

process should be reasonably met whether from local production or from imports. It could, 

therefore, be that the reasonable requirements of the public would not have been satisfied 

simply by the importation of enough patented articles to meet the Australian demand. The 

circumstance that to foster Australian manufacture is an object of the provisions as a whole 

might well dictate that in some circumstances a compulsory licence should be confined to the 

use of the invention for local manufacture and the sale of the products of such manufacture 

and should not afford the licensee the right to import and sell patented articles: Fastening 

Supplies Pty Ltd v Olin Matheson Chemical Corp (1969) 119 CLR 572. 

If the patented invention (subject of the compulsory licence) cannot be worked by the applicant 

without infringing another patent, the Federal Court may only order a compulsory licence if it 

is satisfied that the patented invention involves an important technical advance of considerable 

economic significance on the invention to which the other patent relates. In conjunction with 

such an order, the Federal Court must order that the patentee of the other invention grant a 

licence to work the other invention insofar as is necessary to work the patented invention and 

must also order that the patentee of the other invention be granted a cross-licence to work the 

patented invention on reasonable terms. There are also prescribed conditions to account for 

assignment of a compulsory licence. 

Subsequent to the grant of a compulsory licence, an interested person may apply to the 

Federal Court for an order revoking the patent if 2 years have expired since the grant of the 

first compulsory licence. The court may make such an order if satisfied that: 

– both the reasonable requirements of the public with respect to the patented invention 

have not been satisfied and the patentee has given no satisfactory reason for failing to 

exploit the patent; or 

– the patentee is contravening Part IV of the Trade Practices Act 1974 or an application law 

in connection with the patent. 

Are you aware of any compulsory licenses granted in your country for the domestic manufacture 

and supply of pharmaceutical products? If so, please provide details, including the name of 

the licensor, the licensee and the product covered. 

No compulsory licences have been granted in Australia for the domestic manufacture and 

supply of pharmaceutical products. 

7) Has new Article 31bis TRIPS been ratified in your country? 

Australia has accepted the changes to the TRIPS agreement regarding Article 31bis and 

notified the WTO of its acceptance on 12 September 2007. 

Are you aware of any other legislative amendment in your country with a view to implementing 

the WTO decision of August 30, 2003? 

Acceptance of the new Article 31bis of TRIPS did not require amendment of Australian law - 

the obligation to avoid trade diversion of generic drugs is similar to other obligations in the 

TRIPS Agreement generally and is already adequately covered in Australian legislation. 

Under the Patents Act, pharmaceutical products made under compulsory licence must be 

primarily for supply of the domestic market, ie, not for export. If Australia wishes to export 

drugs made under compulsory licence, amendments to the patents legislation will be required, 

consistent with the provisions of Article 31bis. 


45

However, in discussions regarding the possible acceptance of the changes, it was suggested 

that Australia should accept the changes and then consider whether it was necessary to 

amend legislation to allow Australia to export patented pharmaceuticals and make them 

available for developing countries. The parliamentary committee that considered this issue 

stated: 

The Committee supports acceptance of the Protocol, followed by any necessary amendments 

to the Patents Act 1990 to allow for compulsory licensing to enable export of cheaper 

versions of patented medicines needed to address public health problems to least-developed 

and developing countries. The Committee encourages the consultations to be coordinated 

by IP Australia later this year and urges the Government to actively support the provision of 

patented medicines to least developed and developing countries. 

To date, no amendments to the existing legislation have been made. IP Australia is yet to 

commence consultation on possible legislative changes. 

Are you aware of any compulsory licenses granted in your country for the importation or 

exportation of pharmaceutical products? If so, please provide details, including the name of 

the licensor, the licensee and the product, if they are publicly available. 

No compulsory licenses have been granted in Australia for the importation or exportation of 

pharmaceutical products. 



Exploitation of patent applications and patents by the Crown is permitted under the Patents 

Act. The Crown may exploit an invention if the exploitation of the invention is necessary for 

the proper provision of those services within Australia. 

The purpose of the provisions is to ensure that the Commonwealth and State governments 

have immediate access to inventions which are of benefit to the performance of their functions, 

without them having to wait until the term of a patent expires. The Australian provisions are 

based upon section 27 of the Patents, Designs and Trade Marks Act 1883 (UK) and are 

considered to represent a balance between the rights of the inventor and patentee and the 

rights of the Crown, representing the public interest. It is suggested that the Crown should not 

be prevented from acting in the public interest by patents which it has granted, especially in 

relation to matters such as those of national defence and public health. Furthermore, given 

that the Crown and its agencies are not normally engaged in commercial activities, but in 

the provision of public services, access to patent monopolies should be available where the 

public interest needs to be better served. 

Where an invention is directly used by the Commonwealth or a State in performing its duties 

and functions, such a use will be regarded as falling within the provisions of the legislation. 

However, it is not clear that the legislative provisions are satisfied in circumstances where a 

patented article is acquired by Commonwealth or a State pursuant to the legislation and is 

then supplied to members of the public, possibly at a discounted rate and in competition with 

the patentee. This issue is yet to be authoritatively determined in Australia as in the two cases 

in which the question has been asked, the court has decided that the issue did not need to 

be determined. 

A patentee is able to apply for a declaration that an invention has been exploited by the 

Commonwealth or a State or their authorities and authorized persons. The patentee is also 

entitled to compensation for such use. The Commonwealth and State are obliged, unless it 

appears contrary to the public interest to do so, to inform the applicant for a patent or patentee 

of the fact of exploitation of the invention, and to provide the applicant or patentee with such 

information as to that exploitation as he or she from time to time reasonably requires. 

46 

041-050_Q202_Australia.indd 46 17.07.2009 09:37:29

If the patentee and the Commonwealth or a State cannot agree on reasonable compensation, 

a court may be called upon to set terms and conditions for the exploitation. 


It is possible for the government to expropriate a patent application or a patent under the 

Patents Act. The Governor-General may make such a direction and all rights in respect 

of the patent or the invention are transferred to and vested in the Commonwealth. The 

Commonwealth must pay compensation as agreed between the Commonwealth and the 

compensable person, or in the absence of agreement, as is determined by the Court upon 

application by either party. There are no conditions specified in the legislation under which 

the government may expropriate a patent. 

There have been no reported instances of the Commonwealth expropriating a patent. 





When an extension of the term of a patent is granted, the rights of the patentee during 

the term of the extension are limited. This exception is peculiar to pharmaceuticals, as 

extensions may only be granted if a pharmaceutical substance per se is disclosed in the 

patent. The inclusion of the phrase ‘per se’ means that , as a general proposition, claims for 

pharmaceutical substances produced by a particular process are ineligible for extension. 

To be eligible for extension, the claim must not be qualified by environmental, temporal or 

process components. 

Exploitation of any form of the invention other than the specified pharmaceutical substances 

per se during the extension period does not constitute infringement. That is, once the extension 

period begins, the patent no longer gives the patentee the exclusive right to exploit anything 

claimed other than the pharmaceutical substance itself. For example, a manufacturing 

procedure used to produce the pharmaceutical substance will not continue to be protected 

under the extended patent. 




The Australian Group considers that patent law should provide an exception for research 

and experimental use. Legislative clarification of the exception is appropriate, as it assists 

to provide certainty for researchers, even though any statutory exception will create 

issues of interpretation. Many countries already have an exception for research and 

experimental use, and harmonization is generally desirable. 


The Australian Group considers that the current Australian exception is appropriate in 

balancing the interests of innovator and generic companies. The current springboarding 

provisions adequately address timely access to medicines by ensuring that cheaper 

generic medicines are available promptly following patent expiry. 


While providing another means of accessing medicines, an express exception for parallel 

importation of patented medicines will limit the rights of patentees. Contractual constraints 

can, absent a legislative exception, limit importation, but can only go so far down a 

supply chain. The Australian group considers that such an exception could increase 


47

access to patented medicines and should be considered as it does not unreasonably 

dilute the rights of the patentee. However, in Australia, the introduction of an exception 

for parallel importation of patented medicines would require careful consideration of the 

regulatory regime relating to medicines. 


The Australian Group considers that any exception for individual prescriptions would need 

to be carefully defined. An exception may be appropriate for one-off, non-commercial 

prescriptions in cases of patient need. 


Australia has no express exception for a medical treatment defence. Whilst the courts’ 

view would be that a practitioner should seek a compulsory licence (see question 5), 

in general, the owner of a patent for a pharmaceutical is unlikely to sue a medical 

practitioner for using a pharmaceutical in a way that infringes a method claim, as the 

medical practitioner is ultimately the one who selects the medicine to be used. Thus, in 

a commercial context it is unlikely that a medical practitioner would be confronted by 

infringement action, even though there is no explicit defence. The introduction of a defence 

into Australian law could be argued to be desirable to protect medical practitioners, 

however, the corollary is the reduction of protection for companies who invest in research 

and development to improve medical treatments. On balance the Australian group is of 

the view that an explicit defence is unnecessary. 


Australia has had no experience with compulsory licensing in relation to pharmaceuticals, 

so it is difficult to decide whether it is appropriate in practice. The Australian Group 

considers that compulsory licensing mechanisms will not always be helpful because of 

the long lead times for the production of medicines. Furthermore, the current requirements 

for a compulsory licence in Australia require that the licensee be able to fulfil production 

requirements. In the context of a pandemic, it may be that more than one licensee is 

required to provide sufficient product and hence the current provisions would not provide 

a satisfactory outcome. 


The circumstances in which expropriation may be desirable may be unpredictable, 

rendering legislative proscription of circumstances problematic. There is currently no 

articulation of the conditions in which expropriation could occur and the threshold criteria 

of ‘the proper provision of those services’ (see question 9) provides the government 

with broad latitude to exercise the right if necessary. The Australian Group considers 

that this breadth is acceptable because it allows for unpredictable circumstances to be 

encompassed, but still requires the Government to justify any decision it does make in 

this respect. 



It is the Australian Group’s view that the above exceptions are sufficient to facilitate 

access to medicines. There is no need for further express measures. 



The Australian Group considers that there are no ways other than those which would prove 

limitations on patent rights in which patent law might facilitate access to medicines. 


exception, Bolar exception, and individual prescriptions exception be harmonised? 

48 

041-050_Q202_Australia.indd 48 17.07.2009 09:37:30

The Australian Group considers that all of the exceptions discussed, including the research 

and experimental use exceptions, Bolar exception and individual prescriptions exception, 

should be harmonised to the extent possible. Harmonisation is useful for creating certainty for 

patentees and health organisations operating at an international level. 

If so, how? If not, why not? 

The Australian Group considers that harmonisation is best achieved through bilateral and 

multilateral treaties and through fora like AIPPI. 

Summary 

Australian law recognises several exceptions to the exclusivity of patentees’ rights which may be 

relevant to public health issues. Australian legislation expressly provides for a Bolar-type exception, 

compulsory licensing provisions, and government use of patented inventions and expropriation 

of patents. An exception for experimental use may be implied, though no Australian court has 

considered this question. Parallel importation may be permitted where the patentee has not 

contracted to prevent it, though there is no express exception. Exceptions for individual prescriptions 

and medical treatment are not recognised. 

The Australian Group considers that harmonisation of patent law is generally desirable. It is the 

Australian Group’s view that patent law should expressly allow experimental use and parallel 

importation of patented inventions. The Australian Group considers that the scope of the Australian 

law’s other exceptions strikes an appropriate balance between the rights of the patent holder and 

the interests of other parties. 

Résumé 

En droit australien, plusieurs exceptions sont reconnues dans le cadre de l’exclusivité des droits 

des titulaires de brevets pouvant concerner les problèmes de santé publique. Les lois australiennes 

prévoient expressément l’exception de type “Bolar”, les dispositions relatives aux licences obligatoires 

et l’utilisation par le gouvernement d’inventions sous brevet et d’expropriation de brevets. Une 

exception pour utilisation à titre expérimental peut être implicite, bien qu’aucun tribunal australien 

n’ait pris cette option en considération. L’importation parallèle peut être permise lorsque le titulaire 

du brevet n’est partie à aucun contrat l’en empêchant, bien qu’il n’existe aucune exception expresse. 

Les exceptions pour les cas individuels de traitement médical et d’ordonnance de médicaments ne 

sont pas reconnues. 

Le Groupe australien considère que l’harmonie est généralement désirable en matière de droit 

des brevets. Le Groupe australien pense fermement que le droit des brevets doit expressément 

permettre l’utilisation à titre expérimental et l’importation parallèle d’inventions sous brevet. Le 

Groupe australien considère que l’étendue des autres exceptions, en droit australien, apporte un 

équilibre approprié entre les droits du titulaire du brevet et les intérêts des autres parties. 


Das australische Recht erkennt mehrere Ausnahmen in Bezug auf die Exklusivität des Patentinhabers 

an, die in Bezug auf Fragen der öffentlichen Gesundheit relevant sein mögen. Die australische 

Gesetzgebung sieht ausdrücklich eine Ausnahme vom Bolar-Typ vor (der künftige Hersteller 

eines Generikums darf bereits vor Ablauf der Patentzeit des Originalprodukts Vorbereitungen für 

die Herstellung des Generikums treffen), Vorschriften über Zwangslizenzen und den Gebrauch 

patentierter Erfindungen durch die Regierung und die Enteignung von Patenten. Eine Ausnahme in 


49

Bezug auf experimentelle Verwendung mag unausgesprochen enthalten sein, obschon sich bisher 

kein australisches Gericht zu dieser Frage aussprechen musste. Parallelimport mag gestattet sein, 

wenn der Patentinhaber keinen Vertrag abgeschlossen hat, um ihn zu verhindern; dies ist aber keine 

ausdrückliche Ausnahme. Ausnahmen für einzelne Verschreibungen und medizinische Behandlung 

werden nicht anerkannt. 

Die australische Gruppe geht davon aus, dass die Harmonisierung des Patentrechts allgemein 

wünschenwert ist. Die australische Gruppe ist der Ansicht, dass das Patentgesetz ausdrücklich den 

experimentellen Gebrauch und den Parallelimport patentierter Erfindungen gestatten sollte. Die 

australische Gruppe ist der Ansicht, dass der Umfang der übrigen Ausnahmen des australischen 

Rechts einen angemessenen Ausgleich zwischen den Rechten des Patentinhabers und den Interessen 

anderer Parteien schafft. 

50 

041-050_Q202_Australia.indd 50 17.07.2009 09:37:30

Questions 

Austria 

Autriche 

Österreich 

Report Q202 

in the name of the Austrian Group 

by Christian GASSAUER–FLEISSNER 






Austrian Law does not feature a general research or trial exception in its patent law. 






exception? 

Section 22 of the Austria Patent Act 1970 (Federal Law Gazette 1970/259 – ‘Patentgesetz 

1970’ or ‘PatG’) outlines the effects of a patent, giving the patentee the exclusive authority 

to produce, to circulate, to keep for sale, to use and to import for any of the aforementioned 

actions or to own goods according to the patent granted. Even though the patent confers 

exclusive authority, a patentee is in the execution of the patent pursuant to Sec. 30 PatG 

still bound by substantive Austrian law, for example, covering drugs and medicines. “Use” 

as understood by Austrian Patent law, is every use within a business enterprise; solely use 

for personal purposes, home use and use for teaching purposes1 is not covered by the 

provision. 

Austrian Patent law does recognise a Bolar-type exception as put forth in Sec. 22 para. 3 

PatG, clearly exempting clinical studies and related tests as well as practical requirements 

evolving out of them from the scope of a patent, as far as they are necessary to obtain an 

authorisation for a product under pharmaceutical laws. 




Parallel imports into Austria are permitted when, and only when, the respective products have 

already been introduced into the market of the EEA by the patentee2 . 

There is no case law whether this also applies in the case of compulsory licenses. 

1 Friebel/Pulitzer, Patentrecht 2 , 213. 

2 Urlesberger, Gibt es einen gemeinsamen Markt für Arzneien?, ÖBl. 2006, 4. 

051-054_Q202_Austria.indd 51 17.07.2009 09:38:44 

51


conditions? 

Austrian patent law does not recognise an explicit exception for individual prescriptions. In 

any case, the question remains whether a one time infringement by an individual person may 

fulfil the criterion of commercial use which can be defined as being based on repeatable 

economic activity which follows a certain plan. 3 




Austrian Patent Law does not allow for patents on methods of medical treatment (§ 2 (1) Z 2 

PatG in accordance with Art 27 para.3 TRIPS). 






Sections 36 and 37 of the PatG provide for compulsory licenses, but set forth a series of 

requirements for compulsory licenses to be granted and also distinguish between various 

grounds, on which a compulsory license might be granted. Especially Sec. 36 paras. 1, 4 

and 5 are of interest for the response to the question above. 

Sec. 36 para 1 PatG establishes the case for compulsory licenses on the ground of 

dependency. In the case, that a younger patent can only be used by infringing an older 

patent, its proprietor is, under the prerequisite that the younger patent represents an important 

technical progress of considerable economic value, entitled to a non-exclusive license for the 

older patent. Austrian law provides also for the proprietor of the older patent to be able to 

claim a licence for the younger patent in return. 

A completely different scenario is dealt with in Sec. 36 para. 4 PatG, where compulsory 

licenses of non-exclusive nature are foreseen should a patent not be used or not be used to 

an appropriate extent within the borders of Austria. Under the condition that the patentee 

has not undertaken all necessary steps for the exercise of the patent in an appropriate 

manner, anybody can claim a license for his company, unless the patentee can prove that 

insurmountable obstacles impede the full, or as a second option broader exercise of his rights 

to the patent. 

The third, and for the purpose of this examination, most important norm on compulsory 

licenses can be found in Sec. 36 para. 5 PatG. It provides for non-exclusive licenses for 

anybody’s company in case public interest demands licensing of a patented invention. The 

federal government does not need prove its need of the license for a company. 

Should, in the first two case scenarios, the holder of the older patent refuse to grant a license 

to an applicant, who exerted himself to receive the necessary approval within an appropriate 

period of time, the applicant may turn to the Austrian Patent Office and move to be granted 

such a compulsory license within the procedural rules for the challenge of patents. This rule, 

set forth in Sec. 37 para. 1 Pat G does, however, not apply to cases of compulsory licenses 

based on Sec. 36 para. 5 PatG, as theses licenses can, in times of national states of emergency 

or other situations of utmost urgency, be granted via a preliminary authorization. 

To this date, we are not aware of any compulsory licenses published within the territory of 

Austria. 

3 Austrian Supreme Court 22.5.1973, ÖBl 1973, 126. 

52 

051-054_Q202_Austria.indd 52 17.07.2009 09:38:44






Austria, who joined the GATT (General Agreement on Tariffs and Trade) on January 1, 1951, 

is also a member state of the WTO4 , thus a probable addressee of TRIPS-rules. 

The August 30, 2003 decision by the WTO General Council on the implementation of 

Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health removed 

certain limitations put on compulsory licenses especially in connection with less- or lesser 

developed countries, which cannot themselves produce drugs, but would need to import 

them. In 2005, a protocol of amendment to the TRIPS was adopted to permanently transfer 

this waiver into WTO law. 5 

As a member of the European Union, Austria is bound6 by the declaration of the presidency 

of the Council of the European Union where the Presidency titled “Instrument of Acceptance” 7 , 

which declared all member states of the European Union to be bound by protocol implementing 

the decision of August 30, 2003. As soon as the amendment will enter into force, Austria will 

thus be bound by its content. 

Up to this moment, we are not aware of any compulsory license granted for the importation 

or exportation of pharmaceutical products with regards to Austria. 



Under no circumstance is the government allowed to make use of a patented invention without 

previous license with the only exception being the possibility of a preliminary authorization in 

the case of a compulsory license pursuant to Sec. 36 para. 5 PatG and the prevalent state of 

public emergency according to Sec. 37 para. 3 PatG. 


As a patent is nothing but an asset, its protection from any violation from the side of the 

government has to be analyzed from the view of Art 5 of the Constitutional Act of 1867 

(“Staatsgrundgesetz”). This article protects any private property from any violation and 

clearly states that expropriation is only permitted if it is provided for by Austrian laws. Which 

further leads us back to the Patent Act, where a permission to expropriate cannot be found. 

However, one has even at that point to bear in mind, that compulsory licensing within the 

framework of Sec. 36 para. 5 and Sec. 37 para. 3 PatG indeed provides for something very 

close to expropriation, licensing in a preliminary ruling in cases of emergency. It is exactly 

the wording “states of emergency and other situations of utmost urgency” that will justify a 

violation, as it is a rule set forth by Austrian law – the requirement for Art 5 leg. cit. 





4 Country Information on Member States – Austria, 

http://www.wto.org/english/thewto_e/countries_e/austria_e.htm, last visited on July 9, 2008. 

5 Amendment to the TRIPS Agreement of 8 December 2005, WT/L/641, 

http://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm. 

6 See also Article 300 para. 7 of the EC-Treaty. 

7 Available online under http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm. 

051-054_Q202_Austria.indd 53 17.07.2009 09:38:44 

53

The only reference to public emergency, also covering public health crises, is put forth in Sec. 

37. para 3. PatG where it is stated that in case of public emergency compulsory licenses may 

be granted in a preliminary decision. Apart from this, public emergency does not pose as an 

exception of Austrian patent law. 













No, because investments in innovation needs to be compensated and expropriation, 

compulsory licensing and a lot of exceptions is contrary to it. 



No. 




No, because we are against too many limitations. The first two examples are already more 

or less harmonized. Harmonization is also not necessary since research will be made in 

countries where it is allowed and if a country wants to attract more research, it will react 

on its own and, if not, why should it be forced to do it? We also think that harmonization is 

practically impossible – most countries have research exceptions either I the written law or by 

case law under the concept “patents should not hinder further innovation” but what exactly is 

allowed and what not, differs widely and could only be harmonized by a common Supreme 

Court like the ECJ. 

54 

051-054_Q202_Austria.indd 54 17.07.2009 09:38:44

Questions 

Belgium 

Belgique 

Belgien 

Report Q202 

in the name of the Belgian Group 

by Mireille BUYDENS, Eric DE GRYSE, Carl DE MEYER, 

Renaud DUPONT, Gabriel KIROUBA, Francis LEYDER and Benoît STROWEL 






The experimental use exception was provided by article 28 §1 b) of the Belgian Patent Act of 

28 March 1984, which stated that “The rights conferred by the patent shall not extend to acts 

done for experimental purposes relating to the subject matter of the patented invention”. 

There was some legal uncertainty as to the exact scope of this research exception. Although 

it was accepted by case law that it would not be an infringement to use the patented 

invention to “assess the merits of the invention and to discover its shortcomings and possible 

improvements”, this use must not go beyond a “disinterested purpose” experimentation 1 . 

Article 28 §1 b) of the Belgian Patent Act of 28 March 1984 has been modified by the law 

of 28 April 2005, implementing also the European directive 98/44/CE of 6 July 1998 on 

the legal protection of biotechnological inventions. The text now provides that “The rights 

conferred by the patent shall not extend to acts done for scientific purposes with or on the 

subject matter of the patented invention”. 

During discussions in Parliament it was stated that the term “on” refers to experiments to verify 

the function, efficiency or working condition of the object of the patent, while the term “with” 

refers to experiments in which the patented invention itself is used for research as a means 

or an instrument 2 . 

The new wording of article 28 §1 b) of the Belgian Patent Act shows an intent of the legislator 

to guarantee the application of the exception in all cases involving scientific research. The 

expression “for scientific purposes” may therefore be interpreted in a broad sense, so that 

the research exception can encompass all acts with a purely scientific character, but also so 

called “mixed” acts that are committed for both scientific and commercial purposes. Acts 

committed and intended for commercial purposes only, without any scientific purpose or 

intent, are therefore excluded from this exception. 

1 Brussels, 11 May 1995, Ing.-Cons., 1995, p.254 – Fabricom Air Conditioning v. ABB Flakt AB. 

2 Parl Chambre, 2004-2005, DOC 51 1348/006, p. 58 and 59 (available at http ://www.lachambre.be /FLWB/ 

PDF/51/1348/51K1348006.pdf) 

055-062_Q202_Belgium.indd 55 17.07.2009 09:40:03 

55






exception? 

The Bolar provision has been implemented by amending the Belgian Act on Medicinal 

Products of 25 March 1964, rather than through an amendment of the Belgian Patent Act of 

28 March 1984. 

Article 6bis, 1, of the Belgian Act on Medicinal Products, amended by the law of 1st May 

2006, is almost identical to article 10 of the Directive 2004/27/EC amending Directive 

2001/83/EC on the EU code relating to Medicinal Products for Human Use. Article 6bis, 

1, of the Belgian Act on Medicinal Products reads as follows: “Conducting the necessary 

studies, tests and trials with a view to meeting the conditions and modalities referred to in 

the sections 1 to 8 of this paragraph and the consequential practical requirements shall not 

be regarded as contrary to patent rights or to supplementary protection certificates (…)”. In 

comparison to article 10 of the Directive, the word “tests” has been added into the Belgian 

text. Discussions in Parliament have not clarified this difference which appears to be without 

further consequences. 

This exception is meant to exclude from the scope of protection of patents and supplementary 

protection certificates, studies, tests and bioequivalence tests, performed in order to obtain 

a marketing authorization of a generic drug. Neither the Belgian Act on Medicinal Products 

nor the preparatory works give more details about the specific activities that should fall within 

the exception. 

The scope of the Bolar exception may be clarified further by the European Court of Justice 

whenever a national court refers a question to it on the interpretation of the exemption. 

Before the implementation of the Bolar exception in Belgian law, the Brussels Court of appeal 

had already admitted that the mere fact of filing an administrative request for obtaining a 

marketing authorization for a generic drug, without such request entailing the submission 

and hence introduction of any sample on Belgian territory, could not be considered as an 

infringement of the original patented drug3 . 




Parallel importation is permitted under both Belgian law and EC law. 

Under the Belgian Patent Act, article 28 §2 provides that the rights conferred by a patent shall 

not extend to “acts relating to a product covered by that patent which are committed on the 

Belgian territory after that product has been put on the market in Belgium by the owner of the 

patent or with his express consent”. 

Under EC law, the theory of exhaustion of rights will lead to the same result albeit on a 

Community wide basis: whenever goods are placed on the market of a member state within 

the Community by a holder of an intellectual property right, or with his consent, the intellectual 

property right shall be exhausted. Once the product has been put on the market, the right 

holder is assumed to be rewarded adequately for his intellectual property right. 

3 Brussels 10 November 2000, I.R D.I. 2001, 63. Ely Lilly vs Eurogenerics. 

56 

055-062_Q202_Belgium.indd 56 17.07.2009 09:40:03

The rule that patent rights shall be exhausted whenever the goods are placed on the market 

in Belgium or in another member state within the Community by a holder of an intellectual 

property right, or with his consent, is applicable for any type of patented products, including 

pharmaceutical products or medical devices. 

In case of pharmaceutical products originating from markets where they were made available 

under a compulsory license, parallel importation shall not be allowed since the patent holder 

did not give his consent for the production and eventual placing on the market of its patented 

product4 . 

This rule is confirmed by article 13 §1 of the EC Regulation N° 816/2006 on compulsory 

licensing of patents relating to the manufacture of pharmaceutical products for export into 

countries with public health problems, which prohibits the re-importation into the Community 

of products manufactured under a compulsory license granted pursuant this Regulation. 


conditions? 

The Belgian Patent Act organizes an individual prescriptions exception under article 28 

§1 c). This article provides that the rights conferred by the patent shall not extend to “the 

extemporaneous preparation for individual cases in a pharmacy of a medicine in accordance 

with a medical prescription or acts concerning the medicine so prepared”. 

In order to prevent misuse, it is required that the preparation of the medicine is effected upon 

individual prescription, for immediate use or administration, and in a pharmacy (hence not 

in an industrial enterprise). 




Article 7 of the Belgian Patent Act provides that methods for treatment of the human or animal 

body by surgery or therapy and diagnostic methods practiced on the human or animal body 

shall not be regarded as patentable inventions. 






Compulsory licences are provided by article 31 and 31bis of the Belgian Patent Act of 28 

March 1984. 

The main grounds on which a compulsory license can be granted pursuant to article 31 of the 

Belgian Patent Act of 28 March 1984 are the following 5 : 

1) When the patentee fails to exploit his invention on Belgian territory, without a valid 

justification, within either four years from the application or three years from grant, 

whereby the longest term shall be applied (article 31 §1.1°); 

2) When a patent cannot be exploited without infringing the rights conferred by a patent 

granted on an earlier filing, insofar as the dependent patent permits an important 

technical progress of considerable economic significance in relation to the invention 

claimed in the dominant patent (article 31 §1.2°); 

4 ECJ 9 July 1985, Pharmon BV v. Hoechst AG, ECR, 1985, 2281. 

5 Article 31 provides for two other instances of Compulsory licensing but these seem irrelevant to Question 202. 

055-062_Q202_Belgium.indd 57 17.07.2009 09:40:03 

57

In both instances, the license can only be granted primarily or predominantly for the supply 

of the domestic market. In order to be granted a compulsory license, it is up to the applicant 

to prove that: 

1) The requirements of Article 31 §1° or 2° apply to the owner of the patent; 

2) The applicant has applied in vain to the owner of the patent for a voluntary license; 

3) In case a license is applied for under Article 31 §1.1°, the Applicant has the necessary 

means to undertake effective and continuous manufacturing in Belgium in accordance 

with the patented invention. 

In relation to public health and pursuant to articles 8 and 30 of the TRIPs Agreement, the 

Belgian legislator has provided for an additional compulsory licensing mechanism in article 

31 bis of the Belgian Patent Act. When deemed in the interest of public health, the Government 

may grant a license for the exploitation and application of an invention protected by a patent 

for: 

1) A medicine, a medical device, a product or medical device used for performing a 

diagnosis, a derived or combinable therapeutic product; 

2) The process or product necessary for the manufacture of one or more products indicated 

under a); 

3) A diagnostic method applied outside of the human or animal body. 

In order to be granted a compulsory license under article 31bis of the Belgian Patent Act, 

it is up to the applicant to prove that he has the necessary means or bona fide intention to 

undertake effective and continuous manufacturing in Belgium in accordance with the patented 

invention. 

The request for a compulsory license in the interest of public health must be submitted to the 

Minister of Public Health with a copy for the Consultative Bioethical Committee. The patentee 

shall be allowed to make observations and the Consultative Bioethical Committee shall issue 

a reasoned recommendation. Upon said recommendation, the Minister shall then decide but 

he must formally justify the decision that is made. 






The Belgian legislator has not implemented article 31 bis of the TRIPs agreement in Belgium. 

As of the present date, no legislative initiative was taken by the Belgian parliament in order 

to formally implement the WTO decision of 30 August 2003. 

However, through the adoption of the European Regulation N° 816/2006 on compulsory 

licensing of patents relating to the manufacture of pharmaceutical products for export to 

countries with public health problems, which aims at addressing public health problems 

faced by least developed countries and other developing countries by improving access to 

affordable medicines for these countries, article 31bis TRIPs as well the WTO decision of 

August 30, 2003 may be considered to have been implemented within the Belgian legal 

system as well. Within the European Union, regulations are indeed directly enforceable in 

the Member States. 

It should also be noted that a proposition of law dated 27 December 2007 has been recently 

submitted to the Belgian Senate in order to amend article 28§1 of the Belgian Patent Act of 28 

March 1984. The purpose of this proposition of law is to facilitate the exportation of generic 

58 

055-062_Q202_Belgium.indd 58 17.07.2009 09:40:03

drugs to developing countries which have emitted compulsory licenses in order to deal with 

the major health problems of these countries. As far as we know, the Government has as yet 

not supported this proposition of law. 

So far, no compulsory license of this type has been granted in Belgium for the import or 

export of pharmaceutical products. 



No such specific provision exists under the Belgian law. 


No such specific provision exists under the Belgian law. 





There are no other specific means under Belgian patent law. 


The Belgian Group favours uniform rules and therefore replies as follows: 



Yes. 


Yes. 


Yes. 


Yes. 


Insofar there is a need for a medical treatment defence exception; the Belgian group is 

of opinion that this issue should also be harmonized taking into account both the interests 

of the public health and patent holder. 


Yes. 


The Belgian group is of opinion that compulsory licence mechanisms should be adequate 

to address public health or any other public interest issues and that the expropriation of 

a patent holder from its patented product is disproportionate and goes beyond what is 

necessary. 



No. 

055-062_Q202_Belgium.indd 59 17.07.2009 09:40:03 

59



The Belgian Group has no specific proposals to make. 




The Belgian Group considers that harmonisation is recommended for all three exceptions. 

A common interpretation of these exceptions should avoid discrepancies from country to 

country and allow effective and coherent exploitation of the patent for the rights holder. 

A harmonized research and experimental use exception in particular seems to be necessary 

to encourage the development of both medicine and technology, without putting at risk 

the incentive to innovation, or creating an arbitrary concentration of research activities in 

countries which have the broadest interpretation of this exception. 

Summary 

— In Belgium, Article 28 §1 b) of the Belgian Patent Act provides a research or experimental use 

exception which can encompass all acts with a purely scientific character, but also acts that 

are committed for both scientific and commercial purposes. 

— Article 6bis, 1, of the Belgian Act on Medicinal Products contains a Bolar provision which is 

almost identical to article 10 of the Directive 2004/27/EC. 

— Article 28 § 2 of the Belgian patent act contains the principle of exhaustion of rights which 

is similar to the exhaustion of rights in EC law, albeit on a national basis. Therefore parallel 

imports in Belgium are in principle allowed. 

— The Belgian Patent Act organizes an individual prescriptions exception under article 28 

§1 c). 

— Compulsory licences are provided by article 31 and 31bis of the Belgian Patent Act. 

— Article 31 bis of the TRIPs agreement or the WTO decision of August 30, 2003, may be 

considered to have been implemented within the Belgian legal system by the adoption of 

European Regulation N° 816/2006 which is directly enforceable in the Member States. A 

proposition of law dated 27 December 2007 has recently been submitted to the Belgian 

Senate in order to amend the Belgian Patent Act to facilitate the exportation of generic drugs 

to developing countries which have emitted compulsory licenses. 

Résumé 

— En Belgique, l’article 28 §1 b) de la Loi belge sur les brevets d’invention prévoit une exception 

pour l’usage à des fins expérimentales ou de recherche, qui inclut tous les actes à caractère 

purement scientifique mais qui peut également s’étendre aux actes qui combinent des fins 

scientifiques et commerciales. 

— L’article 6 bis 1, de la Loi belge sur les Produits Médicinaux contient une disposition Bolar qui 

est quasiment identique à l’article 10 de la Directive 2004/27/CE. 

— L’article 28 §2 de la Loi belge sur les brevets d’invention contient le principe de l’épuisement 

des droits, qui est similaire à l’épuisement des droits en droit européen, bien qu’il ait une 

60 

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ase nationale. Pour cette raison les importations parallèles en Belgique sont, en principe, 

autorisées. 

— La Loi belge sur les brevets d’invention organise une exception de prescription individuelle à 

l’article 28 §1 c). 

— Des licences obligatoires peuvent être octroyées conformément aux articles 31 et 31 bis de 

la Loi belge sur les brevets d’invention. 

— L’article 31 bis des ADPIC ou la décision de l’OMC du 30 août 2003 peut être considérée 

comme ayant été transposée dans le système belge par l’adoption du Règlement 816/2006 

qui est directement applicable dans les Etats membres. Une proposition de loi datée du 27 

décembre 2007 a récemment été soumise au Sénat en vue de modifier la Loi belge sur les 

brevets d’invention pour faciliter les exportations de médicaments génériques vers les pays 

en voie de développement qui ont émis des licences obligatoires. 

055-062_Q202_Belgium.indd 61 17.07.2009 09:40:03 

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055-062_Q202_Belgium.indd 62 17.07.2009 09:40:03

Questions 

Brazil 

Brésil 

Brasilien 

Report Q202 

in the name of the Brazilian Group 

by Joao Luis D’OREY FACCO VIANNA and Maitê Cecilia FABBRI MORO 






Yes. Acts practiced by unauthorized third parties for experimental purposes, related to 

studies or to scientific or technological research are expressly determined not to characterize 

infringement of a patent. There is not an established understanding of what would be the 

scope of this research exception, and no case law has been affirmed in this connection. 

Unauthorized third parties cannot use the patented invention for a commercial purpose. 






exception? 

A Bolar-type exception is recognized under the Brazilian Industrial Property Law (Law n. 

9,279/96, hereinafter “BIPL”). The exception encompasses acts carried out to produce 

information, data and test results to seek market approval in Brazil or abroad in order to 

exploit or commercialize the patented product after the patent in question has expired. 

Brazilian legislation does not narrow this provision only to drugs. It literally refers to “products” 

and hence it can be inferred that biological products and research tools are comprehended 

within this exception. 




In principle, parallel importation is not permitted in Brazil. The unauthorized importation of a 

product protected by a patent is considered as patent infringement, but not a criminal offense, 

and, therefore, is subject only to civil sanctions. Importation can be admitted in situations in 

which a compulsory license has been granted in Brazil due to abuse of the economic power 

perpetuated by the patent owner for the period of one year, this permission applying to the 

licensee proposing to manufacture locally, provided it is placed on the market directly by 

the patentee or with his consent. The importation by third parties of a product manufactured 

according to a process or product patent is also allowed in our country in the case wherein 

063-068_Q202_Brazil.indd 63 17.07.2009 09:40:35 

63

the patentee itself exploits the subject-matter of its patent in Brazil by importation due to 

economic inviability for manufacturing same. 


conditions? 

Such an exception is recognized under BIPL. It must refer to the preparation of a medicine 

according to a medical prescription for individual cases, prepared by a qualified professional 

and it covers the medicine thus prepared. 




In Brazil, methods of treatment, as well as operating or surgical techniques are not considered 

to be inventions and thus are not patentable subject-matter. 






Compulsory licenses may be granted under BIPL, and applicable conditions are: 

• use of rights in an abusive manner; 

• abuse of economic power by applying the rights conferred, proven by an administrative 

or court decision; 

• non-exploitation of the subject matter of the patent in Brazil by lack of manufacture or 

incomplete manufacture of the product, except due to economic inviability; 

• lack of complete use of a patented process, except due to economic inviability; 

• when commercialization does not meet the needs of the market; 

• when, cumulatively, a situation of dependency of one patent on another is characterized, 

the subject matter of the dependent patent constitutes a substantial technical advance in 

relation to the earlier patent, and the patentee does not come an agreement with the 

patentee of the dependent patent for the exploitation of the earlier patent; 

• in cases of national emergency or public interest, declared by an act of the Federal 

Executive Authorities. 

In 2007, compulsory licenses of two patents were determined by the Brazilian Government 

based on arguments of public interest regarding invention of anti-HIV drug. The compulsory 

licenses were concluded with the importation, by the government, of the products from 

an Indian company, instead of starting the local production, following the determinations 

established in the Governmental Act that formalized the granting of such licenses. The licensor 

is Merck & Co. Inc., the licensee is the Brazilian Health Ministry and the drug is efavirenz. 

Further to the above case, the Brazilian Patent Office had previously granted four further 

compulsory licenses under the previous Industrial Property Law (Law n. 5772/71) which was 

replaced in 1996 by the current Law (Law n. 9,279/96, BIPL). 

Three compulsory licenses were granted regarding Brazilian Patent No. PI 76.767, referring 

to a process for a viral culture, used for the production of vaccine against aftosa, property 

of National Research Development Corporation and one for Brazilian Patent No. 7.107.076 

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obtained by Nortox Agro-Química S/A in 1984, the patent being property of Monsanto 

Company. 






New article 31 bis of the TRIPS has not been ratified by Brazil. 

Two patents were compulsorily licensed in 2007 based on Article 31 of the TRIPS and Article 

71 of the BIPL. The Governmental Act formalizing the granting of the licenses comprehended 

the possibility of importing the drug object of the patents in order to attend the internal needs. 

The licensor is Merck & Co. Inc., the licensee is the Brazilian Health Ministry and the drug is 

efavirenz. 



No, BIPL does not allow government to use a patented invention without previous license, 

although in case of officially declared national emergency or public interest, a compulsory 

license can be declared ex officio, without prejudice to the rights of the respective patentee. 


BIPL does not establish such possibility. Please note that, according to article 5, XXIV of the 

Brazilian Federal Constitution, the State can expropriate any particular goods, in case of 

public need or utility or social interest, paying a previous monetary indemnification. However, 

no cases of expropriation of patents were registered in Brazil. 





The granting of patents for pharmaceutical products or processes depends on prior consent 

from the National Sanitary Surveillance Agency – ANVISA (equivalent to the US FDA). In 

practical terms, this has meant that patent applications for such subject matter undergo a 

double examination on the merits, one performed by the Brazilian Patent Office and another 

by ANVISA. In many instances, ANVISA’s examination is quite technical, consisting of another 

examination on patentability requirements. However, in some cases, broadly definable 

arguments, such as public interest or national health interests, are used as a basis for denial 

on the needed prior consent for the granting of the patents, thus halting the administrative 

processes at the Brazilian Patent Office, preventing this autarchy from pronouncing their final 

decision, either granting our rejecting the application. An example of ANVISA’s position is the 

objection to the granting of patents for second application of an already known substance. 

There is a clear political bias in ANVISA’s decisions since, although not in large numbers, 

there have been denials on consenting on the granting of patents regarding inventions for 

particular drugs, namely anti-HIV related inventions. ANVISA’s stand seeks to protect the 

public health by assuring access to the medicines. 




063-068_Q202_Brazil.indd 65 17.07.2009 09:40:35 

65










Yes. Patent law should provide for the exemptions to patent holders’ rights, as long as their 

enforcement is directly aimed at achieving a perfect balance between innovation and access 

to drugs, i.e., in order not to harm either development of new drugs or the public health. 

All of the exemptions mentioned in the question are set forth in the BIPL. 



No. There are many other means to facilitate access using governmental and nongovernamental 

aid, however they are not liked with the patent law. 




The limitations of patent rights, specifically the research and experimental use exception, 

Bolar exception, and individual prescriptions exception, should not be harmonized, since it 

should be taken into account the flexibilities in international IP agreements and the different 

levels of development of the countries. 

Summary 

In Brazil, the 1996 Industrial Property Law (BIPL), recognized protection for pharmaceuticals, but 

expressly forbade patent protection for methods of medical treatment. Acts practiced by unauthorized 

third parties for experimental purposes in connection with scientific, technological studies or 

research, may not be considered a patent infringement. Bolar type exception and preparation 

of a medicine according to a medical prescription for individual cases are accepted by BIPL and 

parallel importation is permitted in some very specific cases. The National Government shall not 

explore a patent without a license, however expropriation is possible, since its proceedings obey 

the due process of law and the IPR owner is duly compensated. BIPL guarantees the possibility of 

compulsory license under determined conditions. Since there were compulsory licenses determined 

ex officio by the Government in 2007, the Brazilian Group understands that the Government 

interpretation of this provision is not adequate. Another issue considered by the Group is the 

necessary consent of the National Sanitary Surveillance Agency – ANVISA (equivalent to the US 

FDA) for granting patents of pharmaceutical products. 

Résumé 

Au Brésil, la Loi de Propriété Industrielle (LPI) de 1996, a reconnue la protection des produits 

pharmaceutiques, mais a interdit de forme explicite la protection par brevet des méthodes de 

traitement médical. Des actes pratiqués pour des tiers non autorisés dans un but expérimental, liés 

à des études scientifiques, technologiques ou à des recherches, ne serait probablement considéré 

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une infraction de brevet. L’exception du type Bolar et la préparation de médicaments en accord 

avec la prescription médicale pour les cas individuels sont admis par la LPI et l’importation parallèle 

est permit dans quelques cas bien spécifiés. Le Gouvernement national n’est pas autorisé a explorer 

un brevet sans licence, de toute façon l’expropriation est possible, pourvu que le procès légale soit 

observé et le titulaire soit dûment compensé. La LPI garantie la possibilité de licence obligatoire 

sous de conditions déterminés. Aussitôt qu’il y a eu des licences obligatoires déterminées ex officio 

par le Gouvernement en 2007, le Groupe brésilien comprend que l’interprétation gouvernementale 

de ce dispositif légale n’est pas adéquat. Une autre question considéré par le Groupe était la 

nécessité de l’assentiment de l’Agente National de Surveillance Sanitaire – ANVISA (équivalent de 

la nord américaine FDA) pour la concession de brevets de produits pharmaceutiques. 


In Brasilien anerkannte das 1996 Gesetz zum gewerblichen Eigentum (BIPL) den Schutz für 

Arzneimittel, aber verbat ausdrücklich den Patentschutz für Methoden der medizinischen 

Behandlung. Die von unerlaubten Dritten praktizierten Handlungen, die für experimentelle Zwecke 

in Verbindung mit wissenschaftlichen, technologischen Studien oder Forschungen geübt werden, 

dürfen nicht als Patentverletzung angenommen werden. Die Bolar Ausnahme und die Vorbereitung 

eines Medikaments nach einer ärztlichen Verschreibung für gegebene Fälle werden von BIPL 

zugelassen, und parallele Einfuhr ist in einigen ganz spezifischen Fällen erlaubt. Die Nationale 

Regierung darf nicht ein Patent ohne Lizenz nutzen; dennoch ist die Nutzung möglich, wenn das 

rechtliche Verfahren beobachtet wird und der Rechtsinhaber die entsprechende Entschädigung 

bekommt. BIPL gewährt die Möglichkeit der Zwangslizenz unter gegebenen Voraussetzungen. Da 

2007 die Regierung Zwangslizenzen von Amts angeordnet hat, versteht die brasilianische Gruppe, 

dass die Auslegung der Regierung auf dieser Bestimmung nicht angemessen ist. Ein weiteres 

Problem, das von der Gruppe beobachtet wurde, ist die notwendige Zustimmung der Nationalen 

Sanitären Agentur – ANVISA (gleichbedeutend mit der US FDA) für die Gewährung von Patenten 

in Bezug auf pharmazeutische Produkte. 

063-068_Q202_Brazil.indd 67 17.07.2009 09:40:36 

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063-068_Q202_Brazil.indd 68 17.07.2009 09:40:36

Questions 

Bulgaria 

Bulgarie 

Bulgarien 

Report Q202 

in the name of the Bulgarian Group 

by Valentina NESHEVA 






The exclusive rights of the Patentees are subject to exceptions in cases of use for experimental 

purposes or scientific research. The condition is that the experiments and research must relate 

to the object of the patent used. This condition only defines the scope of the research or 

experimental use exception. There is no explicit prohibition for commercial use in the research 

and experimental use exception but eventual interpretation of the legal provision should 

come to this conclusion because scientific research and experiments by definition are noncommercial 

activities although their outcome can be used commercially if this commercial use 

does not violate others’ rights such as patent rights. 






exception? 

Bulgarian legislation provides for Bolar type exception. The producer of generic pharmaceutical 

product does not need the consent of the Patentee to apply for marketing authorization 

permit before the expiration date of the patent for the reference product if already 8 years 

have passed since the first marketing authorization permit issued within EU. In any case the 

producer of the generic product cannot release it on the market before the expiration of 10 

years after the first marketing authorization permit issued to the reference patented product 

within EU. The exception relates only to pharmaceutical products and such other products that 

may fall within the scope of the research and experimental use exception. 




The parallel import of patented products is not explicitly regulated as such. However the 

regulation of exhaustion of rights can be interpreted to make the conclusion that the parallel 

import on the territory of EU is now allowed. However there is no court practice regarding 

patents at all and the court practice on this subject with regard to trademarks is not uniform. 

069-072_Q202_Bulgaria.indd 69 17.07.2009 09:41:06 

69


conditions? 

Individual prescriptions exception is recognized under the Bulgarian patent law. It is allowed 

only in the case of single immediate preparation of a medicine in a pharmacy according to 

a medical doctor’s prescription. 




Methods of medical treatment are not patentable in Bulgaria. 






Compulsory licenses are available under the Bulgarian patent law. The conditions and 

limitations under which the compulsory license is granted are numerous. In the first place 

the party requesting such a license must have negotiated with the Patentee for a contractual 

license at fair terms and not only once at that. On the other hand the invention must not have 

been used for 4 years after the filing date of the patent application or 3 years after the grant 

of the patent whatever term expires later or the invention must not have been used sufficiently 

to satisfy the national market and there is no serious reason for this inadequate use. The party 

requesting the compulsory license must prove that it is able to use the invention within the 

limits of the requested license and the granted license will be declared void if the preparation 

for the use of the invention according to the granted compulsory license has not started within 

one year after the grant of such license. Lastly a compulsory license cannot be exclusive 

license but only non-exclusive one. 

There is another type of compulsory license – it is requested and granted even if no 

negotiations were conducted with the Patentee but the national interest requires that such a 

license is granted. 

Finally there is another type of compulsory license – the so called cross license which is 

granted in cases when a patented invention with later priority date falls within the scope 

of protection of a patent with an earlier priority date and the later invention represents an 

important technical progress with a significant economic importance in comparison with the 

earlier invention. 

We are not aware of any compulsory licenses granted lately. 






Yes. 



The type of compulsory license described above as granted without previous negotiations 

with the holder of a patent and in case the national interest requires that such a license is 

granted, can be granted to government entities. 

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The government is not allowed to expropriate a patent. 





The patent law does not recognize other means for facilitating access to medicines but 

other laws do – the Law on Medicinal Products for Human Medicine provides for the use 

of pharmaceutical products without marketing authorization permit in cases of epidemics, 

spreading of chemical agents or nuclear radiation. Furthermore this Law admits the use of 

certain products without marketing authorization permit and such is not required at all – e.g. 

medicines prepared in pharmacies under certain conditions, intermittent products used by a 

holder of marketing authorization permit, active and auxiliary substances. The Drug Agency 

provides information to the public about granted marketing authorization permits within 14 

days after the grant. 







All these exceptions are foreseen by the Bulgarian legislation and they seem to us sensible 

and necessary in order to guarantee the public health and to provide the people with 

cost-effective medicines. 


Methods for medical treatment are not patentable under the Bulgarian and European 

patent laws and they should stay so in view of the fact that people across the world are 

not uniform and therefore the applicability of a method of medical treatment with uniform 

results is highly questionable. 


The presence of compulsory licensing as a tool for overcoming unreasonable demands 

on the part of patent holders is useful and necessary especially in cases of inventions with 

great public importance. However there is no doubt that compulsory licensing cannot be 

the rule but only a rare exception. Our opinion is that Bulgarian patent law has dealt with 

this problem quite adequately providing for many limitations and conditions to be fulfilled 

before the grant of a compulsory license. 


Expropriation of a patent seems to be very severe measure violating basic rights of a 

person in democratic society. It should not be allowed. 




Patent rights are anyway additionally limited by the expensive patenting procedures, slow 

prosecution of patent infringement lawsuits and the lack of specialized patent courts in many 

countries. There is no need to limit further the rights of patent holders. 

069-072_Q202_Bulgaria.indd 71 17.07.2009 09:41:06 

71



No. 




It would be advisable to harmonize the limitations of patent rights. The limitations of the 

patent rights in any case should not be used to get round the law and make profit of it, 

therefore any exceptions should exclude commercial use of a patented invention without the 

consent of the Patentee. 

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069-072_Q202_Bulgaria.indd 72 17.07.2009 09:41:06

Questions 

Canada 

Canada 

Kanada 

Report Q202 

in the name of the Canadian Group 

by France Côté and Bill Mayo 






the courts in Canada have recognized an experimental use exception to patent infringement. 

Experimentation for the purpose of establishing a person’s ability to use the invention will not 

constitute infringement provided there is no commercial use. 

there is some uncertainty as to what will constitute an experimental use within this common 

law exception. In a recent decision of the Federal Court of Canada, the experimental use 

exception, also referred to as “fair dealing”, was described as follows1 : 

the Supreme Court in Micro Chemicals, supra, at pages 518 to 520 affirmed a decision of 

the English Court of appeal in Frearson v. Loe (1878), 9 Ch. D. 48, which states that there is 

a doctrine of “fair dealing” in respect of patent infringement: 

Patent rights were never granted to prevent persons of ingenuity exercising their talents in a 

fair way. But if there be neither using nor vending of the invention for profit, the mere making 

for the purpose of experiment, and not for a fraudulent purpose, ought not to be considered 

within the prohibition and, if it were, it is certainly not the subject for an injunction. 

the Supreme Court in Micro Chemicals held it to be significant that the Trial Judge had found 

that small amounts of the patented compound had been produced, put in bottles, kept by 

Micro and never entered into commerce and no damage was suffered by the patentee and 

no profits made by Micro. They held that the Trial Judge was in error in finding that such 

activity constituted infringement. they found that an experimental user, without a license, in 

the course of bona fide experiments with a patented article was not an infringement. the 

use of the product, not for profit, but to establish the fact that a person could manufacture a 

product in accordance with the patent, was not an infringement. 




1 Merck v. Apotex [2006] FCJ No. 671, 53 CPR (4 th )1 at paras 160-161, affd. [2006] FCJ No. 1490, 55 CPR (4 th ) 1 at 

paras 105-113. In this case, it was found that the use of lisinopril in ongoing research and development of alternate 

formulations, alternate techniques for tablet making and the like was within the experimental use exception. 

073-080_Q202_Canada.indd 73 17.07.2009 09:51:39 

73



exception? 

Canada does have a Bolar-type exception, which is provided under section 55.2 of the Patent 

Act SC 1993, c.2: 

Exception 

55.2 (1) It is not an infringement of a patent for any person to make, 

construct, use or sell the patented invention solely for uses reasonably 

related to the development and submission of information required 

under any law of Canada, a province or a country other than Canada that regulates 

the manufacture, construction, use or sale of any product. 

[…] 

For greater certainty 

(6) For greater certainty, subsection (1) does not affect any exception to 

the exclusive property or privilege granted by a patent that exists 

at law in respect of acts done privately and on a non-commercial 

scale or for a non-commercial purpose or in respect of any use, manufacture, 

construction or sale of the patented invention solely for the purpose of experiments that relate 

to the subject-matter of the patent. 

This provision, also referred to as the “early working exception”, was added to the Act in 1993 

and while it is primarily directed to the food and pharmaceutical industries, it specifically 

states that it applies to “any product”. 2 However, the policy objective in adding this exception 

was to “balance the effective patent enforcement over new and innovative drugs with the 

timely entry of their lower priced generic competitors”. 

More specifically, the early-working exception was intended to encourage timely generic 

competition by allowing generic drug companies to develop a drug and take the necessary 

steps to obtain regulatory approval while the equivalent brand-name drug is still under patent. 

This enables generic drug companies to enter the market as soon as the patents for the brandname 

drug expire. 

Section 55.2 also allows the government to “make such regulations as the Governor in 

Counsel considers necessary for preventing the infringement of a patent by any person who 

makes, constructs, uses or sells a patented invention in accordance with subsection 1….”. 

Regulations enacted under that provision, the Patented Medicines (Notice of Compliance) 

Regulations (the “PM(NOC) Regulations”), were intended to provide a patent enforcement 

mechanism to ensure that the early working exception is not abused and that generic drugs 

are not sold before relevant patent expiry. 

Under the PM(NOC) Regulations, a pharmaceutical manufacturer (typically a brand or 

innovative manufacturer) can list patents that are relevant to its product on a Patent Register 

maintained by Health Canada3 . a subsequent manufacturer (typically a generic manufacturer) 

2 When the “Bolar”-type exception to infringement was added to the Patent Act in 1993, a further exception was also 

added to allow the production and stockpiling of an otherwise infringing product for a prescribed period of time prior 

to patent expiry (Section 55.2(2)). However, this exception, along with the early working exception, was challenged by 

the European Union under the WTO dispute settlement mechanism. The WTO panel decision confirmed that an early 

working exception is consistent with the TRIPs Agreement, even in the absence of an extended period of protection 

for the patent, but considered that the right to manufacture and stockpile before the expiration of the patent was not 

consistent with the TRIPs Agreement (see WT/DS114/R, 17 March, 2.000). 

3 Pursuant to sections 3 and 4 of the PM(NOC) Regulations, Health Canada is required to maintain a public register of 

patents and other information submitted by first persons. The requirements that must be met before a patent can be 

listed on the Patent Register are provided by section 4 of the PM(NOC) Regulations. Section 4 describes (i) the timing 

of filing of patent lists; (ii) the information that must be provided on a patent list; (iii) the type of drug submissions for 

which a patent list may be filed; and (iv) more substantive eligibility requirements relating to the claims of the patent. 

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seeking to copy a patented innovative drug is required to address the patents listed on the 

Patent Register against that innovative drug. The subsequent manufacturer may either agree 

to wait for expiry of the patent before receiving regulatory approval (i.e. issuance of a 

compliance or “NOC”) or challenge the patent by making an allegation of non-infringement 

or invalidity that would justify the issuance of the NOC. The allegation may be accepted by 

the innovator or challenged by way of an application to the Federal Court. If the allegation is 

challenged, an automatic stay is triggered which bars the issuance of a NOC to the generic 

company for 24 months or until the litigation is resolved in its favour, whichever comes first. 

It is important to note that a court proceeding under the PM(NOC) Regulations does not result 

in a declaration of invalidity or non-infringement. It is intended to be a summary proceeding 

simply to determine whether the generic manufacturer should receive its NOC. Accordingly, 

if a generic company is successful in litigation under the PM(NOC) Regulations, the innovator 

company can still bring an action for patent infringement in the normal course. 

the PM(NOC) Regulations were created in 1993, along with the “early-working exception” 

through amendments to the Patent Act brought into force by Bill C-91. Both instruments are 

an integral part of the government’s drug patent policy, which seeks to strike an appropriate 

balance between encouraging continued innovation in new drugs and promoting timely 

generic competition. 




Not applicable. 


conditions? 





Methods of medical treatment per se are not permitted. Swiss style and “use” claims, however, 

are permissible and can be used in Canada to provide patent protection for medical treatment 

to some extent. 






the Canadian Patent Act used to have broad compulsory licensing provisions relating to 

medicines and food, but they were repealed in 1993. Compulsory licences granted under 

those provisions before December 20, 1991, and which had not been terminated before 

February 15, 1993 continue to be enforced. any compulsory licences granted on or after 

December 20, 1991, ceased to have effect as of February 14, 1993. 

In 2004, the Patent Act was amended to allow the Commissioner of Patents to grant compulsory 

licences to facilitate access to pharmaceutical products to address public health problems 

in developing and least developed countries. this is discussed further in the response to 

question 7 below. 

073-080_Q202_Canada.indd 75 17.07.2009 09:51:40 

75

there are also general provisions under the Patent Act that allow the Commissioner of Patents 

to grant a compulsory licence where a patent is “deemed to be abused” pursuant to s. 65(2) 

of the Patent act: 

2) the exclusive rights under a patent shall be deemed to have been abused in any of the 

following circumstances: 

a) and b) [Repealed, 1993, c. 44, s. 196] 

c) if the demand for the patented article in Canada is not being met to an adequate extent 

and on reasonable terms; 

d) if, by reason of the refusal of the patentee to grant a licence or licences on reasonable 

terms, the trade or industry of Canada or the trade of any person or class of persons 

trading in Canada, or the establishment of any new trade or industry in Canada, is 

prejudiced, and it is in the public interest that a licence or licences should be granted; 

e) if any trade or industry in Canada, or any person or class of persons engaged therein, 

is unfairly prejudiced by the conditions attached by the patentee, whether before or after 

the passing of this act, to the purchase, hire, licence or use of the patented article or to 

the using or working of the patented process; or 

f) if it is shown that the existence of the patent, being a patent for an invention relating to 

a process involving the use of materials not protected by the patent or for an invention 

relating to a substance produced by such a process, has been utilized by the patentee so 

as unfairly to prejudice in Canada the manufacture, use or sale of any materials. 

3) and 4) [Repealed, 1993, c. 44, s. 196]. 

In an application under s. 65(2)(c), the party seeking a licence must demonstrate that 

“demand for the patented article in Canada” is not being met “to an adequate extent and on 

reasonable terms”. The party seeking a licence must show that the demand in Canada is a 

general one in the sense that there is a market in Canada that demands the patented article 

and that this demand is not being met. A demand created by the party seeking the licence is 

considered an artificial demand. The party seeking a licence must also show that the group of 

consumers to whom they expect to sell their product do not have access to presently available 

products (Brantford Chemicals Inc. v. Canada (Commissioner of Patents), [2006] F.C.J. No. 

1712; aff’d [2006] F.C.J. No. 1712). 

In an application under s. 65(2)(d), the party seeking a licence must first ask the patentee 

for a licence or, if the patentee is making the product, for the product, giving adequate 

opportunity for response. Three elements must be satisfied to establish abuse: a refusal to 

grant a licence on reasonable terms; prejudice to a trade or industry and not merely to an 

individual party seeking to get into the business; and that the public interest is served by 

granting the licence (Brantford Chemicals Inc. v. Canada (Commissioner of Patents), [2006] 

F.C.J. No. 1712). Where the patentee acknowledged that it had been unable to meet the 

demand, a compulsory licence was granted by the Commissioner at the rate offered by 

the applicant to manufacture and sell in Canada, with the requirement to provide quarterly 

statements and payments (Puckhandler Inc. v. BADS Industries Inc. (1998), 81 C.P.R. 

(3d) 261). 

Mere neglect to answer a request for a licence does not constitute a refusal to license (Sarco 

Co. Inc. v. Sarco Canada Ltd., [1969] 2 Ex. C.R. 190 at 207-208; LPA Plastics (1976) Ltd. 

V. Windsurfing Int’l Inc. (1981) 59 C.P.R. (2d) 188 at 199), ample time for response must be 

provided (Torpharm Inc. v. Merck & Co. (2000), 9 C.P.R. (4th) 520 at 530-533). The trade or 

industry of the applicant, while considered broadly, must mean in general terms the existing 

trade or industry of the applicant (Sarco, supra). 

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If the patent is deemed to be abused, the Commissioner of Patent may order any of the 

following (s. 66): 

66. (1) On being satisfied that a case of abuse of the exclusive rights under a patent has been 

established, the Commissioner may exercise any of the following powers as he may deem 

expedient in the circumstances: 

a) he may order the grant to the applicant of a licence on such terms as the Commissioner 

may think expedient, including a term precluding the licensee from importing into 

Canada any goods the importation of which, if made by persons other than the patentee 

or persons claiming under him, would be an infringement of the patent, and in that 

case the patentee and all licensees for the time being shall be deemed to have mutually 

covenanted against that importation; 

b) [Repealed, 1993, c. 44, s. 197] 

c) if the Commissioner is satisfied that the exclusive rights have been abused in the 

circumstances specified in paragraph 65(2)(f), he may order the grant of licences to the 

applicant and to such of his customers, and containing such terms, as the Commissioner 

may think expedient; 

d) if the Commissioner is satisfied that the objects of this section and section 65 cannot be 

attained by the exercise of any of the foregoing powers, the Commissioner shall order 

the patent to be revoked, either forthwith or after such reasonable interval as may be 

specified in the order, unless in the meantime such conditions as may be specified in 

the order with a view to attaining the objects of this section and section 65 are fulfilled, 

and the Commissioner may, on reasonable cause shown in any case, by subsequent 

order extend the interval so specified, but the Commissioner shall not make an order for 

revocation which is at variance with any treaty, convention, arrangement, or engagement 

with any other country to which Canada is a party; or 

e) if the Commissioner is of opinion that the objects of this section and section 65 will be 

best attained by not making an order under the provisions of this section, he may make 

an order refusing the application and dispose of any question as to costs thereon as he 

thinks just. 

a licence when granted operates as if by way of deed executed by the patentee and all other 

necessary parties. 

Since the provisions relating to compulsory licences were repealed there have been 

no compulsory licences granted in Canada for domestic manufacture and supply of 


More generally, there are not many cases interpreting the compulsory licence provisions 

relating to patent abuse. the only case in which the Commissioner granted a compulsory 

licence under these provisions is Puckhandler Inc. v. BADS Industries, Inc. (1998), 81 C.P.R. 

(3d) 261 (Comm’r). In this case the Commissioner granted the applicant a non-exclusive 

compulsory licence under s. 65(2)(c), after the patentee acknowledged that there had been a 

failure to fulfill the demand for the patented article. The patent in this case related to a hockey 

training device, not a pharmaceutical product. 

There are two cases where an applicant seeking a compulsory licence with respect to a 

pharmaceutical. In both cases, the applicant was unsuccessful. In Brantford Chemicals Inc. 

v. Merck & Co. (2005), 29 C.P.R. (4th ) 380, Brantford Chemicals brought an application for 

a licence under s. 65(2)(c) and (d) of the Patent Act alleging that there had been abuse of 

exclusive rights with respect to Merck’s patent for enalapril and its acid addition salts for 

use in the treatment of hypertension. the Commissioner refused the application under s. 

65(2)(c), finding that there was no unmet demand in Canada for the patented article. The 

073-080_Q202_Canada.indd 77 17.07.2009 09:51:40 

77

Commissioner refused the application under s. 65(2)(d) on the basis that he was not satisfied 

that the patentee, Merck, had refused to grant Brantford a licence on reasonable terms, that 

Merck had not been provided with sufficient time to consider its position prior to Brantford 

commencing its application and that there was no prejudice. the decision was upheld on 

appeal to the Federal Court. the Federal Court decision has not been appealed to the 

Federal Court of appeal. 

In Torpharm Inc. v. Merck & Co. (2000), 9 C.P.R. (4 th ) 520 (Comm’r), torpharm sought a 

compulsory licence to allow it to acquire bulk enalapril maleate to manufacture tablets 

containing enalapril maleate for sale in the United States and elsewhere. torpharm alleged 

abuse on the basis of s. 65(2)(c), (d) and 65(1) of the Patent Act. The application was 

dismissed. Under the s. 65(2)(c) application the Commissioner found that the only demand 

that the applicant alleged was not being met was its own demand for bulk enalapril maleate. 

There was no assertion that the patentee refused to supply bulk enalapril or that Torpharm 

had ever made a request for bulk enalapril from Merck. Also, a demand for an article 

in Canada solely for the purpose of exporting the article was not within the scope of the 

section. Under the s. 65(2)(d) application, the Commissioner found that the patentee had 

insufficient time to consider the licence request and that a refusal would not cause prejudice to 

torpharm’s trade. the Commissioner found that the public interest would not be served by the 

issue of a compulsory licence. Torpharm’s third allegation of abuse, under s. 65(1), was also 

dismissed. Torpharm argued that even if it was unsuccessful under the s. 65(2) application, 

the Commissioner could find that the patentee had abused its patent under s. 65(1). The 

Commissioner found that s. 65(2) was exhaustive in delineating the instances in which abuse 

might be found to exist. the appeal of this decision is pending before the Federal Court. 

the hearing in this case was scheduled for May 20, 2003 but was adjourned sine die on 

May 15, 2003. 






Article 31bis has not been ratified in Canada. Canada has, however, implemented the 

August 30, 2003 WTO decision in its national law with the enactment of Bill C-9 (An Act 

to Amend Patent Act and Food and Drugs Act) in May 2005. there has been one licence 

issued under these provisions of the Patent act. In September of 2007 the Commissioner of 

Patents issued a compulsory licence allowing apotex to manufacture and export apotriavir, a 

triple combination aIDS therapy. the licensors were Glaxo Smith Kline, Shire and Boehringer 

Ingelheim. Rwanda has indicated that it will import ApoTriavir. 



The government is allowed to make use of a patented invention pursuant to sections 19, 19.1 

and 65 of the Patent Act. Section 65 is discussed above under the Question 6. Sections 19 

and 19.1 are set out below. 

USE OF PATENTS BY GOVERNMENT 

Government may apply to use patented invention 

19. (1) Subject to section 19.1, the Commissioner may, on application by the Government of 

Canada or the government of a province, authorize the use of a patented invention by that 

government. 

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Terms of use 

2) Subject to section 19.1, the use of the patented invention may be authorized for such 

purpose, for such period and on such other terms as the Commissioner considers expedient 

but the Commissioner shall settle those terms in accordance with the following principles: 

a) the scope and duration of the use shall be limited to the purpose for which the use is 

authorized; 

b) the use authorized shall be non-exclusive; and 

c) any use shall be authorized predominantly to supply the domestic market. 

Notice 

3) the Commissioner shall notify the patentee of any use of the patented invention that is 

authorized under this section. 

Payment of remuneration 

4) Where the use of the patented invention is authorized, the authorized user shall pay to the 

patentee such amount as the Commissioner considers to be adequate remuneration in the 

circumstances, taking into account the economic value of the authorization. 

Termination of authorization 

5) the Commissioner may, on application by the patentee and after giving all concerned 

parties an opportunity to be heard, terminate the authorization if the Commissioner is satisfied 

that the circumstances that led to the granting of the authorization have ceased to exist and 

are unlikely to recur, subject to such conditions as the Commissioner deems appropriate to 

protect the legitimate interests of the authorized user. 

Authorization not transferable 

6) An authorization granted under this section is not transferable. 

Conditions for authorizing use 

19.1 (1) the Commissioner may not authorize the use of a patented invention under section 

19 unless the applicant establishes that: 

a) it has made efforts to obtain from the patentee on reasonable commercial terms and 

conditions the authority to use the patented invention; and 

b) its efforts have not been successful within a reasonable period. 

Exception 

2) Subsection 1) does not apply in cases of national emergency or 

extreme urgency or where the use for which the authorization is 

sought is a public non-commercial use. 

Prescribed uses 

3) the Commissioner may not, under section 19, authorize any use that is a prescribed use 

unless the proposed user complies with the prescribed conditions. 

Limitation on use of semi-conductor technology 

(4) The Commissioner may not, under section 19, authorize any use of semi-conductor 

technology other than a public non-commercial use. 


There is no specific section in the Patent Act conferring rights of expropriation to the 

government. 

073-080_Q202_Canada.indd 79 17.07.2009 09:51:40 

79









We support such an exception of the type currently recognized under Canadian law (see 

Question 1 above). 


We support a Bolar-type exception similar in substance to that provided by s. 55.2 of the 

Canadian Patent act. 


Parallel importation of patented medicines is not currently provided for under Canadian 

law and we take no position at this time. 


We support such an exception. 












Summary 

the courts in Canada have recognized an experimental use exception to patent infringement 

provided there is no commercial use. Canada does have a Bolar-type exception (section 55.2 of 

the Patent act SC 1993, c.2). Parallel imports of patented medicines and medical devices along 

with individual prescriptions exception are not provided to under Canadian law. 

Résumé 

Les courts au Canada ont reconnu une exception à la contrefaçon en brevet pour l’usage 

expérimental à condition que celui-ci soit sans but commercial. Le Canada prévoit une exception 

de type Bolar (article 55.2 de la Loi sur les brevets SC 1993, c.2). Les importations parallèles de 

médicaments et d’appareils médicaux ainsi que l’exception de prescriptions individuelles ne sont 

pas prévus selon la Loi Canadienne. 

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Questions 

China 

Chine 

China 

Report Q202 

in the name of the Chinese Group 

by Wei CHENG 






In accordance with the provision under Article 63(4) of the Patent Law of P. R. China, the 

following action shall be deemed as an infringement of the patent right: “Where any person 

uses the patent concerned solely for the purposes of scientific research and experimentation”. 

The expression “scientific research and experimentation” refers to such scientific research and 

experimentation which is solely made for the patented technique itself, the purposes of which 

consists in reviewing technical characters or technical effects of the patented technique itself, 

or further improving the patented technique itself, and not generally refers to generic scientific 

research and experimentation. The expression “uses the patent concerned” refers to, for the 

above-mentioned purposes, the manufacture of the patented product or the implementation of 

the patented method, or the analysis and the review for the patented technique according to 

the published application documents, and not refers to the implementation of other scientific 

research and experimentation projects by using the means of the patented technique. 

The scientific research and experimentation for the commercial purposes is prohibited under 

the Patent Law of P. R. China. 






exception? 

The present Patent Law of P. R. China does not have any explicit provision concerning for 

Bolar-type exception. However, the provision for Bolar-type exception would probably be 

added into the Patent Law of P. R. China on its third amendment. The term of the Bolar-type 

exception in the draft of the third amendment of the Patent Law involves medicines and 

medical devices. 




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81

The present Law of P. R. China does not have any explicit provision concerning for parallel 

imports. Currently, the principle dealing with “parallel import” is, when the patented products 

legally sold in the output country are “parallel imported”, an explicit or implicit permission 

from the Chinese patentee is required. The implicit permission means that the patentee or 

the licensee does not add explicit limitation when he sells his patented products in the output 

country. As for the products manufactured under compulsory license, an explicit permission 

or implicit permission from the Chinese patentee is required as well when they are “parallel 

imported”. 

The parallel import for some medicine for treating certain epidemic disease is exceptional 

case. In case a patent right is granted to any medicine for treating certain epidemic disease 

in China, the medicines purchased by any entity or natural person from the other countries or 

areas where the medicines are manufactured and sold by the patentee or manufactured and 

sold with the permission of the patentee, can be imported into China without the compulsory 

license granted from the State Intellectual Property Office of P. R. China. 

In addition, the term of permission for parallel import would probably be added into the third 

amendment of the Patent Law of P. R. China. 


conditions? 

In accordance with the requirement of Article 25(1.3) of Patent Law of P.R. China, as to 

methods for the diagnosis or for the treatment of diseases, no patent right shall be granted. 

For humanity and ethical reasons, it is acknowledged that a doctor shall be given the freedom 

to choose any means in the course of diagnosis or treatment of diseases. Moreover, this kind 

of methods are not susceptible of industrial application because they are practiced directly on 

living human or animal bodies, and are not inventions-creations in the context of the patent 

law. Therefore, methods for diagnosis or for treatment of diseases shall not be granted patent 

rights. 

Generally, the prescriptions for individual cases are regarded as methods of treatment for 

diseases by using medicines which are not patentable, should not be granted patent rights. 




In accordance with the requirement of Article 25(1.3) of Patent Law of P.R. China, as to 

methods for the diagnosis or for the treatment of diseases, no patent right shall be granted. 

Methods for diagnosis or for treatment of diseases refer to the processes of identifying, 

determining, or eliminating the cause or focus of diseases which are practiced directly on 

living human or animal bodies. 

However, instruments or apparatus for implementing these methods of diagnosis or treatment, 

or substances or materials for use in such methods are subject matters for which patent right 

may be granted. 






Compulsory license is available under Patent Law of P.R. China. The grounds on which 

compulsory License for exploitation of patent may be granted are provided as follows (the 

Article 48, 49 and 50 of Patent Law of P.R. China may be referred to): 

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1) Where any entity which is qualified to exploit the invention or utility model has made 

requests for authorization from the patentee of an invention or utility model to exploit 

its or his patent on reasonable terms and conditions and such efforts have not been 

successful within a reasonable period of time; 

2) Where a national emergency or any extraordinary state of affairs occurs, or where the 

public interest so requires; or 

3) Where the invention or utility model for which the patent right has been granted involves 

important technical advance of considerable economic significance in relation to another 

invention or utility model for which a patent right has been granted earlier and the 

exploitation of the later invention or utility model depends on the exploitation of the 

earlier invention or utility model. 

In addition, the entity or individual that is granted a compulsory license for exploitation shall 

pay to the patentee a reasonable exploitation fee. 

Up to now, China had not issued any compulsory licences for patent enforcement. 






China has ratified new Article 31bis TRIPS. State Intellectual Property Office of the P.R.C. has 

promulgated “Measures for Compulsory License on Patent Implementation concerning Public 

Health Problems” (promulgated on November 29, 2005, and enter into force on January 1, 

2006) with a view to implementing the WTO decision of August 30, 2003. 

In addition, some interrelated term would probably be added into the third amendment of the 

Patent Law of P. R. China. In the current revised draft of Patent Law of the People’s Republic of 

China (a draft for discussing), the content related to new Article 31bis TRIPS involves that: in 

case a patent right is granted to any medicine for treating certain epidemic disease in China, 

and developing countries or least-developed countries which do not have the capacity for 

the production of the medicine or have insufficient production capacity expect to import the 

medicine from China, the patent administration department under the State Council may, 

according to the provisions of international treaty, grant compulsory license for manufacturing 

the medicine and exporting the medicine to above-mentioned countries to the entity which is 

qualified to exploit the invention. 



The Patent Law of P. R. China allows the government to spread and apply a patent for invention 

without previous license. However, the patent for invention to be spread and applied must be 

of great significance to the interest of the State or to the public interest. Moreover, patentee 

of the patent for invention to be spread and applied only limit to State-owned enterprise or 

institution, a Chinese individual or an entity under collective ownership, and excluding a 

foreign individual, sino-foreign joint ventures, sino-foreign cooperative enterprise, foreignfunded 

enterprise, China private enterprise, and other entity under the mixed ownership. In 

addition, the exploiting entity shall, according to the regulations of the State, pay a fee for 

exploitation to the patentee. 

Up to now, no patent for invention is spread and applied in China. 

081-086_Q202_China.indd 83 17.07.2009 09:52:12 

83


The government is not allowed to expropriate a patent. 





There is no other means in our patent law. 













The Patent law should provide for the above-mentioned exceptions. The corresponding 

exceptions treatments should be made as long as belong to the legal cases. 








The Patent law should protect the benefit of the patentee. However, in the case where the patentee’s 

exclusive rights come into conflict with public health, the public health right should be protected 

firstly. If the measure made for protecting the public health right damage patentee’s benefit, the 

patentee would be paid adequate remuneration. 

Summary 

The present Patent Law of P. R. China recognizes the research or experimental use exception, and 

stipulates that methods for the diagnosis or for the treatment of diseases are not patentable subject 

matter. The Patent Law of P. R. China does not have explicit provision concerning for Bolar-type 

exception and parallel import, but would probably provide Bolar-type exception and allow parallel 

import on its third amendment. While the compulsory license is available under Patent Law of P.R. 

China, no compulsory licences for patent enforcement is issued in China Up to now. China has 

ratified new Article 31bis TRIPS, and promulgated “Measures for Compulsory License on Patent 

Implementation concerning Public Health Problems” (enter into force on January 1, 2006) with 

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a view to implementing the WTO decision of August 30, 2003, in addition, some interrelated 

term would probably be added into the third amendment of the Patent Law of P. R. China. The 

government is not allowed to expropriate a patent in China. 

081-086_Q202_China.indd 85 17.07.2009 09:52:12 

85

081-086_Q202_China.indd 86 17.07.2009 09:52:12

Questions 

Colombia 

Colombie 

Kolumbien 

Report Q202 

in the name of the Colombian Group 






Our Patent Law does recognize the research and experimental use exceptions when the 

research and the experimental use are carried out privately and without commercial purposes. 

This is contemplated in articles 52 and 53 of Decision 486 of the Andean Community, which 

state: 

Article 52 – A patent shall confer on its owner the right to prevent third parties not having 

the owner’s consent from the acts of: 

a) where the subject matter of a patent is a product: 

i) making the product; 

ii) offering for sale, selling, or using the product; or importing it for these purposes; 

and, 

b) where the subject matter of a patent is a process: 

i) using the process; or 

ii) carrying out any of the acts that are specified under paragraph a) above with respect 

to a product obtained directly by that process. 

Article 53 – A patent owner may not exercise the right referred to in the previous article 

with respect to the following acts: 

a) acts carried out in a private circle and for non-commercial purposes; 

b) acts carried out exclusively to experiment with the subject matter of the patented 

invention; 

c) acts carried out exclusively for the purposes of teaching or scientific or academic 

research; 

d) the acts referred to in article 5bis of the Paris Convention for the Protection of Industrial 

Property; 

e) where the patent protects biological material that is capable of being reproduced, except 

for plants, using that material as a basis for obtaining a viable new material, except 

where the patented material must be used repeatedly to obtain the new material. 

087-092_Q202_Colombia.indd 87 17.07.2009 09:52:41 

87






exception? 

No, the Bolar exception is not recognized under our patent law, and the use of an invention 

without the patentee’s consent is not covered by the research exception for the purposes of 

obtaining approval of a generic product. 




In Colombia, parallel imports of patented medicines are permitted, as per article 54 of 

Decision 486 of the Andean Community, which states: 

A patent shall not confer on its owner the right to proceed against a third party making 

commercial use of a product protected by a patent once that product has been introduced 

into the commerce of any country by the owner or another person authorized by the right 

holder or with economic ties to that patent owner. 

For the purposes of the preceding paragraph, two persons shall be considered to have 

economic ties when one of the persons is able to exercise a decisive influence on the other, 

either directly or indirectly, with respect to the exploitation of the patent or when a third party 

is able to exert that influence over both persons. 

Where the patent protects biological material that is capable of being reproduced, the 

patent coverage shall not extend to the biological material that is obtained by means of 

the reproduction, multiplication, or propagation of the material that was introduced into the 

commerce as described in the first paragraph, provided that it was necessary to reproduce, 

multiply, or propagate the material in order to fulfill the purposes for which it was introduced 

into commerce and that the material so obtained is not used for multiplication or propagation 

purposes. 

The same principles do apply if the products originate from markets where they were made 

available under a compulsory licence. 


conditions? 

Our patent law does not contemplate the individual prescriptions exception. 




N.A. 






Yes. Compulsory licences are contemplated in our patent law. Articles 61-69 of Decision 486 

of the Andean Community, which state: 

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Article 61 – At the expiry of a period of three years following a patent grant or of four 

years following the application for a patent, whichever is longer, the competent national 

office may grant a compulsory license mainly for the industrial manufacture of the product 

covered by the patent, or for full use of the patented process, at the request of any interested 

party, but only if, at the time of the request, the patent had not been exploited in the manner 

specified in articles 59 and 60, in the Member Country in which the license is sought, or if 

the exploitation of the invention had been suspended for more than one year. 

Compulsory licenses shall not be granted if patent owners are able to give valid reasons for 

their failure to act, which may be reasons of force majeure or an act of God, in accordance 

with the domestic provisions in effect in each Member Country. 

A compulsory license shall be granted only if, prior to applying for it, the proposed user has 

made efforts to obtain a contractual license from the patent holder on reasonable commercial 

terms and conditions and that such efforts were not successful within a reasonable period of 

time. 

Article 62 – Decisions to grant a compulsory license, as stipulated in the previous article, 

shall be taken after the patent owners have been notified to present their arguments as they 

see fit within the following sixty days. 

The competent national office shall specify the scope or coverage of the license, and in 

particular shall specify the period for which it is granted, the subject matter of the license, the 

amount of the remuneration, and the conditions for the payment thereof. The remuneration 

shall be set at an adequate level in accordance with the individual circumstances of each 

case and, in particular, the economic value of the authorization. 

Opposition to a compulsory license shall not prevent its exploitation or have any effect on any 

periods that may be running. The filing of an objection shall not prevent the patent owner, in 

the meantime, from collecting the remuneration specified by the competent national office on 

the part unaffected by the objection. 

Article 63 – At the request of the owner of the patent or the licensee, the conditions 

governing the compulsory license may be changed by the competent national office where 

new circumstances so dictate and, in particular, when the patent holder grants another license 

on terms that are more favorable than the existing ones. 

Article 64 – The licensee shall exploit the licensed invention within a period of two years 

following the date the license was granted, unless that licensee is able to give valid reasons 

for inaction consisting of force majeure or an act of God. Otherwise, at the patent owner’s 

request, the competent national office shall revoke the compulsory license. 

Article 65 – Following the declaration by a Member Country of the existence of public 

interest, an emergency, or national security considerations, and only for so long as those 

considerations exist, the patent may be subject to compulsory licensing at any time. In that 

case, the competent national office shall grant the licenses that are applied for. The owner of 

the patent so licensed shall be notified as soon as is reasonably possible. 

The competent national office shall specify the scope or extent of the compulsory license and, 

in particular, the term for which it is granted, the subject matter of the license, and the amount 

of remuneration and the conditions for its payment. 

The grant of a compulsory license for reasons of public interest shall not reduce the right of 

the patent owner to continue exploiting it. 

Article 66 – The competent national office may, either ex officio or at the request of 

a party, and after having obtained the consent of the national antitrust authority, grant 

compulsory licenses where practices are noted that are detrimental to the exercise of free 


89

competition, especially where they constitute an abuse by the patent owner of a dominant 

position in the market. 

The need to correct anti-competitive practices shall be taken into account in determining the 

amount of remuneration to be paid in such cases. 

The competent national office shall refuse termination of a compulsory license if and when the 

conditions which led to the granting of the license are likely to recur. 

Article 67 – The competent national office shall grant a license, upon request by the 

owner of a patent whose exploitation necessarily requires the use of another patent, and that 

right holder has been unable to secure a contractual license to the other patent on reasonable 

commercial terms. That license shall, without prejudice to the provisions of article 68, be 

subject to the following conditions: 

a) the invention claimed in the second patent shall involve an important technical advance 

of considerable economic significance in relation to the invention claimed in the first 

patent; 

b) the owner of the first patent shall be entitled to a cross-license on reasonable terms to use 

the invention claimed in the second patent; and, 

c) the license authorized in respect of the first patent shall be non-assignable except with 

the assignment of the second patent. 

Article 68 – In addition to the conditions provided for in the preceding articles, compulsory 

licenses shall be subject to the following: 

a) they shall be non-exclusive and may not be sublicensed; 

b) they shall be non-assignable, except with the part of the business or goodwill which 

permits its industrial use. This shall be evidenced in writing and registered with the 

competent national office. Otherwise, those assignments or transfers shall not be legally 

binding; 

c) they shall be liable, subject to adequate protection of the legitimate interests of the 

persons so authorized, to be terminated if and when the circumstances which led to them 

cease to exist and are unlikely to recur; 

d) their scope and duration shall be limited to the purposes for which they were 

authorized; 

e) in the case of patents protecting semi-conductor technology, a compulsory license shall 

be authorized only for public non-commercial use or to remedy a practice declared by 

the competent national authority to be anti-competitive in accordance with articles 65 

and 66; 

f) they provide for payment of adequate remuneration according to the circumstances of 

each case, taking into account the economic value of the license, without prejudice to the 

stipulations of article 66; and, 

g) they shall be used predominantly for the supply of the domestic market. 

Article 69 – Compulsory licenses that fail to comply with the provisions of this Chapter 

shall be devoid of any legal effect whatsoever. 

We have no knowledge of any compulsory licenses filed for or granted in Colombia. 




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087-092_Q202_Colombia.indd 90 17.07.2009 09:52:42



No, Article 31 bis TRIPS has not been ratified and we have no knowledge of other legislative 

amendments implementing WTO decision of August 30, 2003. 

We have no knowledge of any compulsory licenses filed for or granted in Colombia for 




No, the government cannot make use of a patented invention without previous license. 


No, the government cannot expropriate a patent under any circumstance. 





No, our law does not recognize other means of facilitating access to medicines, medical 

devices and the like. 




Yes, maintaining the restriction to uses with commercial purposes. 


No, because it threatens the patent owner’s rights and could negatively affect research 

and development activities. 


Yes, as currently established in our patent law. 


N.A. 


Yes, as currently legislated. 


Yes, for public interest, emergencies and to remedy anti competitive conduct. 


No, because it threatens the patent owner’s rights and could negatively affect research 

and development activities as well as foreign investment. 



No, we consider the compulsory licenses system sufficient for these purposes. 



91



No. 




Yes, in order to create an incentive to research and development activities and to economies 

in general. 

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Questions 

Denmark 

Danemark 

Dänemark 

Report Q202 

in the name of the Danish Group 

by Torsten NørGaarD, Johnny PeTerseN and ejvind ChrisTiaNseN 






Yes, a research or experimental use exception is recognised under Danish Patent law. 

according to section 3(3)(3) of the Danish Patents act, “The exclusive right shall not extend 

to: ... acts done for experimental purposes relating to the subject-matter of the patented 

invention. 

The research and experimental exemption is not restricted to non-commercial purposes. 






exception? 

Yes, a Bolar-type exception is recognised under Danish Patent law, vide section 3(3)(4) of the 

Danish Patents act stating that: “The exclusive right shall not extend to: ... actions which are 

restricted to the object of a patented invention which actions are necessary in order to get 

marketing authorisation for a medicament to humans or animals in eU, in an eU member state 

or in other countries”. in Denmark, the Bolar exception is limited to drugs. it is to be noted 

that, in Denmark, the Bolar exception is not restricted to generic medicaments, but relates to 

any medicament. 




according to section 3(3)(2) of the Danish Patents act the exclusive right related to a granted 

patent in Denmark does not include actions with regard to products marketed by the patentee 

or with the patentee’s explicit consent in Denmark or in any other country within the european 

economic area (eea). 

section 3(3)(2) of the Danish Patents act comprises only situations where the product is 

marketed in Denmark or in another eea country. if the product is marketed outside the 

eea, the patentee may thus continuously prevent import of products based on the patent to 

Denmark. 

093-098_Q202_Denmark.indd 93 17.07.2009 09:53:10 

93

a principle of regional exhaustion of rights thus applies in Denmark, making parallel imports 

of patented products (including medicines and medical devices) within the eea legal. 

Based on the legal history of section 3(3)(2) of the Danish Patents act as well as case law 

(eCJ case No C-19/84 Pharmon v hoechst) it is, however, assumed that imports of patented 

products within the eea are not allowed in situations where the products are made available 

on the market under a compulsory license only. 


conditions? 

Yes, an individual prescriptions exception is recognised under Danish Patent law, vide section 

3(3)(5) of the Danish Patents act according to which “The exclusive right shall not extend 

to: ... preparation in a pharmacy of a medicinal product according to a prescription in 

individual cases or acts concerning the medicinal product so prepared. 




in Denmark, methods of treatment are not patentable subject matter, vide section 1(3) of the 

Danish Patents act and art. 53(c) ePC 2000. 






The provisions on compulsory licenses are included in chapter Vi (sections 45-50) of the 

Danish Patents act. These provisions are in conformity with TriPs. 

in Denmark, the competence to grant compulsory licenses lies exclusively with the courts. 

according to section 49 of the Danish Patents act the basic requirements for granting 

compulsory licenses are: 

1) The licensee must prove to be able to use the invention in a reasonable and justifiable 

manner and in accordance with the conditions of the license. 

2) The licensee must prove to have tried in good faith to obtain a license by agreement with 

the patentee on reasonable terms. 

The specific requirements for granting compulsory licenses follow from sections 45-48 of 

the Danish Patents act. in relation to public health issues, the following provisions should be 

pointed out. 

1) it follows from section 45(1) of the Danish Patents act that if a patented invention 3 

years after the grant of patent and 4 years after the filing of the patent application has 

not yet been worked “to a reasonable extent”, a third party intending to commercialize 

the invention in Denmark may obtain a compulsory license to do so unless there are 

reasonable grounds for the patentee’s omission to use the invention. 

however, according to Denmark’s eU and international (WTO) obligations, working of 

the invention within eea or in a WTO country is considered to correspond to working in 

Denmark. 

There is no recent case law on section 45(1) of the Danish Patents act, but in a supreme 

Court decision of 17 June 1966 it was confirmed that the Danish pharmaceutical 

company Løvens Kemiske Fabrik had rightfully been granted a compulsory license by the 

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swiss pharmaceutical company J.R. Geigy AG regarding a process for manufacture of 

Phenylbutazone. (Ufr 66/566 h). The supreme Court referred in its reasoning to the fact 

that the patented process – without any reasonable grounds – could not be considered to 

have been worked to a reasonable extent taking into account the demand for the product 

manufactured by use of the patented process. The amount actually produced in Denmark 

was about 30% of the total sales. The royalty was fixed at 5% of the sales. It should be 

noted that prior to the grant of the compulsory license, the supreme Court had found that 

Løven infringed on Geigy’s patent. 

2) according to section 47 of the Danish Patents act a third party intending to commercially 

use a patented invention may be granted a compulsory license to do so in case important 

public interests make it necessary. 

section 47 of the Danish Patents act has successfully been claimed in a supreme Court 

decision from 1972. (Ufr 72/325 h). This case did, however, not concern medicines or 

medical devises (but rather catapult seats for fighter planes). On the other hand, it is quite 

clear that the public’s need for supply of necessary medical products falls within the core 

of section 47 of the Danish Patents act. 






article 31bis of TriPs as stipulated by the WTO Council at its meeting on 6 December 

2005 has been ratified by EU (and thus Denmark) by Regulation (EC) No 816/2006 of the 

european Parliament and of the Council of 17 May 2006 on compulsory licensing of patents 

in relation to the manufacture of pharmaceutical products for export to countries with public 

health problems. 

according to the available information no compulsory licenses have been granted according 

to article 31bis of TriPs for exportation of pharmaceutical products from Denmark to eligible 

importing countries in need of such products in order to address public health problems. 



No, Danish Patent law has no such provisions. 


Previous Danish Patent Acts included specific provisions on the possibility to expropriate a 

patent on condition of full compensation to the patentee. 

The present Danish Patents act does not include such a provision on expropriation simply 

because it is superfluous due to the general provision on expropriation in the Danish 

Constitution (“Grundloven”). according to section 73 of the Danish Constitution the right of 

property shall be inviolable. expropriation may, however, take place under the following 

invariable conditions: 

1) it is required due to public interest, 

2) it is done by or in accordance with statute and 

3) full compensation is awarded. 

No such expropriation has been granted and it is believed that the compulsory license 

provisions will provide sufficient remedy. 

093-098_Q202_Denmark.indd 95 17.07.2009 09:53:10 

95





The Danish Patents act does not have any such provisions. information tools like the Orange 

book is not available in Denmark. 

indirectly, however, the access to medicines is facilitated by the fact that the Danish Medical 

agency pay no attention to patents or possible infringement thereof when granting marketing 

authorizations, and that there is no obligation for the generic companies to submit any such 

information. also Danish pharmacies have the duty to undertake “generic substitution”, unless 

the prescribing doctor has explicitly prescribed the original product. 













The Danish group is of the opinion that Patent law should provide for research and experimental 

use exception, the Bolar exception, the individual prescriptions exception and compulsory 

licensing provisions subject to equitable compensation to the patentee. all of these provisions 

could be phrased as they are in the Danish Patents act. in this connection, we want to stress 

that the Bolar exception must be restricted to actions which are necessary in order to get 

marketing authorization for the medicament in question. 

Furthermore, it is important to note that, e.g., in several european countries, Bolar exception 

for generic medicaments has been specified in the law, whereas it is questionable whether 

the provision also covers non-generic medicaments. 

We are of the opinion that the Bolar exception should cover both generic and non-generic 

medicaments. Non-generic medicaments could also be designated innovative medicaments. 

We see no reason to have provisions which are more favourable to the marketing of generic 

products than to the marketing of non-generic medicaments, rather the contrary. Mostly, 

generic products are identical (or almost identical) to an original product already marketed. 

Non-generic medicaments are medicaments which are mostly developed by innovative 

companies. in the case of a non-generic medicament for which the Bolar exception applies 

in relation to a specific patent, there may or may not already be another medicament on the 

market covered by the patent in question. in one typical case, an innovative company has 

developed a new medicament (with a surprising effect) and, just by chance, the medicament 

is covered by a patent which may not cover other medicaments marketed or foreseen to be 

marketed Alternatively, the therapeutic efficiency of a given compound has inspired other 

innovative companies to look for structurally similar compounds which might arguably be 

selection inventions under the original patent. 

Danish Patent law does not specifically provide for a medical treatment defence, but the 

Danish group is willing to favourably consider a more specific proposal in this respect. 

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The Danish group rejects the general principle of international exhaustion of rights with 

regard to patented medicines. Parallel import of patented medicines on regional levels due 

to economic free markets (such as the eea) should however be accepted, thus stipulating a 

principle of regional exhaustion of rights. 

Patent law should not provide for expropriation of rights. The basic provisions on expropriation 

of property in each country should suffice. 



We think that the limitation provisions mentioned above will contribute sufficiently to a 

balanced public health situation as far as patents are concerned. 




Yes, they should all be harmonised as mentioned above. 



all member countries should be strongly encouraged to ratify the new article 31bis of TriPs so as 

to make the Doha decision from 2003 permanent. 

By the same token, the member countries should be encouraged to take reasonable measures as 

defined in sections 3 and 4 of the annex to Art 31bis TRIPS to prevent reexportation of products 

that have been imported subject to the provisions of art31bis TriPs (Paragraph 6 of the Doha 

Declaration). 

any erosion of the patent rights results in a lower motivation to develop improved medicaments by 

the companies. The challenge is to find the right balance between, on the one hand, the companies’ 

possibilities of obtaining a sufficient patent protection on medicaments and, on the other hand, to 

secure that the patients get the best possible treatment. We think this challenge has been met by 

the above rules and measures. 

Summary 

The Danish group is of the opinion that the decision of august 30, 2003 under paragraph 6 of the 

Doha declaration as now expressed in article 31bis TriPs and its annexes strikes a reasonable 

balance between the legitimate interests of the innovative pharmaceutical companies and those 

of the countries facing public health problems, the solution of which might partly be hampered by 

existing patent rights. Therefore, an early ratification of Article 31bis TRIPS is strongly encouraged 

by all countries not having ratified yet. 

already article 30 TriPs provided for introduction of limited exceptions to the exclusive rights 

conferred by a patent by the member states, and a harmonization of such exceptions as suggested 

by the Danish group is recommended. in particular, the Bolar exception should cover both generic 

and innovative medicaments, but only such measures as are necessary in order to get marketing 

auhorization should be encompassed by the exception. 

international exhaustion of rights is rejected, but regional exhaustion might be acceptable in 

accordance with the relevant regional jurisprudence and/or as provided by national law. 

093-098_Q202_Denmark.indd 97 17.07.2009 09:53:11 

97

Résumé 

Le groupe danois est d’avis que la Décision du 30 août 2003 en vertu de section 6 de la Déclaration 

de DOha comme exprimée maintenant dans article 31bis TriPs et ses annexes a bien équilibré 

les intérêts légitimes des entreprises pharmaceutiques innovatrices et ceux des pays se trouvant en 

face des problèmes de santé publique dont la solution pourrait être freinée par droits de brevet 

existants. Donc, la ratification anticipée de l’Article 31bis TRIPS est fortement encouragée par tous 

les pays n’ayant pas encore ratifié. 

Déjà article 30 TriPs instituait l’introduction des exceptions limitées aux droits conférés par un 

brevet par les états membres, et une harmonisation de telles exceptions comme suggérée par le 

groupe danois est recommandée. Particulièrement, l’exception Bolar doit couvrir les médicaments 

génériques aussi bien que les produits innovateurs, mais exclusivement les moyens jugés nécessaires 

pour obtenir l’autorisation de mise sur le marché doivent se trouver englobés par l’exception. 

epuisement international des droits est rejeté, mais épuisement régional peut être acceptable selon 

la jurisprudence régionale pertinente et/ou comme prévu par le droit nationa 


Die dänische Gruppe ist der auffassung, dass die entscheidung vom 30. august 2003 unter 

abschnitt 6 der Doha-erklärung, wie sie nun in artikel 31bis TriPs und seinen annexen ausgedrückt 

ist, die rechtmässigen interessen innovativer pharmazeutischer Firmen und diejenigen von Ländern 

mit Problemen in der öffentlichen Gesundheitspflege, deren Lösung teilweise durch bestehende 

Patentrechte behindert werden könnte, einigermassen ausgewogen berücksichtigt. Deshalb wird 

eine zeitige Ratifizierung des Artikels 31bis TRIPS durch Länder, die dies noch nicht getan haben, 

stark unterstützt. 

artikel 30 TriPs hat bereits die einführung begrenzter ausnahmen durch Mitgliedstaaten von durch 

Patente erteilten exklusivrechten vorgesehen, und eine harmonisierung solcher ausnahmen, wie von 

der Dänischen Gruppe vorgeschlagen, wird empfohlen. insbesondere sollte die Bolar-ausnahme 

sowohl generische als auch innovative Medikamente umfassen, allerdings sollten nur Massnahmen, 

die notwendig für die erteilung einer Vermarktungsgenehmigung sind, von der ausnahme umfasst 

werden. 

Die Doktrin internationaler erschöpfung von rechten wird abgelehnt, allerdings mag in 

Übereinstimmung mit relevanter regionaler rechtsprechung und/oder durch nationale Gesetze 

vorgesehene regionale erschöpfung akzeptierbar sein. 

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Questions 

Ecuador 

Equateur 

Ecuador 

Report Q202 

in the name of the Ecuadorian Group 






Yes, according to Andean Decision 486, a patented product and or/procedure can be 

used without the patentee’s permission if such use is made with research, experimental or 

teaching purposes. The Ecuadorian Intellectual Property Law further develops such exception 

when allowing the mentioned uses if and only if they are not done with a lucrative purpose. 

Therefore, commercial purposes, understood as the exchange of goods aiming to obtain 

some profit are not allowed under our legislation. 






exception? 

A Bolar type exception is not recognized under the Ecuadorian Patent Law. The use of the 

invention without the patentee’s consent for the purpose of obtaining approval of a generic 

product could, indeed be considered as an experimental use, since the commercial purpose 

will not exist until the generic has been approved and the original patent has expired. 




According to Art. 54 of the Andean Decision 486 “a patent shall not confer on its owner 

the right to proceed against a third party making commercial use of a product protected by 

a patent once that product has been introduced into the commerce of any country by the 

owner or another person authorized by the right holder or with economic ties to that patent 

owner.” 

According to this rule, it would not be a patent infringement for anybody to import a patented 

product into Ecuador from another country where it has been marketed either by the patent 

owner, with his authorization or if by someone with economic ties to that patent owner. 

The Intellectual Property Law is more specific on the subject and clearly states that the owner 

of a Patent can not exercise its rights in case of an import of the product put into the market 

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99

of any country by the owner of the patent, anyone authorized by the owner or anyone having 

a license. 

Concerning the compulsory license issue, our legislation is not very specific about it. However, 

the second paragraph of the same article can be interpreted on the matter; it states that two 

persons are considered to have economic ties when a third party is able to exert influence 

with respect to the exploitation of the patent over both persons (in the particular case both 

persons could be the owner of the patent and the grantee of the compulsory license). 

Therefore, if a compulsory license is granted by the government of another country to someone 

to exploit the patent we would understood that the Government is the third party able to exert 

influence on both the owner of the patent and the licensee. Thus, these two last parties should 

be considered as having economic ties and therefore the import in Ecuador from such country 

of the patented product would not be an infringement of the patent right. 

On the other hand, as previously mentioned, the intellectual property law allows the import 

of the patented product into Ecuador if the product was put into the market by anyone having 

a license. Since it is not specified if such license shall be compulsory or voluntary a broad 

interpretation including both of them can be done. 


conditions? 

An individual prescription exception is not specifically recognized under the Ecuadorian 

patent law. 

The Decision 486 provides to the owner the right to prevent anyone from making the product 

or using the process, or selling it or offering it for sale. However it restricts such rights to be 

exercised with respect to acts carried out in a private circle and for non-commercial purposes. 

An interpretation given to this rule in each particular case, could eventually be transform it 

into an individual prescription exception. However, the moment a physician or pharmacist 

sells the preparation, even if it is only for one specific case, such act might be considered as 

a commercial purpose and thus, it would not be an exception. 









Yes, compulsory licenses are available in Ecuador upon fulfillment of one of the following 

conditions: 

At the expiry of a period of three years following a patent grant or of four years following 

the application for a patent, whichever is longer, the competent national office may grant a 

compulsory license mainly for the industrial manufacture of the product covered by the patent, 

or for full use of the patented process, at the request of any interested party, but only if, at the 

time of the request, the patent had not been exploited in Ecuador, or if the exploitation of the 

invention had been suspended for more than one year. 

Compulsory licenses shall not be granted if patent owners are able to give valid reasons for 

their failure to act, which may be reasons of force majeure or an act of God. 

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A compulsory license shall be granted only if, prior to applying for it, the proposed user has 

made efforts to obtain a contractual license from the patent holder on reasonable commercial 

terms and conditions and that such efforts were not successful within a reasonable period of 

time. 

The licensee shall exploit the licensed invention within a period of two years following the 

date the license was granted, unless that licensee is able to give valid reasons for inaction 

consisting of force majeure or an act of God. Otherwise, at the patent owner’s request, the 

patent office shall revoke the compulsory license. 

The patent office shall specify the scope or coverage of the license, and in particular shall 

specify the period for which it is granted, the subject matter of the license, the amount of 

the remuneration, and the conditions for the payment thereof. The remuneration shall be set 

at an adequate level in accordance with the individual circumstances of each case and, in 

particular, the economic value of the authorization. 

Following the declaration of the Government of the existence of public interest, an emergency, 

or national security considerations, and only for so long as those considerations exist, the 

patent may be subject to compulsory licensing at any time. In that case, the competent national 

office shall grant the licenses that are applied for. The owner of the patent so licensed shall be 

notified as soon as is reasonably possible. 

The grant of a compulsory license for reasons of public interest shall not reduce the right of 

the patent owner to continue exploiting it. 

The patent office may, either ex officio or at the request of a party, and after having obtained 

the consent of the national antitrust authority, grant compulsory licenses where practices are 

noted that are detrimental to the exercise of free competition, especially where they constitute 

an abuse by the patent owner of a dominant position in the market. 

The need to correct anti-competitive practices shall be taken into account in determining the 

amount of remuneration to be paid in such cases. 

The patent office shall refuse termination of a compulsory license if and when the conditions 

which led to the granting of the license are likely to recur. 

The patent office shall grant a license, upon request by the owner of a patent whose 

exploitation necessarily requires the use of another patent, and that right holder has been 

unable to secure a contractual license to the other patent on reasonable commercial terms. 

That license shall be subject to the following conditions: 

a) the invention claimed in the second patent shall involve an important technical advance 

of considerable economic significance in relation to the invention claimed in the first 

patent; 

b) the owner of the first patent shall be entitled to a cross-license on reasonable terms to use 

the invention claimed in the second patent; and, 

c) the license authorized in respect of the first patent shall be non-assignable except with 

the assignment of the second patent. 

The following conditions for compulsory licenses are applicable to all of the above: 





binding; 

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authorized; 



the competent national authority to be anti-competitive. 


each case, taking into account the economic value of the license, and, 


No compulsory licenses have been granted in Ecuador. 






Article 31bis TRIPS have not been ratified by Ecuador by March 17, 2008. There has been no 

legislative amendment in our country concerning the exportation or importation of products 

protected by a compulsory license. There has not been any compulsory license granted in 

Ecuador for the importation or exportation of pharmaceutical products. 



No, the Ecuadorian government is not allowed to make use of a patented invention without 

a previous license. 


According to the Ecuadorian Constitution the Ecuadorian Government is allowed to 

expropriate all kind of private property, without excluding Intellectual Property rights. 

However, the Constitution states that the reasons and processes for such expropriations must 

be determined by the law. Our patent law does not provide the expropriation of patents and 

accordingly, they should not be expropriated. Nevertheless, in a particular case with special 

circumstances, covered by the Constitutional principle the government could eventually justify 

a patent expropriation. 





Together with the experimental exception, our patent law has established an exception for 

academic purposes, such as teaching (without a lucrative intention). Therefore, methods of 

preparing and using a patented product may be thought during the life of a patent, for 

example in a medical school. Nevertheless, the students will not be allowed to use such 

knowledge to prepare the medicines until they have obtained a license or the patent has 

expired. 

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We believe that a research and experimental use exception is essential in the patent 

system. The whole idea of making a patent application public at some time during the 

prosecution of patent application is to facilitate the research on the same area and allow 

a fair competition for the benefit of the collectivity. 


We believe that the Bolar exception should be provided by the patent law, as long as 

the companies making generics have certain limitations concerning the marketing of the 

product or process before the patent has expired. 


In developing countries such as Ecuador, the parallel import of medicines is a very 

important tool to permit a fair access to medicines. If the owner of patent has already 

introduced in the market the patented medicine and is selling it at a lower price in 

another country, there exists a price discrimination against Ecuadorians. As a developing 

country we have the right to be able to access medicines at the best possible price. Thus, 

if someone is able to legally import the same medicine at a lower price it means that the 

owner of the patent could also do it. Therefore, such exception, in our case should be 

provided by the law. 


We believe the individual prescription exception is more controversial. While a pharmacist 

or doctor could prepare a medicine for its own use, when preparing it for someone else, 

according to an individual prescription, he/she is already profiting from such preparation. 

Doctors and pharmacists could begin exercising such right at a larger scale and the rights 

of the owner of the patent would be at risk. Therefore, if this exception is allowed certain 

limits and controls should be done. First of all, each preparation should be done by a 

pharmacist or doctor for one individual case; and the number of preparations in a certain 

period of time (like monthly) should be reported to determine whether the preparations 

are not being done at a larger scale. Finally, there should be a determination of which 

medicines or medical devices might need of individual prescriptions. 


In Ecuador, as methods of medical treatment are not allowed such exception is not 

applicable. 


This exception should be allowed internationally for certain cases determined by each 

country such as national health crises or in cases of acts which are detrimental to 

the exercise of free competition. Compulsory licenses should be granted with a fair 

compensation to the owner of the patent and the owner should be able to continue 

exploiting it. Their scope and duration should be limited to the purposes for which they 

were authorized. The exportation of a product with a compulsory license should be 

done only under special circumstances, such as to other developing or less developed 

countries with a national health crisis or similar problems. The importation of products 

under a compulsory license should be allowed when required to supply a sufficient 

amount for the needs of the Country. 


With the existence of a compulsory licensing system, we believe that expropriation is not 

necessary, because as long as people have the access to medicines guaranteed trough 

the granting of a compulsory license, there is no need to impede the owner of the patent 

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to continue exploiting the medicine. Of course, the owner of the patent will have to take 

certain measures (like lowering the price) if he wants to continue being competitive under 

such circumstances. 






Besides limiting the patent rights there are certain ways which might facilitate the access to 

medicines but they should not be available through a patent law but through other laws as 

methods for controlling the price of medicines. However, we understand that such measures 

should not be discussed in the present document. 

Concerning the patent law, we believe that methods for pharmaceutical treatment should not 

be patentable. On the other hand patent laws should establish a maximum amount of time 

(maybe 5 years) for the prosecution of patent application. This way both the owner of the 

application as well as the generic companies can have a certainty as to when they can start 

exploiting the product. Even when the owner of the invention has the right to its exclusive upon 

filing of the application it is imperative that they can know for certain as soon as possible if 

they will be able to exploit it for a 20 year timer period or not. That way they can look for 

or acquire all the machinery, personal and raw material needed. It is also important that the 

generic companies can know before long, when they can start researching and performing 

trials for the marketing of the product. 




Limitation to patent rights should be harmonized up to a certain point. We believe that, for 

example the compulsory licensing conditions should be dependant to the needs of each 

country. Nevertheless certain conditions for the exportation and importation of products 

being produced under a compulsory licensing should be harmonized so that there exists a 

certainty concerning which countries can be exporters, which countries can be importers, the 

compensation to be paid, etc. 

Other limitations such us the research and experimental use and the Bolar exception should 

be harmonized in order for companies to be able to invest with security in less developed or 

developing countries. If, for example, generic companies know that they can research with a 

patented product in a developing country, they might choose such countries for researching, 

considering that they will probably have to spend less in raw materials or employees. The 

same conditions for all countries will facilitate such investment decisions. What kind of use is 

considered as experimental use should also be harmonized. 

Should there be specific requirements for the applications of the research and experimental 

use and the Bolar exception, such as maybe the time prior to the expiration of a patented 

product, allowed for generics to start seeking approval for commercialization, they should be 

dependant to each country’s rules. 

Concerning the individual prescriptions exception it should be harmonized to allow the 

exception and specify which persons are allowed to prepare such medicines. However other 

requirements such as maybe, the need to inform the owner of the patent, or the determination 

of in which cases individual prescriptions is needed should be for each country to decide. 

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Questions 

Egypt 

Egypte 

Ägypten 

Report Q202 

in the name of the Egyptian Group 

by Ahmed EL–HAKIM and Negad SHAARAWI 






1.1) From our reading to Egyptian IP Law No. 82 of 2002, as amended (the “IP Law”), we 

conclude that the IP Law in its Article 10 provides that for an exception for scientific 

research or experimental use from the right to prevent third parties from exploiting a 

patented invention by any way (i.e. exclusivity rights). 

1.2) Please note that the scope and conditions of this exception are confined to scientific 

purposes. However, we note that Article 10 of the IP Law provides for certain cases, 

where the exception is somehow indirectly connected to commercial purposes. These 

cases can be summarized as follows: 

a) Manufacturing a product, using the method of manufacturing a specific product, or 

taking serious arrangements relating thereto by a third party acting in good faith, in 

the Arab Republic of Egypt, before the date the patent application is filed by another 

person for the same product, or for the method of its manufacture. Despite the issue 

of the patent, that third party, shall have the right of continuing the same said works 

in the interest of his establishment solely and without expanding them. The right 

of carrying out these works may not be assigned or alienated except with the rest 

elements of the establishment. 

b) Manufacturing, assembling, using, or selling the product by a third party during 

the period of its protection, with the aim of extracting or obtaining a license for 

marketing thereof, provided that such marketing shall not take place except following 

the lapse of that period. 

c) Works other than the foregoing, as carried out by third parties, provided that 

they shall not unreasonably contradict the normal use of the patent or irrationally 

prejudice the legitimate interests of the patentee, subject to the legitimate interests of 

third parties. 






exception? 

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2.1) We see that the IP Law does not regulate the Bolar-type exception explicitly. However, 

due to the generality of Article 10 of the IP Law listing the exemptions from patent 

infringement, we see that the Bolar-type exception is implicitly recognized under the IP 

Law. 

2.2) Of course, the scope and conditions of a Bolar exception will not differ from what we 

have prescribed above (mainly using a Bolar exception in a good faith and provided 

that this shall not unreasonably contradict the normal use of the patent or irrationally 

prejudice the legitimate interests of the patentee). 

2.3) We see that this applies to all products. 




3.1) Egypt adopts the concept of International Exhaustion. Hence, parallel imports are 

permitted without restrictions. 

3.2) Egyptian Law did not address the case where the products are originated from markets 

where they were made available under a compulsory license, but we see that pursuant 

to article 31 (bis) of Trips parallel imports should not be permitted in this case. 


conditions? 

No. 




According to Egyptian IP Law methods of medical treatment are not patentable. 






6.1) Yes, compulsory licenses are recognized under Egyptian IP Law. Please find below the 

relevant articles on compulsory license under the IP Law: (Articles 23 and 24 of the 

law). 

I) Grounds 

The Patents Office, following approval of a Ministerial Committee to be formed by 

virtue of a Prime Minister’s decree, shall grant compulsory licenses for exploitation of 

the invention, and the committee shall determine the financial rights of the patentee upon 

issuing these licenses, in the following cases: 

First: 

If the concerned Minster decides, as the case may be, that the exploitation of the invention 

shall realize the following: 

1) Non-commercial public interest. National security, health, environment and food 

safety are considered non-commercial public interest to this effect. 

2) Confronting emergency cases or conditions of paramount necessity. 

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The compulsory license shall be issued in order to confront the cases prescribed in 

items (1) and (2) above without need for a prior negotiation with the patentee, or due 

to the lapse of a period of time following negotiation with him, or because of offering 

reasonable conditions to obtain his approval of exploiting the patent. 

3) Support national efforts in sectors of importance for economic, social and 

technological development, without unreasonable prejudice to the patent owner’s 

rights, and subject to the legitimate interests of third parties. 

The patent owner shall be notified of the compulsory licensing decision, immediately in 

the cases prescribed in items (1) and (3) above, and within as soon as practicable in the 

cases prescribed in item (2) above. 

Second: 

If the Minister of Health demands issuing the compulsory license in any of the cases 

where the quantity of patent protected medicines fails to cope with the needs of the 

State, or due to their low quality, or the unusual hike in their prices, or if the invention is 

connected with medicines for critical cases, or chronic, incurable, or endemic diseases, or 

with products used in protection from these diseases, whether the invention is connected 

with the medicines, the method of their production, the fundamental raw materials used 

in their production, or the method of preparing the raw materials necessary for their 

production. 

In all these cases, the patentee shall be notified immediately of the compulsory license 

decision. 

Third: 

If the patentee refuses to license a third party to exploit the invention, regardless of the 

purpose of exploitation, despite offering him reasonable conditions and the lapse of a 

reasonable negotiations period. 

The compulsory license applicant shall in this case provide evidence of having exerted 

serious attempts and efforts to obtain the voluntary license from the patentee. 

Fourth: 

If the patentee has failed to exploit it in the Arab Republic of Egypt by himself or with his 

approval, or if its exploitation has been inadequate, despite the lapse of four (4) years 

from the date of submitting the application of the patent’s registration, or three (3) years 

from the date of granting it, whichever is longer, and also if the patentee discontinues 

exploiting the invention without a reasonable excuse for a period of more than one (1) 

year. 

The patent shall in this case be exploited by processing the product subject of protection 

in the Arab Republic of Egypt, or by using the method of manufacture which is protected 

by the patent in the Arab Republic of Egypt. 

However, if the Patents Office judges, despite the lapse of any of the aforementioned two 

periods – that non-exploiting the invention is due to legal, technical, or economic reasons 

beyond the power of the patent owner, it may grant him another adequate period of 

exploiting the invention. 

Fifth: 

If proven that the patentee is abusively using his rights derived from the patent or he has 

exercised his rights in an anti-competitive manner. The following are considered instances 

of this sort: 

1) Exaggeration in the sale prices of protected products, or discrimination between 

clients in terms of the sale prices and conditions of these products. 

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2) Failure to provide the protected product in the market, or launching it with unfair 

conditions. 

3) Discontinuing the production of the protected commodity, or producing it in quantities 

inadequate to realize congruence between the productive energy and market 

needs. 

4) Undertaking works or acts negatively affecting the freedom of competition, according 

to the prescribed legal controls. 

5) Using the rights granted by the law in a way negatively affecting the transfer of 

technology. 

In all the previous cases, the compulsory license shall be issued without need for 

negotiation, or upon the lapse of the period prescribed for obtaining it, even if the 

compulsory license does not target the fulfillment of local market needs. 

The Patent Office shall have the authority to refuse terminating the compulsory license if the 

conditions that called for issuing it indicate their continuity, or predict their recurrence. 

In estimating the compensation due to the patent owner, the damages caused by his 

abusive or anti-competitive practices shall be taken into account. 

The Patent Office may cancel the patent if after the lapse of two (2) years from granting the 

compulsory license it transpires that such license was inadequate to repair the negative 

effects caused to national economy on account of the patent owner’s arbitrariness in 

using his rights or due to his anti-competitive practices. 

Sixth: 

If exploiting the invention by the holder of the right to use the patent cannot be realized 

except through exploiting another invention necessary for it, which comprises a concrete 

technological advancement and a technical and economic importance, compared to that 

invention, the patent user shall then have the right to obtain an compulsory license vis-àvis 

that other patent holder, and the latter shall have the same right in this case. 

Assigning the licensed exploitation of either patent shall not be allowed except by 

assigning the exploitation of the other patent. 

Seventh: 

In the cases of inventions connected with semi-conductors technology, the compulsory 

license shall not be granted except for non-commercial public utility purposes, or for 

remedying the effects proven to be anti-competitive. 

II) Conditions 

On issuing the compulsory license the following shall be observed: 

1) The application for issuing the compulsory license shall be decided according to 

each case separately, and the license shall basically aim to provide the local market 

needs. 

2) The license applicant shall establish having exerted serious attempts, within a 

reasonable period, to obtain a voluntary license from the patent holder against a 

fair consideration, but failed to obtain such license. 

3) The patentee shall have the right of to challenge the decision of granting the 

compulsory license to a third party, before a committee formed according to the IP 

Law, within thirty (30) days from the date he is notified of the grant of that license. 

4) The applicant for the compulsory license, or the person in whose favour the license is 

issued shall have the ability to exploit the invention in a serious manner in the Arab 

Republic of Egypt. 

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5) The party to whom the compulsory license is granted shall be committed to use the 

invention within the scope, according to the conditions and throughout the period to 

be determined in the decision granting that compulsory license. 

If the period of the compulsory license expires without realizing the purpose of using 

the invention, the Patent Office may renew auch period. 

6) Using the compulsory license shall be confined to its applicant. However, the Patent 

Office may grant it to a third party. 

7) The party granted the compulsory license shall have no right to alienate it to a 

third party except with the enterprise, or with the portion connected with using the 

invention. 

8) The patent holder shall have the right of obtaining a fair consideration in return 

for exploiting his invention. The economic value of the invention shall be taken into 

account in estimating that consideration. 

9) The compulsory license shall terminate with the expiry of its period. However, the 

Patent Office shall be powered to decide canceling the compulsory license before 

the lapse of its period, if the reasons that led to granting it cease to exist, and that 

there is no probability that these reasons will recur. 

10) The owner of the invention shall have the right to request canceling the compulsory 

license before expiry of the period determined therefor, if the reasons that led to 

obtaining it cease to exist and there is no probability that they will exist once more. 

11) The legitimate interests of the licensee shall be observed on terminating the 

compulsory license before expiry of its period. 

12) The Patent Office shall have the authority to amend the conditions of the compulsory 

license or revoke the license of its own initiative, or upon the request of all concerned 

party, if the licensee who is authorized to exploit the license fails to use it within two 

(2) years from the date of granting it or if he violates the obligations stipulated upon 

in the license. 

6.2) We are not aware of any compulsory licenses granted in Egypt for the domestic 

manufacture and supply of pharmaceutical products. 






7.1) To the best of our knowledge, Egypt has not yet ratified Article 31bis. Also, there is 

no amendment introduced to amend the IP Law with the view to implement the WTO 

decision of August 30, 2003. 

7.2) We are not aware of any compulsory licenses granted in Egypt for the domestic 




Please see our response on compulsory license. 


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Article 25 of the IP Law provides for the following: 

9.1) The concerned Minister may, upon the approval of a Ministerial Committee to be formed 

by virtue of a Prime Minister’s decree, expropriate the ownership of an invention patent for 

national defence and in conditions of extreme emergency purposes, where a compulsory 

license is not sufficient for confronting said conditions. 

9.2) Expropriation of ownership should be limited to exploitation of the invention for the 

purpose of meeting the State’s need. In all cases, expropriation should be made against 

fair compensation. 

9.3) The expropriation decree is to be published in the Patent Journal, and appealing said 

decree and the committee decree before the Administrative Court, within sixty (60) days 

from the date on which the concerned party was notified with said decree by registered 

mail, as the Court will hold its judgment on an urgency basis. 





We do not see other means other than those prescribed above. 

Summary 

The IP Law in its Article 10 provides that for an exception for scientific research or experimental use. 

The scope and conditions of this exception are confined to scientific purposes. However, we note 

that Article 10 of the IP Law provides for certain cases, where the exception is somehow indirectly 

connected to commercial purposes. 

– Manufacturing a product, by a third party acting in good faith, before the date the patent 

application is filed by another person. 

– Manufacturing, assembling, using, or selling the product by a third party during the period of 

its protection, with the aim of extracting or obtaining a license, provided that such marketing 

shall not take place except following the lapse of that period. 

– Works other than the foregoing, provided that they shall not prejudice the legitimate interests 

of the patentee. 

Bolar-type 

The IP Law does not regulate the Bolar-type exception explicitly. However, due to the generality of 

Article 10 of the IP Law, we see that the Bolar-type exception is implicitly recognized under the IP 

Law. 

International Exhaustion 

Egypt adopts the concept of International Exhaustion. Hence, parallel imports are permitted without 

restrictions. The Egyptian Group believes that pursuant to article 31 (bis) of Trips parallel imports 

should not be permitted in this case when the products are originated from markets where they 

were made available under a compulsory license. According to Egyptian IP Law methods of medical 

treatment are not patentable. 

Compulsory licenses 

The Patent Office, following approval of a Ministerial Committee shall grant compulsory licenses for 

exploitation of the invention and the Committee shall determine the financial rights of the patentee. 

The grounds for Compulsory Licensee are: 

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– National security, health, environment and food safety are considered non- commercial public 

interest to this effect. 

– Confronting emergency cases or conditions of paramount necessity. 

– Support national efforts in sectors of importance for economic, social and technological 

development, without unreasonable prejudice to the patent owner’s rights, and subject to the 

legitimate interests of third parties. 

– If the patentee has failed to exploit it in the Arab Republic of Egypt by himself, despite the 

lapse of (3) years from the date of granting it. 

– If proven that the patentee is abusively using his rights derived from the patent or he has 

exercised his rights in an anti-competitive manner. 

In estimating the compensation due to the patent owner, the damages caused by his abusive or anti 

competitive practices shall be taken into account. 

– If exploiting the invention by the holder of the right to use the patent cannot be realized except 

through exploiting another invention necessary for it. 

In the cases of inventions connected with semi-conductors technology, the compulsory license shall 

not be granted except for non-commercial public utility purposes, or for remedying the effects 

proven to be anti-competitive. 

The Ministry of Health or the Ministry of Defence are allowed to stop the registration of a patent 

application (Art. 17) or to expropriate a patent (Art. 25) for the following: 

– For national defence and in conditions of extreme emergency purposes, where a compulsory 

license is not sufficient for confronting said conditions (Art. 17). 

– Expropriation of ownership should be limited to exploitation of the invention for the purpose 

of meeting the State’s need. In all cases, expropriation should be made against fair 

compensation. 

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105-112_Q202_Egypt.indd 112 17.07.2009 09:54:22

Questions 

Estonia 

Estonie 

Estland 

Report Q202 

in the name of the Estonian Group 

by Alla HAMMALOV and Juhan HAMMALOV 






No. 






exception? 

No. 




No. 


conditions? 

No. 









Yes, the compulsory licenses are available under Estonian patent law (§ 47). The conditions 

and grounds are as follows: 

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1) the proprietor of the patent has not used the invention in Estonia within three years after 

publication of the notice concerning the issue of the patent or within four years after filing 

a patent application, and in such case the term which ends later shall apply; 

2) the proprietor of the patent does not use the invention in the extent which would correspond 

to the needs of the domestic market; 

3) the patent hinders the use of another, technically advanced invention significant for the 

economy of Estonia; 

4) national defense, environmental protection, public health and other significant national 

interests of the Republic of Estonia require the use of the invention, including the need to 

use the invention in connection with a natural disaster or other emergency; 

5) the patent hinders the grant of plant variety rights pursuant to the Plant Variety Rights Act 

or the use of a plant variety which is granted legal protection. 

A compulsory license shall not be granted if the proprietor of a patent imports the product 

protected by the patent from any state member of the World Trade Organisation in the extent 

which corresponds to the needs of the domestic market. 

We are not aware of recoding of any compulsory license granted in Estonia. 






No. 



No. 


No. 





No. 










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113-116_Q202_Estonia.indd 114 17.07.2009 09:54:44









Summary 

Answers on the working questions are provided on the bases of the Estonian legislation. No 

proposals are done. 

Résumé 

Les réponses aux questions de travail se fondent sur la législation estonienne. Le group national 

estonian n’a pas des propositions. 


Die Antworten auf die Arbeitsfragen sind auf Grund von estnische Gesetzgebung gegeben. 

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113-116_Q202_Estonia.indd 116 17.07.2009 09:54:44

Questions 

Finland 

Finlande 

Finnland 

Report Q202 

in the name of the Finnish Group 

by Marjut Salokannel, Pia Hjelt, Riikka HöykinPuRo, 

Saara laPiolaHti, jan lindbeRG and jarkko VuoRinen 






experimental use exception is recognised under the Finnish patent law. according to 

paragraph 3 of Section 3 of the Finnish Patents act (550/1967), the exclusive rights conferred 

by a patent shall not apply to use in experiments relating to the invention as such. in other 

words, research on the invention is permitted without the permission of the patent holder, but 

research with or using the invention requires a license. there is no case law relating to the 

application of the research exemption and its scope seems to be unclear in certain cases, 

e.g., research tools, as it may be difficult to make a distinction between “on” or “using” the 

invention. the research exemption covers also commercial purposes. 






exception? 

in connection with the harmonization of the european medicines law, the so-called bolar 

exemption was implemented into the Finnish patent law. according to paragraph 3.3 of 

Section 3 of the Finnish Patents act (550/1967), the exclusive rights conferred by a patent 

shall not apply to studies, trials and the consequential practical requirements, which are 

needed for an application to obtain a marketing authorisation for a medicinal product, and 

which relate to the patented medicinal product. Finland chose to implement this exemption in 

a wide manner to the effect that it covers research, studies and other experiments relating to 

the patented medicine in order to obtain a marketing approval in Finland or abroad. 




Parallel imports only within the european union are permitted. the same principles do 

not apply if the products originate from markets where they were made available under a 

compulsory license. 

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117-122_Q202_Finland.indd 117 17.07.2009 09:56:26


conditions? 

individual prescriptions exception is recognised under the Finnish patent law. according to 

Paragraph 3.5 of Section 3 of the Finnish Patents act (550/1967), exclusive right conferred 

by a patent shall not apply to preparation in a pharmacy of a medicine prescribed by a 

physician in individual cases or treatment given with the aid of a medicine so prepared. 




not applicable. 






Compulsory licenses are available under the Finnish patent law. Compulsory licenses are 

available under the following five main conditions of the Patents Act (550/1967): 

Section 45.1: “Where three years have elapsed since the grant of the patent and four years 

have elapsed from the filing of the application, and if the invention is not worked or brought 

into use to a reasonable extent in Finland, any person who wishes to work the invention in 

Finland may obtain a compulsory licence to do so unless legitimate grounds for failing to 

work the invention may be shown.” 

Section 46.1: “The proprietor of a patent for an invention whose exploitation is dependent 

on a patent held by another person may obtain a compulsory licence to exploit the invention 

protected by such patent if deemed reasonable in view of the importance of the first-mentioned 

invention or for other special reasons.” 

Section 47.1: ”In the event of considerable public interest, a person who wishes to exploit 

commercially an invention for which another person holds a patent may obtain a compulsory 

licence to do so.” 

Section 48.1: “Any person who was commercially exploiting in this country an invention 

which is the subject of a patent application, at the time the application documents were 

made available under section 22, shall, if the application results in a patent, be entitled 

to a compulsory licence for such exploitation, provided there are special reasons for this 

and also provided that he had no knowledge of the application and could not reasonably 

have obtained such knowledge. Such a right shall also be enjoyed, under corresponding 

conditions, by any person who has made substantial preparations for commercial exploitation 

of the invention in this country. Compulsory licences may also relate to the period of time 

preceding the grant of the patent.“ 

Section 49.1: “A compulsory licence may only be granted to a person deemed to be in a 

position to exploit the invention in an acceptable manner and in accordance with the terms of 

the licence who, before filing a claim for a compulsory licence, has made a verifiable effort 

to obtain, on reasonable commercial terms, a licence to the patented invention. a compulsory 

licence shall not prevent the proprietor of the patent from exploiting the invention himself 

or from granting licences under the patent. a compulsory licence may only be transferred 

to a third party together with the business in which it is exploited or was intended to be 

exploited.” 

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Compulsory licenses have not been granted in Finland for the domestic manufacture and 

supply of pharmaceutical products. 






Article 31bis TRIPS has been ratified by the European Council on behalf of the European 

union and its Member States. no compulsory licenses have been granted in Finland for the 

importation or exportation of pharmaceutical products. 



except for situations where the country is at war or there is a danger of war, the Finnish patent 

law does not give the government any right to use a patented invention without previous 

license. 


under the Finnish patent law, the government may if the country is at war or in danger of 

war, decree, where required by the public interest, that the right to a given invention shall be 

assigned to the State or to another party designated by the government. according to the act 

on Inventions with Significance for National Defence (551/1967), certain patent applications 

can be expropriated by the government. Reasonable compensation shall be paid for the right 

to any invention thus assigned. 





the Finnish patent law does not recognise other means of facilitating access to medicines, 

medical devices, diagnostics and the like, even within the context of public health crises. 




yes. 


yes. 


Within economic regions such as EU, yes. 


yes. 


no. 


in principle compulsory licensing provisions should be harmonized according to the 

tRiPS standards. However, with regard to certain mid-level developing countries and 

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small industrialized countries without indigenous manufacturing capacity for medicines, 

the need for current opt-out provisions as provided in connection with the decision of the 

General Council of 30th august 2003 relating to the implementation of paragraph 6 of the 

doha declaration should be re-considered. all countries not having local manufacturing 

capacity for producing medicines should be able to use the tRiPS addendum for national 

health purposes. 


only in very exceptional circumstances. 



in case of evident abuse of the patent system and ensuing harm to society, the government 

should have the possibility to intervene. 




Where the interests of public health demand, and in the event of medicines being made 

available to the public in insufficient quantity, patents granted for medicines or for processes 

for obtaining medicines, for products necessary in obtaining such medicines or for processes 

for manufacturing such products may be subject to ex-officio licenses, e.g. as specified in 

French law (articles l 613-16 and l. 613-17). 




Harmonisation of the limitations should be attempted considering the international nature of 

medical markets and research. 

national Groups are invited to comment on any additional issue concerning the impact of 

public health issues on the patentee’s exclusive rights which they find relevant. 

Generic substitution and reference pricing 

Finland introduced mandatory generic substitution of medicinal products in april 2003. 

the initial law made no exception for patented drugs. the Medicines act was amended 

in February 2006 to exclude from the substitution drugs which were protected by so called 

analogy process patents and were covered by product patents in other countries. this was 

done to compensate the pharmaceutical industry for the lack of product patent protection 

before 1 january 1995 and for the relatively short (6 year) data protection period. the data 

protection period has since been harmonized within the eu and is 10 years with a possible 

extension of one year. 

the exception based on analogy process patents was not required by national nor by 

international regulations and the exception is being debated again when Finland is considering 

adopting a reference pricing system to lower the costs of public health care. 

Summary 

in Finland the Patent act provides for both research and bolar exceptions. Parallel imports from 

other eu countries are permitted. Compulsory license provisions exist but have never been applied. 

With regard to international harmonization we propose harmonization of the research and Bolar 

exceptions as well as introducing an ex officio compulsory license for public health purposes. 

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Résumé 

en Finlande, la loi sur brevets comprend les réglementations sur l’exception de recherche et l’exception 

bolar. l’importation parallèle des pays de l’union européenne est permise. les réglementations 

relatives à la licence obligatoire existent mais elles ne sont jamais mises en application. À l’égard 

de l’harmonisation internationale, nous proposons l’harmonisation de la réglementation sur 

l’exception de recherche et l’exception bolar ainsi que l’introduction d’une licence obligatoire d’ex 

officio pour des raisons de santé publique. 


Unter dem finnischen Patentrecht werden Benutzung zu Forschungszwecken und Ausnahmen vom 

bolar-typ anerkannt. Parallelimporte aus anderen eu-ländern sind zugelassen. Zwangslizenzen 

sind vorhanden, sind aber nie in der Praxis umgesetzt worden. bezüglich der internationalen 

Harmonisierung schlagen wir eine Harmonisierung von den ausnahmen zu Forschungszwecken 

sowie ausnahmen vom bolar-typ vor. auch schlagen wir vor, von amts wegen Zwangslizenzen zu 

Gesundheitszwecken einzuführen. 

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France 

France 

Frankreich 

Rapport Q202 

au nom du Groupe français 

par Alain GALLOCHAT, Jean-Christophe GUERRINI, Laetitia BENARD, Serge BINN, 

Paule DROUAULT–GARDRAT, Chrystel LANXADE, Laurent ROMANO et Grégoire TRIET 

Question Q202 



Questions 






1.1) Le droit français reconnaît l’exception d’expérimentation. 

Ainsi, l’article L. 613-5 b) du Code de la propriété intellectuelle dispose que: “Les droits 

conférés par le brevet ne s’étendent pas aux actes accomplis à titre expérimental qui portent 

sur l’objet de l’invention brevetée.” 

1.2) La jurisprudence a précisé les conditions et l’étendue de cette exception. 

Elle a posé le principe selon lequel la dérogation apportée au monopole du brevet est 

d’interprétation stricte et ne peut s’appliquer qu’aux seuls actes expérimentaux qui ont pour 

objet de participer à la vérification de l’intérêt technique de l’invention ou à son développement 

aux fins de faire progresser la connaissance, et non à des actes à visée commerciale1 . 

Ainsi, il a été jugé que ne peut bénéficier de l’exception d’expérimentation: 

– la présentation d’un produit lors d’un salon, en ce qu’elle ne peut avoir eu pour but “de 

vérifier l’intérêt technique de l’invention, d’en mesurer la portée ou de la perfectionner 

mais de rechercher l’avis commercial du produit en étudiant l’avis de la clientèle pour ce 

dernier” 2 ; 

– la présentation d’un prototype, “amplement relayée auprès du public par la presse 

nationale” en ce qu’elle “excède manifestement la simple expérimentation” 3 ; 

– la mise à disposition d’un prototype auprès de clients potentiels, qui ne saurait en 

conséquence être considéré comme constituant “un simple prototype expérimental” mais 

procède “d’un acte à visée commerciale” 4 . 

1 Arrêts de la Cour d’appel de Paris du 3 juillet 2002, PARIENTI / AUTOMOBILES PEUGEOT, PIBD 2003, n° 756.III.93 

et du 7 octobre 2005, AGROSOL / SODIFAG, PIBD 2005, n° 819.III.685. 

2 Arrêt de la Cour d’appel de Lyon du 5 mars 1992, BABOLAT / BOSCHIAN, PIBD 1992, n° 525.III.363. 

3 Arrêt de la Cour d’appel de Paris du 3 juillet 2002 précité. 

4 Arrêt de la Cour d’appel de Paris du 7 octobre 2005 précité. 

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Les expérimentations effectuées à des fins commerciales ne sont donc pas considérées par la 

jurisprudence comme susceptibles de bénéficier de l’exception d’expérimentation. 

Ainsi, les actes qui consistent en une mise en contact du produit issu de l’expérimentation avec 

la clientèle potentielle ne sont donc pas considérés par la jurisprudence comme susceptibles 

de bénéficier de l’exception d’expérimentation. En revanche, les actes de recherche 

fondamentale ou visant à l’accroissement des connaissances techniques devraient bénéficier 

de l’exception posée par l’article L. 613-5 b) du Code de la propriété intellectuelle. 







1) L’exception de type Bolar, soit l’exception d’expérimentation appliquée aux médicaments, 

a d’abord résulté d’une construction jurisprudentielle 

1.1) La jurisprudence française avait d’abord jugé que les essais réalisés en vue de 

l’obtention d’une autorisation de mise sur le marché ne pouvaient bénéficier de l’exception 

d’expérimentation5 . En l’espèce, des échantillons du médicament objet de la demande 

d’autorisation de mise sur le marché avaient été fabriqués dans le cadre des expérimentations 

nécessaires à l’obtention de l’autorisation de mise sur le marché. Une saisie contrefaçon 

diligentée par le breveté avait permis de saisir des échantillons portant une étiquette 

„essai“. La Cour d’appel de Paris a rejeté le bénéfice de l’exception d’expérimentation et 

considéré que des actes de contrefaçon avaient été commis, au motif que la délivrance d’une 

autorisation de mise sur le marché établissait que la fabrication du produit avant la délivrance 

de l’autorisation de mise sur le marché avait une finalité commerciale. 

1.2) La jurisprudence française a ensuite opéré un revirement et jugé que les essais réalisés en 

vue de l’obtention d’une autorisation de mise sur le marché constituaient des actes accomplis 

à titre expérimental et ne pouvaient par conséquent constituer des actes de contrefaçon. 

Dans une ordonnance de référé rendue le 6 mars 1998, le président du Tribunal de 

Grande Instance de Paris a jugé que „rien ne permet de contester que les essais ont un 

caractère expérimental et visent à développer les possibilités d’application de l’invention“, 

pour conclure que „la perspective d’une éventuelle commercialisation ultérieure du produit 

testé ne peut avoir une incidence quelconque sur les actes dès lors qu’ils sont accomplis 

à titre expérimental et qu’ils portent sur l’invention“. Dans cette espèce, une société avait 

expérimenté une technologie relative à des microcapsules médicamenteuses permettant 

une libération prolongée des principes actifs sur un produit breveté, afin de déterminer si 

l’application de la technique des microcapsules audit produit breveté permettait de réduire 

les doses administrées. 

La Cour d’appel de Paris a confirmé cette décision aux motifs que “ces essais, à supposer 

qu’ils se révèlent positifs, n’excèdent pas, par leur nature même, quelle que soit la finalité 

poursuivie, notamment la commercialisation future, le caractère expérimental et se révèlent 

un préalable nécessaire à une autorisation de mise sur le marché dont il est constant qu’elle 

ne constitue pas, elle-même, un acte de contrefaçon; ils ne rentrent pas dans la définition 

précitée des actes interdits” 6 . 

5 Arrêt de la Cour d’appel de Paris du 27 novembre 1984, SCIENCE UNION & SERVIER/CORBIERE, PIBD 1985, n 366. 

III.118. 

6 Arrêt de la Cour d’appel de Paris du 27 janvier 1999, WELLCOME/PAREXEL & FLAMEL. 

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Par un jugement en date du 20 février 2001, le Tribunal de Grande Instance de Paris a jugé 

qu’en matière de médicament, les actes accomplis à des fins industrielles et commerciales ne 

peuvent s’effectuer que postérieurement à l’autorisation de mise sur le marché de la spécialité 

en cause: “qu’en l’espèce, les essais de bioéquivalence consistant à comparer les propriétés 

du produit expérimenté à la spécialité de référence étant nécessaires à l’obtention de la mise 

sur le marché du Genvir ne peuvent être considérés comme des actes accomplis à des fins 

industrielles et commerciales, leur finalité immédiate étant l’obtention de l’AMM” 7 . 

Dans une décision du 12 octobre 2001, le Tribunal de Grande Instance de Paris a précisé 

sa jurisprudence et a énoncé clairement que des “essais effectués ainsi dans le cadre limité 

d’une demande d’AMM, dont ils sont donc indissociables, ne sont pas susceptibles de fonder 

l’action engagée par les demanderesses, dans la mesure où il est acquis qu’une autorisation 

de mise sur le marché ne constitue pas un acte de contrefaçon” 8 . 

Cette solution a été confirmée par une décision de ce même tribunal du 25 janvier 2002 qui 

a jugé qu’ “il n’est pas établi que les actes reprochés à la société Biophelia sortent du cadre 

des actes nécessaires à la demande d’obtention d’autorisation de mise sur le marché“ et que 

„des essais réalisés en vue de la délivrance d’une autorisation de mise sur le marché dont il 

est acquis qu’elle ne constitue pas un acte de contrefaçon ne peuvent fonder une action en 

contrefaçon” 9 . 

2) Cette jurisprudence a été consacrée par l’article 10 de la loi n°2007-248 du 27 février 

2007, transposant en droit français la directive n°2004/27/CE du Parlement européen et du 

Conseil du 31 mars 2004, qui a ajouté le paragraphe d) suivant, à l’article L. 613-5 du Code 

de la propriété intellectuelle qui prévoit désormais que les droits conférés par le brevet ne 

s’étendent pas: 

“d) aux études et essais requis en vue de l’obtention d’une autorisation de mise sur le marché 

pour un médicament, ainsi qu’aux actes nécessaires à leur réalisation et à l’obtention de 

l’autorisation”. 

Ce texte prévoit donc spécifiquement une exception d’expérimentation concernant les 

essais réalisés en vue de l’obtention d’une autorisation de mise sur le marché pour les 

médicaments. 

Le texte français va au-delà du texte communautaire qui ne visait que le cas des médicaments 

génériques et prévoit que l’exception d’expérimentation concernant les essais réalisés en vue 

l’obtention d’une autorisation de mise sur le marché s’applique pour tous les médicaments 

3) S’il est clair que cette exception est limitée aux médicaments, il convient toutefois de 

préciser que le médicament est défini à l’article L. 5111-1 du Code de la santé publique 

comme “toute substance ou composition présentée comme possédant des propriétés curatives 

ou préventives à l’égard des maladies humaines ou animales, ainsi que toute substance 

ou composition pouvant être utilisée chez l’homme ou chez l’animal ou pouvant leur être 

administrée, en vue d’établir un diagnostic médical ou de restaurer, corriger ou modifier 

leurs fonctions physiologiques en exerçant une action pharmacologique, immunologique ou 

métabolique”. Cet article précise que: “lorsque, eu égard à l’ensemble de ses caractéristiques, 

un produit est susceptible de répondre à la fois à la définition du médicament prévue au 

premier alinéa et à celle d’autres catégories de produits régies par le droit communautaire ou 

national, il est, en cas de doute, considéré comme un médicament”. 

7 Jugement du Tribunal de Grande Instance de Paris du 20 févrer 2001, WELLCOME / PAREXEL & FLAMEL, PIBD 2001, 

n 729.III.530. 

8 Jugement du Tribunal de Grande Instance de Paris du 12 octobre 2001, SCIENCE UNION & SERVIER / EXPANPHARM, 

PIBD 2002, n° 739.III.155. 

9 Jugement du Tribunal de Grande Instance de Paris du 25 janvier 2002, SCIENCE UNION & SERVIER / BIOPHELIA, 

PIBD 2002, n° 747.III.342. 

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Particulièrement, l’article L. 5121-1-14 du Code de la santé publique définit le médicament 

biologique comme “tout médicament dont la substance active est produite à partir d’une 

source biologique ou en est extraite et dont la caractérisation et la détermination de la 

qualité nécessitent une combinaison d’essais physiques, chimiques et biologiques ainsi que 

la connaissance de son procédé de fabrication et de son contrôle”. 

Certains produits biologiques sont donc susceptibles d’être couverts par l’exception précitée 

prévue à l’article L. 615-3 d) du Code de la propriété intellectuelle. 

Les produits qui ne rentreraient pas dans le champ de la définition du médicament posée par 

l’article L. 5111-1 du Code de la santé publique pourraient toutefois bénéficier de l’exception 

d’expérimentation “générale” prévue à l’article L. 615-3 b) du Code de la propriété 

intellectuelle, à la condition que les expérimentations dont ils feraient l’objet aient pour but de 

participer à la vérification de l’intérêt technique de l’invention ou à son développement aux 

fins de faire progresser la connaissance, et ne constituent pas des actes à visée commerciale, 

conformément au principe posé par la jurisprudence et rappelé à la question 1. 




obligatoire? 

1) Les importations parallèles en provenance d’un pays partie à 

l’EEE 

L’article 28 du Traité instituant la Communauté Européenne pose le principe de la libre 

circulation des marchandises sur le territoire communautaire. Des restrictions sont néanmoins 

possibles, notamment pour des raisons liées à la protection de la santé publique et à la vie 

des personnes (article 30 du Traité), mais également à la protection de la propriété industrielle 

(article 36 du Traité), à condition que ces restrictions soient nécessaires et proportionnées à 

l’objectif poursuivi. 

Cette libre circulation des marchandises s’applique à l’ensemble des échanges commerciaux, 

dans le cadre des réseaux de distribution mis en place par les producteurs. Elle bénéficie 

également à des opérateurs qualifiés de „parallèles“, hors des réseaux des fabricants, et 

qui tirant profit des différences de prix d’un Etat à l’autre, font jouer la concurrence en 

s’approvisionnant sur les marchés à bas prix pour revendre sur les marchés à prix élevés. 

Les médicaments n’échappent pas à cette règle, d’autant plus que les différences de prix d’un 

Etat membre à un autre peuvent être sensibles. En effet, coexistent en Europe des Etats dans 

lesquels les prix des médicaments sont libres et d’autres dans lesquels ils sont réglementés. 

Ces derniers ayant en général des niveaux de prix moins élevés, des opérateurs parallèles 

les exportent vers des pays aux prix élevés, en captant une grande partie de la différence 

de prix. 

Il convient de noter la spécificité des importations parallèles de médicaments, qui sont dues 

non pas au libre jeu de l’offre et de la demande entre opérateurs économiques, mais à des 

différences de niveaux de prix dus à l’existence ou non de réglementations étatiques. 

Par ailleurs, sauf exceptions dans certains pays, les consommateurs ne bénéficient que très 

partiellement de l’opération, puisque la différence de prix est en grande partie absorbée par 

les importateurs parallèles. 

• Importations parallèles et droits de propriété intellectuelle 

Les importations parallèles reposent sur le principe de l’épuisement des droits qui a pour 

objectif de garantir la libre circulation des produits et de limiter les risques de cloisonnement 

du marché. Selon ce principe, le titulaire d’un droit de propriété intellectuelle protégé par la 

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législation d’un Etat membre ne peut invoquer cette législation pour s’opposer à l’importation 

d’un produit qui a été légalement mis sur le marché dans un autre Etat membre par lui-même 

ou avec son consentement (licenciés). 

La Commission Européenne a rappelé dans sa communication du 30 décembre 2003 que 

„l’importation parallèle d’un médicament est une forme légale de commerce dans le Marché 

Intérieur sur la base de l’Article 28 du Traité CE sous réserve des dérogations prévues à 

l’article 30 du Traité“. 

La cour de justice des communautés européenne a rendu de très nombreuses décisions 

relatives aux importations parallèles de médicaments, pour tracer les contours de la notion 

d’épuisement des droits, mais aussi pour apprécier la compatibilité de certaines opérations 

liées aux importations parallèles –comme le reconditionnement – avec les droits de propriété 

intellectuelle, mais aussi avec la protection de la santé publique. 

Les Etats ont la possibilité de mettre en place des réglementations des importations parallèles, 

notamment en matière de médicament, afin de vérifier si le produit ainsi importé a bien une 

AMM dans le territoire d’importation (faute de quoi il ne pourrait y être commercialisé, ou 

alors en application de procédure de contrôles beaucoup plus approfondies) et s’il est bien 

identique ou similaire (quelques légères variations peuvent être tolérées) au médicament 

commercialisé localement. 

En revanche, ces réglementations ne doivent pas apporter d’entraves disproportionnées au 

regard de l’objectif de contrôle poursuivi faute de quoi elles seraient censurées par la cour 

de justice. 

• S’agissant de la réglementation française en matière de médicament 

En France, ce n’est qu’à la suite d’une condamnation par la CJCE pour manquement aux 

obligations de l’article 28 CE, qu’un décret n°2004-83 du 23 janvier 2004 relatif aux 

importations de médicaments à usage humain a mis en conformité le droit français avec le 

droit communautaire. 

Le régime juridique mis en place par le décret est prévu aux articles R 5121-115 à R 5121-132 

du code de la santé publique. A ces dispositions s’ajoute un „avis aux demandeurs“ 

d’autorisation d’importation parallèle, publié sur le site de l’AFSSAPS qui détaille et explique 

la procédure à suivre. 

Ce décret définit tout d’abord l’importation parallèle et précise les conditions d’octroi des 

autorisations d’importations parallèles. 

Ainsi, „constitue une importation parallèle, en vue d’une mise sur le marché en France, 

l’importation d’une spécialité pharmaceutique: 

– Qui provient d’un autre Etat membre de la Communauté européenne ou partie à l’accord 

sur l’Espace économique européen, dans lequel elle a obtenu une autorisation de mise 

sur le marché; 

– Dont la composition quantitative et qualitative en principes actifs et en excipients, la 

forme pharmaceutique et les effets thérapeutiques sont identiques à ceux d’une spécialité 

pharmaceutique ayant obtenu une autorisation de mise sur le marché délivrée par 

l’Agence française de sécurité sanitaire des produits de santé, à la condition que les 

deux spécialités soient fabriquées par des entreprises ayant un lien juridique de nature 

à garantir leur origine commune. Toutefois, la spécialité peut comporter des excipients 

différents de ceux de la spécialité ayant obtenu une autorisation de mise sur le marché 

délivrée par l’Agence française de sécurité sanitaire des produits de santé ou les mêmes 

excipients en qualité différente de celle contenue dans cette spécialité, sous réserve que 

cette différence n’ait aucune incidence thérapeutique et qu’elle n’entraîne pas de risque 

pour la santé publique.“ 

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La spécialité importée peut, cependant, comporter des excipients différents ou les mêmes 

en quantité différente, sous réserve de l’absence de toute incidence 

thérapeutique ou risque pour la santé publique. 

La condition portant sur l’existence d’un lien juridique de nature à garantir l’origine commune 

entre, d’une part, la spécialité dont il est demandé une autorisation d’importation en vue d’une 

mise sur le marché en France et d’autre part la spécialité qui a déjà une AMM en France 

a été supprimée en France, par le décret du 12 janvier 2006, afin de mettre en conformité 

le régime juridique français avec la jurisprudence de la Cour de Justice des Communautés 

Européennes. (Arrêt Kohlpharma C-112/02 du 1er avril 2004). 

Le Décret n°2004-83 du 23 janvier 2004 précise également les conditions d’étiquetage 

et de notice pour les médicaments importés, la nécessité pour le titulaire de l’autorisation 

d’importation parallèle d’obtenir le statut d’établissement pharmaceutique exploitant 

l’obligation pour l’importateur d’avertir le titulaire de l’AMM dans le pays d’origine, 

préalablement à la commercialisation en France de la spécialité importée, l’obligation 

pour le Directeur de l’AFSSAPS d’adresser une copie de l’autorisation au titulaire de l’AMM 

en France, le maintien de la durée de validité des autorisations d’importation à 5 ans. 

• Points essentiels de la jurisprudence de la CJCE relative aux importations parallèles de 

médicaments 

La CJCE est intervenue de très nombreuses fois pour préciser les conditions que devaient 

remplir les importations parallèles de médicaments. 

Le 16 décembre 1999, (Rhône-Poulenc C-94/98) la CJCE a admis la possibilité d’utiliser des 

excipients différents et la fabrication selon un processus différent, dès lors que les médicaments 

ont le même ingrédient actif, les mêmes effets thérapeutiques et ne posent aucun problème au 

niveau de la qualité, de l’efficacité et de l’innocuité. 

Le 10 septembre 2002, (Ferring C-172/00) la CJCE a précisé que le retrait de l’AMM 

du médicament de référence dans le pays d’importation, à la demande de son titulaire, 

n’impliquait pas que l’autorisation d’importation parallèle cesse automatiquement d’être 

valide, sauf démonstration de l’existence d’un risque pour la santé des personnes. 

Le 16 octobre 2003, (Astra Zeneca C-223/01) la CJCE a souligné qu’il était „nécessaire 

et suffisant que l’AMM du médicament de référence soit en vigueur dans l’Etat membre 

concerné à la date de cette demande“ et que le retrait postérieur de l’AMM du médicament 

de référence n’a aucune importance. 

Enfin, le 1er avril 2004, (Kohlpharma C-112/02) la CJCE a étendu considérablement la notion 

d’origine commune en estimant que „l’absence d’origine commune des deux médicaments ne 

constitue pas en elle-même un motif de refus de l’AMM pour le second médicament.“ 

La CJCE a rendu le 26 avril 2007, (Boehringer C-348/04) un nouvel arrêt portant sur le 

reconditionnement de médicaments importés parallèlement. Cet arrêt a été rendu suite à des 

questions préjudicielles posées par la Cour d’Appel britannique dans une affaire opposant 

des laboratoires pharmaceutiques à des importateurs parallèles et portant sur les conditions 

dans lesquelles le titulaire d’une marque peut s’opposer à un reconditionnement de ses 

produits. Cet arrêt s’inscrit dans le cadre des décisions rendues précédemment par la Cour, 

qui avalisent la possibilité de reconditionner, à condition notamment que le reconditionnement 

soit nécessaire à la commercialisation du produit dans le pays d’importation et surtout ne 

porte pas atteinte à la santé publique. La Cour apporte cependant des précisions quant aux 

conditions dans lesquelles s’opère le reconditionnement, quant à la charge de la preuve et 

quant à l’information du titulaire de la marque par l’importateur parallèle. 

• S’agissant de la réglementation française en matière de dispositifs médicaux 

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Le droit communautaire ayant posé le principe de la libre circulation des marchandises au 

sein de l’Union Européenne, trois directives ont été prises pour renforcer la sécurité des 

produits. 10 

Pour circuler au sein de l’espace européen tout dispositif médical doit disposer d’un marquage 

CE dont l’octroi nécessite au préalable le respect de procédures de conformité qui permettent 

de prouver que le produit remplit les exigences de sécurité imposées. Une fois les procédures 

respectées, le dispositif médical peut être commercialisé et circuler sur l’ensemble du territoire 

communautaire, y compris en France à condition qu’il contienne des indications en français 

conformément aux dispositions du code de la santé publique. 

2) Les importations parallèles en provenance d’un pays tiers à 

l’EEE 

La loi française ne prévoit pas de disposition spécifique à l’importation parallèle de 

médicaments couverts par un brevet en provenance d’un pays tiers à l’EEE. 

Ce sont donc les dispositions du droit commun des brevets qui s’appliquent. 

L’article L. 613-6 du Code de la Propriété Intellectuelle dispose que: „Les droits conférés par 

le brevet ne s’étendent pas aux actes concernant le produit couvert par ce brevet, accomplis 

sur le territoire français, après que ce produit a été mis dans le commerce en France ou sur le 

territoire d’un Etat partie à l’accord sur l’Espace économique européen par le propriétaire du 

brevet ou avec son consentement exprès“. 

A contrario, le breveté peut s’opposer à toute importation parallèle de produits couverts par 

le brevet provenant de pays tiers à l’EEE. 

La loi ne tient pas compte des conditions dans lesquelles le produit a été fabriqué et 

commercialisé à l’étranger. 

De ce fait, que la fabrication et la commercialisation aient été licites ou illicites, c’est-à-dire, que 

le breveté français possède ou non un brevet correspondant dans le pays de la fabrication ou 

de la mise dans le commerce du produit, l’introduction sur le territoire français constitue une 

contrefaçon (CA Paris, 12 Octobre 2001 et TGI Strasbourg, 18 novembre 1985). 

La contrefaçon est commise par l’importateur, mais il est également possible de poursuivre 

le fournisseur étranger qui a participé activement à l’introduction en France (CA Nancy, 19 

janvier 1988 et TGI Marseille, 13 mai 1997, CA Paris, 7 avril 2004, CA Paris, 28 octobre 

2005 et concernant des sociétés du même groupe TGI Paris, 25 janvier 2006). 

Le Règlement CE n° 953/2003 du 26 mai 2003 prévoit une procédure spécifique aux 

médicaments permettant aux titulaires de droits de lutter plus efficacement notamment contre 

le retour dans la Communauté de certains médicaments brevetés vendus à bas prix dans les 

pays limitativement énumérés. 

Cette procédure repose sur la possibilité pour le titulaire des droits d’utiliser des moyens 

d’identifier spécifiquement ces produits. 

Le breveté ne peut s’opposer au transit des produits brevetés sur le territoire français, quel que 

soit le caractère licite ou illicite de la fabrication ou de la commercialisation du produit dans 

le pays d’origine et dans le pays de destination (CJCE aff. C 405/103, 18 octobre 2005, 

Class international; aff. C 281/05, 9 novembre 2006 Montex et Cass. Com 7 juin 2006). 

10 Dir CEE n° 90/385 20 juin 1990, JOCE 20 juillet n°L 189. 

Dir CEE n° 93/42 14 juin 1993 JOCE 12 juillet n° L 169. 

Dir CE n° 98/79 27 octobre 1998, JOCE 7 dec , n° L331. 

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En revanche, l’admission temporaire de marchandises contrefaisantes est une contrefaçon 

lorsque, durant celle-ci, le produit importé a subi des transformations ou a été conditionné 

(CA Paris, 3 décembre 1985). 

3) Importations parallèles et licences obligatoires 

• Au plan international 

Ainsi qu’il a été indiqué ci-dessus, le titulaire du brevet est en droit de s’opposer à toute 

importation du produit breveté en provenance d’un pays tiers à l’EEE. 

Il est donc indifférent que ce produit ait été mis sur le marché dans le pays d’origine en vertu 

d’une licence obligatoire. 

S’agissant plus spécifiquement des médicaments, le Règlement CE n° 816/2006 du 17 mai 

2006, qui prévoit la possibilité de licence obligatoire pour certains médicaments à destination 

de pays tiers, interdit expressément la réimportation de ces produits dans la Communauté. 

• Au plan européen 

En ce qui concerne les produits en provenance de la Communauté la CJCE a affirmé, dans 

l’arrêt Hoechst du 8 juillet 1985 (CJCE aff. 19/84, 8 juillet 1985, Pharmon c/ Hoechst. V. 

également CJCE aff. C-191/90, 27 octobre 1992, Generics et Harris Pharmaceuticals c/ 

Smith Kline & French Laboratories), que la mise en circulation d’un produit breveté par le 

titulaire d’une licence obligatoire n’épuise pas les droits du détenteur de brevet, faute de 

consentement de sa part. 

Le titulaire d’un brevet a donc le droit de s’opposer aux importations de produits brevetés 

en provenance d’un autre État partie à l’EEE où ils avaient été fabriqués sous couvert d’une 

licence obligatoire. 

4) Propositions pour l’adoption de règles communes 

Le groupe français estime que l’assouplissement des règles relatives aux importations parallèles 

n’est pas un moyen approprié pour faciliter l’accès de certains pays aux médicaments. 

Un tel assouplissement aurait pour conséquence d’une part de faciliter la contrefaçon, 

particulièrement dangereuse en matière de médicaments, du fait de l’augmentation des flux de 

produits, d’autre part d’inciter les industriels à adopter une politique restrictive d’exportation, 

ce qui irait à l’encontre de l’effet recherché. 

Le groupe français considère que la théorie de l’épuisement des droits, telle qu’elle est définie 

et appliquée aujourd’hui, permet un juste équilibre entre les besoins en matière d’accès aux 

médicaments, et la protection légitime des droits des titulaires de brevets. 


conditions? 

OUI. 

Le législateur a souhaité soustraire de la protection conférée par le brevet un certain nombre 

d’actes considérés comme échappant à une exploitation commerciale, dont fait partie la 

préparation officinale de médicaments. 

L’article L.613-5 c) du CPI dispose: „Les droits conférés par le brevet ne s’étendent pas: 

a) aux actes accomplis dans un cadre privé et à des fins non commerciales; 

b) aux actes accomplis à titre expérimental qui portent sur l’objet de l’invention brevetée; 

c) à la préparation de médicaments faite extemporanément et par unité dans les officines 

de pharmacie, sur ordonnance médicale, ni aux actes concernant les médicaments ainsi 

préparés“. 

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La réalisation de ces actes constitue un fait justificatif échappant ainsi à la sanction d’une 

contrefaçon. 

Cette dérogation caractérise une atteinte au monopole du breveté et ne doit pas dégénérer 

en abus. Elle doit par conséquent être enfermée dans des limites strictes. 

Pour échapper à l’emprise du brevet, la préparation ne doit avoir aucun caractère industriel 

ou même semi-industriel, ce qui exclut l’intervention d’un façonnier. 

Le législateur se borne à exclure de la protection conférée par le brevet les actes relatifs aux 

préparations magistrales confectionnées par les pharmaciens d’officine. 

Il n’a en revanche pas prévu le cas des préparations hospitalières préparées en raison 

de l’absence de spécialité pharmaceutique disponible ou adaptée dans une pharmacie à 

usage intérieur d’un établissement de santé selon l’article L.5121-1 2°) du Code de la santé 

publique. 

Si on s’en tient à la lettre du texte, sont exclues les préparations de thérapie génique et de 

thérapie xénogénique (Article L. 5121-1 12°) et 13°) du Code de la santé publique), celles-ci 

n’étant pas, à ce jour, susceptibles d’être réalisées en pharmacie d’officine. 

L’exception, traditionnelle, s’étend à tous les brevets de produits ou de procédés. 

Elle permet aux pharmaciens d’officine de continuer de réaliser des préparations magistrales, 

c’est-à-dire de pratiquer librement leur art. 

Il n’existe aucune jurisprudence sur la question. 




Sans objet. 







La législation française prévoit un certain nombre de licences obligatoires, dont certaines sont 

accordées par voie judiciaire, et d’autres par voie administrative. 

1) les licences obligatoires accordées par voie judiciaire 

a) situations donnant lieu à ces licences 

i) non exploitation du brevet 

C’est l’article L. 613-11 du CPI qui regroupe les dispositions spécifiques à ce type de 

situation: 

„Toute personne de droit public ou privé peut, à l’expiration d’un délai de trois ans après la 

délivrance d’un brevet, ou de quatre ans à compter de la date du dépôt de la demande, 

obtenir une licence obligatoire de ce brevet, dans les conditions prévues aux articles suivants, 

si au moment de la requête, et sauf excuses légitimes le propriétaire du brevet ou son ayant 

cause: 

a) N’a pas commencé à exploiter ou fait des préparatifs effectifs et sérieux pour exploiter 

l’invention objet du brevet sur le territoire d’un Etat membre de la Communauté économique 

européenne ou d’un autre Etat partie à l’accord sur l’Espace économique européen. 

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) N’a pas commercialisé le produit objet du brevet en quantité suffisante pour satisfaire 

aux besoins du marché français. 

Il en est de même lorsque l’exploitation prévue au a) ci-dessus ou la commercialisation prévue 

au b) ci-dessus a été abandonnée depuis plus de trois ans. 

Pour l’application du présent article, l’importation de produits objets de brevets fabriqués 

dans un Etat partie à l’accord instituant l’Organisation mondiale du commerce est considérée 

comme une exploitation de ce brevet.“ 

C’est au breveté à apporter la preuve de la réalité de son exploitation, qu’elle soit directe 

ou indirecte, c’est-à-dire par le biais de licences, voire d’une excuse légitime justifiant la non 

exploitation de son invention brevetée (il en irait ainsi par exemple d’un médicament breveté 

et non exploité en raison de la non délivrance de l’AMM). 

Enfin, la simple importation de produits objets de brevets, fabriqués dans un état membre de 

l’OMC étant considérée comme une exploitation desdits brevets (Cf. dernier alinéa de l’article 

L. 613-11 du CPI), il est vraisemblable que cette disposition aboutira, sinon à la disparition de 

ce type de licence, tout au moins à une sérieuse limitation quant à son octroi. 

ii) brevet dépendant 

L’article L. 613-15, dernièrement modifié par les Lois n° 2004-800 du 6 août 2004 et n° 

2004-1338 du 8 décembre 2004, notamment par l’adjonction d’un article L. 613-15-1, prévoit 

dans quelles conditions une licence de dépendance, autrefois également dénommée licence 

de perfectionnement, peut être accordée. 

„Le titulaire d’un brevet portant atteinte à un brevet antérieur ne peut exploiter son brevet 

sans l’autorisation du titulaire du brevet antérieur; ledit titulaire ne peut exploiter le brevet 

postérieur sans l’autorisation du titulaire du brevet postérieur. 

Lorsque le titulaire d’un brevet ne peut l’exploiter sans porter atteinte à un brevet antérieur dont 

un tiers est titulaire, le tribunal de grande instance peut lui accorder une licence d’exploitation 

du brevet antérieur dans la mesure nécessaire à l’exploitation du brevet dont il est titulaire et 

pour autant que cette invention constitue à l’égard du brevet antérieur un progrès technique 

important et présente un intérêt économique considérable. 

La licence accordée au titulaire du brevet postérieur ne peut être transmise qu’avec ledit 

brevet. 

Le titulaire du brevet antérieur obtient, sur demande présentée au tribunal, la concession 

d’une licence réciproque sur le brevet postérieur.“ 

Il est intéressant de relever la double condition portant sur le progrès technique, qui doit être 

„important“ et sur l’intérêt économique, qui doit être „considérable“; cette double condition 

est bien entendu destinée à éviter que des titulaires de brevets dépendants présentant un 

faible intérêt n’obtienne trop aisément une licence du brevet de base (brevet dominant). 

L’article L. 613-15-1 du CPI règle quant à lui la dépendance qui peut survenir entre d’une part 

une invention faisant l’objet d’un brevet et d’autre part une variété végétale susceptible d’être 

protégée par un droit, en l’occurrence un COV (certificat d’obtention végétale). 

b) dispositions communes à ces licences 

Les articles L. 613-12 à L. 613-14 du CPI définissent les conditions dans lesquelles une telle 

licence obligatoire peut être obtenue: 

– la demande est à former auprès du tribunal de grande instance qui fixera les conditions 

de la licence (durée, champs d’application, montant des redevances) et qui pourra le cas 

échéant modifier ces conditions, voire prononcer le retrait de ladite licence; 

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– le demandeur devra justifier qu’il n’a pu obtenir du propriétaire du brevet une licence 

d’exploitation et qu’il est en état d’exploiter l’invention de manière sérieuse et effective; 

– il s’agira toujours d’une licence non exclusive; 

– les droits attachés à cette licence ne peuvent être transmis qu’avec le fonds de commerce, 

l’entreprise ou la partie de l’entreprise auquel ils sont attachés. Cette disposition s’applique 

également aux licences d’office, c’est-à-dire accordées par voie administrative. 

2) les licences obligatoires accordées par voie administrative 

L’Etat peut exiger qu’une invention soit exploitée, le cas échéant au travers d’une licence 

obligatoire (qui est alors dénommée en droit français „licence d’office“) dans l’intérêt de 

la santé publique (articles L. 613-16 et L. 613-17 du CPI), de l’économie nationale (article L. 

613-18 du CPI) ou de la défense nationale (articles L. 613-19 et L. 613-19-1 du CPI). 

a) licence d’office dans l’intérêt de la santé publique 

L’article L. 613-16 a été substantiellement amendé par les Lois n° 2004-800 du 6 août 2004 

et 2004-1338 du 8 décembre 2004, en ce sens que le type d’inventions susceptibles de 

donner lieu à une licence d’office dans l’intérêt de la santé publique a été étendu; jusqu’alors 

les brevets placés sous le régime de la licence d’office étaient limités aux: „brevets délivrés 

pour des médicaments, pour des procédés d’obtention de médicaments, pour des produits 

nécessaires à l’obtention de ces médicaments ou pour des procédés de fabrication de tels 

produits“. 

L’article L. 613-16 du CPI actuel concerne les brevets délivrés pour: 

„a) Un médicament, un dispositif médical, un dispositif médical de diagnostic in vitro, un 

produit thérapeutique annexe; 

b) Leur procédé d’obtention, un produit nécessaire à leur obtention ou un procédé de 

fabrication d’un tel produit; 

c) Une méthode de diagnostic ex vivo.“ 

De même, jusqu’à la modification législative, un brevet n’était placé sous le régime de la 

licence d’office que dans la mesure où “ces médicaments ne sont mis à la disposition du 

public qu’en quantité ou qualité insuffisantes ou à des prix anormalement élevés“. 

Là encore, la rédaction actuelle de l’article L. 613-16 du CPI élargit les raisons pour lesquelles 

une telle licence d’office peut être accordée, à savoir: 

„lorsque ces produits, ou des produits issus de ces procédés, ou ces méthodes sont mis à 

la disposition du public en quantité ou qualité insuffisantes ou à des prix anormalement 

élevés, ou lorsque le brevet est exploité dans des conditions contraires à l’intérêt de la santé 

publique ou constitutives de pratiques déclarées anticoncurrentielles à la suite d’une décision 

administrative ou juridictionnelle devenue définitive.“ 

L’article L. 613-17 du CPI va préciser la procédure à suivre pour obtenir une telle licence 

d’office: 

„Du jour de la publication de l’arrêté qui soumet le brevet au régime de la licence d’office, 

toute personne qualifiée peut demander au ministre chargé de la propriété industrielle 

l’octroi d’une licence d’exploitation. Cette licence est accordée par arrêté dudit ministre à 

des conditions déterminées, notamment quant à sa durée et son champ d’application, mais à 

l’exclusion des redevances auxquelles elle donne lieu. 

Elle prend effet à la date de la notification de l’arrêté aux parties. 

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A défaut d’accord amiable approuvé par le ministre chargé de la propriété industrielle et le 

ministre chargé de la santé publique, le montant des redevances est fixé par le tribunal de 

grande instance.“ 

En outre, comme le mentionne le dernier alinéa de l’article L. 613-16 du CPI, „Lorsque la licence 

a pour but de remédier à une pratique déclarée anticoncurrentielle ou en cas d’urgence, le 

ministre chargé de la propriété industrielle n’est pas tenu de rechercher un accord amiable.“ 

Enfin, il convient de rappeler que cet article L. 613-17 a été complété par les articles L. 

613-17-1 et L. 613-17-2 à la suite de l’adoption de la Loi du 29 octobre 2007 ainsi que cela 

sera précisé dans la réponse à la question n° 7 ci-après. 

A notre connaissance, aucune licence d’office dans l’intérêt de la santé publique n’a été 

accordée en France à ce jour. Dans les années 1970, une telle possibilité avait toutefois 

vu le jour lorsque les Laboratoires ROUSSEL UCLAF avaient envisagé de ne pas mettre à 

la disposition du public une pilule contraceptive (ces laboratoires avaient en effet reçu des 

menaces de boycott international de leurs produits dans l’hypothèse où cette pilule serait 

commercialisée). A cette époque, le ministre chargé de la santé avait indiqué aux Laboratoires 

ROUSSEL UCLAF que la non commercialisation de cette pilule aboutirait à placer le brevet 

sous le régime de la licence d’office, la commercialisation d’une telle pilule présentant un 

intérêt pour la santé publique. Finalement, les Laboratoires ROUSSEL UCLAF décidèrent le 

maintien de la commercialisation de la pilule et le ministre n’eut pas besoin de recourir au 

système de la licence d’office... 

b) licence d’office dans l’intérêt de l’économie nationale 

Conformément aux dispositions de l’article L. 613-18 du CPI, le ministre chargé de la propriété 

industrielle peut, après mise en demeure, non suivie d’effet, du propriétaire du brevet d’en 

entreprendre l’exploitation de manière à satisfaire aux besoins de l’économie nationale, 

mettre le brevet en question sous le régime de la licence d’office dans l’intérêt de l’économie 

nationale. Cet article L 613-18 stipule que: 

„Du jour de la publication du décret qui soumet le brevet au régime de la licence d’office, 

toute personne qualifiée peut demander au ministre chargé de la propriété industrielle l’octroi 

d’une licence d’exploitation. 

Cette licence est accordée par arrêté dudit ministre à des conditions déterminées quant à sa 

durée et son champ d’application, mais à l’exclusion des redevances auxquelles elle donne 

lieu. Elle prend effet à la date de notification de l’arrêté aux parties. 

A défaut d’accord amiable, le montant des redevances est fixé par le tribunal de grande 

instance.“ 

En tout état de cause, la licence accordée l’est à titre non exclusif. 

Nous n’avons pas connaissance de licence d’office accordée dans ce cadre. 

c) licence d’office dans l’intérêt de la défense nationale 

C’est l’article L. 613-19 qui va préciser dans quelles conditions un brevet peut être placé sous 

le régime de la licence d’office dans l’intérêt de la défense nationale, l’article L. 613-19-1 

concernant plus particulièrement les inventions dans le domaine des semi-conducteurs. 

Cette licence est accordée par arrêté du ministre chargé de la propriété industrielle, à la 

demande du ministre chargé de la défense. 

Comme dans le cas de la licence d’office dans l’intérêt de l’économie nationale, la licence 

d’office dans l’intérêt de la défense nationale est accordée à titre non exclusif et en contrepartie 

du versement de redevances. 

Nous n’avons pas connaissance de licence d’office accordée dans ce cadre. 

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Introduction 

La question a trait aux licences obligatoires pour la fabrication de produits pharmaceutiques 

destinés à l’exportation vers des pays n’ayant pas les capacités de production 

suffisantes. 

• On rappellera que les accords ADPIC entrés en vigueur en 1995 comportaient déjà 

un article 31 consacré aux licences obligatoires. Cependant l’alinéa f) de cet article 

précisait que ces licences étaient “principalement” destinées à “l’approvisionnement du 

marché intérieur du membre qui a autorisé cette utilisation”. Cette limitation a conduit à 

s’intéresser aux pays en proie à de graves problèmes de santé publique et ne disposant 

pas de capacités de production de médicaments sur leur territoire (Déclaration de Doha 

du 14 novembre 2001 sur la modification des accords ADPIC). 

• Les travaux lancés par la déclaration de Doha ont abouti, le 30 août 2003, 

à une Décision du Conseil général de l’OMC intitulée “Mise en œuvre 

du paragraphe 6 de la déclaration de Doha sur l’Accord sur les ADPIC et la santé 

publique”. 

La Décision du 30 août 2003 prévoit qu’il est dérogé à l’article 31 f) de l’Accord sur les 

ADPIC en ce qui concerne l’octroi, par un Etat membre, d’une licence obligatoire sur un 

produit pharmaceutique breveté, dans la mesure nécessaire aux fins de la production et de 

l’exportation de ce produit vers un Etat membre reconnu comme admissible à 

une telle importation. 

Les Etats importateurs admissibles sont les pays membres de l’OMC les moins avancés (sans 

condition de notification) et les autres pays membres ayant notifié au Conseil des ADPIC leur 

intention d’utiliser le système en tant qu’importateur. Cette notification comprend notamment 

les noms et quantités attendues du produit concerné et la confirmation que l’Etat effectuant 

la notification a bien établi l’insuffisance ou l’absence de ses capacités de production de 

produits pharmaceutiques. Ces Etats importateurs devront prendre des mesures raisonnables 

pour empêcher la réexportation des produits importés dans ce cadre. 

S’agissant des Etats exportateurs, ils doivent respecter certaines conditions quant aux modalités 

de la licence obligatoire, notamment quant aux volumes autorisés, l’identification des produits 

concernés et la rémunération du titulaire des droits. Ils sont par ailleurs également assujettis 

à des obligations de notification et doivent veiller à la disponibilité de moyens juridiques 

effectifs pour empêcher l’importation et la vente, sur leur territoire, de produits détournés vers 

leur marché. 

Cette Décision est actuellement applicable pour chaque Etat membre de l’OMC. 

• La Décision du Conseil Général de l’OMC du 6 décembre 2005 

d’incorporer les dispositions prévues dans la Décision du 30 août 

2003 dans l’Accord ADPIC. 

C’est par cette Décision qu’il a été prévu d’ajouter aux accords ADPIC un article 31 bis 

et une Annexe, reprenant le régime de la licence obligatoire, tel qu’il avait été fixé par 

la Décision du 30 août 2003. 

Pour que cet amendement devienne effectif, la procédure est lourde puisqu’il faut que le 

Protocole prévoyant cet amendement soit accepté par les deux-tiers des membres de l’OMC. 

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La procédure d’acceptation initialement ouverte jusqu’au 1er décembre 2007 a été prorogée 

jusqu’en 2009. 

Dans l’intervalle, la Décision du 30 août continue à s’appliquer. 

1ère sous-question: 

Le nouvel article 31bis ADPIC a-t-il été ratifié dans votre pays? 

La France n’a pas directement ratifié l’article 31 bis ADPIC contenu dans la Décision du 

Conseil Général de l’OMC du 6 décembre 2005. 

Cependant, la Communauté européenne a accepté ce protocole le 19 novembre 2007, au 

nom des Etats membres. Par conséquent, sous réserve des débats relatifs aux rôles respectifs 

de la communauté européenne et des Etats membres s’agissant de la ratification de traités 

internationaux, la France n’a, a priori, pas vocation à ratifier directement ce Protocole. 

A l’heure actuelle, la majorité des deux tiers des membres de l’OMC n’a pas été réunie. 

2ème sous-question: 

Avez-vous connaissance de tout autre amendement législatif dans 

votre pays, visant à mettre en oeuvre la Décision de l’OMC du 30 

août 2003? 

On distinguera le droit communautaire et le droit interne. 

1) Règlement (CE) n° 816/2006 du 17 mai 2006 concernant l’octroi 

de licences obligatoires pour des brevets visant la fabrication de 

produits pharmaceutiques destinés à l’exportation vers des pays 

connaissant des problèmes de santé 

A la suite de l’entrée en vigueur de la Décision de l’OMC du 30 août 2003, la Communauté 

européenne a décidé de mettre en œuvre les dispositions contenues dans cette Décision dans 

l’ordre juridique communautaire. 

Ce Règlement est entré en vigueur le 29 juin 2006. 

Il établit une procédure d’octroi de licences obligatoires pour des brevets et certificats 

complémentaires de protection concernant la fabrication et la vente de produits 

pharmaceutiques dès lors que ces produits sont destinés à l’exportation vers des pays 

importateurs admissibles ayant besoin de tels produits pour faire face à des problèmes de 

santé publique. 

L’autorité compétente dans chaque Etat pour délivrer de telles licences est la même que celle 

chargée d’octroyer des licences obligatoires en matière de brevet en vertu du droit national, 

à moins que l’Etat n’en décide autrement. Cette autorité doit être notifiée à la Commission. 

Le Règlement définit les pays importateurs admissibles de façon plus large que 

l’OMC puisqu’il étend le dispositif aux pays les moins avancés et aux pays en développement 

non membres de l’OMC à condition qu’ils aient notifié à la Commission leur intention d’utiliser 

le système en tant qu’importateur. 

Le Règlement énumère la liste des informations que doit fournir la personne déposant une 

demande de licence obligatoire dans un Etat membre. Les Etats membres peuvent ajouter 

d’autres éléments à condition de ne pas rendre la procédure d’octroi de licence obligatoire 

prévue dans ce cadre, plus lourde que celle prévue pour les autres licences obligatoires. 

Le demandeur doit, sauf dans des situations d’urgence nationale, fournir des éléments de 

preuve pour démontrer qu’il s’est efforcé d’obtenir une licence volontaire du titulaire des droits 

et que ses efforts n’ont pas abouti dans un délai de 30 jours avant le dépôt de la demande. 

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Le propriétaire du brevet est informé de la demande et peut présenter des observations. 

L’autorité compétente doit vérifier que le pays importateur cité dans la demande a bien 

souscrit à ses éventuelles obligations en termes de notification et que les quantités visées dans 

la demande sont cohérentes avec celles notifiées. 

Lorsqu’une licence est accordée, l’Etat membre doit le notifier à la Commission qui transmet 

cette notification au Conseil des ADPIC. 

Le Règlement reprend les conditions prévues par la Décision de l’OMC du 30 août 2003 en 

ce qui concerne les caractéristiques de cette licence. Elle ajoute en outre: 

a) le caractère incessible de la licence, sauf avec le fonds de commerce; 

b) l’exigence de l’indication de la durée; 

c) la possibilité pour l’autorité compétente, d’accéder aux registres du titulaire de la licence 

pour vérifier le respect des conditions. 

En ce qui concerne la rémunération du titulaire du brevet, le Règlement prévoit les règles 

suivantes: 

a) Dans les cas d’urgence nationale, la rémunération est fixée à un maximum de 4% du prix 

total à verser par le pays importateur; 

b) Dans les autres cas, la rémunération est déterminée compte tenu d’une part de la valeur 

économique de l’utilisation autorisée au/aux pays importateurs concernés dans le 

cadre de la licence, tout comme, d’autre part, des circonstances humanitaires ou non 

commerciales liées à l’octroi de la licence. 

Le Règlement prévoit que l’importation dans l’UE, de produits fabriqués dans le cadre d’une 

telle licence, y compris en vue de leur placement sous un régime suspensif, est interdite. Des 

procédures douanières sont prévues pour permettre l’appréhension de ces produits. 

Des mesures de contrôle de la licence sont prévues, ainsi que des mesures de retrait en cas 

de non-respect des conditions de la licence. 

2) La loi du 29 octobre 2007 

Le règlement communautaire précité s’applique en droit interne. Une intervention du 

législateur français était néanmoins nécessaire afin d’adapter le droit français aux exigences 

du règlement. 

Cette adaptation a été réalisée récemment à l’occasion du vote de la loi du 29 octobre 2007 

sur la lutte contre la contrefaçon. 

La loi a simplement introduit deux courts nouveaux articles dans le code de la propriété 

intellectuelle, à la suite des articles traitant des licences d’office dans l’intérêt de la santé 

publique. 

L’article L613-17-1, qui vise l’octroi d’une licence obligatoire en vue de l’exportation vers un 

pays connaissant des problèmes de santé publique, renvoie pour l’essentiel au Règlement 

communautaire du 17 mai 2006. 

Art. L. 613-17-1 

La demande d’une licence obligatoire, présentée en application du Règlement (CE) n° 

816/2006 du Parlement européen et du Conseil, du 17 mai 2006, concernant l’octroi de 

licences obligatoires pour des brevets visant la fabrication de produits pharmaceutiques 

destinés à l’exportation vers des pays connaissant des problèmes de santé publique, est 

adressée à l’autorité administrative. La licence est délivrée conformément aux conditions 

déterminées par l’article 10 de ce Règlement. L’arrêté d’octroi de la licence fixe le montant 

des redevances dues. 

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La licence prend effet à la date la plus tardive à laquelle l’arrêté est notifié au demandeur et 

au titulaire du droit. 

L’article L 613-17-2 assimile à la contrefaçon, en termes de sanctions, les actes consistant à 

importer en France, des produits pharmaceutiques destinés spécifiquement aux pays pauvres 

connaissant des problèmes de santé publique: 

Art. L. 613-17-2 

Toute violation de l’interdiction prévue à l’article 13 du Règlement (CE) n° 816/2006 du 

Parlement européen et du Conseil, du 17 mai 2006, précité et à l’article 2 du Règlement (CE) 

n° 953/2003 du Conseil, du 26 mai 2003, visant à éviter le détournement vers des pays de 

l’Union européenne de certains médicaments essentiels constitue une contrefaçon punie des 

peines prévues à l’article L. 615-14 du présent code. 

Un avant-projet de décret a été diffusé dans le courant du mois de décembre 2007 

pour introduire les dispositions d’application dans la partie réglementaire du CPI. 

3ème sous-question: 

Avez-vous connaissance de l’existence de licences obligatoires 

qui auraient été accordées dans votre pays pour l’importation ou 

l’exportation de produits pharmaceutiques? Dans l’affirmative, 

indiquer le détail y compris le nom du breveté, du licencié et du 

produit si ces données sont publiques. 

• Importations: De nombreux Etats développés (dont la France) ont d’ores et 

déjà déclaré qu’ils n’utiliseront pas le système mis en place par la Décision de l’OMC du 

30 août 2003 en tant que membres importateurs, tandis que d’autres ont indiqué que, 

s’ils utilisaient le système, ce serait uniquement en cas d’urgence nationale ou d’autres 

circonstances d’extrême urgence. La France n’a donc pas vocation à utiliser le système 

en tant qu’importateur. 

• Exportations: Aucune licence d’office n’a été accordée à ce jour par la France en 

vue d’une exportation. 



Aucune disposition du CPI n’autorise l’Etat à exploiter une invention brevetée sans en avoir 

obtenu préalablement une licence, quand bien même une telle exploitation se limiterait à ses 

propres besoins. 

Cependant, l’article L. 3131-1 du Code de la santé publique dispose: “En cas de menace 

sanitaire grave appelant des mesures d’urgence, notamment en cas de menace d’épidémie, 

le ministre chargé de la santé peut, par arrêté motivé, prescrire dans l’intérêt de la santé 

publique toute mesure proportionnée aux risques courus et appropriée aux circonstances de 

temps et de lieu afin de prévenir et de limiter les conséquences des menaces possibles sur la 

santé de la population. 

Le ministre peut habiliter le représentant de l’Etat territorialement compétent à prendre toutes les 

mesures d’application de ces dispositions, y compris des mesures individuelles. Ces dernières 

mesures font immédiatement l’objet d’une information du procureur de la République. 

Le représentant de l’Etat dans le département et les personnes placées sous son autorité sont 

tenus de préserver la confidentialité des données recueillies à l’égard des tiers. 

Le représentant de l’Etat rend compte au ministre chargé de la santé des actions entreprises 

et des résultats obtenus en application du présent article”. 

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L’article L 3131-5 du même code prévoit: „Un fonds finance les actions nécessaires à la 

préservation de la santé de la population en cas de menace sanitaire grave ou d’alerte 

épidémique, notamment celles prescrites à l’article L. 3131-1 ainsi que les compensations 

financières auxquelles elles peuvent donner lieu à l’exclusion de celles prévues par d’autres 

dispositions législatives et réglementaires. Il finance également la réparation instituée par 

l’article L. 3131-4. Les conditions de constitution du fonds sont fixées par la loi de finances ou 

la loi de financement de la sécurité sociale.“ 

Il est possible de penser que ce texte pourrait servir de fondement à une utilisation, par l’Etat, 

sans licence préalable, d’une invention brevetée. 


L’article L. 613-20 du CPI prévoit les conditions dans lesquelles l’Etat peut exproprier les 

inventions, objet de demandes de brevet ou de brevets. 

– la justification de cette expropriation est limitée aux besoins de la défense nationale; 

– à défaut d’accord amiable, l’indemnité d’expropriation est fixée par le tribunal de grande 

instance. 

Compte tenu de la matière, à savoir la défense nationale, les débats ont lieu, à tous les 

degrés de juridiction, en chambre du conseil. 






En ce qui concerne le droit des brevets, le Code de la propriété intellectuelle ne contient pas 

de dispositions destinées à faciliter l’accès aux médicaments autres que celles qui auraient 

été visées ci-dessus. 

En revanche, certaines dispositions du Code de la santé publique et du Code de la sécurité 

sociale contiennent des dispositions de nature à faciliter un tel accès. 

Des dispositions du Code de la propriété intellectuelle en matière de marque visent également 

à favoriser cet accès. 

1) Le dépôt de la demande d’AMM 

L’article L. 5121-10 du Code de la santé publique prévoit que l’autorisation de mise sur 

le marché des médicaments génériques peut être délivrée avant l’expiration des droits de 

propriété intellectuelle attachés à la spécialité de référence. 

2) L’inscription au répertoire des génériques 

Le même texte prévoit que „le directeur général de l’agence procède à l’inscription de la 

spécialité générique dans le répertoire des groupes génériques au terme d’un délai de 

soixante jours, après avoir informé de la délivrance de l’autorisation de mise sur le marché de 

celle-ci le titulaire de l’autorisation de mise sur le marché de la spécialité de référence“. 

Dès lors qu’une spécialité générique est inscrite dans un groupe générique du répertoire, le 

pharmacien est autorisé à exercer la faculté de substitution prévue à l’article L. 5125-23 du 

code de la santé publique. 

La loi rappelle que „toutefois, la commercialisation de cette spécialité générique ne peut 

intervenir qu’après l’expiration des droits de propriété intellectuelle, sauf accord du titulaire 

de ces droits.“ 

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L’inscription au répertoire des génériques est désormais automatique, au terme du délai de 

soixante jours suivant la notification de la délivrance de l’AMM de la spécialité générique au 

titulaire de l’AMM de la spécialité de référence. 

3) L’adaptation du droit des marques 

L’article L. 716-10 c) du Code de la propriété intellectuelle prévoit que constitue une infraction 

pénale le fait de reproduire, imiter, utiliser, apposer, supprimer, modifier une marque, une 

marque collective ou une marque collective de certification en violation des droits conférés 

par son enregistrement et des interdictions qui découlent de celui-ci. 

Cependant cette infraction n’est pas constituée lorsqu’un logiciel d’aide à la prescription 

permet, si le prescripteur le décide, de prescrire en dénomination commune internationale, 

selon les règles de bonne pratique prévues à l’article L. 161-38 du Code de la sécurité 

sociale. 

L’article L. 716-10 d) du Code de la propriété intellectuelle dispose que l’infraction consistant 

à sciemment livrer un produit ou fournir un service autre que celui qui lui est demandé sous 

une marque enregistrée n’est pas constituée en cas d’exercice par un pharmacien de la 

faculté de substitution prévue à l’article L. 5125-23 du code de la santé publique. 

Recommandations 

Aux termes de l’article L. 5121-10 du Code de la santé publique, une autorisation de mise 

sur le marché peut être délivrée à un médicament générique avant l’expiration des droits de 

propriété attachés à la spécialité de référence. 

La commercialisation du produit générique ne peut toutefois intervenir licitement, conformément 

aux dispositions du Code de la propriété intellectuelle, qu’une fois expirés les droits de 

propriété attachés au produit d’origine. 

Dans les soixante jours de la délivrance de l’autorisation de mise sur le marché, le directeur 

général de l’AFSSAPS procède à l’inscription du médicament au répertoire des génériques, 

sans avoir à vérifier préalablement l’existence éventuelle de droits attachés au produit 

princeps. 

Dans l’hypothèse d’une commercialisation du générique avant l’expiration des droits couvrant 

le produit princeps, la responsabilité de l’Etat, de l’AFSSAPS et des pharmaciens ne pourrait 

en aucune façon être mise en cause; seule la responsabilité de l’entreprise ou de l’organisme 

assurant l’exploitation du générique pourrait être recherchée par le titulaire desdits droits. 

Dans la mesure où la puissance publique ne procède pas à une vérification a priori, la 

défense des intérêts des producteurs de spécialités de référence prend exclusivement la forme 

d’une action contentieuse a posteriori. 

Il convient de rappeler que le titulaire des droits de propriété industrielle n’est pas en mesure 

d’agir tant que les produits génériques n’ont pas été fabriqués, détenus ou commercialisés 

en France. En effet, la jurisprudence française considère que la publication d’une AMM ne 

constitue pas un acte de contrefaçon (Cass. com., Allen & Hanburys c. Promedica & Chiesi 

Farmaceutici, 24 mars 1998, PIBD 1998, n° 656, III-320). 

Il en résulte que le fabricant de générique peut commercialiser son produit, si ce risque 

lui paraît valoir d’être pris, sans attendre que les droits attachés au produit de référence 

soient expirés. De plus, ces génériqueurs indélicats recueillent le bénéfice de la possibilité de 

substitution offerte aux pharmaciens. 

Ceci étant, l’article 11 de la loi n° 2007-1544 de lutte contre la contrefaçon du 29 octobre 

2007 a modifié les dispositions de l’article L. 615-3 du Code de la propriété intellectuelle 

qui dispose désormais que toute personne ayant qualité pour agir en contrefaçon peut saisir 

en référé la juridiction civile compétente afin de voir ordonner, au besoin sous astreinte, 

à l’encontre du prétendu contrefacteur ou des intermédiaires dont il utilise les services, 

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toute mesure destinée à prévenir une atteinte imminente aux droits 

conférés par le titre ou à empêcher la poursuite d’actes argués de contrefaçon. 

Si la demande ou la délivrance d’une AMM d’un médicament générique, voire son inscription 

au répertoire des génériques, devait être considérée, par la jurisprudence, comme constitutive 

d’une atteinte imminente, les titulaires de droits disposeraient alors d’un moyen efficace pour 

prévenir la mise sur le marché de génériques argués de contrefaçon. 

Il résulte de ce qui précède qu’un juste équilibre entre les droits de propriété industrielle et les 

impératifs de santé publique devrait être recherché. 

Aussi, le Groupe français émet le souhait qu’une réponse judiciaire efficace permette aux titulaires 

de droits de brevets d’avoir la possibilité d’empêcher effectivement la mise sur le marché d’une 

spécialité générique arguée de contrefaçon avant l’expiration des droits de brevets. 

Sur ce point, le Groupe français se félicite des nouvelles dispositions du Code de la Propriété 

Intellectuelle qui résultent de la loi n° 2007-1544 du 29 octobre 2007, et notamment de l’article L 

615-3 qui prévoit la possibilité d’obtenir, par le biais de procédures rapides, contradictoires voire 

non contradictoires, toute mesure destinée à prévenir une atteinte imminente aux droits conférés 

par le titre de propriété industrielle. 

Le Groupe français souhaite que l’application qui sera faite de ce texte par les juridictions 

nationales permette d’obtenir des mesures d’interdiction de l’accès au marché pour les médicaments 

„génériques“ avant l’expiration des droits de propriété industrielle. 

En outre, et plus généralement, le Groupe français estime qu’il n’est pas opportun de prévoir des 

assouplissements aux limites prévues par les ADPIC pour l’accès aux médicaments. 

Résumé 

Le droit français reconnaît un certain nombre de limites au monopole accordé au breveté pour des 

motifs de santé publique. 

Tout d’abord, il admet l’exception d’expérimentation. La dérogation apportée au monopole du brevet 

est d’interprétation stricte et ne peut s’appliquer qu’aux seuls actes expérimentaux qui ont pour objet 

de participer à la vérification de l’intérêt technique de l’invention ou à son développement aux fins 

de faire progresser la connaissance, et non à des actes à visée commerciale. Plus particulièrement 

en ce qui concerne les médicaments, la loi française prévoit que les droits conférés par le brevet 

ne s’étendent pas “aux études et essais requis en vue de l’obtention d’une autorisation de mise sur 

le marché pour un médicament, ainsi qu’aux actes nécessaires à leur réalisation et à l’obtention de 

l’autorisation”. 

Par ailleurs, la loi prévoit que les droits conférés par le brevet ne s’étendent pas à la préparation de 

médicaments faite extemporanément et par unité dans les officines de pharmacie, sur ordonnance 

médicale, ni aux actes concernant les médicaments ainsi préparés. 

De plus, la législation française prévoit un certain nombre de licences obligatoires, dont certaines 

sont accordées par voie judiciaire (non exploitation du brevet, brevet dépendant), et d’autres par 

voie administrative (dans l’intérêt de la santé publique, dans l’intérêt de l’économie nationale, dans 

l’intérêt de la défense nationale). 

En revanche, aucune disposition n’autorise l’Etat à exploiter une invention brevetée sans en avoir 

obtenu préalablement une licence, quand bien même une telle exploitation se limiterait à ses 

propres besoins. 

L’Etat est autorisé à exproprier un breveté pour les besoins de la défense nationale. L’article L. 

613-20 du CPI en prévoit les conditions. 

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Enfin, les méthodes de traitement thérapeutique ne sont pas brevetables. 

Ensuite, concernant la circulation des médicaments, la France admet les importations parallèles en 

provenance de pays membres de la Communauté européenne ou membres de l’Espace économique 

européen. En revanche, le breveté peut s’opposer à toute importation parallèle de produits couverts 

par le brevet provenant de pays tiers à l’EEE. Il en est de même si le produit breveté a été fabriqué 

dans le cadre d’une licence obligatoire, et ce quel que soit le lieu de provenance. 

Par ailleurs, la France n’a pas directement ratifié l’article 31 bis ADPIC contenu dans la Décision du 

Conseil Général de l’OMC du 6 décembre 2005. 

Cependant, la Communauté européenne a accepté ce protocole prévoyant l’amendement le 19 

novembre 2007, au nom des Etats membres; la France n’a donc, a priori, plus vocation à ratifier 

directement ce Protocole. 

De plus, à la suite de l’entrée en vigueur de la Décision de l’OMC du 30 août 2003, la Communauté 

européenne a adopté le Règlement (CE) n° 816/2006 du 17 mai 2006 concernant l’octroi de 

licences obligatoires pour des brevets visant la fabrication de produits pharmaceutiques destinés à 

l’exportation vers des pays connaissant des problèmes de santé. 

La France a adapté sa législation à ce règlement à l’occasion du vote de la loi du 29 octobre 2007 

sur la lutte contre la contrefaçon, en introduisant deux courts nouveaux articles dans le CPI, à la 

suite des articles traitant des licences d’office dans l’intérêt de la santé publique (articles L 613-17-1 

et L 613-17-2 du CPI). 

Enfin, la France a déclaré qu’elle n’utilisera pas le système mis en place par la Décision de l’OMC 

du 30 août 2003 en tant que membre importateur. De plus, aucune licence d’office n’a été accordée 

à ce jour par la France en vue d’une exportation 

En ce qui concerne le droit des brevets, le CPI ne contient pas d’autres dispositions destinées à 

faciliter l’accès aux médicaments. 

En revanche, certaines dispositions du Code de la santé publique et du Code de la sécurité 

sociale contiennent des dispositions de nature à faciliter un tel accès, notamment aux médicaments 

génériques. 

De même, des dispositions du CPI en matière de marque visent également à favoriser cet accès. 

Recommandations 

Le Groupe français émet le souhait qu’une réponse judiciaire efficace permette aux titulaires 

de droits de brevets d’avoir la possibilité d’empêcher effectivement la mise sur le marché d’une 

spécialité générique arguée de contrefaçon avant l’expiration des droits de brevets. 

Le Groupe français souhaite que l’application qui sera faite des nouvelles dispositions de l’article 

L 615-3 du CPI par les juridictions nationales permette d’obtenir des mesures d’interdiction de 

l’accès au marché pour les médicaments „génériques“ avant l’expiration des droits de propriété 

industrielle. 

En outre, et plus généralement, le Groupe français estime qu’il n’est pas opportun de prévoir des 

assouplissements aux limites prévues par les ADPIC pour l’accès aux médicaments. 

Summary 

French law recognised some limitations to the monopoly granted to the patentee for public health 

reasons. 

First, it provides for the experimental use exception. This limitation on the monopoly must be 

construed strictly. It can only apply to the experimental acts whose aim is to test the technical 

interest of the invention or to develop the invention in order to contribute to the improvement of 

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the general knowledge, but does not apply to acts with commercial purposes. More specifically, 

concerning medicines, French law provides that the rights conferred by the patent shall not extend 

to “the studies and trials necessary to obtain a marketing authorisation for a medicinal product, 

nor to the acts necessary to the conduct of such studies and trials and to the acts required for the 

granting of the marketing authorisation“. 

French law also provides that the rights conferred by the patent shall not extend to the extemporaneous 

preparation of a drug for individual cases in a pharmacy pursuant to a medical prescription nor to 

the acts in relation with such preparation. 

Moreover, French law provides for a certain number of compulsory licenses, some being granted 

by a judicial court (non-exploitation of a patent, dependant patent), others being granted by an 

administrative authority (in the interest of public health, in the interest of national economy, in the 

interest of national defence). 

However, there is no provision allowing the State to work a patented invention without the prior 

granting of a license, even though such working would be limited to the needs of the State. 

The State is allowed to expropriate a patentee for the needs of national defence, under the 

conditions set forth by Article L. 613-20 of the Intellectual Property Code. 

Finally, methods of medical treatment are not patentable subject matter. 

Then, concerning the circulation of medicines, France allows parallel imports from countries of the 

European Community or of the European Economic Area. However, the patentee can resist any 

parallel import of products covered by the patent from countries outside of the EEA. The same 

would apply if the product originates from countries where they were made available under a 

compulsory license. 

In addition, France did not ratify directly Article 31 bis TRIPS provided in the Decision of the WTO 

General Council of 6 December 2005. 

However, the European Community did accept, on behalf of the Member States, the Protocol 

providing for such amendment on 19 November 2007; France does no longer have to ratify 

directly this Protocol. 

Moreover, after the entry into force of the WTO Decision of 30 August 2003, the European 

Community adopted Regulation EC 816/2006 of 17 May 2006 on compulsory licensing of patents 

relating to the manufacture of pharmaceutical products for export to countries with public health 

problems. 

France implemented this Regulation with the law of 29 October 2007 relating to enforcement of 

intellectual property rights, introducing two new short Articles in the Intellectual Property Code 

following the Articles on the ex- officio licenses in the interest of public health (Articles L. 613-17-1 

and L. 613-17-2 of the Intellectual Property Code). 

Finally, France has declared that it would not use the system created by the WTO Decision of 30 

August 2003 as an importing member. Besides, no ex-officio license has been granted to date by 

France for an export. 

Concerning patent law, the Intellectual Property Code does not contain other provisions facilitating 

access to medicines. 

However, some provisions of the Public Health Code and of the Social Security Code aim at 

facilitating such access, particularly for the generic medicines. 

Some provisions of the Intellectual Property Code relating to trademarks also aim at facilitating this 

access. 

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Recommendations 

The French group expresses the wish that an efficient judicial response allows the owners of patent 

rights to have the possibility of actually preventing the marketing of an alleged infringing generic 

medicine before the expiry of the patent rights. 

The French group wishes that the application of the new provisions of Article L. 615-3 of the 

Intellectual Property Code by the national jurisdictions allows to obtain injunctions against the 

access to the market of generic medicines prior the expiry of intellectual property rights. 

Moreover, and more generally, the French group considers that it is not appropriate to increase the 

limitations provided by the TRIPS for access to medicines 


Das französische Recht anerkennt eine gewisse Anzahl von Einschränkungen des dem Patentinhaber 

gewährten Monopols aus Gründen der öffentlichen Gesundheit. 

Zunächst lässt es die Ausnahme der Experimentierung zu. Die am Monopol des Patents 

vorgenommene Abweichung muss streng ausgelegt werden und kann nur für die alleinigen 

Handlungen zu Versuchszwecken angewendet werden, deren Gegenstand in der Teilnahme an 

der Überprüfung des technischen Interesses der Erfindung oder an seiner Entwicklung zum Zwecke 

des Fortschritts des Wissens und nicht an Handlungen mit gewerblichen Zwecken besteht. Was 

die Arzneimittel betrieft sieht das französische Recht insbesondere vor, dass die durch das Patent 

eingeräumten Rechte sich nicht auf “die im Hinblick auf die Erteilung einer Genehmigung für das 

Inverkehrbringen eines Arzneimittels erforderliche Studien und Versuche, und die Handlungen, die 

für ihre Durchführung und den Erhalt der Genehmigung erforderlich sind” erstrecken. 

Ausserdem sieht das Gesetz vor, dass die vom Patent eingeräumten Rechte sich weder auf die 

unmittelbare Einzelzubereitung von Arzneimitteln die Apotheken auf Grund ärztlicher Verordnung 

noch auf die Handlungen betreffend die auf diese Weise zubereiteten Arzneimittel erstrecken. 

Zudem sieht die französische Gesetzgebung mehrere Zwanglizenzen vor, von denen manche auf 

gerichtlichem Wege (Nichtverwertung des Patents, abhängiges Patent), und andere wiederum 

auf verwaltungsrechtlichem Wege (im Interesse der öffentlichen Gesundheit, im Interesse der 

Binnenwirtschaft, im Interesse der Landesverteidigung) gewährt werden. 

Hingegen ist der Staat durch keine Bestimmung berechtigt, eine patentierte Erfindung zu enteignen, 

ohne vorher eine Lizenz hierzu erhalten zu haben, auch wenn eine solche Verwertung sich auf 

seine eigenen Bedürfnisse beschränken würde. 

Der Staat ist berechtigt, einen Patentinhaber für die Bedürfnisse der Landesverteidigung zu enteignen. 

Die entsprechenden Bedingungen sind in Artikel L. 613-30 des Gesetzes zum Gewerblichen 

Rechtschutz angegeben. 

Die Methoden der therapeutischen Behandlung sind nicht patentierbar. 

Des Weiteren lässt Frankreich betreffend den Verkehr von Arzneimitteln das Parallelimport aus 

Mitgliedsländern der Europäischen Gemeinschaft oder Mitgliedsländern des Europäischen 

Wirtschaftsraums (EWR) zu. Hingegen kann der Patentinhaber sich gegen jeden Parallelimport 

eines aus einem Drittland des EWR stammenden patentierten Produkts widersetzen. Das gleiche 

gilt, wenn das patentierte Produkt im Rahmen einer Zwangslizenz hergestellt wurde, dies ungeachtet 

des Herkunftsortes. 

Frankreich hat den in der Entscheidung des Generalrates der WTO vom 6. Dezember 2005 

enthaltenen Artikel 31 bis des TRIPS übrigens nicht direkt ratifiziert. 

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Die Europäische Gemeinschaft hat im Namen der Mitgliedsstaaten dieses Protokoll, das die 

Abänderung vorsieht am 19. November 2007 jedoch angenommen; Frankreich hat deswegen 

dieses Protokoll nicht direkt zu ratifizieren. 

Zudem hat die Europäische Gemeinschaft nach dem Inkrafttreten der Entscheidung der WTO vom 

30. August 2003 die Verordnung (EG) Nr. 816/2006 vom 17. Mai 2006 über die Gewährung von 

Zwangslizenzen für Patente an der Herstellung von pharmazeutischen Erzeugnissen für die Ausfuhr 

in Länder mit Problemen im Bereich der öffentlichen Gesundheit verabschiedet. 

Frankreich hat seine Gesetzgebung anlässlich der Verabschiedung des Gesetzes vom 29. Oktober 

2007 über die Bekämpfung von Verletzungshandlungen angepasst, indem es in das Gesetz zum 

gewerblichen Rechtschutz nach den Artikeln über die Zwangslizenzen im Interesse der öffentlichen 

Gesundheit (Artikel L 613-17-1 und L 613-17-2 des Gesetzes zum gewerblichen Rechtschutz) zwei 

neue kurze Artikel eingefügt hat. 

Nicht zuletzt hat Frankreich erklärt, dass es als Importland das durch die Entscheidung der WTO 

vom 30. August 2003 eingeführtem System nicht in Anspruch nehmen wird. Zudem hat Frankreich 

bisher keine Zwangslizenz im Hinblick auf eine Ausfuhr gewährt. 

Betreffend das Patentrecht enthält das Gesetz zum gewerblichen Rechtschutz keine weiteren 

Bestimmungen zur Erleichterung des Zugangs zu den Arzneimitteln. 

Hingegen enthalten das Gesetz über die öffentliche Gesundheit und das Gesetz über die 

Sozialversicherung gewisse Bestimmungen zur Erleichterung eines solchen Zugangs, insbesondere 

zu Generika. 

Desgleichen streben die Bestimmungen des Gesetzes zum gewerblichen Rechtschutz in Bezug auf 

Marken ebenfalls die Erleichterung dieses Zugangs an. 

Empfehlungen 

Die französische Landesgruppe wünscht eine effiziente gerichtliche Lösung, die den 

Patentrechtinhabern die Möglichkeit einräumt, die Markteinführung einer verletzenden Generikum- 

Spezialität vor dem Ablauf der Patentrechte effektiv zu verhindern. 

Die französische Landesgruppe wünscht, dass die Anwendung der neuen Bestimmungen des Artikels 

L 615-3 des Gesetzes zum gewerblichen Rechtschutz durch die nationalen Gerichte ermöglicht, 

Verbotsmassnahmen für den Zugang zum Markt von “Generika” vor dem Ablauf der Rechte des 

gewerblichen Rechtschutzes zu erhalten. 

Die französische Landesgruppe ist zudem und allgemein der Meinung, dass es nicht angebracht 

ist, Erleichterungen für die von den TRIPS für den Zugang zu Arzneimitteln vorgesehenen 

Einschränkungen vorzusehen. 

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Questions 

Germany 

Allemagne 

Deutschland 

Report Q202 

in the name of the German Group 

by Thorsten BAusch, uli FoersTl, Michael KoMpTer, 

christian leDerer, Andrea schüssler and hubert WiTTe 






The German patent Act was amended in 1981 and with the amendment of sec. 11(2) what 

has become known as “experimental privilege” came into force. This provision stipulates that 

the effect of a patent shall not extend to those acts performed for experimental purposes that 

are part of the subject matter of a patented invention. 

however, the case law initially remained restrictive and only experiments on the subject 

matter of the patented invention were authorized. A liberalization of the case law did not take 

place until 1995 when extension of experimental privilege was established by the decision 

of the Federal supreme court “Klinische Versuche I” [clinical Trial i] and then by “Klinische 

Versuche II“ in 1997 [clinical Trial i ii]. 

a) privileged experiments 

The intent of the rulings as rendered by the Federal supreme court is that any systematic 

action directed at obtaining data on the subject matter of an invention is privileged. The 

ultimate purpose of the studies and experimental acts is not decisive thereby. Thus tests aimed 

at commercial exploitation of the results may also be carried out. hence, basic academic 

research is no more privileged today than commercial, application-oriented industrial 

research. privileged experiments can include experiments for a commercial use, e.g. 

experiments required for a pharmaceutical marketing authorization, or experiments carried 

out with an economic interest, e.g. obtaining another patent. 

Furthermore, such experiments are considered to be harmless which contribute to the 

advancement aspired under patent law of research and development. The decision “Klinische 

Versuche I” initially privileged experiments aimed at finding new, unknown uses (what is called 

use experiments), whereas according to the decision “Klinische Versuche II”, experiments 

were also permitted directed at finding data on characteristics and effects of the patented 

active substance within the limits of the indications already known (what is called indication 

experiments). The following tests are thus admissible today: 

• to find indications and contra-indications within and beyond known fields of 

application, 

• to analyze the pharmaceutical form and dosage of an active substance to discover a cure 

for or to alleviate certain illnesses, 

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• to find clinically-relevant differences over other products, in particular the effectiveness 

and tolerance thereof as well as 

• testing by plant protection authorities in field trials of a patented active substance of a 

plant-treatment agent. 

b) Non-privileged experiments 

experimental privilege, however, is limited in that experiments will only then be deemed 

harmless if they use the patented subject matter as the object of the test and not merely as a 

means of realization. 

Furthermore, only such tests are deemed harmless that are directed at the technical findings of 

the patented invention and not only at satisfying a commercial, i.e. entrepreneurial, interest. 

Thus, it may not be the exclusive aim just to clarify economic factors, such as market demand, 

price acceptability or distribution possibilities. Obtaining technical/scientific findings may not 

moreover only be a secondary purpose of the trial on the patented invention. 

one criterion has been set up to restrict abuse by experimental privilege, i.e. the so-called 

quantity argument: The experiments may only be carried out to an extent justifying the 

experimental purpose. 






exception? 

in addition to experimental privilege as stipulated in sec. 11(2) German patent Act, a Bolartype 

experimental privilege was incorporated into the German patent Act by sec. 11(2b), 

and has been in force since 6 september 2005. The introduction of sec. 11(2b) German 

patent Act was carried out as part of the implementation of Directive 2004/27/ec. The 

German Bolar-type experimental privilege excludes from the effect of a patent the studies and 

trials necessary in order to obtain a marketing authorization for a medicinal product in any 

member state of the european community or any member state of the european economic 

Area, as well as any acts necessary for their performance. 

case law concerning the scope of the Bolar-type experimental privilege has not as of yet 

been published in Germany. Thus, the exact limits of the Bolar-type experimental privilege 

have not yet been defined. The wording of the law, however, does not provide any indication 

of a restriction of the Bolar-type experimental privilege to pharmaceutical substances. To the 

contrary, the wording and history of the Bolar-type experimental privilege in Germany very 

much suggest that a very broad experimental privilege is intended that will exempt from the 

effect of a patent all studies and experiments required to obtain an authorization under the 

German law on Drugs. These can include, according to the wording of sec. 11(2b) German 

patent Act, also experiments with patented, biological substances or “research tools”. This will 

at least be the case if these are exclusively used for experiments required for the authorization 

of pharmaceuticals. Many questions in this regard, however, still remain unanswered. on the 

other hand, it appears to be clear that the German Bolar-type experimental privilege is not 

restricted to experiments as part of the authorization process of generic pharmaceuticals, 

but also includes experiments with innovative pharmaceuticals. An overlap with the classical 

experimental privilege of sec. 11(2) German patent Act could therefore result that is however 

additionally restricted by the legal requirement that the experimental acts must relate to the 

subject matter of the patented invention. 

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parallel imports from countries outside the european economic Area (eeA) can be prohibited 

on the grounds of a patent or a Supplementary Protection Certificate. 

if, however, a patented product is marketed in the eeA by its proprietor or with its consent, 

e.g. by its licensee, patentee’s rights to the product will also be exhausted in Germany, i.e. 

the product can be further distributed with limitations within the eeA. The same shall apply to 

pharmaceuticals. These can therefore, in principle, be re-imported and imported in parallel 

from any eeA country to Germany. 

According to the case law of the european court of Justice, the parallel import of medicines 

and medical devices is possible if the product was placed on the market by patentee or with 

patentee’s consent (by way of a license) (cf. decision “Centrafarm vs. Sterling Drug” by the 

european court of Justice, ecr [1974], at 1147). This even applies if the price of the medicine 

in the country of export, due to governmental provisions, is regulated and considerably lower 

than in the country of import or if patentee does not hold a patent in the country of export 

since he did not apply for one as corresponding protection was not possible at the time of 

application (cf. decision “Merck vs. Stephar” by the european court of Justice, ecr [1981], 

at 2063). 

As far as imports of medicines from the ten new Member states are concerned, i.e. czech 

republic, slovakia, hungary, poland, slovenia, estonia, lithuania and latvia as well as 

Bulgaria and Romania, what is called “specific mechanism”, according to the Accession 

Treaties, must apply. Under the “specific mechanism” provision, the IP-right proprietor can 

prevent the parallel import of a pharmaceutical product that was first put on the market in one 

of the aforesaid states if the ip right for the relevant pharmaceutical product was applied for in 

one of the prior eu states at a time when corresponding protection could not yet be obtained 

for said product in each of the ten new Member states. 

As to pharmaceuticals that were marketed on the basis of a compulsory license (hence without 

approval of ip-right proprietor), the principle of exhaustion of rights does not apply. These 

pharmaceuticals may therefore not be imported in parallel, provided there is corresponding 

patent protection (decision “Pharmon vs. Hoechst” by the european court of Justice, ecr 

[1985], at 2281). Nor does exhaustion arise if patentee is legally obliged to market the 

product in the country of export (decision “Merck vs. Primecrown” by the european court of 

Justice, ecr [1996], at 6285). 

The situation is somewhat different with regard to trademark rights if the products are repackaged. 

A series of criteria and requirements have been instituted to protect the trademark 

owner. 


conditions? 

Yes. sec. 11(3) German patent Act provides that the effects of a patent shall not extend to 

the direct, individual preparation of a pharmaceutical in pharmacies as a result of a doctor’s 

prescription or to the acts of preparing said pharmaceutical. 

There is very little case law on this provision as well. This will, when in doubt, be interpreted 

narrowly as an exemption to the effects of a patent that are otherwise recognized under the 

law. it has already been decided that this exemption does not authorize the stockpiling of 

pharmaceuticals in a pharmacy. What is always required is a doctor’s prescription for one 

single patient, on the basis of which the pharmaceutical is prepared in the pharmacy. 

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Methods of medical treatment are not patentable in Germany. 






Compulsory licenses under a patent in the field of preventive health care can in Germany, in 

principle, be based on four different grounds. 

According to sec. 24(1) German patent Act, a compulsory license can be granted under 

a patent if this is required in the public interest and if the patentee refuses to grant a 

license under the adequate conditions customary in trade. public preventive health care is 

recognized as a public interest within the meaning of sec. 24 German patent Act. in practice, 

compulsory licenses, as stipulated in sec. 24 German patent Act, have so far been of very 

minor significance since the German Federal Supreme Court in its decision “Polyferon” of 

1995 refused the grant of a license on a pharmaceutical substance and placed the entire 

burden of proof for the public interest in the compulsory license on plaintiff as the party 

seeking a license. plaintiff would have needed to prove that the license would not merely 

make room for a more or less equivalent medicament in a certain class, but would fill a 

real supply gap, for since if only the novel preparation could avoid the problematical side 

effects of the treatment. Neither the fact that a patent had already been granted for a new 

use of a patented substance nor the authorization of a new pharmaceutical on the basis 

of the patented substance were considered as sufficient proof of public interest. Ever since 

this decision was rendered, no further proceedings pertaining to the grant of a compulsory 

license have become known. 

According to sec. 24(2) German patent Act, a compulsory license could also be granted in 

case of a dependent invention if the dependent invention were to constitute, compared with 

an earlier patent, an important technical progress of considerable economic significance. 

This provision was introduced in 2005 with the law on the implementation of the Directive on 

the legal protection of Biotechnological inventions. sec. 24(2) German patent Act, however, 

concerns all types of inventions and will probably become more important than sec. 24(1) 

German patent Act. 

The grant of a compulsory license can only be effected after a patent has been granted 

and must be requested at the Federal supreme court which has to decide on compulsory 

licenses. it is not possible to request the grant of a compulsory license for a pending patent 

application. 

in Germany, the grant of compulsory licenses under patents for pharmaceuticals is also possible 

for the export to countries having insufficient health care, i.e. on the basis of Regulation (EC) 

No 816/2006 of 17 May 2006. This provision at the european level corresponds to the 

provisions of new Art. 31bis Trips (for details see below question 7). however, no compulsory 

licenses have as of yet been granted on this basis in Germany, according to the public 

register at the WTo. 

The right to the grant of a license under a patent on the basis of German or european antitrust 

laws has a far greater practical importance in Germany than the explicitly regulated 

compulsory licenses. A compulsory license under anti-trust laws is not regulated by the 

requirements of sec. 24 German patent Act and can, according to the decision “Standard- 

Spundfass” issued by the German Federal supreme court (K Zr 40/02), also be brought 

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forward as a defense against a patent infringement act. one requirement that must be met 

when claiming the right under anti-trust laws to the grant of a license is that the refusal to grant 

a license by patentee is, according to German and european anti-trust laws, contrary to fair 

competition, and hence constitutes an unjustified discrimination or abuse of market power, and 

that patentee must have refused a sufficiently specific and acceptable offer for the conclusion 

of a license agreement. The application of the provisions under anti-trust laws, however, 

requires that said patentee must be a company having, within the meaning of anti-trust laws, 

a dominating and powerful position on the market. The requirements for a compulsory license 

under anti-trust laws can be met particularly in cases where the compliance with a general 

industry standard requires the use of a patent. 

It has not yet been finally clarified whether an interested party must first submit a specific 

written offer before starting to use the patent or whether he can also submit this offer at a later 

date should he be sued by patentee on the grounds of patent infringement. The objection 

that a compulsory license must be granted was recently recognized as a defense against 

the accusation of patent infringement in proceedings at the regional court Düsseldorf which 

dealt with patents required for the use of GsM standards. in other published decisions, the 

right to the grant of a compulsory license was largely rejected or no decision was rendered. 






New Art. 31bis TRIPS has not been ratified by Germany. Despite this, its provisions have 

already become established law in Germany. The starting point in this regard is the ratification, 

for the european community, of Art. 31bis Trips on 30 November 2007 by the president 

of the Council of the European Union, also having binding effect for Germany. Ratified at 

this point was the protocol Amending the Trips Agreement, adopted by the General council 

of the WTo in Geneva on 6 December 2005, by which, according to Art. 31 of the Trips 

Agreement, a new Art. 31a (Art. 31bis) was to be added. With decision of 19 November 

2007, the council of the european union decided to adopt, in the name of the european 

community, the protocol Amending the Trips Agreement signed by the General council of 

the WTo in Geneva on 6 December 2005. With its entry into force, the protocol according 

to Art. 300(7) of the ec Treaty will also be binding for Germany. 

The decision of the General council of the WTo of 30 August 2003 on the implementation of 

No 6 of the Doha Declaration (“decision”) was implemented, upon proposal by the european 

commission, with regulation (ec) No 816/2006 on compulsory licensing for patents relating 

to the manufacture of pharmaceutical products for export to countries with public health 

problems (“regulation”) which was adopted by the european parliament and the council of 

the european union on 17 May 2006. The regulation entered into force on 29 June 2006. 

According to Art. 249 ec Treaty, a regulation is obligatory in all its parts and is directly valid 

in each Member state. The regulation, consequently, has to be applied as directly applicable 

law and must be observed in Germany. 

The background for the issuance of a regulation under community law was, according to 

recital (4) of the regulation, the uniform implementation of the decision on the establishment 

of the same requirements in all Member states of the european community for the grant of 

compulsory licenses regarding the manufacture and sale of certain pharmaceutical products 

intended for export and for the prevention of unfair competition for economic operators on 

the domestic market. The uniform implementation moreover contributes to the prevention of 

re-imports of pharmaceutical products, produced according to the decision of the General 

council of the WTo of 30 August 2003, into the territory of the european community. 

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ecital (8) of the regulation stipulates that the grant of compulsory licenses according to this 

Regulation shall be attached to clear requirements for the licensee. The recital specifically 

states the activities covered by the license, the identifiability of the pharmaceutical products 

manufactured under the license and the countries to which these products are exported. 

According to Art. 1 of the regulation, the regulation establishes a procedure for the grant 

of compulsory licenses for patents and Supplementary Protection Certificates relating to the 

manufacture and sale of pharmaceutical products, when such products are intended for 

export to eligible importing countries in need of such products in order to address public 

health problems. “pharmaceutical product” means any product of the pharmaceutical 

sector, including medicinal products. The following are eligible countries according to the 

regulation: 

a) any least-developed country appearing as such in the united Nations’ list; 

b) any member of the WTO that has made a notification to the Council for TRIPs of its 

intention to use the system as an importer, including whether it will use the system in 

whole or in a limited way; 

c) Any country that is not a member of the WTo and is listed in the oecD Development 

Assistance Committee’s list of low-income countries and has made a notification to the 

commission of its intention to use the system as an importer, including whether it will use 

the system in whole or in a limited way. 

According to Art. 6 of the regulation, any person may, in principle, submit an application 

for a compulsory license to a competent authority in the Member state where the respective 

patent has effect. The applicant shall provide inter alia evidence to satisfy the competent 

authority that he has made efforts to obtain authorization from the rights-holder and that 

such efforts have not been successful within a period of thirty days before submitting the 

application. This requirement according to Art. 9(2) of the regulation shall only be dispensable 

in situations of national emergency or other circumstances of extreme urgency or in cases of 

public non-commercial use under Art. 31 lit.(b) of Trips Agreement. According to Art. 11 of 

the regulation, the competent authority shall refuse an application if any of the conditions 

for grant is not met. one condition for the grant is inter alia the indication of the amount 

of products the applicant intends to manufacture of the pharmaceutical product under the 

license. The reason herefor is that a compulsory license is, for the protection of the rightsholder, 

strictly limited to the quantities required in the import country cited in the application. 

The products that are manufactured under the license shall be clearly identified through 

specific labeling or marking to distinguish them from the products manufactured by the rightsholder. 

The license granted according to Art. 10(1) of the regulation shall be non-assignable 

and non-exclusive. The duration of the license shall moreover be indicated. According to 

Art. 10(9) of the regulation, the licensee shall pay an adequate remuneration to the rightsholder. 

The re-import into the territory of the european union of the products manufactured 

and distributed on the basis of the compulsory license shall be prohibited. if licensee fails to 

comply with the license conditions, the competent authority can withdraw the license. 

As far as is known, no compulsory license for the import or export of pharmaceutical products 

has been granted in Germany as of yet. This is true both with regard to compulsory license 

proceedings pursuant to the regulation (ec) No 816/2006 and to German proceedings 

according to sec. 24 German patent Act (see in this regard also question 6). 



in sec. 13 patG (German Patent Act), German patent law defines the concept of an official 

order to exploit an invention, which may be issued by the federal government or an appropriate 

supreme federal authority (or by a subordinate agency acting on behalf of the latter). The 

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order may be issued if the invention shall be used in the interest of public welfare or in the 

interest of the security of the Federal republic. pursuant to sec. 13 patG, a patented invention 

may also be exploited against the patentee’s will, if so required by a superior public interest. 

The patent itself remains valid. 

The order to exploit an invention in the interest of public welfare is specified in Sec. 13 (1) 

sentence 1 patG. only the federal government is authorised to issue such orders. The order is 

issued by virtue of an administrative act which has to indicate the types or acts of exploitation 

and the duration of the order. The term “public welfare” has to be construed broadly and, 

as a rule, includes all cases where state welfare seems necessary. A typical case would be 

a state of emergency caused for instance by an epidemic. Given the interfering nature of the 

order to exploit an invention, the order may only be issued if it appears necessary. There is no 

such necessity if the objective can also be achieved otherwise. Also, an inquiry for a license 

has to be made with the patentee before the order is issued, except in cases of urgency. 

According to sec. 13 (1) sentence 2 patG, the order to exploit an invention may also be issued 

by an appropriate supreme federal authority or, on its behalf, by a subordinate agency, if the 

invention shall be exploited in the interest of the security of the Federal republic. An interest 

in the security of the Federal republic is given in cases of national defence against attacks 

from the outside or inside, or other, comparable serious dangers to the security of the Federal 

republic, including disaster control. 

Although an order for the exploitation of an invention under sec. 13 patG does not affect the 

validity of the patent, it restricts the patent within the limits defined by the order. The scope 

of an order can be equivalent to an exclusive or nonexclusive license. Within these limits, 

the patentee cannot prohibit the use of the invention. other than that, the patentee’s right of 

exclusivity as well as the right of use held by the patentee and other authorised parties remain 

unaffected. The government or appropriate authority can transfer the right of exploitation, as 

ordered, to third parties, including private individuals, who, however, have to observe the 

limits of the order when using the invention. exploitation is permissible only to promote public 

welfare or the interest in security. Any use for one’s own commercial purposes based on the 

order for exploitation is inadmissible. When issuing the order the agency has to ensure that 

the impairment of the patentee’s rights is kept to a minimum. 

pursuant to sec. 13 (3) sentence 1 patG, the patentee is entitled to a claim against the Federal 

republic for a reasonable compensation in the event of a lawful order for exploitation. in the 

case of an order for exploitation in the interest of public welfare (sec. 13 (1) sentence 1 patG), 

the claim arises when the order is issued, whereas it arises only with the actual exploitation if 

the order was issued in the interest of the security of the Federal republic (sec. 13 (1) sentence 

2 patG). 

if an order for exploitation fails to comply with the stipulations in sec. 13 patG and unlawfully 

encroaches upon the patent, the holder of the patent rights is entitled to a claim for 

compensation against the state agency that benefited from the infringement. 


in Germany, property is protected under the constitution, Article 14 (1) sentence 1 Grundgesetz 

(German Constitution – GG); the terms and restrictions are defined by the individual statutes 

(Art. 14 (1) sentence 2 GG). pursuant to Art. 14 (3) sentence 1 GG, expropriation is permissible 

only for the public good and may be ordered only by or pursuant to a law which defines the 

nature and extent of the compensation. 

According to common consent, the patent right qualifies as “property” in the sense of the 

constitution. Thus, it is covered by the constitutional guarantee and protected under Art. 14 

(1) GG. This has been confirmed by the Federal Constitutional Court as supreme instance. 

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Art. 14 (3) sentence 2 GG permits expropriation, provided it is ordered by or pursuant 

to a law. As a law requires an appropriate parliamentary resolution, it is ultimately not 

the government (executive) but only the legislator (legislature) that can expropriate. Given 

the substantial nature of the encroachment upon a person’s legal position, expropriation is 

permitted only for the public good, Art. 14 (3) sentence 1 GG, and must in fact be necessary 

to achieve this particular purpose, i.e. it is not permitted if there is a less severe measure to 

achieve the same purpose. 

There is no law in Germany which explicitly deals with the expropriation of patents. The 

following provisions of the German patent Act could be considered laws within the meaning 

of Art. 14 (3) sentence 2 GG: 

sec. 11 patG (exemptions from the effects of the patent), sec. 24 patG (compulsory license), 

sec. 50 patG (order of nondisclosure) and sec. 13 patG (order for exploitation). 

With respect to sec. 11 patG (exemptions from the effects of the patent) the Federal 

constitutional court held in the decision of 10 May 2000 (“clinical Trials”) in view of the 

experimental use exception of sec. 11 No. 2 patG that this provision does not qualify as an 

expropriation but as an admissible definition of the scope and limitations of property within 

the meaning of Art. 14 (1) sentence 2 GG. 

As for sec. 24 patG (compulsory license, cf. question 6 above), it is assumed in the literature 

that this provision is a limitation of property as protected by the constitution in the sense 

of a definition of the scope and limits, and thus does not qualify as expropriation. This is 

supported by the fact that sec. 24 (1) patG leaves the protection of the public interest to the 

license seeker’s private initiative and private willingness to take risks and, ultimately, only 

grants the license seeker a claim under private law to the grant of a compulsory license by the 

patent court. The compulsory license has the effect of granting the license seeker a position 

comparable to that of a contractual licensee. 

§ 50 patG (order of nondisclosure) provides for an ex officio order by the patent office to the 

effect that no publication of a patent shall take place if the patent is sought for an invention 

which is a state secret. The Federal court of Justice ruled already on 4 May 1972 (“Nuclear 

energy”) with respect to (former) sec. 30 a patG, the predecessor provision of sec. 50 patG, 

that the order of nondisclosure does not represent an expropriation measure. 

only sec. 13 patG (order for exploitation) is considered at least similar to expropriation in 

literature. It is referred to as an official measure of a nature similar to expropriation, which lies 

within the reasonably exercised discretion of the federal government and/or the appropriate 

supreme federal authority. under the law as well, the order issued by the federal government 

is treated as an expropriation measure, with the difference that it is effected for an adequate 

compensation. 

The preconditions for the grant of an order for exploitation under sec. 13 patG have been 

discussed in question 8 above. 

Generally, an expropriation by virtue of the law is possible, provided the constitutional 

regulations, especially Art. 14 GG, are complied with. in light of the available possibilities 

described earlier, however, any thoughts about additional expropriation laws in the field of 

patents most likely are of a theoretical nature only. 





German patent law does not provide for any such procedures or means. 

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For the following questions, it should generally be noted that exemptions from the effects of 

the patent should always be considered in their entirety instead of individually. 



since more than 15 years German patent law provides for an experimental use exception 

in sec. 11 (2) patG. however, the question of which “acts done for experimental purposes” 

are covered by the exception, to this date has not been answered by a final court 

decision. The high practical relevance of this issue is obvious especially in the field of 

generics, as competitors are able to launch generic drugs after the expiry of the patent 

term only after a substantial number of preparatory acts. For example, these acts include 

the importation, the manufacture and transportation of substances or devices used in 

the trial, and possibly also the delivery of raw materials or components to be used in 

the production of the substances or devices. even after the introduction of the Bolar 

exception (please see below), a need for clarification and thus a level of legal uncertainty 

persists. 


The introduction of a Bolar-type exception in Germany had been demanded for a long 

time, especially by the generics industry, and became necessary after the Directive 

2004/27/ec entered into force. All in all, the Bolar exception entails a higher legal 

certainty with respect to clinical trials with pharmaceuticals in Germany and should thus, 

in principle, facilitate the performance of such trials in Germany. Accordingly, the long 

open question of the limits of the classic experimental use exception in trials with generics 

has lost much of its urgency. 

Generally, the introduction of the Bolar exception has shifted the (legal) leeway somewhat 

towards the generics manufacturers. The european and German legislators hoped to 

stimulate competition and promote a faster placing on the market of “new”, cost-efficient 

drugs. It remains to be seen whether the Bolar exception will be able to fulfil these 

expectations. 

Nevertheless, the (harmonised) introduction of this experimental use exception to promote 

public health and stimulate competition in the pharmaceutical market seems to offer 

more benefits than drawbacks. It appears reasonable to not restrict the experimental use 

exception to generics, as trials with patented, innovative active substances often tend to 

have new, useful results for the public health and should, therefore, also be promoted or 

at least not obstructed by the legislation. 


Given the existing legal situation (practice of the Federal Court of Justice and Specific 

Mechanism for eu accession countries), there seems to be no need for a regulation of 

parallel imports of medicines by patent law. 


The direct individual preparation of medicines in pharmacies is not covered by the effects 

of the patent, either. This exemption from the effects of the patent, however, has hardly 

any relevance in practice, nor does it seem required in the interest of public health or for 

cost-efficient access to pharmaceuticals. It would probably go more or less unnoticed if 

this provision was cancelled altogether. 


As medical treatments are not patentable under German law, there is no need for such 

a protective mechanism. 

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In the field of medicinal products and medical devices, the issue of a compulsory license 

under Sec. 24 PatG should be clarified before investing into the development of a new 

product. 

At this time, a compulsory license can be requested only for a granted patent but not for 

a pending patent application. A proceeding for a compulsory license for a new drug 

stands chances of a success only if clinical data are available which prove the special 

value of the new drug compared to previously available products. Further, the patentee 

can delay or prevent the grant of a compulsory license, for instance by developing a rival 

product to the planned new product before the decision on the grant of the compulsory 

license, or by deriving divisional applications from a patent application which will be 

examined only after the grant of the original patent. 

Thus, the compulsory license usually comes too late for potential applicants. Although 

development work and clinical trials are possible without a compulsory license under the 

experimental use exception, hardly anyone will make the substantial investments into a 

new drug if he cannot be sure that the new product will be marketed later. 

For those interested in a compulsory license, it would thus be reasonable to first clarify 

the situation before investing in the development of a new product. 

Generally, the possibility of “compulsory licensing of patents relating to the manufacture 

of pharmaceutical products for export to countries with public health problems“ (title of 

the regulation (ec) 816/2006) in the interest of the poor countries as well as the resulting, 

relatively quick transposition of new Article 31bis Trips by the community legislator, is 

highly appreciated. The procedure set out in the regulation, however, does not seem 

suited to provide fast, unbureaucratic support, especially in times of crises. For instance, 

time limits would be desirable within which the authorities of the Member states have 

to decide on an application for a compulsory license. The regulation provides for such 

time limits for the actions of customs authorities defined in Article 14: If it is suspected 

that products manufactured under a compulsory license are being re-imported into the 

community contrary to the regulation, the review by the authority and related detaining 

of the goods may not exceed ten working days. 

As far as can be seen, the German legislator has not yet defined any rules for the 

implementation of the regulation, in particular in view of the procedure before the 

national authorities for the grant of a compulsory license. The legislator should adjust 

and/or amend the German (patent) laws as quickly as possible so as not to unnecessarily 

complicate the enforcement of rights under Article 31bis Trips. 


especially with the provisions on compulsory licenses (sec. 24 patG) and the order of 

exploitation (sec. 13 patG), German patent law already today provides for possibilities 

to use granted patents against the patentee’s will through the state and/or private third 

parties, which allow for flexible solutions tailored to the specific case within the limits 

of what is permissible under the constitution. in light of the fact that expropriations are 

permitted only for the public good under Article 14 (3) sentence 1 GG anyway and, 

given the related severe consequences for right holders, may be contemplated only if no 

other, less severe means are available, hardly any cases are conceivable which would 

require additional regulations above and beyond the existing ones in German patent 

law. 



Beyond the limitations of the exclusive rights that have been realised by the legislator in 

Germany and in the european union, no further limitations seem necessary or reasonable. 

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it has to be considered that effective patent protection is essential to the researching 

pharmaceutical industry and represents a valuable asset also in the sense of medical 

progress and public health, which should not be carelessly put at risk. 



please refer to the explanations in the preceding paragraph. 

Further, patent law could facilitate access to medicines and the like also by excluding certain 

inventions from patentability. This idea is behind the exception from patentability of therapy 

and diagnostic measures on the human or animal body as set out in european and German 

patent law (Art. 53 c epc 2000, sec. 5 patG). 




For reasons of equal legal opportunities alone, a global harmonisation of patent laws and of 

the legal requirements for acts of business in competition always seems desirable. however, 

it appears hardly reasonable and useful to only harmonise the exceptions from the effects of 

a patent, but not the effects as such or the preconditions for maintaining patent protection. 

it is true that the Bolar exception exists in all eu Member states as a result of the Directive 

2004/27/ec, providing for “harmonised legislation” in this respect. however, the national 

transpositions of this Directive differ surprisingly, ranging from a verbatim implementation of 

Art. 10(6) Directive to a substantial extension of the Bolar exception, for instance in Germany 

and italy. Whether this promotes the development of a common market and common legal 

area can be justifiably doubted. On the other hand, the need for harmonisation surely is 

considerably greater in other areas. 

Summary 

in view of the public interest German law provides for certain restrictions of the exclusive patent 

rights of a patentee. Firstly the experimental use exemption enables the aimed further development 

of research and development, with the Bolar exemption also considering experiments focusing 

a commercial exploitation. Moreover parallel imports within the eeA and exemptions in case of 

individual prescriptions are legal. Theoretically compulsory licenses can be granted, if any, which 

do, however, not yet really play a role. in this regard the provisions of Article 31bis TRIPS are 

already applicable law in Germany. The legislator has, however, not yet set any rules for their 

enforcement. 

These restrictions of exclusive patent rights do not constitute an expropriation of patent rights which 

are property constitutionally guaranteed by the German Basic constitutional law. only the order 

of use entitling to a use of a patented invention against the patentee’s will is a drastic encroachment 

on the rights of a patentee. however, in practice an order of use has never been rendered. 

A global harmonization of the patent laws and their exemptions from the effect of the patent is 

desirable according to the opinion of the German National Group. 

Résumé 

Dans un souci d’intérêt public, le droit allemand prévoit certaines restrictions aux droits de 

brevet exclusifs d’un breveté. D’une part l’exception d’une utilisation à titre expérimental permet 

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l’évolution souhaitée de la recherche et du développement et l’exception Bolar tient également 

compte des expérimentations faites en vue d’une exploitation commerciale. en outre, sont légales 

des importations parallèles au sein de l’eee ainsi que les exceptions liées à des prescriptions 

individuelles. en théorie, peuvent également être concédées des licences obligatoires qui ne jouent 

cependant qu’un rôle mineur jusqu’ici. Dans ce contexte les dispositions de l’article 31bis ADpic 

sont des dispositions légales déjà en vigueur en Allemagne. Mais le législateur n’a pas encore mise 

en place une réglementation d’application de ces dispositions. 

ces restrictions aux droits de brevet exclusifs ne représentant toutefois pas une privation des droits 

de brevet qui, en tant que droits de propriété, sont garantis par la constitution allemande. seule 

l’arrêté d’utilisation qui permet l’utilisation d’une invention brevetée contre la volonté du breveté 

constitue une atteinte profonde aux droits du breveté. en pratique un tel arrêté d’utilisation n’a 

toutefois encore jamais édicté. 

une harmonisation globale des lois relatifs aux brevets et des exceptions des effets des brevets 

apparaît souhaitable selon le Groupe Allemand. 


im sinne eines öffentlichen interesses sind nach deutschem recht gewisse einschränkungen der 

exklusiven patentrechte eines patentinhabers vorgesehen. Zum einen ermöglicht das Versuchsprivileg 

die erstrebte Fortentwicklung von Forschung und entwicklung, wobei die Bolar-Ausnahme zudem 

Versuche berücksichtigt, die auf eine kommerzielle Verwertung hin abzielen. Darüber hinaus sind 

Parallelimporte innerhalb des eWr und Ausnahmen bei individuellen Verschreibungen legal. 

Theoretischerweise können ebenfalls Zwangslizenzen erteilt werden, die bisher jedoch kaum 

eine rolle spielen. in diesem Zusammenhang sind die regelungen des Artikels 31bis TRIPS in 

Deutschland bereits geltendes recht. Der Gesetzgeber hat aber noch keine regelungen zu seinem 

Vollzug vorgegeben. 

Diese einschränkungen der exklusiven patentrechte stellen keine Enteignung des patentrechts 

dar, welches als eigentum im Grundgesetz verfassungsrechtlich gewährleistet ist. lediglich die 

Benutzungsanordnung, die das Benutzen einer patentierten Erfindung gegen den Willen des 

patentinhabers ermöglicht, ist ein tiefgreifender eingriff in die rechte eines patentinhabers. in der 

praxis wurde eine Benutzungsanordnung aber noch nie erlassen. 

eine globale harmonisierung der patentgesetze und deren Ausnahmen von der Wirkung des 

patents ist nach Auffassung der Deutschen landesgruppe wünschenswert. 

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Germany 

Allemagne 

Deutschland 

Frage Q202 

im Namen der Deutschen Landesgruppe 

von Thorsten BAusch, uli FoersTL, Michael KoMpTer, 

christian LeDerer, Andrea schüssLer und hubert WiTTe 

Auswirkungen von Fragen der Volksgesundheit 


Fragen 






im Jahr 1981 wurde das deutsche patentgesetz geändert und durch Neufassung des § 11 Nr. 

2 patentgesetz (patG) trat das so genannte „Versuchsprivileg“ in Kraft. hierin wird bestimmt, 

dass sich die Wirkung des patents nicht auf handlungen zu Versuchszwecken erstreckt, die 

sich auf den Gegenstand der patentierten Erfindung beziehen. 

Allerdings blieb die rechtsprechung zunächst weiterhin restriktiv, da nur Versuche an 

dem Gegenstand der patentierten Erfindung zugelassen waren. Eine Liberalisierung der 

rechtsprechung erfolgte über die erweiterung des Versuchsprivilegs mit den entscheidungen 

des Bundesgerichtshofs (BGh) „Klinische Versuche i“ im Jahre 1995 und „Klinische Versuche 

ii“ im Jahre 1997. 

a) privilegierte Versuche 

im sinne der rechtsprechung des BGh ist jedes planmässige Vorgehen zur Gewinnung 

von Erkenntnissen über den Gegenstand der Erfindung privilegiert, wobei der finale Zweck 

der Forschungs- und Versuchshandlungen nicht entscheidend ist. Das bedeutet, dass auch 

untersuchungen durchgeführt werden dürfen, die eine kommerzielle Verwertung der 

Ergebnisse zum Ziel haben. Somit ist heutzutage die akademische Grundlagenforschung 

nicht mehr privilegierter als die kommerzielle, anwendungsorientierte industrielle Forschung. 

privilegierte experimente können also auch Versuche sein, die auf eine gewerbliche Nutzung 

abzielen, beispielsweise Experimente zur Erlangung einer arzneimittelrechtlichen Zulassung 

oder Versuche aus wirtschaftlichem interesse, mit denen auf die erlangung eines weiteren 

patents abgezielt wird. 

insbesondere sind solche untersuchungen unschädlich, die zu der patentrechtlich erstrebten 

Fortentwicklung von Forschung und entwicklung beitragen. Die entscheidung „Klinische 

Versuche I“ privilegierte zunächst Versuche zum Auffinden neuer, bisher unbekannter 

Anwendungsmöglichkeiten (sog. Verwendungsversuche), wobei nach „Klinische Versuche 

II“ auch Experimente zum Auffinden von Erkenntnissen über Eigenschaften und Wirkungen 

des patentgemässen Wirkstoffs im rahmen der bereits bekannten indikationen (sog. 

Indikationsversuche) erlaubt waren. insoweit sind heutzutage folgende Tests zulässig: 

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• Auffinden von Indikationen und Kontraindikationen innerhalb und ausserhalb bekannter 

Anwendungsbereiche, 

• Analyse der Darreichungsform und Dosierung des Wirkstoffs, um bestimmte Krankheiten 

zu heilen oder zu lindern, 

• Auffinden klinisch relevanter Unterschiede zu anderen Produkten, insbesondere deren 

Wirksamkeit und Verträglichkeit, sowie 

• Prüfung eines patentgeschützten Wirkstoffs eines Pflanzenbehandlungsmittels durch 

Pflanzenschutzämter in Feldversuchen. 

b) Nicht privilegierte Versuche 

Das Versuchsprivileg findet seine Grenzen jedoch darin, dass Versuche nur dann unschädlich 

sind, wenn sie den patentierten Gegenstand als objekt der untersuchung nutzen und nicht 

lediglich als ein Mittel zu deren Durchführung. 

Darüber hinaus sind nur solche untersuchungen unschädlich, die sich auf die technischen 

Erkenntnisse der patentierten Erfindung richten und nicht nur ein kaufmännisches bzw. 

unternehmerisches Interesse aufweisen. Demnach darf es nicht das ausschliessliche Ziel sein, 

wirtschaftliche Fakten, wie Marktbedürfnis, preisakzeptanz oder Vertriebsmöglichkeiten zu 

klären. Zudem darf auch die Erlangung technisch-wissenschaftlicher Erkenntnisse nicht nur 

Nebenzweck des Versuchs an der patentierten Erfindung sein. 

ein Abgrenzungskriterium gegenüber Missbrauch des Versuchsprivilegs wird durch 

das sogenannte Mengenargument geschaffen: Die Versuche dürfen nur in einem dem 

Versuchszweck zu rechtfertigendem umfang durchgeführt werden. 







Zusätzlich zum Versuchsprivileg nach § 11 Nr. 2 PatG wurde ein Bolar-Versuchsprivileg in Form 

des § 11 Nr. 2b patG in das deutsche patentgesetz eingeführt und ist seit dem 6. september 

2005 in Kraft. Die einfügung des § 11 Nr. 2b patG erfolgte im rahmen der umsetzung der 

richtlinie 2004/27/eG. Das deutsche Bolar-Versuchsprivileg nimmt studien und Versuche 

und die sich daraus ergebenden praktischen Anforderungen, die für die erlangung einer 

arzneimittelrechtlichen Genehmigung für das inverkehrbringen in der europäischen union 

oder einer arzneimittelrechtlichen Zulassung in den Mitgliedstaaten der Europäischen Union 

oder in Drittstaaten erforderlich sind, von den Wirkungen des patentes aus. 

rechtsprechung zur Tragweite des Bolar-Versuchsprivilegs in Deutschland ist bisher nicht 

veröffentlicht worden; insoweit sind die genauen Grenzen des Bolar-Versuchsprivilegs auch 

noch nicht abgesteckt. Der Gesetzeswortlaut gibt jedoch nichts für eine Beschränkung des 

Bolar-Versuchsprivilegs auf arzneiliche Wirkstoffe her. Vielmehr spricht aus Wortlaut und 

entstehungsgeschichte des Bolar-Versuchsprivilegs in Deutschland viel dafür, dass an ein 

sehr extensives Versuchsprivileg gedacht wurde, das sämtliche studien und Versuche von 

den Wirkungen des patents ausnimmt, die für die erlangung einer arzneimittelrechtlichen 

Genehmigung erforderlich sind; nach dem Wortlaut des § 11 Nr. 2b patG können dazu auch 

Versuche mit patentgeschützten biologischen substanzen oder „research tools“ gehören, 

jedenfalls dann, wenn diese ausschliesslich für Versuche eingesetzt werden, die für die 

Arzneimittelzulassung erforderlich sind. im einzelnen sind hier jedoch noch viele Fragen 

offen. eindeutig scheint hingegen zu sein, dass das deutsche Bolar-Versuchsprivileg nicht 

beschränkt ist auf Versuche im Rahmen der Zulassung generischer Arzneimittel, sondern 

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auch Versuche mit innovativen Arzneimitteln erfasst. insoweit kann eine überschneidung mit 

dem klassischen Versuchsprivileg des § 11 Nr. 2 patG eintreten, das allerdings zusätzlich 

durch das Tatbestandsmerkmal eingeschränkt ist, dass sich die Versuchshandlungen auf den 

Gegenstand der patentierten Erfindung beziehen müssen. 




wurden? 

parallelimporte aus Ländern ausserhalb des europäischen Wirtschaftsraums (eWr) können 

aufgrund eines Patents oder Ergänzenden Schutzzertifikats unterbunden werden. 

Wird ein patentgeschütztes produkt aber vom patentinhaber oder mit seinem einverständnis, 

z.B. durch seinen Lizenznehmer, im eWr in Verkehr gebracht, sind die rechte des 

patentinhabers an dem produkt auch in Deutschland erschöpft, d.h. es kann innerhalb des 

eWr beliebig weiter vertrieben werden. Das gilt auch für Arzneimittel. Diese können daher 

grundsätzlich aus jedem eWr-staat nach Deutschland re- bzw. parallel importiert werden. 

Nach der rechtsprechung des euGh ist der parallelimport von Medikamenten und 

medizinischen Geräten möglich, wenn der patentinhaber das produkt selbst auf den Markt 

gebracht hat oder es mit seiner Zustimmung (unter seiner Lizenz) auf den Markt gebracht 

wurde (vgl. euGh centrafarm v. sterling Drug, euGh slg. 1974, 1147). Dies gilt selbst dann, 

wenn der preis des Medikamentes im exportland auf Grund staatlicher Vorgaben reguliert 

und wesentlich niedriger ist als im importland, oder wenn der patentinhaber im exportland 

kein Patent hat, weil er es nicht angemeldet hat, da der entsprechende Schutz zum Zeitpunkt 

der Anmeldung nicht möglich war (vgl. euGh Merck v. stephar, euGh slg. 1981, 2063). 

Für importe von Medikamenten aus den 10 neuen Mitgliedsländern Tschechische republik, 

slowakei, ungarn, polen, slowenien, estland, Lettland und Litauen, sowie Bulgarien und 

rumänien gilt nach den Beitrittsverträgen der so genannte „Besondere Mechanismus“, 

wonach der schutzrechtsinhaber den parallelimport eines erstmalig in einem der genannten 

Länder auf den Markt gebrachten Arzneimittels verhindern kann, wenn das schutzrecht für 

das betreffende Arzneimittel in einem der früheren EU-Staaten zu einem Zeitpunkt beantragt 

wurde, zu dem für dieses ein entsprechender schutz in jenem der 10 neuen Mitgliedstaaten 

noch nicht erlangt werden konnte. 

Für Arzneimittel, die aufgrund einer Zwangslizenz (also ohne Einverständnis des 

schutzrechtsinhabers) in Verkehr gebracht wurden, gilt der erschöpfungsgrundsatz nicht; 

diese Arzneimittel dürfen also – bei entsprechendem patentschutz – nicht parallel importiert 

werden (euGh, pharmon v. hoechst, euGh slg. 1985, 2281); ebensowenig tritt erschöpfung 

ein, wenn den Patentinhaber eine rechtliche Verpflichtung zum Inverkehrbringen im Exportland 

trifft (euGh, Merck v. primecrown, euGh slg. 1996, 6285). 

etwas anders gelagert ist die situation in bezug auf Markenrechte, wenn die produkte 

umverpackt werden. hier gelten zum schutz des Markeninhabers eine reihe von Kriterien 

und Anforderungen. 



Ja. § 11 Nr. 3 patG nimmt von den Wirkungen des patents auch die unmittelbare 

einzelzubereitung von Arzneimitteln in Apotheken auf Grund ärztlicher Verordnung sowie 

handlungen, welche die auf diese Weise zubereiteten Arzneimittel betreffen, aus. 

Auch zu dieser Bestimmung gibt es nur wenig rechtsprechung. Als Ausnahmeregelung 

zu den ansonsten vom Gesetz anerkannten Wirkungen eines Patents wird sie im Zweifel 

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eng auszulegen sein. Bereits entschieden wurde, dass diese Ausnahme die Vorratshaltung 

von Arzneimitteln in einer Apotheke nicht gestattet. erforderlich ist stets eine auf einen 

einzelpatienten bezogene ärztliche Verordnung, aufgrund derer das Arzneimittel in der 

Apotheke zubereitet wird. 




in Deutschland sind heilverfahren nicht patentierbar. 








Grundsätzlich können Zwangslizenzen an einem Patent in Deutschland im Bereich der 

Gesundheitsvorsorge auf vier unterschiedliche Gründe gestützt werden. 

Nach § 24 Abs. 1 PatG kann eine Zwangslizenz an einem Patent erteilt werden, wenn 

dies im öffentlichen interesse erforderlich ist und der patentinhaber sich weigert, eine 

Lizenz zu angemessenen und geschäftsüblichen Bedingungen zu erteilen. Die öffentliche 

Gesundheitsvorsorge ist als öffentliches interesse im sinne des § 24 patG anerkannt. in der 

Praxis spielen Zwangslizenzen nach § 24 PatG bislang kaum eine Rolle, nachdem der BGH in 

der Entscheidung „Polyferon“ aus dem Jahr 1995 die Erteilung einer Zwangslizenz an einen 

Arzneimittelwirkstoff abgelehnt und der Klägerin als Lizenzsucherin die volle Beweislast für das 

öffentliche Interesse an der Zwangslizenz auferlegt hat. Der Kläger hätte nachweisen müssen, 

dass die Lizenz nicht lediglich ein weiteres mehr oder weniger gleichwertiges Medikament 

in einer bestimmten Klasse ermöglicht, sondern eine echte Versorgungslücke schliesst, zum 

Beispiel weil das nur neue präparat problematische Nebenwirkungen der Behandlung 

vermeidet. Weder die Tatsache, dass auf eine neue Verwendung eines patentierten stoffes 

bereits ein Patent erteilt wurde, noch die Zulassung eines neuen Arzneimittels auf der Grundlage 

des patentierten stoffes sind für den Nachweis des öffentlichen interesses ausreichend. seit 

dieser Entscheidung sind keine Verfahren über die Erteilung einer Zwangslizenz mehr bekannt 

geworden. 

Nach § 24 Abs. 2 PatG kann im Fall einer abhängigen Erfindung eine Zwangslizenz auch 

dann erteilt werden, wenn die abhängige Erfindung im Vergleich zu dem früheren Patent 

einen wichtigen technischen Fortschritt von erheblicher wirtschaftlicher Bedeutung darstellt. 

Die Vorschrift wurde 2005 durch das Gesetz zur umsetzung der richtlinie über den rechtlichen 

Schutz biotechnologischer Erfindungen eingefügt. § 24 Abs. 2 PatG betrifft aber alle Arten 

von Erfindungen und wird in seiner Bedeutung § 24 Abs. 1 PatG in Zukunft voraussichtlich 

übertreffen. 

Die Erteilung der Zwangslizenz kann erst nach Erteilung des Patents erfolgen und muss beim 

Bundespatentgericht beantragt werden, das über die Zwangslizenz entscheidet. Ein Antrag 

auf Erteilung einer Zwangslizenz im Hinblick auf schwebende Patentanmeldungen ist also 

nicht möglich. 

Auch in Deutschland ist die Erteilung von Zwangslizenzen an Patenten für Arzneimittel zum 

Zwecke des Exports in Länder mit unzureichender Gesundheitsversorgung auf der Grundlage 

der Verordnung (eG) Nr. 816/2006 vom 17. Mai 2006 möglich. Diese regelung auf 

europäischer ebene entspricht den Vorgaben des neuen Art. 31bis Trips (einzelheiten siehe 

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unten zu Frage 7). Bislang sind in Deutschland ausweislich des öffentlichen registers bei der 

WTO allerdings noch keine Zwangslizenzen auf dieser Grundlage erteilt worden. 

Grössere praktische Bedeutung als die ausdrücklich geregelten Fälle der Zwangslizenz hat 

in Deutschland der Anspruch auf erteilung einer Lizenz an einem patent auf der Grundlage 

des deutschen oder europäischen Kartellrechts. Die kartellrechtliche Zwangslizenz ist von 

den Bedingungen des § 24 patG unabhängig und kann nach der entscheidung „standard- 

Spundfass“ des Bundesgerichtshofes (K ZR 40/02) auch als Verteidigung gegen eine 

patentverletzungsklage vorgebracht werden. Voraussetzung für einen kartellrechtlichen 

Anspruch auf Lizenzerteilung ist, dass die Verweigerung der Lizenz durch den patentinhaber 

nach deutschem oder europäischem Kartellrecht ein wettbewerbswidriges Verhalten, also 

eine ungerechtfertigte Diskriminierung oder einen Missbrauch von Marktmacht, darstellt und 

dass der patentinhaber ein hinreichend konkretes und akzeptables Angebot für den Abschluss 

eines Lizenzvertrages abgelehnt hat. Die Anwendung der kartellrechtlichen Bestimmungen 

setzt allerdings voraus, dass der patentinhaber ein marktbeherrschendes oder marktstarkes 

unternehmen im sinne des Kartellrechts ist. Die Voraussetzungen für eine kartellrechtliche 

Zwangslizenz können insbesondere in Fällen gegeben sein, in denen die Nutzung eines 

patents zur einhaltung eines allgemeinen industriestandards erforderlich ist. 

es ist derzeit noch nicht abschliessend geklärt, ob ein interessent zunächst ein konkretes 

schriftliches Angebot unterbreiten muss, bevor er mit der Nutzung des patents beginnt, 

oder ob er dieses Angebot auch später nachholen kann, falls er vom patentinhaber wegen 

Patentverletzung verklagt wird. Der Einwand auf Erteilung einer Zwangslizenz wurde als 

Verteidigung gegen den Vorwurf der patentverletzung kürzlich in einem Verfahren vor dem 

Landgericht Düsseldorf anerkannt, in der es um patente ging, die zur Nutzung des GsMstandards 

erforderlich sind. in weiteren veröffentlichten entscheidungen wurde der Anspruch 

auf Erteilung einer Zwangslizenz überwiegend abgelehnt oder im Ergebnis offengelassen. 







Der neue Artikel 31bis TRIPS wurde nicht von Deutschland selbst ratifiziert. Dennoch sind seine 

Regelungen in Deutschland bereits geltendes Recht. Ausgangspunkt hierfür ist die Ratifizierung 

von Artikel 31bis Trips am 30. November 2007 durch den präsidenten des rates der 

europäischen union für die europäische Gemeinschaft mit auch für Deutschland verbindlicher 

Wirkung. Ratifiziert wurde hierbei das am 6. Dezember 2005 durch den Allgemeinen Rat 

der WTo in Genf verabschiedete protokoll zur Änderung des Trips-übereinkommens, durch 

das nach Artikel 31 des Trips-übereinkommens ein neuer Artikel 31a (Artikel 31bis) eingefügt 

werden soll. Mit Beschluss vom 19. November 2007 entschied der rat der europäischen 

union, das am 6. Dezember 2005 in Genf unterzeichnete protokoll zur Änderung des Tripsübereinkommens 

im Namen der europäischen Gemeinschaft anzunehmen. Mit inkrafttreten 

des protokolls wird dieses gemäss Artikel 300 Absatz 7 des eG-Vertrags auch für Deutschland 

verbindlich. 

Der Beschluss des Allgemeinen rats der WTo vom 30. August 2003 über die Durchführung 

von Ziffer 6 der Erklärung von Doha („Beschluss“) wurde auf Vorschlag der Europäischen 

Kommission durch die vom europäischen parlament und dem rat der europäischen union am 

17. Mai 2006 erlassene Verordnung (EG) Nr. 816/2006 über Zwangslizenzen für Patente an 

der herstellung von pharmazeutischen erzeugnissen für die Ausfuhr in Länder mit problemen 

im Bereich der öffentlichen Gesundheit („Verordnung“) umgesetzt. Die Verordnung trat am 29. 

Juni 2006 in Kraft. Gemäss Artikel 249 eG-Vertrag ist eine Verordnung in allen ihren Teilen 

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verbindlich und gilt unmittelbar in jedem Mitgliedstaat. sie ist somit auch in Deutschland als 

unmittelbar geltendes recht anzuwenden und zu beachten. 

hintergrund für den erlass einer gemeinschaftsrechtlichen Verordnung war ausweislich 

des erwägungsgrundes (4) der Verordnung die einheitliche umsetzung des Beschlusses 

zur schaffung von in allen Mitgliedstaaten der europäischen Gemeinschaft gleichen 

Voraussetzungen für die Erteilung von Zwangslizenzen für die Herstellung und den Verkauf 

von für die Ausfuhr bestimmten pharmazeutischen erzeugnissen und zur Vermeidung von 

Wettbewerbsverzerrungen für die Wirtschaftsteilnehmer im Binnenmarkt. Die einheitliche 

umsetzung dient zudem der Verhinderung des reimports von pharmazeutischen erzeugnissen, 

die gemäss dem Beschluss des Allgemeinen rats der WTo vom 30. August 2003 hergestellt 

wurden, in das Gebiet der Gemeinschaft. Nach erwägungsgrund (8) der Verordnung muss 

die Erteilung von Zwangslizenzen nach der Verordnung an klare Bedingungen für den 

Lizenznehmer geknüpft werden. Der erwägungsgrund nennt ausdrücklich die mit der Lizenz 

abgedeckten Tätigkeiten, die Identifizierbarkeit der in Lizenz hergestellten pharmazeutischen 

erzeugnisse und die Länder, in die diese erzeugnisse ausgeführt werden. 

Gemäss Artikel 1 der Verordnung schafft diese ein Verfahren zur Erteilung von Zwangslizenzen 

für Patente und ergänzende Schutzzertifikate betreffend die Herstellung und den Verkauf 

von pharmazeutischen erzeugnissen, die für die Ausfuhr in anspruchsberechtigte einführende 

Länder bestimmt sind, die diese erzeugnisse benötigen, um probleme im Bereich der öffentlichen 

Gesundheit bekämpfen zu können. Als „pharmazeutisches erzeugnis“ gelten erzeugnisse des 

pharmazeutischen sektors, einschliesslich Arzneimitteln. Nach der Verordnung sind folgende 

Länder anspruchsberechtigt: 

a) Die am wenigsten entwickelten Länder, die als solche im Verzeichnis der Vereinten 

Nationen aufgeführt sind, 

b) die WTO-Mitglieder, die dem Rat für TRIPS gemeldet haben, dass sie das System 

uneingeschränkt oder eingeschränkt als einführer zu nutzen beabsichtigen, 

c) Nichtmitglieder der WTo, die sich auf der Liste der Länder mit niedrigem einkommen des 

Ausschusses für Entwicklungshilfe der Organisation für wirtschaftliche Zusammenarbeit 

und Entwicklung (OECD) befinden und die der Kommission gemeldet haben, dass sie das 

System uneingeschränkt oder eingeschränkt als Einführer zu nutzen beabsichtigen. 

Nach Artikel 6 der Verordnung kann grundsätzlich jede person Antrag auf erteilung einer 

Zwangslizenz bei den zuständigen Behörden des Mitgliedstaats stellen, in dem das jeweilige 

patent besteht. Der Antragsteller hat gegenüber der zuständigen Behörde unter anderem 

nachzuweisen, dass er sich bemüht hat, die Zustimmung des Rechteinhabers zu erhalten, 

diese Bemühungen jedoch innerhalb eines Zeitraums von 30 Tagen vor Einreichung des 

Antrags auf Erteilung einer Zwangslizenz erfolglos geblieben sind. Diese Anforderung ist 

nach Artikel 9 Absatz 2 der Verordnung nur entbehrlich, wenn eine situation des nationalen 

Notstands, sonstige umstände äusserster Dringlichkeit oder ein Fall nichtkommerzieller 

öffentlicher Nutzung gemäss Artikel 31 lit. (b) des Trips-übereinkommens vorliegt. Gemäss 

Artikel 11 der Verordnung lehnt die zuständige Behörde einen Antrag ab, wenn eine 

der Erteilungsvoraussetzungen nicht vorliegt. Zu den Erteilungsvoraussetzungen gehört 

u.a. die Angabe der Menge, die der Antragsteller im Rahmen der Zwangslizenz von 

dem pharmazeutischen erzeugnis herzustellen gedenkt. hintergrund hierfür ist, dass eine 

Zwangslizenz sich zum Schutz des Rechteinhabers streng auf die vom im Antrag genannten 

einfuhrland benötigten Mengen beschränkt. Die erzeugnisse, die unter der Lizenz hergestellt 

werden, sind durch eine besondere etikettierung oder Markierung klar zu kennzeichnen, 

um sie von jenen aus der herstellung des rechteinhabers unterscheiden zu können. Die 

erteilte Lizenz ist gemäss Artikel 10 Absatz 1 der Verordnung nicht übertragbar und nicht 

ausschliesslich. Zudem ist die Geltungsdauer der Lizenz anzugeben. Gemäss Artikel 10 

Absatz 9 der Verordnung hat der Lizenznehmer dem rechteinhaber eine angemessene 

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Entschädigung zahlen. Die Wiedereinfuhr der aufgrund der Zwangslizenz hergestellten 

und vertriebenen erzeugnisse in das Gebiet der europäischen union ist verboten. im Fall 

der Nichtbeachtung der Lizenzbedingungen durch den Lizenznehmer kann die zuständige 

Behörde die Lizenz entziehen. 

Soweit bekannt, wurde bislang in Deutschland keine Zwangslizenz für den Im- oder Export von 

pharmazeutischen Produkten erteilt. Dies gilt sowohl in Bezug auf das Zwangslizenzverfahren 

nach der Verordnung (eG) Nr. 816/2006 als auch für das nationale, deutsche Verfahren 

nach § 24 patG (dazu auch oben Frage 6). 



Das deutsche patentrecht sieht in § 13 patG den erlass einer Benutzungsanordnung durch 

die Bundesregierung oder eine zuständige oberste Bundesbehörde (oder in deren Auftrag 

einer nachgeordneten stelle) vor. Voraussetzung für eine derartige Benutzungsanordnung 

ist, dass die Erfindung entweder im Interesse der öffentlichen Wohlfahrt oder im Interesse 

der sicherheit des Bundes benutzt werden soll. § 13 patG ermöglicht die Benutzung einer 

patentierten Erfindung auch gegen den Willen des Patentinhabers, wenn ein höherwertiges, 

öffentliches interesse dies gebietet. Das patent selbst bleibt bestehen. 

Die Benutzungsanordnung im interesse der öffentlichen Wohlfahrt ist in § 13 Absatz 1 satz 1 

patG geregelt. Anordnungsbefugt ist allein die Bundesregierung. Die Anordnung erfolgt durch 

Verwaltungsakt, der angeben muss, welche Benutzungsarten oder –handlungen für welche 

Dauer von der Anordnung umfasst sein sollen. Der Begriff der „öffentlichen Wohlfahrt“ ist 

weit auszulegen und umfasst grundsätzlich alle Fälle, in denen gerade staatliche Fürsorge 

notwendig erscheint. Ein typischer Fall ist das Vorliegen eines Notstands wie beispielsweise 

seuchen. Aufgrund des eingriffscharakters der Benutzungsanordnung darf eine solche nur 

erlassen werden, wenn sie notwendig erscheint. Hieran fehlt es, wenn das Ziel auch auf 

andere Weise sicherzustellen ist. Zudem ist vor Erlass einer Benutzungsanordnung – mit 

Ausnahme von eilfällen – eine entsprechende Nachfrage beim patentinhaber bezüglich einer 

Lizenzierung zu fordern. 

Gemäss § 13 Absatz 1 satz 2 patG kann auch eine zuständige oberste Bundesbehörde oder 

in deren Auftrag eine nachgeordnete stelle eine Benutzungsanordnung erteilen, wenn diese 

die Benutzung einer Erfindung im Interesse der Sicherheit des Bundes zum Gegenstand hat. Ein 

interesse der sicherheit des Bundes liegt vor in Fällen der Landesverteidigung gegen von aussen 

oder von innen kommende Angriffe sowie bei sonstigen vergleichbaren schwerwiegenden 

Gefahren für die sicherheit des Bundes wie zum Beispiel dem Katastrophenschutz. 

eine Benutzungsanordnung nach § 13 patG lässt den Bestand des patents unberührt. 

sie bewirkt jedoch, dass die Wirkung des patents im durch die Benutzungsanordnung 

vorgegebenen rahmen eingeschränkt wird. Der umfang der Benutzungsanordnung kann 

einer ausschliesslichen oder einfachen Lizenz entsprechen. Der patentinhaber kann eine 

Benutzung innerhalb dieses rahmens insoweit nicht untersagen. im übrigen bleibt das 

Ausschliesslichkeitsrecht des patentinhabers sowie das Benutzungsrecht von patentinhaber 

und sonstigen Berechtigten unberührt. Die angeordnete Benutzung kann von der regierung 

oder der zuständigen Behörde auch auf – auch private – Dritte übertragen werden, die 

sich jedoch bei der Benutzung ebenfalls innerhalb der Grenzen der Benutzungsanordnung 

halten müssen. Zulässig ist die Benutzung nur zur Förderung der öffentlichen Wohlfahrt 

oder des Sicherheitsinteresses. Eine Nutzung für eigene gewerbliche Zwecke aufgrund 

der Benutzungsanordnung ist unzulässig. Bei erlass der Benutzungsanordnung ist darauf 

zu achten, dass der patentinhaber in möglichst geringem umfang in seinem patentrecht 

beeinträchtigt wird. 

Gemäss § 13 Absatz 3 satz 1 patG hat der patentinhaber im Fall einer rechtmässigen 

Benutzungsanordnung nach Absatz 1 gegen den Bund Anspruch auf angemessene Vergütung, 

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die im Falle einer Benutzungsanordnung im interesse der öffentlichen Wohlfahrt (§ 13 Absatz 

1 satz 1 patG) bereits mit der Anordnung entsteht, bei Anordnung im interesse der sicherheit 

des Bundes (§ 13 Absatz 1 satz 2 patG) erst durch entsprechende Benutzung. 

im Falle eines rechtswidrigen eingriffs in das patent durch eine Benutzungsanordnung, 

die die Vorgaben von § 13 patG nicht einhält, steht dem am patent Berechtigten ein 

entschädigungsanspruch zu, der sich gegen diejenige staatliche stelle richtet, der die Vorteile 

der Rechtsverletzung zugeflossen sind. 


in Deutschland ist das eigentum verfassungsrechtlich gemäss Artikel 14 Absatz 1 satz 1 

Grundgesetz (GG) gewährleistet, wobei inhalt und schranken durch die einfachen Gesetze 

bestimmt werden (Artikel 14 Absatz 1 satz 2 GG). eine enteignung ist gemäss Artikel 14 

Absatz 3 satz 1 GG grundsätzlich nur zum Wohle der Allgemeinheit zulässig und darf 

nur durch ein Gesetz oder aufgrund eines Gesetzes erfolgen, das Art und Ausmass der 

entschädigung regelt. 

Nach einhelliger Meinung stellt das patentrecht „eigentum“ im sinne der Verfassung dar. 

es unterliegt damit der Garantie des Grundgesetzes und ist nach Artikel 14 Absatz 1 GG 

geschützt. Das Bundesverfassungsgericht hat dies höchstrichterlich bestätigt. 

Gemäss Artikel 14 Absatz 3 satz 2 GG ist eine enteignung möglich, sie muss aber entweder 

durch Gesetz oder aufgrund eines Gesetzes erfolgen. Da ein Gesetz einen entsprechenden 

parlamentsbeschluss voraussetzt, kann letztlich nicht die regierung (exekutive), sondern 

nur der Gesetzgeber (Legislative) enteignen. Aufgrund der erheblichkeit des eingriffs in die 

rechtsposition des einzelnen ist die enteignung gemäss Artikel 14 Absatz 3 satz 1 GG nur 

zum Wohle der Allgemeinheit zulässig und muss hierzu auch tatsächlich erforderlich sein, 

d.h., es darf kein milderes Mittel geben, um den Zweck zu erreichen. 

es gibt in Deutschland kein Gesetz, das sich ausdrücklich mit der enteignung von patenten 

befasst. Als Gesetz im sinne von Artikel 14 Absatz 3 satz 2 GG kommen im deutschen 

patentgesetz folgende Vorschriften in Betracht: 

§ 11 PatG (Ausnahmen von der Wirkung des Patents), § 24 PatG (Zwangslizenz), § 50 PatG 

(Geheimhaltungsanordnung) sowie § 13 patG (Benutzungsanordnung). 

in Bezug auf § 11 patG (Ausnahmen von der Wirkung des patents) hat das 

Bundesverfassungsgericht mit Beschluss vom 10. Mai 2000 („Klinische Versuche“) hinsichtlich 

des Versuchsprivilegs des § 11 Nr. 2 patG festgestellt, dass diese regelung keine enteignung, 

sondern eine zulässige Bestimmung des inhalts und der schranken des eigentums im sinne 

von Artikel 14 Absatz 1 satz 2 GG darstellt. 

In Bezug auf § 24 PatG (Zwangslizenz, vgl. dazu oben Frage 6) wird in der Literatur 

angenommen, dass es sich bei dieser regelung um eine einschränkung des durch das 

Grundgesetz geschützten eigentums im sinne einer inhalts- und schrankenbestimmung und 

damit nicht um eine enteignung handelt. hierfür spricht insbesondere, dass § 24 Absatz 1 patG 

die Wahrnehmung des öffentlichen interesses der privatinitiative und privaten risikobereitschaft 

eines Lizenzsuchers überlässt und diesem letztlich nur einen privatrechtlichen Anspruch auf 

Erteilung einer Zwangslizenz durch das Patentgericht gibt. Die Wirkung der Zwangslizenz 

besteht in der einräumung einer einem vertraglichen Lizenznehmer vergleichbaren stellung 

an den Lizenzsucher. 

§ 50 patG (Geheimhaltungsanordnung) sieht eine von Amts wegen vorzunehmende Anordnung 

durch das patentamt des inhalts vor, dass eine patentveröffentlichung in dem Fall zu unterbleiben 

hat, dass ein Patent für eine Erfindung nachgesucht wird, die ein Staatsgeheimnis ist. Bereits 

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mit urteil vom 04. Mai 1972 („Kernenergie“) entschied der BGh zur Vorgängervorschrift 

des § 50 patG, dem (alten) § 30 a patG, dass die Geheimhaltungsanordnung keine 

enteignungsmassnahme darstelle. 

Letztlich wird lediglich die regelung von § 13 patG (Benutzungsanordnung) in der Literatur 

als zumindest enteignungsähnliche regelung angesehen. sie wird bezeichnet als eine im 

pflichtmässigen Ermessen der Bundesregierung bzw. der zuständigen obersten Bundesbehörde 

stehende hoheitliche Massnahme enteignungsähnlichen charakters. Die Anordnung der 

Bundesregierung wird auch nach den Gesetz wie eine enteignungsmassnahme behandelt, 

sie erfolgt nur gegen eine angemessene entschädigung. 

Die Voraussetzungen für die erteilung einer Benutzungsanordnung gemäss § 13 patG sind 

bereits unter Frage 8 dargestellt. 

Grundsätzlich kann unter Beachtung der verfassungsrechtlichen Voraussetzungen, 

insbesondere des Artikels 14 GG, neben den dargestellten regelungen eine enteignung 

durch Gesetz vorgenommen werden. Angesichts der erwähnten, bereits zur Verfügung 

stehenden Möglichkeiten sind überlegungen bezüglich zusätzlicher enteignender Gesetze 

auf dem Gebiet des patentrechts aber wohl eher theoretischer Natur. 






solche Verfahren bzw. Mittel sind im deutschen patentgesetz nicht vorgesehen. 




Das deutsche patentgesetz sieht in § 11 Nr. 2 patG bereits seit über 15 Jahren ein 

Versuchsprivileg vor. Darüber hinaus stellt sich jedoch die Frage, welche „handlungen zu 

Versuchszwecken“ dem Versuchsprivileg unterfallen. Diese Frage wurde bislang noch nicht 

abschliessend gerichtlich entschieden. Die hohe praktische relevanz zeigt sich vor allem 

im Bereich der Generika, da Konkurrenzunternehmen mit generischen pharmazeutika 

nach Auslaufen der patentlaufzeit erst in den Markt eintreten können, wenn sie eine 

umfangreiche Anzahl von Vorbereitungshandlungen vorgenommen haben. Dazu werden 

beispielsweise der import, die herstellung und der Transport von im Versuch verwendeten 

stoffen oder Vorrichtungen gezählt und unter umständen auch die Lieferung von rohstoffen 

oder Komponenten, mit denen die stoffe bzw. Vorrichtungen erst noch hergestellt werden 

sollen. Auch nach einführung des Bolar-Versuchsprivilegs (siehe nachfolgend) besteht hier 

noch Klärungsbedarf und damit eine gewisse rechtsunsicherheit. 


Die einführung eines Bolar-Versuchsprivilegs in Deutschland wurde – besonders von der 

generischen pharmazeutischen industrie – seit langem gefordert und war nach dem 

inkrafttreten der richtlinie 2004/27/eG notwendig. sie führt insgesamt zu einer grösseren 

rechtssicherheit im Bereich der klinischen Versuche mit Arzneimitteln in Deutschland und 

sollte daher im prinzip die Durchführung solcher Versuche in Deutschland tendenziell 

erleichtern. Damit hat auch die seit langem offene Frage nach den Grenzen des 

klassischen Versuchsprivilegs bei Versuchen mit generischen Arzneimitteln viel von ihrer 

Brisanz verloren. 

insgesamt verschiebt die einführung des Bolar-Versuchsprivilegs die (rechtlichen) 

spielräume etwas zugunsten der Generika-hersteller. Der europäische und deutsche 

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Gesetzgeber erhoffte sich dadurch eine stimulierung des Wettbewerbs und ein rascheres 

inverkehrbringen „neuer“ kostengünstiger Arzneimittel. ob das Bolar-Versuchsprivileg 

diesen erwartungen freilich gerecht werden wird, bleibt wohl abzuwarten. 

Dennoch erscheint die (harmonisierte) einführung eines solchen Versuchsprivilegs zur 

Förderung der Volksgesundheit und stimulierung des Wettbewerbs auf dem Gebiet der 

Arzneimittel insgesamt mehr Vor- als Nachteile mit sich zu bringen. es erscheint auch 

sinnvoll, das Bolar-Versuchsprivileg nicht auf Generika zu beschränken, da Versuche mit 

patentgeschützten innovativen Wirkstoffen oftmals neue und nützliche resultate für die 

Volksgesundheit erbringen dürften und daher auch durch die Gesetzgebung gefördert 

bzw. zumindest nicht behindert werden sollten. 


im hinblick auf die bestehende rechtslage (entscheidungen des euGh und Besonderer 

Mechanismus für eu Beitrittsländer) erscheint hier kein Bedarf einer regulierung des 

parallelimports von Medikamenten durch das patentgesetz. 


Die unmittelbare einzelzubereitung von Arzneimitteln in Apotheken wird ebenfalls nicht 

von den Wirkungen des patents erfasst. Diese Ausnahme von den Wirkungen des patents 

hat aber in der praxis so gut wie keine Bedeutung und erscheint auch nicht für die 

Belange der Volksgesundheit oder für den kostengünstigen Zugang zu Arzneimitteln 

erforderlich zu sein. Wahrscheinlich würde es kaum jemandem auffallen, wenn diese 

Vorschrift ersatzlos gestrichen würde. 


Nachdem heilverfahren nach deutschem recht nicht patentierbar sind, bedarf es keines 

derartigen schutzmechanismusses. 


Im Bereich der Arzneimittel und der Medizinprodukte sollte die Frage der Zwangslizenz 

nach § 24 patG geklärt werden, bevor in die entwicklung eines neuen produkts investiert 

wird. 

Eine Zwangslizenz kann derzeit nur für ein erteiltes Patent verlangt werden, nicht im 

hinblick auf eine schwebende patentanmeldung. Für ein neues Arzneimittel kann ein 

Zwangslizenzverfahren auch erst dann mit Aussicht auf Erfolg betrieben werden, wenn 

bereits klinische Daten vorliegen, die den besonderen Wert des neuen Arzneimittels im 

Vergleich zu bereits erhältlichen produkten belegen. Ausserdem kann der patentinhaber 

die Erteilung einer Zwangslizenz verzögern oder verhindern, in dem er beispielsweise 

selbst ein Konkurrenzprodukt zu dem geplanten neuen produkt entwickelt, bevor über 

die Erteilung der Zwangslizenz entschieden wird, oder indem er Teilanmeldungen aus 

einer patentanmeldung abzweigt, deren prüfung erst nach erteilung des stammpatents 

erfolgt. 

Damit kommt die Zwangslizenz für potentielle Interessenten regelmässig zu spät. Zwar sind 

entwicklungsarbeiten und klinische Versuche unter dem Versuchsprivileg grundsätzlich 

ohne Zwangslizenz möglich. Kaum einer wird aber die hohen Investitionen für ein neues 

Arzneimittel in Kauf nehmen, wenn er nicht sicher sein kann, dass er das neue produkt 

später nicht auch vermarkten kann. 

Für die Interessenten an einer Zwangslizenz wäre es daher vorteilhaft, eine Klärung 

herbeizuführen, bevor investitionen in die entwicklung eines neuen produkts getätigt 

werden. 

Grundsätzlich ist die Möglichkeit einer „Zwangslizenz für Patente an der Herstellung 

von pharmazeutischen erzeugnissen für die Ausfuhr in Länder mit problemen im Bereich 

der öffentlichen Gesundheit“ (so der Titel der Verordnung (eG) 816/2006 im interesse 

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der armen Länder sowie die hierdurch erfolgte relativ rasche umsetzung des neuen 

Artikel 31bis Trips durch den Gemeinschaftsgesetzgeber sehr zu begrüssen. Das 

durch die Verordnung vorgesehene Verfahren scheint jedoch nicht für eine schnelle, 

unbürokratische unterstützung, insbesondere in Krisenzeiten, geeignet. Wünschenswert 

wären beispielsweise zeitliche Vorgaben, innerhalb derer die zuständigen Behörden 

der Mitgliedstaaten über einen Antrag auf Erteilung einer Zwangslizenz zu entscheiden 

haben. Derartige Vorgaben sieht die Verordnung in Bezug auf die zollbehördlichen 

Massnahmen nach Artikel 14 der Verordnung vor: Bei dem Verdacht auf nach der 

Verordnung unzulässige Reimporte von unter Zwangslizenz hergestellter Erzeugnisse in 

das Gemeinschaftsgebiet darf die behördliche überprüfung sowie die hiermit verbundene 

Zurückhaltung der Ware höchstens zehn Arbeitstage betragen. 

soweit ersichtlich, hat der deutsche Gesetzgeber noch keine regelungen zum Vollzug 

der Verordnung, insbesondere in Bezug auf das für die Erteilung einer Zwangslizenz 

durchzuführende Verfahren vor den nationalen Behörden, getroffen. schon um die 

Durchsetzbarkeit der rechte nach Artikel 31bis Trips nicht unnötig zu erschweren, wäre 

eine möglichst rasche Anpassung bzw. ergänzung der deutschen (patentrechtlichen) 

Vorschriften durch den Gesetzgeber erforderlich. 


Insbesondere mit den Regelungen bezüglich der Erteilung von Zwangslizenzen (§ 24 

patG) sowie der Benutzungsanordnung (§ 13 patG) sieht das deutsche patentrecht 

bereits heute Möglichkeiten einer Benutzung von erteilten patenten gegen den Willen 

des Patentinhabers durch den Staat und/oder private Dritte vor, die flexible, auf den 

Einzelfall zugeschnittene Lösungen im Rahmen des verfassungsrechtlich Zulässigen 

erlauben. Angesichts der Tatsache, dass enteignungen nach Artikel 14 Absatz 3 satz 1 

des deutschen Grundgesetzes ohnehin nur zum Wohle der Allgemeinheit zulässig sind 

und angesichts der hiermit verbundenen gravierenden Folgen für den rechteinhaber nur 

in Betracht gezogen werden dürfen, wenn keine anderen, milderen Mittel zur Verfügung 

stehen, sind kaum Fälle denkbar, die darüber hinausgehende, zusätzliche regelungen 

diesbezüglich im deutschen patentrecht erfordern würden. 



vorsehen? 

über die in Deutschland und in der europäischen union gesetzgeberisch realisierten 

Beschränkungen der exklusivrechte hinaus erscheinen keine weiteren einschränkungen 

erforderlich oder sinnvoll. es gilt sich zu vergegenwärtigen, dass gerade wirkungsvoller 

patentschutz essentiell für die forschende pharmazeutische industrie ist und daher auch 

im sinne des therapeutischen Fortschritts und der Volksgesundheit ein hohes Gut darstellt, 

das nicht leichtfertig aufs spiel gesetzt werden sollte. 



könnte? 

hier kann zunächst auf die vorstehenden Ausführungen im vorangegangenen Absatz 

verwiesen werden. 

Daneben könnte das Patentrecht auch durch Ausschluss bestimmter Erfindungen von der 

Patentierbarkeit Zugang zu Arzneimitteln etc. erleichtern. Dieser Gedanke steht hinter dem 

Ausschluss von heil- und Diagnoseverfahren am menschlichen und tierischen Körper im 

europäischen und deutschen patentrecht (Art. 53 c epü 2000, § 5 patG). 

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eine globale harmonisierung der patentgesetze und der rechtlichen Voraussetzungen 

für geschäftliches handeln im Wettbewerb erscheint im prinzip schon aus Gründen der 

rechtlichen chancengleichheit stets wünschenswert. Wenig sinnvoll und zielführend dürfte 

es allerdings sein, nur die Ausnahmen von den Wirkungen eines patents zu harmonisieren 

und nicht zugleich auch die Wirkungen selbst sowie die Voraussetzungen für den erhalt von 

patentschutz. 

Das Bolar-Versuchsprivileg existiert zwar als Ausfluss der Richtlinie 2004/27/EG in allen 

eu-staaten, so dass man insoweit von „harmonisiertem recht“ sprechen kann. Allerdings 

divergieren die einzelstaatlichen umsetzungen dieser richtlinie insoweit erstaunlich und 

reichen von einer 1:1 buchstabengetreuen umsetzung von Art. 10(6) der richtlinie bis zu einer 

starken erweiterung des Bolar-privilegs wie beispielsweise in Deutschland und italien. ob das 

im sinne der schaffung eines gemeinsamen Binnenmarktes und rechtsraums innerhalb der 

eu war und ist, darf mit Fug und recht bezweifelt werden. Allerdings gibt es auf anderen 

Gebieten sicherlich noch wesentlich grösseren harmonisierungsbedarf. 

Summary 

in view of the public interest German law provides for certain restrictions of the exclusive patent 

rights of a patentee. Firstly the experimental use exemption enables the aimed further development 

of research and development, with the Bolar exemption also considering experiments focusing 

a commercial exploitation. Moreover parallel imports within the eeA and exemptions in case of 

individual prescriptions are legal. Theoretically compulsory licenses can be granted, if any, which 

do, however, not yet really play a role. In this regard the provisions of Article 31bis TRIPS are 

already applicable law in Germany. The legislator has, however, not yet set any rules for their 

enforcement. 

These restrictions of exclusive patent rights do not constitute an expropriation of patent rights which 

are property constitutionally guaranteed by the German Basic Constitutional Law. Only the order 

of use entitling to a use of a patented invention against the patentee’s will is a drastic encroachment 

on the rights of a patentee. however, in practice an order of use has never been rendered. 

A global harmonization of the patent laws and their exemptions from the effect of the patent is 

desirable according to the opinion of the German National Group. 

Résumé 

Dans un souci d’intérêt public, le droit allemand prévoit certaines restrictions aux droits de 

brevet exclusifs d’un breveté. D’une part l’exception d’une utilisation à titre expérimental permet 

l’évolution souhaitée de la recherche et du développement et l’exception Bolar tient également 

compte des expérimentations faites en vue d’une exploitation commerciale. en outre, sont légales 

des importations parallèles au sein de L’eee ainsi que les exceptions liées à des prescriptions 

individuelles. en théorie, peuvent également être concédées des licences obligatoires qui ne jouent 

cependant qu’un rôle mineur jusqu’ici. Dans ce contexte les dispositions de l’article 31bis ADpic 

sont des dispositions légales déjà en vigueur en Allemagne. Mais le législateur n’a pas encore mise 

en place une réglementation d’application de ces dispositions. 

ces restrictions aux droits de brevet exclusifs ne représentant toutefois pas une privation des droits 

de brevet qui, en tant que droits de propriété, sont garantis par la constitution allemande. seule 

l’arrêté d’utilisation qui permet l’utilisation d’une invention brevetée contre la volonté du breveté 

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constitue une atteinte profonde aux droits du breveté. en pratique un tel arrêté d’utilisation n’a 

toutefois encore jamais édicté. 

une harmonisation globale des lois relatifs aux brevets et des exceptions des effets des brevets 

apparaît souhaitable selon le Groupe Allemand. 


im sinne eines öffentlichen interesses sind nach deutschem recht gewisse einschränkungen der 

exklusiven Patentrechte eines Patentinhabers vorgesehen. Zum einen ermöglicht das Versuchsprivileg 

die erstrebte Fortentwicklung von Forschung und entwicklung, wobei die Bolar-Ausnahme zudem 

Versuche berücksichtigt, die auf eine kommerzielle Verwertung hin abzielen. Darüber hinaus sind 

Parallelimporte innerhalb des eWr und Ausnahmen bei individuellen Verschreibungen legal. 

Theoretischerweise können ebenfalls Zwangslizenzen erteilt werden, die bisher jedoch kaum 

eine Rolle spielen. In diesem Zusammenhang sind die Regelungen des Artikels 31bis Trips in 

Deutschland bereits geltendes recht. Der Gesetzgeber hat aber noch keine regelungen zu seinem 

Vollzug vorgegeben. 

Diese einschränkungen der exklusiven patentrechte stellen keine Enteignung des patentrechts 

dar, welches als eigentum im Grundgesetz verfassungsrechtlich gewährleistet ist. Lediglich die 

Benutzungsanordnung, die das Benutzen einer patentierten Erfindung gegen den Willen des 

patentinhabers ermöglicht, ist ein tiefgreifender eingriff in die rechte eines patentinhabers. in der 

praxis wurde eine Benutzungsanordnung aber noch nie erlassen. 

eine globale harmonisierung der patentgesetze und deren Ausnahmen von der Wirkung des 

patents ist nach Auffassung der Deutschen Landesgruppe wünschenswert. 

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159-172_Q202_Germany_DE.indd 172 17.07.2009 10:18:04

Questions 

Hungary 

Hongrie 

Ungarn 

Report Q202 

in the name of the Hungarian Group 

by Zsófia LENDVAI, Zoltán KOVÁRI, Attila MÁNDI, Imre MOLNÁR, 

Éva SOMFAI and Eszter SZAKÁCS 






According to Art. 19(6)(a) of the Hungarian Patent Act (Act No. XXXIII of 1995, hereinafter 

referred to as “Patent Act”) “the exclusive right of exploitation shall not extend to acts 

performed for the purpose of private use, or being outside the sphere of economic activities”. 

Therefore, any acts which are performed either for private purpose or outside the sphere of 

economic activities are stipulated as an exemption from the scope of patent protection. So, 

pursuant to this provision any activity, thus also the research activity is allowed if it is for noncommercial 

purposes. 

A specific research exception is provided for as a Bolar-type exception. See our answer to 

the question No. 2. 






exception? 

The Bolar-type exception with a specific reference to pharmaceutical products was introduced 

into the Hungarian patent law as the present Patent Act was codified in 1995. According 

to the original (1995) wording of Art. 19(6)(b) of the Patent Act: “The exclusive right of 

exploitation shall not extend to […] acts for experimental purposes relating to the subject 

matter of the invention, including experiments and tests necessary for the authorization of the 

marketing of pharmaceuticals” 

After the ratification of the TRIPS-Agreement this provision of the Patent Act had been made 

product neutral by an amendment of the Patent Act in 2001. Since then Art. 19(6)(b) reads 

as follows: “The exclusive right of exploitation shall not extend to […] acts for experimental 

purposes relating to the subject matter of the invention, including experiments and tests 

necessary for the authorization of the marketing of a product being the subject matter of 

the invention or a product that is produced by the process being the subject matter of the 

invention”. 

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A drug-specific form of the same provision exists in connection with the registration of generic 

medicines in Art. 7(9) of the Decree of the Health Minister No. 52/2005 (XI. 18.) on the 

Registration of Medicinal Products for Human Use. 




Parallel import of patented medicines, etc. is not allowed unless they originate from the 

territory of the European Economic Area. According to Art. 20 of the Patent Act “the exclusive 

right of exploitation pursuant to the patent protection shall not cover further acts related to a 

product marketed within the European Economic Area by the holder of the patent or with his 

express consent, unless the holder of the patent has rightful interest in opposing the further 

marketing of the product.” 

Thus, parallel imports are only allowed from within the European Economic Area if within this 

territory the product had been marketed by the patent owner or with his explicit consent. Even 

this general permission is limited by the last part of Art. 20. 

The Decree of the Minister for Health, Social and Family Affairs No. 53/2004 (VI. 2.) on 

the Wholesale and Parallel Import of Pharmaceutical Products provides for the regulatory 

requirements for parallel import. 

According to Art. 33(2) of the Patent Act the compulsory license – in accordance with Art. 31(f) 

of the TRIPS-Agreement – the scope of the compulsory license shall be limited predominantly 

for satisfaction of the domestic need, which constitutes a territorial limit to the license. Since 

no precedent exists in Hungary, according to the authors of the present report, in view of the 

ECJ judgement in the case Pharmon v. Hoechst this would mean that products made under 

a compulsory license do not exhaust the rights of a patent holder, because the patent holder 

has not given his consent, thus within the European Economic Area no parallel import is 

possible for a product which was manufactured under a compulsory license. 

Since Hungary is a Member State of the European Union in cases of compulsory licenses 

of patents relating to the manufacture of pharmaceutical products for export to countries 

with public health problems, the relevant EC Regulation No. 816/2006/EC states “that the 

import into the Community of products manufactured under a compulsory licence […] shall 

be prohibited” [Art. 13(1)]. 


conditions? 

Individual prescriptions are recognized among the exceptions from the exclusive right granted 

by a patent. According to Art. 19(6)(c) of the Patent Act the exclusive right of exploitation 

shall not extend to “the preparation for individual cases, in a pharmacy, of a medicine in 

accordance with a medical prescription, or acts concerning the medicine so prepared.” 




Does not apply. 






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According to the Hungarian Patent Act there are three grounds upon which a compulsory 

license can be granted: for lack of exploitation, in case of dependent patents and for export 

to countries with public health problems. 

Lack of exploitation: Art. 31 of the Patent Act: “If within four years from the date of 

filing of the patent application or within three years from the grant of the patent, whichever 

period expires last, the patentee has not exploited the invention in the territory of the country 

to satisfy the domestic demand or if he has not undertaken serious preparations for such 

purpose, or has not granted a license to others, a compulsory license shall be granted to the 

applicant for the license, unless the patentee justifies its failure to act.” 

It has to be remarked that according to Art. 19(2)(a) of the Patent Act importation is regarded 

as one of the forms of exploitation of patent rights. 

Dependent patents: Art. 32(1) of the Patent Act: „If the patented invention cannot be 

exploited without infringing another patent (hereinafter referred to as “the dominant patent”), 

a compulsory license for the exploitation of the dominant patent shall be granted, on request 

and to the extent necessary, to the holder of the dependent patent, provided that the invention 

according to the dependent patent involves an important technical advance of considerable 

economic significance in relation to the invention according to the dominant patent.” 

Compulsory licenses for lack of exploitation and in case of dependent patents are in the 

competence of the Metropolitan Court of Budapest. 

Export to countries with public health problems: according to Regulation (EC) 

No. 816/2006 of the Parliament and of the Council of 17 May 2006 on compulsory licensing 

of patents relating to the manufacture of pharmaceutical products for export to countries with 

public health problems and in accordance with Art. 33/A of the Patent Act providing for the 

necessary execution rules, the Hungarian Patent Office may grant a compulsory license in 

such cases. 

In the last ten years no case has been known where a compulsory license was granted. 






The answer to all of these questions is no. As stated above, Regulation (EC) No. 816/2006 

referred to by Art. 33/A(1) of the Patent Act, is directly applicable. 



Art. 53(5) of the Patent Act stipulates as follows: „The President of the Hungarian Patent Office 

may order, at the request of the competent Minister and in the interest of national defense 

or on the basis of an international treaty, that a patent application be dealt with as a State 

secret. In such case, publication of the application and printing of the specification shall be 

waived.” This provision was introduced into the Patent Act as a consequence of the accession 

to the Agreement for the mutual safeguarding of secrecy of inventions relating to defense and 

for which applications for patents have been made. Nevertheless, this provision does not 

make it possible for the government to use a patented invention without any license. 

Theoretically, the state or the government as an entity with legal personality is not excluded 

from applying for a compulsory license under Art. 31 of the Patent Act referred to above. We 

are not aware of any case with this issue. 

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Regarding patents, there is no specific provision in the Hungarian law that would permit 

expropriation. 

The Decision No. 1338/B/1992 of the Hungarian Constitutional Court has extended the 

rights to property as set forth in Art. 13 of the Constitution of the Republic of Hungary 

(Act No. XX of 1949 as amended) to patent rights as well. According to Art. 13(2) of the 

Constitution expropriation of property shall only be permitted in exceptional cases, when 

such action is in the public interest, and only in such cases and in the manner stipulated by 

law, with the provision of a full, unconditional and immediate compensation. 





The question does not apply in Hungary. 













The Hungarian Group is of the opinion that the provisions of the present Hungarian law 

regarding the above issues are appropriate. 



The Hungarian Group any other ways for facilitating the access to the subject matters 

protected by patent law. 




We think that this question should only be considered in merits as part of a full harmonisation 

of substantive patent law. 

Summary 

Hungarian patent law provides for a right balance between the interest of public access to 

medicines and the patent owner’s exclusive rights. Thus the main exceptions allowing under certain 

circumstances easier access to medicine – such as the research and experimental exception, the 

Bolar-exception, the parallel import, the individual prescription exception, the compulsory licensing 

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– are part of Hungarian patent law, either historically, or as a consequence of Hungary’s accession 

to the TRIPS-Agreement or as a consequence of being one the Member States of the European Union. 

At the same time, however, credit is also given to the patent owners’ interests: thus patent right was 

recognised as a property right by the Hungarian Constitutional Court giving it the constitutional 

protection of property. In the opinion of the Hungarian Group the introduction of further exceptions 

could harm this balance and is therefore unnecessary. 

Résumé 

Le droit de brevet en Hongrie prévoit un équilibre correct entre l’intérêt de l’accès public aux 

médicaments et les droits exclusifs du propriétaire de brevet. Par conséquent, les exceptions 

principales – comme l’exception expérimentale et l’exception de recherche, l’exception Bolar, 

l’importation parallèle, l’exception de la prescription individuelle, la licence obligatoire – qui, dans 

certaines conditions, permettent un accès facilité aux médicaments, font partie du droit de brevet 

hongrois, soit pour des raisons historiques, soit à la suite de l’adhésion de la Hongrie à l’accord 

TRIPS, ou parce que la Hongrie est membre de l’Union européenne. D’autre part, l’intérêt du 

propriétaire de brevet est également pris en compte: ainsi, le droit au brevet a été reconnu par la Cour 

constitutionnelle hongroise comme droit de propriété, lui accordant la protection constitutionnelle 

de la propriété. Selon l’équipe hongroise, l’introduction d’exceptions supplémentaires pourrait 

nuire à cet équilibre, et pour cette raison, elle est inutile. 


Ungarisches Patentrecht sorgt für eine richtige Balance zwischen den Interessen von öffentlichem 

Zugang zu Medikamenten und den ausschliesslichen Rechten der Patentinhaber. So sind die 

wichtigsten Ausnahmen, die unter bestimmten Umständen leichteren Zugang zu Medikamenten 

sichern – wie die Ausnahme zur Benutzung zu Forschungs- und Versuchszwecken, die Bolar-Ausnahme, 

Parallelimport, die Ausnahme für individuelle Verschreibungen und die Zwangslizensierung – teil 

des ungarischen Patentrechts entweder historisch, oder als Folge des Beitritts Ungarns zum TRIPS- 

Übereinkommen oder weil Ungarn ein Mitgliedstaat der Europäischen Union ist. Gleichzeitig aber 

wird auch den Interessen der Patentinhaber Rechnung getragen: das ungarische Verfassungsgericht 

hat den Begriff des verfassungsrechtlichen Eigentumsrecht auf das Patentrecht erweitert, wodurch 

Patenten der verfassungsrechtliche Schutz des Eigentums zukommt. Nach Meinung der ungarischen 

Landesgruppe könnte die Einführung weiterer Ausnahmen diesem Gleichgewicht schaden und ist 

daher nicht von Nöten. 

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Questions 

Indonesia 

Indonésie 

Indonesien 

Report Q202 

in the name of the Indonesian Group 






Yes, exception for research, experimental use, education or analysis is recognized under our 

patent law. The above exception is applicable under the condition that it does not violate 

normal interest of the patent holder [Article 16]. The Elucidation of Article 16 explains 

that the scope of the research exception merely covers research and education including 

bioequivalent experiments or other forms of experiments. The exception does not cover 

commercial exploitation of a patent. 






exception? 

Yes, we do have Bolar-type exception under our patent law. Article 135 (b) stipulates that it 

is exempted from criminal provisions to produce patented pharmaceutical product within two 

years prior to the expiry of the patent with the purpose to process market permit. It is clear 

from this provision that the Bolar exception only covers pharmaceutical products. 




Yes, Article 135 (a) stipulates that it is exempted from criminal provisions to import a patented 

pharmaceutical product if the product has been marketed in a country by the patent holder 

and the importation is conducted in accordance with the prevailing laws. 


conditions? 

No, there is no provision under our patent law which regulates this matter. 

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Methods of medical treatment are not patentable under our patent law. 






Yes, compulsory licenses are available under our patent law. Compulsory licenses can be 

granted under any of the following conditions: 

a) if the patent has not been used within 36 months from the grant date of the patent (non 

use); 

b) if the patent has been implemented in a manner that contravenes the public interests; 

c) if a patent holder can not implement his patent without violating another existing patent 

(cross-license); and 

d) if the Government considers that a patent is very important for the conduct of defense 

and security and for an urgent need of public interest. 






– Yes. 

– Not yet. 



Not allowed. 


There is no provision under our patent law which allows the Government to expropriate a 

patent. The Government can only exploit the patent by giving royalty to the patent holder. The 

conditions for such exploitation can be seen in the above answer of point 6.d. 





Not yet. 




(Article 16 (3)). 

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(Article 135 (b)). 


(Article 135 (a)). 


(Not yet). 


(Not applicable as medical treatment is unpatentable under our patent law). 


(See point I.6). 


(Not yet). 



(Not yet). 




Not available. 




Yes, by balancing the cost if R & D and the profit of selling the patentee’s medicine. 

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Questions 

Ireland 

Irlande 

Irland 

Report Q202 

in the name of the Irish Group 

by Anne RYAN and David O’CONNOR 






Under Section 42(b) of the Irish Patents Act, 1992, the rights conferred by a patent shall not 

extend to acts done for experimental purposes relating to the subject-matter of the relevant 

patented invention. 

However, no guidance was provided in Irish legislation as to what exactly constitutes 

“experimental use”. Accordingly, we would look to the case law for guidance in this regard. 

There is little case law in Ireland in the area of patents and the Irish Courts would be guided 

by the decisions of the English courts in this regard. 

In the United Kingdom a narrow construction of the experimental use exemption has traditionally 

been preferred. For example, the Court of Appeal in Monsanto v Stauffer (1984) indicated 

that clinical trials aimed at obtaining regulatory approval constituted patent infringement. 

In Smith Kline & French -v- Evans Medical Limited, the Court held that experiments carried out 

with a commercial end in view may be covered provided that the purpose of the experiments 

had to relate to the subject-matter in suit in the sense of having a real and direct connection 

with the subject-matter. Thus, in this case the Court held that experiments on material covered 

by a patent were not being carried out to investigate the invention of that patent but for the 

purposes of litigation in order to invalidate the patent and their acts did not fall under the 

“experimental use” exemption. 

The German courts, on the other hand, in Clinical Trials I and Clinical Trials II (1994) held that 

tests whose aim is to yield new knowledge on the patented subject matter are non-infringing 

even where they have a collateral commercial purpose. 

There is one major exception to the experimental use exemption under Irish law, namely the 

Bolar type exemption. 

Like Ireland, most Member States of the EU exempt “experimental uses” of patents from patent 

infringement suits. As indicated above, the Member States adopted different interpretations 

of “experimental use” and accordingly the position in relation to undertaking tests and trials 

for the purpose of obtaining a future marketing authorisation differs across the EU. 

The EU introduced Community-wide Bolar exemptions under Directive 2004/27/EC (with 

respect to medicinal products for human use) and Directive 2004/28/EC (with respect to 

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veterinary medicinal products), which were implemented by all Member States on October 

30, 2005. 

Statutory Instrument No. 50 of 2006 gives effect to Directive 2004/27/EC and involved 

insertion of a new subsection (g) into Section 42 of the Patents Act 1992, which reads as 

follows: 

The rights conferred by a patent shall not extend to: 

g) acts done relating to the subject matter of the relevant patented invention which consist 

of: 

i) acts done in conducting the studies, tests and trials which are necessary for and are 

conducted with a view to satisfying the application requirements under Community 

law for a marketing authorization for a medicinal product for human use; or 

ii) acts done in conducting the studies, tests and trials which are necessary for and are 

conducted with a view to satisfying the application requirements under Community 

law for a marketing authorization for a medicinal product for human use; or 

iii) any other act which is required as a consequence of the acts referred to in 

subparagraph (i) or (ii) for the purposes specified in those subparagraphs, as 

appropriate. 

The key point to note about this new exemption is that it only applies to experimental activities 

carried out by generic manufacturers with a view to obtaining a marketing authorisation 

for a generic drug. It does not entitle innovative companies to make experimental uses of 

patented medicines or research tools for the purpose of seeking a marketing authorisation 

for a new medicinal product. As the existing experimental use exception under section 

42(b) of the Patents Act 1992 is generally viewed as excluding experimental uses that have 

a commercial purpose, innovative pharmaceutical companies based in Ireland are being 

placed in an anomalous position: generic companies will be able to conduct experiments and 

trials necessary for obtaining marketing authorisation of generic medicines, but innovative 

companies will probably not have the same entitlement with respect to their new drugs. 






exception? 

Answered in Question 1 above. 




The parallel importation of patented medicines, medical devices and such is permitted in 

Ireland in accordance with the Community Treaty. In order to fulfil the aims of the E.U. “single 

market”, the ECJ has adopted what has come to be called the “exhaustion of rights” doctrine 

applied under what are now Articles 28 and 30 of the Community Treaty. Under this doctrine, 

the first marketing within the European Economic Area (EEA) of a product protected anywhere 

within the E.U. by an industrial property right “exhausts” that industrial property right, not only 

in the country of first sale, but also in any other country within the EEA, provided that such 

first marketing was carried out by the holder of that right or with his consent, either express 

or implied. 

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Simply put, this doctrine means that patent rights cannot be used to prevent the import of 

goods which have been marketed by the patentee or with his consent in another Member 

State. 

The “exhaustion of rights” doctrine relies heavily upon the first sale having been made either 

by the rights holder or with his consent, express or implied. Thus, in Pharmon-v-Hoechst, 

where the first sale arose under a United Kingdom compulsory licence, the ECJ held that the 

product was not put on the market with the patentee’s consent, so that infringement action 

could be brought under a parallel patent. 

Likewise, where patents exist in some, but not all, E.U. States and the patentee has deliberately 

not granted licences under those patents, although a general know-how licence may have 

been granted, there is no exhaustion of right when goods manufactured under the knowhow 

licence are imported into a State where no patent licence was granted, again because 

consent cannot exist where a licence had not been given. Nor is a refusal to license patents 

in itself a breach of Articles 81 and 82 (anti-competition) of the Community Treaty unless that 

is an aspect of an overall anti-competitive conduct, see Sandvik-v-Pfiffner. 

In Allen & Hanbury-v-Generics, the “licence of right” provisions of Section 46 of the U.K. 

Patents Act, 1977, were considered equivalent to the grant of compulsory licences, the 

“licence of right” endorsement had in this case been made involuntarily. The position could 

be different if the patentee elects so to endorse his patent. 


conditions? 

Under Section 42(c) of the Irish Patents Act, 1992, no infringement arises where there is 

extemporaneous preparation of a medicine in a pharmacy for individual cases where such is 

in accordance with a medical prescription issued by a registered medical practitioner or acts 

concerning the medicine so prepared. 

This provision excludes the extemporaneous preparation in a pharmacy of medicine for an 

individual to a prescription by a registered medical practitioner or dentist. “Extemporaneous” 

is not defined, but may be taken as meaning as and when required, so that medicines 

prepared for stock in advance of a specific need therefor arising are probably not exempt; 

and, in any case, the preparation must be “for an individual”. It would appear that veterinary 

preparations are not exempted by the provision as such a preparation would not be provided 

for an individual, this presumably meaning a human being, nor would it be provided by 

a “medical or dental practitioner”, at least by a person practicing as such. Anyway, it is 

currently rare for a pharmacy itself to prepare a medicine since medicinal products are 

normally supplied to the pharmacy in a pre-packed condition. Thus, the acts exempted under 

the provision are probably of little consequence. 










Under Section 70(1) of the Irish Patents Act, 1992, and as amended by the Patents Amendment 

Act, 2006, at any time after the expiration of the period of three years, or such other period 

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as may be prescribed, beginning on the date of the publication of notice of grant of a patent 

any person may apply to the Controller for a licence under the patent, or for an entry in the 

register to the effect that licences under the patent are to be available as of right, on any or 

all of the following grounds: 

a) that: 

i) a demand in the State for the subject matter of the patent is not being met or is not 

being met on reasonable terms; or 

ii) a demand in the State for a product which is protected by the patent is being met by 

importation other than from a member of the World Trade Organisation; 

b) that the establishment or development of commercial or industrial activities in the State is 

unfairly prejudiced. 

The Group is not currently aware of any compulsory licences granted in Ireland for the 

domestic manufacture and supply of pharmaceutical products since Ireland became a 

member of the WTO Agreement (including TRIPS) on January 1, 1995. 






The Irish Patents Act, 1992, as amended by the Patents (Amendment) Act, 2006, does not 

contain any provision that is equivalent to Article 31bis of the TRIPS Agreement. 

However, Regulation 816/2006 of the European Parliament and of the Council on compulsory 

licensing of patents relating to the manufacture of pharmaceutical products for export to 

countries with public health problems has now been adopted. Notice of this Regulation 

appeared in the Official Journal on 9th June 2006 and the Regulation entered into force on 

29 June 2006. 

The Regulation enables the manufacture of patented pharmaceutical products under license by 

someone other than the patent holder for export to countries with public health problems. 

Most national laws do not allow compulsory licenses for export because, under Article 31 (f) 

of the TRIPS Agreement, products made under compulsory licensing must be “predominantly 

for the supply of the domestic market.” The Regulation implements at EU level the WTO 

General Council Decision of 30 August 2003 which sets out a mechanism to allow export of 

medicines made under a compulsory licence to poor countries. 

The Regulation prohibits re-importation into the EU of medicines produced under the 

compulsory licence system and provides for customs authorities to take action against goods 

being re-imported. Poor countries which are not members of the WTO may also take part in 

the scheme. 

The Group is not currently aware of any compulsory licences granted in Ireland for the 




Under Section 77(1) of the Irish Patents Act, 1992, it is permissible for a Minister of the 

government, his officers, servants, agents or persons authorised in writing, to use patented 

inventions for the service of the State and without the consent of the patentee. Under Section 

77(2), certain acts which would otherwise amount to an infringement are not to be considered 

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as such. Service of the State is broadly defined to mean a service financed out of moneys 

charged on or advanced out of the central fund or moneys provided by the Oireachtas or by 

a local authority for the purposed of the Local Government Act, 1941. 

The TRIPS Agreement recognises that a State may, in certain circumstances, use a patented 

invention without the authority of the right holder and on terms which include the right to be 

paid adequate remuneration taking into account the economic value of the authorisation. 

Under Section 77(6), the terms governing State use are agreed between the parties or failing 

which, the matter is referred to the High Court which in turn can refer the whole matter or any 

question or issue of fact to an arbitrator. 

Under Section 77(4), if the invention prior to the filing or priority date has been recorded 

in a document by, or been tried by or on behalf of a Minister, then the State may use such 

royalty free or without any other payment. Evidence of such documentary recordal or the 

trial may be given to counsel representing the patent applicant/proprietor or to any agreed 

independent expert where the Minister determines that such disclosure would be detrimental 

to the public interest. 

Under Section 77(8), the rights to State use include a power to dispose of, or sell, or offer to 

dispose of or sell, any products made in pursuance of such a right which are no longer required 

for the services of the State. Section 77(9) covers any persons acquiring such products. 

There are extended provisions for State use during a period where there are in existence 

exceptional circumstances and it is desirable in the interests of the public. In such circumstances, 

the government may by order empower the State to use the invention for any purpose which 

appears to be necessary or expedient for one or more stated reasons which are set out in 

Section 78 of the Irish Patents Act, 1992. 

These reasons include to ensure public safety and the preservation of the State, the 

maintenance and sufficiency of supplies and services essential to the life or well-being of the 

community and for assisting in the relief or suffering in any country outside of the State that is 

in grave distress. However, included in the reasons are broadly stated objectives such as for 

promoting the productivity of commerce and industry, including agriculture. 


Answered in Question 8. 





There are no provisions under Irish patent law that recognises other means of facilitating 

access to medicines, medical devices, diagnostics and the like, notably in the context of 

public health crises that have not already been discussed above. 










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As indicated in the answers to the questions above, Irish patent law already provides for 

the research and experimental use exception; Bolar exemption; parallel import of patented 

medicines; individual prescriptions exception; compulsory licensing; and expropriation of 

patents. The medical treatment defence is not applicable to Irish or European patent law 

as methods of medical treatment are unpatentable and the Group would lend its support 

to any proposed uniform legal provisions that would render methods of medical treatment 

unpatentable. 

The research and experimental use exception, Bolar exemption, parallel import of patented 

medicines; individual prescriptions exception are already uniformly adopted in patent law 

across the EEA. The Group would be in favour of the introduction of similar provisions under 

the TRIPS Agreement or the Patent Co-operation Treaty. 

However, the Group is of the view that it would appear to be somewhat more difficult to 

introduce uniform rules under patent law governing the parallel import of patented medicines 

as parallel importation of patented medicines involves complex economic issues that would 

be difficult to encompass uniformly under patent law. 

With regard to compulsory licensing, the provision under Article 31bis would appear to be 

adequate for the time being. 



At present, it is difficult to envisage other ways other than limitations of patent rights that could 

facilitate access to medicines, diagnostics, medical devices and the like. 




Answered in Proposal 1 above. 

Summary 

Provisions exist under the Irish Patents Act, 1992, and European law for the research and 

experimental use exception; the so-called Bolar exemption; the parallel import of patented 

medicines; the individual prescriptions exception; compulsory licensing; and expropriation of 

patents. All of the abovementioned provisions facilitate access to medicines, diagnostics, medical 

devices and the like. The Group would lend its support to any proposed uniform legal provisions 

that would encompass the research and experimental use exception; the so-called Bolar exemption; 

and the individual prescriptions exception. Methods of medical treatment are unpatentable under 

Irish and European patent law and the Group would lend its support to any proposed uniform legal 

provisions that would render methods of medical treatment unpatentable. 

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Questions 

Israel 

Israël 

Israel 

Report Q202 

in the name of the Israeli Group 

by Tal BAND 






In 1998 the Patents Law, 1967 was amended to allow for an experimental use exception as 

well as a Bolar-type exception. The same amendment also made provisions for patent term 

extensions. 

The experimental use exception stipulates that “an experimental act in connection with the 

invention, the objective of which is to improve the invention or to develop another invention” 

does not amount to patent infringement. Experimental use of this nature is allowed for 

commercial purposes as well as for purposes which are purely academic. 






exception? 

The Bolar-type exception introduced into the Patents Law in 1998 allows for otherwise 

infringing experimental acts if they form part of an effort to obtain a marketing licence for a 

patented product following the expiry of the patent. Said licence may be an Israeli licence 

or a licence issued in other countries which implement Bolar-type exceptions. Any products 

manufactured prior to the expiry of the patent may not be used – whether during or after the 

patent term – for any other purpose save for obtaining the licence, i.e., stockpiling patented 

products for distribution following expiration of the patent is not permitted. 

The Bolar-type exception relates to any product, the marketing of which is conditional upon 

the receipt of a certificate, permit or any other regulatory document. 




Some uncertainty exists regarding the legality of parallel imports of patented products. In the 

past, district courts have deemed parallel importation of patented products as constituting 

patent infringement. However, in a later Supreme Court decision, it was noted, in an 

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obiter dictum, that the doctrine of international exhaustion should apply to patent rights. A 

recent district court decision applied international exhaustion with regard to design rights 

and allowed the parallel importation of goods protected by a registered design (including 

translated user manuals). 


conditions? 

The Patents Law permits the use of a patent on a non-commercial scale, for non-commercial 

purposes. This has been construed to mean personal use of the patent, bearing no profits. The 

personal importation of patented medicine for personal consumption on a reasonable scale 

may satisfy this condition, although there is no case law on the particular subject. 




N/A. 






Compulsory licences are available under the Patents Law in cases where a patentee abuses 

his monopoly, i.e. fails to supply the demand for the patented product in Israel on reasonable 

terms or stipulates conditions for the supply, production or licensing of his invention which 

are unfair under the circumstances, do not take into account the public interest and arise 

essentially due to the existence of the patent. A compulsory licence cannot be obtained 

prior to three years from the grant of the patent or four years from the filing of the patent 

application, whichever is the later. 

When a compulsory licence is insufficient to prevent the patentee’s abuse of his monopoly, 

the patent may be revoked. We are not aware of any such precedent. 

In the past, the Patents Law perceived the public interest in the exploitation of a patented 

invention by way of domestic manufacture as a major consideration, so that lack of “local 

working” would be relevant for granting a compulsory licence. However, the scope of 

compulsory licences was not restricted to manufacture for the domestic market. The Patents 

Law has since been amended to conform with Article 27(1) TRIPS, so that lack of domestic 

manufacture does not constitute a ground for obtaining a compulsory licence. Additionally, in 

accordance with Article 31(f) TRIPS, compulsory licences are allowed predominantly for the 

supply of the domestic market. 

In the past, the Patents Law contained special provisions that eased the obtainment 

of compulsory licences for medical products, processes and devices, for the purpose of 

guaranteeing “a reasonable quantity of medical supplies” and regardless of whether or 

not the patentee abuses his monopoly. However, those provisions were repealed in 1999 

in order to conform with Article 31(b) TRIPS. Prior to the repeal of those provisions, several 

compulsory licences were granted in Israel in order to facilitate the domestic manufacture of 

pharmaceuticals and ensure their supply, including: 

• In 1995 Bio-Technology General (Israel) Ltd. obtained a compulsory licence from Biogen 

Inc. for a patent covering Hepatitis B diagnosis and vaccination, based on a recombinant 

HBV antigen. 

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• In 1989 Agis Ltd. obtained a compulsory licence from Bayer Aktiengesellschaft for a 

patent relating to Bifonazole, an anti-fungal medication. 

• In 1988 Agis Ltd. obtained a compulsory licence from Fisons Plc. for several patents 

relating to pharmaceutical preparations for the treatment of asthma. 

• In 1984 Abic Ltd. obtained a compulsory licence from Ciba Geigy A.G. for a patent 

relating to Diclofenac Sodium, a non-steroidal anti-inflammatory drug (NSAID). 

• In 1983 Teva Pharmaceutical Industries Ltd. and others obtained a compulsory licence 

from Farbwerke Hoechst A.G. for a patent covering Glibenclamide, an anti-diabetic 

drug. 

• In 1972 Assia Chemical Industries Ltd. obtained a compulsory licence from Beecham 

Group Limited, England for two patents relating to the antibiotic Ampicillin. 

• In 1970 Assia Chemical Industries Ltd. obtained a compulsory licence from Boots Pure 

Drug Company Ltd. for a patent relating to derivatives of Acetanilide, a now obsolete 

drug with analgesic and antipyretic properties. 






Israel was one of the first ten WTO members to ratify Article 31bis TRIPS. The Patents Law 

has yet to be amended accordingly. In any event, Israel has agreed to restrict importation 

under the Doha Declaration only to situations of national emergency or other circumstances 

of extreme urgency. 



The Patents Law allows the relevant Minister to permit exploitation of an invention, whether 

patented or not, through governmental departments and state enterprises or agencies, if 

such exploitation is necessary for interests of national security or for the maintenance of 

essential supplies and services. Third parties operating under a contract with the state may 

also be granted a permit to exploit an invention, in order to facilitate consummation of such 

contract, solely for the above purposes and as required by the state. In the absence of an 

understanding, a statutory committee may set the royalties payable to the patentee or to the 

exclusive licensee. 


The Minister of Defence may restrict the publication of patent applications and the granting 

of patents in the interests of national security. The Minister of Defence may similarly restrict 

inventions essential to the development of nuclear energy in Israel or whose publication may 

harm nuclear research in Israel. Furthermore, permanent residents of Israel or other persons 

owning allegiance to the state wishing to file patent applications of this nature, must do so 

in Israel first, thereby allowing the authorities to restrict the applications before they are filed 

abroad. A statutory committee may decide on the compensation payable to the owner of any 

such patent application. 





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The Pharmacists’ Ordinance, 1981 allows for the parallel importation of pharmaceutical 

preparations. In the past, only the original sponsor of a drug could import it into Israel. Some 

leeway was provided to non-profit medical institutions, allowing them to independently import 

pharmaceutical preparations. However, since 1999, it is possible to import pharmaceutical 

preparations by reliance on the original entry in the Drug Registry. The importer is required 

to obtain certification that his goods are comparable to the registered drug. Of course, the 

Pharmacists’ Ordinance has no bearing on patent rights. 




Yes. 


Yes. 



Yes. 



Yes. 


Yes. 






Harmonize the rules on patents of selection, review and assess practices of the pharmaceutical 

industries aimed at “evergreening”. 




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Questions 

Italy 

Italie 

Italien 

Report Q202 

in the name of the Italian Group 






Yes, according to Italian Industrial Property Code (CPI), art.68, the exclusive right granted 

by the patent right shall not extend to acts performed in private and for non commercial 

purposes or for experimental uses even though aimed at obtaining, even in foreign countries, 

an authorization for the commercialization of a medical product and for the subsequent 

practical fulfilment, including therein the preparation and the use of the pharmacologically 

active raw materials strictly necessary for that purpose. Research or experimental use are not 

permitted for commercial purposes. 






exception? 

Yes, according to Art.61.5 CPI, in addition to the provision mentioned above, the companies 

which intend to produce pharmaceutical products for commercial purposes, may start the 

registration procedure regarding the active principle one year before the expiration of the 

complementary patent protection related to the active principle. 




Yes, it’s contrary to Articles 28 and 30 of the European Treaty for a patentee to assert its 

patent rights in one Member State to prevent parallel imports of patented products placed in 

the market of another Member State by the patentee or with its consent. According to art.5 

CPI, the exclusive rights are exhausted once products have been put on the market in the State 

or in the European Community or in the EEA by the proprietor or with his consent. 

There are not decisions of national courts on this matter. 


conditions? 

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Yes, according to art.68 CPI, the exclusive right granted by the patent right shall not extend to 

the extemporary preparation of medicine in chemists’ shop according to a prescription and 

to the medicaments thus prepared, and to the units thereof, on condition that active principles 

industrially obtained are not used. 




No, according to art. 45 CPI, methods for treatment of the human and animal body by 

surgery or therapy and diagnostic methods practiced on the human and animal body shall 

not be regarded as inventions. 






Yes, according to art. 70 CPI, after three years from the date of granting of the patent or four 

years from the date of filing of the application, whicheer is later, a compulsory license may 

be granted for a non exclusive use of such invention, in favour of any interested party upon 

request, if the owner of the patent, or his successor has not put into practice the patented 

invention, by producing in the territory of the state or importing objects produced in a Country 

being a member of the European Union or of the European Economic Area or of the World 

Trade Organization, or put into practice it in a way as to result seriously out of the proportion 

having regard to the need of the Country. 

Moreover, according to art. 71 CPI, a compulsory license may be granted if the invention 

protected by the patent cannot be used without infringing a patent granted on the basis 

of the previous application. In such a case, a license can be granted to the owner of the 

second patent to the extent that it’s necessary to exploit the invention. The owner of the patent 

covering the main invention shall be entitled, in his turn, to be granted a compulsory license 

over the patent covering the dependent invention on reasonable conditions. 

According to art. 81 CPI, third parties that intend to manufacture for exportation an active 

principle covered by complementary protection certificates granted according to Act 19 

October 1991, n. 349, shall have the right to start, with the owners of the above mentioned 

certificates, a procedure at the Ministry of Production Activities aimed at obtaining the 

granting of a non exclusive licenses, against payment. The licenses shall in any case be 

valid solely for the exportation to Countries in which patent protection and the protection 

conferred by a complementary protection certificate does not exist, is expired or in which the 

exportation of the active principle does not represent an infringement of the relevant patent. 

The effects of the license shall cease upon the expiration of the relevant complementary 

protection certificate. As regards the procedure of license on active principles (art. 200 

CPI), the applicant shall send a request to UIBM (Italian Patents and Trade Marks Office). 

UIBM shall promptly communicate the request to the interested parties and to those who 

have acquired rights in the patent. Within ninety days the parties shall reach an agreement 

as to the amount of a royalty. If the Office has not given any communication to the parties, 

the license agreement shall be considered as reached. When the parties communicate to 

the UIBM that an agreement has not been reached, the Office shall start a conciliation 

proceeding. When, notwithstanding the above conciliation proceeding, the settlement for the 

license is not concluded, the Office provides for the transmission of the proceeding acts to 

the antitrust Authority. 

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On 23 February 2005, the Authority opened an investigations into alleged abuses of dominant 

positions by Merck & Co. Inc (Case A364), preventing the development of the market for a 

certain generic drug. The investigation originated in complaints from producers of generic 

drugs (DOBFAR S.p.A.), who complianed that they were refused a license under artt.81 

and 200 CPI by Merck on an active principle (IMIPENEM CILASTATINA, CCP n.76). The 

complainants considered that they needed the principles in order to be able to compete with 

Merck’s products. The Authority ordered to Merck to grant a license, because the refusal of 

Merck was at the same time exclusionary, since it prevents the development of the competing 

products, and exploitative, since it allows the owner of the active principle to charge higher 

prices and may amount to an abuse under art. 82 of the European Treaty. 






The European Council Decision of 19 November 2007, on behalf of the European Community, 

has decided to accept the Protocol amending the TRIPS Agreement, done at Geneva on 6 

December 2005. Therefore the art. 31 bis is in force. 



No. 


According to art. 141 CPI, an industrial property rights may be expropriated by the State 

in the interest of the military defence of the country or for other reasons of public interest. 

Expropriation may be limited to the right to use for the needs of the country, without prejudice 

to the provisions concerning compulsory licenses if applicable. 

A decree ordering the expropriation for reasons of public interest shall also determine the 

compensation to which the owner of the industrial property right shall be entitled, based on 

the market value of the invention. 





No other means are provided. 




Yes. 


Yes. 


Yes. 


Yes. 

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No. 


Yes. 


Yes. 




Yes e.g according to Art 31bis TRIPs. 



No. 




Yes. Harmonisation should be promoted taking into account the different characteristics of the 

sanitary systems, hence by homogeneous areas. 

Summary 

With regards to the experimental use exception the big question is whether during the period of 

protection of a pharmaceutical patent, pre- clinical and/or clinical test may be conducted. 

Generally, tests for market approval of a patented substance during the protection of a pharmaceutical 

patent are permitted. As a result, immediately upon expiration of such patent, the pharmaceutical 

in question can be put onto marketplace without risk of patent infringement. 

According to Italian Industrial Property Code, the companies which intend to produce pharmaceutical 

products may start the registration procedure containing the active principle one year before the 

expiration of the patent protection. 

Moreover, the extempore preparation of medecine in chemists’ shop are permitted, on condition 

that active principles industrially obtained are not used 

With regards to the subject matter of the patent, methods for treatment of the human and animal 

body by surgery or therapy and diagnostic methods practiced on the human and animal are 

excluded from patentability. This provision, however, shall not apply to products, in particular 

substances or compositions of substances, for use in any of these methods. In other words, an 

invention comprising the use of a substance or composition in such a method may be patentable. 

Concerning the compulsory license, nations currently have the right to issue compulsory licenses 

on patents. The Paris Convention for the Protection of Industrial Property plainly states that “each 

country of the Union shall have the right to take legislative measures providing for the grant of 

compulsory licenses to prevent the abuses which might result from the exercise of the exclusive 

rights conferred by the patent, for example, failure to work.” In Italy is in force art. 70 of Industrial 

Property Code: a compulsory license can be granted for non exclusive use if the owner of the patent 

has not put into practice the patented invention. 

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A particular complusory license can be granted if the invention protected by the patent cannot be 

used without infringing a patent granted on the basis of the previous application. In such a case, a 

license can be granted to the owner of the second patent to the extent that it’s necessary to exploit 

the invention. 

The procedure of license on active principles is very detailed: the applicant shall send a request to 

UIBM (Italian Patents and Trade Marks Office) and, if the parties communicate to the UIBM that an 

agreement has not been reached, the Office shall start a conciliation prooceeding. If the settlement 

for the license is not concluded, the Office provides for the transmission of the proceeding acts to 

the antitrust Authority. 

With regards to expropiation, an industrial property rights may be expropriated by the State in 

the interest of the military defence of the country or for other reasons of public interest. The decree 

ordering the expropiation for reasons of public interest shall also determine the compensation to 

the owner of the patent. 

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193-198_Q202_Italy.indd 198 17.07.2009 10:24:09

Questions 

Japan 

Japon 

Japan 

Report Q202 

in the name of the Japanese Group 






YES. 

The Japanese Patent Law provides in Article 69 (1) that “A patent right shall not be effective 

against the working of the patented invention for experimental or research purposes.” 

Detailed explanation: 

Meaning of Article 69 (1): 

The purpose of the Patent Law is “to encourage inventions, and thereby to contribute to the 

development of industry” (Article 1). If a patent right were also effective against experiments 

and research intended for technological progress, it would prevent such progress and thus 

impede the development of industries. To achieve the purpose of the Patent Law, Article 69 (1) 

defines the working of the patented invention for “experiments and research” as a limitation 

of the patent right and thereby achieves a fair balance between the patentees’ interests and 

the public interest. 

Since a patent right is only effective against working of the patented invention conducted “as 

a business” (Article 68), Article 69 (1) only applies for the working of the patented invention 

conducted as a business for the purpose of experiments and research. Needless to say, a 

patent right is not effective against the working of the patented invention for the purpose of 

experiments and research that are not conducted as a business. 

Interpretation of “as a business”: 

The Japanese Patent Law states that a patent right is not effective against working of the 

patent invention that is not conducted as a business in the first place. However, the details 

of working “as a business” are not specified in the Act, and there are not sufficient judicial 

precedents regarding the meaning of this statutory phrase. Thus the interpretation of “as a 

business” is left entirely to academic doctrines. In academic circles, the prevailing view is 

that the working of a patented invention “as a business” includes all activities except those 

not related to industrial activities, such as individual or domestic ones. The term “industrial 

activities” is not limited to activities conducted for profit or conducted strictly for the purpose 

of business, but includes all activities relating to business. In other words, working can be 

deemed as being “as a business” even if its direct purpose is not profit. Working of the 

patented invention conducted in the course of public work projects, medical service and legal 

practice is also considered to be working “as a business.” According to this interpretation, it is 

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highly likely that the working of a patented invention for experiments and research conducted 

by universities, etc. will be regarded “as a business.” 

Interpretation of “experiment or research”: 

General interpretation of “experimental or research purposes” in Article 69 (1) of the Patent 

Law depends largely on academic doctrines since there are not enough judicial precedents. 

In the prevailing doctrine, it is considered that whether or not an experiment or research falls 

within the scope of “experiment or research” exempted by Article 69 should be decided 

depending on its subject and purpose, and that an experiment or research should be 

regarded as falling within such a scope only when its subject is limited to the patented 

invention itself and when its purpose is limited to “technological progress” (e.g. patentability 

research, function research, experiment for improvement or development of the invention). 

With regard to patentability research, etc., Keiko Someno, Shiken Kenkyu ni okeru 

Tokkyohatsumei no Jisshi (Working of a Patented Invention for Experiments or Research), 

AIPPI, Vol. 33, No. 3, 5 (1998) explains as follows: 

Patentability research 

An experiment conducted to find whether another party’s patented invention has novelty and 

involves inventive step, for the purpose of deciding whether or not it is possible to petition the 

for an invalidation trial or an opposition. 

Functionality research 

An experiment conducted to see whether another party’s invention can be worked or has 

the effects as described in the description (in some cases, to verify whether the invention will 

bring about adverse side-effects). This type of experiments is conducted most often. It also 

includes experiments conducted for the purpose of ascertaining what economic advantage 

or disadvantage the invention has or deciding what costs will be required to put the invention 

into practice. It is sometimes conducted for the purpose of deciding whether the experimenting 

party should seek a licence for the patent. 

Experiment for improvement/innovation 

An experiment conducted for the purpose of improving another party’s invention or creating 

a better invention. For working of an improvement invention arising from such an experiment 

(dependent invention), it is necessary to use the other party’s invention and therefore to obtain 

a license from the other party. Once such a license has been agreed, the owner of the basic 

invention (the other party) will receive benefits from the use of the improvement invention. 

On the other hand, a “design-around” invention does not use the other party’s invention. 

However, it is necessary even for such an invention to satisfy the requirements of novelty 

and inventive step in order to be patented. Therefore, an experiment for designing around 

another’s invention will contribute to technological progress. 

The Japanese Patent Law does not differentiate the working of another person’s invention 

for profit from that which is not for profit. Therefore, the scope within which a patent right 

is effective does not differ depending on whether the patented invention is worked by a 

corporation (profit-making institution) or a university (non-profit institution). 






exception? 

NO. 

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The Japanese Patent Law has no “Bolar exception.” In other words, it has no exception specially 

designed for clinical trials and other experiments for obtaining approval of production of 

generic products, exists in Japan. However, clinical trials and other procedures for generic 

products are exempted under Article 69 (1) of the Patent Law, which provides for limitation of 

patent rights for “experiments and research.” 

Detailed Explanation: 

The Supreme Court decided on April 16, 1999 that the working of a patented invention for 

the clinical trials necessary to file an application for approval of production of a generic 

product falls under “experiments or research“ exempted by Article 69 (1).” Thus, it can be 

said that the rule that a patent is not effective against the working of the patented invention 

for a clinical trial conducted to file an application for approval of production of a drug is 

established under case law. 

The Supreme Court decision reaches the aforementioned conclusion by holding that: 

1) If the clinical trials necessary to file an application for approval of production of a generic 

product are not permitted during the patent term, the third party will be unable to work 

the invention even after the expiration of the patent term. 

2) The patentee can secure economic benefits through the exclusive use of the patented 

invention during the patent term. 

This Supreme Court decision is made based on the regulation of the Pharmaceutical Affairs 

Act and it is construed that the scope of exemption covered by the decision includes patented 

inventions on drugs, quasi drugs, cosmetics with ingredients specified by the Minister of Health, 

Labor and Welfare, or medical devices for which approval of production under Article 14 

(1) of the Pharmaceutical Affairs Law is required. In addition, it is considered that the scope 

of exemption also includes patented inventions on agrichemicals for which registration under 

Article 2 (1) of the Agricultural Chemicals Regulation Law is required. Biological products are 

also regarded as falling under medical drugs and are exempted from patent infringement 

liability as far as it is subject to control under the Pharmaceutical Affairs Law. 

On the other hand, since exemption under the decision is limited to “the case where someone 

owns a patent right for a chemical substance or a medical drug that has the chemical 

substance as its active component,” it thus seems that a research tool patent is not covered by 

the exemption. It is also construed that the applicability of Article 69 (1) to the working of a 

patented invention for a research tool is likely to be denied in the case where the subject of 

research is not the patented invention itself, under the aforementioned prevailing academic 

doctrine. 




NO. 

The Japanese Patent Law has no specific provisions regarding parallel imports of patented 

products. 


In Japan, It was traditionally considered that importing a patented product which is legally 

distributed in a foreign country and assigning it in Japan was an infringement of the patent 

right. However, a Supreme Court decision on July 1, 1997 (Case No. Heisei 7(wo)1988) held 

that in the case where the owner of a patent in Japan sold a patented product outside Japan, 

the patent owner should not be allowed to enforce its patent in Japan against the assignee 

of the patented goods or subsequent acquirers who acquired the patented product from the 

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asignee, unless the assignee explicitly agrees to exclude Japan from the place of sale or 

use of the patented products and a notice of such an agreement is clearly indicated on the 

patented product. The Supreme Court decision indicated that its conclusion was not derived 

based on the exhaustion doctrine, by clearly stating that the conclusion would be the same 

regardless of whether the patentee has a foreign patent in the country where the patented 

product was originally assigned. Instead, the Supreme Court cited the necessity of protecting 

the assignee’s confidence in free distribution as the rationale for prohibiting the exercise of 

the Japanese patent right on the parallel-imported patented products. Such a necessity arose 

from the fact that the transaction in the foreign country was made on the assumption that 

the assignee obtained (and was implicitly given) all rights that the assignor had (including 

the right to import the product into Japan). In other words, the Supreme Court Decision was 

rendered based on implicit license doctrine. 

Parallel imports of genuine patented products need to satisfy the following requirements to 

avoid the exercise of Japanese patent rights: 

a) The product must be assigned in a foreign country by the patent owner or a person who 

can be regarded as a person equivalent to the patent owner; 

b) There is no agreement between the assignee and the patent owner to the effect that 

Japan is excluded from the place of sale or use of the product; 

c) A notice of such an agreement is not clearly indicated on the patented product. 

Therefore, it is possible for the patentee to assert infringement of the patent right and breach of 

the agreement against the assignee’s act of importing the product into Japan if the agreement 

is made as specified by (b) above, and the notice is clearly indicated on the product as 

specified by (c). This rule is considered to apply not only to pharmaceuticals, medical devices 

or the like, but to all products. 

From this, we can conclude that importation of products produced in a foreign country under 

a compulsory license to Japan could not allowed, since. g the compulsory license will be 

generally ordered to satisfy the domestic demand of that foreign country and will thus restrict 

the place to which the products manufactured thereunder may be sold to that country. 

Furthermore, Japan has accepted the Protocol amending the TRIPS Agreement and is obliged 

to ensure the availability of effective legal means to prevent the importation into, and sale in, 

its territory of products produced under the system provided for in the protocol and diverted 

to its market inconsistently with the protocol’s provisions, using the means already required to 

be available under the TRIPS Agreement (including injunction). 


conditions? 

YES. 

The Japanese Patent Law provides that a patent right for the invention of a process to 

manufacture a medicine by mixing two or more medicines shall not be effective against the 

act of preparation of a medicine as is written in a prescription from a physician or a dentist 

and the medicine so prepared. 

Article 69 (Limitations of patent right) 

3) A patent right for the invention of a medicine (refers to a product used for the diagnosis, 

therapy, treatment or prevention of human diseases, hereinafter the same shall apply in this 

paragraph) to be manufactured by mixing two or more medicines or for the invention of a 

process to manufacture a medicine by mixing two or more medicines shall not be effective 

against the act of preparation of a medicine as is written in a prescription from a physician 

or a dentist and the medicine prepared as is written in a prescription from a physician or a 

dentist. 

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No answer to this question is needed. 


In Japan, the “methods for treatment of the human body by surgery or therapy and diagnostic 

methods practiced on the human body” are regarded as an “industrially inapplicable 

invention” under the JPO’s “Examination Guidelines for Patent and Utility Model,” and are 

not patentable. 






YES. 

The Japanese Patent Law does not use the term “compulsory license,” but it has a system of 

“award granting non-exclusive license,“ which plays the same role as a compulsory license 

under certain conditions. The Patent Law provides the following three types of awards of nonexclusive 

license, 1 which have been in place since the former Patent Law enacted in 1921. 

1) Award granting non-exclusive license where the invention is not worked (Article 83) 

2) Award granting non-exclusive license of the basic invention to work a dependent invention 

(Article 92) 

3) Award granting non-exclusive license for public interest (Article 93) 

However, as of February 2008, there has been no case where any of the above awards 

were granted. 


1) Award granting non-exclusive license where invention is not worked 

A person intending to work a patented invention may request its patentee or its exclusive 

licensee to hold consultations to discuss granting a non-exclusive license for the patented 

invention after four years have lapsed from the filing date of the patent application for the 

invention, if the patented invention is not sufficiently and continuously worked for three 

years or longer in Japan. Where there is a legitimate reason for the failure to sufficiently 

work the patented invention, however, the Director General of the Patent Office shall not 

award a non-exclusive license. 

2) Award granting non-exclusive license to work own patented invention 

Where a patented invention uses another party’s patented invention, registered utility 

model, or registered design (or design similar thereto) for which a patent application 

or an application of registration was filed prior to the date of filing of the application 

for said patented invention, or where the patent right for a patented invention is in 

conflict with another person’s design right or trademark right obtained based on an 

application filed prior to the date of filing of the application for said patented invention 

(Article 72), the patentee or exclusive licensee of the patented invention may request the 

other person to hold consultations to discuss granting a non-exclusive license to work 

1 see Berline Shikkoiinkai no Gidai ni taisuru Nihonbukai no Iken (2) (Gidai 187: Haitateki (Dokusenteki) Chitekizaisanken 

no Kyosoho ni yoru Seigen (AIPPI Japan’s Opinion on Questions on the Agenda at Executive Committee Meeting in 

Berlin (2) (Q187: Limitations on Exclusive IP Rights by Competition Law), AIPPI Vol. 50, No. 3, 164-165(2005). 

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the patented invention or a non-exclusive license for the utility model right or the design 

right (Article 92(1)). The rightholder of the basic invention (the other person’s invention) 

may request the patentee or exclusive licensee requesting such consultations to hold 

consultations to discuss granting a non-exclusive license to the extent of the patented 

invention that said patentee or exclusive licensee intend to work under the non-exclusive 

license for the other party’s patent right (Article 92(2)). Where no agreement is reached 

through the consultations or no consultations can be held, the other party may request the 

Commissioner of the Patent Office for an award granting such a non-exclusive license. 

3) Award granting non-exclusive license for public interest 

A person intending to work a patented invention may request its patentee or its exclusive 

licensee to hold consultations to discuss granting a non-exclusive license on the condition 

that “the working of a patented invention is particularly necessary for the public 

interest.” 

In any of the above three cases, consultations between the parties are to be held first. 

Where no agreement is reached through consultations or no consultations can be held, a 

non-exclusive license may be awarded by the Commissioner of the Patent Office (Article 

83 and Article 92) or the Minister of Economy, Trade and Industry (Article 93) upon the 

request of the person intending to work the patented invention. Even after a non-exclusive 

license is awarded, it may be cancelled upon the request of an interested party or by the 

Commissioner’s own authority, if the person to whom the non-exclusive license was granted 

fails to work the patented invention properly. 

With regard to the non-exclusive license for public interest mentioned in (3) above, “Saitei 

Seido no Unyo youryo (Instructions on Implementation of the System of Awarding Non- 

Exclusive Licenses)” issued by the Industrial Property Council defines “cases where the 

working of a patented invention is particularly necessary for the public interest” as “(i) cases 

where it is particularly needed in areas relating directly to the lives of citizens, such as the 

areas of public health, asset protection and construction of public facilities, or (ii) cases where 

the sound development of the relevant industry will be damaged if a non-exclusive license for 

the patented invention is not granted, and as a result, substantial damage will be caused to 

lives of citizens.” It is interpreted that the word “particularly” is used for the purpose of strictly 

limiting the applicability of the requirement of “non-exclusive license for public interest,” and 

if there are any alternate means to protect the public interest other than awarding a nonexclusive 

license for the patent in question, a non-exclusive license cannot be awarded even 

if the costs of these alternate means would be higher than in the case where a non-exclusive 

license for the patent was awarded. 

A report published by the Foreign Investment Council’s Expert Committee in 1968 put forward 

its view that a non-exclusive license may be awarded even for the sake of the national economy, 

by stating: ”A non-exclusive license under Section 93 of the Patent Law may be allowed when 

the patent is regarded as being important for areas relating directly to the lives of citizens, 

such as the areas of public health, protection of assets and construction of public facilities. 

It may also be allowed when substantial adverse effects on the national economy are likely 

to occur due to the following events arising as a result of the monopolization of an important 

patented invention that is necessary for the production of certain products or is related to the 

implementation of certain industrial processes: (i) It is feared that a huge number of people 

will be made unemployed due to bankruptcy or other disruptions occurring for a corporation 

that is expected to use the patented invention; (ii) it is feared that, through bankruptcy or 

other disruptions occurring for corporations in a certain industry that are expected to use 

the patented invention, a huge amount of existing facilities in the industry, which would be 

utilized if the industry could use the patented invention, is likely to be destroyed; and (iii) when 

bankruptcy or other disruptions occur for corporations in a key industry, important export 

industry or hi–tech industry that is expected to use the patented invention, the sound economic 

or technological development of the industry is likely to be substantially hindered.” 

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The provisions for awarding a non-exclusive license were introduced in the Patent Law for the 

following reason. For the non-exclusive license for non–working invention mentioned in (1) 

above, it is because patents could not contribute to the development of domestic industries if 

they were not used appropriately. The provisions for awarding a non-exclusive license to work 

one’s own patented invention mentioned in above (2) above were stipulated to encourage 

improvement invention. Both of them were considered to contribute to the original purpose 

of the patent system. In addition, at the time of enactment, these provisions were considered 

to promote technology transfer from advanced nations. The provisions for non-exclusive 

license for public interest stated in (3) above were adopted in order to provide a remedy 

for situations where the public interest was harmed by the adverse effects of exclusive rights 

given to patents. However, unlike the former Patent Law, which provided for the restriction, 

expropriation or cancellation of patent rights as a measure for providing such a remedy, the 

current Patent Law attempts to achieve this purpose only by allowing the competent authorities 

to give an award to force a patentee to grant a non–exclusive license. 

It seems that any of the three non-exclusive licensing schemes can be justified by the necessity 

of ensuring free competition. In particular, according to the aforementioned criteria (ii) for 

awarding a non–exclusive license for the public interest in the Instructions on Implementation 

of the System of Awarding Non-Exclusive Licenses, it can be understood that the term ”public 

interest” in Section 93 of the Patent Law means the interests of businesses and consumers, 

and that a non-exclusive license may be granted when the exclusive patent right has the effect 

of limiting or precluding competition. 

In any case, a party that has received an award may, if unsatisfied with the amount of 

compensation determined in the award, institute an action demanding an increase or 

decrease of said amount. (Article 183 of the Patent Law). 






YES. 

Japan accepted the Protocol amending the TRIPS Agreement on August 31, 2007. However, 

Japan does not need any new legislative measures to implement the protocol, and thus no 

legal revisions have been made. There have not been any cases where a compulsory license 

(award of non-exclusive license) has been exercised for the import or export of medical 

drugs. 



NO. 

There is no provision in the Japanese Patent Law that makes it possible for any party (even the 

government) to implement a patented invention without obtaining the license. 


As described in 6) above, although the former Patent Law had provisions to expropriate or 

cancel a patent right if the public interest is particularly damaged as an adverse effect of 

monopoly through a patent right, the current Act permits only the awarding of a non-exclusive 

license. 

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NO. 


See the answer to question 8) above. 





NO. 


There are no means other than the ones mentioned in the answers to questions 1) through 9) 

above. 




It should not necessarily require every country to provide this exception in their patent 

laws. The policies given in the resolution for Q105 (except for 4) adopted by the Tokyo 

World Congress in 1992 should be followed, if this exception is introduced to any patent 

laws. 


It should not necessarily require every country to provide the Bolar exception in their 

patent laws. In the case of a country that provides the research and experimental use 

exception in its patent law, the Bolar exception should be given in the provision on 

research and experimental use or through interpretation of such a provision. If a country 

decides to provide in its patent law to the effect that a patent is not effective against the 

working of the patented invention for a clinical trial conducted to file an application for 

approval of production of a generic drug, production of only the quantity required for 

the trial should be allowed. It should not be allowed to produce the patented medicines 

for the purpose of production and storage with the intention of selling them after the date 

of expiration of the patent. 


It should not require every country to provide permissibility of such parallel importation in 

their patent laws. If a country introduces such a provision in its patent law, it should not 

allow this parallel importation on the grounds of international exhaustion, as noted in the 

resolution for Q101 adopted by the Melbourne Executive Committee in 2001. 


It seems acceptable to require every country to provide such an exception in their patent 

laws, since medical composition is a patentable subject matter under the TRIPS Agreement. 

However, it is necessary to provide the definition of individual prescription first. 


Such a defence should be allowed in countries where a medical treatment method is 

patentable. However, it should not require every country to adopt this defence since most 

countries do not allow a patent on a medical treatment method. 


It seems acceptable to require every country to provide a compulsory licensing scheme, 

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ut it should be provided within the scope of the TRIPS Agreement and the Protocol 

amending the TRIPS Agreement, in a manner consistent with the direction indicated in 

the resolution on Q187 adopted by the Executive Committee in Berlin in 2005. Since 

if a globally uniform system for compulsory licensing is to be established within the 

framework of patent law, it should be designed within the TRIPS Agreement and the 

Protocol amending the TRIPS Agreement, the first thing to do is discuss the issue of access 

to medicines – which is the underlying issue of this question (Q202) – in the General 

Council and to effectuate and implement the Protocol amending the TRIPS Agreement, 

which was prepared in December 2005 and achieves a fair balance between incentives 

for the development of new useful products or processes and the public interest in limiting 

the scope of patent rights. Therefore, a resolution should be made to prompt member 

states to accept the protocol without delay. 


It should not require every country to provide expropriation in their patent laws, since 

there are some countries, such as Japan, where expropriation is not allowed. 



It should be neither established nor obliged. 


Countries have different legal structures: some adopt a statute law system and others adopta 

common law system. Thus, for the purpose of establishing globally uniform rules, it seems 

sufficient if substantially similar action will be taken on the same issue under the legal systems 

of respective countries. In addition, these limitations on patents may be provided by acts 

other than the Patent Law. In any case, since these limitations are exceptions to patent rights to 

be established to protect public health, they should ensure a fair balance between incentives 

for the development of new useful products or processes and third party interests, and their 

scope should be narrowly defined and construed. They should basically be provided in 

accordance with the policies underlying the relevant provisions in the TRIPS Agreement. 



No. 




Many countries have limitations of patent rights under their statutory provisions or case 

law. However, the scope of these differs by country. (Inventions relating to public health 

have unique characteristics in that products produced based on these inventions may be 

put on the market only after the regulatory authorities examine them from the viewpoint of 

safety and grant approval for their manufacture or sale. On the other hand, the situations 

surrounding public health issues vary greatly among countries depending on what systems – 

for example, systems based on private practice and free competition, official price systems for 

pharmaceuticals, systems requiring all nationals to be covered by public health insurance – 

are adopted, what authorities and powers are given to the regulatory authorities, the level of 

the country’s competence in developing new pharmaceuticals, the level of medical treatment 

in the country, the country’s fiscal condition, etc.) 

Although it would be ideal if patent laws around the world were harmonised in this respect, it 

seems difficult to achieve this given the current status of WIPO negotiations on the Substantive 

Patent Law Treaty (SPLT). This is because the issue of the relationship between patents and 

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public health cannot be discussed without linking it to the issue of access to medicines in 

developing countries and least developed countries. In fact, it has been proposed in the SPLT 

negotiations that not only the harmonization of substantive aspects of the patent granting 

process but also the harmonization of issues such as compulsory licensing, technology transfer 

and the limitation of patent rights should be discussed in the framework of the SPLT, and 

the negotiations have not made much progress. We believe that the attempt to harmonize 

issues such as the research and experimental use exception, Bolar exception and individual 

prescriptions exception should first be started at the meeting of Group B+ member states or 

another similar forum consisting of developed countries. 

Regarding this issue, it should be noted that the development of new medicines has come 

to require higher costs and longer-term research due to the more stringent safety criteria of 

regulatory authorities. In such circumstances, if the limitations of patent rights expand and 

the incentives for development are impeded, there is a possibility that it would stifle research 

and development activities in the pharmaceutical and other related industries, which would 

ultimately harm the interests of consumers. The patent system is designed to give incentives 

for the development of new useful technologies, and any limitation of patent rights should be 

provided in an exceptional and limited manner. The issue of access to medicines is, in its very 

nature, an issue that lies outside of patent law and should be discussed at an appropriate 

forum such as the WHO. 

Summary 

1) The Japanese Patent Act specifies that a patent right shall not be effective against the working 

of the patented invention for the purpose of “experiments and research.” However, there 

are no widely-accepted criteria for judging what activities fall under the “experiments and 

research” category, due to there being insufficient judicial precedents. As a result, in order 

to make such a judgment, one has to rely on academic theories developed in the late 1980s, 

which is before we started to face the issues of the “experiments and research” exception and 

Bolar exception. Although said Act lacks a provision corresponding to the “Bolar exception” 

rule, clinical trials and other experiments for the production of generic products are exempted 

by the Supreme Court under a general provision that limits patent rights for “experiments and 

research.” 

2) The Japanese Patent Act has no specific provisions about parallel imports of patented 

products. There is a judicial precedent where the Supreme Court prohibited the exercise of 

a patent right on the grounds that the patentee had implicitly assigned all of its rights to the 

assignee, who purchased the patented goods from the patentee outside Japan. It should be 

noted that this judgment was not made based on the patent exhaustion doctrine, which aims 

to prevent patent owners from “double-dipping.” 

3) The Japanese Patent Act provides that a patent right for the invention of a process to 

manufacture a medicine by mixing two or more medicines shall not be effective against the 

act of preparing a medicine according to a prescription written by a physician or a dentist, 

or against the medicine so prepared. 

4) The Japanese Patent Act has a provision effective as a compulsory license under certain 

conditions, but not under the term “compulsory license,” but “discretionary license” (Article 

93). Although several petitions were filed in the past, such discretionary license has never 

been ruled for issuance. 

5) Japan accepted the Protocol amending Article 31bis of the TRIPS Agreement on August 31, 

2007. Japan does not need to take any new legislative measures for the implementation of 

the protocol. In Japan, there are no precedents where a compulsory license (discretionary 

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license) was issued for the import or export of medical drugs. The Japanese Patent Act does 

not explicitly permit any party, even the government, to exploit a patented invention without 

a license. 

6) Since the patent system is designed to give incentives for the development of new useful 

technologies, any restrictions on patent protection should be limited in terms of scope and 

applicability. Having too many restrictions on patents would reduce scientists’ incentives to 

conduct research and development and consequently harm consumers’ interests. Regarding 

the availability of medicine, most of the associated issues are unrelated to patent law. These 

issues should be discussed further at WHO meetings and other appropriate occasions. 

Résumé 

1) La loi sur le brevet japonaise spécifie que l’effet de droit de brevet ne s’étend pas sur la mise 

en exécution des inventions brevetées dans le but de “l’examen ou la recherche”. Cependant, 

vue la jurisprudence sur l’interprétation générale de “l’examen ou la recherche” qui n’est 

pas encore assez accumulée, l’interprétation de cette disposition reste fondée sur la doctrine 

issue de l’ère où les problématiques de l’exception de “l’examen ou la recherche” et de 

l’exceoption Bolar ne se sont pas encore produits, c‘est-à-dire de la seconde moitiée des 

années 1980. Il n’y a pas de disposition qui correspond à l’exception Bolar et les sujets tels 

que l’examen clinique des médicaments génériques sont traités comme des problématiques 

relatives à l’application des dispositions générales sur “l’examen ou la recherche” suivant la 

jurisprudence de la Cour suprême. 

2) Aucune disposition concrète concernant l’importation parallèle de produits brevetés n’est 

établie. Or, la jurisprudence de la Cour suprême restreint l’effet de droit de brevet du cédant, 

parce que le transfert du droit de brevet est une transaction qui implicitement accorde au 

cessionnaire tous les droits détenus par le cédant dans les commerces économiques à 

l’étranger. Mais il faut noter que cette décision n’est pas une décision basée sur la doctrine 

d’épuisement, qui nie le double profit. 

3) Une disposition stipule que l’effet de droit de brevet relatif à l’invention de méthodes pour 

fabriquer des médicaments en mélangeant plus de deux médicaments ne s’étend pas aux 

actes des médecins ou dentistes pour préparer des médicaments selon l’ordonnance et aux 

médicaments résultant de ces actes. 

4) La loi sur le brevet japonaise établit une disposition portant sur la “licence non-exclusive 

par arbitrage” (non pas la “licence forcée”) qui accorde, sous certaines conditions, un effet 

similaire à la licence forcée. A cet égard, il y a eu des requêtes de la licence non-exclusive 

par arbitrage dans le passé, mais aucune décision n’a été rendue au Japon. 

5) Le Japon a accepté le protocole modifiant l’article 31-2 de l’Accord sur les ADPIC au 31 août 

2007. Une nouvelle mesure législative n’est pas nécessaire pour la mise en vigueur de ce 

protocole. Or la licence forcée (licence non-exclusive par arbitrage) n’a jamais été accordée 

pour l’importation ou l’exportation de médicaments. En outre, la loi sur le brevet japonaise 

ne permet même pas au Gouvernement de réaliser l’invention brevetée sans avoir obtenu la 

licence. 

6) Le système de brevet vise à fournir une incitation au développement technique et la restriction du 

droit de brevet doit rester rigoureusement exceptionnelle et limitative. Au cas où la restriction du 

droit de brevet se développe et que l’incitation ne suffit pas, la recherche et le développement 

seraient abandonnés et il en résulte des désavantages pour les consommateurs. Le problème 

d’accès aux médicaments est d’ailleurs en grande partie un problème autre que celui du 

droit de brevet et par conséquent, l’OMT ou d’autres organisations responsables doivent 

approfondir la discussion. 

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1) Das japanische Patentrecht regelt ausdrücklich, dass der Patentschutz im Falle einer Benutzung 

patentierter Erfindungen zu „Forschungs- und Versuchszwecken“ nicht wirksam ist; allerdings 

gibt es für eine allgemeine Auslegung dessen, was unter „Forschungs- und Versuchszwecken“ 

zu verstehen ist, noch keine ausreichende Zahl von Präzedenzfällen, und die Auslegung 

dieser Bestimmung beruht auf einer Lehre aus der zweiten Hälfte der 1980er Jahre, also 

aus einer Zeit vor dem Ausnahmeregelung für „Forschungs- und Versuchszwecke“ bzw. 

dem Problem der „Bolar-Ausnahme“. Es existiert keine der „Bolar-Ausnahme“ entsprechende 

Regelung; bei klinischen Versuchen von generischen Arzneimitteln usw. finden nach einer 

Entscheidung des Obersten Gerichts die allgemeinen Bestimmungen bezüglich „Forschungs- 

und Versuchszwecken“ Anwendung. 

2) Es existieren keine konkreten Regelungen zum Parallelimport patentierter Produkte. Zwar 

liegt ein Urteil des Obersten Gerichts vor, nach dem es sich bei im Ausland getätigten 

Geschäften um Geschäftsakte handelt, bei die vollständige Abtretung der gesamten Rechte 

des Abtretenden impliziert ist; dabei handelt es sich jedoch nicht um ein erschöpfendes Urteil 

gegen doppelten Profit. 

3) Die Gültigkeit des Patentrechts im Zusammenhang mit Verfahrenserfindungen, bei denen ein 

Präparat durch Vermischen von zwei oder mehr Präparaten hergestellt wird, erstreckt sich 

nicht auf das Zubereiten von Präparaten auf Rezept durch einen Mediziner bzw. auf in dieser 

Weise entstandene Präparate. 

4) Das japanische Patentgesetz kennt keine „Zwangslizenz“, wobei allerdings Bestimmungen 

existieren, nach denen durch eine nicht-exklusive Lizenzierung unter bestimmten Bedingungen 

dasselbe Resultat wie bei einer Zwangslizenz erzielbar ist. Zwar wurden bereits solche 

nicht-exklusive Lizenzierungen beantragt, doch ist bislang kein Bescheid tatsächlich erteilt 

worden. 

5) Zum 31. August 2007 hat Japan das Änderungsprotokoll für Artikel 31bis des TRIPS- 

Übereinkommens übernommen; daraus ergab sich allerdings kein Bedarf an neuen 

legislativen Massnahmen. Es wurden bisher keine Zwangslizenzen (nicht-exklusive Lizenzen) 

zum Import oder Export von Arzneimitteln erteilt, und das japanische Patentrecht verfügt über 

keinerlei Bestimmungen, die die Ausübung einer patentierten Erfindung ohne Lizenzerwerb 

ermöglichen würden, auch nicht durch die Regierung. 

6) Das Patentsystem dient der Förderung der technischen Entwicklung, weshalb eine Einschränkung 

von Rechten in jedem Fall eine begrenzte Ausnahme bleiben sollte. Eine weitere Einschränkung 

der Patentrechte bedeutet geringere Entwicklungsanreize, wodurch die Forschungstätigkeit 

zum Erliegen kommt; dies wirkt sich letztlich negativ auf den Verbraucher aus. Der Kern der 

Frage des Zugangs zu Arzneimitteln liegt nicht im Patentsystem, und wir hoffen, dass eine 

weitere Eingrenzung der Diskussion im Rahmen der WHO sowie an anderer geeigneter Stelle 

stattfinden wird. 

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Questions 

Malaysia 

Malaisie 

Malaysia 

Report Q202 

in the name of the Malaysian Group 

by Chew Phye KEAT and HK Sharminee DEVI 






YES, research and experimental use of inventions is an exception under the Malaysian Patent 

Law pursuant to Section 37(1) of the Patents Act, 1983 (the Act) which 

provides as follows: 

The rights under the patent shall extend only to acts done for industrial or commercial purposes 

and in particular not to acts done only for scientific research. 

The Act limits such exception to scientific research only. Research and experimental use for 

commercial purposes is not permitted. 






exception? 

YES, a Bolar-type exception is recognized under the Malaysian Patent Law as provided in 

Section 37(1A) of the Patents Act 1983 which provides as follows: 

The rights under the patent shall not extend to acts done to make, use, offer to sell a patented 

invention solely for use reasonably related to the development and submission of information 

to the relevant authority which regulates the manufacture, use or sale of drugs. 

As provided above the exception is limited solely to use of the patented invention in connection 

with information to be given to the relevant authority which regulates the manufacture, use of 

drugs (ie the Ministry of Heatth). 

The term used in the above exception is “patented invention“ and is therefore not limited to 

drugs and can include biological products, research tools etc. 




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YES, parallel imports of patented medicines, medical devices or similar are permitted in 

Malaysia pursuant to Section 37(2)(i) of the Patents Act 1983 and Section 

58A of the Patents Act 1983 which provide as follows: 

Section 37(2)(i) of the Patents Act 1983 

Without prejudice to Section 58A the rights under the patent shall not extend to acts in 

respect of products which have been put on the market ... by the owner of the patent. 

Section 58A(1) of the Patents Act 1983 

It shall not be an act of infringement to import, offer for sale, sell or use: 

a) any patented product; 

b) any product obtained directly by means of the patented process or to which the patented 

process has been applied; 

which is produced by, or with consent, conditional or otherwise, of the owner of the patent 

or his licensee. 

Based on the above provisions parallel import does not seem to be permitted where the 

products originate from markets where they are made available under a compulsory licence 

since such products would not have been put on the market by the patent owner (under 

Section 37(2)(i)) and further would not have been produced with the consent of the patent 

owner (under Section 58A(1)). 


conditions? 

NO, there is no express exception for individual prescriptions under the Act. 




Pursuant to the provisions of Section 13(d) of the Patents Act 1983 methods 

for the treatment of human or animal body by surgery or therapy, and diagnostic methods 

practiced on the human or animal body are inventions that are not patentable. 






YES, compulsory license is available in Malaysia pursuant to the provisions of Part X of the 

Patents Act 1983 which includes Sections 48 to Section 54 of the Patents Act 

1983. 

Section 48 of the Patents Act 1983 defines “compulsory license” to mean the authorization 

to perform in Malaysia without the agreement of the owner of the patent in respect of the 

patented invention including any acts to exploit the patented invention: 

The acts which consist of exploitation is limited to the following acts namely; 

a) where the patent is granted in respect of a product: making, importing, offering for sale, 

selling or using the product; stocking such product for the purpose of offering for sale, 

selling or using. 

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) where the patent is granted in respect of a process: using the process, doing any of the 

acts referred to in paragraph (a), in respect of a product obtained directly by means of 

the process. 

Pursuant to Section 49 of the Patents Act 1983 a compulsory license can be 

applied by a person anytime after the expiration of three years from the grant of the patent 

or four years from the filing date of the patent application, whichever is later on the following 

conditions: 

a) Where there is no production of the patented product or application of the patented 

process in Malaysia without any legitimate reason; 

b) Where there is no product produced in Malaysia under the patent for sale in any domestic 

market, or there are some but they are sold at unreasonably high prices or do not meet 

the public demand without any legitimate reason; 

c) Where the invention claimed in a patent cannot be worked in Malaysia without infringing 

a patent granted earlier. Such ground is known as the interdependent patents. 

The application for compulsory licence is made to the Registrar of Patents and the compulsory 

licence is granted by the Intellectual Property Corporation of Malaysia which operates under 

the name of the Malaysian Intellectual Property Office (MyIPO). 

Under Section 53 of the Patents Act 1983 of the Act a compulsory licence cannot 

be assigned otherwise than in conection with the goodwill or business or that part of the 

goodwill or business ion which the patented invention is used. Furthermore the compulsory 

licence is limited to the supply of the patented invention predominantly in Malaysia and the 

beneficiary of the compulsory licence is not allowed to conclude licence contracts with third 

persons under the patent in respect of which the compulsory licence was granted. 

No compulsory licences have yet been granted in Malaysia under the above provisions. 

However the Government has in 2003 used its power under Section 84 of the Act to authorise 

a third party to exploit a patented invention (which is a different form of compulsory licensing) 

but this is discussed under Question 8 below. 






NO, the new Article 31bis TRIPS has not yet been ratified by Malaysia but we understand that 

the Government is currently studying the issue with a view towards considering ratification of 

the provision. We are not aware of any legislative amendment in Malaysia made with a view 

to implementing the WTO decision of August 30, 2003. 



YES, the Government has the right to use a patented invention without previous license 

based on the conditions set out under Section 84(1)(a) and (b) of the Patents 

Act 1983. 

Pursuant to Section 84(1) of the Patents Act 1983 the Government may authorize 

a Government Agency or a third party designated by the Government to exploit a patented 

invention on the following grounds and conditions: 

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i) Where there is national emergency or where the public interest, in particular, national 

security, nutrition, health or the development of other vital sectors of the national economy 

as determined by the Government; 

ii) Where a judicial or relevant authority has determined that the manner of exploitation by 

this owner of the patent or his licensee is anti-competitive. 

This right of the Government has been exercised once before in October 2003 whereby 

a Malaysian company was given the authorisation for a period of 2 years (1 November 

2003 to 31 October 2005) to exploit patented inventions for certain anti-retroviral medicines 

used in the treatment of Acquired Immuno Deficiency Syndrome (AIDS) including Didnosine, 

Zidovudine and Lamivudine with a correspondiong limited right to import the said drugs from 

Mumbai-based pharma manufacturer CIPLA. 


Currently there is no law which allows the Government to expropriate a patent. 





Our patent law does not seem to recognise other means of facilitating access to medicines, 

medical devices, diagnostics and the like. 













We are unable to comment on the above except to say that the above appear to be policy 

decisions which the Government need to consider in seeking to balance the interests of patent 

owners and public health. 



We are unable to comment on the above. 




We are unable to comment on the above. 

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Questions 

Mexico 

Mexique 

Mexiko 

Report Q202 

in the name of the Mexican Group 

by Hedwig LINDNER and Manuel MORANTE 






Article 22.I of the Mexican Industrial Property Law states the right conferred by a patent shall 

not have any effect against a third party who, in the private or academic sphere and for 

non-commercial purposes, engages in scientific or technological research activities 

for purely experimental, testing or teaching purposes, and to that end, manufactures or uses 

a product or a process identical to the one patented. 






exception? 

The Bolar exception is not recognized under the Mexican Industrial Property Law, but is 

recognized, in the case of pharmaceutical products, by regulations issued under the Health 

Law. Specifically, Article 167bis of the Reglamento de Insumos para la Salud (Regulations on 

Health-Related Consumable Goods) states: 

ARTICLE 167 bis. – An applicant for registration [of a patent] covering an allopathic 

medicine must attach to the application documentation which demonstrates that it is the 

owner of the patent for the substance or active ingredient or has a license for the same, which 

in either case must be recorded with the Mexican Institute of Industrial Property. 

Alternatively, and in accordance with the list of products contained in Article 47bis of the 

Industrial Property Regulations, [the applicant] may state under oath that it has complied 

with the applicable provisions of patent law regarding the substance or active ingredient 

that is the subject of the application. In this case, the Secretary will immediately request the 

technical assistance of the Mexican Institute of Industrial Property in order to determine, within 

the scope of its competence, within ten business days of the reception of the request, if any 

subsisting patent rights are infringed. If the Mexican Institute of Industrial Property concludes 

that there are subsisting patents covering the substance or active ingredient which are not 

owned by or licensed to the applicant, it will so inform the Secretary so that the applicant may 

be notified. The applicant must demonstrate that it is the owner of the patent or has a license 

to use the same, within such period as may be determined by the Secretary, and which may 

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not be less than five business days counted from the date on which the notification becomes 

effective. If the applicant does not respond to the omission, the Secretary shall reject the 

application, and inform the applicant of the basis for its determination, so that the issue may 

be resolved [on appeal] by the competent authority. The lack of a response by the Mexican 

Institute of Industrial Property within the period noted above shall be understood in a manner 

favorable to the applicant. 

Notwithstanding the provisions of the previous paragraphs, it shall be possible to request 

registration of a generic [substance] with respect to a medication, the substance or active 

ingredient of which is protected by a patent, for the purpose of undertaking studies, tests, or 

experimental production of the same, within three years of the expiration of the patent. En 

such a case, the sanitary registration shall be granted only until the expiration of the patent. 

Information referenced in Articles 167 and 167bis of this Regulation which is of a confidential 

or secret nature as provided in international treaties to which Mexico is a party, or other legal 

provisions, shall be protected from disclosure to other private parties. 




Parallel imports of patented goods are permitted under Mexican law. Article 22.II of the 

Mexican Industrial Property Law states that the rights conferred by a patent shall have no 

effect against any person who markets, acquires or uses the patented product or the product 

obtained by means of the patented process, after the product has been lawfully placed 

on the market. The patent provisions of the Industrial Property Law (unlike the trademark 

provisions) do not state whether exhaustion is national or international in scope. 


conditions? 

The individual prescriptions exception is not recognized under Mexican patent law. 




The Mexican Industrial Property law expressly excludes methods of medical treatment from 

patentability. Article 19.VII expressly states that “methods of surgical, therapeutic or diagnostic 

treatment applicable to the human body or to animals” are not “inventions” eligible for patent 

protection. 






Any person may apply for a compulsory license within three years of the patent grant, or 

four years from the filing of the application (whichever is later), if the invention has not been 

exploited, and there are no valid reasons for the lack of exploitation. The license may not be 

granted if the patent owner or a licensee is importing the patented product. 

The applicant for a compulsory license must have the technical ability and economic means 

to efficiently use the patented invention. 

Before the grant of a first compulsory license, the Institute shall allow the patent owner one 

year to make use of the patent. The license, if granted must state the duration, terms and 

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scope of the license, and the amount of royalties due. If a compulsory license has previously 

been granted, the holder of that license shall be notified and heard. 

The Institute may declare that the patent has lapsed if the compulsory license does not result 

in use of the patented invention within two years of the grant of the license, or if the patent 

owner fails to show use of the patented invention, or justify its lack of use. 

The Institute may modify the terms of the compulsory license at the request of the licensor or 

licensee, if, for example, the patent owner has granted another party a license under more 

favorable terms. 

The compulsory license may be revoked after two years (ex officio or at the licensor’s request) 

if the licensee does not begin using the patent, or justify its lack of use. 

The compulsory license shall not be exclusive. The licensee may not assign the license without 

permission of the institute, and the license may be transferred in connection with that part of 

the production unit in which the licensed patent is being used. 

The payment of royalties under the compulsory license shall terminate when the patent lapses 

or is terminated. 






On December 2007, Article 31bis of TRIPS was ratified by the Mexican Senate. On January 21st, 2008, the Decree of Implementation was published in the Official Gazette of the Federation. 

However, no compulsory licenses regarding the import or export of pharmaceutical products 

have been granted to date. 



The Mexican government is not allowed to make use of a patented invention without a 

previous license. 


The Mexican government is not allowed to expropriate a patent. 





Article 77 of the Mexican Industrial Property Law allows licenses to be granted for reasons of 

national security or emergency, for as long as these conditions continue to exist. The outbreak 

of a serious disease may constitute an emergency. The outbreak of a serious disease may 

constitute an emergency if the production, supply or public distribution of staple goods or 

services or medicines would be prevented, hindered, or made more expensive in the absence 

of a license. 

The General Health Council may issue a Declaration of Priority Attention on its own initiative, 

or in response to a written request from an accredited organization. Once the Council’s 

declaration has been published in the Official Journal, pharmaceutical firms may request 

that the Institute grant a license of public utility, and the Institute shall grant the license after 

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hearing the parties, within 90 days of the request, or such shorter period as may be justified 

by the circumstances. 

The Secretary of Health shall determine the conditions of production and quality, duration 

and scope of the license, and the classification of the applicant’s technical ability. After 

hearing both parties, the Institute shall establish a reasonable royalty to be paid to the patent 

owner. 

Licenses granted under this provision may not be exclusive or transferable. 















Heightened scrutiny of patentability, in order to avoid the grant of incremental patents that 

unduly extend patent protection. 




Harmonization of exceptions to patent rights should be achieved, to permit better responses 

to health emergencies by the social security regimes of developed and underdeveloped 

economies. 

Summary 

Mexican patent law already recognizes some limitations to the exclusive rights conferred by 

pharmaceutical patents, such as research and experiment exception, Bolar exception, compulsory 

licenses and licenses of public utility. However there are still grey areas like the parallel imports 

regime. 

It would be desirable to have a more harmonized system which balances all the interests involved 

in the patent system, in order to achieve a better scenario for public health. 

Résumé 

Dans la loi mexicaine de propriété industrielle, se reconnaissent déjà quelque les limitations a la 

exclusivité des droits attribuent aux brevets pharmaceutiques, comment les suivants: l’exception du 

recherche et expérimentation, léxception Bolar, les licences obligatoire et les licences de utilité 

publique. Ceci dit, il y a des zones inconnues comme le régime de l’importation parallèle. 

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Il serait souhaitable d´ avoir un panorama du système plus harmonieux, dans le quel tous les 

intérêts en relation avec la protection des brevets, avec lóbjectif dácquérir une meilleure situation 

pour la santé publique. 


Das mexikanische Patentrecht anerkennt bereits gewisse Begrenzungen in den ausschliesslichen 

Rechten welche die pharmazeutischen Patente gewähren, wie zum Beispiel die Untersuchungs- und 

Versuchsausnahme, die Bolar Ausnahme, Zwangslizenzen und Lizenzen der öffentlichen Dienste. Es 

bestehen allerdings immer noch Grauzonen wie die Paralleleinfuhrregelung. 

Es wäre wünschenswert über ein harmonischeres System zu verfügen, welches alle Interessen im 

Zusammenhang mit dem Patentsystem in ein Gleichgewicht bringen würde, um auf diese Weise 

bessere Bedingungen für das öffentliche Gesundheitswesen zu schaffen. 

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215-220_Q202_Mexico.indd 220 17.07.2009 10:25:53

Netherlands 

Pays–Bas 

Niederlande 

Report Q202 

in the name of the Dutch Group 

by Koen BijvaNK, Peter BreePoel, anke Heezius, otto sweNs and Francis vaN velseN 

Questions 






summary: 

Yes. under article 53(3) Dutch Patent act 1995, the exclusive rights of the patent owner are 

curtailed by the experimental use exemption. 

answer: 

Therefore, acts solely serving for research on the patented subject matter are permitted, 

including the product obtained directly as a result of using the patented process. The research 

or experimental use is not permitted for commercial purposes, but this does not mean that the 

research may not be performed in a commercial company or further to an assignment by a 

commercial company (ars v organon [1994] Nj 1995, 33). 

The exemption, however, has to be interpreted restrictively, meaning that patent infringing 

activities are allowed only if this is justified by the purpose of the research. 

This is only the case if the party undertaking the research can prove that the research is entirely 

scientific in nature or if the research is aimed at realising a purpose that is in conformity with 

the intent of the patent law (iCi v Medicopharma [1992] Nj 1993/81). 

such a purpose can be further developing a certain technique. a good example hereof, is the 

research and manufacturing of pharmaceutical substances and/ or products with the purpose 

to find a second (or next) medical use (Boehringer v Kirin Amgen [1995] ‘NJ 1995/103). 

However, clinical trials that take place on a very large scale (various research centers) and 

which are aimed at examining whether a patented invention can be put into practice and 

can be further developed does not fall under the research exemption. This type of research 

concerns the application of the patented invention and, therefore, research with the patented 

invention (ars v organon [1995] Nj 1997, 41). 






exception? 

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221-226_Q202_Netherlands.indd 221 17.07.2009 10:26:20

summary: 

Yes, Article 10 (6) of the EU Directive 2004/27/EC and Article 13 (6) of EU Directive 2004/28 

introduced the Bolar exception in the european Community law. 

answer: 

These two provisions have been implemented in Dutch law in the Dutch Patent act 1995, in 

a new article 53 (4) which stipulates that conducting the necessary studies and trials with 

a view to the application of article 10, paragraphs 1, 2, 3 and 4 of EU Directive 2001/83 

or article 13, paragraphs 1 to 5 of EU Directive 2001/82 and the consequential practical 

requirements shall not be regarded as contrary to patent rights or to supplementary protection 

certificates for medicinal products. 

The Bolar exception relates to studies and trials relating to generic human and veterinary 

(biological) medicinal products, as set forth in the aforementioned paragraphs of the two eu 

Directives. it can be assumed that the exception does not relate to research tools or medical 

devices, as these product will – generally – not meet the definition of ‘medicinal product’. 

with respect to the relation between article 53 (3), discussed above under 1, and 53 (4), it 

is noted that the Bolar exception of article 53 (4) can be seen as a lex specialis vis-à-vis the 

general experimental use exception of article 53 (3). This general experimental use remains 

in force and also the case law referred to above under 1 is still relevant for the interpretation 

of this general exception. However, it should be noted that where the case law relates to 

research that (now) falls within the scope of the new Bolar provision of article 53 (4) – and 

contains stricter views on when trials are exempted from patent infringement than this new 

article –, it is no longer valid. 




summary: 

Yes. under article 53(5) Dutch Patent act 1995, once a patented product has been put on 

the market lawfully in the Netherlands or the Netherlands antilles, or once it is put on the 

market lawfully in one of the Member states of the european union or in another state that 

is party to the agreement concerning the european economic area by the patentee or with 

his consent, the person who obtains or later holds the product shall not infringe the patent by 

parallel import and/or further distribution. 

answer: 

This article in the Patent act does not distinguish in the type of consent. However, in accordance 

with eCj 9 july 1985, C-19/84 Pharmon vs Hoechst, the term “consent” does not include 

consent under a compulsory license. 

Furthermore, the ‘specific mechanism’ (Annex IV(2) of the Act of Accession signed on 16 April 

2003) has introduced the requirement that parallel traders in certain circumstances need to 

provide confirmation to the competent authority that they have informed the patent holder 

one month in advance of a notification for a parallel distribution. In a recent case, Court of 

The Hague, 19 March 2008, Fisher Farma vs Z-Index, it was confirmed that only notice by 

the parallel distributor is required, and not a notice of the relevant health authority confirming 

that the proposed repackaged medicinal product complies with the terms of the Community 

Marketing authorisation and the pharmaceutical legislation. 

although branding issues may play a role in parallel distribution, these are disregarded 

within the context of Q202. 


conditions? 

222 


summary: 

No, the current Dutch Patent act 1995 does not (longer) recognise an individual prescriptions 

exception. 

answer: 

The old Dutch Patent act used to contain this exception, in article 53(3) DPa (old): “The 

exclusive right shall likewise not extend to the preparation of medicines in pharmacies for 

immediate use in individual cases on medical prescription, or to acts related to medicines 

prepared in this manner.” This article was never enacted, and has been removed from the 

law in November 2004. 




under article 3(1)(f) Dutch Patent act 1995 methods for treatment of the human body or 

animal body whether through surgery or medical treatment and diagnostic methods practiced 

on the human or animal body, are excluded from patentability. 






summary: 

Yes, compulsory licenses are available under Dutch law. 

answer: 

according to art. 57 Dutch Patent act 1995, a compulsory license may be obtained: 

– if the public interest warrants it (paragraph 1), 

– if neither the patentee, nor a licensee uses the invention in the Netherlands within three 

years after the grant of the patent (paragraphs 2 and 3), 

– for using an invention protected by a later patent, which invention constitutes a 

technological progress of a significant economic meaning (paragraph 4), 

– in case the license is necessary for using a granted plant breeder’s right (paragraph 5). 

The Minister of justice of aruba can, based on the “arubaanse octrooiverordening” (aB, 

1997, 29) grant a compulsory license in the ‘general interest’. For the Netherlands Antilles, 

the Dutch Patent act 1995 is applicable and the Dutch Minister of economic affairs can grant 

a compulsory license. 

For the public health related scope of Q202, the compulsory licenses that may be obtained 

in view of the public interest are of primary interest. These compulsory licenses are granted 

by the Minister of economic affairs upon request under certain conditions. These conditions 

include a specific definition of the scope of the license and of the entity requesting it. The 

Minister will inquire whether the patentee is willing to grant the license voluntarily. if the 

patentee refuses, and the Minister is convinced that granting the license is in the public 

interest he may do so. The Minister may require that the licensee deposits a security. The 

compulsory license so obtained may be limited in time. also, a suitable compensation for the 

limitation of the patentee’s rights will be payable by the licensee. In case of a dispute about 

the height of the compensation, parties may resort to the Court. 

The law does not give a definition of when the requirement that the license is in the public 

interest is met. Case law clarifies that the public interest must be of considerable weight to 

justify a limitation of the patentee’s rights. The sole examples in the Netherlands of granting 

223 


a compulsory license in the public interest dates from shortly after world war ii, when 

the financial situation and reconstruction of the country was deemed to justify the grant 

of a compulsory license to rebuild national industries. Compulsory license for medical or 

pharmaceutical products in the Netherlands have, to our knowledge, never been granted. 

High prices are by the Dutch court not considered as a reason to grant a compulsory license 

in the ‘general interest’. In some cases, alleged infringers have invoked a provision from 

civil law (Art. 6:168 of the Dutch Civil Code) to try to prevent an injunction. This provision 

stipulates that an injunction of an illegitimate act will not be granted in case this act needs to 

be condoned on the basis of significant public interest. The case law is not unambiguous in 

this respect. 

in a case where this provision was invoked successfully (District Court of the Hague, November 

21, 1989 in schneider/aCs), the Court held that the interest of patients undergoing treatment 

could outweigh the financial interests of the patentee to obtain an injunction. It was considered 

that the financial interests of the patentee could be compensated by way of damages and an 

injunction was refused. 

That condoning of the infringement must serve a significant public interest is clear from 

another case (District Court of the Hague, May 3, 1995 in C.r. Bard inc./TD Medical). The 

Court decided that the evidence merely supported that some cardiologists had a personal 

preference for the infringing catheter, and not that the infringing product was so unique that 

there were no real alternatives. 

In another case (District Court of the Hague, December 17, 2003 in Medinol/Boston Scientific), 

the Court was confronted with a defense from the infringer that he was the only one marketing 

drug coated stents. an injunction would thus be detrimental to the public health. The Court 

decided that the patentee had to grant a license to the infringer under reasonable conditions, 

pending the outcome of the appeal and of the (then still pending) oppositions proceedings 

against the patents involved before the European Patent Office. 






summary: 

Yes, the Dutch Parliament has ratified the Protocol of Geneva (2005), amending the TRIPS 

agreement in accordance with the Doha declaration, on 31st October 2007, as the sixth 

country of the 150 Members. 

answer: 

Parliament have requested that the same shall be approved by the Netherlands antilles and 

aruba (Kamerstuk 31 272 (r 1838)). 

Voting on ratification of the new Article 31 bis of TRIPS was not deemed necessary for The 

Netherlands as EC regulation No 816/2006 on compulsory licensing of patents relating 

to the manufacture of pharmaceutical products for export to countries with public health 

problems, was already in place, implementing the Doha declaration into Dutch law. This 

Regulation was issued in May 2006. The Regulation has direct effect in the Netherlands and 

supersedes the previous rules of policy adopted on 17 December 2004, which have been 

withdrawn by decision of 7 December 2006 (see Q 94). 

The Dutch Group is not aware of any compulsory licenses that have been granted for the 

importation or exportation of pharmaceutical products granted under these new rules in the 

Netherlands. 

224 




summary: 

Yes. according to article 59 of the Dutch Patent act 1995 the Dutch government can decide 

(by a royal Decree) that it can make use of a patented invention without previous license. 

answer: 

This can be done under the condition that it is necessary for the defense of the Kingdom. This 

decision has to be requested collectively by the Minister of economic affairs and the Minister 

responsible for the defense of the country. subsequent to this decision the Minister responsible 

for the defense of the country shall negotiate with the patentee about a compensation for 

such use. if such negotiation does not lead to an agreement, a party can request the judge to 

decide on the compensation to be paid (Article 58(6) Dutch Patent Act). 


No mechanism of expropriation of patents by the government is available in the Dutch Patent 

act 1995. The principle of expropriation as existing under general Dutch law has never been 

applied to patent law. 





No such other tools for facilitating access to medicines and the like are available. 




Yes, and in particular the Dutch group recommends to clearly define which research and 

experimental use is exactly exempted. 


Yes, although the term Bolar exception may be ambiguous, particularly where it concerns 

borderline products (part medical device, part medicinal product). They also fall under the 

definition of ‘medical device’ provided for in EU Directive 93/42. The new EU Directive 

2007/47 which revises the rules on medical devices, provides that the ‘medicinal product’ 

part of borderline products must be examined in conformity with the rules on medicinal 

products, to which the Bolar exception does apply. The Dutch group believes that there 

is no good reason not to apply the Bolar exception to such borderline products that will 

be subject to the same regulatory approval as generic medicines. 


No, parallel import should only be possible when patent rights have been exhausted. 


No; the Dutch group does not see a need for this provision. There does not seem to exist 

a clear purpose to include such exception. 


No; as a method of medical treatment is not always considered as a patentable invention 

(as in The Netherlands), such a defence not be regulated in patent law. 

225 



Yes, as a general principle the government should have means to limit the scope of 

exclusive rights that have been granted where the interest of the public so requires. 


The Dutch group does not see a need for expropriation of patent rights. 




No. The Dutch group does not expect that limitations to patent rights will facilitate access to 

medicines etc. in a substantial and sustainable manner. The solution of the problem of public 

health may also be a political and/or budgetarial problem, which requires social economic 

restructuring. 



access to medicines e.g. by export to thrid world countries may be facilitated and so 

encouraged if inter alia the rights of the patent owner and protection against parallel import 

are better safeguarded (in conformity with article 4 of the annex to the TriPs agreement). 

This requires a pro-active role of the Council for TriPs. 

also, the Dutch Group recommends the use of (non-violation) complaints against countries 

who, when applying compulsory licenses in the context of public health, strictly act in 

accordance with the rules but de facto act against the spirit of the TriPs agreement (articles 

XXiii:1b GaTT 1994). 

also, additional measures might be introduced into patent law in order to limit the 

disadvantageous consequences of the grant of a compulsory license for a patentee. examples 

are: the grant of a limited period of extension of the patent term as a compensation to (periods 

of) compulsory licensing, subject to certain further requirements that need to be defined; and/ 

or attribution of (more) intellectual or moral recognition to the inventor(s) of a patent subject 

to a compulsory license. 

in order to limit the risk of potential consequent (infringing) parallel trade of exported 

medicines, pro-active enforcement of rights by customs (also in the country of export) is seen 

as a relevant means to minimize such risk (article 69 TRIPS). It might be helpful if it would 

be clarified whether in that context export or transport can be considered as acts of patent 

infringement. 




The Dutch group is in favour of harmonisation of these provisions on a supra national 

level. However, as individual prescriptions will generally take place on a small scale and 

will normally not have a cross border effect, the need for harmonization of the individual 

prescription exception is not seen as a priority. 

226 


Questions 

Norway 

Norvège 

Norwegen 

Report Q202 

in the name of the Norwegian Group 

by Inga KAASEN and Erik HELSTAD 






Under Norwegian law there is an experimental use exception. A prerequisite is that the 

experiment is set up to investigate or improve the invention itself. 






exception? 

The Norwegian Patents Act does not currently mention a Bolar-type exception. However, 

a Bolar-type exception as set out in EU/EEA marketing authorisation regulations for 

pharmaceutical products will be introduced in Norway. In the meantime, it is not unlikely that 

the experimental use exception would be construed so as to include a Bolar type exception 

for drugs. 




Parallel imports of any type of product are permitted, provided the products were brought to 

market in the EEA. However, imports of medicines from certain EEAcountries where patent 

protection for drugs was not available when the Norwegian patent application was submitted, 

could be refused by the patent holder. 


conditions? 

An individual prescriptions exception is recognised under Norwegian patent law. The 

prerequisite is that the prescription is an isolated incidence. 

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227-230_Q202_Norway.indd 227 17.07.2009 10:26:50




N/A. 






Compulsory licenses are available on the grounds of non-use, use of the invention being 

necessary for the use of another patented invention or plant variety right, important public 

interests, the patent holder significantly limiting competition, and in some instances of prior 

use or substantial preparation for exploitation of the invention. Compulsory licenses are 

granted by the court or by the Norwegian Competition Authority. There are a considerable 

number of prerequisites for the granting of compulsory licenses on the different grounds. The 

general prerequisites are (i) that effort has been made to obtain a license on normal business 

terms by agreement without achieving it in reasonable time, and (ii) the party aspiring the 

compulsory license is presumed to be able to exploit the invention in an acceptable manner. 

A compulsory licence will not prevent the patent holder from exploiting the invention or 

granting licences. A compulsory licence is only assignable in conjunction with the enterprise 

where it is being used or intended to be used, and it should mainly be given with the aim 

of supplying the domestic market. There is an exception from the latter for the export of 

medicines to certain developing countries. 






The new article has been adopted by Norway (decision by the Ministry of Foreign Affairs). 

The rules were implemented effective January 1, 2008. To our knowledge, no such licenses 

have been granted. 



There are no regulations allowing the government to make use of a patented invention without 

previous licence, except a provision to the effect that a right to utilize inventions which the 

government deems to have significance for the national defence may be granted to the 

authorities or others, when desirable in order that the invention may have the maximum utility 

for the national defence. 


According to the Patent Act section 70, when it is necessary because of war or danger of war 

and situations of crisis connected therewith, the government may expropriate the right to an 

invention on behalf of the government itself or a third party. Compensation shall be paid. 

According to the section 6 of the Act on inventions with significance for the Defence of the 

Realm, inventions that the government deems to have significance for the defence, be ceded 

to the authorities or other persons, when this is desirable in order that the invention may have 

the maximum utility for the defence. 

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Under the Civil Defense Act, the Ministry of Justice can expropriate any property and rights 

necessary to prevent or repair harm an to the civilian population from acts of war, but also, 

subject to governmental decree, to prevent or repair harm that is not caused by acts of war. 





In the context of public health crises, the compulsory licensing system would 

ensure access to medicines, medical devices, diagnostics and the like; see our 

answer to question 6. 

In relation to the issue of timely consumer information on generic drug approvals, it should be 

noted that the access to generic drugs is an integral part of the prescription and distribution 

system for pharmaceuticals. 

The system includes a list of the products that are interchangeable; the original product and 

the different generics in each group. 

This list can be found and accessed on the web page of the Medicines Agency. 

The maximum price eligible for reimbursement will be reduced step-wise, following the 

introduction of a product on the list of interchangeable products. 

For products included in this system, following the prescription of the physician the pharmacy 

shall be able to deliver one product within the fixed maximum for reimbursement (in most cases 

a generic drug) in each group. The patient will only be reimbursed the fixed reimbursement 

price. If he chooses to buy the more expensive original he must pay the balance amount 

himself. 

However, if the physician makes a specific note on the prescription, stating that the patient 

shall receive the original product, and setting out medical grounds for this, the patient will be 

reimbursed accordingly. 




YES. These means may facilitate new inventions in the medical area. Once the inventions 

are made, the holder of the original patent will be protected to the normal extent in 

cases where utilization of the new invention infringes the original patent. In order to not 

undermine patents on research tools, such exceptions should be limited to instances were 

the invention is being examined or improved. 


There are different views on this issue within the Norwegian group, so the group has no 

official position. 


NO. A general rule, based on global exhaustion of patent rights, and not limited to 

regional exhaustion within the EEA, is likely to undermine the economic function of 

patents. 


YES. This could be important in some few instances, and is unlikely to affect the patent 

holder in any substantial way. 

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YES To the extent that medical treatments are patentable, the availability of a medical 

treatment defence appears to be justified. 


YES. On the grounds of important public interests. 


NO. It is thought that compulsory licensing will be sufficient. 






A well-functioning patent system will have this effect. 




Yes, harmonisation of these rules between jurisdiction would bring considerable advantages. 

The group has no specific suggestions as to what approach one should take to achieve 

harmonisation. 

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Questions 

Peru 

Pérou 

Peru 

Report Q202 

in the name of the Peruvian Group 

by María DEL CARMEN ARANA COURREJOLLES 






Our patent law recognises as exception patent rights, research and experimentation, so the 

invention is allowed to be used for those purposes without any compensation for the owner. 

Our law allows experimentation of an invention without the authorization of the patent owner 

for acts which only purpose is experimentation. 

This recognition is set forth in Article 53, paragraphs b) and c) of Decision 486, Common 

Intellectual Property Regime, wherein it is stated that a patent owner may not exercise the 

right referred to in Article 52 with respect to the following acts: 

b) acts carried out exclusively to experiment with the subject matter of the patented 

invention; 

c) acts carried out exclusively for the purposes of teaching or scientific or academic 

research; 

Paragraph b) refers to the possibility of manufacturing products with the invention but in a 

restricted way, that is to say those which are only necessary for experimentation but not for 

trade. 

With regard to scientific research, it is also recognised in paragraph c) as an exception under 

the condition of teaching, scientific and academic purposes. It is possible to manufacture 

products with a patented matter in order to achieve a better understanding at the learning 

level and to develop abilities and skills of scientific research and, for this end, it may be 

necessary to use certain protected patent. 






exception? 

A Bolar-type exception is not at present recognised under our current law, but a regulation on 

bolar-type exception will be incorporated, since article 16.9.5. of Trade Promotion Agreement 

Peru-USA includes the bolar-type exception which allows a third party using a matter 

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protected by an in force patent in order to produce the necessary information for supporting 

the approval application for trading a pharmaceutical or chemical-agricultural product. That 

third party will cause that any good manufactured by virtue of said authorization will not be 

manufactured, used, sold, offered for sale, or imported in its territory with purposes other 

than those related to produce information; in order to fulfil the approval requirements for 

trading that product once the patent has expired and, if the patent allows export the product 

will only be exported outside the territory of said third party in order to fulfil its approval 

requirements for trading. 

The bolar-type exception is not also covered by the research investigation. 




Article 54 of Decision 486, Common Intellectual Property Regime, allows parallel imports of 

any product protected by a patent, including medicines, medical devices or similar, under 

the way of international exhaustion right, which consists in that a patent shall not confer on 

its owner the right to proceed against a third party making commercial use of a product 

protected by a patent once that product has been introduced into the commerce of any 

country by the owner or another person authorized by the right holder or with economic ties 

to that patent owner; that is to say, inventor after the first sale loses his exclusive right of resale 

or distribution since his rights have been exhausted remaining without any control upon the 

prices. 


conditions? 

With regard to individual prescriptions, and from a public health point of view, our patent 

law does not have any exclusion of patent effects to the medicines prepared in an individual 

case in a drugstore or by a practitioner, that is to say, Article 54 regarding exceptions does 

not include a regulation related to medicine acts for individual cases. 




They are not patentable. 






Yes, they are. Chapter VII of Decision 486, On the Regime of Compulsory Licensing, sets forth 

some aspects concerning compulsory licenses by regulating it in nine articles. 

Fields: 

A compulsory license would be granted in the following fields: 

– When on applying for the compulsory license the patent had not been exploited in the 

member country wherein the license has been applied for, in the terms set forth in Articles 

59 and 60 of Decision 486, or if the patent exploitation had been suspended for more 

than one year, provided that the patent owner does not justify his inactivity with rightful 

excuses, including force majeure reasons or act of God. In this case, the interested 

party applying for the compulsory license should have attempted to obtain a contractual 

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license in reasonable conditions, and there should have elapsed a term of three years 

counted from the granting date of the patent or four years from its application date, 

whatever is the oldest. 

– Due to reasons of public interest, emergency or national security, after a declaration of 

a member country of the existence of said reasons, and only during the period these 

reasons elapse. Granting of compulsory license due to reasons of public interest does 

not impede the patent owner the right to continuing exploiting it. 

– When it is applied for the patent owner, the exploitation of which necessarily requires the 

use of another one, provided that the owner had not obtained a contractual license under 

reasonable commercial conditions. This license will be under the following conditions: 

• The invention claimed in the second patent should be an important technical progress 

of a considerable economic importance with regard to the invention claimed in the 

first patent; 

• The first patent owner will have right to a cross-license under reasonable conditions 

for exploiting the invention claimed in the second patent; and 

• License of the first patent cannot be assigned without the assignment of the second 

one. 

Conditions: 

Compulsory licenses will be under the following conditions: 





binding; 





authorized; 



the competent national authority to be anti-competitive in accordance with articles 65 

and 66; 


each case, taking into account the economic value of the license, without prejudice to the 

stipulations of article 66; and 


In our country no compulsory licenses have been granted yet, although they are included in 

our law. 






Article 31bis TRIPS has not yet been ratified in our country. 

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In order to implement the WTO decision, on August 30, 2003, in the Trade Promotion 

Agreement Peru-USA an Article 13 has been included regarding an understanding with 

regard to certain measures of public health whereby it is recognised the undertaking of 

having access to medicines supplied pursuant to Decision of General Counsel of August 30, 

2003 on Implementation of Paragraph Six of Doha Declaration, related to TRIPS. 

In our country a compulsory license for import or export of pharmaceutical products has not 

been granted yet. 



The government cannot use a patented invention without a previous compulsory license. 


Our law does not include any regulation allowing expropriation of a patent. 





Our patent law recognises facilitating access to medicines and the like in the context of 

public health crises, through compulsory licenses in emergency cases, public interest and 

national security, with a prior declaration of reasons of the member country. Within cases 

of emergency, public interest and national security it is included to adopt the necessary 

measures for protecting public health. These cases may be HIV AIDS, tuberculosis, malaria 

and other epidemics. 




Yes, provided that the purposes are scientific and teaching which suppose the need of 

technical progress. 


It is allowed that third parties use a matter protected by an in force patent for information 

of support for approval application in order to trade the product once the patent has 

expired. This will allow production of generic products before the expiration of the patent 

in order to guarantee its introduction immediately after the patent has expired but without 

authorizing its trade. 

Peru has the following proposal: 

“The patent owner will not be able to exercise the right of ius prohibendi, referred to in 

Article 52 when a third party uses the matter protected by and in force patent in order to 

produce the necessary information for supporting the approval application for trading a 

pharmaceutical or chemical-agricultural product.” 


Parallel imports are based on the owner exhaustion right principle once the product has 

been launched into the market. Therefore the countries are at the liberty to purchase 

medicines in the most convenient market. Parallel imports make possible competition 

of products of the same manufacturer of different markets and allow fixing different 

prices for the same product thus the consumer takes advantage thereof. In Peru most of 

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the population has limited access to medicaments due to economic limitations, which 

circumstance has lead to take special attention regarding public health. 


As an individual prescriptions exception it can mentioned the fact that the patent owner 

will not be able to exercise the right to avoid third parties without his consent to carry out 

acts consisting of medical preparations for individual cases of emergency. 


It is not patentable. 


In exceptional cases expressly foreseen by law. 


It will not be accepted in general terms. It only would be accepted in those cases wherein 

after trying to obtain a compulsory license it has not been granted and exploitation of 

the patent is necessary for the treatment of an epidemic afflicting the country with a high 

death rate. 



In our case these methods are not patentable. 






Yes, they should. In the case of individual prescriptions for emergency cases, in the case of 

bolar-type exceptions limited to agro-chemical products and drugs and only for obtaining 

necessary information for trade authorizations. In the case of research and experimental use, 

when the patent refers to knowledge in the matter of biotechnology, which is necessary to 

continue with the research and scientific development, and with regard to the experimental 

use when it is a matter of a patentable matter that is necessary for continuing the experimental 

use for obtaining a result in the health field. 

Résumé 

Notre Péruvienne régulation reconnaître comme l’exception droits de patent, l’investigation and 

l’expérimentation. 

En ce qui concerne avec la Médicine, notre régulation aussi reconnaître des parelles d’importation. 

Il rende possible la compétition de produits des mêmes fabricants du différent marchés et permet 

d’établir différent prix pour le mêmes produits; alors, les consommateurs bénéficier de cet là. 

Notre régulation comprendre les licences obligatoires pour les raisons de publique intérêts, 

d’urgences ou de sécurité nationale. Nous vous saurions gré d’être au courant que les permis forcés 

seront dans certaines conditions. Dans notre pays, on n’a accordé encore aucun permis forcé, bien 

qu’ils soient inclus dans notre loi. 

D’ailleurs, nous considérons cela dans le contexte des crises de santé publique, par les permis 

forcés, dans les cas d’urgence, l’intérêt public et la sécurité nationale qu’il est inclus pour adopter 

les mesures nécessaires pour protéger la santé publique. 

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D’une part, notre droit des brevets péruvien ni n’a n’importe quelle exclusion de prescription 

individuelle ni inclut n’importe quelle expropriation laissant réglementaire d’un brevet. D’ailleurs, 

rendez-vous compte avec bonté que les méthodes thérapeutiques ne sont pas patentable. 

Le groupe péruvien considère également que l’inclusion de l’exception de Bolar dans la législation 

péruvienne permettra à la production des produits génériques avant que l’expiration du brevet afin 

de garantir son introduction juste après le pâté. 


Unser peruanisches Recht erkennt das Patentrecht, die Forschung und das Experimentieren als 

Ausnahme an. 

Unsere Vorschriften erkennen auch den parallelen Import im Fall der Medizin an. 

Dies ermöglicht den Wettbewerb von Produkten der gleichen Hersteller in verschiedenen Märkten 

und erlaubt die Festlegung von unterschiedlichen Preisen für dasselbe Erzeugnis, so dass der 

Verbraucher Vorteile erzielt. 

Es sind auch Zwangslizenzen aus besonderen Gründen z.B. der Nationalen Sicherheit, der 

öffentlichen Interessen oder im Notfall zu genehmigen. 

Man sollte unterstreichen, dass die Zwangslizenzen unter bestimmten Bedingungen herbeigeführt 

werden. In unserem Land wurden noch nicht Zwangslizenzen bewilligt, selbst wenn sie in unserem 

Gesetz einbezogen werden. 

Ausserdem sind wir der Meinung, dass im Rahmen der Krise des öffentlichen Gesundheitswesens 

durch die Zwangslizenzen im Notfall, Nationale Sicherheit und öffentliche Interessen, die richtigen 

Massnahme zum Schutz des Gesundheitswesens beschlossen werden. 

Andererseits hat unser peruanisches Patentrecht weder ausschliessende Ausnahmen für individuelle 

Rezepte noch Vorschriften zur Enteignung eines Patents. 

Allerdings wird darin festgestellt, dass therapeutische Methoden nicht patentierbar sind. 

Die peruanische Gruppe ist auch der Meinung, dass die Annahme der Bolar Ausnahme in der 

peruanischen Gesetzgebung die Produktion von einem pharmazeutischem Generikum vor Ende 

der Lizenz erlauben wird. Damit wird ihre schnelle Einführung nach dem Ende der Lizenz garantiert, 

trotz keiner vorhandenen Genehmigung zum Handel. 

236 

231-236_Q202_Peru.indd 236 17.07.2009 10:27:20

Questions 

Philippines 

Philippines 

Philippinen 

Report Q202 

in the name of the Philippine Group 

by Rogelio NICANDRO 






Yes. Section 72.3) of the Philippine IP Code (Republic Act No. 8293) provides that the owner 

of a patent has no right to prevent third parties from making or using a patented product or 

process where the making or using is done exclusively for the purpose of experiments that 

relate to the subject matter of the patented invention. 

Section 72.3), however, does not specify the conditions under which the provision applies. 

Neither is the scope of the research exception defined. 

We believe that research or experimental use for commercial purposes is not covered because 

of the employment of the phrase “exclusively for the purpose of experiments.” 






exception? 

There is no specific provision under our Intellectual Property Code covering a Bolar-type 

exception. 

We believe that the use of an invention without the patentee’s consent for the purpose of 

obtaining approval of a generic product before the expiry date of the patent is not covered 

by the research exception. The Bolar type exception appears to be not for purely experimental 

purposes but is undertaken with a view to the marketing of a generic product. 

However, a proposed law, House Bill No. 2844, entitled “Cheaper Medicine Act” provides 

for a Bolar type exception, subject to certain rules and regulations to be issued by the IPO in 

consultation with appropriate government agencies. 




237 

237-244_Q202_Philippines.indd 237 17.07.2009 10:27:45

There is no specific provision under the Intellectual Property Code allowing parallel imports 

of patented medicines, medical devices or similar goods. Article 6 of the TRIPS Agreement, to 

which the Philippines is a signatory, has given member countries the freedom to incorporate 

the principle of exhaustion of rights into their domestic law with a national, regional or 

international reach. Internationally applied, the exhaustion principle will allow parallel 

imports from any country. For now, however there is yet no law on this matter although there 

is a pending bill (House Bill No. 2844, supra) intended to cover this matter. 


conditions? 

Section 72.4) of our IP Code provides that the owner of a patent has no right to prevent third 

parties from the preparation for individual cases, in a pharmacy or by a medical professional, 

of a medicine in accordance with a medical prescription or acts concerning the medicine so 

prepared; 

For the exception to apply, therefore, the preparation of the patented drug for an individual 

case must be done in a pharmacy or by a medical professional pursuant to a medical 

prescription. 




Our IP Code in Section 22.3) specifically excludes from patent protection methods of treatment 

for both human or animal body. We quote the said provision. 

Sec. 22) Non Patentable Inventions – The following shall be excluded from patent 

protection: 

22.3) Methods for treatment of the human or animal body by surgery or therapy and 

diagnostic methods practiced on the human or animal body. This provision shall not apply to 

products and composition for use in any of these methods; 






Yes, Sections 93-102 of our IP Code cover compulsory licenses. Sec. 93) specifically provides 

the circumstances or grounds under which a compulsory license may be granted, namely: 

1) National emergency or other circumstances of extreme urgency; 

2) Where the public interest, in particular, national security, nutrition, health or the 

development of other vital sectors of the national economy as determined by the 

appropriate agency of the Government, so requires; or 

3) Where a judicial or administrative body has determined that the manner of exploitation 

by the owner of the patent or his licensee is anti-competitive; or 

4) In case of public non-commercial use of the patent by the patentee, without satisfactory 

reason; 

5) If the patented invention is not being worked in the Philippines on a commercial scale, 

although capable of being worked, without satisfactory reason: Provided, That the 

importation of the patented article shall constitute working or using the patent. 

238 


It may be instructive to likewise state the conditions under which the requirements for the grant 

of a compulsory license need not be observed; in other words, the situations where compulsory 

license may be issued even though no efforts have been exerted by the petitioner to obtain a 

voluntary license before filing a petition for compulsory license. Section 95 provides: 

Sec. 95) Requirement to obtain a License on Reasonable Commercial Terms. 

95.1) The license will only be granted after the petitioner has made efforts to obtain 

authorization from the patent owner on reasonable commercial terms and conditions 

but such efforts have not been successful within a reasonable period of time. 

95.2) The requirement under Subsection 95.1 shall not apply in the following cases: 

a) where the petition for compulsory license seeks to remedy a practice determined 

after judicial or administrative process to be anti-competitive; 

b) in situations of national emergency or other circumstances of extreme urgency; 

c) in cases of public non-commercial use. 

95.3) In situations of national emergency or other circumstances of exreme urgency, the 

right holder shall be notified as soon as reasonably practicable. 

95.4) In the case of public non-commercial use, where the government or contractor, without 

making a patent search, knows or has demonstrable grounds to know that a valid 

patent is or will be used by or for the government, the right holder shall be informed 

promptly. 

Yes, we are aware of a few compulsory licenses for the manufacture and supply of 

pharmaceutical products granted in our country. The said compulsory licenses together with 

their respective status are as follows: 

1. IPC No. 1907 – 1-(1,3-DIOXOLAN-2-YLMETHYL)-1H-IMIDAZOLES AND 1H-1,2,4- 

TRIAZOLES 

PETITIONER UNITED LABORATORIES, INC., LOCAL (MANDALUYONG CITY RESPONDENT- 

PATENTEE-JAN HEERES, LEO J.J. BACKX AND JOSEPH H. MOSTMANS, FOREIGN 

(BELGIUM) 

– Date Filed: February 18, 1985 

– Decided under ORDER NO. 2002-16 (D) dated 04/11/2002 

– Lapse/expired 

2. IPC NO. 2058 – MAINTENANCE TREATMENT FOR THE PROPHYLAXIS..... 

PETITIONER – DOCTORS PHARMACEUTICAL, INC., LOCAL (CALOOCAN) RESPONDENT- 

PATENTEE-SMITHKLINE & FRENCH LAB., FOREIGN (ENGLAND) 

– Date Filed: 3/30/1987 

– Decided under DECISION NO. 94-20 DATED 02/14/1994 

– Granted Petitioner 

3. IPC NO. 2065 – NOVEL N-HETEROCYCLYL-4-PIPERIDINAMINES, PHARMACEUTICAL 

COMPOSITION CONTAINING SAME & METHOD OF USE. 

PETITIONER-UNITED LABORATORIES, INC., LOCAL 

RESPONDENT-PATENTEE-JANSSEN PHARMACEUTICA, N.V., FOREIGN 

– Date Filed: 6/30/1987 


– Lapse/expired 

239 


4. IPC NO. 2085-1-CYCLOPROPYL-6 FLUORO-1..... 

PETITIONER – UNITED LABORATORIES INC., LOCAL – (MANDALUYONG) RESPONDENT- 

PATENTEE – BAYER AKTIENGESELLSCHAFT, FOREIGN (GERMANY) 

– Date Filed: 10/02/1987 

– Decided under DECISION NO. 2002-15 dated 08/23/2002 

– Granted/Petitioner 

5. IPC NO. 3098 –CARBOSTYRIL DERIVATIVES AND PROCESS FOR PREPARING THE 

SAME. 

PETITIONER-UNITED LABORATORIES, INC., LOCAL (MANDALUYONG) 

RESPONDENT-PATENTEE – KAZAYUKI NAKAGAWA, ET. AL., FOREIGN (JAPAN) 

– Date Filed: 06/30/1988 



6. IPC NO. 3252 –BUSPIRONE ANTI-ANXIETY METHOD 

PETITIONER-UNITED LABORATORIES INC., LOCAL (MANDALUYONG) 

RESPONDENT-PATENTEE-BRISTOL-MYERS COMPANY LTD., FOREIGN (U.S.A.) 

– Date Filed: 10/04/1988 


– Lapse /expired 

7. IPC NO. 3851 –AMINOALKYL-FURAN DERIVATIVES 

PETITIONER – UNITED LABORATORIES INC., LOCAL (MANDALUYONG) 

RESPONDENT-PATENTEE-GLAXO GROUP LIMITED, FOREIGN (ENGLAND) 

– Date Filed: 12/08/1992 



8. IPC NO. 3852 – PHARMACEUTICAL COMPOSITION CONTAINING FORM 2 RANITIDINE 

HYDROCHLORIDE & PROCESS 

PETITIONER – UNITED LABORATORIES INC., LOCAL (MANDALUYONG) 

RESPONDENT-PATENTEE – GLAXO GROUP LIMITED, FOREIGN (ENGLAND) 

– Date Filed: 12/08/1992 








Article 31 bis TRIPS has not been ratified in the Philippines. 

The aforementioned House Bill 2844 provides specifically in the proposed new Section 93-A 

of the IP Code for the grant of a compulsory license to import patented drugs or medicines 

pursuant to the WTO decision of August 30, 2003. 

No compulsory licenses have been granted in the Philippines for the importation or exportation 

of pharmaceutical products. 

240 




Our IP Code specifically provides the conditions under which the government may make use 

of a patented invention without previous license. Sec. 74) provides as follows: 

Sec. 74) Use of invention by Government – 74.1) A Government agency or third person 

authorized by the Government may exploit the invention even without agreement of the 

patent owner where: 

a) the public interest, in particular, national security, nutrition, health or the development of 

other sectors, as determined by the appropriate agency of the government, so requires; 

or 

b) a judicial or administrative body has determined that the manner of exploitation, by the 

owner of the patent or his licensee, is anti-competitive. 

74.2) The use by the Government, or third person authorized by the Government shall be 

subject, mutatis mutandis, to the conditions set forth in Sections 95 to 97 and 100 to 102. 

For a better grasp and understanding of these conditions and for easy reference, we quote 

verbatim Sections 95-97 and 100-102: 

Sec. 95) Requirement to obtain a License on Reasonable Commercial Terms. 

95.1) The license will only be granted after the petitioner has made efforts to obtain 

authorization from the patent owner on reasonable commercial terms and conditions but 

such efforts have not been successful within a reasonable period of time. 

95.2) The requirement under Subsection 95.1 shall not apply in the following cases: 

d) where the petition for compulsory license seeks to remedy a practice determined after 

judicial or administrative process to be anti-competitive; 

e) in situations of national emergency or other circumstances of extreme urgency; 

f) in cases of public non-commercial use. 

95.3) In situations of national emergency or other circumstances of exreme urgency, the right 

holder shall be notified as soon as reasonably practicable. 

95.4) In the case of public non-commercial use, where the government or contractor, without 

making a patent search, knows or has demonstrable grounds to know that a valid patent is or 

will be used by or for the government, the right holder shall be informed promptly. 

Sec. 96) Compulsory Licensing of Patents Involving Semi-Conductor Technology- In the case 

of compulsory licensing of patents involving semi-conductor technology, the license may only 

be granted in case of public non-commercial use or to remedy a practice determined after 

judicial or administrative process to be anti-competetive. 

Sec. 97) Compulsory License Based on Interdependence of Patents. – If the invention protected 

by a patent, hereafter referred to as the “second patent,” within the country cannot be worked 

without infringing another patent, hereafter referred to as the “first patent,” granted on a prior 

application or benefiting from an earlier priority, a compulsory license may be granted to the 

owner of the second patent to the extent necessary for the working of his invention, subject 

to the following conditions: 

97.1) The invention claimed in the second patent involves an important technical advance 

of considerable economic significance in relation to the first patent; 

97.2) The owner of the first patent shall be entitled to a cross-license on reasonable terms 

to use the invention claimed in the second patent; 

241 


97.3) The use authorized in respect of the first patent shall be non-assignable except with 

the assignment of the second patent; and 

97.4) The terms and conditions of Sections 95, 96 and 98 to 100 of this Act. (Sec. 34-C, 

R.A. No. 165a) 

Sec. 100) Terms and Conditions of Compulsory License – The basic terms and conditions 

including the rate of royalties of a compulsory license shall be fixed by the Director of Legal 

Affairs subject to the following conditions: 

100.1) The scope and duration of such license shall be limited to the purpose for which it was 

authorized; 

100.2) The license shall be non-exclusive; 

100.3) The license shall be non-assignable, except with that part of the enterprise or business 

with which the invention is being exploited; 

100.4) Use of the subject matter of the license shall be devoted predominantly for the supply 

of the Philippine market: Provided, That this limitation shall not apply where the grant of 

the license is based on the ground that the patentee’s manner of exploiting the patent is 

determined by judicial or administrative process, to be anti-competitive; 

100.5) The license may be terminated upon proper showing that circumstances which led to 

its grant have ceased to exist and are unlikely to recur: Provided, That adequate protection 

shall be afforded to the legitimate interest of the licensee; and 

100.6) The patentee shall be paid adequate remuneration taking into account the economic 

value of the grant or authorization, except that in cases where the license was granted to 

remedy a practice which was determined after judicial or administrative process, to be anticompetitive, 

the need to correct the anti-competitive practice may be taken into account in 

fixing the amount of remuneration. 

Sec. 101) Amendment, Cancellation, Surrender of Compulsory License. – 101.1. Upon the 

request of the patentee or the licensee, the Director of Legal Affairs may amend the decision 

granting the compulsory license, upon proper showing of new facts or circumstances justifying 

such amendment. 

101.2) Upon the request of the patentee, the said Director may cancel the compulsory 

license: 

a) If the ground for the grant of the compulsory license no longer exists and is unlikely to 

recur; 

b) If the licensee has neither begun to supply the domestic market nor made serious 

preparation threfor; 

c) If the licensee has not complied with the prescribed terms of the license; 

101.3) The licensee may surrender the license by a written declaration submitted to the 

Office. 

101.4) The said Director shall cause the amendment, surrender, or cancellation in the Register, 

notify the patentee, and/or the licensee, and cause notice thereof to be published in the IPO 

Gazette. 

Sec. 102) Licensees Exemption from Liability – Any person who works a patented product, 

substance and/or process under a license granted under this Chapter, shall be free from 

any liability for infringement: Provided, however, That in the case of voluntary licensing, no 

collusion with the licensor is proven. This is without prejudice to the right of the rightful owner 

of the patent to recover from the licensor whatever he may have received as royalties under 

the license. 

242 



There is no specific provision in the IP Code allowing outright expropriation by the government 

of a patent. 





Our IP Code does not specifically provide for means to facilitate access to medicines, medical 

devices, etc. in the context of public health crisis. 

However, the Philippines is a signatory to the Doha Convention which recognizes the need 

to make provisions to allow access by the poorer sector of the society to medicines, medical 

devices, etc. Presently, the pending bill (House Bill No. 2844, supra) in the Philippine Congress 

is intended to address this situation. 




Since our IP Code already provides for use of experimental exception this item need not 

be answered here. 


Under certain circumstances, a Bolar exception may be likewise provided in the IP Code 

with sufficient safeguard to protect investment of patentees for their patented medical 

product. 


The authorization of parallel imports of patented medicine may likewise be provided but 

the conditions under which such import may be made to protect drug companies and or 

distributor from losing their investments should be provided. 


Since the Philippine IP Code already provides an individual prescription exception, this 

question does not apply to the Philippines. 


This exception is already provided in our IP Code (Sec. 72.4, supra). 


Our IP Code already provides an entire chapter to this subject. 


This may be only provided in extreme situations because it is a harsh measure even if just 

compensation is required. 



None. Regard should also be made for the time, research and promotion efforts and 

expense of the patentee to create and develop the patented medicine. Additional 

limitations to the patentee’s rights may affect adversely new research and development 

efforts. 

243 




At the present time, No. 




Yes, through the WTO. 

244 


Questions 

Portugal 

Portugal 

Portugal 

Report Q202 

in the name of the Portuguese Group 

by António ANDRADE, António CORTE-REAL CRUZ, João Paulo MIOLUDO, 

Miguel QUINTANS and João PIMENTA 




Yes, in accordance with paragraph c) of Article 102 of the Portuguese Industrial Property 

Code – IPC (“Limitation of the rights conferred by a patent”): 

“The rights conferred by a patent shall not cover: 

c) Acts carried out exclusively for testing or experimental purposes (…)”. 

If so, under which conditions? What is the scope of the research exception? 

“(…) although the industrial or commercial working of such products cannot begin before the 

patent which protects them has lapsed” (Article 102(c) in fine). 

The scope of use for testing or experimen¬tal purposes covers, in particular, scientific acts in 

the field of research, including in-house tests and experiments. 

Specifically, is research or experimental use permitted for commercial purposes? 

Portuguese law does not expressly provide that use within the scope of tests or experiments 

cannot be carried out for commercial purposes. 

Accordingly, commercial purposes per se in the abovementioned field are not legally 

prohibited. 

However, commercial purposes naturally do not include the actual commercial working of the 

product resulting from experiments or tests. In fact, it is necessary to bear in mind the express 

limitation laid down in the law, i.e. “(…) although the industrial or commercial working of 

such products cannot begin before the patent which protects them has lapsed” (Article 102(c) 

in fine). 


Yes, in accordance with paragraph c) of Article 102 of the IPC (“Limitation of the rights 

conferred by a patent”): 


c) Acts carried out exclusively for testing or experimental purposes, including experiments for 

the preparation of the administrative procedures necessary for the approval of products by 

the competent official bodies (…)”. 

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245-252_Q202_Portugal.indd 245 17.07.2009 10:28:21

If so, under which conditions? What is the scope of the Bolar exception? 

The conditions are limited to the preparation of the administrative procedures necessary for 

the approval of products by the competent official bodies. 

In Portugal, the commercialisation of medicinal products requires the prior administrative 

authorisation of the National Health and Drug Agency (INFARMED), which is responsible 

for the approval of authorisations to place products on the market (Marketing Authorisations 

– MAs). 

The statute which regulates this matter is Decree-Law no. 176/2006 of 30th August 2006 

(known as the Medicinal Product Statute). 

The MA normally leads to a subsequent and necessary approval of the price of the medicinal 

product by the Portuguese Department of Economic Activities, in accordance with Decree- 

Law no. 65/2007 of 14th March 2007. 

Generic drugs for which MAs and public price approval have been obtained are sold at a 

price which is 35% lower than the price of the original drug, in accordance with Decree-Law 

no. 65/2007 of 14 th March 2007. 

It is also necessary to take into account that the abovementioned Decree-Law no. 176/2006 

of 30th August 2006 provides in Article 19(8) that “Notwithstanding the provisions of Article 

102 of the Industrial Property Code, the conducting of the studies and tests necessary for the 

application of paragraphs 1 to 6, and the practical requirements arising therefrom, do not go 

against the rights relating to patents or to supplementary protection certificates for medicinal 

products.” 

Thus, the use of chemico-pharmaceutical products which are protected by patents that are 

valid and in force is permitted for the purpose of the said studies and tests, within the scope 

of the administrative procedures for the approval of medicinal products. 

However, once again, the abovementioned legal limitation within the scope of the IPC must 

be borne in mind, i.e. “(…) although the industrial or commercial working of such products 

cannot begin before the patent which protects them has lapsed” (Article 102(c) in fine). 

Specifically, is it limited to drugs or does it also apply to other products, including biological 

products, research tools, etc.? 

The law is not expressly limited to drugs, meaning that there is no reason to sustain that the 

Bolar exception does not also apply to biological products, research tools, etc. 




This is not applicable, in view of the fact that Portuguese law specifically contains a Bolar 

provision/clause. 




This matter is related to the exhaustion of the right as provided, with regard to patents, under 

Article 103 of the IPC, which states as follows: 

“1. The rights conferred by a patent shall not allow the patentee to prohibit acts relating to 

the patented products after they have been put on the market, by himself or with his consent, 

in the European Economic Area.” 

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245-252_Q202_Portugal.indd 246 17.07.2009 10:28:21

That is to say, exhaustion of the right at Community level is expressly provided for, but 

international exhaustion is not. 

Thus, there is no provision in Portuguese law providing for international exhaustion. 

In any case, the aforementioned Medicinal Product Statute (Decree-Law no. 176/2006 of 

30th August 2006) contains a section devoted to parallel importation, wherein the conditions 

under which it is permitted and the respective requirements are duly defined: 

“1 – The parallel importation of medicinal products is subject to the following conditions and 

requirements: 

a) A valid marketing authorisation has been granted for the medicinal product in the 

Member State of origin; 

b) The parallel import is notified to the holder of the Portuguese marketing authorisation for 

the medicinal product concerned; 

c) The parallel import is authorised on the terms provided in the present decree-law; 

d) The medicinal product is commercialised in compliance with the conditions laid down in 

the present decree-law and other applicable legislation. 

2 – Parallel importation is only permitted in the case of medicinal products which meet the 

following requirements: 

a) In relation to the medicinal product concerned, they have the same quantitative and 

qualitative composition in terms of active substances, the same pharmaceutical form and 

the same therapeutic indications; 

b) They have a common origin; 

c) Where there is no common origin, authorisation does not constitute a risk to public 

health; 

d) They use different excipients or excipients in different quantities without any therapeutic 

impact.” 

The entity responsible for authorising the parallel import is INFARMED, which verifies whether 

the abovementioned conditions and other formal requirements stipulated in the aforesaid law 

are met. 


conditions? 

Yes, in accordance with paragraph b) of Article 102 of the IPC (“Limitation of the rights 

conferred by a patent”): 


b) The preparation of medicines made instantly and for individual cases with a prescription in 

pharmacy laboratories, or acts related to medicines prepared in this way.” 





Portuguese law does not permit the protection, as a patent right, of “surgical or therapeutic 

methods of treatment of humans or animals and diagnostic methods applicable to humans or 

animals shall not be patentable, although the products, substances or compositions used in 

any of these methods shall be patentable” (Article 52(2) of the IPC). 

247 

245-252_Q202_Portugal.indd 247 17.07.2009 10:28:21



public interest grounds, etc.)? 

Yes, in accordance with Article 107 of the IPC (“Compulsory licences”): 

“1. Compulsory licences may be recorded against a certain patent in any of the following 

cases: 

a) Non-working or insufficient working of the patented invention; 

b) Dependency between patents; 

c) For reasons of public interest.” 

Public interest is defined in Article 110(2) and (3) of the IPC: 

“2. Reasons of public interest shall be considered to exist if the commencement, increase or 

generalisation of the working of the invention or the improvement of the conditions in which 

such working is effected are of supreme importance to public health or national defence. 

3. Reasons of public interest shall also be considered to exist if failure to work the invention 

or insufficient working in terms of quality or quantity causes serious damage to Portugal’s 

economic or technological development.” 

The conditions and requirements for compulsory licences are laid down in Article 107(2) to 

(7) of the IPC. 

Furthermore, the aforementioned Medicinal Product Statute (Decree-Law no. 176/2006 of 

30th August 2006) provides in Article 92(1)(a) and (b) two situations which fall within the 

concept of public interest, by express reference to the said Article 110 of the IPC, through 

Article 93(4) of the Medicinal Product Statute. 

These situations are the following: 

“INFARMED can authorise the use in Portugal of medicinal products not possessing the 

authorisations stipulated in the present decree-law under either of the following conditions: 

a) When, based on clinical grounds, they are considered to be essential for the prevention, 

diagnosis or treatment of certain pathologies; 

b) When they are necessary in response to the actual or potential spread of pathogenic 

agents, toxins, chemical agents or nuclear radiation susceptible of causing harm.” 


and supply of pharmaceutical products? If so, please provide details, including the name of 

the licensor, the licensee and the product covered. 

Yes, there was a case involving a patent whose subject matter was a plant protection product 

(Portuguese patent no. 76.136), in respect of which a compulsory licence was granted by the 

Portuguese Industrial Property Office on 31st October 2002 (Patentee: Syngenta; Licensee: 

Sapec Agro). 






Article 31bis TRIPS has not yet been ratified in Portugal. 

There are no other legislative instruments with a view to implementing the WTO decision 

of 30th August 2003. In any case, this decision can naturally be applied in Portugal, even 

248 

245-252_Q202_Portugal.indd 248 17.07.2009 10:28:21

though there are no practical cases exemplifying specific situations in which the said decision 

has been taken into consideration by the Portuguese State. 

Regarding compulsory licences, please see the reply to question 6). 



The short answer is no, i.e. without previous licence, the government cannot use a patent, not 

even for a type of “crown use”. 

However, although Portuguese law does not expressly permit this situation, it is possible to 

sustain the analogous application of Article 110 of the IPC, which stipulates that the owner of 

a patent may be compelled to grant a licence for the use or working of a patent, provided that 

the legal requirements which define public interest are duly met, and the potential licensees 

would include the State. Therefore, the State could force the owner of a patent to grant a 

licence in its favour, which would constitute a type of “crown use”, but through the formal 

existence of a licence. 

In fact, the abovementioned article of the IPC states that: 

“1. For reasons of public interest the patentee may be compelled to grant a licence to work 

the respective invention.” 

Public interest is defined in Article 110(2) and (3) of the same legal statute: 

“2. Reasons of public interest shall be considered to exist if the commencement, increase or 

generalisation of the working of the invention or the improvement of the conditions in which 

such working is effected are of supreme importance to public health or national defence. 

3. Reasons of public interest shall also be considered to exist if failure to work the invention 

or insufficient working in terms of quality or quantity causes serious damage to Portugal’s 

economic or technological development.” 


Yes, in view of the fact that Portuguese law provides as follows (in Article 105 of the IPC): 

“1. A person may be legally deprived of a patent on account of contractual obligations with 

others or if the patent is expropriated for a public purpose. 

2. Any patent may be expropriated for public purposes, against payment of just compensation, 

should it become necessary to make the invention accessible to the public or should its use 

by public bodies so require. 

3. The terms of the Expropriation Code, with the necessary adaptations, shall apply.” 





This is not applicable, as Portuguese law does not recognise these other means. 






249 

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As discussed in the replies set out above, Portuguese law provides for most of the normal 

limitations of patent rights, i.e. the research and experimental use exception, Bolar 

exception, parallel importation, individual prescriptions exception, compulsory licences and 


Thus, we consider that the provisions relating to legal limitations, on the precise terms on 

which they are defined, are in themselves sufficient for safeguarding issues concerning the 

public interest of public health, in general terms. 



Bearing in mind what was stated in the previous reply, i.e. that the provisions relating to legal 

limitations are sufficient, we do not see any other limitations that might be useful for facilitating 

access to medicines, diagnostics, medical devices and the like. 




Likewise, we do not believe that it would be advisable to harmonise the limitations in question, 

in view of the fact that each State has its own specific needs, which relate in particular to a 

market that is also specific. 

Therefore, a harmonisation of the exceptions in question could prejudice these specificities of 

each State and leave no room for issues that need to be adapted to each market. 

Nevertheless, since Portuguese law is sufficient and balanced in terms of its provisions 

regarding the limitations of patent rights, it could serve as the “basis”, or at least as a “good 

example”, for a possible harmonisation, even though some of the limitations provided under 

Portuguese law are naturally already the result of harmonisation within the field of Community/ 

European Union law. 

Summary 

The protection of public health is one of the most relevant and pressing issues all over the world. 

The “Patent System”, and in the case of the present question chemico-pharmaceutical patents, 

promote scientific and technological innovation and, as a result, there have been significant 

advances in the treatment of diseases and general health conditions among the population. 

Although they may naturally be compatible, what is under discussion here is the dual-faceted 

question of the protection of public health/“Patent System”, in particular the ideal way in which they 

can be made to work together. 

This is a complex issue, which involves many different aspects, with some of the main concerns 

relating to the capacity to manufacture/produce and commercialise/distribute (patented) medicines, 

especially during epidemics or pandemics. 

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245-252_Q202_Portugal.indd 250 17.07.2009 10:28:21

In order both to resolve the abovementioned problem and to contribute towards research, the 

“Patent System” provides for limitations of the rights conferred by patents. 

Some of these limitations are examined in the question under analysis, particularly in terms of 

“access” to chemico-pharmaceutical and biotechnological patents by third parties. 

Portuguese law provides for most of the normal limitations of patent rights, i.e. the research and 

experimental use exception (Article 102(c) of the Portuguese Industrial Property Code), the Bolar 

exception (same article and paragraph), parallel importation (the IPC provides for exhaustion at 

Community level, but not international exhaustion), the individual prescriptions exception (Article 

102(b) IPC), compulsory licences (Article 107 IPC) and expropriation (Article 105 IPC). 

Article 31bis TRIPS, however, has not yet been ratified in Portugal and there are no other legislative 

instruments with a view to implementing the WTO decision of 30th August 2003. In any case, this 

decision can naturally be applied in Portugal, even though there are no practical cases exemplifying 

specific situations in which the said decision has been taken into consideration by the Portuguese 

State. 

Finally, it is considered that Portuguese law is sufficient and balanced in terms of its provisions 

regarding the limitations of patent rights and it could thus serve as the “basis”, or at least as a 

“good example”, for a possible harmonisation, even though some of the limitations provided under 

Portuguese law are naturally already the result of harmonisation within the field of Community/ 

European Union law. 

Résumé 

La protection de la santé publique est l’une des questions les plus pertinentes et pressantes dans 

tout le monde. 

Le „Système des Brevets“, et dans le cas de la présente question les brevets chimio-pharmaceutiques, 

promeuvent l’innovation scientifique et technologique et, en conséquence, il y a eu d’importants 

progrès dans le traitement de maladies et des conditions générales de santé de la population. 

Bien qu’ils puissant naturellement être compatibles, ce qui est en discussion ici, c’est la question à 

deux facettes de la protection de la santé publique et du „Système des Brevets“, en particulier la 

façon idéale de les faire fonctionner ensemble. 

Il s’agit d’une question complexe, qui porte sur de multiples aspects, l’une des principales 

inquiétudes concernant la capacité de fabrication/production et la commercialisation/distribution 

de médicaments (brevetés), surtout pendant les périodes d’épidémies ou de pandémies. 

Afin de résoudre le problème décrit ci-dessus et de contribuer à la recherche, le „Système des 

Brevets“ prévoit des limitations aux droits conférés par les brevets. 

Cette question traitera de quelques-unes de ces limitations, notamment du point de vue de „l’accès“ 

aux brevets chimio-pharmaceutiques et biotechnologiques par les tiers. 

La loi portugaise prévoit la plupart des limitations normales aux droits conférés par les brevets, 

c’est-à-dire l’exception d’utilisation de recherche et d’expérimentation (article 102, paragraphe c) 

du Code de la Propriété Industrielle portugais), l’exception Bolar (mêmes article et paragraphe), 

l’importation parallèle (le CPI prévoit l’épuisement communautaire des droits, mais non pas 

l’épuisement international), l’exception de prescription individuelle (article 102, paragraphe b) du 

CPI), la licence obligatoire (article 107 du CPI) et l’expropriation (article 105 du CPI). 

L’article 31 bis TRIPS, pourtant, n’a pas encore été ratifié au Portugal et il n’existe aucun autre 

instrument législatif en vue d’appliquer la décision WTO du 30 août 2003. De toute façon, cette 

251 

245-252_Q202_Portugal.indd 251 17.07.2009 10:28:22

décision peut naturellement être appliquée au Portugal, bien qu’il n’existe pas de cas pratiques 

permettant d’exemplifier des situations concrètes où ladite décision ait été considérée par l’État 

portugais. 

Finalement, la loi portugaise est jugée suffisante et équilibrée par rapport aux dispositions concernant 

les limitations aux droits conférés par les brevets et donc elle pourrait server de „base“, ou au moins 

comme un „bon exemple“ pour une éventuelle harmonisation, malgré le fait que certaines des 

limitations prévues par la loi portugaise résultent déjà naturellement d’une harmonisation dans le 

cadre du droit communautaire/de l’Union Européenne. 


Der Schutz der öffentlichen Gesundheitspflege ist eines der wichtigsten und dringensten Themen in 

der heutigen Welt. 

Das “Patentsystem” – oder, was das gegenwärtige Thema angeht, die chemischen und 

pharmazeutischen Patenten – fördert die wissenschaftliche und technologische Innovation, was als 

Folge zu signifikanten Fortschritte bei der Behandlung von Krankheiten und den Gesundheitszustand 

der Bevölkerung beigetragen hat. 

Obwohl beide offensichtlich vereinbar sein können wird heutzutage die Beziehung zwischen 

öffentliche Gesundheitspflege und “Patentsystem”, d.h. die ideale Form ihrer Vereinbarkeit, 

Gegenstand ständiger Diskussionen. 

Es handelt sich um ein komplexes Thema das zahlreiche Varianten unfasst, insbesondere gibt 

es Bedenken in Bezug auf die Fähigkeit der Herstellung/Erzeugung und des Handels/Verteilung 

von Medikamente (die Gegenstand von Patenten sind), haupsächlich im Hinblick auf mögliche 

zukünftige Epidemien und Pandemien. 

Im “Patentsystem” werden Einschränkungen der Patentrechte vorgesehen, nicht nur um das 

vorgehende Problem zu lösen, als auch um zur Forschung der Produkte beizutragen. 

Einige dieser Einschränkungen werden hier erwähnt, namentlich in Bezug auf den “Zugang” von 

Dritten zu chemischen, pharmazeutischen und biotechnologischen Patenten. 

Das portugiesische Recht umfasst die meisten der normalen Einschränkungen der Patentrechte, 

namentlich Forschung und Versuchszwecken-Ausnahme (Artikel 102, Absatz c) des portugiesischen 

Patentgesetz), Bolar-Ausnahme (derselbe Artikel und Absatz), Parallelimport (im portugiesischen 

Patentgesetz ist die gemeinschaftliche aber nicht die internationale Erschöpfung vorgesehen), 

individuelle Verschreibung-Ausnahme (Artikel 102, Absatz b) des portugiesischen Patentgesetz), 

Zwangslizenz (Artikel 107 des Patentgesetz) und Enteignung (Artikel 105 des Patentgesetz). 

Zu erwähnen ist auch dass Artikel 31 bis) TRIPS noch nicht ratifiziert worden ist in Portugal, und 

ebenfalls dass es keine gesetzgebende Instrumente verfügbar sind zur Ausführung der Entschliessung 

des WTO vom 30. August 2003. Auf jeden Fall, kann diese Entschliessung sebstverständig in 

Portugal angewendet werden, obwohl man keine praktische Fälle kennt die als Beispiel dienen 

können in Bezug auf konkreter Umstände wo die Entschliessung vom portugiesischen Staat 

angenommen worden ist. 

Schliesslich muss man hervorheben dass das portugiesische Recht sowohl genügend als auch 

ausgeglichen ist im Voraussehen der Einschränkungen der Patentrechte und deshalb als “Grundlage” 

oder mindestens als “ein gutes Beispiel” dienen könnte für eine eventuelle Harmonisierung, obwohl 

einige im portugiesischen Recht vorgesehenen Einschränkungen tatsächlich bereits von einer 

Harmonisierung ableiten im Rahmen des Gemeinschaftsrechts der Europäischen Gemeinschaft. 

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245-252_Q202_Portugal.indd 252 17.07.2009 10:28:22

Questions 

Republic of Korea 

République de Corée 

Republik Korea 

Report Q202 

in the name of the Korean Group 

by Seong-Ki KIM 




Yes. Art. 96-1. 


The patented invention is worked for the purpose of research on experiment. 

What is the scope o the research exception? 

Research or experiment conducted for the purpose of improvement on advancement of the 

subject technology is considered to the exempted from patent infringement. 

Specifically, is research or experimental use permitted for commercial purposes? 

Up to now, it is not clear whether experimental use is permitted for commercial purpose. 

Recently, a legislative bill is introduced to allow such use for commercial purpose in case of 

pharmaceutical or agrochemical inventions. 


No provision is provided in a statute including the Patent Act. 

If so, under which conditions? What is the scope of the Bolar exception? Specifically, is 

it limited to drugs or does it also apply to other products, including biological products, 

research tools, etc.? 

N/A. 




Though we do not have case law on the question, commentator believe such using would be 

covered by the research exception. 

3) Are parallel imports of patented medicines, medical devices or similar permitted? 

Yes, parallel imports of patented medicines are permitted, unless an agreement has been 

made to the contrary upon its first sale. 


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253-256_Q202_Rep-Korea.indd 253 17.07.2009 10:28:57

The same as the answer above. 



Yes. 

4) Is an individual prescriptions exception recognised under your patent law? 

Yes. 


The Patent Act provides that such an exception is applicable to individual prescription mixing 

two or more ingredients. 




N/A. 

6) Are compulsory licenses available under your patent law? 

Yes, Art. 107 and Art. 138, Patent Act. 

If so, under which conditions and on which grounds (e.g. to remedy anticompetitive conduct, 

for cases of emergency, other public interest grounds, etc.)? 

One of the following grounds: 

i) insufficient working; 

ii) public interests; 

iii) to rectify anti-competitive activities; 

iv) to exploit a second, improved patent. 


and supply of pharmaceutical products? 

Six applications have made since 1966, but no grant of compulsory license has been 

made. 

If so, please provide details, including the name of the licensor, the licensee and the product 

covered. 

N/A. 


Yes. 



Amendment to the Patent Act implementing Art. 31 bis TRIS has been made and is in force 

currently. 


exportation of pharmaceutical products? 

No. 

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253-256_Q202_Rep-Korea.indd 254 17.07.2009 10:28:57

If so, please provide details, including the name of the licensor, the licensee and the product, 

if they are publicly available. 

N/A. 



In case of emergency, the Government is allowed to make use of a patented invention related 

to national defense. 


Yes, in case of national emergency of war or the like. 





N/A. 













Yes. 



Tools disseminating information on medical inventions/innovations such as the Orange Book 

should be adopted to facilitate access to medicines. 




Should be harmonized by an international treaty as guidelines. 

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253-256_Q202_Rep-Korea.indd 255 17.07.2009 10:28:57

253-256_Q202_Rep-Korea.indd 256 17.07.2009 10:28:57

Questions 

Singapore 

Singapour 

Singapur 

Report Q202 

in the name of the Singapore Group 

by Winnie THAM and Jessica WAYE 






An experimental use exception is recognised under Singapore patent law. Research use, 

while not specifically recognised under Singapore patent law, may fall into the exception 

of acts which are done privately for non-commercial purposes which is permitted under 

Singapore law. 

The scope of the experimental use exception is limited to experimental purposes “relating 

to the subject-matter of the invention”, however, while there is no established body of case 

law on this provision, there appears to be no limitation of this exception to non-commercial 

purposes. 






exception? 

Yes, a Bolar-type exception is recognised under Singapore patent law. The Bolar exception 

is limited in scope and applies only to acts performed in relation to the subject matter of 

the patent to support an application for marketing approval for a pharmaceutical product 

provided that anything produced to support the application is not 

i) made, used or sold in Singapore; or 

ii) exported outside Singapore. 

For purposes other than for purposes relating to meeting the requirements for marketing 

approval for that pharmaceutical product. 

Use of an invention without the patentee’s consent for the purpose of obtaining approval of 

a generic product would unlikely be covered under the exception of acts done privately for 

non-commercial purposes. The phrase “non-commercial purposes” is unlikely to exclude all 

acts which may have a commercial end, however, as the approval of the generic drug has an 

immediate commercial purpose and is not used for an individual’s own use and benefit, this 

exception is unlikely to apply. 

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257-260_Q202_Singapore.indd 257 17.07.2009 10:29:37




Parallel imports of patented products or products obtained by means of a patented process 

produced with the consent of the patentee is an exception to infringement. However, if 

following conditions are met, the exception does not apply 

i) the product has not previously been sold or distributed in Singapore by or with the 

written consent of the patentee or his licensee; and 

ii) the import of the product by the importer would result in the product being distributed in 

breach of contract between the patentee and his licensee; and 

iii) the importer has actual or constructive knowledge of the breach of contract indicated 

in (ii). 

This, in effect, gives the patentee the “first mover advantage” that allows him to be the first 

one to bring in the patented pharmaceutical product. However, once the patentee brings the 

pharmaceutical product into Singapore, the parallel importer will then be allowed to similarly 

import, use or dispose of a generic drug in Singapore. 

Furthermore, under Singapore law, a parallel importer is also entitled to import and use 

a drug for use by or on a specific patient. The use of the pharmaceutical product for that 

specific patient must meet the following conditions 

i) the use of the pharmaceutical product shall be by or on that patient; 

ii) the authorities must have granted approval specifically for the import of that product for 

use by or on that patient; and 

iii) that product was produced by or with the consent of the patentee or his licensee. 

It is unclear whether the same principles would apply if the products originated from markets 

where they were made available under a compulsory licence. 

However, it is suggested that the importation of products made under a compulsory licensing 

scheme would not fall under the exception as Singapore is a party to the TRIPS Agreement, and 

particularly Article 31(f). Article 31(f) enables grant of compulsory licences for “predominately 

the supply of the domestic market”. For countries that are unable to domestically manufacture 

pharmaceuticals this is problematic. Accordingly, under the 6 December 2005 amendment 

(or Article 31bis), parties have agreed to waive the restriction under Article 31(f) thereby 

allowing countries to export pharmaceutical products made under a compulsory licence. 

In this regard, Singapore has indicated that such system would only be used in emergencies 

or extremely urgent situations. Accordingly, it is unlikely that Singapore would take the general 

position to allow parallel importation of pharmaceutical products made under compulsory 

licence 

In addition to any restrictions under the Patents Act in Singapore, all medicines are subject 

to the Medicines Act and, except in accordance with a licence granted, no person shall deal 

with, procure the dealing with or exportation of, or procure the manufacture or assembly of 

a medical product. However, in order for an applicant to obtain a licence, the applicant is 

required to make a declaration, such declaration including the following information: 

i) whether a patent under the Patents Act is in force; 

ii) if there is such a patent in force, whether he is the proprietor of the patent; 

iii) if there is a patent in force, and he is not the proprietor of the patent, a declaration 

stating: 

258 

257-260_Q202_Singapore.indd 258 17.07.2009 10:29:37

• the name and particulars of the proprietor; 

• whether the proprietor has consented or has acquiesced in the grant of the licence 

to the applicant; or, in his opinion and to the best of his believe, that the patent is 

invalid or would not be infringed by the doing of the act for which the licence is 

sought. 

In the event that the applicant declares that he is not the proprietor under (iii) (listed above) 

the licensing authority may require the applicant to serve on the proprietor of the patent, 

a copy of his application and to furnish the Health Science Authority, such evidence of the 

service of the application form as the licensing authority may require. The added step of 

alerting the patent owner of the applicant’s interest in a licence assists the patent owner with 

the enforcement of his rights. 


conditions? 

An individual prescriptions exception is recognised under Singapore patent law provided 

that it meets the following conditions 

i) the act must consist of extemporaneous preparation of a medicine (or consist of dealing 

with a medicine so prepared); 

ii) the act must be performed by an individual; and 

iii) the act must be performed in accordance with a prescription given by a registered 

medical or dental practitioner. 




Under Singapore Law, a method of medical treatment is not regarded as being capable of 

industrial application and not patentable. 






Under the Singapore Patents Act any person may apply to the court for the grant of a patent 

licence on the grounds that the grant of the licence is necessary to remedy an anti-competitive 

practice if: 

i) there is a market for the patented invention in Singapore; and 

ii) that market is not being supplied or not being supplied on reasonable terms; and 

iii) the court is of the view that the proprietor of the patent has no valid reason for failing to 

supply the market with the patented invention. 

The licence granted under the compulsory licensing scheme is non-exclusive and is not 

assignable otherwise than with the goodwill of the business in which the invention was 

used. 

We are unaware of any compulsory licences granted in Singapore. 



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257-260_Q202_Singapore.indd 259 17.07.2009 10:29:38




Singapore has ratified Article 31bis however, no legislative amendments have yet been made. 

We are unaware of any compulsory licences granted in Singapore. 



The government, or any party authorised in writing by the government, is entitled to make use 

of a patented invention without a previous licence for a public non-commercial use or in the 

event of a national emergency or other circumstances of extreme urgency. 


The government has no right of expropriating a patent under Singapore law. 






















No further comment, save that Singapore is quite current with developments in this area, and has 

been moving towards the harmonisation initiatives. 

260 

257-260_Q202_Singapore.indd 260 17.07.2009 10:29:38

Questions 

South Africa 

Afrique du Sud 

Südafrika 

Report Q202 

in the name of the South African Group 

by Esmé DU PLESSIS 






There is no express provision in the South African Patents Act no. 57 of 1978 (“the Patents 

Act”) to provide for a research or experimental use exception from infringement. The only 

indication in the Patents Act that the legislature may have intended to exclude non-commercial 

use from the definition of infringement is to be found in section 45(1) of the Act. Section 45(1) 

provides as follows: 

“45.(1) The effect of a patent shall be to grant to the patentee in the Republic, subject 

to the provisions of this Act, for the duration of the patent, the right to exclude 

other persons from making, using, exercising, disposing or offering to dispose of, or 

importing the invention, so that he or she shall have and enjoy the whole profit 

and advantage accruing by reason of the invention.” (Emphasis 

added) 

It could be argued that the reference to “the whole profit and advantage” in this provision 

could be indicative of an intention by the legislature to exclude other persons from carrying out 

the prohibited acts only insofar as those acts would have prejudicial commercial implications 

for the patent owner. 

However, South Africa courts have not yet considered this aspect to pronounce a clear 

principle (on the basis of section 45(1) or any other consideration) to the effect that noncommercial 

use of a patented invention (eg for research or experiment) would avoid 

infringement. 

This issue was considered in a somewhat different context by the High Court in the case of 

Stauffer Chemicals v Monsanto Company 1988(1) SA 805(T), and the Court confirmed the 

interpretation of section 45(1) – in its form then – by finding that it entitled the patent owner to 

have and enjoy the whole profit and advantage of the invention, but that it does not prohibit 

the mere possession of an infringing article/product without an intention to use or dispose 

of it. The Court stated obiter that even experimental use of a patented invention will amount 

to an infringement in that the experiment uses the patented invention. In the Stauffer case 

the alleged infringer used the patented invention during the term of the patent to prepare 

for marketing registration of its own similar product, and the Court found that such activity 

in fact used the patented invention as a springboard to obtain an improper advantage. 

This could be viewed as gaining a commercial advantage; such use was found to constitute 

infringement. 

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261-268_Q202_South-Africa.indd 261 17.07.2009 10:30:11

Since the Stauffer case, a Bolar-type exception has been introduced by a legislative amendment 

in 2002 (see question 2) below). 






exception? 

Section 69A of the Patents Act was introduced by a legislative amendment in 2002 and 

provides for a Bolar-type exception. Section 69A provides as follows: 

“69.A(1) It shall not be an act of infringement of a patent to make, use, exercise, offer to 

dispose of, dispose of or import the patented invention on a non-commercial scale 

and solely for the purposes reasonably related to the obtaining, development and 

submission of information required under any law that regulates the manufacture, 

production, distribution, use or sale of any product. 

(2) It shall not be permitted to possess the patented invention made, used, imported 

or acquired in terms of subsection (1) for any purpose other than for the obtaining, 

development or submission of information as contemplated in that subsection.” 

It will be noted that the exception is not limited to pharmaceutical products; it applies to any 

invention (in any field of technology) in respect of which any law requires the submission of 

information for the manufacture, distribution or sale of a product. This would for example 

cover pharmaceutical and agrochemical products which require marketing authorisation 

before such products may be put on the market. 

The formulation of the provision to apply generally to all patents was specifically intended to 

comply with TRIPS Art 27.1 which provides that all inventions are to enjoy patent rights without 

discrimination as to the field of technology. 

It will also be noted that stock-piling of products made or imported under section 69A(1) is 

prohibited by section 69A(2). 




Although this aspect has not specifically been decided by South African courts in respect of 

medicines or medical devices, it is generally accepted that parallel importation of patented 

products is not permitted. In general, section 45(1) of the Patents Act (see question 1) above) 

affords the patent owner the right to exclude others from importing the invention to which 

the patent relates, while section 45(2), which provides for the exhaustion of rights, does not 

contain any wording which would indicate that international exhaustion would apply; in other 

words, that parallel importation would be permitted. 

Section 45(2) provides as follows: 

“45.(2) The disposal of a patented article by or on behalf of a patentee or his licensee shall, 

subject to other patent rights, give the purchaser the right to use, offer to dispose of 

and dispose of that article.” 

It should be noted that the acts which a purchaser would be permitted to carry out, do not 

include the importation of the patented invention. Accordingly, it is generally accepted that 

only national exhaustion of rights applies in South Africa, and that parallel importation in 

general is not permitted under the Patents Act. 

262 


This aspect was considered by the High Court in the case of Stauffer Chemical Company v 

Agricura Ltd (1979) BP 168. The Judge confirmed that only national exhaustion was intended; 

he found that he could “read nothing into section 45(2) which would induce (him) to depart 

from this principle”, namely that a purchaser of an article in a foreign country from a licensee 

of the patent owner in the foreign country, which article is patented both in the foreign country 

and in South Africa, would not acquire the right to import the article into, and sell it in, South 

Africa. 

Therefore, the principle of national exhaustion of a patent right was endorsed, so that parallel 

importation would not be permitted. 

However, the parallel importation of patented medicines was specifically 

provided for by a 1997 Amendment Act which amended the South African Medicines and 

Related Substances Act no. 101 of 1965 to introduce a new section 15C which provides as 

follows: 

“15C The Minister may prescribe conditions for the supply of more affordable medicines 

in certain circumstances so as to protect the health of the public, and in particular 

may: 

a) notwithstanding anything to the contrary contained in the Patents Act, 1978 (Act no. 

57 of 1978), determine that the rights with regard to any medicine under a patent 

granted in the Republic shall not extend to acts in respect of such medicine which has 

been put onto the market by the owner of the medicine, or with his or her consent; 

b) prescribe the conditions on which any medicine which is identical in composition, 

meets the same quality standard and is intended to have the same proprietary name 

as that of another medicine already registered in the Republic, but which is imported 

by a person other than the person who is the holder of the registration certificate of 

the medicine already registered and which originates from any site of manufacture 

of the original manufacturer as approved by the council in the prescribed manner, 

may be imported; …..” 

When section 15C was first published for comment, the initial reaction was that such a 

provision would enable the Minister to override patent rights and as such could potentially 

be contrary to TRIPS. 

However, article 8 of TRIPS allows a member state, in formulating or amending its laws and 

regulations, to adopt measures necessary to protect public health and nutrition, provided that 

such measures are consistent with the provisions of TRIPS. Accordingly, provided that section 

15C could be implemented by the Minister in a fashion which is in accordance with TRIPS, a 

strong argument could be made out that section 15C would not be contravening TRIPS. 

It should be noted that paragraph (b) of section 15C, which deals with the importation of an 

“identical” medicine does not refer to importation by persons other than the patent owner, 

but to importation by persons other than the holder of the “registration certificate” 

in respect of the medicine – presumably the certificate authorising the marketing of the 

medicines. This discrepancy created some uncertainty in the patent context. 

In regulation 7 of the Regulations issued by the Minister in terms of section 15C, there is a 

clear reference to the importation of a patented medicine sold outside South Africa with the 

consent of the patent holder, ie by the patent holder or a voluntary licensee. This is 

interpreted as an indication that parallel importation was in fact contemplated and legalised 

by the legislature in respect of patented medicines, provided the required importation permit 

is required. 

Unfortunately, however, some doubt remained because the term “parallel importation” (which 

is defined in the definitions part of the Regulations as the “importation into the Republic of a 

263 


medicine protected under patent and/or registered in the Republic that has been put onto the 

market outside the Republic by or with the consent of such patent holder”) has not been used 

in Regulation 7 itself. However, the Guidelines issued in respect of the Regulations appear to 

support the contention that parallel importation is indeed what is contemplated in Regulation 

7, and that Regulation 7 should be interpreted and applied in this sense, namely to refer to 

the importation of branded products obtained outside South Africa from the patentee or its 

authorised licensees. 

Regulation 7 sets out the requirements and conditions to be met in order to obtain an 

importation permit: 

• The medicine must have been sold outside South Africa with the consent of the patent 

holder. This means that the medicines may be obtained from a licensee under a voluntary 

licence but not under a compulsory licence. 

• The medicine must be imported from a person licensed (for marketing) by a regulatory 

authority recognised by the South African Medicines Control Council. 

• The medicine must be registered (for marketing in South Africa) in terms of the South 

African Medicines Act. 

• The medicine so imported may only be sold to the State or to a person authorised to sell 

medicines in terms of South African legislation. 

• An importation permit is valid for a period of two years. 


conditions? 

No such exception is recognised in South Africa. 




Methods of medical treatment are not patentable in South Africa. 






The Patents Act provides for compulsory licences to be obtained in two circumstances: section 

56 provides for a compulsory licence to be granted in cases of “abuse of patent rights”, and 

section 55 in the case of a so-called “dependent patent”. 

In addition, the Act provides in section 4 for a Minister of State to acquire the right to use a 

patented invention “for public purposes”. This is referred to in more detail under question 8) 

below. 

Compulsory licences for abuse of patent rights 

Section 56 identifies four scenarios in which patent rights shall be deemed to be abused: 

a) where the patented invention is not being worked in South Africa on a commercial scale 

or to an adequate extent, within certain time periods; 

b) where the demand for the patented product in South Africa is not being met to an 

adequate extent and on reasonable terms; 

264 


c) where trade or industry in South Africa is being prejudiced by reason of the refusal of 

the patent holder to grant a voluntary licence on reasonable terms, and it is in the public 

interest that a licence be granted; 

d) where the demand in South Africa for the patented product is being met by importation 

and the price charged by the patent holder is excessive in relation to the price charged 

in other countries. 

The applicant has to apply to the Court of the Commissioner of Patents for a compulsory 

licence; the procedure is a judicial one. Section 56 is substantially compliant with TRIPS Art 

31. 

Compulsory licences for a dependent patent 

Section 55 provides for a compulsory licence to be granted in the case where a “dependent” 

patent cannot be worked without infringement of a “prior” patent. Again application must be 

made to the Court of the Commissioner of Patents (ie a judicial procedure), and it is required 

that the dependent patent must involve an important technical advance of considerable 

economic benefit. 

Section 55 is substantially compliant with TRIPS Art 31(l). 

Compulsory licences for State use 

See question 8) below. 






Article 31bis of TRIPS has not yet been ratified or implemented in South Africa. No other 

legislation has been passed to implement the WTO decision of 30 August 2003. 

Four cases have been decided by the South African courts under section 56 on compulsory 

licences. None of these related to pharmaceutical products. 

Licences for the manufacture, importation and exportation of pharmaceutical products were 

granted in 2003 as a result of an intervention by the Competition Commission. In 2003 the 

provisions of the South African Competition Act no. 89 of 1993 were invoked when an NGO 

known as the Treatment Action Campaign (TAC) laid a complaint against two pharmaceutical 

companies, namely Boehringer Ingelheim and GlaxoSmithKline. 

The basis of the complaint was that these companies, in refusing to grant voluntary licences 

under their patents in respect of first-line ARVs, had engaged in prohibited anti-competitive 

acts, namely 

• denied a competitor access to an essential facility; 

• engaged in excessive pricing; 

• engaged in an exclusionary act. 

Settlement agreements were concluded as a result of the investigation by the Competition 

Commission, in terms of which one of these companies agreed to issue four licences, and the 

other three, under their patents for the ARVs to generic manufacturers. The licences were to 

permit the manufacture in, and importation into, South Africa of the ARVs. The agreements 

also allowed for the exportation of any ARVs manufactured in South Africa to all sub-Saharan 

African countries. More specifically, where the licensees did not have manufacturing 

capabilities in South Africa, the licensor permitted the importation of the drugs for distribution 

265 


in South Africa; and the licensees were permitted to combine the relevant ARV with other 

ARVs and were charged royalties of no more than 5% of the nett sales of the relevant ARVs. 



The Patents Act contains two provisions which give special powers to the State and which 

could be used as a basis for “crown use” of a patented invention. 

Section 4 provides that a Minister of State may use a patented invention “for public 

purposes” on such conditions as may be agreed upon with the patent owner, or failing 

agreement, on such conditions as one determined by the Court of the Commissioner of 

Patents. In essence this would amount to a compulsory licence mechanism. This provision, 

which is not limited to pharmaceutical products, has not yet been invoked. 

Section 78 provides that the Minister (of Trade and Industry) may, on behalf of the State, 

acquire any patented invention on such terms and conditions as may be agreed upon. In 

essence this merely enables the State to acquire patents in the normal course of business, by 

agreement with a patent owner. 


The acquisition mechanism provided for in section 78 of the Patents Act (see question 8) 

above) is not an expropriation. Moreover, section 25(1) of the Constitution of South Africa (Act 

no. 108 of 1996) provides that “no one may be deprived of property except in terms of a law 

of general application, and no law may permit arbitrary deprivation of property”. Although 

section 25(2) of the Constitution provides specifically that property may be expropriated, 

under specified circumstances, for a public purpose, no attempt has been made to create a 

law of general application which would enable the State to expropriate patents. 





The specific legislative initiative for facilitating access to medicines and medical products was 

introduced by way of the 1997 Amendment of the Medicines and Related Substances Act no. 

101 of 1965 (see question 3) above). 













It is important to accept that access to affordable medicines, particularly for poor populations 

in developing and least-developed countries, is a critical issue, and that measures to facilitate 

such access must be high on the priority list of AIPPI and individual countries. 

266 


It is also important to recognise that access to affordable medicines is not the only critical 

factor for ensuring effective treatment to poor people suffering from pandemic and endemic 

illnesses. Effective and accessible health care systems, improved living (sanitary and dietary) 

conditions, better education all play an important part. 

In adopting and promoting a workable and sustainable basket of principles for addressing 

the current public health demands, a balanced solution must be found, which would be based 

on a balanced recognition of the importance of patent and other IP rights as an incentive 

while facilitating access to medicines and health care. 

Unduly eroding the effective term and ambit of the protection afforded by patent rights on its 

own will not necessarily provide a solution. 

To achieve such a balanced solution, a uniform set of rules in regard to appropriate and 

reasonable limitations or exceptions on patent rights would be a step in the right direction 

(inter alia to discourage inappropriate and unreasonable interferences). 



Some further initiatives should also be considered within the context of patent law, eg: 

• providing for incentives to encourage relevant R&D (eg innovation prize models) 

• supporting relevant innovative activities, eg projects at universities, research on the basis 

of traditional remedies, etc 

• promoting effective and sustainable technology transfer. 

More specifically it is recommended that AIPPI should make a study of the work of the WHO’s 

Intergovernmental Working Group (IGWG), and its draft Global Strategy and Plan of Action 

on Public Health, Innovation and Intellectual Property; and, furthermore, that AIPPI should 

participate in this initiative by preparing and submitting comments and suggestions. 




Harmonisation would be good. A variety of different dispensations applicable in different 

countries open the door for price and quality differentials which would not be in the public 

interest, and could indeed be abused. 

Summary 

Although research or experimental use is not recognised as non-infringing activities, and although 

Art 39bis of TRIPS has not yet been implemented, the South African legal system provides for a 

number of different mechanisms to enable or facilitate access to patented medicines, including a 

Bolar-type early use exception; compulsory licences in the case of the abuse of the patent rights 

(eg when the demand for the patented product is not being met to an adequate extent and on 

reasonable terms); and parallel importation in terms of a permit issued under the Medicines and 

Related Substances Act, 1965. 

267 



Spain 

Espagne 

Spanien 

Report Q202 

in the name of the Spanish Group 

by Montserrat BallEStEr rodéS, Marcel.lí CurEll aGuilà, 

luis–alfonso durán, isidro José GarCía EGEa, Montserrat GarCía–MonCó, 

Patricia KoCh, Mònica lòPEz, Jorge llEvat and Marta PonS dE vall i aloMar 

Questions 






the experimental use exception is recognised under the Spanish law. in particular, article 52, 

paragraph (b) of the Patent act (act 11/1986, of 20 March, on Patents) excludes the “acts 

carried out for experimental purposes related to the subject matter of the patented invention” 

from the scope of the patents. this provision has been amended by the Second Final Provision 

of the act 29/2006, of 26 July, on Guarantees and rational use of Medicines and Medical 

devices, which implements directive 2004/27/EC of the European Parliament and of the 

Council of 31 March 2004 by including the so-called Bolar clause or Bolar exception within 

the scope of the experimental use exception. 

Prior to the amendment introduced by the said act 29/2006, it was controversial that the acts 

carried out for any purpose other than contributing to the progress of the scientific knowledge 

could be considered as included within the scope of the experimental use exception but the 

Act 29/2006 clarifies this issue by stating that other acts, in particular the preparatory acts 

for the application and obtention of regulatory approval of generic drugs, also fall within the 

scope of the said exception. 






exception? 

the act 29/2006 has amended article 52, paragraph (1)(b) of the Patent act by introducing 

the Bolar exception within the scope of the experimental use exception: “The rights conferred 

by the patent shall not extend to: (b) acts carried out for experimental purposes related to the 

subject matter of the patented invention, in particular, the studies and the tests carried out to 

obtain regulatory approval of generic drugs, either in Spain and abroad, and the subsequent 

practical requirements, including preparation, obtention and use of the active principle for 

this purpose”. 

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Even though the wording of the Bolar exception refers only to medicines, as this exception 

is covered by the experimental use exception, it cannot be excluded that it might be also 

applicable to other products whose commercialisation be subject to regulatory approval. 

nevertheless, for the time being, there is no case law which allows to clearly conclude that 

this exception extends to products other than medicines. 




the Spanish law (article 53 of the Patent act) foresees the exhaustation of patent rights. 

according to Community case law and Community legislation, this possibility extends to the 

European Economic area. 

Accordingly, parallel imports of any kind of product, including patented medicines, are 

permitted within the European Economic area. Yet, they are prohibited for products originated 

from those countries which do not belong to the European Economic area. 

In order to allow a parallel import the product must have been put on the market, within the 

European Economic area, by the patent owner or with his express consent. 

the product may not have been altered in any way (there are some exceptions established 

by European case law as regards alterations in trade marks, but these exceptions do not 

affect patents). 

These principles are not applicable to products originated from markets where they are 

commercialised under compulsory licence; patent rights are only exhausted by the placing on 

the market by the owner or with his express consent. As the owner’s consent is not required to 

obtain a compulsory licence, the “ius prohibendi” conferred by patents may not be considered 

to be exhausted. 


conditions? 

individual prescriptions or the so-called “magistral formulae” are recognised in Spain, in 

particular by article 52, paragraph (c) of the Patent act, which provides as follows: “The 

rights conferred by the patent shall not extend to: (c) the extemporaneous preparation of 

medicines in pharmacies carried out singly in making up a prescription and acts related to 

the medicines thus prepared”. 




Yes, article 4, paragraph (4) of the Patent act provides as follows: “(4) Methods for treatment 

of the human or animal body by surgery or therapy and diagnostic methods practiced on 

the human or animal body shall not be regarded as inventions which are susceptible of 

industrial application within the meaning of paragraph (1), above. This provision shall not 

apply to products, in particular, substances or compositions, nor to inventions of apparatus or 

instruments for use in any of these methods”. 






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the Spanish Patent act foresees the possibility to apply for compulsory licences (title iX). a 

compulsory licence may be applied for in four circumstances (article 86): 

a) failure or insufficiency of working of the patented invention 

b) export necessities 

c) dependency of patents 

d) existence of reasons of public interest 

According to the information provided by the Spanish Patent and Trademark Office, since 

1992 no compulsory licences have been granted for domestic manufacturing and supply 

of pharmaceutical products. Prior to that year, some compulsory licences based upon nonexploitation 

(which the Spanish law defined as lack of manufacturing within the Spanish 

territory) did exist. 

Since the amendment of the definition of exploitation to include not only the manufacturing 

but also the selling within the national territory, thus covering the market needs -provided that 

the manufacturing be carried out in a Wto member country (article 83 of the Patent act)compulsory 

licences for any of the purposes indicated in the question have no longer been 

applied for or, at least, have no longer been granted. 


article 31bis triPS was introduced by the Wto decision of 6 december 2005 in order to 

allow those countries which were not able to produce pharmaceutical products to obtain, 

if necessary, affordable copies elsewhere, in compliance with the provisions of the doha 

decision of 30 august 2003. on 30 november 2007 the European union, who is a Wto 

member, ratified this amendment, which according to Article 300, paragraph (7) of the 

treaty establishing the European Community, is legally binding in all the Eu member states, 

including Spain. Spain is also in the process to ratify this amendment. 

Be that as it may, the said amendment has not yet been formally incorporated into the triPS 

insofar as it has not yet been ratified by two thirds of its member countries, which is the 

required majority for incorporation. 



it has not been approved in Spain any legislative amendment to implement the said decision 

of 30 august 2003. Yet, the European union has adopted regulation (EC) no. 816/2006 

of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of 

patents relating to the manufacture of pharmaceutical products for export to countries with 

public health problems in order to implement the said decision. this regulation is directly 

applicable in Spain. 


exportation of pharmaceutical products? If so, please provide details, including the name of 

the licensor, the licensee and the product, if they are publicly available. 

no. 



no. 


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article 73 of the Patent act 11/1986 (SPa) foresees the possibility that the government 

expropriate patents or patent applications by paying a fair compensation. 

Art. 73 – “(1) Any patent application or patent already granted may be expropriated for 

reasons of public utility or public interest, subject to fair compensation. 

(2) Expropriation may be for the purpose of placing the invention within the public domain so 

that it may be freely worked by any person without the need to apply for licenses, or it may 

be for the purpose of exclusive working by the State, which would then acquire ownership 

of the patent. 

(3) Public utility or public interest shall be declared in the Act authorising the expropriation, 

which shall also state whether the invention shall fall within the public domain or whether the 

State shall acquire ownership of the patent or application. The procedure to be followed shall 

conform in every aspect, including fixing of fair compensation, to the general procedure laid 

down in the Act on Compulsory Expropriation.” 

a reason of public interest or public utility must exist in order to expropriate a patent or a patent 

application. the government must compensate the patent owner with a fair compensation. 

the public utility or social interest must be declared by the act ordering the expropriation. 

according to article 73, expropriation is possible in two circumstances: (i) expropriation 

for reasons of public interest carried out for the purpose of placing the invention within the 

public domain so that it may be freely worked by any person, without the need to apply for 

a licence, or (iii) expropriation for the purpose that the government may exclusively work the 

invention. 





the Spanish patent law does not set forth other means to facilitate access to medicines, 

except for those already cited in this paper (compulsory licences, Bolar clause and so on). 

the act 29/2006, of 26 July, on Guarantees and rational use of Medicines and Medical 

devices, establishes some mechanisms to facilitate access to medicines. For example, article 

24, paragraph (3) provides the possibility of “comparative use” of medicines, which means 

an authorisation to use a medicine for clinical situations of specific patients before such a 

medicine be approved in Spain. 

Equally, the Act 29/2006 provides that the Spanish Agency of Medicines and Sanitary 

Products may authorise the importation of medicines which have not been approved in Spain 

-but are being lawfully commercialised in other States- when the importation is absolutely 

necessary for the prevention, diagnostics and treatment of specific pathologies, either 

because no appropriate approved alternative for such a specific indication exists or there is 

a situation of shortage which justifies so. 

the Spanish agency of Medicines and Medical devices may also temporally authorise 

the distribution of non-approved medicines to prevent potential or actual propagation of a 

pathogen or chemical agent, toxin or nuclear radiation which may cause damages. 

the above-mentioned mechanisms do not affect the legal patent system. 





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the Spanish Patent act foresees all the above-mentioned limitations of the exclusive patent 

rights. In our opinion, this is appropriate. We have only a comment to make in this respect as 

regards the Bolar exception, which is presently foreseen in the framework of the experimental 

use exception: we think that it should be contained in a specific paragraph. 

Furthermore, a possible limitation of the exclusive rights derived from the patent system in 

order to facilitate access to medicines and the like could be envisaged. For example, such 

limitation could consist in allowing the government to use the patented invention during a 

limited period of time, without the need to request a previous licence but with the need to pay 

compensation to the patent owner. in any event, such a limitation should be applicable only 

in exceptional cases for reasons of urgency or public interest. 



no. 




Yes, in Europe by directive or regulation, and in other countries through the Wto or the 

SPlt. 

Summary 

the Spanish Patent act recognises an exception for experimental purposes of patents by establishing 

that the rights conferred by the patent shall not extend to the acts carried out for experimental 

purposes related to the subject matter of the patented invention, in particular, the studies and tests 

carried out to obtain regulatory approval of generic drugs, either in Spain or abroad, and the 

subsequent practical requirements including preparation, obtention and use of the active principle 

for this purpose. 

in applying the regulations of the European Economic Community, Spain foresees an exhaustion of 

patent rights in the field of the European Economical Area (EEA), but the international exhaustion is 

not applied. thus, parallel imports of products from the EEa are allowed, but imports of products 

originated from third countries are prohibited. the exhaustion is not applied to products produced 

in the EEa under a compulsory license. 

in Spain, the rights conferred by a patent shall not extend to the extemporaneous preparation of 

medicines in pharmacies carried out singly in making up a prescription and acts related to the 

medicines thus prepared. 

in Spain, methods for treatment of the human or animal body by surgery or therapy and diagnostic 

methods practised on the human or animal body shall be regarded as inventions, which are not 

susceptible of industrial application and thus not patentable. Spain, as a country adhered to the 

European Patent Convention follows the criteria of the European Patent Office in this sense. 

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the Spanish Patent act also foresees the possibility to apply for compulsory licenses for: 

a) Failure or insufficiency of working of the patented invention 

b) Export necessities 

c) dependency of patents 

d) Existence of reasons of public interest. 

In applying TRIPS, it is assumed that an invention is worked in Spain if the object is manufactured 

or sold in Spain. 

Spain has not modified its legislation in order to adapt it to article 31 bis of TRIPS, although 

the European union has done so by adopting regulation (EC) no. 816/2006 which is directly 

applicable to Spain. 

the Spanish legislation does not allow the Government to use a patented invention without a 

previous license. nevertheless, the law allows the Government to expropriate a patent for reasons 

of public utility or public interest, by means of a fair compensation. the public utility or public 

interest must be declared by law. 

The Spanish Group considers that the Bolar exception should be included as a specific exception, 

instead of being regulated within the scope of the experimental use exception. 

Furthermore, it is considered that it would be advisable to harmonise the limitations to the right of 

patents in the framework of the International Substantive Patent Law Treaty (SPLT) which is being 

discussed in the WiPo. 

Résumé 

La Loi sur les Brevets espagnole reconnaît une exception pour l’utilisation expérimentale des 

brevets, en établissant que les droits conférés par les brevets ne s’étendent pas aux actes qui sont 

réalisés à des fins expérimentales et qui se réfèrent à l’objet de l’invention brevetée, en particulier 

les études et les essais réalisés pour l’autorisation de médicaments génériques, en Espagne et en 

dehors de l’Espagne, ainsi que les pratiques requises correspondantes, ce qui inclut la préparation, 

l’obtention et l’utilisation du principe actif à ces fins. 

En application de la réglementation de la Communauté Économique Européenne, il existe en 

Espagne un épuisement du droit du breveté dans le cadre de l’Espace Economique Européen (EEE); 

cependant, un épuisement international n’est pas applicable. En conséquence, les importations 

parallèles de produits en provenance de l’EEE sont autorisées, mais pas les importations en 

provenance de pays tiers. L’épuisement ne s’applique pas aux produits qui ont été produits dans 

l’EEE sous une licence obligatoire. 

En Espagne, les droits conférés par un brevet ne s’étendent pas à la préparation de médicaments 

réalisée dans les pharmacies extemporanément et par unité en exécutant une ordonnance médicale, 

ni aux actes relatifs aux médicaments ainsi préparés. 

En Espagne, sont considérées comme des inventions non susceptibles d’application industrielle, et 

donc non brevetables, les méthodes de traitement chirurgical ou thérapeutique du corps humain ou 

animal ainsi que les méthodes de diagnostic appliquées au corps humain ou animal. L’Espagne, 

en tant que pays membre de la Convention sur le Brevet Européen, suit les critères de l’Office 

Européen des Brevets en cette matière. 

la loi Espagnole établit également la possibilité de demander des licences obligatoires pour: 

a) Absence ou insuffisance d’utilisation de l’invention brevetée 

b) Besoin pour l’exportation 

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c) dépendance entre brevets 

d) Existence de raisons d’intérêt public pour l’octroi. 

En application de l’Accord sur les ADPIC, on entend qu’une invention s’exploite en Espagne si 

l’objet est fabriqué ou vendu en Espagne. 

L’Espagne n’a pas modifié sa législation de façon à l’adapter à l’article 31 bis de l’Accord sur les 

ADPIC, mais une telle adaptation a été réalisée par l’Union Européenne à travers le Règlement 

(CCE) nº 816/2006, qui est directement applicable en Espagne. 

La législation espagnole ne permet pas au gouvernement d’utiliser une invention brevetée sans 

licence préalable. Cependant, la loi permet au gouvernement d’exproprier un brevet pour cause 

d’utilité publique ou d’intérêt social, moyennant une indemnité appropriée. L’utilité publique ou 

l’intérêt social doivent êtres déclarés par la loi. 

Le Groupe Espagnol considère que l’exception « Bolar » devrait être inclue comme une exception 

spécifique, au lieu d’être régulée dans le domaine de l’exception pour utilisation expérimentale. 

Il considère également qu’il conviendrait d’harmoniser les limitations au droit du brevet dans le 

cadre du Traité International sur le Droit Matériel des Brevets (SPLT) qui est en discussion à la 

oMPi. 


Das Spanische Patentgesetz kennt die Ausnahme zur Forschungs- und Versuchszwecken und hat 

festgelegt, dass die Wirkung eines Patents erstreckt sich nicht auf Handlungen zu Versuchszwecken, 

die sich auf den Gegenstand der patentierten Erfindung beziehen, insbesondere Studien und 

Versuche, die für die Erlangung einer Generika Zulassung für das Inverkehrbringen in Spanien und 

ausserhalb Spaniens erforderlich sind; und die sich daraus ergebenden praktischen Anforderungen, 

einschliesslich der Vorbereitung, Erhalt und Benutzung des aktiven Elements für diese Zwecke. 

die umsetzung in Spanien der EG-vorschriften sieht die Erschöpfung eines Patentrechts im Bereich 

Europäischer Wirtschaftsraum (EWr) vor, nicht aber die internationale Erschöpfung. damit ist das 

Parallelimport aller Produkte von der EWR erlaubt, während das Parallelimport von Produkte aus 

drittstaaten verboten ist. die Erschöpfung wird nicht auf innerhalb des EWr mit einer zwangslizenz 

hergestellten Produkten angewandt. 

In Spanien, die Wirkung eines Patents erstreckt sich nicht auf die unmittelbare Einzelzubereitung 

von Arzneimitteln in Apotheken auf Grund ärztlicher Verordnung sowie auf Handlungen, welche 

die auf diese Weise zubereiteten arzneimittel betreffen 

in Spanien gelten verfahren zur chirurgischen oder therapeutischen Behandlung des menschlichen 

oder tierischen Körpers und diagnostizierverfahren, die am menschlichen oder tierischen Körper 

vorgenommen werden, nicht als gewerblich anwendware Erfindungen und werden deswegen 

keine Patente dafür erteilt. Spanien, als Mitgliedstaat des Europäisches Patentsübereinkommens, 

folgt demnach die Kriterien des Europäischen Patentamtes. 

das spanische Patentgesetz sieht auch die Erteilung von zwangslizenzen vor, wegen: 

a) Fehlende oder ungenügende Übung der patentierten Erfindung 

b) Notwendigkeit für den Export 

c) Abhängigkeit zwischen Patenten 

d) offentliche interesse für die Erteilung. 

TRIPS-Abkommen zufolge, gilt eine Erfindung in Spanien als benutzt solange das Produkt in Spanien 

hergestellt oder verkauft wird. 

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Spanien hat keine legislative Änderung durchgeführt um das Gesetz an Artikel 31 bis vom TRIPS- 

Abkommen anzupassen, obwohl dieses im EU Rahmen durch die Verordnung 816/2006 umgesetzt 

worden ist, die in Spanien direkt anwendbar ist. 

Das spanische Gesetz erlaubt der Regierung nicht, eine patentierte Erfindung ohne Lizenz zu 

benutzen. Das Gesetz erlaubt jedoch der Regierung, aus Gründen öffentlicher Nützlichkeit oder 

sozialen interesses, ein Patent gegen eine gerechte vergütung zu enteignen. das öffentliche nutzen 

oder soziale interesse muss gesetztlich geregelt werden. 

Die Spanische Gruppe ist der Meinung, dass die Bolarausnahme als spezifische Ausnahme im 

Gesetz aufgenommen werden sollte, anstatt sie als Ausnahme zur Forschungs- und Versuchszwecken 

zu regeln. 

Die Gruppe ist auch der Meinung, dass die Beschränkungen auf das Patentrecht im Abkommen über 

das materielle Patentrecht (SPLT), die zurzeit an der WIPO diskutiert werden, auch zu harmonisieren 

wären. 

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Sweden 

Suède 

Schweden 

Report Q202 

in the name of the Swedish Group 

by Fredrik CARLSSON, Ivan HJERTMAN, Bo JOHANSSON, Birgitta LARSSON, 

Hampus RYSTEDT, Louise WALLIN, Claudia WALLMAN and Johan ÖBERG 


The Swedish Group wishes to make the following introductory comments. 

The Working Guidelines for Q202 clearly express in the Introduction, section 4), that this question 

only looks at limitations on patent protection applicable to medicines and other medical products 

at a general level, notably in cases of public health crises. Further, it is specified that aspects of 

trademark law, competition law, medical and health care law, as well as issues of patentability, e.g. 

exclusions based on public policy or morality grounds, are not to be covered by the question, nor 

the issue of access to affordable medicines in developing and least developed countries. 

While the aspect of data exclusivity is not mentioned in the Guidelines, the Swedish Group 

understands that also that aspect is excluded from consideration as being a regulatory issue rather 

than a patent law issue. Data exclusivity will therefore not be taken up in the comments below. 

The Swedish Group notes that the Working Guidelines for Q202 focuses on improved protection 

of public health by limitations of the exclusive rights of a patent. However, it is important to notice 

that rather than taking into account only limitations of patent rights – with the risk of undermining 

the positive effects of the patent system – incentives for development of new products may also have 

the effect of such improvements (see our answer to question 2, below). 

However, the question Q202 is by the Working Guidelines effectively limited to considering 

technical patent law aspects. 

On the level of the European Union, where Sweden is one of 27 member states, one of the 

foundations is the concept of a single market and that distortions of the functioning of the single 

market are not accepted. In the field of patent law this means that harmonised law and rules are 

very important, as otherwise elements in the patent system which are available in one member state 

but not in other member states may be used in order to obtain commercial advantages. 

Questions 





Yes, Swedish patent law provides a statutory experimental use exception (Section 3, 

paragraph 3, item 3 of the Swedish Patents Act). As is the case in many other European 

countries, the exception is derived from the draft Community Patent Convention of 1975. 

The exception is applicable in relation to the use of a patented invention for experiments 

which relate to the invention itself, such as for the purposes of creating improvements to the 

invention or evaluating its utility. Research and experimental activities performed with the 

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help of the patented invention, such as where the invention itself is used as a research tool 

in the same manner as is intended under the patent, is not covered by the exception. That is, 

the patented invention must be the object of the experiment as such, not merely a tool used 

in the experiment. 

The exception is applicable regardless of the setting, i.e. the experiment may be conducted 

in a commercial or in a non-commercial/academic setting. The exception is, furthermore, 

applicable irrespective of the purpose of the experimental activities. Consequently, 

experiments conducted with a commercial purpose as well as experiments conducted with a 

non-commercial/academic purpose are covered by the exception. 

The scope of the exception is yet to be considered or clarified in Swedish case law with 

significant precedential value. The impact of European case law, which in our understanding 

varies between the different European jurisdictions, on the Swedish exception’s scope and 

applicability, is yet to be determined by Swedish courts. 






exception? 

Is a Bolar-type exception recognized under your patent law? 

Yes. Directive 2001/83/EC as amended by Directive 2004/27/EC has been implemented 

into the Swedish Patents Act (Section 3, paragraph 3, item 4). This paragraph exempts 

infringement studies, trials, investigations and practical requirements relating to a reference 

medicinal product, insofar as these are necessary for the grant of a marketing approval for a 

human or veterinary medicinal product, in accordance with the Swedish Medicinal Products 

Act or corresponding European provisions. 

A ‘reference medicinal product’ shall mean a medicinal product authorised for marketing in 

an EU member state. 


To fall under the exception, any activity must relate to procedures necessary for the grant 

of a marketing approval in Sweden or the European Union, or for a scientific report on a 

pharmaceutical for exclusive marketing outside the EU. 

What is the scope of the Bolar exception? 

The language used in the Patents Act is taken almost word-by-word from the directive and 

allows for future interpretation by the courts. It is however acknowledged in the preparatory 

works that the exception covers a number of different uses and practical requirements, which 

may also differ depending on what kind of drug is studied. Ultimately, it is the Medical 

Products Agency’s position on what documentation is necessary in the individual case that 

decides what use of patent protected inventions shall fall under the exception. It was not 

considered possible to give an exhaustive list of exempt uses. 

The exception is intended to only relate to the reference medicinal product and should not extend 

to any other protected method, substance or combination of protected substances, according 

to the preparatory works. Notably, the preparatory works do not mention protected apparatus, 

such as administration devices. It is however probable that a protected administration device 

that is necessary for a clinical trial, would also fall under the exception. 

The exception would include biological products, if these are to be considered as reference 

medicinal products, cf. Article 10.4 of Directive 2001/83 as amended by Directive 2004/27. 

The use of research tools and other products would only be covered by the exception if they 

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are substantially related to the reference medicinal product and their patent rights need to be 

infringed in order for performing any trial or investigation requested by the MPA. 


which conditions? 

EU/EEA 

Sweden is a member of the European Union (EU) and therefore the principle of regional 

exhaustion of patent rights applies in Sweden. This means that parallel imports of patented 

medicines, medical devices or other goods are allowed as soon as the products have been 

put on the market within the EU or European Economic Area (EEA), by or with the consent of 

the patent holder. However, member states which have recently joined the EU, have agreed 

to an IP transitional mechanism in the Treaty of Accession, which gives the patent holder 

rights to object to parallel importation from the new member states into Sweden under certain 

conditions. This means that with regard to the Czech Republic, Estonia, Latvia, Lithuania, 

Hungary, Poland, Slovenia, Slovakia, Bulgaria or Romania the holder, or his beneficiary, of a 

patent or supplementary protection certificate for a pharmaceutical product filed in Sweden 

at a time when such protection could not be obtained in one of the above-mentioned new 

Member States for that product, may rely on the rights granted by that patent or supplementary 

protection certificate in order to prevent the import and marketing of that product in Sweden 

where the product in question enjoys patent protection or supplementary protection, even if 

the product was put on the market in that new Member State for the first time by him or with 

his consent. The IP transitional mechanism refers to a “pharmaceutical product”. The scope 

of that wording – e.g. if it includes also medical devices or similar - has not been defined by 

the Swedish Courts. 

Outside of EU/EEA 

The patent holder can prevent products (patented medicines, medical devices or similar) 

that were put on the market outside of the EU/EEA territory and then parallel imported into 

Sweden, even if the products were put on the market by the patent holder or with the patent 

holders consent. 



EU/EEA 

According to the Swedish Patents Act (Section 3, paragraph 3, item 2) regional exhaustion 

occurs when the product (includes patented medicines, medical devices or similar) has been 

put on the EU/EEA market by or with the patent holders consent. If a product is put on the 

market under a compulsory license there is no consent and the patent right is not exhausted 

in Sweden. 

Outside EU/EEA 

Similarly, a product made under a compulsory license outside of the EU/EEA would not 

exhaust the patent holders rights to exclusivity in Sweden. Further, the TRIPs agreement also 

requires that compulsory licenses only be issued for goods intended chiefly for the domestic 

market (Article 31 f.) 


conditions? 

Yes, the Swedish Patents Act (Section 3, paragraph 3, item 5), excludes preparation in a 

pharmacy of a medicine in accordance with a physician’s prescription in individual cases or 

acts with the medicine so prepared from the exclusive right conferred by a patent. 

The exception means that pharmaceutical staff can always expedite medicine in a pharmacy 

to an individual with a physician’s prescription without risking to infringe a patent. The 

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exception is only valid for individual cases where a physician has issued a prescription to a 

specific person. Hence, preparing a patented medicine to keep in stock, or selling a medicine 

prepared under the exception to someone else than the individual with the prescription, 

would be an act of infringement. 

The Swedish Patents Act was influenced by Article 31 c) of the Community Patent Convention 

in this respect. It is considered from the wording “in accordance with a physician’s prescription 

in individual cases” that the preparation intended in Section 3, paragraph 3, item 5 must be 

extemporaneous, which is explicit in the Community Patent Convention. 




Not applicable in Sweden. 






Compulsory licenses are available under Swedish patent law. Compulsory licences have not 

been used in Sweden, at least not under the current patent law. 

A compulsory licence can be granted by the competent court, Stockholm District Court, 

(Section 65, paragraph 3 of the Swedish Patents Act), which determines the conditions of 

the compulsory licence and the compensation to the patent holder. The court can change the 

conditions of a granted licence and determine new conditions, if the circumstances change 

considerably (Section 50 of the Swedish Patents Act). 

A compulsory license can only be granted to anyone who can be expected to have the 

capability to use the invention in an acceptable manner and to comply with the conditions of 

the compulsory licence. The applicant for the compulsory licence must show that he without 

success has tried to obtain a licence under reasonable conditions from the patent holder. If 

a compulsory licence is granted the patent holder can nevertheless use the invention and sell 

licences (Section 49 of the Swedish Patents Act). 

If an applicant for a compulsory licence fulfils the conditions above, then a compulsory 

licence to use an invention can be granted in Sweden in the following different cases: 

1) If the patent holder has not made reasonable use of the protected invention in Sweden 

after three years from grant and after four years from the application date, provided that 

there is no acceptable explanation to why the invention has not been used. In this respect 

use in Sweden is equal to import from an EES-state or a WTO-state (Section 45 of the 

Swedish Patents Act). 

2) If there is a patent where the use of the invention protected by that patent is dependent 

on another patent. It is required that the applicant for the compulsory licence shows that 

his invention is a significant technical contribution and of great economical importance 

as compared to the other patented invention (Section 49 of the Swedish Patents Act). Item 

2 is also applicable to plant protection (Section 46a of the Swedish Patents Act). 

3) If it is required by the public interest and is of extreme importance (Section 47 of the 

Swedish Patents Act). 

4) If anyone has used an invention or made serious preparations for using an invention 

subject to a patent application before the application was published. There must be 

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very special reasons. In the literature it has been mentioned that one example of such 

very special reason is a matter affecting the national economy. The infringer must not 

have had any knowledge of the application and must not have had any reasonable 

possibilities to gain knowledge about the application (Section 48 of the Swedish Patents 

Act). 

Compulsory licences can also be granted in Sweden for the manufacture of pharmaceutical 

products for export to countries with public health problems according to EC 816/2006, see 

question 7 below. 

Compulsory licences have not been used in Sweden at least not under the current patent law 

originating from 1967. 






Ratification of Article 31bis TRIPS is a matter of EU competence. 

On November 19, 2007, the Council of the European Union confirmed that the protocol 

amending TRIPS, done at Geneva on 6 December 2005, will be binding on the Member 

States of the European Union. Hence, Sweden is bound by Article 31bis TRIPS. 

With regard to the Treaty establishing the European Community, in particular Articles 95 

and 113, considering the need for uniform implementation of the WTO decision of August 

30, 2003 to ensure that the conditions for the granting of compulsory licences for export 

are the same in all Member Stats and to avoid distortion of competition for operators in 

the single market as well as preventing re-importation into the territory of the Community, 

implementation of the Decision is a matter of Community law. 

The WTO decision of August 30, 2003, was implemented in Sweden by European Community 

legislation, i.e. the European Parliament and Council has, on May 17, 2006, adopted 

Regulation 816/2006 on compulsory licensing of patents relating to the manufacture of 

pharmaceutical products for export to countries with public health problems. 

Compulsory licences have not been granted in Sweden for the exportation of pharmaceutical 

products. Sweden has stated that it will not use the system for importation of pharmaceutical 

products. 



There are no special provisions for the government in this regard, except for expropriation as 

discussed below. The government may also request a compulsory license as discussed under 

question 6. 


The Swedish government has the right to expropriate the right to an invention if expropriation 

is considered necessary in the public interest (Section 78 of the Swedish Patents Act). However, 

the government may only exercise such right when Sweden is at war or in danger of war. 

A wider applicability was in fact discussed during the preparatory work of the present 

provision. It was, however, concluded that states of emergency other than war or danger 

thereof would not be as pressing. Provisions for expropriation under such circumstances could 

therefore be provided if or when such a need arises. 

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This right of expropriation covers “inventions” and is thus not limited to patented inventions. 

Consequently, both patent applications and inventions which have not yet been the object 

of an application may be expropriated. Furthermore, licences including, but not limited to, 

compulsory licences, may also be the object of expropriation under the present provision. 

The right to an invention may be expropriated in full or in part, i.e. either in the form of 

a license or in the form of a complete transfer of rights. The government may either grant 

itself or a third party (such as an industrial actor with suitable production capabilities) the 

expropriated rights. The original right holder is entitled to receive reasonable compensation 

in respect of the expropriated rights. 

Furthermore, inventions, subject to a patent or not, classified as a “defence invention” can 

be expropriated by the Swedish government under the Swedish Act on defence inventions 

(Sections 13 and 18) if it is of significant importance to the Swedish defence. An invention may, 

but does not need to, be classified as a defence invention if it pertains to what the government 

has classified as “war equipment”. The current definition of war equipment includes nuclear, 

biological and chemical weapons and “products designed for military use and for protection 

against the action of weapons”. This could potentially include drugs for protection against 

chemical, biological or nuclear weapons. 

To our knowledge, the government has never expropriated a patent or an invention. However, 

as this could be a question of national security, such an expropriation would not necessarily 

come to the public’s knowledge. 





Swedish patent law does not provide for any specific information tools equivalent to the 

Orange Book which exists in the US. It does however contain some general provisions in 

Article 56 which may potentially be used to obtain information as to whether a marketed 

pharmaceutical is covered by patent protection. 

The Swedish Patents Act, Section 56, paragraph 2, provides that if someone directly or 

indirectly states that a product is patent protected or the subject of a patent application 

without giving information of patent number or patent application number, such information 

shall be provided on request. 

In addition to this, Swedish patent and pharmaceutical regulatory laws contain the following 

means for helping facilitate access to medicines, medical devices, diagnostics etc: 

• As discussed under question 3 above, the concept of regional exhaustion of patent rights 

means that pharmaceuticals manufactured in the EU/EEA can be more readily imported 

into the country. 

• The Swedish Patents Act (like the patent legislation of many countries pursuant to 

international conventions) contains a prohibition against patenting of surgical or 

therapeutic treatment or diagnostic methods practiced on the human body. 

• The regulatory regime for pharmaceutical benefits in Sweden contains a scheme which 

enables manufacturers of generics to make an application to the relevant government 

agency for inclusion in the benefits scheme without stating if and when the applicant 

intends to market the drug. In a recent decision by Svea Court of Appeal, it was held 

that under the regulatory regime for pharmaceutical benefits in Sweden, manufacturers 

of generics may – prior to the expiry of the patent or supplementary protection certificate 

covering the original drug – agree with the relevant governmental agency on its sales 

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prices for the generic drug to the Swedish pharmacy retail monopolist. The judgment has 

been appealed to the Swedish Supreme Court which has granted a leave to appeal. 




Yes, a research and experimental use exception stimulates further innovation by 

balancing the patent holder’s right to exclude others. The exception facilitates research in 

respect of the patented invention’s utility and encourages further research through which 

improvements to the patented invention and/or new independent inventions may be 

generated. A research and experimental use exception facilitates use of the information 

disclosed in the patent application process during the time the patent is valid. Thus, 

the exception can be viewed as an integrated element of patent law’s requirement of 

disclosure. 


This is acceptable, provided that the introduction of a Bolar exception is balanced with 

compensating rights, such as a system for patent term extension. 


The Swedish group notes that regional exhaustion of patent rights is generally applied in 

the EU/EEA area (see the response to question 3 in section I). The Swedish group is not 

in favour of extending this regional exhaustion to countries outside the EU/EEA area. 


Yes, however the person preparing a medicine under such an exception shall be deemed 

to have the right to carry out the invention only in the case of the original prescription. 


Not applicable in Sweden. The medical treatment defence can apparently only be 

applicable if it is possible to patent medical treatments as such. The Swedish Patents Act 

and the European Patent Convention (EPC) do not allow patents for methods for surgical 

or therapeutic treatment or for diagnostic methods that are intended for use on humans 

or animals. The Swedish group would not suggest a change in the Swedish Patents Act 

and the EPC that would allow such patents. 


Yes, however only under strictly defined circumstances. The Swedish Group sees a danger 

in the calls for extensive use of compulsory licensing which are made in developed as 

well as in developing and least developed countries. Those calls are often based on 

extensive interpretation of the grounds for “compulsory licensing”, especially under TRIPS 

Article 31(b): “national emergency or other circumstances of extreme urgency”, or TRIPS 

Article 30. Widespread compulsory licensing based on a premise that practically any 

medicine for any disease could be deemed to fall under those provisions would erode 

the patent system to an extent where incentives for research and development for new 

products might be weakened or even eliminated. 


If at all to be applied, it must be allowed only as a final resort under the most extreme 

circumstances. In the event of a public health crisis, specific provisions for expropriation 

should be provided, rather than implementing a wider general governmental right to 

expropriate, which would need to be interpreted under the circumstances present at the 

time of the crisis. Furthermore, there is a need for increased awareness, guidance and 

uniformity in the application of provisions on expropriation so as to limit the influence 

of temporary political views in an affected state. The Swedish group has not, however, 

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elaborated further on which normative actor that may be in the position to provide such 

guidance to promote increased uniformity. 



No, not under the constraints of the Q202 Working Guidelines. 


Improvements might be achieved by introduction of patent listings (what has become known 

as “patent linkage”), meaning that the originator of the product would submit to an authority, 

e.g. the medicinal authority, a list of the patents which are relevant for the product. For 

generic products that would mean an improved legal certainty on the patent position of the 

product. However such a system should then at the same time oblige the medicinal authorities 

to take the listed patents into account when dealing with product registration files. 



Incentives for development of new products, for example on basis of market exclusivity for 

a limited time, may well have the effect of such improvements. Examples here on EU level 

are the systems for what is called „paediatric exclusivity“, Regulation (EC) No 1901/2006 

dated December 12, 2006, which may provide a six months extension of the time of a 

Supplementary Protection Certificate, SPC, and Regulation (EC) No 141/2000 dated 16 

December 1999 on so called orphan medical products, which may provide a 10 years 

market exclusivity in return for development of such product. 




It is important that countries provide market rules and opportunities which are equal and 

foreseeable for all actors on the market. That applies also to the field of patents. Harmonisation 

of the exceptions from patent rights is therefore desirable. For a regional market such as 

the EU, with established common rules for its member states, this is especially important. 

Increased globalisation means that differences in these respects between countries/regions 

have more immediate consequences. 

In the view of the Swedish Group, the experimental use exception is a realistic example of an 

area where harmonisation could be accomplished. 

Summary 

The impact of public health issues on the patent system should take into account not only the effect 

of limitations of patent rights, but also the effect of incentives for development of new products. 

Harmonisation of exceptions from patent rights is generally desirable, especially for regional markets 

such as the EU. A realistic area for harmonisation could be the experimental use exception. 

Résumé 

L’influence des questions de santé publique sur les droits de brevet devrait prendre en compte non 

seulement l’effet des limitations des droits de brevet, mais aussi l’effet des encouragements pour le 

développement de nouveaux produits. 

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L’harmonisation des exceptions des droits de brevet est généralement désirable, en particulier pour 

les marchés régionaux comme l’Union européenne. L’exception d’utilisation à des fins de recherché 

ou d’expérimentation pourrait être un réaliste domaine de l’harmonisation. 


Der Einfluss von Themen der öffentlichen Gesundheitspflege auf exklusive Patentrechte sollte nicht 

nur die Auswirkung von Einschränkungen der Patentrechte, sondern auch die Auswirkung von 

Anreizen für Entwicklung neuer Produkte berücksichtigen. 

Die Harmonisierung der Ausnahmen von Patentrechten ist allgemein wünschenswert, vor allem für 

regionale Märkte wie die EU. Die AusnahmeN zur Benutzung zu Forschungs- und Versuchszwecken 

könnte ein realistischer Bereich für Harmonisierung sein. 

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277-286_Q202_Sweden.indd 286 17.07.2009 10:31:04

Questions 

Switzerland 

Suisse 

Schweiz 

Report Q202 

in the name of the Swiss Group 

by Konrad BecKer, Anja Dietel, christian Alexander Meyer and Beat rAuBer 



Preamble: 

the answers are given based on the revised Swiss Patent law (Pl) which is foreseen to enter 

into force on July 1, 2008. 




yes, while Art. 9, par. 1 lit. a Pl deals with exemption for uses in the private sphere, lit. b deals 

with research and experimental use: 

1) the effect of the patent does not extend to 

a) … 

b) acts for the purpose of research and experimentation, which serve to gain insight 

about the object of an invention including its uses; in particular any scientific research 

on the object of the invention is allowed; 

…. (non-official translation) 

Accordingly scientific or experimental research for gaining further insights into the patented 

invention is allowed even if the focus of the experiments is commercial. this is in line with 

German case law of the BGH “Klinische Versuche i (1995)” and “Klinische Versuche ii 

(1997)”. 

The materials for the law revision expressly indicate that scientific research is exempted also 

if experiments are done with a commercial aim, as long as they serve to obtain insight 

into the patented invention. the exception not only covers basic research, but also applied 

research; however, stockpiling seems to be excluded. Further to that, Art. 40b Pl grants a 

licence of right under patents protecting biotechnology research tools (see below). research 

and experiments in the field of medicines is dealt with in a separate paragraph of the law to 

minimize uncertainties, see question 2), “Bolar-type exception”. 

However, the precise scope of the exception and the limit between forbidden and allowed 

commercial use is still subject to legal interpretation by the courts. 




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exception? 

yes. Further the general research and experimental exception of Art. 9, par.1, lit. b Pl (Question 

1), lit. c expressly deals with uses connected with requests for marketing authorisation: 

1) the effect of the patent does not extend to 

… 

c) acts required for the obtainment of a market authorisation of a medicament in 

Switzerland or in a country with a comparable drug control system; 

… (non-official translation) 

As can be seen from the materials, this exception covers all experiments done in view of a 

request for a marketing authorization, such as pre-clinical and clinical testing, production, 

import and storage of samples and validation batches for the purpose of registration, 

except stockpiling as defined in the WTO dispute settlement panel EU v. Canada of 2000 

(WT/DS114/R). During discussion in parliament the article was amended to include not 

only acts done in view of requests of marketing authorization in Switzerland, but also as 

required by the drug agencies of other countries with a comparable system for marketing 

authorization. No definition is available what “comparable” means in this respect. There is 

no doubt that experiments in view of registration in a eu country (and in the uS) are included, 

since harmonization with the legal framework in the european union (article 8 of Directive 

2004/27/EC of March 31, 2004 amending Directive 2001/83/EC on the Community code 

relating to medicinal products for human use) was intended. 

the law uses the expressions “Arzneimittel” (German), “medicament” (French), “medicamento” 

(italian). As far as biological products are concerned it is the position of the Swiss group that 

they do fall under the exception as long as their commercialisation requires authorization by 

the respective authorities, but it remains open whether medical devices are covered. it may 

be noted in this respect that the Swiss law on medicaments and medicinal products makes 

a distinction between medicaments (drug products of chemical or biological origin) and 

medicinal products (medical devices, instruments, in vitro diagnostics, software and other 

objects for medicinal use). 

Since the exploitation of patented research tools such as screening assays as a rule do not 

require any market authorization their application seems not to be exempted under Art. 9 

par. 1 lit. c Pl. 

Again the precise scope of the exception and the limit between forbidden and allowed 

commercial use is still subject to legal interpretation by the courts. 




Switzerland does not allow parallel import of patented goods. the principle of national 

exhaustion of patented goods is applied following the jurisdiction of the Federal Supreme 

court in its judgement of 7.12.1999 (Kodak SA vs. Jumbo Markt AG). 

the revised Swiss Patent law does not contain an explicit ruling of parallel imports. in fact the 

proposed Article 9a par. 1 Pl has been removed in the current revision of the patent law. 

Art. 9a Pl which rules misuse and which in principle allows international exhaustion for 

patented goods where patent protection plays a minor role remained. this article seems to 

support the principle of national exhaustion in Switzerland. 

288 


in light of Swiss antitrust legislation market foreclosure is forbidden. Swiss Federal cartel 

Statute article 3 exempts from its applicability on the one hand all effects deriving from the 

laws on intellectual property rights but states expressly that import limitations are subject to 

the cartel Statute. 

it is the position of the Swiss Group that the same principle, i.e. national exhaustion, applies, 

if the products originate from markets where they were made available under a compulsory 

license. 


conditions? 

No, the Swiss Patent Law does not know a ruling similar to e.g. in Germany with §11(3) 

German Patent law. 




Methods of medical treatment are not patentable subject matter in Switzerland. 






existing Art. 40 of the Swiss Patent law foresees that licenses are available on public interest 

in case a patentee declines to grant a license without plausible reasons. 

the revised Swiss Patent law added Art. 40 b which rules that a license of right can be 

obtained for research tools and Art. 40 c Pl which states that a compulsory license is available 

for diagnostic products or diagnostic processes. 

However, no actual cases of compulsory licenses are known in Switzerland, thus an 

interpretation of the law by the courts is lacking. 






Yes, Article 31bis TRIPS has been translated into Art. 40 d of the revised Swiss Patent Law 

which foresees the availability of a compulsory license for the manufacture of patented 

pharmaceutical products for export to a country which has no or insufficient capacities to 

manufacture. 

Switzerland declared that it will not use the system as importing member for the purposes of 

Article 31bis TRIPS and its Annex. 

However, no actual cases of compulsory licenses are known in Switzerland, thus an 

interpretation of the law by the courts is lacking. 



No! 

289 



Yes. Art. 32 Swiss Patent law allows the Federal Government to expropriate a patent, if the 

public interest requires so. the patentee has a right for full compensation.No actual cases of 

patent expropriation are known. 





No! 




the Swiss group is of the opinion that patent law should provide for a limited research 

and experimental use exception. the exception should not be dependent on whether 

results of such research may be or will be used commercially, but whether such use leads 

to a gain of scientific knowledge and/or practical insight into the patented invention. 

the exception should not cover the use of a patented invention as a tool in research on 

other objects. 


the Swiss group is of the opinion that patent law should provide for a Bolar-type 

exception. the exception should exempt all acts done in preparation for a request of 

marketing authorization. Such Bolar-type exception falls under the general research and 

experimental use exception as defined in the preceding paragraph, but further allows 

the use of patented inventions in bioequivalence studies, batch validation and the like 

going further than a general research exception. the Bolar-type exception should not 

allow stock-piling and preparation for large scale manufacturing going beyond batch 

validation. 


the Swiss group is of the opinion that patent law should not allow parallel import of 

patented medicines. in almost all countries the drug market is highly regulated, imposing 

price limits and other restrictions. Parallel imports would only mean that such state 

interventions into the drug market are exported to other countries. in the end the parallel 

importers would benefit from price differentials at the cost of the patent owner, and 

usually without or only with very limited benefit for the end user and the health system 

as a whole. Moreover, parallel import bears the danger of supply shortages in low-price 

countries and should therefore be seen as an obstacle rather than a means of facilitating 



the Swiss group is of the opinion that there is no need for the patent law to provide a 

ruling for individual prescription exceptions. 


Since in Switzerland methods of medical treatment are not patentable subject matter no 

answer can be provided for this question. 


the Swiss group is of the opinion that the patent law shall allow compulsory licensing. 

the measures for compulsory licenses shall comply with the triPS rules provided by the 

WTO. 

290 



the Swiss group is of the opinion that patent law should not allow expropriation of a 

patent. The measure of compulsory licenses as defined in the TRIPS agreement gives 

enough flexibility for states in a health emergency to deal with patent owners unwilling 

to cooperate in solving such an emergency. 



See 2) below. 




the Swiss group is of the opinion that patents are not an obstacle to the access to medicines 

but to the contrary stimulate research and ensure that new medicines are found and brought 

to the market. Patents form the essential framework of the research-based industry and, in 

view of the substantial investments in time and capital and the high risk of failure, are vital to 

sustain continued R & D into new treatments. Because of patents as an incentive to find and 

market new medicines, the general public profits by having access to better medical treatment. 

Moreover, patent applications are published, providing thus transparency of the research 

done. Sharing this information with the scientific community forms the basis of the generation 

of more knowledge and further development of new and innovative products. Without 

patent protection of the published research, any dissemination of innovation, and thus, faster 

progress in the development of new medicines, is highly unlikely. it is therefore apparent that 

the notion that patents hinder the access to new medicines is a misconception. 

the present provisions in the law, namely the research exception, the Bolar exception as well 

as compulsory licenses in emergency situations, are sufficient to facilitate further the access to 

medicines without destroying the incentive to spend enormous amounts of time and money to 

develop new medicines and to share information on such innovations. In fact they strike a fine 

balance between rewarding innovation without unduly monopolizing same. 

it should be borne in mind that the major impact on the accessibility of medicines is not due to 

patent protection. consequently, no further limitations to the exclusivity conferred by patents 

are required. Most of the drugs classed by the WHO as essential drugs are either available 

off-patent or are not patent protected, yet over a third of the world’s population still has no 

access to these essential drugs. Access to medicines is rather facilitated by a combination 

of appropriate development policies, health policies, best practices applied in the health 

system, a rational use of medicines, and adequately funded health services. the patent law 

does not affect any of these. 




the Swiss Group is of the opinion that a harmonization of the major exceptions, namely the 

Bolar exception and the experimental use exception, would be desirable in view of ensuring 

fair conditions of competition between different countries. Harmonization would also lead to 

more legal certainty which can only be beneficial for everyone involved and would avoid or 

at least minimize national legal disputes. 

However, any harmonized ruling should not go beyond reliable boundaries as e.g. outlined 

above for the experimental use exception in the answer to question 1 and for the Bolar 

exception in the answer to question 2. 

291 


Summary 

the revised Swiss Patent law, which should enter into force on July 1, 2008, foresees a research 

exception. Scientific or experimental research for gaining further insights into the patented invention 

are allowed even if the focus of the experiments is commercial. Also experiments done in view 

of a request for a marketing authorization for pharmaceuticals in Switzerland and in countries 

with a comparable system are exempted. However, this exception seems to be restricted to drugs 

of chemical or biological origin and does not encompass medicinal devices. Parallel imports of 

patented pharmaceuticals are not allowed. under the revised Swiss Patent law it is possible to get a 

compulsory license not only for reasons of public interest, but also for research tools and diagnostic 

products and processes, and for export of pharmaceuticals to countries with no or insufficient 

manufacturing capacity in line with TRIPS Art. 31bis. 

the Swiss group is of the opinion that research and experimental use exception and Bolar-type 

exception should be internationally harmonized. Any rules on compulsory licensing should comply 

with the conditions set out in triPS. in our opinion patents are not an obstacle to the access 

to medicines but to the contrary stimulate research and ensure that new medicines are found 

and brought to the market. Because of patents the general public profits by having access to 

better medical treatment. A research exception, Bolar exception as well as compulsory licenses 

in emergency situations strike a fine balance between rewarding innovation without unduly 

monopolizing same. 

Résumé 

La loi suisse des brevets d’invention modifiée, qui doit entrer en vigueur le 1 Juillet 2008, comptera 

une exemption expérimentale. La recherche expérimentale ou scientifique servant à obtenir des 

connaissances sur l’objet de l’invention est permise même si l’intérêt des expérimentations est 

commercial. Les actes expérimentaux, en vue de l’obtention d’une autorisation de mise sur le marché 

pour un médicament en Suisse ou dans un pays possédant un système comparable, sont également 

exemptés. Toutefois, cette exemption parait être limitée aux médicaments d’origine chimique ou 

biologique et n’inclut pas les dispositifs médicaux. Les importations parallèles de médicaments 

brevetés ne sont pas autorisées. D’après la loi de Brevet Suisse modifiée, il est possible d’obtenir 

une licence obligatoire non seulement pour des raisons d’intérêt public, mais également pour 

des instruments de recherche, des produits ou procédés de diagnostic, et pour l’exportation de 

produits pharmaceutiques vers un pays n’ayant aucune ou une capacité insuffisante de fabrication 

en accord avec l’art. 31 bis des accords TRIPS. 

Le groupe Suisse est d’avis que l’exemption des actes de recherche et d’utilisation expérimentale, 

ainsi que l’exemption dite de Bolar devraient être harmonisées au niveau international. Toutes les 

lois de licences obligatoires devraient se conformer aux conditions visées dans les accords TRIPS. 

Nous sommes d’avis que les brevets ne sont pas un obstacle à l’accès aux médecines, mais au 

contraire, encouragent la recherche et assurent la découverte et l’introduction sur le marché de 

nouveaux médicaments. C’est par le biais des brevets que le public bénéficie d’un accès à de 

meilleurs traitements médicaux. L’exemption des actes à titres expérimentaux, l’exemption de Bolar 

ainsi que les licences obligatoires dans des situations d’urgence, permettent un juste équilibre entre 

une récompense de l’innovation et un monopole trop injuste de celle-ci. 


Das revidierte Schweizer Patentgesetz, das am 1. Juli 2008 in Kraft treten soll, sieht eine Ausnahme 

für Forschung vor. Wissenschaftliche Forschung und Versuche mit dem Ziel, weitere Einsichten in 

eine patentierte Erfindung zu gewinnen, sind zugelassen, auch wenn die Zielsetzung kommerziell 

292 


ist. Versuche im Hinblick auf einen Zulassungsantrag für Vermarktung von Pharmazeutika in der 

Schweiz und in ländern mit einem vergleichbaren System sind auch zugelassen. Diese Ausnahme 

scheint jedoch auf Medikamente chemischen oder biologischen ursprungs beschränkt zu sein und 

nicht für medizinische Geräte zu gelten. Parallelimporte von patentierten Pharmazeutika sind nicht 

zugelassen. Unter dem revidierten Schweizer Patentgesetz ist es möglich, eine Zwangslizenz nicht nur 

aus Gründen öffentlichen interesses, sondern auch für Forschungshilfsmittel, diagnostische Produkte 

und Verfahren und für den export von Pharmazeutika in länder ohne oder mit ungenügender 

Herstellungskapazität gemäss Art. 31bis TRIPS zu erlangen. 

Die Schweizer Gruppe ist der Ansicht, dass die Ausnahme für Forschung und für die Vorbereitung 

der Marktzulassung von Pharmazeutika international harmonisiert werden sollte. regeln zu 

Zwangslizenzen sollten in Einklang mit den Bedingungen in TRIPS sein. Unserer Meinung nach 

sind Patente kein Hindernis für den Zugang zu Medikamenten, sondern fördern im Gegenteil die 

Forschung und sichern damit, dass neue Medikamente gefunden und auf den Markt gebracht 

werden. Wegen Patenten profitiert die Öffentlichkeit vom Zugang zu besserer medizinischer 

Behandlung. Ausnahmen für Forschung und für die Vorbereitung der Markt¬zulassung sowie 

Zwangslizenzen in Notlagen ergeben ein Gleichgewicht der Belohnung für Innovationen ohne 

ungehörige Monopolisierung. 

293 



Questions 

Thailand 

Thaïlande 

Thailand 

Report Q202 

in the name of the Thai Group 

by Chavalit UTTasarT and Kallayarat ChinsrivonGKUl 






a research or experimental use exception is recognised under the Thai Patent act B.E. 2522 

(a.D. 1979) as amended. 

any act for the purpose of study, research, experimentation or analysis of the valid patent, 

without the patent holder’s permission, shall not constitute an infringement, provided that 

it does not unreasonably conflict with a normal exploitation of the patent and does not 

unreasonably prejudice the legitimate interests of the patent holder. (section 36, paragraph 

two, (1)). 

This statutory provision is not clearly limited to non-commercial purposes only. Therefore, the 

research or experimental use for a commercial purpose is permitted, provided that it does 

not unreasonably conflict with a normal exploitation of the patent and does not unreasonably 

prejudice the legitimate interests of the patent holder. 






exception? 

The Bolar-type exception was first recognised by Patent Act (No. 2) B.E. 2535 (A.D. 1992). 

any act concerning an application for drug registration, the applicant intending to produce, 

distribute or import the patented pharmaceutical product after the expiration of the patent 

term, shall not constitute a patent infringement. (section 36, paragraph two, (4)). 

A definition of drug is not explicitly prescribed under the current Patent Act (as amended). 

Therefore, the provision of section 4 of the Drug act B.E. 2510 (a.D. 1967) as amended 

concerning the definition of drug shall be applied mutatis mutandis. 

section 4 of the Drug act B.E. 2510 as amended provides that “Drugs” means: 

1) substances recognized by pharmacopoeias notified by the Minister; 

2) substances intended for use in the diagnosis, treatment, relief, cure or prevention of 

human or animal disease or illness; 

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3) substances which are pharma chemicals or semi-processed pharma chemicals; and 

4) substances intended to affect the health, structure or function of the human or animal 

body. 

The Bolar-type exception is limited to drugs only. Therefore, other products, such as biological 

products, research tools, etc., are excluded from the Bolar-type exception. 




The principle of parallel import of patented products was first introduced by Patent Act (No. 

3) B.E. 2542 (a.D. 1999). 

The use, sale, having in possession for sale, offering for sale or importation of a patented 

product shall not constitute a patent infringement when the product has been produced or 

sold with the authorization or consent of the patent holder. (section 36, paragraph two, 

(7)). 

The parallel import exception does not apply to the patented products originating from markets 

where they are made available under the compulsory license because the compulsory licensing 

forces the patent holder to allow others to use the patent at a fee set by the government. The 

patent holder is not allowed to refuse to license or to negotiate voluntary license fee. 


conditions? 

An individual prescription exception was first prescribed by the Patent Act (No. 2) B.E. 2535 

(a.D. 1992). 

The preparation of drugs for an individual case according to a doctor’s prescription by a 

professional pharmacist or medical professional, including any act done to such pharmaceutical 

product shall not constitute a patent infringement. (section 36, paragraph two, (3)). 




Methods of medical treatment are not patentable subject matter under the Thai Patent Act B.E. 

2522 (a.D. 1979) as amended. 






The principle of compulsory licensing was first introduced into the Thai Patent Act B.E. 2522 

(a.D. 1979). 

Under the current Patent act (as amended), a compulsory licensing may be granted in the 

following circumstances. 

1) Insufficient working of a patent 

at any time after the expiration of three years from a grant of patent or four years from 

the date of application, whichever is later, any person may apply to the Director General 

for a license if it appears, at the time when such application is filed, that a patent holder 

unjustifiably fails to exercise his legitimate rights as follows: 

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– that the patented product has not been produced or the patented process has not been 

used in the country, without any legitimate reason; or 

– that no product produced under the patent is sold in any domestic market, or that such 

a product is sold but at unreasonably high prices or does not meet the public demand, 

without any legitimate reason. 

an applicant is required to show that he or she has attempted to obtain a license by offering 

sufficient conditions and royalties to the patent holder but an agreement could not be reached 

within a reasonable period. (section 46). 

2) interdependent patents 

if an exploitation of patented claims is likely to constitute an infringement of another person’s 

patented claims, a patent holder, desiring to exploit his or her own patent, may apply to 

the Director General for a license under the patent of the other person under the following 

criteria: 

– the applicant’s patent involves an importation technical advance of considerable 

economic significance in relation to the invention for which the license is applied; 

– the patent holder shall be entitled to a cross-license on reasonable term; 

– the applicant shall not assign his or her right in the license to other persons except with 

the assignment of his or her patent. 

an applicant is required to show that he or she is attempted to obtain a license by offering 

sufficient conditions and royalties to the patent holder but an agreement could not be reached 

within a reasonable period. (section 47). 

According to the above circumstances, the Director General shall fix the royalties, conditions 

and restrictions as he or she deems appropriate subject to the following requirements: 

– the scope and duration of the license shall not exceed what is necessary under the 

circumstances; 

– the patent holder shall be entitled to further license others; 

– the licensee shall not be entitled to assign the license to others, except with that part of 

the enterprise or goodwill particularly of the part under the license; 

– the license shall be aimed predominantly for the supply of the domestic market; and 

– the royalties fixed shall be adequate for the circumstances of the case. (Section 50). 

3) Public interest 

The Patent Act authorises the government to utilize a patent for the benefit of the public in 

two circumstances: 

– a Ministry, Bureau or Department may use any granted patent under Section 36 by itself 

or authorise another person to use it for the benefit of public utilities; national defence; 

the preservation or acquisition of natural resources or the environment; the prevention 

of severe shortages of food, medicine or other consumption items; or for other public 

interest. The authority is obliged to pay a royalty to the patent holder or the patent 

holder’s licensee (Section 51); and 

– the Prime Minister, with the approval of the Cabinet, shall have the power to issue an 

order to exercise any granted patent, during a state of war or emergency, necessary to 

defence and security of the country by paying a fair remuneration to the patent holder 

and shall notify the patent holder in writing without a delay. (section 52). 

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By virtue of section 51 of the Patent act (as amended), the compulsory licenses have 

been granted by Ministry of Public Health to exercise the granted patents of the following 


1) Efavirenz ( Stocrin®) for the treatment of HIV /AIDS owned by Merck & Co., Inc.; 

2) lopinavir and ritonavir (Kaletra®) for the treatment of hiv /aiDs owned by abbott 

Laboratories; 

3) Clopidogrel (Plavix®) for the treatment of myocardial ischemia and cerebro-vascular 

accident owned by Sanofi-Aventis; 

4) Docetaxel (Taxotere®) for the treatment of lung and breast cancers owned by Sanofiaventis. 

5) Femara (Letrozole®) for the treatment of breast cancer owned by Novartis; 

6) Erlotinib (Tarceva®) for the treatment of lung cancer owned by Roche; and 

7) imatinib ( Glivec®) for the treatment of chronic myeloid leukemia and gastro-intestinal 

stromal tumours owned by novartis. 

The Ministry of Public Health has entrusted the Government Pharmaceutical Organization 

(GPo) in its name to exercise the patent rights under section 36 paragraph one of the Patent 

act (as amended), with a payment of royalties to the patent holders as prescribed by the 

Notifications of Ministry of Public Health. 






New Article 31 bis TRIPS is not yet ratified in Thailand. However, Ministry of Commerce has 

proposed to ratify the said article in a draft of amendment to the current Patent act which is 

in the process of reviewing the draft. 

Thereafter, the Ministry of Commerce will forward the approved draft to the Office of the 

Council of state for review and approval before submitting the same to the Cabinet and the 

house of representative, respectively. 



The government is allowed to make use of a patented invention without previous license in 

the following two circumstances. 

1) A Ministry, Bureau or Department may exercise any granted patent by itself or authorise 

another person to exercise it for the benefit of public utilities; national defence; the 

preservation or acquisition of natural resources or the environment; the prevention of 

severe shortages of food, medicine or other consumption items; or other public interest; 

and 

2) The Prime Minister, with the approval of the Cabinet, shall have the power to issue an 

order to exercise any granted patent necessary to defence and security of the country. 


The Director General may request the Board of Patents to revoke a valid patent when a 

compulsory license has been granted under section 50 and a period of two years has lapsed 

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from the date of grant of license, the patent holder, the patent holder’s licensee or the license’s 

holder fails to produce the patented product or use the patented process in the country 

without any legitimate reason, or no patented product or product made by the patented 

process is sold or imported into the country or such a product is sold at unreasonably high 

price, and the director general is of the view that there is a good cause to revoke a patent. 

(section 55 (1)). 





other means of facilitating access to medicines, medical devices, diagnostics and the like are 

not explicitly prescribed by the Patent act B.E. 2522 as amended. 




Yes. The research and experimental use exception should not be limited to non-commercial 

purpose only in order to further develop and improve the technology of the patented 

invention, under the conditions that the said use does not unreasonably conflict with a 

normal exploitation of the patent and does not unreasonably prejudice the legitimate 

interests of the patent holder. 


Yes. The Bolar exception should also extend to other products, including biological 

products, research tool, etc. 


Yes. The parallel import exception should not be limited to patented medicines, but the 

exception should also extend to all patented products made under the authorization or 

consent of the patent holder. 


Yes. The individual prescription exception should be recognised under the developing 

countries’ patent law to remedy the pharmaceutical access problem. 


We are of the view that the medical treatment should not be patentable subject matter. 

however, the country where the methods of medical treatment are patentable subject 

matter should stipulate the limitations to the exclusive rights in a patent law. 


Yes. The compulsory licensing is required in some circumstances, such as non-working 

of patent, national defence, or the needs of the national economy, or public health, etc. 

Each country should freely stipulate the grounds upon which compulsory licenses are 

granted. 


Yes. The expropriation of patent should be recognised under the patent law under the 

condition that the patent has not been worked without any legitimate reason or within 

the reasonable period. 



none. 

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none. 




We are of the view that the limitations of patent rights, specifically the research and 

experimental use exception, Bolar exception, and individual prescriptions exception should 

not be harmonised. This is because each country should have a freedom to stipulate the 

limitations of patent rights, taking into account the public interests of the country. some 

limitations of patent rights may not be required in developed countries, but they may need in 

several developing countries. 

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Questions 

Turkey 

Turquie 

Türkei 

Report Q202 

in the name of the Turkish Group 

by Hulya CAYLI, Elisavet YAKOVIDIS CINLEMEZ, Revan DUNDAR, 

Ayse ILDES ERDEM, Onur MUTLU, Erkan SEVINC and Ertan YILDIZ 






Yes, according to Article 75(b) of Decree-Law No. 551 on the Protection of Patent Rights 

(hereafter “DL 551”), acts involving the patented invention for experimental purposes shall 

remain outside the scope of rights conferred by a patent. Scope of the experimental use 

exception is not specified in Article 75(b). On the other hand, according to Article 75(a), acts 

devoid of any industrial or commercial purpose and limited to private ends/aims shall remain 

outside the scope of rights conferred by a patent. Accordingly, it is possible to evaluate Article 

75(b) in terms of Article 75(a) and argue that experimental use is not permitted for commercial 

purposes. On the other hand, Article 75(b) is worded in such general terms that it may be 

argued that experimental use is permitted for commercial purposes. 






exception? 

Yes, it is recognized under DL 551. Bolar-type exception is implemented in Turkey on 

22.06.2004 by the addition of Article 75(f). Limits of the scope of rights conferred by a patent 

are defined in Article 75. It states that third parties can apply for marketing authorization 

and perform tests and experiments required for the authorization of medicaments while the 

patent is in force. While “medicaments” are not defined in DL 551, it may be argued that this 

exception does not apply to biological products or research tools. DL 551 and draft copy 

of the new patent law narrowly defines the pre-expiry exemption to testing for marketing 

authorizations, but leaves room for interpretation indicating that stockpiling etc. may be 

acceptable. 

Article 75 

The following acts shall remain outside the scope of rights conferred by a patent: 

a) Acts devoid of any industrial or commercial purpose and limited to private ends/aims; 

b) Acts involving, for experimental purposes, the invention, subject matter of a patent; 

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c) Extemporaneous preparations of medicines in pharmacies involving no mass production 

and carried out solely in making up a prescription and acts related to the medicines thus 

prepared; 

d) Use of patented invention in the manufacture or operation of ships or spaceships or 

airplanes or land transportation vehicles of countries signatory of the Paris Convention or 

for satisfying the needs of these, provided that said vehicles happen to be, temporarily 

or accidentally, within the boundaries of the Republic of Turkey; 

e) Where acts provided under Article 27 of the International Convention for Civil Aviation 

dated December 7, 1944 are related to an aircraft of a State, the provisions of this 

present Article shall apply likewise to said aircrafts. 

f) Registration of medicaments and acts involving the subject matter of the invention for 

experimental purposes in order to obtain marketing authorization for medicinal products, 

including the required tests and experiments for this purpose. 




Parallel imports of patented medicines, medical devices or other pharmaceutical products are 

not allowed according to DL 551 and pharmaceutical products authorization regulations. 

Rights on the products that are subject to the trade should be exhausted to do parallel trade. 

Exhaustion of rights is mentioned in DL 551 Article 76 which is in force since 27.06.1995 and 

states that “rights conferred by a patent shall not extend to the acts committed with regard 

to a product under patent protection after said product has been put to sale in Turkey by the 

right holder of the patent or with his consent”. In other words national exhaustion principle is 

accepted according to this Article by the “product, under patent protection, has been put to 

sale in Turkey” expression. 

Meanwhile there is a customs union agreement between Turkey and the European Union. 

And according to the EC- Turkey Association Council Decision 1/95, in which EU-Turkey 

trade relations are regulated, parallel trade is agreed as follows; “this decision does not 

imply exhaustion of intellectual, industrial and commercial property rights applied in the 

trade relations between the two Parties under this Decision”. Considering this Article, regional 

exhaustion is not possible between Turkey and EU for intellectual, industrial and commercial 

property rights. 

Exhaustion of Rights Conferred by a Patent 

Article 76: 

Rights conferred by a patent shall not extend to acts committed with regard to a product 

under patent protection after said product has been put to sale in Turkey by the right holder 

of the patent or with his consent. 

EC-Turkey Association Council Decision 1/95 Annex 8 Article 10. 

The Parties agree that for the purpose of this Decision, intellectual, industrial and commercial 

property includes in particular copyright, including the copyright in computer programmes, 

and neighbouring rights, patents, industrial designs, geographical indications including 

appellations of origin, trade marks and service marks, topographies of integrated circuits 

as well as protection against unfair competition as referred to in Article 10a of the Paris 

Convention for the protection of industrial property and protection of undisclosed information 

on know-how. 

165. This decision does not imply exhaustion of intellectual, industrial and commercial 

property rights applied in the trade relations between the two Parties under this Decision. 

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On the other hand, as thoroughly explained in the answer to Q205 “Exhaustion of IPRs in 

cases of recycling and repair of goods,” Part I (Analysis of the current statutory and case 

laws), Question 2 as to exhaustion of rights regarding patents, designs and trademarks, the 

system of national exhaustion is applied in Turkish law, however to date 11 th Chamber of the 

Supreme Court rendered decisions as if the principle of international exhaustion is applied. It 

is important to note that these decisions do not relate to patented medicines, medical devices 

or other pharmaceutical products, however we presume that the Court would apply the 

principle of international exhaustion in a case involving above-referenced goods. 


conditions? 

Yes, Art. 75(c) of DL 551 addresses an exception for individual prescriptions, provided that 

medications are produced in a pharmacy shop extemporaneously and not in mass form. 

Acts relating to the medicines thus prepared are also deemed to be outside the scope of 

protection conferred by a patent. There are no other provisions that limit an extemporaneous 

preparation of an individual prescription. 




No, methods of medical treatment are NOT patentable according to DL 551. 






Yes the compulsory licenses are available under the Article 99 of DL 551: Compulsory license 

is (to be) granted where no offer for licensing has been made and where any one of the 

following situations/conditions materializes: 

– Failure to put to use/work the patented invention; 

The delay in the use of the patent was not due to justifiable/legitimate reasons or the 

use thereof had been suspended during an uninterrupted period of 3 years without 

justifiable/legitimate reason”. 

– Dependency of subject matter of patents as mentioned in Article 79: 

This Article concerns the possibility of using the subject matter of a patent with the subject 

matter protected under a prior patent. The right holder of the prior patent and the right 

holder of the latter patent may not use the patent of the other party, without his consent, 

during the term of the validity of his patent. However the right holder of the latter patent 

may use also the prior patent upon authorization of the right holder of the prior patent or 

in case he has been granted compulsory license to use said prior patent; 

– On grounds of public interest as mentioned in Article 103: 

The Council of Ministers decides for the grant of the compulsory license on grounds of 

public interest when the subject matter of the patent concerns topics like public health, 

national defense. Situations where the non-use of the invention or its insufficient use 

in terms of quality and quantity, causes serious damage to the country’s economic or 

technical development shall be deemed to also involve public interest. 

The compulsory license is not exclusive. Only, the compulsory license on grounds of public 

interest may be granted as an exclusive license. 

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There are no compulsory licenses granted in Turkey for the domestic manufacture and supply 

of pharmaceutical products. 






No, new Article 31bis TRIPS has not been ratified in Turkey and there are no other legislative 

amendments in effect. On the other hand, the draft copy of the new patent law includes 

provisions as to the grant of compulsory licenses for exportation of pharmaceutical products 

due to public health reasons to countries unable to manufacture the products or do not have 

sufficient capacity to manufacture the products. We cannot foresee when the new patent law 

will come into effect. There are no compulsory licenses granted in Turkey for the importation 

or exportation of pharmaceutical products. 



No. 


No. 





DL 551 does not recognise further means of facilitating access to medicines, medical devices, 

and diagnostics. 




The Turkish Group is of the opinion that patent law should provide for research or 

experimental use exception for scientific/academic purposes to promote scientific 

innovation, however not for commercial purposes. Application of this exception for 

scientific/academic purposes may contribute to improvements in the health sector and 

to improved products/pharmaceuticals. On the other hand, we are of the opinion that 

authorizing experimenting on an invention for commercial purposes will infringe the 

patent owner’s rights. A balance between interests of public at large and interests and 

rights of a patent owner must be maintained. 


This provision allows not only performing tests and experiments required for the 

authorization but also registration of medicaments. 

The scope of Bolar-type exception is not certain in Article 75(f) of DL 551. We propose 

that the scope of this exception may be extended in order to launch generic product in the 

market as of the 1st day on which the patent protection for that medicament expires. 


National exhaustion is accepted in Turkey and parallel trade between EU and Turkey 

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is not allowed although customs union exists. As mentioned in Q205 “Exhaustion of 

IPRs in cases of recycling and repair of goods,” Part II (Proposals for uniform rules), 

Proposal 6, the Turkish Group is of the opinion that EU Directives and Turkish law 

should be harmonized, thereby regional exhaustion should be adopted in Turkish law 

and implemented within the borders of Customs Union. Parallel trade of medicines and 

medicinal products may help lowering their price and help accessibility of drugs in 

Turkey regarding public health. 


Yes, it is believed that the patent law should allow an exception for preparation of 

individual prescriptions. In spite of the fact that an exception may mean delimitation of 

rights of a patentee, it is believed that corresponding provisions in the law considerably 

limit the scope of the exception, and hence, eliminate the possibility of its use to cover 

commercial uses of a patented medicine. These provisions are believed to be sufficiently 

defending rights conferred by a patent while providing a certain degree of flexibility for 

those in need of personal exploitation of a patented medicine. 


This would be the case if the patent law had provided protection for methods of treatment. 

While this is not the case in DL 551 and hence no proposal will be made, it is found 

preferable to prevent medical treatment methods from being patentable subject matter 

for protecting public health in general. 


National patent laws should allow compulsory licensing for using a patented invention 

without the patent owner’s consent, by taking into account some provisions mentioned 

below: 

i) the compulsory license may be restricted and may depend on conditions, like extend 

and duration of use, 

ii) patent owner should receive a reasonable royalty from the compulsory license, 

iii) the patentee may raise a complaint to lift the compulsory license, when the 

circumstances have been changed. 

Moreover the patent law should provide for compulsory license considering that the 

public health and the national defense remain the main targets to be protected by a 

government. Topics like public health and national defense prevail over the exclusive 

right conferred by the patent to his owner. This is the reason that in most countries 

provisions of compulsory license are included in the national patent laws. 

This is also supported by the draft copy of the new patent law, which contains more 

detailed provisions of compulsory license to be granted by court, which in addition to 

the grounds already existing has added the condition of granting compulsory license in 

case of exportation of pharmaceutical products to countries for reasons of public health 

problems. 


Expropriation of a patent by the government should be allowed only in state of war or 

widely distributed outbreak of epidemic diseases. 



In compulsory license cases, the government may provide some provisions in national patent 

law aiming to extend the term of protection of patent, in case the owner of the patent agreed 

to give a license or even transfer of know-how of producing the required patented medicines 

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in public health crises or other serious conditions, such as war. In these provisions, the term of 

protection shall be extended with a period equal to the term of compulsory license. 




We believe that it is fairly difficult, if not impossible, to harmonize limitations of patent rights 

such as the research and experimental use exception, Bolar exception or the individual 

prescriptions exception. The primary reason is the highly heterogeneous social and economical 

structure of different countries and their individual regions or states. Each country has the 

right to defend its own interests when regulating or at least interpreting the limits of these 

restrictions. A secondary reason would be the inevitable result of practically inapplicable 

provisions in a large bundle of national laws. 

Summary 

The Turkish Group is of the opinion that patent laws should provide for exceptions regarding 

health-sensitive issues with a view to protecting public health to the extent that these are allowed 

only for non-commercial purposes. Particularly, the scope of this exception may be extended in 

order to launch generic product in the market as of the 1 st day on which the patent protection for 

that pharmaceutical product expires. With regard to the harmonization of limitations, we believe 

that it is fairly difficult, if not impossible, to harmonize these exceptions worldwide. While one of 

the reasons for this finding is the highly heterogeneous social and economical structure of different 

countries or regions which might lead these provisions practically inapplicable, a second one might 

be the inevitable right and need for a particular country to defend its own interests when regulating 

or at least interpreting the limits of these restrictions. 

Résumé 

Le Groupe Turc est de l’avis que les lois sur le brevet doivent prévoir des exceptions sur des cas 

sensibles touchant à la santé dans le but de protégér la santé publique et dans la mesure où de 

telles exceptions sont uniquement prévues pour des fins non-commerciales. Particulièrement, la 

portée de cette exception pourrait être étendue envue de lancer le produit générique dans le 

marché à partir du premier jour de l’expiration de protection du produit pharmaceutique. En ce qui 

concerne l’harmonization des limitations, nous estimons qu’il est assez difficile, sinon impossible, 

d’harmoniser ces exceptions à l’ échelle mondiale. Alors qu’une des raisons de cette constatation 

est fortement liée à la structure hétérogène sociale et économique de différents pays ou régions qui 

pourrait aboutir à l’inapplicabilité pratique de ces dispositions, une seconde raison pourrait être le 

droit indispensable et le besoin pour un pays particulier de défendre ses propres intérêts lorsqu’il 

règle ou tout au moins interprète les limites de ces restrictions. 


Die türkische Gruppe vertritt die Meinung, dass die Patentgesetze bei Fragen der öffentlichen 

Gesundheitspflege zum Schutz der öffentlichen Gesundheit Ausnahmen zulassen sollte, wenn diese 

ausschliesslich nicht kommerziellen Zweck dienen. Als besonderer Punkt, kann der Rahmen dieser 

Ausnahme für das Inverkehrbringen von Generikum vom ersten Tag an ausgedehnt werden, an dem 

die Patentschutz für dieses Arzneimittel verfällt. Hinsichtlich der Harmonisierung der Ausnahmen 

und Einschränkungen zukünftiger Verordnungen glauben wir, dass eine weltweite Harmonisierung 

nicht unbedingt unmöglich aber bestimmt sehr schwierig sein wird. Diese Stellungnahme wird 

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erstens durch die Behauptung begründet, dass verschiedene Länder und Regionen über recht 

verschiedenartige soziale und ökonomische Strukturen verfügen, und dies wiederum dazu führen 

kann, dass derartige Verordnungen praktisch unausführbar werden. Als zweite Begründung 

wird aufgeführt, dass im Rahmen der Verteidigung des Staatsinteresse das Recht die Grenzen 

dieser Ausnahmen und Einschränkungen festzulegen oder mindestens zu interpretieren im 

Ermessungsspielraum der einzelnen Länder liegen sollte. 

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301-308_Q202_Turkey.indd 308 17.07.2009 10:35:07

United Kingdom 

Royaume–Uni 

Vereinigtes Königreich 

Report Q202 

in the name of the United Kingdom Group 

by Jeremy BROWN, Alan MCBRIDE, Tony ROLLINS, Trevor COOK, 

Sebastian MOORE, Gareth MORGAN, Ian KARET, Alpha DLUBAC INDRACCOLO, 

Andrew ALLAN-JONES, Miles GAYTHWAITE and Sally MANNION 


Introduction 

All references to the Patents Act 1977 are abbreviated as “PA 77”. Although trade mark, regulatory 

and competition law provisions may be relevant to the questions posed below, the following 

comments have been considered in light of UK patent law alone. 

Questions 





Yes. 

Conditions: s.60(5)(b) PA 77 provides that an otherwise infringing act will not infringe if “it 

is done for experimental purposes relating to the subject-matter of the invention” (emphasis 

added). 

Scope: PA 77 gives no definition of “experimental” but it is likely that an act is an “experiment” 

if it seeks to generate genuinely new information (and not if it seeks simply to verify existing 

knowledge). 

Guidance was provided by the Court of Appeal in Monsanto v Stauffer [1985] RPC 155 (CA) 

where it was observed: 

“…trials carried out in order to discover something unknown, or to test an hypothesis, or even 

in order to find out whether something which is known to work in specific conditions…will 

work in different conditions can fairly…be regarded as experiments.” 

This does not rule out an ultimate commercial aim, so long as the trials are experiments. On 

the other hand, trials to demonstrate to a third party (e.g. a regulator) that a product works 

as its maker claims are not “experiments”. 






exception? 

309 

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Yes. s.60(5)(i) PA 77 implements European Directive 2004/27/EC and exempts such trials as 

are required under Art 10 of Directive 2001/83/EC on the Community code for medicinal 

products for human use and Art 13 of Directive 2001/82/EC on the Community code relating 

to veterinary medical products. These are essentially bioequivalence studies and such further 

studies as may be required to cater for any differences between the basic approved product 

and the “generic” or “biosimilar” product. It is limited to medicinal products, namely products 

for preventing disease in human beings or which may be used in or administered to human 

beings either with a view to restoring, correcting or modifying physiological functions by 

exerting a pharmacological, immunological or metabolic action, or to making a medical 

diagnosis (Art 1(2) Directive 2001/83/EC) and the comparable definition for veterinary 

medicinal products (Art 1(2) Directive 2001/82/EC). 




Parallel importation is not dealt with specifically as a matter of UK patent law. The position 

differs according to whether parallel imports are from within or from outside the EEA. Within 

the EEA, it is well established under EC rules of free movement that a patented product, put 

on the market anywhere in the EEA by the patentee or with his consent, is then free to move 

anywhere in the EEA. The patent rights are exhausted. 

As regards parallel imports from outside the EEA, national law applies. s.60(1) PA 77 

provides that a product is infringed by certain acts including “importing without the consent 

of the proprietor”. 

Under pre-PA 77 English domestic law it was held that if the patentee itself markets the 

product anywhere without any restriction there is an “implied” consent. The purchaser obtains 

an absolute right to deal with the product, including the right to import into the UK (Betts v 

Willmott (1871) 6 Ch App 239). It remains to be decided definitively whether this applies 

now that s.60(1) PA 77 specifically defines which acts constitute infringement and requires 

absence of “consent”. 

If a patentee’s licensee markets abroad then whether or not the UK patent rights are exhausted 

will depend on the scope of the licence granted (Tilghman’s Patent [1884] LR 25 ChD 1). 

In the case of compulsory licensing, the ECJ has held that there is no consent by the patentee, 

and so no exhaustion (Pharmon v Hoechst (Case 19/84 [1985] ECR 2281)). 

There are also regulatory requirements (PL(PI)s) and trade mark and repackaging issues to 

consider. These are beyond the scope of this exercise. This response is confined to patent 

issues. 


conditions? 

Yes. Subsection 60(5)(c) PA 77 exempts “the extemporaneous preparation in a pharmacy of 

a medicine for an individual in accordance with a prescription given by a registered medical 

or dental practitioner” and “dealing with a medicine so prepared.” (emphasis added) 

“Extemporaneous” is not defined but probably means “as and when required” so that 

medicines prepared for stock in advance of a specific need are probably not exempt. 




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Medical treatment methods are not in themselves patentable. Products for use in such methods 

are. Use of such products by practitioners in therapy not being patentable does not constitute 

infringement. 






Yes. s.48 PA 77 provides that at any time after the expiry of three years from the date of grant 

of a patent, any person may apply to the UK Intellectual Property Office (the “UK-IPO”) for a 

compulsory licence under the patent. Grounds differ depending on whether the proprietor of 

the patent is a WTO proprietor or not. 

“WTO Proprietor” is defined widely. According to section 48(5) PA 77, a WTO Proprietor 

is someone who is a national of, or domiciled in, a WTO country or who has a real and 

effective industrial commercial establishment in that country. 

If the proprietor of the patent is a WTO proprietor, the grounds available are: 

• that a demand in the UK for the product is not being met on reasonable terms; 

• the refusal of the patent proprietor to grant a licence on reasonable terms is unfairly 

prejudicing the exploitation in the UK of another patented invention which relies upon the 

technology for which a licence cannot reasonably be obtained; 

• the conditions imposed by the proprietor of the patent concerned on the grant of licences 

under the patent means that the establishment or development of commercial activities in 

the UK is unfairly prejudiced. 

If the proprietor of the patent is not a WTO proprietor, the grounds available are: 

• the patented invention is capable of being commercially worked in the UK; 

• where the patented invention is a product, a demand for the product in the UK is not 

being met on reasonable terms or is being met to a substantial extent by importation from 

a country which is not a Member State; 

• where the patented invention is capable of being commercially worked in the UK, that it 

is being prevented or hindered from being so worked by the importation of the product 

from a country which is not a Member State (where the invention is a product) or by the 

importation from such a country of a product obtained directly by means of the process 

or to which the process has been applied (where the invention is a process); 

• that by reason of the refusal of the patent proprietor to grant a licence or licences on 

reasonable terms, a market for the export of any patented product made in the UK is 

not being supplied or the working or efficient working in the UK of any other patented 

invention which makes a substantial contribution to the art is prevented or hindered or the 

establishment or development of commercial or industrial activities in the UK is unfairly 

prejudiced; 

• that by reason of conditions imposed by the patent proprietor on the grant of licences 

under the patent, or on the disposal or use of the patent product or on the use of the 

patented process, the manufacture, use or disposal of materials not protected by the 

patent, or the establishment or development of commercial or industrial activities in the 

UK, is unfairly prejudiced. 

“Member State” is not defined but is generally accepted as extending to any member of the 

EEA. 

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The UK-IPO will not grant a compulsory licence under a patent, unless, prior to making 

an application, the applicant has made efforts to obtain a licence from the proprietor on 

reasonable commercial terms and conditions and his efforts have not been successful within 

a reasonable period. 

Once the applicant has established a case for a compulsory licence to be granted, the UK- 

IPO has no discretion as to whether or not to grant one. However, in fixing the terms of such 

a licence, it will take into account many factors including the nature of the invention, the time 

period since the patent was granted, measures taken by the proprietor or licensees to use the 

invention, the ability of the applicant to work the invention to the advantage of the public, and 

the risks of the applicant in terms of providing capital and working the invention. 

Any compulsory licence granted will not be exclusive; it cannot be assigned unless it is assigned 

with the enterprise that enjoys the use of the patented invention; it will be predominantly for 

the supply of the market in the UK; it will include conditions entitling the proprietor of the 

patent concerned to remuneration adequate in the circumstances of the case and it shall be 

limited in scope and in duration to the purpose for which the licence was granted. 

Other provisions 

Under s.51 PA 77 a Government Minister has the right to apply for a licence under a patent, 

or seek an entry in the register that licences are obtainable as of right, in each case when “a 

report of the Competition Commission has been laid before Parliament” relating to findings 

following a monopoly, merger or competition reference that a situation, practice or course of 

conduct “operates [or “may be expected to operate”] against the public interest.” 

ss.55-59 PA 77 provide in effect for compulsory licences for Crown use of a patented 

invention, though they are not “licences” in law because Crown use of a patented invention 

is deemed not to be an act of patent infringement. 

Under Article 82(1) EC Treaty a compulsory licence could be a consequence of a finding of 

“abuse of a dominant position”. 

We are not aware of any compulsory licences granted in the UK under ss.48 & 51 PA 77 

for the domestic manufacture and supply of pharmaceutical products. A number of licences 

of right were granted under the transitional provisions and compulsory licences granted 

under the 1949 Act. In those cases the Courts sought to provide patentees with proper 

compensation, recognising that the drugs concerned were established and successful, taking 

into consideration factors such as expected return on R&D, promotion and return on capital 

investment to compute the royalty rate. 






Article 31bis TRIPS has been ratified by the UK in its capacity as a member of the EU. 

The Member States of the EU (and Australia, Canada, Iceland, Japan, New Zealand, Norway, 

Switzerland and the United States) will not use the system as importing Members as set out 

in Article 31bis. 

No compulsory licences have been granted in the UK for exportation of pharmaceutical 

products. 



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ss.55-59 PA 77 provide in effect for compulsory licences for Crown use of a patented 

invention, though they are not “licences” in law because Crown use of a patented invention 

is deemed not to be an act of patent infringement. 

Under s.55, any government department and any person authorised in writing by a 

government department may make use of a patented invention without previous licence. The 

term “government department” is not defined in the Act and it can be sometimes difficult to 

discover the status of a public body; the National Health Service’s use of an invention has 

been deemed to be Crown use (Dory v Sheffield Health Authority [1991] FSR 221). By s.55(1) 

(b) if the invention is a process, the Crown has broad rights in relation to the process, or the 

product obtained directly by means thereof. This includes specifically the right to sell or offer 

to sell the invention where it, or the product directly obtained by it, is a “specified” drug or 

medicine, i.e. one required for the services set up as part of the National Health Service. 

Under s.57 Crown use of an invention is not inhibited by the existence of any licence, 

assignment or agreement made between the patentee and a third party. s.58 PA 77 specifies 

the procedure to be followed if a dispute arises concerning the use or the terms of use, by the 

Crown of a patented invention, or compensation. 

s.59 PA 77 provides wider powers during a declared emergency for use by the Crown of 

inventions. 

Compensation is available for the patentee under both ss.55(4) & 57A PA 77. Under s.55(4) 

compensation will normally be on a willing licensor/willing licensee basis, not taking into 

account loss of manufacturing profit. s.57A provides for compensation in respect of loss that a 

manufacturing patentee or licensee incurs as a result of not being awarded a contract which, 

but for the exercise of powers under s.55, he might reasonably be expected to have received. 

This compensation is additional to compensation under s.55(4) and can be paid either to the 

patentee or an exclusive licensee of the patent. Regarding quantum, regard is to be had to the 

profit that would have been made on such contract and to the extent to which manufacturing 

or other capacity was under-used. 

In addition to the PA 77, The Defence Contracts Act 1958 provides powers for a Secretary of 

State to authorise persons to make use of technical information for the purpose of any contract 

or order for the production of defence materials without restriction under any agreement 

which the supplier may have with another. 


There is no provision for this in the PA 77. 





UK patent law does not recognise any other such means. 




Yes, provided the exempted use is a genuine experiment and limited to experiments on 

the subject matter of invention. 


Yes. AIPPI UK recommends that the exception should apply to all acts necessary for 

getting regulatory approval for any drug (not just generics). 

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We believe AIPPI resolution 101 below remains appropriate: 

“The AIPPI resolves that a patentee be able to invoke its patent against parallel import of a 

patented product, notwithstanding the circumstances under which such product has been 

put on the market in country B, subject to exception by contractual agreement authorizing 

import of the product into country A. The ability to invoke the patent against parallel 

import of patented products is a logical consequence of the fundamental principle of 

territoriality of patent rights. The inability to prevent parallel import diminishes the value 

of patents and the benefits deriving therefrom. 

The AIPPI observes that arrangements may exist where a number of countries decide 

to form a single regional market, in effect defining a single regional territory. In such 

an arrangement, a requirement for freedom of movement of goods within the single 

market may lead to acceptance of the legitimacy of parallel imports between countries 

which are party to the arrangement, provided that those countries together agree among 

themselves that such a restriction of the rights of a patentee is necessary in the realization 

of such a single market.” 

Whether or not an importation infringes should simply be a matter of presence or absence 

of “consent”. Such “consent” should be clear and unambiguous. 


No harm if strictly limited? May not be particularly relevant given that most medicines 

are pre-packaged? 


Patent law should not prevent doctors from being free to treat patients but proper 

protection must be available for innovators inventing new products and methods (e.g. 

dosage regimes) for such treatment. This may be a “defence” or as in Europe a simple 

exclusion from patentability of medical treatment methods as such. 


This should only be granted in very limited circumstances. Compensation should be full 

and proper. 


We cannot see any practical justification for this. We cannot see how this would improve 




We do not believe any further limitations are appropriate. 



We do not see any ways in which patent law should be modified. Patent law is an unlikely 

source of lack of access to medicines. The WHO estimates that one third of the world’s 

population lacks access to essential drugs. However, the vast majority of the 300 odd drugs 

on the WHO’s Model List of Essential Drugs are not under patent protection in any country. 

Further, prior to the Indian 2005 Patents Act around 70% of the population of India did not 

have access to pharmaceuticals despite the lack of product protection for pharmaceuticals. 




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It would be useful if such rules were harmonised provided they are appropriately limited in 

accordance with our responses above. 

Summary 

UK patent law provides for various limitations to the scope of patent rights including Bolar-type 

provisions and exceptions for experimental use, individual prescriptions, compulsory licences and 

Crown use. Additionally, EC rules of free movement regulate parallel trade of patented products 

within the EEA. We believe that AIPPI resolution 101 on parallel imported patented medicines 

remains appropriate. AIPPI UK does not believe that any further limitations to UK patent law are 

necessary. 

AIPPI UK believes that Bolar provisions should be harmonised and suggests that, as in Germany, 

exceptions should apply to all acts necessary for getting regulatory approval for any drug, not just 

generics. 

Résumé 

Le droit anglais des brevets prévoit certaines limites à l’étendue des droits de brevet telles que 

les dispositions Bolar, les exceptions d’usage expérimental, les prescriptions individuelles, les 

licences obligatoires et le privilège de la Couronne. De plus, les règles communautaires sur la 

libre circulation encadrent le commerce parallèle des produits brevetés à l’intérieur de l’Espace 

Economique Européen. Nous pensons que la résolution 101 de l’AIPPI sur l’importation parallèle 

des produits brevetés demeure adaptée. L’AIPPI UK ne croit pas que d’autres limitations dans la 

législation anglaise des brevets soient nécessaires. 

L’AIPPI UK considère que les dispositions Bolar devraient être harmonisées et suggère que, à l’instar 

de l’Allemagne, les exceptions soient appliquées à tous les actes nécessaires à l’obtention d’une 

autorisation administrative pour tout médicament et pas seulement pour les génériques.” 


Das Patentrecht des Vereinigten Königreichs sieht verschiedene Einschränkungen des Umfanges 

von Patentrechten vor einschliesslich der Roche-Bolar- Vorschriften und Ausnahmen für Versuche, 

individuelle Verschreibungen, Zwangslizenzen und dem Gebrauch durch die Krone. Zusätzlich 

regulieren die EU-Regeln über den freien Warenverkehr den parallelen Handel mit patentierten 

Produkten in der EWG. Wir glauben, dass die AIPPI Entschliessung 101 über parallel importierte 

Arzneimittel weiterhin angemessen ist. AIPPI UK glaubt nicht, dass irgendwelche weiteren 

Einschränkungen im Patentgesetz des Vereinigten Königreiches notwendig sind. 

AIPPI UK meint, dass die Bolar Vorschriften harmonisiert werden sollten und schlägt vor, dass 

wie in Deutschland Ausnahmen für alle Handlungen gelten sollten, die für die Erlangung einer 

Genehmigung für jedes Arzneimittel notwendig sind, nicht nur für Generika. 

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Questions 

United States of America 

Etats–Unis d’Amérique 

Vereinigte Staaten von Amerika 

Report Q202 

in the name of the United States Group 

by Amanda HOLLIS, Henry BLANCO–WHITE and Jason BROST 






Yes, in general. Except for the Bolar exception discussed below, this exception is limited to 

narrowly non-commercial uses such as “gratifying a philosophical taste, or curiosity, or for 

mere amusement.” Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc., 733 F.2d 858, 221 

U.S.P.Q. 937, 940 (Fed. Cir. 1984). This exception does not even extend to pure scientific 

research if research is the infringer’s business. Madey v. Duke University, 307 F.3d 1351, 64 

U.S.P.Q.2d 1737, 1746 (Fed. Cir. 2002). 






exception? 

Yes. 35 USC § 271(e). The exception is broadly applied to pre-clinical testing of drugs or 

potential drugs “at least as long as there is a reasonable basis to believe that the compound 

tested could be the subject of ... and the experiments will produce the types of information 

relevant to” an application for approval for clinical trials or marketing. Merck KGaA v. Integra 

Lifesciences I, Ltd., 545 U.S. 193 (2005). The exception is effectively limited to drugs for 

human use; other biological products would be covered only to the extent that they are 

regulated as drugs. The exception does not apply if the drug “is primarily manufactured using 

recombinant DNA, recombinant RNA, hybridoma technology, or other process involving site 

specific genetic manipulation techniques,” or is “a new animal drug or veterinary biological 

product.” (If a license for commercial exploitation is applied for, the license sought must not 

take effect before the patent expires. 35 USC § 271(e)(2).) 




No. 

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conditions? 

No. 




Yes. Where a medical practitioner performs a medical activity that infringes or actively 

induces infringement of a patent, the medical practitioner and a related health care entity 

(hospital, clinic, medical school, etc.), are exempt from suit for infringement, and from 

injunction, damages, and attorneys’ fees. 35 U.S.C. § 287(c). The exemption extends to the 

performance of a medical or surgical procedure on a human body, organ, or cadaver, or on 

a nonhuman animal used in medical research or instruction directly related to the treatment 

of humans. However, the exemption does not extend to use of a patented product, a patented 

use of a composition of matter, or to a process that infringes a biotechnology patent §287(c) 

(2)(A). 






Yes, compulsory licensing of patents has been allowed under the laws of the United States 

under limited circumstances. One longstanding use of compulsory licenses is as a remedy 

for violations of antitrust laws. See Besser Mfg. Co. v. United States, 343 U.S. 444, 447 

(1952) (referring to compulsory licenses as “a well-recognized remedy” in this area). While 

in modern practice it is rare for courts to order such compulsory licenses in cases litigated 

to verdict, they are frequently agreed to in consent decrees. 2-8 Roger M. Milgrim and Eric 

E. Bensen, Milgrim on Licensing § 8.55 (2007). Congress has occasionally provided for the 

compulsory licensing of specific classes of patents considered especially important to public 

welfare. Examples of this include patents related to “nuclear material or atomic energy,” 

42 U.S.C. § 2183, and patents that are “necessary to enable any person” to comply with 

the restrictions of the Clean Air Act when “the unavailability of such right may result in a 

substantial lessening of competition or tendency to create a monopoly.” 42 U.S.C. § 7608. 

The broadest legal authority for the compulsory licensing of patents exists when patents 

are used by the federal government, as recognized in 28 U.S.C. § 1498(a), which creates 

a mechanism for compensating the owners of such patents. Courts interpreting this statute 

have held that the government’s right to do this is “premised on a theory of an eminent 

domain taking under the Fifth Amendment.” See, e.g., Tektronix, Inc. v. United States, 213 

Ct. Cl. 257 (Ct. Cl. 1977). This also protects private contractors who use or manufacture 

patented inventions for the federal government. Crater Corp. v. Lucent Techs., 255 F.3d 1361, 

1363 (Fed. Cir. 2001). Some commentators have suggested that the Supreme Court’s recent 

rejection of a general policy of granting permanent injunctions against patent infringers in 

eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), creates a de facto compulsory 

license in favor of patent infringers who are willing to let the courts decide the appropriate 

licensing fee. See, e.g., Andrew Beckerman-Rodau, The Supreme Court Engages in Judicial 

Activism in Interpreting the Patent Law in eBay, Inc. v. MercExchange, L.L.C., 10 Tul. J. Tech 

& Intell. Prop. 165, 204 (2007). 

No, we are not aware of any compulsory licenses granted in the United States for the domestic 


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Yes. The United States was the first country to accept new Article 31bis TRIPS, doing so on 

December 17, 2005. http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm. 

No, we are not aware of any other legislative amendment in the United States with a view to 

implementing the WTO decision of August 30, 2003. 

No, we are not aware of any compulsory licenses granted in the United States for the 




Yes. The United States government’s power of eminent domain allows it to make use of 

patented inventions without previous license, with a method for compensating the owners of 

such patents established by 28 U.S.C. § 1498, as discussed above in the answer to Question 

6. No limitations to this power, beyond the requirement of just compensation found in the Fifth 

Amendment to the United States Constitution, have been recognized. 


Yes. We are not aware of any circumstances in which the United States government has 

actually expropriated a patent completely, as opposed to simply using it without the owner’s 

permission. However, the way the law of eminent domain has been applied in the United 

States suggests that the government could expropriate any patent it chose to, limited only by 

the Fifth Amendment’s requirement of just compensation. 





The Orange Book, which, as mentioned in the question, provides up to date information on 

generic drug approvals, is made available by the Food and Drug Administration in electronic 

form at http://www.fda.gov/cder/ob/default.htm. 

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Summary Report 

Question Q202 


This Question considers the limitations of exclusive patent rights in a wide variety of countries. Its 

particular focus is limitations which may play a role in providing access to patented medicines and 

other medical or biological products so as to facilitate health care, notably in the context of public 

health crises. 

The Reporter General has received 33 Group Reports from the following countries (in alphabetical 

order): Argentina, Australia, Belgium, Brazil, Bulgaria, China, Columbia, Denmark, Ecuador, Egypt, 

Estonia, Finland, France, Germany, Ireland, Italy, Japan, Malaysia, Mexico, the Netherlands, 

Norway, Peru, Philippines, Portugal, Republic of Korea, South Africa, Spain, Sweden, Switzerland, 

Thailand, Turkey, United Kingdom and United States of America. 

The Reports provide a comprehensive review of the limitations imposed on exclusive patent rights 

under national patent laws. This Summary Report cannot attempt to reproduce the detailed rules 

explained by each Group or carefully selected examples used to illustrate those rules in practice. 

It may also be the case that particular words and phrases which have a specific meaning in 

their original language cannot be translated fully. If any doubt exists as to the exact position in a 

particular jurisdiction, reference should be made to the original Group Reports. 





The vast majority of the Groups reported that a research or experimental use exception 

was recognised in their jurisdiction (either through statutory measures or doctrine and 

jurisprudence). In these jurisdictions an otherwise infringing act will not infringe if it is done 

for experimental purposes relating to the subject matter of the invention. 

The patent laws generally do not give a definition of “experimental” but it is recognised that 

an act is an experiment if it seeks to generate genuinely new information (and not if it seeks 

simply to verify existing knowledge). The UK Group Report quoted the Court of Appeal in 

Monsanto v Stauffer where it was observed that experiments are “trials carried out in order 

to discover something unknown, or to test a hypothesis, or even in order to find out whether 

something which is known to work in specific conditions ... will work in different conditions”. 

A number of Group Reports (Belgium, Denmark, Finland, Germany, Sweden, Switzerland, 

UK) note that this does not rule out an ultimate commercial aim, so long as the trials are 

experiments. In these jurisdictions experimental use is not only permitted for a purely scientific 

purpose, but also for mixed scientific and commercial purposes. 

On the other hand, trials to demonstrate to a third party (e.g. a regulator) that a product 

works as its maker claims are not “experiments”, according to the UK Group Report. 

The German Group Report emphasises that the experimental use exception is limited in that 

experiments will only be deemed permissible if they use the patented subject matter as the 

object of the test and not merely as a means of realisation. Moreover, experiments which 

are conducted to clarify economic factors, such as market demand, price acceptability or 

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distribution possibilities are not permissible. The German and Dutch Group Reports point out 

that experiments may only be carried out to an extent justifying the experimental purpose; 

clinical trials that take place on a very large scale do not fall under the research exception. 

In a number of countries (Argentina, Brazil, Ecuador, France, Italy, Malaysia, the Philippines), 

research and experimental use are only permitted for a purely scientific purpose, but not 

a commercial purpose. Similarly, in the United States, the research exception is limited to 

narrowly non-commercial uses such as “gratifying a philosophical taste, or curiosity, or for 

mere amusement”. The exception does not even extend to pure scientific research if research 

is the infringer’s business. 

Turkey and the Republic of Korea provide for a research or experimental use exception, but it 

is not clear whether experimental use is permitted for commercial purposes. 

In Thailand experimental use for a commercial purpose is permitted provided that it does not 

unreasonably conflict with a normal exploitation of the patent and does not unreasonably 

prejudice the legitimate interests of the patent holder. The Thai Group Report does not specify 

what this proviso means. 

In Australia and South Africa, there is no express provision to provide for a research or 

experimental use exception from infringement. In the South African case of Monsanto v 

Stauffer the High Court stated that even experimental use will amount to infringement if 

the experiment uses the patented invention. The use of the patent to prepare for marketing 

registration of its own similar product was, therefore, found to constitute infringement. In 

Australia, researchers tend to act on the assumption that a research exception exists, but in 

the absence of Australian court authority, it is not clear what the conditions are in which the 

exception would operate or what the scope of the exception would be. 






exception? 

The European Union (EU) introduced a Community-wide Bolar exemption under Directive 

2004/27/EC (with respect to medicinal products for human use) and Directive 2004/28/EC 

(with respect to veterinary medicinal products) which were implemented by all member states 

on October 30, 2005. Therefore, all of the reporting Groups which are member states of 

the European Union or the European Economic Area (EEA), respectively (Belgium, Bulgaria, 

Denmark, Estonia, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, 

Portugal, Spain, Sweden, United Kingdom) recognise a Bolar-type exception. This Bolar 

exemption applies to experimental activities carried out by generic manufacturers with a view 

to obtaining a marketing authorisation for a generic drug. These are essentially bioequivalence 

studies and such further studies as may be required to cater for any differences between the 

basic approved product and the “generic” or “biosimilar” product. 

The Bolar exception is limited to human and veterinary medicinal products. The Dutch Group 

Report states that research tools or medical devices would not be covered by this exception 

as these products will generally not meet the definition of medicinal product. Conversely, the 

Swedish Group reports that the Bolar exception would include biological products if these 

are to be considered as reference medicinal products, and the use of research tools would be 

covered by the exception if they are substantially related to the reference medicinal product. 

The Irish Group report notes that the Bolar exemption does not entitle innovative companies 

to make experimental uses of patented medicines or research tools for the purpose of seeking 

a marketing authorisation for a new medicinal product. On the other hand, in Denmark, 

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France and Germany the Bolar exception is not limited to acts directed at obtaining market 

approval of a generic, but rather encompasses market approval of innovative drugs as well. 

A Bolar-type exception is also recognised in most other jurisdictions (Argentina, Australia, 

Brazil, Malaysia, South Africa, Switzerland, Thailand, Turkey, United States). 

In the United States, the Bolar exception is broadly applied to pre-clinical testing of drugs or 

potential drugs “at least as long as there is a reasonable basis to believe that the compound 

tested could be the subject of ... and the experiments will produce the types of information 

relevant to” an application for approval for clinical trials or marketing (Merck KGaA v Integra 

Lifesciences). The Bolar exception is limited to drugs for human use; other biological products 

would only be covered to the extent that they are regulated as drugs. The exception does not 

apply if the drug is primarily manufactured using recombinant DNA or hybridoma technology 

or if the drug is a new animal drug or veterinary biological product. 

The Australian and Thai Group Reports note that the Bolar exception is limited to drugs; other 

products such as biological products, medical devices, and research tools are excluded from 

the exception. 

In Argentina, Brazil, Malaysia, and South Africa, the Bolar-type exception is not limited to 

pharmaceutical products; it applies to any other product requiring regulatory approval. This 

would for example not only cover pharmaceutical, but also agrochemical products which 

require marketing authorisations before such products may be put on the market. The Brazilian 

and Malaysian Group Reports state that biological tools and research tools would also be 

covered by this exception. The Swiss Group is of the opinion that biological products would 

also be covered to the extent they require regulatory approval; however, medical devices and 

research tools do not seem to be exempted. 

In Ecuador, Japan and the Republic of Korea, no Bolar-type exception is recognised under 

the patent laws. However, in Ecuador and in Japan, clinical trials and other acts seeking to 

obtain approval of a generic product are exempted under the research exception. Also in the 

Republic of Korea, researchers tend to act on the assumption that using an invention without 

the patentee’s consent for the purpose of obtaining approval of a generic product will be 

covered by the research exception; there is, however, no court authority. 

In China, Columbia, Peru and the Philippines, a Bolar-type exception is not recognised and 

using an invention without the patentee’s consent for the purpose of obtaining approval of 

a generic product will not be covered by the research exception. However, in Peru a Bolartype 

exception will soon be recognised under the patent law since the Trade Promotion 

Agreement Peru-USA includes a Bolar-type exception. Similarly, in China and the Philippines 

it is expected that the law will soon be amended to provide for a Bolar-type exception. 




Within the EEA, regional exhaustion applies, i.e. a patented product, put on the market 

anywhere in the EEA by the patentee or with his consent, is free to move anywhere in the EEA. 

However, parallel imports of patented medicines, medical devices or similar from outside the 

EEA are not permitted. 

In most other countries, only national exhaustion of rights applies and parallel imports of 

patented medicines, medical devices or similar from outside the country are generally not 

permitted (Brazil, China, the Philippines, South Africa, Switzerland, Turkey, United States). 

In Argentina, Columbia, Ecuador, Egypt and Peru, international exhaustion of patent rights 

applies; as a result, parallel imports of patented medicines, medical devices or similar are 

permitted. 

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In Australia and Japan, parallel importation is only permissible to the extent the patentee has 

not made it a condition of sale that the purchaser may not import their goods into Australia 

and Japan. 

In South Africa, even though national exhaustion applies, the parallel importation of patented 

medicines has specifically been provided for by an amendment of the South African Medicines 

and Related Substances Act. According to this amendment, the Minister may, based on Article 

8 of TRIPS, prescribe conditions for the supply of more affordable medicines so as to protect 

the health of the public, and in particular may determine that the patent rights shall not extend 

to acts in respect of medicines which have been put on the market. 

The principle of exhaustion does not apply if the products were put on the market under a 

compulsory license, the reason being that they were not made available “by the patentee or 

with his consent”. This is the general view in Europe, in accordance with ECJ 9 July 1985, 

C-19/84 Pharmon v. Hoechst. This is also the view in Egypt, Japan and Malaysia, but not in 

the Republic of Korea where the patent rights are exhausted even if the products were put on 

the market under a compulsory license. 


conditions? 

An individual prescriptions exception is recognised under the patent laws of Argentina, 

Belgium, Brazil, Bulgaria, Denmark, Finland, France, Germany, Italy, Japan, Philippines, 

Republic of Korea, Spain, Sweden, Thailand, Turkey, and UK. 

The patent laws in these countries provide that no infringement arises where there is an 

extemporaneous preparation of a medicine in a pharmacy for individual cases where such 

is in accordance with a medical prescription issued by a registered medical practitioner. The 

German and Swedish Group Reports state that this exemption does not allow stockpiling 

of pharmaceuticals in a pharmacy. Rather, a doctor’s prescription for one single patient is 

required on the basis of which the medicine is prepared in the pharmacy. 

An individual prescriptions exception is not recognised under the patent laws of Australia, Peru, 

Ecuador, Egypt, Estonia, Malaysia, Mexico, Netherlands, Peru, South Africa, Switzerland, 

and United States. 




Methods of medical treatment are only patentable subject matter in Australia and in the United 

States. In all other reporting countries methods of medical treatment are not patentable. 

Australian patent law does not provide for a medical treatment defence or similar exception 

to the patentee’s rights. One Australian case (Bristol-Myers Squibb & Co. v FH Faulding & 

Co. Ltd.) suggested that medical practitioners who wish to use patented methods of medical 

treatment should seek a compulsory license. 

In the United States where a medical practitioner performs a medical activity that infringes 

or actively induces infringement of a patent, the medical practitioner and related healthcare 

entity (hospital, clinic, medical school, etc.) are exempt from suit for infringement. The 

exemption extends to the performance of methods of medical treatment, but not to the use of 

a patented product. 




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Compulsory licenses are available under the patent laws of all reporting countries. 

The general requirements of Art. 31 TRIPS are applicable in all reporting countries. For 

instance, as a general rule, a person may only apply for a compulsory licence under the 

patent provided he has made efforts to obtain a license from the proprietor on reasonable 

commercial terms and conditions and his efforts have not been successful within a reasonable 

period. In accordance with TRIPS, this requirement may be waived by a Member in the case 

of national emergency or other circumstances of extreme urgency or in cases of public noncommercial 

use, as pointed out by the Philippine Group. In situations of national emergency 

or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as 

soon as reasonably practicable. 

Compulsory licenses are available on a number of grounds. Generally speaking, the following 

grounds are available: 

• In most reporting countries (Argentina, Belgium, Brazil, Columbia, Denmark, Ecuador, 

Egypt, Estonia, Finland, France, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, 

Portugal, Philippines, Republic of Korea, Spain, Sweden, Thailand, Turkey), a compulsory 

license may be applied for on the ground of failure to work or insufficient working. 

The Argentine, Mexican and Philippine Group Reports point out that importation of the 

product embodying the invention is deemed to be sufficient working of the patent. 

Compulsory licenses are not granted if the patent owner is able to give valid reasons for 

their failure to work the invention, e.g. if the inactivity derived from a force majeure event, 

including objective difficulties in obtaining market approval before a regulatory authority. 

This is specifically stated in the Group Reports of Argentina, Brazil, Columbia, Ecuador, 

Japan, Malaysia, Mexico, Peru, Philippines, Thailand, and Turkey. 

In accordance with Article 5 (A) (4) Paris Convention, a compulsory license may not be 

applied for on the ground of failure to work or insufficient working before the expiration 

of a period of four years from the date of filing of the patent application or three years 

from the date of the grant of the patent, whichever period expires last. This is specifically 

stated in the Group Reports of Argentina, Australia, Belgium, Bulgaria, Denmark, Egypt, 

France, Japan, Sweden, Thailand, and UK. 

The Belgian and Mexican Group Reports state that the applicant must have the necessary 

means to undertake effective and continuous manufacturing in accordance with the 

patented invention. 

The Danish, Italian and Spanish Group Reports note that working of the invention within 

the EEA or in a WTO country is considered working in the respective country. 

• In the vast majority of the reporting countries (Argentina, Australia, Belgium, Brazil, 

Bulgaria, China, Columbia, Ecuador, Egypt, Estonia, Finland, France, Germany, Italy, 

Japan, Malaysia, Netherlands, Peru, Portugal, Republic of Korea, South Africa, Spain, 

Sweden, Switzerland, Thailand, Turkey, and UK) a compulsory license may be applied for 

in the case of dependency, i.e. if the holder of a second patent covering an improvement 

on an invention that has already been patented by a third party may not practice its 

invention without authorization by the holder of the prior (first) patent. In accordance with 

Art. 31 (l) TRIPS agreement, in case of dependency the additional condition applies that 

the invention claimed in the second patent has to involve an important technical advance 

of considerable economic significance in relation to the invention claimed in the prior 

(first) patent. 

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• In Estonia, the Netherlands, and Norway a compulsory license may also be granted if it 

is necessary for using a granted plant breeder’s right. 

• In most reporting countries (Argentina, Brazil, Bulgaria, China, Columbia, Denmark, 

Ecuador, Egypt, Estonia, Finland, France, Netherlands, Peru, Portugal, Philippines, 

Republic of Korea, Spain, Sweden, Switzerland, Thailand, and Turkey) a compulsory 

license may be applied for in the case of a national emergency or national security and/ 

or based on other public interest grounds. 

United States patent law also provides for the compulsory licensing of patents considered 

especially important to public welfare, i.e. patents related to “nuclear material or atomic 

energy” and patents that are necessary to enable a person to comply with the restrictions 

of the Clean Air Act. 

Public health is expressly recognised as a public interest within the meaning of 

compulsory licensing provisions. This is expressly mentioned by the German, Japanese, 

and Portuguese Groups. Specifically, in Belgium and France a compulsory license 

may be applied for in the interest of public health for a medicine, a medical device, a 

product or medical device used for performing a diagnosis, the process necessary for 

the manufacture thereof, or a diagnosis method applied outside of the human or animal 

body. Some Groups (France, Egypt, South Africa) specify that compulsory licenses may 

be granted in case the quantity and/or quality of patent protected medicines do not meet 

the public demand, if such medicines are sold at excessive prices or in case of chronic, 

incurable or endemic diseases. 

Malaysian law does not refer to the concept of compulsory licensing in relation to public 

interest, but allows the government to authorize a Government Agency or a third party 

designated by the government to use a patent without previous license. For instance, in 

October 2003, the Malaysian government authorised a Malaysian company to import 

anti-retroviral medicines used in the treatment of AIDS from Indian manufacturer CIPLA. 

• In some reporting countries (Argentina, Australia, Brazil, Columbia, Ecuador, Egypt, 

Germany, Italy, Philippines, Republic of Korea, Switzerland, UK, and United States) a 

compulsory license may be applied for to remedy a practice determined after judicial 

or administrative process to be anti-competitive. A similar concept applies in Malaysia 

although it is not referred to as compulsory licensing. The German Group emphasises that 

compulsory licenses on the basis of anti-trust law have a greater practical significance 

than compulsory licences on the basis of patent law. Notably, compulsory licenses under 

anti-trust law are generally available in cases where the compliance with a general 

industry standard requires the use of a patent. 

• In Switzerland compulsory licences are also available for research tools and diagnostic 

products. 

In the United States, the broadest legal authority for the compulsory licensing of patents exists 

when patents are used by the federal government, limited only by a constitutional requirement 

of just compensation. In addition, some commentators in the United States have suggested that 

the Supreme Court’s recent rejection of a general policy of granting permanent injunctions 

against patent infringers in eBay Inc. v. MercExchange creates a de facto compulsory license 

in favour of patent infringers who are willing to let the courts decide the appropriate licensing 

fee. 

In Bulgaria, a granted compulsory licence will be revoked if the licensee does not start 

preparations for the use of the invention within one year after the grant of the compulsory 

licence. In Columbia, Ecuador, and Mexico the same rule applies, but two years after the 

grant of the compulsory license. 

In the vast majority of the reporting countries no compulsory licenses have been granted. 

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In Brazil two compulsory licenses have been granted to the Brazilian Ministry of Health based 

on public interest grounds for the importation of the anti-retroviral drug Efavirenz of Merck 

& Co. In addition, three compulsory licenses were granted for a Brazilian patent covering a 

process for manufacture of a vaccine against aftosa and one compulsory license was granted 

for a Brazilian patent of Monsanto Company. 

In Denmark, in 1969 the Supreme Court granted a compulsory license to a Danish 

pharmaceutical company for a patent of Swiss Geigy AG regarding a process for manufacture 

of phenylbutazone on the ground of failure to work. 

In Italy, the Competition Authority granted generic manufacturers compulsory licences to 

remedy an abuse of dominant position by Merck & Co. 

In Portugal, a compulsory licence was granted to SAPEC AGRO for Portuguese patent no. 

76,136 of Syngenta regarding a plant protection product. 

In the Philippines, a total number of 6 compulsory licences have been granted, and in 

Thailand a total of 7 compulsory licenses have been granted. For more detailed information, 

including the name of the licensor, the licensee and the product covered, please refer to the 

respective Group Reports. 

In the Republic of Korea, a total number of 6 compulsory licences have been applied for, but 

none granted so far. 






The majority of reporting countries have ratified and implemented Article 31bis TRIPS either 

directly (Australia, China, Japan, Mexico, Norway, Switzerland, UK, USA) or through the 

adoption of European Regulation 816/2006 on compulsory licensing of patents relating to the 

manufacture of pharmaceutical products for export to countries with public health problems 

(Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, 

Sweden, UK). 

Argentina, Columbia, Ecuador, Egypt, Estonia, Malaysia, the Philippines, Thailand and 

Turkey have not yet ratified Article 31bis TRIPS or enacted any other legislative amendment 

with a view to implementing the WTO decision of August 30, 2003. Brazil has not ratified 

Article 31bis TRIPS, but enacted another legislative amendment with a view to implementing 

the WTO decision of August 30, 2003. Peru has not ratified Article 31bis TRIPS, but the 

Trade Promotion Agreement Peru-USA recognises the necessity of access to medicines in 

accordance with the WTO decision of August 30, 2003. 

France, Switzerland, Sweden, and UK, among others, declared that they will not use the 

system as importing member for the purposes of Article 31bis TRIPS and its Annex. 

In the vast majority of the reporting countries no compulsory licenses have been granted for 

the importation or exportation of pharmaceutical products. 

In Brazil two compulsory licenses have been granted to the Brazilian Ministry of Health for 

the importation of Efavirenz patented by Merck & Co. 



In most reporting countries the government is allowed to make use of a patented invention 

without previous license based on public interest grounds. For instance, in Brazil and in 

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Thailand the government is allowed to make use of a patented invention without previous 

license in the case of a national emergency or national security. Similarly, in Finland, the 

Netherlands, and Norway the government is only allowed to make use of a patented 

invention without previous license in the case of war or national defence, respectively. In 

China, Germany, Ireland, Malaysia, the Netherlands, and the Philippines the government 

is required to compensate the patentee. The French Group notes that the government may 

rely on the Public Health Act to make use of a patented invention in case of an emergency, 

notably an epidemic. 

The United States government is allowed to make any use of patents without previous licenses, 

limited only by a constitutional requirement of just compensation. Similarly, in the UK any 

government department may make use of a patented invention without previous licence, 

limited only by the statutory requirement of reasonable compensation. Even the National 

Health Service’s use of an invention has been deemed to be Crown use. Analogous rules 

regarding Crown use apply in Australia. 

The South African and UK Groups point out that the State use and Crown use, of a patented 

invention in essence amount to compulsory licenses, although they are not “licenses” in law 

because State use and Crown use are deemed not to be an act of patent infringement. 

The Swedish Group Report notes that the government may also apply for a compulsory 

licence. 

The Argentine, Columbian, Ecuadorian, Estonian, Italian, Japanese, Mexican, Peruvian, 

Portuguese, Spanish, Swiss and Turkish Groups state that their governments are not allowed 

to make use of patents without previous licenses. 

The Belgian and Danish Groups state that no such provision exists under their laws. 


In most reporting countries (Argentina, Brazil, Denmark, Egypt, Italy, Portugal, Spain, 

Switzerland, Sweden, USA) the governments are allowed to expropriate a patent, if the 

public interest requires so and the patentee is fully compensated. Similarly, in Finland, France, 

Norway, Sweden the government is only allowed to expropriate a patent in the case of 

war. 

There have been no reported instances of the government expropriating a patent. The Swedish 

Group points out that in case of expropriation of a patent regarding national security, such 

expropriation would likely be kept confidential. The Danish Group stresses that expropriation 

is not necessary as compulsory licensing provides sufficient remedy. 

The Bulgarian, Columbian, Chinese, Estonian, Japanese, Malaysian, Mexican and Turkish 

Groups state that their governments are not allowed to expropriate a patent. 

The Belgian, Ecuadorian, Peruvian, Philippine, and South African Groups state that no such 

provision exists under their laws. 





The Brazilian Group notes that patent applications for pharmaceutical products undergo 

a double examination in Brazil, one performed by the Brazilian Patent Office and one 

performed by the regulatory authority ANVISA for the purpose of taking into account public 

health policy grounds. For instance, ANVISA has rejected second medical use claims and 

patent applications relating to anti-HIV drugs to assure access to essential medicines. 

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The Bulgarian and Spanish Groups state that regulatory law rather than patent law 

facilitates access to medicines by waiving the requirement of marketing authorizations for 

pharmaceutical products in the case of epidemics, spreading of chemical agents or nuclear 

radiation. In addition, the Spanish Group Report notes that allowing the importation and use 

of medicines which are not approved in Spain, but necessary for the medical treatment, in 

essence amounts to facilitating access to medicines. 

The Danish and French Groups point out that access to medicines is facilitated by the fact 

that the regulatory authorities may grant marketing authorizations for generics prior to expiry 

of the patent protection. The Danish, French, and Norwegian Groups note that their laws 

specifically facilitate access to generic drugs to the extent that they provide incentives for 

doctors to prescribe generic drugs (for instance, by providing for reimbursement by the health 

insurance for the cost of the generic only unless the doctor sets out medical grounds for 

prescribing the original product). 

In this regard, United States Group refers to the Orange Book mentioned in the question 

which provides up to date information on generic drug approvals and is made available by 

the Food and Drug Administration in electronic form at http://www.fda.gov/cder/ob/default. 

htm. Similarly, in Norway, generic drug approvals are also accessible on the website of the 

Medicines Agency. 













Research and experimental use exception 

The majority of Groups (Argentina, Australia, Belgium, Brazil, Bulgaria, China, Columbia, 

Denmark, Ecuador, Finland, Ireland, Italy, Mexico, Netherlands, Norway, Peru, Portugal, 

Republic of Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UK) are in favour of a 

research and experimental use exception. 

The Australian and Dutch Groups stress that legal clarification of the exception is required. 

Some Groups (Argentina, Peru, Turkey) think that the experimental use exception should be 

strictly limited to cases involving non-commercial purposes. On the other hand, the Thai Group 

specifically states that the exception should not be limited to non-commercial purposes. 

The Norwegian and UK Groups are of the opinion that this exception should be limited to 

experiments on the subject matter of the invention. The Swiss Group notes that the exception 

should not cover the use of a patented invention as a tool in research on other objects. 

The Japanese Group does not think that the experimental use exception is required. In case 

the patent laws provide for such exception, the Japanese Group believes that resolution Q105 

adopted in Tokyo in 1992 should be followed (with the exception of point 4). According to 

this resolution the experimental use exception is supported by AIPPI and should essentially 

be limited to non-commercial purposes (the resolution mentions use of the patented invention 

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for academic purposes having no commercial nature, testing to evaluate the teaching of 

the patent and validity of the patent, improving the invention or making an advance over 

the invention or finding an alternative to the invention, but not the commercial exploitation 

of the subject of any improvement or advance). The resolution further stresses that the use 

must involve work on the subject of the patent; use merely to obtain the advantage of the 

invention disclosed by the patent is not experimental use. AIPPI further resolved that the 

experimental use exception should be narrowly interpreted and the burden of proof should lie 

on the third party relying on the experimental use exception. Point 4 of the resolution Q105 

(which, according to the Japanese Group, should not be followed) states that use by a party 

during patent life for the purpose of any regulatory approval to sell after patent expiry is not 

experimental use. 

Bolar exception 

The majority of Groups (Argentina, Australia, Belgium, Brazil, Bulgaria, China, Denmark, 

Ecuador, Finland, Germany, Ireland, Italy, Mexico, Netherlands, Peru, Portugal, Republic of 

Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UK) is in favour of a Bolar exception. 

Some Groups (Denmark, Germany, UK) are of the opinion that the Bolar exception should 

cover both generic and non-generic (innovative) drugs (e.g. selection inventions), but should 

only encompass such measures which are necessary to obtain market approval. 

The Dutch Group thinks that the Bolar exception should apply to all products that require 

regulatory approval. The Thai Group thinks it should also cover biological products and 

research tools. 

The Swedish Group thinks a Bolar exception is acceptable if it is balanced with a system of 

patent term extension. Similarly, the Ecuadorian Group stresses that the Bolar exception is 

only acceptable as long as generic manufacturers may not market the product prior to expiry 

of the patent. In this regard, the French group thinks that there should be an efficient legal 

remedy for patentees to prevent the marketing of generics prior to expiry of the patents. 

The Japanese Group again does not think that this exception is required, but in case it is 

deemed to be required, it should be covered by the experimental use exception. Conversely, 

the Swiss Group takes the view that the Bolar exception should go beyond the general 

research exception and allow the use of patented inventions in bioequivalence studies, batch 

validation and the like. It should, however, not allow stock-piling and preparation for largescale 

manufacturing. 

The Columbian Group is against a Bolar exception. 

Parallel import of patented medicines 

The majority of Groups (Argentina, Denmark, Finland, Germany, Ireland, Italy, Norway 

Japan, Netherlands, Sweden, Switzerland, Turkey, UK) is against international exhaustion 

and parallel import of patented medicines. The Japanese and UK Groups think that AIPPI 

should reconfirm resolution Q101 (adopted in Melbourne in 2001) which rejected international 

exhaustion. 

Most European Groups (Denmark, Finland, Germany, Ireland, Italy, Norway, Sweden, as 

well as Turkey) think that regional exhaustion in homogenous economic areas such as the 

EEA is acceptable. 

Some Groups (Brazil, Bulgaria, China, Columbia, Ecuador, Mexico, Peru, Thailand) are in 

favour of parallel import. The Ecuadorian Group stresses that any developing country should 

be entitled to have access to medicines at the best possible price. 

The Australian Group thinks that parallel imports could increase access to patented medicines 

and does not unreasonably dilute the rights of the patentee. 

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Individuals prescriptions exception 

Most Groups (Argentina, Belgium, Brazil, Bulgaria, China, Finland, Ireland, Italy, Japan, 

Mexico, Norway, Portugal, Republic of Korea, Sweden, Thailand, Turkey) are in favour of an 

individual prescriptions exception. Some Groups (Australia, Ecuador) think that the exception 

may be appropriate for one-off, non-commercial prescriptions in cases of patient need, but 

agree that situations should be avoided where medicines are prepared on a large scale 

basis. 

The Dutch, German, Swiss and UK Groups think that this exception has no relevance in 

practice and, therefore, do not see the need for it. 

Medical treatment defence 

Some Groups (Argentina, Belgium, Brazil, China, Columbia, Japan, Mexico, Norway) are in 

favour of a medical treatment defence, insofar as there is a need for such exception. 

The Australian Group (which is the only reporting country where – besides the United States 

– methods for medical treatment are patentable) is of the view that in a commercial context it 

is unlikely that a medical practitioner would be sued and that, therefore, an explicit defence 

is unnecessary. 

Some Groups (Bulgaria, Ecuador, Ireland, Sweden, Turkey) think that methods for medical 

treatment should remain non patentable. 

Compulsory licensing 

Most Groups (Argentina, Belgium, Brazil, Bulgaria, China, Columbia, Denmark, Ecuador, 

Finland, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Republic of Korea, 

Sweden, Switzerland, Thailand, Turkey, UK) are in favour of compulsory licensing under the 

current regime. 

Some Groups (Australia, Germany) are critical because of the long lead times for the 

production of medicines. In the context of a pandemic, it may be that more than one licensee 

is required to provide sufficient product. 

Some Groups (Argentina, Bulgaria, Sweden, UK) emphasize that compulsory licensing should 

be narrowly construed. The Swedish Group notes that extensive interpretation of Article 31(1) 

TRIPS “national emergency or other circumstances of extreme urgency” would erode the 

patent system to an extent where incentives for R&D might be weakened. 

The Japanese Group thinks that AIPPI should reconfirm resolution Q187 (Limitations on 

exclusive IP Rights by competition law) adopted in Berlin in 2005. This resolution does not 

specifically mention compulsory licensing, but makes it clear that if the exercise of IP rights 

contravenes competition law, then the law should allow for the necessary remedies. 

Expropriation 

Only few Groups (Argentina, Australia, Brazil, China, Thailand) are in favour of 


Some Groups (Finland, Mexico, Philippines, Sweden, Turkey) take the view that expropriation 

should only be allowed in very exceptional circumstances. 

Many Groups (Belgium, Columbia, Ecuador, Germany, Norway, Switzerland) think that 

compulsory licensing is adequate to address public health concerns and that expropriation 

is disproportionate and unnecessary. Additional Groups (Bulgaria, Japan, Netherlands, UK) 

are also against expropriation. 

The Argentinean Group stresses that the limitation should be narrowly construed. The 

Australian Group states that the government needs to justify any expropriation decision it 

makes. 

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Other limitations 

No Group has suggested other limitations of the exclusive patent rights to facilitate access to 

medicines, diagnostics, and medical devices. The French Group stresses that there should not 

be additional limitations beyond those provided by TRIPS. 



The South-African and Swiss Groups note that access to affordable medicine is not the only 

critical factor for ensuring effective treatment to poor people suffering from pandemic and 

endemic illnesses. Effective and accessible health care systems, improved living (sanitary 

and dietary) conditions and better education all play an important part. The Swiss and UK 

Groups further mention that most of the drugs classified by WHO as essential drugs are either 

available off-patent or not patent protected, yet over a third of the world’s population still has 

no access to these drugs. 

The Argentinean and Ecuadorian Groups stress that governments and laws may facilitate 

access in other ways by limitation of patent rights, for instance by controlling (subsidizing) the 

prices of patented medicines. 

The Korean Group stresses the importance of adopting information tools such as the Orange 

Book to facilitate access to medicines. 

As to patent law, the Swiss Group is of the opinion that patents are not an obstacle to the 

access to medicines, but to the contrary stimulate research and ensure that new medicines are 

found and brought to the market. Similarly, the South African Group points out that unduly 

limiting the protection afforded by patent rights on its own will not necessarily provide a 

solution. The Norwegian Group is also of the opinion that a well-functioning patent system 

will in itself have the effect of facilitating access. The Dutch Group is also of the view that 

a better safeguarding of the patentee’s rights will facilitate access. The Dutch Group even 

recommends the use of non-violation complaints against countries which, when applying 

compulsory licenses in the context of public health, strictly act in accordance with the rules, 

but de facto against the spirit of TRIPS. Furthermore, the Dutch Group proposes that additional 

measures (such as extension of patent term, additional recognition of inventors) be introduced 

into patent law in order to compensate the disadvantageous consequences of the grant of 

compulsory licenses. 

In the context of patent law, the South African Group further proposes that the following 

initiatives be considered: providing for incentives to encourage relevant R&D (e.g. innovation 

prize models), supporting relevant innovative activities (e.g. research on the basis of traditional 

remedies) and promoting effective and sustainable technology transfer. Similarly, the Swedish 

Group thinks that incentives for development of new products, based on market exclusivity 

for a limited time should be considered. The Swedish Group makes reference to the orphan 

drug provisions adopted in the EU in this context. These provisions grant 10 years of market 

exclusivity in the EU in return for the development of orphan medical products, meaning that 

for 10 years no other company could obtain permission to market a similar drug. Orphan 

drugs are defined as drugs intended to alleviate rare diseases. Another example would be 

the pediatric exclusivity provisions adopted in the EU. In order to enhance the development 

of pediatric medicines these provisions offer a 6 months patent term extension to makers of 

pediatric medicines. Similar provisions exist in the US. 

The German Group points out that exclusions from patentability (as in the case of methods for 

medical treatment) also serve to facilitate access to medicines and the like. 

The Mexican Group notes that more stringent examination of patentability also facilitates 

access to the extent that unjustified patents are avoided. 

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Most Groups (Argentina, Australia, Bulgaria, Columbia, Denmark, Finland, Italy, Mexico, 

Norway, the Philippines, Republic of Korea, South Africa, Spain, Sweden, UK) are in favour 

of harmonizing limitations of patent rights. 

Some Groups (Argentina, Philippines, Spain) think that harmonization should be achieved 

through WTO. The Spanish Group also mentions the SPLT as possible means of harmonization. 

The Australian Group suggests that AIPPI takes the lead in promoting harmonization efforts. 

Some Groups (Belgium, Ecuador, Ireland, Switzerland) are specifically in favour of 

harmonizing the major exceptions, notably the research and experimental use exception and 

Bolar exception. 

The German Group thinks it is more important to harmonize the effects of a patent rather than 

the exceptions. 

The Irish Group is against harmonizing the rules governing parallel import as this involves 

complex economic issues. Furthermore, the Irish group thinks that harmonization of compulsory 

licensing at TRIPS level is sufficient. 

Some Groups (Brazil, Portugal, Thailand) are against harmonizing limitations of patent rights. 

The Thai Group states that each country should have the freedom to stipulate the limitations 

of patent rights taking into account the public interests of the country. The Turkish Group does 

not think that harmonizing the limitations of patent law will be possible. 

Conclusion 

It appears from the Reports that patent law provides for a number of limitations which may play a 

role in providing access to patented medicines, diagnostics, medical devices and the like. Most of 

these limitations, including the research and experimental use exception, individual prescriptions 

exception, medical treatment defence, compulsory licensing provisions, and expropriation, facilitate 

access to new medical products per se, either on a short term or long term basis. Some limitations 

specifically seek to provide access to affordable medicines and the like, i.e. the parallel import of 

patented medicines as well as the Bolar exemption – to the extent that it only covers generic drugs. 

Finally, access to medical products may also be affected by the availability of sufficient supplies. 

Some of the limitations will also ensure access to adequate supplies, notably in the context of public 

health crises. These include above all the compulsory licensing provisions, and expropriation. Most 

Groups focussed on medicines in their Reports, but depending on the circumstances diagnostics, 

medical devices, biological products and the like may be just as important. 

It follows from the Group Reports that there is large consensus as to the necessity of a research 

and experimental use exception, but it needs to be debated in the Working Committee whether 

the Groups are in favour of a research and experimental use exception which does not rule out an 

ultimate commercial aim, so long as the trials are experiments. If so, Q105 (Experimental use as 

a defence to a claim of patent infringement) which was adopted in Tokyo in 1992 will have to be 

revisited. Similarly, the Groups generally support a Bolar exception, but it will have to be discussed 

in the Working Committee whether the Bolar exception should also cover non-generic (innovative) 

products and extend to all products that require regulatory approval. It may be that this is another 

area where harmonisation could be achieved. The parallel import of patented medicines does not 

seem to have support and resolution Q101 (rejecting international exhaustion) could, therefore, 

be reconfirmed. The individual prescriptions exception – to the extent it has any relevance in 

practice - appears to be generally accepted, provided medicines are not to be prepared on a 

large scale basis. It is not entirely clear whether there is sufficient support in the Group Reports 

for a statement saying that medical methods should remain non-patentable, but it appears from 

the Group Reports that to the extent medical methods are patentable, the law should provide for 

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a medical treatment defence. It also follows from the Group Reports that not only the necessity of 

compulsory licensing provisions is recognised, the Groups also seem to agree that they should 

generally be narrowly construed. Only few Groups are in favour of expropriation, but due to the 

inherent linkage to national public policy principles this is unlikely an area where harmonisation 

could be achieved, except perhaps a resolution providing that expropriation should only be allowed 

in exceptional circumstances as determined by governments, given that compulsory licensing is the 

more adequate and proportionate means of providing access. Finally, the Working Committee will 

have to consider whether AIPPI should support initiatives which provide for incentives, including 

patent term extension and market exclusivity, for development of new medical products. 

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Rapport de Synthèse* 

Question Q202 



Cette question considère les limitations relatives aux droits exclusifs de brevet dans une large variété 

de pays. L’accent est mis sur les limitations qui peuvent jouer un rôle dans l’accès aux médicaments 

brevetés ainsi qu’à d’autres produits médicaux ou biologiques afin de faciliter les services de santé, 

particulièrement dans un contexte de crises de santé publique. 

Le Rapporteur Général a reçu 33 Rapports de Groupes en provenance des pays suivants (dans 

l’ordre alphabétique): Afrique du Sud, Allemagne, Argentine, Australie, Belgique, Brésil, Bulgarie, 

Chine, Colombie, Danemark, Equateur, Egypte, Espagne, Estonie, Etats-Unis d’Amérique, Finlande, 

France, Irlande, Italie, Japon, Malaisie, Mexique, Norvège, Pays-Bas, Pérou, Philippines, Portugal, 

République de Corée, Royaume-Uni, Suède, Suisse, Thaïlande, Turquie. 

Les Rapports proposent une vision exhaustive des limitations imposées sur les droits exclusifs de 

brevet dans les droits nationaux. Ce rapport de synthèse ne prétend pas répertorier le détail des 

règles expliquées par chaque Groupe ou les exemples soigneusement sélectionnés illustrant la 

mise en pratique de ces règles. Il est possible que certains mots ou certaines phrases ayant un sens 

spécifique dans leur langue initiale aient souffert d’une traduction ne reflétant pas entièrement leur 

sens réel. S’il existe des doutes quant à la situation exacte dans une juridiction particulière, il pourra 

être fait référence aux Rapports originaux des Groupes. 






La vaste majorité des Groupes rapporte que leur loi prévoit une exception d’utilisation à 

des fins de recherche ou d’expérimentation (que cela soit par des actes législatifs ou à 

travers la doctrine et la jurisprudence). Dans ces juridictions, les actes effectués dans des buts 

d’expérimentations portant sur le sujet de l’invention, ne pourront être considérés comme des 

infractions. 

Les législations relatives aux brevets ne précisent généralement pas la définition 

d’“expérimental“, mais il est admis qu’un acte est une expérimentation s’il tend réellement 

à apporter de nouvelles informations (et qu’il ne cherche pas simplement à corroborer des 

connaissances déjà établies). Le Rapport du Groupe anglais cite la Cour d’Appel dans 

l’affaire Monsanto V Stauffer, dans laquelle il a été observé que les expérimentations sont des 

„tests mis en place en vue de découvrir quelque chose d’inconnu, ou de tester une hypothèse, 

ou même de découvrir si quelque chose qui est connu pour fonctionner dans des conditions 

particulières … peut fonctionner dans d’autres conditions“. 

Plusieurs Rapports de Groupes (Belgique, France, Danemark, Finlande, Allemagne, Suède, 

Suisse, Royaume-Uni) notent que ceci n’exclut pas un but commercial final, tant que les essais 

* Traduit par Didier BOULINGUIEZ (Cabinet Plasseraud – FRANCE) 

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sont des expérimentations. Dans ces juridictions, l’usage des expérimentations sont permis 

non seulement dans un but purement scientifique, mais aussi dans un but à la fois scientifique 

et commercial. 

D’autre part, selon le Rapport du Groupe anglais, les essais tentant de démontrer à un tiers 

(par exemple un régulateur) qu’un produit fonctionne tel que le déposant le revendique ne 

constituent pas des „expérimentations“. 

Le Rapport du Groupe allemand insiste sur le fait que les exceptions d’utilisation à des fins 

d’expérimentation sont limitées dans la mesure où les expérimentations peuvent uniquement 

être jugées acceptables si elles utilisent le sujet de l’invention comme l’objet du test et pas 

comme un simple moyen de mise en œuvre. De plus, les expérimentations qui sont mises 

en œuvre en vue de clarifier les facteurs économiques, tels que la demande du marché, 

l’acceptabilité du prix, ou la possibilité de distribution ne sont pas permises. Les rapports 

des Groupes allemand et hollandais soulignent le fait que les expérimentations peuvent 

uniquement être menées dans une mesure justifiant le but expérimental; les essais cliniques 

qui ont lieu à une très grande échelle ne tombent pas dans l’exception d’utilisation à des fins 

de recherche. 

Dans un certain nombre d’Etats (Argentine, Brésil, Equateur, France, Italie, Malaisie, les 

Philippines), l’utilisation à des fins de recherche ou d’expérimentation n’est permise que dans 

un but purement scientifique, et non dans un but commercial. De même, aux Etats-Unis, 

l’exception liée à la recherche est limitée aux utilisations rigoureusement non commerciales, 

par exemple afin de „répondre à un questionnement philosophique, à une curiosité, ou à une 

simple distraction“. L’exception ne s’étend d’ailleurs pas à des pures recherches scientifiques 

si cette recherche est dans l’activité commerciale du contrefacteur. 

La Turquie et la République de Corée prévoient une exception d’utilisation à des fins de 

recherche et d’expérimentation, mais la position quant à l’utilisation d’expérimentations à des 

fins commerciales n’est pas claire. 

En Thaïlande, la mise en œuvre d’expérimentations à des fins commerciales est permise si 

cela n’implique pas de conflit excessif avec l’exploitation normale d’un brevet et ne porte pas 

préjudice de manière excessive aux intérêts légitimes du détenteur du brevet. Le Rapport du 

Groupe thaïlandais ne précise pas la définition et la portée de cette réserve. 

En Australie et en Afrique du Sud, il n’existe pas de clauses expressément établies relatives 

à l’exception à des fins de recherche et d’expérimentations liées aux contrefaçons. Dans 

l’affaire Sud-Africaine Monsanto v Stauffer, la Haute Cour a établi que même l’utilisation 

expérimentale est considérée comme une contrefaçon si cette dernière utilise l’invention 

brevetée. L’utilisation du brevet en vue de préparer un enregistrement commercial pour des 

produits similaires à ceux qui sont protégés, constitue ainsi une contrefaçon. En Australie, les 

chercheurs ont tendance à agir dans l’hypothèse qu’une exception à des fins de recherche 

existe, mais en l’absence de jurisprudence, les conditions dans lesquelles l’exception pourrait 

opérer, ou la portée de cette exception, ne sont clairement pas définies. 







L’union Européenne (UE) a introduit une exemption communautaire sous la Directive 2004/27/ 

EC (en rapport avec les produits médicaux à usage humain) et la Directive 2004/28/EC (en 

rapport avec les produits vétérinaires), qui ont été transposées par l’ensemble des pays 

membres le 30 Octobre 2005. Par conséquent, tous les Groupes ayant répondu et qui 

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sont membres de l’Union Européenne ou de l’Espace Economique Européen (respectivement 

Allemagne Belgique, Bulgarie, Danemark, Espagne, Estonie, Finlande, France, Irlande, Italie, 

Pays-Bas, Norvège, Portugal, Royaume-Uni, Suisse) reconnaissent l’exception de type Bolar. 

Cette exception Bolar s’applique aux activités expérimentales mises en œuvre par les 

industries du générique dans le but d’obtenir une autorisation de mise sur le marché pour 

un médicament générique. Cela concerne principalement les études de bioéquivalence et 

d’autres études similaires pouvant établir des différences entre le produit original approuvé et 

le produit „générique“ ou „biosimilaire“. 

L’exception de type Bolar est limitée aux produits humains et vétérinaires. Le Groupe de 

rapport hollandais établit que les instruments de recherche ou les dispositifs médicaux ne 

peuvent pas être couverts par cette exception puisque ces produits ne répondent généralement 

pas à la définition de produit médical. Inversement, le Groupe de rapport suédois rapporte 

que l’exception Bolar devrait inclure les produits biologiques si ces derniers peuvent être 

considérés comme des produits médicaux de référence, et l’utilisation des instruments de 

recherche devrait être couverte par l’exception, si ces derniers sont substantiellement liés à 

des produits médicaux de référence. 

Le Groupe de rapport irlandais précise que l’exception Bolar n’autorise pas les entreprises 

innovantes à utiliser expérimentalement des médicament brevetés ou des instruments de 

recherche dans le but d’obtenir une autorisation de mise sur le marché de produit médical 

nouveau. D’autre part, au Danemark, en France et en Allemagne, l’exception Bolar n’est 

pas limitée aux actes destinés à obtenir l’autorisation de mise sur le marché d’un générique, 

mais inclut également l’autorisation de mise sur le marché de médicaments innovants. 

Une exception de type Bolar est également reconnue dans la majorité des autres juridictions 

(Argentine, Australie, Brésil, Etats-Unis, Malaisie, Afrique du Sud, Suisse, Thaïlande, 

Turquie). 

Aux Etats-Unis, l’exception Bolar est généralement appliquée dans le cadre de tests précliniques 

de médicaments ou de médicaments potentiels „au moins tant qu’il existe une base raisonnable 

laissant croire que le composé testé peut être le sujet de…..et les expérimentations peuvent 

produire des informations pertinentes pour“ une demande d’autorisation de tests cliniques 

ou de mise sur le marché (Merck KGaA v Integra Lifesciences). L’exception Bolar est limitée 

aux médicaments à usage humain; les autres produits biologiques peuvent être couverts 

dans la mesure où ces derniers sont considérés comme des médicaments. L’exception ne 

s’applique pas si le médicament est fabriqué essentiellement en utilisant les technologies 

d’ADN recombinant ou d’hybride, ou si le médicament est un nouveau produit vétérinaire ou 

un produit vétérinaire biologique. 

Les Rapports des Groupes australien et thaïlandais précisent que l’exception Bolar est 

limitée aux médicaments; les autres produits, tels que les produits biologiques, les dispositifs 

médicaux, et les instruments de recherche, sont exclus de cette exception. 

En Argentine, Malaisie, et Afrique du Sud, l’exception de type Bolar n’est pas limitée aux 

produits pharmaceutiques; ils s’appliquent à tout autre produit nécessitant une approbation 

réglementaire. Ceci couvre, par exemple, non seulement les produits pharmaceutiques, mais 

aussi les produits agrochimiques qui nécessitent des autorisations de mise sur le marché avant 

leur commercialisation. Les Rapports des Groupes brésilien et malaisien établissent que les 

instruments biologiques et les instruments de recherche peuvent aussi être couverts par cette 

exception. Le Groupe suisse estime que les produits biologiques pourraient être couverts 

dans la mesure où ils nécessitent une approbation réglementaire; cependant, les dispositifs 

médicaux et les instruments de recherche ne semblent pas exemptés. 

En Equateur, au Japon, et en République de Corée, les droits des brevets ne reconnaissent 

pas d’exception de type Bolar. Toutefois, en Equateur et au Japon, les essais cliniques et 

les autres actes tendant à obtenir une autorisation pour un produit générique sont couverts 

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par l’exception à des fins de recherche. Aussi, en République de Corée, les chercheurs 

tentent d’agir dans l’hypothèse selon laquelle l’utilisation d’une invention sans l’autorisation 

du détenteur de brevet, dans le but d’obtenir une approbation pour un produit générique, 

serait couverte par l’exception à des fins de recherche; il n’existe cependant aucun arrêt 

faisant autorité. 

En Chine, en Colombie, au Pérou et aux Philippines, une exception de type Bolar n’est 

pas reconnue et exploiter l’invention sans l’autorisation du détenteur du brevet dans le but 

d’obtenir une approbation pour un produit générique ne justifie pas une exception à des fins 

de recherche. Toutefois, au Pérou, une exception de type Bolar sera bientôt reconnue par la 

loi sur les brevets sachant que l’accord de Promotion du Commerce entre le Pérou et les USA 

inclut une exception de type Bolar. De manière similaire, en Chine et aux Philippines, les lois 

devraient bientôt inclure une exception de type Bolar. 




obligatoire? 

A l’intérieur de l’EEE (Espace Economique Européen), l’épuisement du droit s’applique, c’està-dire 

qu’un produit breveté, mis sur le marché n’importe où dans l’EEE par le détenteur du 

brevet ou avec son consentement, est libre de circuler n’importe où dans l’EEE. Cependant, les 

importations parallèles de médicaments brevetés, dispositifs médicaux ou produits similaires 

en provenance de l’extérieur de l’EEE ne sont pas permises. 

Dans la majorité des autres Etats, seul l’épuisement des droits nationaux s’applique et les 

importations parallèles de médicaments brevetés, dispositifs médicaux ou produits similaires 

en provenance de l’extérieur de l’Etat concerné ne sont généralement pas permises (Afrique 

du Sud, Brésil, Chine, Etats-Unis, Philippines, Suisse, Turquie). 

En Argentine, Colombie, Equateur, Egypte et Pérou, l’épuisement international des droits de 

brevet s’applique; en conséquence, les importations parallèles de médicaments brevetés, de 

dispositifs médicaux et produits similaires sont permises. 

En Australie et au Japon, les importations parallèles sont permises uniquement dans la mesure 

où le détenteur de brevet n’a pas spécifiquement établi dans les conditions de vente que 

l’acquéreur ne pourra importer les marchandises en Australie ou au Japon. 

En Afrique du Sud, bien que le principe d’épuisement du droit national s’applique, l’importation 

parallèle de médicaments brevetés a spécifiquement été établie dans un amendement de “The 

South Africa Medicines and Related Substances Act”. Selon cet amendement, le Ministère 

peut, d’après l’article 8 du TRIPS, imposer des conditions permettant la mise à disposition 

de médicaments moins onéreux afin de préserver la santé du public, et plus particulièrement 

établir que les droits du brevet ne pourront s’étendre aux actes concernant les médicaments 

qui ont été mis sur le marché. 

Le principe de l’épuisement du droit ne s’applique pas si les produits ont été mis sur le marché 

sous une licence obligatoire, puisque ces derniers n’ont pas été mis à disposition “par le 

détenteur du brevet ou avec son consentement“. Ceci constitue la vision généralement admise 

en Europe, en accord avec la décision de la CJCE du 9 juillet 1985, C-18/84 Pharmon v 

Hoechst. Ceci est également admis en Égypte, au Japon, en Malaisie, mais pas en République 

de Corée, où les droits de brevets sont expirés même si les produits ont été mis sur le marché 

sous licence obligatoire. 


conditions? 

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Une exception pour les prescriptions individuelles est reconnue par les lois sur les brevets dans 

les pays suivants: Allemagne, Argentine, Belgique, Brésil, Bulgarie, Danemark, Espagne, 

Finlande, France, Italie, Japon, Philippines, République de Corée, Royaume-Uni, Suède, 

Thaïlande, Turquie. 

Les lois sur les brevets dans ces pays stipulent que les préparations extemporanées de 

médicaments (préparations magistrales) dans une pharmacie pour des patients individuels, 

suivant une prescription médicale rédigée par un praticien médical agréé, ne peuvent 

constituer une contrefaçon. Les Rapports des Groupes allemand et suédois indiquent que cette 

exception n’autorise pas le stockage de produits pharmaceutiques dans une pharmacie. Une 

prescription d’un médecin pour un patient individuel est donc nécessaire pour la préparation 

du médicament dans la pharmacie. 

Une exception pour les prescriptions individuelles n’est pas reconnue par les lois sur les 

brevets des pays suivants: Australie, Pérou, Equateur, Egypte, Estonie, Malaisie, Mexique, 

Pays-Bas, et Etats-Unis. 




Les méthodes de traitement médical sont susceptibles d’être des objets brevetables uniquement 

en Australie et aux Etats-Unis. Dans tous les autres pays ayant participé à l’Etude, les méthodes 

de traitement médical ne sont pas brevetables. 

La loi australienne sur les brevets ne propose pas une défense pour traitement médical, ou 

une exception similaire aux droits du breveté. Un cas australien (Bristol-Myers Squibb & Co 

v FH Faulding & Co. Ltd.) suggère que les médecins qui désirent utiliser une méthode de 

traitement médical brevetée doivent solliciter une licence obligatoire. 

Aux Etats-Unis, lorsqu’un praticien médical accomplit une activité médicale qui contrefait 

ou induit activement une contrefaçon d’un brevet, le praticien et l’entité de soin concernée 

(hôpital, clinique, école médicale) sont exempts de poursuite pour contrefaçon. L’exemption 

s’applique à la mise en œuvre des méthodes de traitements médicaux, mais pas à l’utilisation 

d’un produit breveté. 







Les licences obligatoires sont disponibles dans les lois sur les brevets de tous les pays ayant 

participé à l’Etude. 

Les conditions générales de l’article 31 du TRIPS sont applicables dans les pays ayant 

participé à l’Etude. Par exemple, de manière générale, une personne peut seulement solliciter 

une licence obligatoire si elle a tenté d’obtenir une licence du détenteur dans des termes et 

conditions commercialement raisonnables et que ses efforts ont été vains durant une période 

raisonnable. En accord avec le TRIPS, cette règle peut être abrogée par un Membre en cas 

d’urgence nationale, ou dans d’autres circonstances d’extrême urgence ou en cas d’utilisation 

publique non commerciale, comme le souligne le Groupe des Philippines. En cas d’urgence 

nationale ou d’autres circonstances d’extrême urgence, le détenteur du droit doit, toutefois, 

être notifié dans les plus brefs délais. 

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Les licences obligatoires sont disponibles pour plusieurs motifs. De manière générale, les 

motifs suivants sont recevables: 

• Dans la majorité des pays ayant participé à l’Etude (Argentine, Belgique, Brésil, Colombie, 

Danemark, Equateur, Egypte, Espagne, Estonie, Finlande, France, Italie, Japon, Malaisie, 

Mexique, Pays-Bas, Pérou, Philippines, Portugal, République de Corée, Suède, Thaïlande, 

Turquie), une licence obligatoire peut être demandée pour non exploitation de l’invention 

ou exploitation insuffisante. 

Les Rapports des Groupes argentin, mexicain et philippin soulignent le fait que 

l’importation de produit matérialisant l’invention est considérée comme une exploitation 

suffisante du brevet. 

Les licences obligatoires ne sont pas octroyées si le détenteur du brevet est capable de 

donner des raisons valables expliquant la non exploitation de l’invention, par exemple 

si cette non exploitation est due à un cas de force majeure, incluant la réelle difficulté 

d’obtenir une autorisation de mise sur le marché auprès de l’autorité compétente. Ceci 

est spécifiquement établi dans les Rapports des Groupes argentin, brésilien, colombien, 

équatorien, japonais, malaisien, mexicain, péruvien, philippin, thaïlandais, et turc. 

Conformément à l’article 5 (A) (4) de la Convention de Paris, une licence obligatoire ne 

peut être demandée sur la base d’une non exploitation ou d’une exploitation insuffisante 

avant l’expiration d’un délai de quatre années à compter du dépôt de la demande de 

brevet, ou de trois années à compter de la délivrance du brevet, le délai qui expire 

le plus tard devant être appliqué. Ceci est spécifiquement établi par les Rapport des 

Groupes d’Argentine, d’Australie, de Belgique, de Bulgarie, du Danemark, d’Egypte, de 

France, du Japon, de Suède, de Thaïlande, et du Royaume-Uni. 

Les Rapports des Groupes belge et mexicain indiquent que le Demandeur doit posséder 

les moyens permettant la prise en charge de la production de manière efficace et continue 

en accord avec l’invention brevetée. 

Les Rapports des Groupes danois, italien, et espagnol indiquent que l’exploitation de 

l’invention à l’intérieur de l’EEE ou dans un pays de l’OMC est considérée comme une 

exploitation dans les pays respectifs. 

• Dans la vaste majorité des pays ayant participé à l’Etude (Afrique du Sud, Allemagne, 

Argentine, Australie, Belgique, Brésil, Bulgarie, Chine, Colombie, Equateur, Egypte, 

Espagne, Estonie, Finlande, France, Italie, Japon, Malaisie, Pays-Bas, Pérou, Portugal, 

République de Corée, Royaume-Uni, Suède, Suisse, Thaïlande, Turquie) une licence 

obligatoire peut être demandée dans le cas de dépendance, c’est-à-dire si le détenteur 

d’un second brevet couvrant un perfectionnement d’une invention déjà brevetée par 

un tiers, ne peut exploiter son invention sans l’autorisation du détenteur du premier 

brevet. En accord avec l’article 31 (I) du TRIPS, en cas de dépendance, une condition 

supplémentaire s’applique: l’invention revendiquée dans le second brevet doit présenter 

d’importantes avancées technologiques ou des avantages économiques significatifs en 

relation avec l’invention préalablement revendiquée dans le premier brevet. 

• En Estonie, aux Pays-Bas, et en Norvège, une licence obligatoire peut également être 

octroyée si cela s’avère nécessaire pour l’utilisation d’une obtention végétale protégée. 

• Dans la plupart des pays ayant participé à l’Etude (Argentine, Brésil, Bulgarie, Chine, 

Colombie, Danemark, Equateur, Egypte, Estonie, Finlande, France, Pays-Bas, Pérou, 

Portugal, Philippines, République de Corée, Espagne, Suède, Suisse, Thaïlande et 

Turquie) une licence obligatoire peut être demandée dans le cas d’une urgence nationale 

ou de sécurité nationale et/ou sur la base d’autres intérêts publics. 

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Le droit américain des brevets prévoit également les licences obligatoires de brevets, 

considéré comme particulièrement importantes pour la santé, c’est-à-dire les brevets 

relatifs à „du matériel nucléaire ou l’énergie atomique“ et les brevets qui sont nécessaires 

au respect des restrictions définies dans „Clean Air Act“. 

La santé publique est formellement reconnue comme intérêt public dans le cadre de 

la définition des dispositions relatives aux licences obligatoires. Ceci est clairement 

mentionné par les Groupes allemand, japonais et portugais. Plus spécifiquement, en 

Belgique et en France, une licence obligatoire peut être demandée dans l’intérêt de la 

santé publique pour un médicament, un dispositif médical, un produit ou dispositif médical 

utilisé pour la mise en œuvre d’un diagnostic, le procédé nécessaire à leur fabrication, 

ou une méthode de diagnostic appliquée en dehors du corps humain ou animal. Certains 

Groupes (France, Egypte, Afrique du Sud) spécifient que les licences obligatoires peuvent 

être octroyées dans le cas où la quantité et/ou la qualité des médicaments brevetés ne 

répondent pas à la demande du public, ou si ces médicaments sont vendus à des prix 

excessifs ou encore dans le cas d’une endémie chronique et incurable. 

La loi malaisienne ne se réfère pas à un concept de licence obligatoire en relation avec 

l’intérêt public, mais permet au gouvernement d’autoriser une Agence Gouvernementale 

ou une tierce partie désignée par le gouvernement à exploiter le brevet sans licence. 

Par exemple, en octobre 2003, le gouvernement malaisien a autorisé une entreprise 

malaisienne à importer un médicament antirétroviral utilisé dans le traitement du SIDA 

du fabricant indien CIPLA. 

• Dans certains des pays ayant participé à l’Etude (Allemagne, Argentine, Australie, 

Brésil, Colombie, Equateur, Egypte, Etats-Unis, Italie, Philippines, République de Corée, 

Royaume-Uni et Suisse) une licence obligatoire peut être demandée pour remédier à une 

technique considérée comme anti-compétitive, après procès judiciaire ou administratif. 

Un concept similaire s’applique en Malaisie bien qu’il n’y soit pas fait référence sous 

le nom de licence obligatoire. Le Groupe allemand souligne le fait que les licences 

obligatoires dans le cadre des lois antitrust ont une application pratique plus significative 

que les licences obligatoires dans le cadre de la loi sur les brevets. En effet, les licences 

obligatoires sous les lois antitrust sont généralement disponibles dans les cas où la mise 

en conformité avec un standard industriel général nécessite l’exploitation d’un brevet. 

• En Suisse, les licences obligatoires sont également disponibles pour les outils de recherche 

et les produits de diagnostic. 

Aux Etats-Unis, la plus grande autorité légale en matière de licence obligatoire de brevet 

existe quand les brevets sont utilisés par le gouvernement fédéral, qui est uniquement limité 

par les dispositions constitutionnelles exigeant une juste indemnisation. De plus, certains 

commentateurs aux Etats-Unis ont suggéré que le récent rejet, par la Cour Suprême, d’une 

politique générale de rejet des injonctions permanentes à l’encontre des contrefacteurs de 

brevets dans l’affaire eBay Inc. V. MercExchange crée, de fait, une licence obligatoire en 

faveur des contrefacteurs de brevets qui sont désireux de laisser les tribunaux compétents 

décider du prix approprié pour l’obtention de la licence. 

En Bulgarie, une licence obligatoire octroyée sera révoquée si le détenteur de la licence ne 

débute pas les préparatifs d’exploitation de l’invention dans un délai d’un an après l’obtention 

de la licence obligatoire. En Colombie, en Equateur et au Mexique, la même règle s’applique, 

à la différence que le délai est de 2 ans après l’obtention de la licence obligatoire. 

Dans la plus grande majorité des pays ayant participé à l’Etude, aucune licence obligatoire 

n’a été octroyée. 

Au Brésil, deux licences obligatoires ont été octroyées au Ministère Brésilien de la Santé sur la 

base des intérêts de la santé publique pour l’importation d’anti-rétrovirus Efavirenz de Merck 

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& Co. De plus, trois licences obligatoires ont été octroyées pour un brevet brésilien couvrant 

un procédé de fabrication d’un vaccin contre la fièvre aphteuse et une licence obligatoire a 

été octroyée pour un brevet brésilien de Monsanto Compagny. 

Au Danemark, en 1969, la Cour Suprême a accordé une licence obligatoire à une entreprise 

pharmaceutique danoise pour un brevet de Swiss Geigy AG concernant un procédé de 

fabrication de la phénylbutazone, sur la base de défaut d’exploitation. 

En Italie, l’Autorité compétente en matière de Concurrence a accordé des licences obligatoires 

aux producteurs de génériques pour remédier à un abus de position dominante de 

Merck & Co. 

Au Portugal, une licence obligatoire a été accordée à SAPEC AGRO pour le brevet portugais 

n° 76,136 de Syngenta concernant un produit de protection de plantes. 

Aux Philippines, 6 licences obligatoires ont été concédées au total, contre 7 licences 

obligatoires en Thaïlande. Pour de plus amples informations, incluant le nom du donneur 

de licence, le licencié et le produit protégé, veuillez vous référer aux Rapports des Groupes 

respectifs. 

En République de Corée, au total 6 licences obligatoires ont été sollicitées, mais aucune n’a 

été concédée pour le moment. 







La majorité des Groupes ayant participé à l’Etude ont ratifié et transposé l’article 31bis 

du TRIPS, soit directement (Australie, Chine, Japon, Mexique, Norvège, Suisse, Royaume- 

Uni, Etats-Unis), soit via l’adoption du Règlement européen 816/2006 concernant l’octroi 

de licences obligatoires pour des brevets visant la fabrication de produits pharmaceutiques 

destinés à l’exportation vers des pays connaissant des problèmes de santé publique (Belgique, 

Danemark, Finlande, France, Allemagne, Irlande, Italie, Pays-Bas, Portugal, Espagne, Suède, 

Royaume-Uni). 

L’Argentine, la Colombie, l’Equateur, l’Egypte, l’Estonie, la Malaisie, les Philippines, la 

Thaïlande, et la Turquie n’ont pas encore ratifié l’article 31bis du TRIPS, ou promulgué tout autre 

amendement législatif dans l’optique de transposer la décision de l’OMC du 30 Août 2003. 

Le Brésil n’a pas encore ratifié l’article 31bis du TRIPS, mais a promulgué un amendement 

législatif dans l’optique de transposer la décision de l’OMC du 30 août 2003. Le Pérou n’a 

pas encore ratifié l’article 31bis du TRIPS, mais l’accord de Promotion du Commerce entre le 

Pérou et les USA reconnait la nécessité d’accès aux médicaments en accord avec la décision 

de l’OMC du 30 Août 2003. 

La France, la Suisse, la Suède, et le Royaume-Uni, parmi d’autres, ont déclaré qu’ils n’utiliseront 

pas le système en tant que membre importateur dans les buts définis dans l’article 31bis du 

TRIPS et ses annexes. 

Dans la grande majorité des pays ayant participé à l’Etude, aucune licence obligatoire n’a 

été concédée pour l’importation ou l’exportation de produits pharmaceutiques. 

Au Brésil, deux licences obligatoires ont été octroyées par le Ministre de la Santé pour 

l’importation de l’Efavirenz, breveté par Merck & Co. 

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Dans la plupart de pays ayant participé à l’Etude, le gouvernement est en droit d’autoriser 

l’exploitation d’une invention brevetée sans licence préalable sur la base de l’intérêt public. 

Par exemple, au Brésil et en Thaïlande, le gouvernement est autorisé à faire exploiter une 

invention brevetée, sans licence préalable, dans le cas d’urgence nationale ou de sécurité 

nationale. De manière similaire, en Finlande, aux Pays-Bas et en Norvège, le gouvernement 

peut uniquement faire exploiter une invention brevetée, sans licence préalable, respectivement 

en cas de guerre ou pour des motifs de défense nationale. En Chine, en Allemagne, en 

Irlande, en Malaisie, aux Pays-Bas et aux Philippines, le gouvernement doit prévoir une 

compensation pour le détenteur du brevet. Le Groupe français mentionne que le gouvernement 

peut s’appuyer sur la loi sur la Santé Publique afin de faire exploiter l’invention brevetée en 

cas d’urgence, notamment en cas d’épidémie. 

Le gouvernement américain est autorisé à faire un usage quelconque des brevets sans 

licence préalable, et est uniquement limité par des dispositions constitutionnelles impliquant 

une juste indemnisation. De manière similaire, au Royaume-Uni, n’importe quel département 

gouvernemental peut faire usage d’une invention brevetée, sans licence préalable, en étant 

exclusivement limité par les dispositions légales impliquant une indemnisation raisonnable. 

Même l’exploitation d’invention par les services de l’Institut National de la Santé a été 

considérée comme une utilisation par la Couronne. Des règles analogues concernant 

l’utilisation par la Couronne sont appliquées en Australie. 

Les Groupes d’Afrique du Sud et du Royaume Uni soulignent le fait que l’exploitation 

d’invention brevetée par l’Etat ou par la Couronne équivaut à une licence obligatoire, même 

s’il ne s’agit pas de „licences“ au sens légal, compte tenu du fait que l’exploitation par l’Etat 

et par la Couronne n’est pas considérée comme un acte de contrefaçon. 

Le Rapport du Groupe suédois précise que le gouvernement peut également solliciter une 

licence obligatoire. 

Les Rapports des Groupes argentin, colombien, équatorien, espagnol, estonien, italien, 

japonais, mexicain, péruvien, portugais, suisse et turc précisent que leur gouvernement ne 

peut pas exploiter des brevets sans licence préalable. 

Les Groupes belges et danois notent qu’il n’existe pas de telles dispositions dans leurs lois. 


Dans la plupart des pays ayant participé à l’Etude (Argentine, Brésil, Danemark, Egypte, 

Espagne, Italie, Portugal, Suisse, Suède, Etats-Unis), les gouvernements sont autorisés à 

exproprier un brevet, si cela s’avère nécessaire pour les intérêts publics et si le détenteur 

du brevet est entièrement indemnisé. De manière similaire, en Finlande, France et Norvège, 

Suède, le gouvernement est uniquement autorisé à exproprier un brevet en cas de guerre. 

Il n’a pas été rapporté d’exemple de gouvernement expropriant un brevet. Le Groupe suédois 

souligne le fait qu’une expropriation de brevet, pour des raisons de sécurité nationale, est 

susceptible de rester confidentielle. Le Groupe danois précise que l’expropriation ne s’avère 

pas nécessaire, puisque le système de licence obligatoire apporte une réponse suffisante. 

Les Groupes bulgare, colombien, chinois, estonien, japonais, malaisien, mexicain, et turc 

indiquent que leur gouvernement n’est pas autorisé à exproprier un brevet. 

Les Groupes belge, équatorien, péruvien, philippin et sud-africain indiquent qu’il n’existe pas 

de telles dispositions dans leur loi. 

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Le Groupe brésilien précise que les demandes de brevet pour les produits pharmaceutiques 

suivent un double examen au Brésil, une première pratiquée par le Bureau des Brevets 

Brésilien, et une autre par l’autorité régulatrice ANVISA dans le but de prendre en compte 

les motifs de la politique de santé publique. Par exemple, ANVISA a rejeté les revendications 

de seconde utilisation et les demandes de brevet relatives aux médicaments anti-HIV afin 

d’assurer l’accès aux médicaments essentiels. 

Les Groupes bulgare et espagnol indiquent que les lois de régulation facilitent davantage l’accès 

aux soins que les lois sur les brevets, en supprimant les exigences liées aux autorisations de 

mise sur le marché des produits pharmaceutiques en cas d’épidémies, ainsi que d’exposition 

à des agents chimiques ou à des radiations nucléaires. De plus, le Rapport du Groupe 

espagnol indique que l’autorisation d’importation et d’exploitation de médicaments qui ne 

sont pas autorisés en Espagne, mais nécessaires au traitement médical, permet l’amélioration 

de l’accès aux soins. 

Les Groupes danois et français soulignent le fait que l’accès aux médicaments est facilité du 

fait que les autorités régulatrices peuvent accorder une autorisation de commercialisation de 

génériques avant l’épuisement de la protection par le brevet. Les Groupes danois, français et 

norvégien indiquent que leurs lois facilitent explicitement l’accès aux médicaments génériques 

dans la mesure où elles prévoient des incitations pour que les médecins prescrivent des 

médicaments génériques (par exemple, en assurant un remboursement par la Sécurité 

Sociale uniquement du coût des génériques, à moins que le médecin présente des arguments 

médicaux justifiant la prescription du princeps). 

A cet égard, le Groupe américain se réfère au livre Orange, mentionné dans la question, 

qui propose des informations à jour, relatives à l’approbation des médicaments génériques 

et sont mises à disposition par la Food and Drug Administration sous forme électronique à 

l’adresse http://www.fda.gov/cder/ob/default.htm. De manière similaire, en Norvège, les 

approbations des médicaments génériques sont également accessibles sur le site de l’Agence 

des Médicaments. 

II) Proposition pour l’adoption de règles uniformes 

1) Le droit des brevets doit-il prévoir: 

– une exception d’utilisation de recherche et d’expérimentation; 

– une exception Bolar; 

– une importation parallèle de médicaments brevetés; 

– une exception de prescription individuelle; 

– une défense de traitement médical; 

– une licence obligatoire; 

– une expropriation; 

– toute autre limitation à l’exclusivité du brevet afin de faciliter l’accès à des médicaments, 

diagnostics, appareils médicaux et autres? 

Si oui, en quelles circonstances? Si non, pourquoi? 

Exception d’utilisation à des fins de recherche et d’expérimentation 

La majorité des Groupes (Argentine, Australie, Belgique, Brésil, Bulgarie, Chine, Colombie, 

Danemark, Equateur, Espagne, Finlande, Irlande, Mexique, Pays-Bas, Norvège, Pérou, 

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Portugal, République de Corée, Royaume-Uni Suède, Suisse, Thaïlande, Turquie) sont 

favorables à l’exception d’utilisation à des fins de recherche et d’expérimentation. 

Les Groupes australien et hollandais insistent sur le fait qu’une clarification légale de 

l’exception est nécessaire. 

Certains Groupes (Argentine, Pérou, Turquie) estiment que l’exception d’utilisation à des 

fins d’expérimentation devrait être strictement limitée aux cas impliquant des objectifs non 

commerciaux. D’un autre coté, le Groupe thaïlandais précise clairement que l’exception ne 

devrait pas être limitée aux buts non commerciaux. 

Les Groupes norvégien et anglais estiment que l’exception devrait être limitée aux 

expérimentations concernant le sujet de l’invention. Le Groupe suisse note que l’exception 

ne devrait pas couvrir l’utilisation de l’invention brevetée comme outil dans la recherche 

concernant d’autres sujets. 

Le Groupe japonais ne considère pas que l’exception d’utilisation à des fins d’expérimentation 

soit nécessaire. Au cas où les lois sur les brevets prévoient une telle exception, le Groupe 

japonais estime que la résolution Q105 adoptée à Tokyo en 1992 devrait être appliquée 

(avec l’exception énoncée au point 4). Concernant cette résolution, l’exception d’utilisation 

à des fins d’expérimentation est appuyée par l’AIPPI et devrait essentiellement être limitée 

à des objectifs non commerciaux (la résolution mentionne l’exploitation de l’invention 

brevetée à des fins académiques n’ayant aucune nature commerciale, les tests d’évaluation 

de l’enseignement du brevet et la validité de ce dernier, l’amélioration de l’invention ou son 

perfectionnement, ou la découverte d’une alternative à l’invention, mais pas l’exploitation 

commerciale de quelque perfectionnement ou avancée technologique. La résolution insiste 

également sur le fait que l’utilisation doit impliquer un réel travail sur le sujet du brevet, une 

simple utilisation dans l’optique de profiter des avantages procurés par l’invention divulguée 

par le brevet ne constitue pas une utilisation à des fins d’expérimentation. L’AIPPI ajoute 

que l’exception d’utilisation à des fins expérimentales doit être rigoureusement interprétée 

et la charge de la preuve doit être apportée par la tierce partie qui demande l’exception 

d’utilisation à des fins expérimentales. Le point 4 de la résolution Q105 (qui, selon le Groupe 

japonais, ne devrait pas être appliqué) établit que l’exploitation de l’invention dans le but 

d’obtenir une autorisation de mise sur le marché et de commercialisation après l’expiration 

du brevet ne constitue pas une utilisation à des fins d’expérimentation. 

Exception Bolar 

La majorité des Groupes (Allemagne, Argentine, Australie, Belgique, Brésil, Bulgarie, Chine, 

Danemark, Equateur, Espagne, Finlande, Irlande, Italie, Mexique, Pays-Bas, Pérou, Portugal, 

République de Corée, Suède, Suisse, Thaïlande, Turquie, Royaume-Uni) est favorable à une 

exception Bolar. Certains Groupes (Allemagne, Danemark, Royaume-Uni) sont d’avis que 

l’exception Bolar devrait couvrir à la fois les médicaments génériques et les médicaments 

non génériques (innovants) (par exemple inventions de sélection), mais devrait uniquement 

concerner les mesures nécessaires à l’obtention d’une autorisation de mise sur le marché. 

Le Groupe hollandais pense que l’exception Bolar devrait être appliquée à tous les produits 

qui nécessitent une autorisation réglementaire. Le Groupe thaïlandais, quant à lui, pense 

qu’elle devrait également couvrir les produits biologiques et les outils de recherche. 

Le Groupe suédois estime que l’exception Bolar est acceptable si elle est compensée par 

un système d’extension de la durée d’un brevet. De manière similaire, le Groupe équatorien 

insiste sur le fait que l’exception Bolar est uniquement acceptable tant que les producteurs 

de génériques ne commercialisent pas le produit avant l’expiration du brevet. A cet égard, 

le Groupe français estime qu’il devrait exister un remède légal efficace pour empêcher la 

commercialisation de génériques préalablement à l’expiration des brevets. 

Le Groupe japonais ne pense pas, une fois de plus, que cette exception soit nécessaire, 

mais dans le cas où cette exception serait reconnue nécessaire, elle devrait être couverte 

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par l’exception d’utilisation à des fins d’expérimentation. Par contre, le Groupe suisse est 

d’avis que l’exception Bolar devrait aller au-delà de l’exception générale d’utilisation à des 

fins de recherche et permettre l’utilisation d’inventions brevetées dans le cadre d’études de 

bioéquivalence, de validation de lots, ou autres, sans pour autant autoriser le stockage et la 

préparation de production à grande échelle. 

Le Groupe colombien est contre l’exception Bolar. 

Importation parallèle de médicaments brevetés 

La majorité des Groupes (Allemagne, Argentine, Danemark, Finlande, Irlande, Italie, 

Norvège, Japon, Pays-Bas, Royaume-Uni, Suède, Suisse et Turquie) est contre l’épuisement 

international et l’importation parallèle de médicaments brevetés. Les Groupes japonais et 

britannique estiment que l’AIPPI devrait reconfirmer la résolution Q101 (adoptée à Melbourne 

en 2001) qui a rejeté l’épuisement international. 

La majorité des Groupes européens (Danemark, Finlande, Allemagne, Irlande, Italie, Norvège, 

Suède, ainsi que la Turquie) estime que l’épuisement régional dans des zones économiques 

homogènes telles que l’EEE est acceptable. 

Certains Groupes (Brésil, Bulgarie, Chine, Colombie, Equateur, Mexique, Pérou, Thaïlande) 

sont favorables à l’importation parallèle. Le Groupe équatorien insiste sur le fait que n’importe 

quel pays en voie de développement devrait être autorisé à avoir accès aux médicaments au 

meilleur prix possible. 

Le Groupe australien pense que l’importation parallèle pourrait augmenter l’accès aux 

médicaments brevetés et n’atténue pas, de manière déraisonnable, les droits du détenteur 

de brevet. 

Exception de prescription individuelle 

La plupart des Groupes (Argentine, Belgique, Brésil, Bulgarie, Chine, Finlande, Irlande, Italie, 

Japon, Mexique, Norvège, Portugal, République de Corée, Suède, Thaïlande, Turquie) sont 

favorables à une exception de prescription individuelle. Certains Groupes (Australie, Equateur) 

estiment que l’exception peut être appropriée de manière sporadique, pour les prescriptions 

non commerciales répondant aux besoins des patients, mais s’accordent toutefois à dire 

qu’elle devrait être évitée lorsque les médicaments sont produits à grande échelle. 

Les Groupes hollandais, allemand, suisse et anglais estiment que cette exception ne fait 

preuve d’aucune pertinence en pratique et n’en voient donc pas l’utilité. 

Défense pour traitement médical 

Certains Groupes (Argentine, Belgique, Brésil, Chine, Colombie, Japon, Mexique, Norvège) 

sont favorables à une défense pour traitement médical dans la mesure où une telle exception 

est nécessaire. 

Le Groupe australien (qui est le seul Groupe, avec les Etats-Unis, où les méthodes de traitement 

médical sont brevetables) considère que dans un contexte commercial il est peu probable 

qu’un praticien médical soit poursuivi et qu’une telle exception n’est donc pas nécessaire. 

Certains Groupes (Bulgarie, Equateur, Irlande, Suède, Turquie) estiment que les méthodes de 

traitement médical devraient rester non brevetables. 

Licences obligatoires 

La plupart des Groupes (Argentine, Belgique, Brésil, Bulgarie, Chine, Colombie, Danemark, 

Equateur, Finlande, Irlande, Italie, Japon, Mexique, Pays-Bas, Norvège, Portugal, République 

de Corée, Royaume-Uni, Suède, Suisse, Thaïlande, Turquie) sont en faveur d’une licence 

obligatoire sous le régime actuel. 

Certains Groupes (Australie, Allemagne) sont sceptiques, compte tenu du long délai de 

production des médicaments. Dans le contexte de pandémie, il est possible que plus d’une 

licence octroyée s’avère nécessaire pour fournir suffisamment de produits. 

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Certains Groupes (Argentine, Bulgarie, Suède, Royaume-Uni) insistent sur le fait que les 

licences obligatoires doivent être interprétées étroitement. Le Groupe suédois note qu’une 

interprétation élargie d’“urgence nationale où autres circonstances d’extrême urgence“ 

mentionnées dans l’article 31(1) du TRIPS pourrait éroder le système des brevets dans la 

mesure où la R&D pourrait souffrir d’une diminution des incitations. 

Le Groupe japonais estime que l’AIPPI devrait reconfirmer la résolution Q187 (Limitation des 

droits exclusifs de la propriété industrielle par le droit de la concurrence) adoptée à Berlin 

en 2005. Cette résolution ne mentionne pas spécifiquement les licences obligatoires, mais 

spécifie clairement que dans le cas où l’exercice des droits de propriété industrielle enfreint le 

droit de la concurrence, la loi devrait autoriser la mise en place des solutions nécessaires. 

Expropriation 

Seuls certains Groupes (Argentine, Australie, Brésil, Chine, Thaïlande) sont favorables à 

l’expropriation. 

Certains Groupes (Finlande, Mexique, Philippines, Suède, Turquie) estiment que l’expropriation 

devrait être uniquement autorisée dans des circonstances exceptionnelles. 

De nombreux Groupes (Belgique, Colombie, Equateur, Allemagne, Norvège, Suisse) 

estiment que les licences obligatoires sont appropriées pour répondre aux intérêts de la 

santé publique et que les expropriations, quant à elles, s’avèrent disproportionnées et non 

nécessaires. D’autres Groupes (Bulgarie, Japon, Pays-Bas, Royaume-Uni) sont également 

contre l’expropriation. 

Le Groupe argentin insiste sur le fait que la limitation devrait être rigoureusement interprétée. 

Le Groupe australien affirme que le gouvernement doit justifier toutes les décisions 

d’expropriation qu’il peut prendre. 

Autres limitations 

Aucun Groupe n’a suggéré d’autres limitations à l’exclusivité des droits de brevet facilitant 

l’accès aux médicaments, aux diagnostics, et aux dispositifs médicaux. Le Groupe français 

insiste sur le fait qu’il ne devrait pas y avoir de limitations supplémentaires à celles proposées 

par le TRIPS. 

2) Voyez-vous d’autres moyens que les limitations à l’exclusivité pour que le droit des brevets 

puisse faciliter l’accès aux médicaments, aux diagnostics, aux appareils médicaux et 

autres? 

Les Groupes sud-africain et suisse notent que l’accès aux médicaments abordables n’est pas le 

seul facteur critique garantissant le traitement efficace des personnes démunies, souffrant de 

maladies pandémiques et endémiques. Les systèmes de santé publique efficaces et accessibles, 

l’amélioration des conditions de vie (du point de vue sanitaire et alimentaire), et une meilleure 

éducation jouent un rôle important. Les Groupes suisse et anglais mentionnent également le 

fait que la plupart des médicaments classés par l’OMS comme médicaments essentiels sont 

soit disponibles dans le domaine public, soit non protégés par un brevet; toutefois, plus d’un 

tiers de la population mondiale n’a aujourd’hui pas accès à ces médicaments. 

Le Groupe coréen insiste sur l’importance d’adopter des outils d’information tels que le livre 

Orange afin de faciliter l’accès aux soins. 

Quant au droit de brevets, le Groupe suisse estime que les brevets ne sont pas des 

obstacles à l’accès aux médicaments, mais au contraire stimulent la recherche et assurent 

la disponibilité et la mise sur le marché de nouveaux médicaments. De manière similaire, 

le Groupe sud- africain souligne le fait que la limitation excessive de la protection apportée 

par la loi sur les brevets ne constitue pas nécessairement une solution. Le Groupe norvégien 

estime également que le bon fonctionnent du système des brevets aura pour effet de 

faciliter l’accès aux médicaments. Le Groupe hollandais s’accorde également à dire qu’une 

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meilleure protection des droits des détenteurs de brevets facilite l’accès aux soins. Le Groupe 

hollandais recommande même l’utilisation de plaintes de non-violation contre les pays, qui, 

en concédant des licences obligatoires pour des raisons de santé publique, agissent en stricte 

application des règles mais, de fait, contre l’esprit du TRIPS. En outre, le Groupe hollandais 

propose que des mesures supplémentaires (telles qu’une extension de la durée du brevet, une 

reconnaissance supplémentaire pour les inventeurs) soient introduites dans le droit de brevets 

afin de compenser les conséquences néfastes des concessions de licences obligatoires. 

Dans le contexte du droit de brevets, le Groupe sud-africain propose que les initiatives suivantes 

soient considérées: proposer des financements pour encourager la R&D (par exemple mise 

en place de prix d’innovation), soutenir les activités innovantes pertinentes (par exemple, les 

recherches s’appuyant sur la base des remèdes traditionnels), et promouvoir les transferts 

de technologies efficaces et durables. De manière similaire, le Groupe suédois estime que 

les financements pour le développement de nouveaux produits, basés sur l’exclusivité de 

commercialisation pour une période de temps limitée, devraient être considérés. Le Groupe 

suédois fait référence aux clauses relatives aux médicaments orphelins adoptées par l’UE dans 

ce contexte. Ces clauses prévoient 10 ans d’exclusivité de commercialisation dans l’UE en 

échange de développement de médicaments orphelins, ce qui signifie que durant 10 années, 

aucune autre entreprise ne pourra obtenir la permission de commercialiser un médicament 

similaire. Les médicaments orphelins sont définis comme étant destinés au traitement de 

pathologies rares. Un autre exemple pourrait être celui des clauses d’exclusivité de produits 

pédiatriques adoptées dans l’UE. Afin d’améliorer le développement de médicaments 

pédiatriques, ces clauses proposent une extension de la durée du brevet de 6 mois. Des 

dispositions similaires existent aux Etats-Unis. 

Le Groupe allemand souligne le fait que les exclusions de la brevetabilité (notamment 

dans le cas des méthodes de traitement médical) servent également à faciliter l’accès aux 

médicaments et autres produit similaires. 

Le Groupe mexicain note qu’un examen plus rigoureux de la brevetabilité améliore également 

l’accès aux soins dans la mesure où cela écarte les brevets injustifiés. 

3) Les limitations à l’exclusivité, particulièrement l’exception d’utilisation à des fins de recherche 

et d’expérimentation, l’exception Bolar, et les exceptions de prescription individuelle doiventelles 

être harmonisées? Si oui, comment? Si non, pourquoi? 

La plupart des Groupes (Argentine, Australie, Bulgarie, Colombie, Danemark, Finlande, Italie, 

Mexique, Norvège, Philippines, République de Corée, Afrique du Sud, Espagne, Suède, 

Royaume-Uni) sont favorables à l’harmonisation des limitations des droits des brevets. 

Certains Groupes (Argentine, Philippines, Espagne) estiment que cette harmonisation devrait 

être accomplie via l’OMC. Le Groupe espagnol mentionne également le SPLT comme moyen 

d’harmonisation. Le Groupe australien suggère que l’AIPPI prenne l’initiative de promouvoir 

l’harmonisation. 

Certains Groupes (Belgique, Equateur, Irlande, Suisse) sont particulièrement favorables 

à l’harmonisation des principales exceptions, notamment celles relatives à l’exception 

d’utilisation à des fins de recherche et d’expérimentation et l’exception Bolar. 

Le Groupe allemand estime qu’il est plus important d’harmoniser les effets des brevets plutôt 

que les exceptions. 

Le Groupe irlandais est contre l’harmonisation des règles régissant l’importation parallèle 

puisque ces dernières impliquent des problèmes économiques complexes. En outre, le 

Groupe irlandais estime que l’harmonisation des licences obligatoires au niveau du TRIPS 

est suffisante. 

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Certains Groupes (Brésil, Portugal, Thaïlande) sont contre l’harmonisation des limitations des 

droits de brevets. Le Groupe thaïlandais estime que chaque pays devrait être libre de stipuler 

les limitations des droits de brevets, en considérant les intérêts publics propres au pays. Le 

Groupe turc ne pense pas que cette harmonisation de limitation des droits de brevets soit 

possible. 

Conclusion 

Il apparait, d’après ce Rapport, que le droit des brevets prévoit un certain nombre de limitations 

qui peuvent jouer un rôle dans l’accès aux médicaments brevetés, aux diagnostics, aux dispositifs 

médicaux et autres. La majorité de ces limitations, y compris l’exception d’utilisation à des fins de 

recherche et d’expérimentation, l’exception de prescription individuelle, la défense pour traitement 

médical, les dispositions sur les licences obligatoires et l’expropriation, facilitent l’accès à de 

nouveaux produits médicaux per se, autant à court terme qu’à long terme. Certaines limitations 

ont spécifiquement pour objectif l’accès à des médicaments abordables, c’est-à-dire l’importation 

parallèle de médicaments brevetés, tout comme l’exception Bolar – dans la mesure où cela 

couvre uniquement les médicaments génériques. Finalement, l’accès aux produits médicaux peut 

également dépendre de la disponibilité de réserves suffisantes. Certaines limitations pourront 

également assurer l’accès à des fournitures adéquates, notamment dans le contexte de crise de 

santé publique. Ceci inclut surtout les clauses relatives aux licences obligatoires et l’expropriation. 

La plupart des Groupes se sont concentrés sur les médicaments dans leur Rapport, mais selon les 

circonstances, le diagnostic, les dispositifs médicaux, et les produits biologiques peuvent être tout 

aussi importants. 

Il ressort des Rapports des Groupes qu’il y a un large consensus quant à la nécessité d’une exception 

d’utilisation à des fins de recherche et d’expérimentation, mais il est nécessaire de déterminer, lors 

du Comité de Travail, si les Groupes sont favorables à une exception d’utilisation à des fins de 

recherche et d’expérimentation qui n’exclut pas un objectif final de nature commerciale, tant que les 

essais sont des expérimentations. Si tel est le cas, Q105 (Usage expérimental en tant qu’exception 

à l’action de contrefaçon de brevet), qui a été adoptée a Tokyo en 1992, devra être réformée. 

De manière similaire, les Groupes soutiennent généralement l’exception Bolar, mais il devra être 

déterminé, au Comité de Travail, si l’exception Bolar devrait également couvrir les produits non 

génériques (innovants) et s’étendre à tous les produits qui nécessitent une approbation réglementaire. 

Cela semble constituer un point sur lequel l’harmonisation pourrait être mise en place. L’importation 

parallèle de médicaments brevetés ne semble pas être soutenue et la résolution Q101 (Rejet de 

l’épuisement international) pourrait donc être reconfirmée. L’exception de prescription individuelle – 

dans la mesure où cela ne présente pas d’intérêt en pratique – semble être généralement acceptée, 

à condition que les médicaments ne soient pas produits à grande échelle. La position des Groupes 

quant à la brevetabilité des méthodes médicales n’est pas suffisamment claire pour permettre 

d’affirmer que ces méthodes doivent rester non brevetables. Il ressort toutefois des Rapports des 

Groupes que dans la mesure où les méthodes médicales sont brevetables, la loi devrait prévoir une 

défense pour traitement médical. Il ressort également des Rapports des Groupes qu’il est nécessaire 

de reconnaitre les clauses relatives aux licences obligatoires, et que ces dernières devraient être 

rigoureusement interprétées. Seuls certains Groupes sont favorables à l’expropriation, mais compte 

tenu du lien inhérent aux principes des politiques nationales publiques, il est fort peu probable que 

ce point puisse faire l’objet d’une harmonisation, à l’exception peut-être d’une résolution statuant 

sur la fait que l’expropriation est uniquement possible dans des conditions exceptionnelles, telles 

que celles déterminées par les gouvernements, compte tenu que les licences obligatoires constituent 

le moyen le plus adéquat permettant l’accès aux soins. Finalement, le Comité de travail devra 

examiner si l’AIPPI doit soutenir les initiatives d’encouragement, comprenant l’extension de la durée 

des brevets, et l’exclusivité commerciale, pour le développement de nouveaux produits médicaux. 

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Zusammenfassender Bericht 

Frage Q202 



Diese Frage betrachtet die Limitation exklusiver Patentrechte in einer grossen Vielfalt von Ländern. 

Ihr besonderer Schwerpunkt sind Limitationen, die eine Rolle bei der Zugriffsverschaffung auf 

patentierte Medikamente und andere medizinische oder biologische Produkte für die Vereinfachung 

der Gesundheitsversorgung insbesondere im Zusammenhang mit Krisen im öffentlichen 

Gesundheitswesen spielen können. 

Der Generalberichterstatter hat 33 Gruppenberichte über die folgenden Länder (in alphabetischer 

Reihenfolge) erhalten: Ägypten, Argentinien, Australien, Belgien, Brasilien, Bulgarien, China, 

Dänemark, Deutschland, Ecuador, Estland, Finnland, Frankreich, Irland, Italien, Japan, Kolumbien, 

Malaysia, Mexiko, die Niederlande, Norwegen, Peru, Philippinen, Portugal, Republik Korea, 

Schweden, Schweiz, Spanien, Südafrika, Thailand, Türkei, die Vereinigten Staaten von Amerika 

und das Vereinigtes Königreich. 

Die Berichte bieten eine umfassende Übersicht über die Limitationen, die mit nationalen 

Patentgesetzen auf exklusive Patentrechte verhängt wurden. Die detaillierten Regeln, die von 

jeder Gruppe erklärt wurden oder sorgfältig ausgewählte Beispiele zur Veranschaulichung dieser 

Regeln in der Praxis können in diesem zusammenfassenden Bericht nicht wiedergeben werden. 

Es kann ausserdem vorkommen, dass bestimmte Worte und Sätze, die in ihrer jeweiligen Sprache 

eine bestimmte Bedeutung haben, nicht ganz übersetzt werden können. Sollte es Zweifel zur 

genauen Rechtslage eines bestimmten Gerichtsstandes geben, sollte Bezug auf die originalen 

Gruppenberichte genommen werden. 






Die grosse Mehrheit der Gruppen berichtete, dass eine Ausnahme für Forschungs- oder 

Experimentierzwecke in ihrem Gerichtsstand anerkannt sei (entweder durch das Gesetz oder 

Lehren und Rechtsprechung). In diesen Gerichtsständen verletzt eine andernfalls verletzende 

Handlung nicht, wenn diese aus Versuchswecken in Bezug auf den Gegenstand der Erfindung 

vollzogen wird. 

Die Patentgesetze liefern üblicherweise keine Definition für „experimentell“, doch wird 

eine Handlung als Experiment angesehen, wenn sie darauf ausgelegt ist, wirklich neue 

Informationen hervorzubringen (und nicht, wenn sie nur bestehendes Wissen verifizieren soll). 

Der UK-Gruppenbericht zitierte das Berufungsgericht bei der Entscheidung Monsanto gegen 

Stauffer, wo festgestellt wurde, dass Experimente Untersuchungen sind, die durchgeführt 

werden, um etwas Unbekanntes zu entdecken oder um eine Hypothese zu überprüfen oder 

sogar um herauszufinden, ob etwas, das bekannterweise unter bestimmten Umständen 

funktioniert auch unter anderen Umständen funktioniert. 

Eine Reihe von Gruppenberichten (Belgien, Dänemark, Deutschland, Finnland, Schweden, 

Schweiz, Vereinigtes Königreich) weisen darauf hin, dass dies ein gewerbliches Endziel nicht 

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ausschliesse, solange die Untersuchungen Experimente seien. In diesen Gerichtsständen 

ist die Benutzung zu Versuchszwecken nicht nur für rein wissenschaftliche Zwecke erlaubt, 

sondern auch für eine Mischung aus wissenschaftlichen und gewerblichen Zwecken. 

Andererseits sind laut Bericht der UK-Gruppe Untersuchungen, die dazu dienen, einem 

Dritten (z.B. einer Behörde) zu beweisen, dass ein Produkt so funktioniert, wie vom Hersteller 

behauptet, keine „Experimente“. 

Im Bericht der deutschen Gruppe wird betont, dass die Benutzung zu Versuchszwecken insofern 

limitiert sei, dass sie nur dann als zulässig erachtet würde, wenn diese den Gegenstand des 

Patents zum Ziel der Untersuchung mache und nicht nur als Mittel für deren Realisation diene. 

Des Weiteren seien Experimente, die durchgeführt würden, um wirtschaftliche Faktoren zu 

klären, wie zum Beispiel die Marktnachfrage, die Preisakzeptanz oder Vertriebsmöglichkeiten, 

nicht zulässig. Der deutsche und niederländische Gruppenbericht weist darauf hin, dass 

Experimente nur in dem Umfang durchgeführt werden können, der den Versuchszweck 

rechtfertigt; klinische Studien, die in sehr grossem Rahmen durchgeführt werden, fallen nicht 

unter das Forschungsprivileg. 

In einer Reihe von Ländern (Argentinien, Brasilien, Ecuador, Frankreich, Italien, Malaysia, 

Philippinen) sind Forschung und die Benutzung zu Versuchszwecken nur für rein 

wissenschaftliche Zwecke, jedoch nicht für gewerbliche Zwecke erlaubt. Ähnlich ist in 

den Vereinigten Staaten das Forschungsprivileg auf begrenzte nichtgewerbliche Versuche 

beschränkt, wie zum Beispiel für „die Befriedigung eines philosophischen Geschmacks, oder 

Neugierde oder reine Unterhaltung“. Das Privileg erstreckt sich nicht einmal auf die rein 

wissenschaftliche Forschung, wenn Forschung der Geschäftsbereich des Verletzers ist. 

Die Türkei und die Republik Korea sehen ein Forschungsprivileg oder eine Benutzung zu 

Versuchszwecken vor, jedoch ist nicht eindeutig, ob die Benutzung für Versuchszwecke für 

gewerbliche Zwecke zulässig sind. 

In Thailand ist die Benutzung zu Versuchszwecken für gewerbliche Zwecke erlaubt, 

vorausgesetzt, dies steht nicht im unverhältnismässigen Widerspruch zu einer normalen 

Benutzung des Patents und vorausgesetzt, dies beeinträchtigt nicht unverhältnismässig 

die rechtmässigen Interessen des Patentinhabers. Der Bericht der thailändischen Gruppe 

spezifiziert nicht, was diese einschränkende Bedingung bedeutet. 

In Australien und Südafrika finden sich keine ausdrücklichen Bestimmungen, die Forschung 

oder Benutzung zu Versuchszwecken privilegieren. Im südafrikanischen Fall von Monsanto 

gegen Stauffer setzte das oberste Gericht fest, dass selbst die Benutzung zu Versuchszwecken 

als Verletzung gilt, wenn das Experiment die patentierte Erfindung benutzt. Die Benutzung 

des Patents für die Vorbereitung einer Handelsregistrierung des eigenen ähnlichen Produkts 

wurde deshalb als Verletzungshandlung erkannt. In Australien neigen Forscher dazu, davon 

auszugehen, dass ein Forschungsprivileg besteht, jedoch ist es mangels einer australischen 

Gerichtsbehörde nicht eindeutig, was die Voraussetzungen für eine Privilegierung sind und 

welchen Umfang sie hätte. 







Die Europäische Union (EU) führte eine gemeinschaftsweite Bolar-Ausnahme unter der Richtlinie 

2004/27/EG (im Hinblick auf humanmedizinische Produkte) und Richtlinie 2004/28/ 

EG (im Hinblick auf tiermedizinische Produkte) ein, die am 30. Oktober 2005 von allen 

Mitgliedsstaaten implementiert wurde. Deshalb gibt es in allen berichtenden Gruppen, die 

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Mitgliedsstaaten der Europäischen Union beziehungsweise des Europäischen Wirtschafsraums 

(EWR) sind (Belgien, Bulgarien, Dänemark, Deutschland, Estland, Finnland, Frankreich, Irland, 

Italien, die Niederlande, Norwegen, Portugal, Schweden, Spanien, Vereinigtes Königreich), 

eine Bolar-artige Ausnahme. Diese Bolar-Ausnahme gilt für experimentelle Handlungen 

durch Generikahersteller, die die Absicht haben, eine Zulassung für das Inverkehrbringen 

generischer Medikamente zu erhalten. Dies sind im Wesentlichen Bioäquivalenzstudien 

und jene weiteren Studien, die nötig sind, um auf eventuelle Unterschiede zwischen dem 

grundlegenden genehmigten Produkt und dem „generischen“ oder „bioähnlichen“ Produkt 

einzugehen. 

Die Bolar-Ausnahme beschränkt sich auf human- und tiermedizinische Produkte. Im 

niederländischen Gruppenbericht wird erklärt, dass Forschungswerkzeug und medizinische 

Vorrichtungen nicht von dieser Ausnahme umfasst sind, da diese Produkte in der Regel nicht 

unter die Definition eines medizinischen Produkts fallen. Umgekehrt berichtet die schwedische 

Gruppe, dass die Bolar-Ausnahme biologische Produkte umfasst, wenn diese als medizinische 

Referenzprodukte bezeichnet werden können, und dass die Ausnahme die Benutzung von 

Forschungswerkzeug beinhaltet, wenn dieses sich im Wesentlichen auf das medizinische 

Referenzprodukt bezieht. 

Im irischen Gruppenbericht wird festgestellt, dass die Bolar-Ausnahme innovative Unternehmen 

nicht berechtigt, patentierte Medikamente oder Forschungswerkzeuge experimentell zu 

benutzen, um eine Zulassung für das Inverkehrbringen eines neuen medizinischen Produkts 

zu erhalten. Andererseits ist die Bolar-Ausnahme in Dänemark, Deutschland und Frankreich 

nicht auf den Erhalt einer Marktzulassung für ein Generikum beschränkt, sondern sie umfasst 

vielmehr auch die Marktzulassung für innovative Medikamente. 

Auch in den meisten anderen Rechtskreisen (Argentinien, Australien, Brasilien, Malaysia, 

Schweiz, Südafrika, Thailand, Türkei, Vereinigte Staaten von Amerika) ist eine Bolar-artige 

Ausnahme anerkannt. 

In den Vereinigten Staaten gilt die Bolar-Ausnahme weitgehend für präklinische Erprobungen 

von Medikamenten oder möglichen Medikamenten „zumindest solange es vertretbare 

Hinweise für die Annahme gibt, dass die untersuchten Bestandteile Gegenstand eines … und 

die Experimente, die Informationen hervorbringen werden, die relevant für einen“ Antrag(s) 

auf Zulassung für klinische Studien oder Marketing sind (Merck KGaA gegen Integra 

Lifesciences). Die Bolar-Ausnahme beschränkt sich auf Medikamente für den menschlichen 

Gebrauch; andere biologische Produkte wären nur insoweit inbegriffen, dass sie als 

Medikamente gelten. Diese Ausnahme gilt nicht, wenn das Medikament in erster Linie unter 

Einsatz von rekombinantem DNA oder Hybridomatechnik hergestellt wird oder wenn das 

Medikament ein neues Tiermedikament oder ein veterinärbiologisches Produkt ist. 

Die australischen und thailändischen Gruppenberichte besagen, dass die Bolar-Ausnahme 

auf Medikamente beschränkt ist; andere Produkte, wie beispielsweise biologische 

Produkte, medizinische Vorrichtungen und Forschungswerkzeug sind von der Ausnahme 

ausgeschlossen. 

In Argentinien, Brasilien, Malaysia und Südafrika ist die Bolar-artige Ausnahme nicht auf 

pharmazeutische Produkte beschränkt; sie gilt für jedes andere Produkt, für das es einer 

behördlichen Zustimmung bedarf. Dies wären beispielsweise nicht nur Pharmazeutika, sondern 

auch agrochemische Produkte, die eine Zulassung für das Inverkehrbringen benötigen. Die 

brasilianischen und malaysischen Gruppenberichte berichten, dass diese Ausnahme auch 

biologisches Werkzeug und Forschungswerkzeug mit einschliesst. Die schweizerische 

Gruppe ist der Meinung, dass biologische Produkte auch inbegriffen seien, wenn diese 

einer behördlichen Zustimmung bedürfen, jedoch scheinen medizinische Vorrichtungen und 

Forschungswerkzeug nicht zur Ausnahme zu zählen. 

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In Ecuador, Japan und der Republik Korea ist keine Bolar-artige Ausnahme in den Patentgesetzen 

vorgesehen. Jedoch fallen in Ecuador und Japan klinische Studien und andere Versuche, eine 

Zulassung für ein generisches Produkt zu erhalten, unter das Forschungsprivileg. Auch in 

der Republik Korea neigen Forscher dazu, davon auszugehen, dass für die Benutzung eines 

Patents ohne die Zustimmung des Patentinhabers zum Zweck des Erhalts einer Zulassung für 

ein generisches Produkt ein Forschungsprivileg besteht. Eine Gerichtsautorität gibt es jedoch 

nicht. 

In China, Kolumbien, Peru und den Philippinen gibt es keine Bolar-artige Ausnahme und für 

die Benutzung eines Patents ohne die Zustimmung des Patentinhabers zum Zweck des Erhalts 

einer Zulassung für ein generisches Produkt besteht kein Forschungsprivileg. In Peru wird 

jedoch in naher Zukunft eine Bolar-artige Ausnahme vom Patentgesetz anerkannt werden, 

da das Übereinkommen zur Förderung des Handels zwischen Peru und den USA eine Bolarartige 

Ausnahme beinhaltet. Ähnlich wird in China und auf den Philippinen erwartet, dass 

das Gesetz bald so geändert wird, dass eine Bolar-artige Ausnahme vorgesehen ist. 




wurden? 

Innerhalb des EWRs gilt die regionale Erschöpfung, d.h. ein patentiertes Produkt, das vom 

Patentinhaber oder mit dessen Zustimmung irgendwo innerhalb des EWRs auf den Markt 

gebracht wird, kann innerhalb des EWRs frei wandern. Jedoch sind parallele Importe 

patentierter Medikamente, medizinischer Vorrichtungen oder Ähnlichem von ausserhalb des 

EWRs nicht erlaubt. 

In den meisten anderen Ländern gilt nur eine nationale Erschöpfung von Rechten und parallele 

Importe von patentierten Medikamenten, medizinischen Vorrichtungen oder Ähnlichem von 

ausserhalb des Landes sind in der Regel nicht erlaubt (Brasilien, China, den Philippinen, 

Schweiz, Südafrika, Türkei, Vereinigte Staaten von Amerika). 

In Ägypten, Argentinien, Kolumbien, Ecuador, und Peru gilt eine internationale Erschöpfung 

von Patentrechten. Demzufolge sind parallele Importe von patentierten Medikamenten, 

medizinischen Vorrichtungen oder Ähnlichem erlaubt. 

In Australien und Japan ist ein paralleler Import nur zulässig, solange der Patentinhaber nicht 

die Verkaufsbedingung gestellt hat, dass der Käufer die Waren nicht nach Australien oder 

Japan importieren darf. 

In Südafrika wurde – trotz nationaler Erschöpfung – der parallele Import von patentierten 

Medikamenten durch eine Änderung des südafrikanischen Gesetzes über Medikamente und 

ähnliche Substanzen (South African Medicines and Related Substances Act) vorgesehen. 

Diesem Gesetz zufolge kann der Minister laut Artikel 8 des TRIPS-Abkommens Auflagen für 

die Versorgung mit preiswerteren Medikamenten anordnen, um die Gesundheit des Volkes 

zu schützen und er kann insbesondere festlegen, dass die Patentechte nicht auf Gesetze in 

Bezug auf Medikamente, die bereits auf dem Markt eingeführt wurden, ausgeweitet werden 

können. 

Das Prinzip der Erschöpfung gilt nicht, wenn die Produkte unter einer Zwangslizenz auf den 

Markt gebracht wurden, da diese nicht „vom Patentinhaber oder mit dessen Zustimmung“ zur 

Verfügung gestellt wurden. Dies ist entsprechend EuGH 9. Juli 1985, C-19/84 Pharmon gegen 

Hoechst die allgemeine Ansicht in Europa. Dies ist ebenso die Ansicht in Ägypten, Japan und 

Malaysia, jedoch nicht in der Republik Korea, wo die Patentrechte erschöpft werden, selbst 

wenn die Produkte unter einer Zwangslizenz auf den Market gebracht wurden. 

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Eine Freistellung für individuelle Rezepte gibt es in den Patentgesetzen Argentiniens, Belgiens, 

Brasiliens, Bulgariens, Dänemarks, Deutschlands, Finnlands, Frankreichs, Italiens, Japans, 

der Philippinen, der Republik Korea, Schwedens, Spaniens, Thailands, der Türkei und des 

Vereinigten Königreichs. 

Die Patentgesetze in diesen Ländern sehen vor, dass es zu keiner Verletzung kommt, wenn 

eine Rezeptur eines Medikaments in einer Apotheke für einzelne Fälle zubereitet wird und 

dies in Einklang mit einem ärztlichen Rezept ist, die von einem eingetragenen praktischen Arzt 

ausgestellt wurde. Die deutschen und schwedischen Gruppenberichte besagen, dass diese 

Ausnahme keine Vorratsbildung von Pharmazeutika in Apotheken erlaubt. Es wird vielmehr 

ein ärztliches Rezept für einen einzelnen Patienten benötigt, auf dessen Grundlage ein 

Medikament in der Apotheke zubereitet wird. In den Patentgesetzen Ägyptens, Australiens, 

Ecuadors, Estlands, Malaysias, Mexikos, der Niederlande, Perus, der Schweiz, Südafrikas 

und der Vereinigten Staaten ist keine Freistellung für individuelle Rezepte anerkannt. 




Ärztliche Behandlungsmethoden sind nur in Australien und den Vereinigten Staaten 

patentierbarer Gegenstand. In allen weiteren berichterstattenden Ländern sind ärztliche 

Behandlungsmethoden kein patentierbarer Gegenstand. 

Das australische Patentgesetz sieht keinen Einwand der ärztlichen Behandlung oder eine 

ähnliche Ausnahme zu den Exklusivrechten des Patentinhabers vor. In einem australischen 

Fall (Bristol-Myers Squibb & Co. gegen FH Faulding & Co. Ltd.) wurde empfohlen, dass 

praktische Ärzte, die patentierte Methoden für ärztliche Behandlungen anwenden wollen, 

eine Zwangslizenz anstreben sollen. 

Wenn in den Vereinigten Staaten ein praktizierender Arzt eine ärztliche Handlung ausführt, 

die ein Patent verletzt oder eine Verletzung eines Patents aktiv herbeiführt, sind der 

praktizierende Arzt sowie die Gesundheitseinrichtung (Krankenhaus, Klinik, medizinische 

Fakultät, etc.) von einer Patentverletzungsklage ausgenommen. Diese Ausnahme gilt für die 

Anwendung von ärztlichen Behandlungsmethoden, jedoch nicht für die Benutzung eines 

patentierten Produkts. 








Zwangslizenzen sind in den Patentgesetzen aller berichterstattenden Länder vorgesehen. 

Die allgemeinen Anforderungen des Artikels 31 TRIPS sind in allen berichterstattenden Ländern 

erfüllt. Beispielsweise gilt die allgemeine Regel, dass eine Person nur eine Zwangslizenz 

für ein Patent beantragen darf, wenn sie Erstrebungen angestellt hat, unter angemessenen 

Geschäftsbedingungen eine Lizenz vom Inhaber zu erlangen und ihre Erstrebungen für eine 

angemessene Zeit erfolglos waren. In Übereinstimmung mit TRIPS kann ein Mitglied im Falle 

eines nationalen Notfalls oder von Umständen äusserster Dringlichkeit oder in Fällen von 

allgemeiner nichtgewerblicher Nutzung den Verzicht auf diese Anforderung aussprechen, 

so die philippinische Gruppe. In Situationen nationaler Notfälle oder in anderen Umständen 

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äusserster Dringlichkeit soll der Rechtsinhaber jedoch sobald wie möglich informiert 

werden. 

Zwangslizenzen sind aus verschiedenen Gründen vorgesehen. Im Allgemeinen gibt es 

folgende Gründe: 

• In den meisten berichterstattenden Ländern (Ägypten, Argentinien, Belgien, Brasilien, 

Dänemark, Ecuador, Estland, Finnland, Frankreich, Italien, Japan, Kolumbien, 

Malaysia, Mexiko, den Niederlanden, Peru, Portugal, den Philippinen, der Republik 

Korea, Schweden, Spanien, Thailand, Türkei) kann eine Zwangslizenz auf Grund einer 

Nichtverwertung oder ungenügenden Verwertung verlangt werden. 

In den argentinischen, mexikanischen und philippinischen Gruppenberichten wird darauf 

hingewiesen, dass der Import von Produkten, die eine Ausführungsform der Erfindung 

sind, als eine ausreichende Verwertung eines Patents gilt. 

Zwangslizenzen werden nicht erteilt, wenn der Patentinhaber berechtigte Gründe für 

die Nichtverwertung der Erfindung vorbringen kann, z.B. wenn die Inaktivität durch ein 

Ereignis höherer Gewalt verursacht wurde, einschliesslich objektiver Schwierigkeiten 

beim Erhalt einer Marktzulassung bei einer Kontrollbehörde. Dies wird besonders in 

den Gruppenberichten der Länder Argentinien, Brasilien, Ecuador, Japan, Kolumbien, 

Malaysia, Mexiko, Peru, den Philippinen, Thailand und Türkei hervorgehoben. 

In Übereinstimmung mit Artikel 5 (A) (4) des Pariser Übereinkommens kann eine 

Zwangslizenz nicht auf Grund einer Nichtverwertung oder ungenügenden Verwertung vor 

Ablauf einer Frist von vier Jahren ab Einreichung der Patentanmeldung beziehungsweise 

drei Jahren ab Erteilung des Patents – je nach dem, welche Frist zuletzt abläuft – beantragt 

werden. Dies wird besonders in den Gruppenberichten der Länder Ägypten, Argentinien, 

Australien, Belgien, Bulgarien, Dänemark, Frankreich, Japan, Schweden, Thailand und 

des Vereinigten Königreichs berichtet. 

Die Gruppenberichte der Belgier und Mexikaner sagen aus, dass der Antragsteller die 

nötigen Mittel besitzen muss, um für eine effiziente und andauernde Herstellung im Sinne 

der patentierten Erfindung sorgen zu können. 

Die Gruppenberichte der Dänen, Italiener und Spanier besagen, dass eine Verwertung 

der Erfindung innerhalb des EWRs oder in einem der Länder der WTO als eine Verwertung 

im jeweiligen Land angesehen wird. 

• In den meisten berichterstattenden Ländern (Ägypten, Argentinien, Australien, Belgien, 

Brasilien, Bulgarien, China, Deutschland, Ecuador, Estland, Finnland, Frankreich, Italien, 

Japan, Kolumbien, Malaysia, den Niederlanden, Peru, Portugal, der Republik Korea, 

Schweden, Schweiz, Spanien, Südafrika, Thailand, Türkei und dem Vereinigten Königreich) 

kann eine Zwangslizenz beantragt werden, wenn eine Abhängigkeit besteht, d.h. wenn 

der Inhaber eines zweiten Patents, das eine Verbesserung einer Erfindung aufweist, die 

bereits von einem Dritten patentiert wurde, seine Erfindung nicht ohne die Berechtigung 

des Inhabers des vorigen (ersten) Patents nutzen kann. In Übereinstimmung mit Artikel 31 

(I) des TRIPS-Abkommens besteht im Falle einer Abhängigkeit das zusätzliche Erfordernis, 

dass die im zweiten Patent beanspruchte Erfindung einen wichtigen technischen 

Fortschritt grosser wirtschaftlicher Bedeutung in Bezug auf die im vorigen (ersten) Patent 

beanspruchte Erfindung aufweisen muss. 

• In Estland, den Niederlanden und in Norwegen kann eine Zwangslizenz auch dann erteilt 

werden, wenn diese benötigt wird, um die eingeräumten Rechte eines Pflanzenzüchters 

zu nutzen. 

• In den meisten berichterstattenden Ländern (Ägypten, Argentinien, Brasilien, Bulgarien, 

China, Dänemark, Ecuador, Estland, Finnland, Frankreich, Kolumbien, den Niederlanden, 

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Peru, Portugal, den Philippinen, der Republik Korea, Schweden, Schweiz, Spanien, 

Thailand und Türkei) kann man in Fällen nationaler Notfälle oder für die nationale 

Sicherheit und/oder aufgrund eines anderen öffentlichen Interesses eine Zwangslizenz 

beantragen. 

Das US-amerikanische Patentgesetz sieht auch Zwangslizenzierungen von Patenten vor, 

die als besonders wichtig für das Gemeinwohl gelten, d.h. von Patenten in Bezug auf 

„Kernmaterial oder Atomenergie“ und von Patenten, die nötig sind, um es einer Person 

möglich zu machen, die Auflagen des Bundesimmisionsschutzgesetzes (Clean Air Act) 

zu befolgen. 

Das Gesundheitswesen wird ausdrücklich als öffentliches Interesse im Sinne von 

Zwangslizenzvorkehrungen anerkannt. Dies wurde ausdrücklich von den deutschen, 

japanischen und portugiesischen Gruppen betont. Besonders in Belgien und Frankreich 

kann man im Interesse des Gesundheitswesens für ein Medikament, ein Produkt oder eine 

medizinische Vorrichtung für die Durchführung einer Diagnose, für den dafür nötigen 

Herstellungsprozess oder eine Diagnosemethode, die ausserhalb des Körpers eines 

Menschen oder eines Tieres angewandt wird, einen Antrag auf eine Zwangslizenz stellen. 

Einige Gruppen (Ägypten, Frankreich, Südafrika) spezifizieren, dass Zwangslizenzen 

erteilt werden können, falls die Menge und/oder die Qualität von durch Patente 

geschützte Medikamente nicht ausreichend für die öffentliche Nachfrage sind, wenn 

diese Medikamente überteuert verkauft werden oder wenn chronische, unheilbare oder 

endemische Krankheiten vorherrschen. 

Das malaysische Gesetz bezieht sich nicht auf das Konzept von Zwangslizenzen in Bezug 

auf das öffentliche Interesse, jedoch erlaubt es, die Regierung, eine Regierungsbehörde 

oder einen von der Regierung ernannten Dritten zu bevollmächtigen, ein Patent ohne 

vorherige Lizenzierung zu benutzen. Beispielsweise hat die malaysische Regierung 

im Oktober 2003 ein malaysisches Unternehmen bevollmächtigt, antiretrovirale 

Medikamente, die bei der Behandlung von AIDS eingesetzt werden, vom indischen 

Hersteller CIPLA zu importieren. 

• In einigen berichterstattenden Ländern (Ägypten, Argentinien, Australien, Brasilien, 

Deutschland, Ecuador, Italien, Kolumbien, den Philippinen, der Republik Korea, Schweiz, 

dem Vereinigten Königreich) kann Antrag auf eine Zwangslizenz gestellt werden, 

um Praxis abzuhelfen, die in einem gerichtlichen oder administrativen Verfahren als 

wettbewerbswidrig angesehen wurde. In Malaysia gibt es ein ähnliches Konzept, 

obwohl es nicht als Zwangslizenzierung bezeichnet wird. Die deutsche Gruppe betont, 

dass Zwangslizenzierungen, die auf dem Kartellrecht basieren, eine grössere praktische 

Bedeutung haben, als Zwangslizenzierungen, die auf dem Patentgesetz basieren. 

Insbesondere werden Zwangslizenzen, die unter das Kartellrecht fallen, üblicherweise 

erteilt, wenn die Einhaltung eines allgemeinen Industriestandards die Benutzung eines 

Patents erfordert 

• In der Schweiz werden auch für Forschungswerkzeug und Diagnostikprodukte 

Zwangslizenzen erteilt. 

In den Vereinigten Staaten können im umfangreichsten Rahmen Zwangslizenzierungen von 

Patenten durch die Justizbehörde erteilt werden, wenn Patente von der Landesregierung 

benutzt werden, wobei lediglich die verfassungsrechtliche Auflage einer angemessenen 

Entschädigung besteht. Des Weiteren meinten einige US-Berichterstatter, dass die vor 

kurzem erteilte Ablehnung einer dauerhaften Unterlassungsverfügung gegen Patentverletzer 

im Fall eBay Inc. gegen MercExchange durch den Obersten Gerichtshof eine tatsächliche 

Zwangslizenz zugunsten der Patentverletzer, die bereit sind, die angemessene Lizenzgebühr 

von den Gerichten bestimmen zu lassen, schaffe. 

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In Bulgarien wird eine erteilte Zwangslizenz aufgehoben, wenn der Lizenznehmer innerhalb 

eines Jahres ab Erteilung der Zwangslizenz keine Vorbereitungsmassnahmen für die Benutzung 

des Patents trifft. In Ecuador, Kolumbien und Mexiko gilt dasselbe, jedoch erst zwei Jahre ab 

Erteilung der Zwangslizenz. 

In den meisten berichterstattenden Ländern wurden noch keine Zwangslizenzen erteilt. 

In Brasilien wurden dem brasilianischen Gesundheitsministerium aus Gründen öffentlichen 

Interesses zwei Zwangslizenzen für den Import des antiretroviralen Medikaments Efavirenz 

von Merck & Co. erteilt. Zusätzlich wurden drei Zwangslizenzen für ein brasilianisches Patent 

umfassend ein Verfahren für die Herstellung eines Impfstoffs gegen Apthenseuche und eine 

Zwangslizenz für ein brasilianisches Patent der Firma Monsanto erteilt. 

In Dänemark erteilte das oberste Gericht im Jahre 1969 einem dänischen Pharmakonzern auf 

Grund einer Nichtverwertung eine Zwangslizenz für ein Patent der Swiss Geigy AG in Bezug 

auf ein Verfahren zur Herstellung von Phenylbutazon. 

In Italien erteilte die Kartellbehörde Herstellern von Generika Zwangslizenzen, um Abhilfe 

gegen einen Missbrauch der marktbeherrschenden Stellung von Merck & Co. zu schaffen. 

In Portugal wurde SAPEC AGRO für das portugiesische Patent Nr. 76,136 von Syngenta 

betreffend ein Pflanzenschutzmittel eine Zwangslizenz erteilt. 

Auf den Philippinen wurden insgesamt sechs Zwangslizenzen erteilt und in Thailand insgesamt 

sieben. Nähere Informationen, wie der Name des Lizenzgebers, des Lizenznehmers sowie 

des Produkts können den entsprechenden Gruppenberichten entnommen werden. 

In der Republik Korea wurden insgesamt 6 Anträge auf Zwangslizenzen gestellt, jedoch 

wurde noch keine Zwangslizenz erteilt. 







Die Mehrzahl der berichterstattenden Länder haben den Artikel 31bis TRIPS ratifiziert 

und umgesetzt, entweder direkt (Australien, China, Japan, Mexiko, Norwegen, Schweiz, 

Vereinigtes Königreich, USA) oder über die Einführung der Verordnung (EG) Nr. 816/2006 

über Zwangslizenzen für Patente an der Herstellung von pharmazeutischen Erzeugnissen 

für die Ausfuhr in Länder mit Problemen im Bereich der öffentlichen Gesundheit (Belgien 

Dänemark, Deutschland, Finnland, Frankreich, Irland, Italien, die Niederlande, Portugal, 

Schweden, Spanien, Vereinigtes Königreich). 

Ägypten, Argentinien, Ecuador, Estland, Kolumbien, Malaysia, die Philippinen, Thailand 

und die Türkei haben den Artikel 31bis TRIPS noch nicht ratifiziert oder haben noch keine 

andere Gesetzesänderung im Hinblick auf die Umsetzung der WTO-Entscheidung vom 30. 

August 2003 vorgenommen. Brasilien hat den Artikel 31bis TRIPS nicht ratifiziert, jedoch 

eine andere Gesetzesänderung im Hinblick auf die Umsetzung der WTO-Entscheidung vom 

30. August 2003 vorgenommen. Peru hat den Artikel 31bis TRIPS nicht ratifiziert, jedoch 

erkennt das Übereinkommen zur Förderung des Handels zwischen Peru und den USA die 

Notwendigkeit des Zugriffs auf Medikamente im Hinblick auf die WTO-Entscheidung vom 

30. August 2003. 

Frankreich, Schweden, die Schweiz und das Vereinigte Königreich haben neben Anderen 

offiziell erklärt, dass sie das System nicht als Importmittel im Sinne des Artikels 31bis TRIPS 

und dessen Anlage benutzen werden. 

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In den meisten berichterstattenden Ländern wurden keine Zwangslizenzen für den Import 

oder Export von Pharmazeutika erteilt. 

In Brasilien wurden dem brasilianischen Gesundheitsministerium zwei Zwangslizenzen für 

den Import des von Merck & Co. patentierten Medikaments Efavirenz erteilt. 



In den meisten berichterstattenden Ländern ist es der Regierung aus Gründen öffentlichen 

Interesses erlaubt, eine patentierte Erfindung ohne vorherige Lizenzierung zu benutzen. 

Beispielsweise ist die Regierung in Brasilien und in Thailand im Fall eines nationalen Notfalls 

oder für die Erhaltung der nationalen Sicherheit berechtigt, eine patentierte Erfindung ohne 

vorherige Lizenzierung zu benutzen. Ähnlich ist in Finnland, den Niederlanden und Norwegen 

die Regierung nur im Fall von Krieg bzw. aus Gründen nationaler Verteidigung berechtigt, eine 

patentierte Erfindung ohne vorhergehende Lizenzierung zu benutzen. In China, Deutschland, 

Irland, Malaysia, den Niederlanden und auf den Philippinen ist die Regierung verpflichtet, 

den Patentinhaber zu entschädigen. Die französische Gruppe weist darauf hin, dass sich die 

Regierung im Falle eines Notfalls, besonders im Falle einer Epidemie, auf das Gesetz zum 

Schutz der öffentlichen Gesundheit stützen kann. 

Die US-amerikanische Regierung darf Patente beliebig und ohne vorhergehende 

Lizenzierungen benutzen, wobei lediglich die verfassungsrechtliche Auflage einer 

angemessenen Entschädigung besteht. Ähnlich kann im Vereinigten Königreich jedes 

Ministerium eine patentierte Erfindung ohne vorhergehende Lizenzierung benutzen, wobei 

lediglich die gesetzliche Auflage einer angemessenen Entschädigung besteht. Selbst die 

Benutzung einer Erfindung durch den staatlichen Gesundheitsdienst fällt unter die so genannte 

Crown-Use-Bestimmung. Entsprechende Regelungen im Hinblick auf Crown-Use gelten auch 

in Australien. 

Die Gruppen Südafrika und Vereinigtes Königreich weisen darauf hin, dass die Benutzung 

einer patentierten Erfindung durch den Staat oder die Krone (Crown-Use) im Wesentlichen 

Zwangslizenzen gleichkommt, obwohl dies keine „Lizenz“ im rechtlichen Sinne ist, da die 

Benutzung durch den Staat und durch die Krone nicht als Patentverletzung angesehen wird. 

Der schwedische Gruppenbericht weist darauf hin, dass auch die Regierung einen Antrag auf 

Zwangslizenz stellen kann. 

Die Gruppen aus Argentinien, Ecuador, Estland, Italien, Japan, Kolumbien, Mexiko, Peru, 

Portugal, Schweiz, Spanien und der Türkei berichten, dass ihre Regierungen keine Patente 

ohne vorhergehende Lizenzierung benutzen dürfen. 

Die Gruppen aus Belgien und Dänemark berichten, dass es keine derartige Bestimmung in 

ihrem Land gibt. 


In den meisten berichterstattenden Ländern (Ägypten, Argentinien, Brasilien, Dänemark, 

Italien, Portugal, Schweden, Schweiz, Spanien, USA) dürfen die Regierungen Patente 

zwangsenteignen, falls dies das öffentliche Interesse verlangt und vorausgesetzt der 

Patentinhaber wird voll entschädigt. Ähnlich sind die Regierungen in Finnland, Frankreich, 

Norwegen und Schweden nur im Kriegsfall zu einer Zwangsenteignung von Patenten 

berechtigt. 

Es gibt keine Aufzeichnungen über Fälle von Zwangsenteignungen durch die Regierung. Die 

schwedische Gruppe berichtet, dass eine Zwangsenteignung eines die nationale Sicherheit 

betreffendes Patents vertraulich behandelt würde. Die dänische Gruppe betont, dass eine 

Zwangsenteignung nicht nötig ist, da Zwangslizenzierungen ein ausreichendes Mittel ist. 

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Die Gruppen aus Bulgarien, China, Estland, Japan, Kolumbien, Malaysia, Mexiko und der 

Türkei beschreiben, dass ihre Regierungen nicht berechtigt sind, Zwangsenteignungen von 

Patent durchzuführen. 

Die Gruppen aus Belgien, Ecuador, Peru, den Philippinen und Südafrika berichten, dass es in 

den Gesetzen ihrer Länder keine derartige Bestimmung gibt. 






Die brasilianische Gruppe berichtet, dass Patentanmeldungen für pharmazeutische Produkte in 

Brasilien durch ein zweifaches Prüfverfahren gehen. Eines wird vom brasilianischen Patentamt 

durchgeführt und eines von der Aufsichtsbehörde ANVISA, um auch gesundheitspolitische 

Fragen zu berücksichtigen. Beispielsweise hat die ANVISA Ansprüche auf zweite medizinische 

Verwendung und Patentanmeldungen in Bezug auf Anti-HIV-Medikamente zurückgewiesen, 

um den Zugriff auf essenzielle Medikamente zu sichern. 

Die Gruppen aus Bulgarien und Spanien berichten, dass das Verwaltungsrecht eher als 

das Patentgesetz den Zugriff auf Medikamente erleichtert, indem auf das Erfordernis von 

Marktzulassungen für pharmazeutische Produkte im Fall von Epidemien, der Verbreitung 

chemischer Substanzen oder nuklearer Strahlung verzichtet wird. Zusätzlich wird im 

spanischen Gruppenbericht darauf hingewiesen, dass die Erlaubnis für den Import und die 

Benutzung von Medikamenten, die in Spanien keine Genehmigung haben, jedoch nötig 

für eine medizinische Behandlung sind, im Wesentlichen auf einen erleichterten Zugriff auf 

Medikamente hinausläuft. 

Die Gruppen aus Dänemark und Frankreich weisen darauf hin, dass der Zugriff auf 

Medikamente durch die Tatsache erleichtert wird, dass die Aufsichtsbehörden Zulassungen 

für das Inverkehrbringen von Generika vor Auslaufen des Patentschutzes erteilen können. 

Die Gruppen aus Dänemark, Frankreich und Norwegen berichten, dass ihre Gesetze 

insbesondere den Zugriff auf Generika erleichtern, indem Anreize für Ärzte geschaffen 

werden, Generika zu verschreiben (z.B. durch Erstattungsfähigkeit der Kosten für Generika 

durch die Krankenkassen, es sei denn, der Arzt legt medizinische Gründe dar, warum er das 

originale Produkt verschreibt). 

In dieser Hinsicht bezieht sich die US-Gruppe auf das in der Frage erwähnte Orange Book, 

welches aktuelle Informationen über die Zulassungen von Generika bietet und welches 

durch die Bundesbehörde zur Überwachung von Nahrungs- und Arzneimitteln (Food and 

Drug Administration) in elektronischer Form unter http://www.fda.gov/cder/ob/default.htm. 

bereitgestellt wird. Ähnlich sind in Norwegen Zulassungen für Generika auf der Website der 

Arzneimittelbehörde zugänglich. 










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vorsehen? 

Falls ja, unter welchen Umständen? Falls nein, warum nicht? 

Forschungsprivileg und Benutzung zu Versuchszwecken 

Die Mehrheit der Gruppen (Argentinien, Australien, Belgien, Brasilien, Bulgarien, China, 

Dänemark, Ecuador, Finnland, Irland, Italien, Kolumbien, Mexiko, die Niederlande, Norwegen, 

Peru, Portugal, die Republik Korea, Schweden, Schweiz, Spanien, Thailand, Türkei, Vereinigtes 

Königreich) sind für ein Forschungsprivileg und die Benutzung zu Versuchszwecken. 

Die Gruppen aus Australien und den Niederlanden betonen, dass eine rechtliche Klarstellung 

des Privilegs erforderlich ist. 

Einige Gruppen (Argentinien, Peru, Türkei) sind der Ansicht, dass die Benutzung zu 

Versuchszwecken streng auf Fälle begrenzt sein soll, die keinem gewerblichen Zweck 

dienen. Andererseits betont die thailändische Gruppe, dass es keine Beschränkung auf 

nichtgewerbliche Zwecke geben soll. 

Die Gruppen aus Norwegen und dem Vereinigten Königreich sind der Meinung, dass diese 

Ausnahme auf Experimente im Hinblick auf den Gegenstand der Erfindung beschränkt sein 

sollte. Die schweizerische Gruppe erklärt, dass die Ausnahme nicht die Benutzung einer 

patentierten Erfindung als Instrument für die Forschung an anderen Objekten umfassen 

solle. 

Die japanische Gruppe ist nicht der Meinung, dass eine Benutzung zu Versuchszwecken 

erforderlich sei. Die japanische Gruppe meint, dass für den Fall, dass Patentgesetze eine 

solche Ausnahme erfassen, man dem Beschluss Q105, der 1992 in Tokio gebilligt wurde, 

folgen solle (mit Ausnahme des Punkts 4). Entsprechend dieses Beschlusses wird die 

Benutzung zu Versuchszwecken von der AIPPI unterstützt und sie sollte im Wesentlichen auf 

nichtgewerbliche Zwecke beschränkt sein (der Beschluss nennt die Benutzung der patentierten 

Erfindung für akademische Zwecke nicht gewerblicher Natur, Versuche zur Evaluierung der 

Lehre des Patents und der Validität des Patents, die Verbesserung der Erfindung oder die 

Erzielung eines Fortschritts über die Erfindung oder das Finden einer Alternative zur Erfindung, 

jedoch nicht die gewerbliche Verwertung des Gegenstands irgendeiner Verbesserung oder 

irgendeines Fortschritts). Der Beschluss hebt weiter hervor, dass die Benutzung eine Arbeit am 

Gegenstand des Patents beinhalten muss; eine Benutzung, die lediglich dem Erhalt des vom 

Patent offenbarten Vorteils der Erfindung dient, ist keine Benutzung zu Versuchszwecken. Die 

AIPPI hat zudem beschlossen, dass die Benutzung zu Versuchszwecken eng ausgelegt werden 

soll und die Beweispflicht dem Dritten, der sich auf die Benutzung zu Versuchszwecken beruft, 

auferlegt werden soll. Punkt 4 des Beschlusses Q105 (der laut der japanischen Gruppe nicht 

befolgt werden soll) besagt, dass die Benutzung durch eine Partei während der Patentdauer 

zum Zweck irgendeiner behördlichen Genehmigung, das Patent nach seinem Erlöschen 

verkaufen zu können, keine Benutzung zu Versuchszwecken ist. 

Die Bolar-Ausnahme 

Die Mehrzahl der Gruppen (Argentinien, Australien, Belgien, Brasilien, Bulgarien, China, 

Dänemark, Deutschland, Ecuador, Finnland, Irland, Italien, Mexiko, die Niederlande, Peru, 

Portugal, die Republik Korea, Schweden, Schweiz, Spanien, Thailand, Türkei, Vereinigtes 

Königreich) ist für eine Bolar-Ausnahme. 

Einige Gruppen (Dänemark, Deutschland, Vereinigtes Königreich) sind der Meinung, dass die 

Bolar-Ausnahme sowohl generische als auch nicht generische (innovative) Medikamente (z.B. 

Auswahlerfindungen) abdecken solle, jedoch sollte sie nur solche Massnahmen umfassen, die 

nötig sind, um eine Marktzulassung zu erhalten. 

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Die niederländische Gruppe meint, dass die Bolar-Ausnahme für alle Produkte gelten solle, 

bei denen eine behördliche Genehmigung erforderlich sei. Die thailändische Gruppe ist 

der Meinung, dass auch biologische Produkte und Forschungswerkzeug abgedeckt werden 

sollen. 

Die schwedische Gruppe meint, eine Bolar-Ausnahme sei akzeptabel, wenn sie mit einem 

System für erweiterte Patentlaufzeiten ausgeglichen würde. Ähnlich betont die ecuadorianische 

Gruppe, dass die Bolar-Ausnahme nur angemessen sei, wenn Hersteller von Generika die 

Produkte nicht vor Erlöschen eines Patents vertreiben dürfen. In diesem Zusammenhang ist die 

französische Gruppe der Meinung, dass es für Patentinhaber wirksame Rechtsmittel geben 

müsse, um den Vertrieb von Generika vor Erlöschen der Patente verhindern zu können. 

Die japanische Gruppe ist wieder der Meinung, diese Ausnahme würde nicht benötigt, doch 

falls sie als nötig erachtet würde, sollte sie von der Benutzung zu Versuchszwecken abgedeckt 

werden. Umgekehrt ist die schweizerische Gruppe der Meinung, dass die Bolar-Ausnahme 

über das allgemeine Forschungsprivileg hinaus gehen sollte und die Benutzung patentierter 

Erfindungen bei Bioäquivalenzstudien, Batch-Validierungen und Ähnlichem erlauben sollte. 

Jedoch sollten keine Vorratsbildung und Vorbereitungen für Produktionen in grossem Umfang 

erlaubt werden. 

Die kolumbianische Gruppe ist gegen eine Bolar-Ausnahme. 

Paralleler Import patentierter Medikamente 

Die Mehrzahl der Gruppen (Argentinien, Dänemark, Deutschland, Finnland, Irland, 

Italien, Japan, die Niederlande, Norwegen, Schweden, Schweiz, Türkei, UK) sind gegen 

eine internationale Erschöpfung und den parallelen Import patentierter Medikamente. Die 

Gruppen aus Japan und dem Vereinigten Königreich glauben, dass die AIPPI den Beschluss 

Q101 (2001 in Melbourne gebilligt), mit dem die internationale Erschöpfung zurückgewiesen 

wurde, neu bestätigen soll. 

Die meisten europäischen Gruppen (Dänemark, Deutschland, Finnland, Irland, Italien, 

Norwegen, Schweden sowie die Türkei) glauben, dass eine regionale Erschöpfung in 

gleichwertigen Wirtschaftsräumen, wie zum Beispiel dem EWR, zulässig sei. 

Einige Gruppen (Brasilien, Bulgarien, China, Ecuador, Kolumbien, Mexiko, Peru, Thailand) 

sind für einen parallelen Import. Die ecuadorianische Gruppe betont, dass es jedem 

Entwicklungsland zustehe, Zugriff auf Medikamente zum bestmöglichen Preis zu haben. 

Die australische Gruppe ist der Meinung, dass parallele Importe den Zugriff auf patentierte 

Medikamente erhöhen könnten, und nicht bewirken, dass die Rechte des Patentinhabers 

unangemessen geschwächt werden. 

Freistellung für individuelle Rezepte 

Die meisten Gruppen (Argentinien, Belgien, Brasilien, Bulgarien, China, Finnland, Irland, 

Italien, Japan, Mexiko, Norwegen, Portugal, die Republik Korea, Schweden, Thailand, 

Türkei) sind für eine Freistellung für individuelle Rezepte. Einige Gruppen (Australien, Ecuador) 

glauben, dass die Ausnahme für einmalige, nicht gewerbliche Rezepte bei Bedarfsfällen 

einzelner Patienten angemessen sei, jedoch stimmen sie zu, dass Situationen vermieden 

werden sollten, in denen Medikamente in grossem Umfang zubereitet werden. 

Die Gruppen aus den Niederlanden, Deutschland, der Schweiz und dem Vereinigten 

Königreich glauben, dass diese Ausnahme unrelevant für die Praxis sei, weshalb sie keine 

Notwendigkeit für diese Ausnahme sehen. 

Einwand der ärztlichen Behandlung 

Einige Gruppen (Argentinien, Belgien, Brasilien, China, Japan, Kolumbien, Mexiko, 

Norwegen) sind für einen Einwand der ärztlichen Behandlung, soweit eine solche Ausnahme 

vonnöten ist. 

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Die Gruppe aus Australien (das das einzige berichterstattende Land - neben den USA - ist, 

in dem Verfahren medizinischer Behandlung patentierbar sind) ist der Meinung, dass es 

unwahrscheinlich sei, dass ein praktischer Arzt im gewerblichen Rahmen verklagt würde und 

dass deshalb ein expliziter Einwand unnötig sei. 

Einige Gruppen (Bulgarien, Ecuador, Irland, Schweden, Türkei) glauben, dass Verfahren 

medizinischer Behandlung nicht patentierbar bleiben sollten. 

Zwangslizenzierung 

Die meisten Gruppen (Argentinien, Belgien, Brasilien, Bulgarien, China, Dänemark, Ecuador, 

Finnland, Irland, Italien, Japan, Kolumbien, Mexiko, die Niederlande, Norwegen, Portugal, 

die Republik Korea, Schweden, Schweiz, Thailand, Türkei, UK) sind für Zwangslizenzierungen 

unter dem aktuellen Regierungssystem. 

Einige Gruppen (Australien, Deutschland) sind auf Grund der langen Durchlaufzeiten für die 

Produktion von Medikamenten kritisch. Im Falle einer Pandemie könnte es sein, dass mehr als 

ein Lizenznehmer benötigt würde, um ausreichend Produkte bereitzustellen. 

Einige Gruppen (Argentinien, Bulgarien, Schweden, UK) betonen, dass Zwangslizenzierung 

eng ausgelegt werden sollte. Die schwedische Gruppe weist darauf hin, dass eine breite 

Auslegung des Artikels 31(1) TRIPS „nationaler Notfall oder andere Umstände extremer 

Dringlichkeit“ das Patentsystem soweit schwächen würde, dass Anreize für Forschung und 

Entwicklung abgeschwächt würden. 

Die Japanische Gruppe ist der Auffassung, dass die AIPPI den Beschluss Q187 (Beschränkung 

von ausschliesslichen Rechten des geistigen Eigentums durch das Wettbewerbsrecht), 

der 2005 in Berlin gebilligt wurde, neu bestätigen solle. Dieser Beschluss erwähnt nicht 

ausdrücklich Zwangslizenzierungen, jedoch stellt er klar, dass wenn die Ausübung von 

Rechten geistigen Eigentums im Widerspruch mit dem Wettbewerbsrecht steht, das Gesetz 

die nötigen Rechtsmittel bieten sollte. 

Zwangsenteignung 

Nur wenige Gruppen (Argentinien, Australien, Brasilien, China, Thailand) sind für 

Zwangsenteignung. 

Einige Gruppen (Finnland, Mexiko, Philippinen, Schweden, Türkei) sind der Ansicht, dass 

Zwangsenteignungen nur unter sehr aussergewöhnlichen Umständen erlaubt sein sollten. 

Viele Gruppen (Belgien, Deutschland, Ecuador, Kolumbien, Norwegen, Schweiz) glauben, 

dass Zwangslizenzierungen geeignet seien, um Angelegenheiten im Hinblick auf die 

öffentliche Gesundheit zu berücksichtigen und dass Zwangsenteignungen unverhältnismässig 

und unnötig seien. Weitere Gruppen (Bulgarien, Japan, die Niederlande, UK) sind auch 

gegen Zwangsenteignung. 

Die argentinische Gruppe betont, dass die Ausnahme eng ausgelegt werden 

sollte. Die australische Gruppe weist darauf hin, dass die Regierung jeden erteilten 

Zwangsenteignungsbeschluss rechtfertigen muss. 

Sonstige Beschränkungen 

Keine Gruppe hat andere Beschränkungen hinsichtlich exklusiver Patentrechte vorgeschlagen, 

die einen Zugriff auf Medikamente, Diagnosen und medizinische Vorrichtung erleichtern. Die 

französische Gruppe betont, dass es keine Beschränkungen geben sollte, die über die des 

TRIPS-Abkommens hinaus gehen. 



könnte? 

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Die Gruppen aus Südafrika und der Schweiz weisen darauf hin, dass der Zugriff auf 

erschwingliche Medikamente nicht der einzige kritische Faktor ist, wenn es darum geht, 

armen Menschen, die an einer pandemischen oder endemischen Krankheit leiden, eine 

effiziente Behandlung zu gewährleisten. Effiziente und unkomplizierte Gesundheitssysteme, 

verbesserte Lebensbedingungen (Hygiene und Ernährung) und eine bessere Aufklärung 

spielen eine grosse Rolle. Die Gruppen aus der Schweiz und dem Vereinigten Königreich 

berichten weiter, dass die meisten Medikamente, die von der Weltgesundheitsorganisation 

als essenzielle Medikamente eingestuft wurden, entweder als nicht patentierte oder nicht 

durch ein Patent geschützte Medikamente zugänglich sind. Jedoch hat über ein Drittel der 

Weltbevölkerung noch immer keinen Zugriff auf diese Medikamente. 

Die Gruppen aus Argentinien und Ecuador betonen, dass Regierungen und Gesetze den Zugriff 

auf eine andere Weise erleichtern können, indem sie Patentrechte einschränken, beispielsweise 

durch ein Kontrollieren (Subventionieren) der Preise patentierter Medikamente. 

Die koreanische Gruppe betont die Wichtigkeit einer Einführung von Informationsmitteln wie 

zum Beispiel dem Orange Book, um den Zugriff auf Medikamente zu erleichtern. 

In Bezug auf das Patentgesetz ist die schweizerische Gruppe der Ansicht, dass Patente kein 

Hindernis für den Zugriff auf Medikamente bilden, sondern ganz im Gegenteil die Forschung 

ankurbeln und dafür sorgen, dass neue Medikamente entwickelt und auf den Markt gebracht 

werden. Ähnlich weist die südafrikanische Gruppe darauf hin, dass ein übermässiges 

Beschränken des allein durch Patentrechte gewährten Schutzes nicht zwangsläufig eine Lösung 

hervorbringe. Die norwegische Gruppe ist auch der Meinung, dass ein gut funktionierendes 

Patentsystem selbst einen verbesserten Zugriff bewirken werde. Die niederländische Gruppe 

ist auch der Meinung, dass eine bessere Sicherung der Rechte des Patentinhabers den Zugriff 

erleichtern würde. Die niederländische Gruppe empfiehlt sogar Verletzungsklagen gegen 

Länder, die, wenn sie Antrag auf Zwangslizenzen im Zusammenhang mit der öffentlichen 

Gesundheit stellen, genau nach den Regeln, tatsächlich aber gegen die Philosophie von 

TRIPS handeln. Des Weiteren schlägt die niederländische Gruppe vor, dass zusätzliche 

Massnahmen (wie zum Beispiel Verlängerung der Patentlaufzeit, zusätzliche Anerkennung 

von Erfindern) in das Patentgesetz integriert werden könnten, um die nachteiligen Folgen 

einer Zwangslizenzerteilung auszugleichen. 

In Bezug auf das Patentgesetz schlägt die südafrikanische Gruppe weiter vor, dass die 

folgenden Initiativen in Betracht gezogen werden sollten: das Schaffen von Anreizen für 

Forschung und Entwicklung (z.B. Modelle für Innovationsprämien), die Unterstützung wichtiger 

innovativer Tätigkeiten (z.B. Forschung auf der Grundlage traditioneller Rechtsmittel) und 

die Förderung effektiver und nachhaltiger Technologietransfers. Ähnlich ist die schwedische 

Gruppe der Ansicht, dass das Schaffen von Anreizen für Entwicklung und neue Produkte 

auf der Grundlage der Marktausschliesslichkeit für eine beschränkte Zeit in Betracht 

gezogen werden sollten. Die schwedische Gruppe bezieht sich auf Massnahmen in Bezug 

auf Waisen-Medikamente, die in diesem Zusammenhang von der EU eingeführt wurden. 

Diese Massnahmen garantieren ein zehnjähriges Exklusivvermarktungsrecht in der EU als 

Gegenleistung für die Entwicklung von Waisen-Medikamenten, was bedeutet, dass zehn 

Jahre lang kein anderes Unternehmen die Marktlizenz für ein ähnliches Medikament erhalten 

kann. Waisen-Medikamente sind Medikamente, die seltene Krankheiten lindern sollen. 

Ein anderes Beispiel wären die von der EU eingeführten Ausschliesslichkeitsmassnahmen 

für pädiatrische Medikamente. Um die Entwicklung von Kinderarzneimitteln zu fördern, 

bieten diese Massnahmen eine Patentverlängerung von sechs Monaten für Hersteller von 

Kinderarzneimitteln. In den USA gibt es ähnliche Massnahmen. 

Die deutsche Gruppe weist darauf hin, dass ein Ausschluss der Patentierbarkeit (wie es 

der Fall bei Verfahren medizinischer Behandlung) auch den Zugriff auf Medikamente und 

Ähnliches erleichtere. 

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Die mexikanische Gruppe merkt an, dass eine strengere Prüfung der Patentierbarkeit ebenso 

den Zugriff erleichtere, da unberechtigte Patente vermieden werden. 




Die meisten Gruppen (Argentinien, Australien, Bulgarien, Dänemark, Finnland, Italien, 

Kolumbien, Mexiko, Norwegen, Philippinen, Republik Korea, Südafrika, Spanien, 

Schweden, Vereinigtes Königreich) sind für eine Harmonisierung von Einschränkungen von 

Patentrechten. 

Einige Gruppen (Argentinien, Philippinen, Spanien) sind der Ansicht, dass eine Harmonisierung 

über die Welthandelsorganisation erfolgen sollte. Die spanische Gruppe nennt auch die SPLT 

(Substantive Patent Law Treaty) als mögliches Harmonisierungsmittel. Die australische Gruppe 

schlägt vor, dass die AIPPI die Führung bei der Förderung von Harmonisierungsbestrebungen 

übernimmt. 

Einige Gruppen (Belgien, Ecuador, Irland, Schweiz) sind besonders für die Harmonisierung der 

Hauptausnahmen, besonders des Forschungsprivilegs und der Benutzung zu Versuchszwecken 

sowie der Bolar-Ausnahme. 

Die deutsche Gruppe ist der Meinung es sei wichtiger, die Auswirkungen eines Patents zu 

harmonisieren, als die Ausnahmen. 

Die irische Gruppe ist gegen eine Harmonisierung der Richtlinien, die den parallelen Import 

regulieren, da dies komplexe wirtschaftliche Probleme mit sich bringe. Des Weiteren glaubt 

die irische Gruppe, dass die Harmonisierung von Zwangslizenzierung auf dem TRIPS-Niveau 

ausreiche. 

Einige Gruppen (Brasilien, Portugal, Thailand) sind gegen die Harmonisierung von 

Einschränkungen von Patentrechten. Die thailändische Gruppe meint, dass jedes Land die 

Freiheit haben sollte, die Einschränkungen der Patentrechte unter Berücksichtigung des 

öffentlichen Interesses des Landes festzulegen. Die türkische Gruppe ist nicht der Meinung, 

dass eine Harmonisierung der Einschränkungen des Patentgesetzes möglich sei. 


Aus den Berichten geht hervor, dass das Patentgesetz eine Reihe von Einschränkungen bietet, die 

eine Rolle beim Erlangen eines Zugriffs auf patentierte Medikamente, Diagnosen, medizinische 

Vorrichtungen und Ähnliches spielen können. Die meisten dieser Einschränkungen, wie unter anderem 

das Forschungsprivileg und die Benutzung zu Versuchszwecken, die Freistellung für individuelle 

Rezepte, der Einwand der ärztlichen Behandlung, Massnahmen für Zwangslizenzierungen sowie 

Zwangsenteignung, erleichtern an sich den Zugriff auf neue medizinische Produkte – entweder kurzoder 

langfristig. Einige Einschränkungen sind insbesondere darauf ausgelegt, einen Zugriff auf 

erschwingliche Medikamente und Ähnliches zu verschaffen, d.h. der parallele Import patentierter 

Medikamente sowie die Bolar-Ausnahme – soweit es nur um Generika geht. Schliesslich kann der 

Zugriff auf medizinische Produkte auch durch die Verfügbarkeit ausreichender Vorräte beeinflusst 

sein. Einige der Einschränkungen stellen auch den Zugriff auf angemessene Vorräte sicher, 

besonders im Zusammenhang mit öffentlichen Gesundheitskrisen. Diese beinhalten vor allem die 

Massnahmen für Zwangslizenzierungen und Zwangsenteignungen. Die meisten Gruppen haben 

sich in ihren Berichten auf Medikamente konzentriert, jedoch können je nach Umständen auch 

Diagnosen, medizinische Vorrichtungen, biologische Produkte und Ähnliches von ebenso grosser 

Wichtigkeit sein. 

Aus den Gruppenberichten lässt sich erschliessen, dass es in Bezug auf die Notwendigkeit eines 

Forschungsprivilegs und einer Benutzung zu Versuchszwecken ein grosser Konsens herrscht, 

jedoch muss im Arbeitsausschuss debattiert werden, ob die Gruppen für ein Forschungsprivileg 

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und die Benutzung zu Versuchszwecken sind, die einen endgültigen gewerblichen Zweck nicht 

ausschliessen, wenn die Versuche Experimente sind. Wenn dies der Fall ist, wird der Beschluss 

Q105 (Benutzung zu Versuchszwecken als Verteidigung gegen einen Patentverletzungsanspruch), 

der 1992 in Tokio gebilligt wurde, neu überdacht werden müssen. Ähnlich unterstützen die Gruppen 

generell eine Bolar-Ausnahme, jedoch wird im Arbeitsausschuss diskutiert werden müssen, ob die 

Bolar-Ausnahme auch nicht generische (innovative) Produkte umfassen sollte und für alle Produkte 

gelten sollte, die einer behördlichen Zustimmung bedürfen. Es wäre möglich, dass dies ein weiterer 

Bereich ist, in dem eine Harmonisierung erzielt werden könnte. Der parallele Import patentierter 

Medikamente scheint nicht unterstützt zu werden und der Beschluss Q101 (Ablehnung einer 

internationalen Erschöpfung) könnte deshalb neu bestätigt werden. Die Freistellung für individuelle 

Rezepte – soweit sie in der Praxis relevant ist – scheint allgemein akzeptiert zu sein, vorausgesetzt 

dass Medikamente nicht in grossem Umfang hergestellt werden. Es ist nicht völlig klar, ob die 

Gruppenberichte für die Aussage genügen, dass medizinische Verfahren nicht patentierbar bleiben 

sollten, jedoch geht aus den Gruppenberichten hervor, dass in dem Umfang, in dem medizinische 

Verfahren patentierbar sind, das Gesetz einen Einwand der ärztlichen Behandlung bereitstellen 

sollte. Aus den Gruppenberichten geht ebenfalls hervor, dass nicht nur die Notwendigkeit für 

Zwangslizenzierungsvorkehrungen erkannt wird, sondern dass die Gruppen sich auch einig zu 

sein scheinen, dass diese im Allgemeinen eng ausgelegt sein sollten. Nur wenige Gruppen sind für 

Zwangsenteignung, jedoch ist es aufgrund der inhärenten Verknüpfung mit den nationalpolitischen 

Prinzipien unwahrscheinlich, dass es auf diesem Bereich zu einer Harmonisierung kommt– 

ausser vielleicht zu einem Beschluss, der besagt, dass Zwangsenteignungen ausschliesslich unter 

aussergewöhnlichen, von der Regierung festgelegten Umständen erlaubt werden sollen–, da 

Zwangslizenzierungen ein ausreichendes und angemesseneres Mittel zur Zugriffsverschaffung sind. 

Schliesslich wird der Arbeitsausschuss noch prüfen müssen, ob die AIPPI Initiativen unterstützen 

sollte, die Anreize für die Entwicklung neuer medizinischer Produkte schaffen, wie zum Beispiel die 

Verlängerung von Patentlaufzeiten und Marktexklusivität. 

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AIPPI 

Resolution 

Question Q202 


Noting that: 

1) The focus of this resolution is exceptions to exclusive patent rights applicable to medicines and 

other medical products. 

2) Access to affordable medicines and other medical products is a pressing issue but exceptions 

to exclusive patent rights alone cannot resolve this issue. 

3) AIPPI has studied exceptions to exclusive patent rights in previous questions, leading in 

particular to: 

i) The resolution of the Executive Committee of Barcelona in 1990 – Question Q101, 

Yearbook 1991/I, page 298 entitled ‘Parallel Import Of Patented Products’ (Barcelona 

Parallel Import Resolution); 

ii) The resolution of the Executive Committee of Tokyo in 1992 – Question Q105, Yearbook 

1992/III, pages 282-283 entitled ‘Experimental Use as a Defence to a Claim of Patent 

Infringement’ (Tokyo Experimental Use Resolution); and 

iii) The resolution of the 38th Congress of Melbourne in 2001 – Question Q156, Yearbook 

2001/I, pages 511-512 entitled ‘International Exhaustion of Industrial Property Rights’ 

(Melbourne International Exhaustion Resolution). 

4) The Barcelona Parallel Import Resolution resolved that a patentee be able to invoke its patent 

against parallel import of a patented product, notwithstanding the circumstances under which 

such product has first been put on the market in a given country “B”, subject to exception by 

contractual agreement authorising import into another country “A”. 

5) Paragraph 3 of the Tokyo Experimental Use Resolution resolved that each country should 

except acts done for experimental purposes from the rights of the patentee on the basis that 

experimental use: 

i) Includes any use of the patented invention performed for academic purposes and having 

no commercial nature; 

ii) Includes testing to evaluate the teaching of the patent and validity of the patent; 

iii) Includes any use of the patented invention to an extent appropriate to experimentation 

(as opposed to commercial use) which is for the purpose of improving the invention or 

making an advance over the invention or finding an alternative to the invention, but not 

the commercial exploitation of the subject of any improvement or advance; and 

iv) Should be subject to the overriding principle that the use must involve work on the subject 

of the patent; use merely to obtain the advantage of the invention disclosed by the patent 

is not experimental use. 

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6) The Melbourne International Exhaustion Resolution affirmed the Barcelona Parallel Import 

Resolution and resolved that there should be no international exhaustion of industrial property 

rights (patents, trademarks, designs and plant breeder’s rights) notwithstanding that regional 

exhaustion may be applied in order to foster regional integration of different national 

economies under a uniform regulatory and legal framework. 

7) The patent law in some countries provides for an exception to exclusive patent rights for 

an “extemporaneous” preparation of a medicine in a pharmacy for individual cases in 

accordance with a medical prescription issued by a medical doctor (commonly referred to as 

the individual prescriptions exception). 

8) A number of WTO Members have not yet ratified Article 31bis of the TRIPs. 

Considering that: 

1) Patent law provides for a number of exceptions to exclusive patent rights which may play a 

role in providing access to patented medicines and other medical products. 

2) Compulsory licensing is a more appropriate and proportionate means of providing access to 

patented medicines and other medical products than expropriation of patent rights. 

Resolves that: 

1.1) Patent law should provide for an exception to the rights of a patentee, allowing a party to 

undertake, without the authorisation of the patentee, experiments relating to the subjectmatter 

of the invention, irrespective of whether the ultimate aim of the experiments may be 

commercial. 

1.2) Paragraph 3 of the Tokyo Experimental Use Resolution is affirmed insofar as it is not in conflict 

with paragraph 1.1. 

2) Patent law should provide for an exception to the rights of a patentee, allowing a party 

to undertake, without the authorisation of the patentee, acts necessary for the purpose of 

obtaining regulatory approval for medicines and other medical products such as medical 

devices, diagnostics, research tools and the like. 

3) The Barcelona Parallel Import Resolution and the Melbourne International Exhaustion 

Resolution are each affirmed. 

4) To the extent that the patent law provides for an individual prescriptions exception, the 

exception should be limited to preparation of medicines as and when required for an 

individual patient and should not extend to situations where medicines are prepared on a 

larger scale. 

5) To the extent that the patent law permits patentability of methods of medical treatment, the 

law should provide for an exception to the rights of a patentee, allowing medical personnel 

to use patented methods of medical treatment, without the authorisation of the patentee, in 

circumstances where it is not practicable to negotiate a licence before treatment. 

368 


6) Concerning public health: 

a) the patent law should provide that a compulsory license can only be granted in exceptional 

and strictly defined circumstances. 

b) the law should not permit expropriation of patent rights. 

7) Article 31bis of the TRIPs should be promptly ratified by WTO Members that have not yet 

done so. 

369 




Observant que: 

Résolution 

Question Q202 



1) Cette résolution traite des exceptions aux droits exclusifs de brevet applicables aux 

médicaments et autres produits médicaux. 

2) L’accès aux médicaments et aux autres produits médicaux à un prix abordable est une 

question fondamentale, mais les exceptions aux droits exclusifs de brevet ne peuvent seules 

la résoudre. 

3) L’AIPPI a déjà étudié les exceptions aux droits exclusifs de brevet dans des questions 

précédentes, ce qui a conduit en particulier à: 

i) La résolution du Comité Exécutif de Barcelone en 1990 – Question Q101, Annuaire 

1991/I, page 274 intitulée „Importations parallèles des produits brevetés“ (Résolution de 

Barcelone sur les importations parallèles); 

ii) La résolution du Comité Exécutif de Tokyo en 1992 – Question Q105, Annuaire 1992/ 

III, pages 260-261 intitulée „Usage expérimental en tant qu’exception à l’action de 

contrefaçon de brevet“ (Résolution de Tokyo sur l’usage expérimental); et 

iii) La résolution du 38ème Congrès de Melbourne en 2001 – Question Q156, Annuaire 

2001/I, pages que 513-514 intitulée „L’épuisement international des droits de propriété 

industrielle“ (Résolution de Melbourne sur l’épuisement international). 

4) La résolution de Barcelone sur les importations parallèles a admis qu’un titulaire de brevet 

doit pouvoir invoquer son brevet pour arrêter une importation parallèle d’un produit breveté, 

quelles que soient les circonstances dans lesquelles le produit a été mis pour la première fois 

sur le marché dans un pays „B“, sauf en cas d’accord contractuel autorisant l’importation du 

produit dans un autre pays „A“. 

5) Le paragraphe 3 de la résolution de Tokyo sur l’usage expérimental a retenu que chaque 

pays devrait admettre le principe selon lequel les actes effectués dans un but expérimental 

ne portent pas atteinte aux droits du breveté sur le fondement d’un usage expérimental qui: 

i) comprend toute utilisation de l’invention brevetée, effectuée à des fins purement 

académiques et sans caractère commercial; 

ii) comprend les essais menés pour évaluer l’enseignement du brevet et la validité du 

brevet; 

iii) comprend toute utilisation de l’invention brevetée de manière appropriée à l’expérimentation 

(et non à l’usage commercial), dont le but est de perfectionner l’invention, de la faire 

progresser ou de lui trouver une alternative, mais pas l’exploitation commerciale de ce 

perfectionnement ou de ce progrès; et 

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iv) doit respecter le principe selon lequel cet usage doit impliquer des travaux sur l’objet du 

brevet; un usage fait uniquement pour tirer avantage de l’invention décrite au brevet n’est 

pas un usage expérimental. 

6) La résolution de Melbourne sur l’épuisement international a confirmé la résolution de 

Barcelone sur l’importation parallèle, et a considéré qu’il ne devait y avoir aucun épuisement 

international des droits de propriété industrielle (brevets, marques, dessins et modèles, 

certificats d’obtentions végétales), nonobstant le fait qu’un épuisement régional peut être 

appliqué dans le but de promouvoir l’intégration régionale de différentes économies 

nationales dans un cadre réglementaire et juridique uniforme. 

7) Dans certains pays, le droit des brevets prévoit une exception aux droits exclusifs de brevet 

pour la préparation de médicaments faite extemporanément et par unité dans les officines de 

pharmacie, sur ordonnance médicale établie par un médecin (habituellement connue sous le 

nom d’exception de prescription individuelle). 

8) Un certain nombre de pays membres de l’OMC n’ont pas encore ratifié l’article 31bis des 

accords ADPIC. 

Considérant que: 

1) Le droit des brevets prévoit un certain nombre d’exceptions aux droits exclusifs de brevet qui 

peuvent jouer un rôle dans l’accès aux médicaments brevetés et autres produits médicaux. 

2) Un système des licences obligatoires constitue un moyen plus approprié et plus équilibré 

de permettre l’accès aux médicaments brevetés et autres produits médicaux, que 

l’expropriation. 

Adopte la résolution suivante: 

1.1) Le droit des brevets devrait prévoir une exception aux droits du breveté, permettant à une 

partie, d’entreprendre, sans l’autorisation du breveté, des expérimentations sur l’objet de 

l’invention, que la finalité de ces expérimentations soit ou non commerciale. 

1.2) Le Paragraphe 3 de la résolution de Tokyo sur l’usage expérimental est confirmé pour autant 

qu’il ne se trouve pas en contradiction avec le paragraphe 1.1 de la présente résolution. 

2) Le droit des brevets devrait prévoir une exception aux droits du breveté, permettant à une 

partie d’entreprendre, sans l’autorisation du breveté, les actes nécessaires à l’obtention des 

autorisations réglementaires pour des médicaments et autres produits médicaux comme les 

dispositifs médicaux, tests de diagnostic, outils de recherches et similaires. 

3) La résolution de Barcelone sur l’importation parallèle et la résolution de Melbourne sur 

l’épuisement international sont chacune confirmées. 

4) Dans la mesure où le droit des brevets prévoit une exception de prescription individuelle, cette 

exception devrait être limitée à la préparation de médicaments en cas de besoin d’un patient, 

et ne devrait pas s’étendre aux situations où des médicaments sont préparés à plus grande 

échelle. 

372 


5) Dans la mesure où le droit des brevets prévoit la brevetabilité des méthodes de traitement 

médical, la loi devrait prévoir une exception aux droits du breveté, permettant au personnel 

médical de faire usage des méthodes de traitement médical brevetées, sans l’autorisation du 

breveté, lorsque la situation factuelle rend impossible de négocier une licence avant la mise 

en œuvre du traitement. 

6) En ce qui concerne la santé publique: 

a) Le droit des brevets devrait prévoir que l’octroi de licences obligatoires ne peut intervenir 

qu’en cas de circonstances exceptionnelles et strictement définies. 

b) La loi ne devrait pas permettre l’expropriation des droits de brevet. 

7) L’article 31bis des ADPIC devrait être rapidement ratifié par les pays membres de l’OMC qui 

n’y ont pas encore procédé. 

373 




Feststellend: 

Entschliessung 

Frage Q202 



1) Der Fokus dieser Entschliessung richtet sich auf Ausnahmen von exklusiven Patentrechten 

betreffend Arzneimittel und andere medizinische Produkte. 

2) Der Zugang zu erschwinglichen Arzneimitteln und anderen medizinischen Produkten ist 

ein drängendes Thema, wobei aber die Ausnahmen von exklusiven Patentrechten nicht die 

alleinige Lösung darstellen können. 

3) AIPPI hat Ausnahmen von exklusiven Patentrechten bereits in früheren Fragen untersucht. Dies 

hat im Wesentlichen zu nachfolgenden Entschliessungen geführt: 

i) Entschliessung des Geschäftsführenden Ausschusses von Barcelona im Jahr 1990 zu 

Frage Q101, Jahrbuch 1991/I, Seite 323 ‘Parallelimport von patentierten Erzeugnissen’ 

(Barcelona Entschliessung betreffend Parallelimport); 

ii) Entschliessung des Geschäftsführenden Ausschusses von Tokio im Jahr 1992 zu Frage 

Q105, Jahrbuch 1992/III, Seiten 304-305 ‘Benutzung zu Versuchszwecken als Einwand 

gegenüber einem Anspruch wegen Patentverletzung’ (Tokio Entschliessung betreffend die 

Benutzung zu Versuchszwecken); und 

iii) Entschliessung des 38. Kongresses von Melbourne im Jahr 2001 zu Frage Q156, Jahrbuch 

2001/I, Seiten 515-516 ‘Internationale Erschöpfung der gewerblichen Schutzrechte’ 

(Melbourne Entschliessung betreffend die internationale Erschöpfung gewerblicher 

Schutzrechte). 

4) In der Barcelona Entschliessung betreffend Parallelimport wurde festgehalten, dass der 

Patentinhaber in der Lage sein sollte, sein Patent gegen den Parallelimport eines patentierten 

Erzeugnisses geltend zu machen, ungeachtet der Umstände, unter welchen dieses Erzeugnis 

zunächst in einem Land B in Verkehr gebracht worden ist, vorbehaltlich einer Ausnahme durch 

eine Übereinkunft, welche den Import des Erzeugnisses in ein anderes Land A gestattet. 

5) Paragraph 3 der Tokio Entschliessung betreffend die Benutzung zu Versuchszwecken hielt 

fest, dass jedes Land Handlungen zu Versuchszwecken von den Wirkungen des Patentes 

ausnehmen sollte, wobei folgende Regeln gelten sollen: 

i) Eine Versuchsbenutzung umfasst jede Benutzung einer patentierten Erfindung zu 

akademischen Zwecken und ohne wirtschaftliche Zielsetzung; 

ii) Eine Versuchsbenutzung umfasst die Überprüfung der Lehre und der Rechtsbeständigkeit 

des Patentes; 

iii) Eine Versuchsbenutzung umfasst jede Benutzung einer patentierten Erfindung in einem 

dem Versuch angemessenen Umfang (ohne bereits eine wirtschaftliche Benutzung 

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darzustellen) mit dem Ziel, die Erfindung zu verbessern oder weiterzuentwickeln oder eine 

Umgehungslösung zur Erfindung zu finden. Dies schliesst die wirtschaftliche Verwertung 

des verbesserten oder weiterentwickelten Gegenstandes nicht ein; und 

iv) Eine Versuchsbenutzung steht unter der der generellen Begrenzung, dass die Benutzung 

sich auf den Gegenstand der Erfindung beziehen muss; eine Verwendung nur zu 

dem Zweck, den im Patent offenbarten Vorteil der Erfindung zu erzielen, stellt keine 

Versuchsbenutzung dar. 

6) Die Melbourne Entschliessung betreffend die internationale Erschöpfung gewerblicher 

Schutzrechte bestätigte die Barcelona Entschliessung betreffend Parallelimport und hielt 

fest, dass die internationale Erschöpfung von gewerblichen Schutzrechten (Patente, Marken, 

Geschmacksmuster und Sortenschutzrechte) nicht angewendet werden soll. Regionale 

Erschöpfung kann jedoch im Interesse einer Stärkung regionaler Integration unterschiedlicher 

nationaler Volkswirtschaften unter einem einheitlichen regulatorischen und rechtlichen Rahmen 

vorgesehen werden. 

7) Das Patentrecht in einigen Ländern sieht Ausnahmen von exklusiven Patentrechten vor für 

instante, individuelle Arzneimittelzubereitungen in Apotheken, die auf einem ärztlichen 

Rezept basieren (üblicherweise als Ausnahme der individuellen Arzneimittelzubereitung 

bezeichnet). 

8) Eine Anzahl von WTO Mitgliedern hat Art. 31bis des TRIPS Abkommens noch nicht 

ratifiziert. 

In Erwägung folgender Gesichtspunkte: 

1) Das Patentrecht sieht eine Reihe von Ausnahmen von exklusiven Patentrechten vor, welche 

einen Einfluss auf den Zugang zu patentierten Arzneimitteln und anderen medizinischen 

Produkten haben können. 

2) Die Erteilung von Zwangslizenzen stellt ein angemesseneres und verhältnismässigeres Mittel 

als die Enteignung von Patentrechten dar, um den Zugang zu patentierten Arzneimitteln und 

anderen medizinischen Produkten zu ermöglichen. 

Fasst die folgende Entschliessung: 

1.1) Das Patentrecht sollte eine Ausnahme von den Rechten des Patentinhabers vorsehen 

für Experimente, die den Gegenstand der Erfindung betreffen und ohne Erlaubnis des 

Patentinhabers vorgenommen werden, selbst wenn die ultimative Zielrichtung der Experimente 

kommerziell ist. 

1.2) Paragraph 3 der Tokio Entschliessung betreffend die Benutzung zu Versuchszwecken wird 

insofern bestätigt, als sie nicht mit Paragraph 1.1 im Konflikt steht. 

2) Das Patentrecht sollte eine Ausnahme von den Rechten des Patentinhabers vorsehen, die 

es Dritten erlaubt, ohne Einverständnis des Patentinhabers, Handlungen vorzunehmen, die 

notwendig sind, um für Arzneimittel und andere medizinische Produkte wie medizinische 

Geräte, Diagnostika, Forschungswerkzeuge u.ä. die behördliche Zulassung zu erlangen. 

376 


3) Die Barcelona Entschliessung betreffend Parallelimport und die Melbourne Entschliessung 

betreffend die internationale Erschöpfung gewerblicher Schutzrechte werden bestätigt. 

4) Insofern, als das Patentrecht Einzelzubereitungen von Arzneien von der Wirkung des Patentes 

ausnimmt, sollte diese Ausnahme auf Arzneimittelzubereitungen beschränkt werden, sofern 

und soweit diese für einen einzelnen Patienten benötigt werden, und nicht Situationen 

einschliessen, in denen Arzneien in grösserem Massstab hergestellt werden. 

5) Insofern, als das Patentrecht die Patentierung von medizinischen Behandlungsverfahren 

erlaubt, sollte das Gesetz eine Ausnahme von den Rechten des Patentinhabers vorsehen, 

die es medizinischem Personal dann gestattet, medizinische Behandlungsverfahren ohne 

Einverständnis des Patentinhabers durchzuführen, wenn die Umstände es nicht zulassen, vor 

der Behandlung eine Lizenz zu verhandeln. 

6) Betreffend die Volksgesundheit: 

a) Das Patentrecht sollte vorsehen, dass eine Zwangslizenz nur ausnahmsweise und unter 

streng definierten Umständen erteilt werden kann. 

b) Das Gesetz sollte keine Enteignung von Patentrechten erlauben. 

7) Artikel 31bis des TRIPS Abkommens sollte von denjenigen WTO Mitgliedern, die den Artikel 

noch nicht ratifiziert haben, umgehend ratifiziert werden. 

377 



Table of contents 

Congress (Boston, 6 – 11 September 2008) 

I. The Questions on the Agenda .............................................................. 5 

II. Q202: The impact of public health issues 

on exclusive patent rights .................................................... 9 

Working Guidelines ................................................................................ 11 

Group Reports: 

Argentina ........................................................................................................ 35 

Australia.......................................................................................................... 41 

Austria ............................................................................................................ 51 

Belgium ........................................................................................................... 55 

Brazil .............................................................................................................. 63 

Bulgaria .......................................................................................................... 69 

Canada .......................................................................................................... 73 

China ............................................................................................................. 81 

Colombia ........................................................................................................ 87 

Denmark ......................................................................................................... 93 

Ecuador .......................................................................................................... 99 

Egypt .............................................................................................................. 105 

Estonia ............................................................................................................ 113 

Finland ............................................................................................................ 117 

France ............................................................................................................ 123 

Germany ......................................................................................................... 147 

Hungary .......................................................................................................... 173 

Indonesia ........................................................................................................ 179 

Ireland ............................................................................................................ 183 

Israel .............................................................................................................. 189 

Italy ................................................................................................................ 193 

Japan ............................................................................................................. 199 

Malaysia ......................................................................................................... 211 

Mexico............................................................................................................ 215 

Netherlands ..................................................................................................... 221 

Norway .......................................................................................................... 227 

Peru ................................................................................................................ 231 

Philippines ....................................................................................................... 237 

Portugal .......................................................................................................... 245 

Republic of Korea ............................................................................................. 253 

Singapore ....................................................................................................... 257 

South Africa ..................................................................................................... 261 

Spain .............................................................................................................. 269 

Sweden ........................................................................................................... 277 

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Switzerland ..................................................................................................... 287 

Thailand .......................................................................................................... 295 

Turkey ............................................................................................................. 301 

United Kingdom ............................................................................................... 309 

United States of America ................................................................................... 317 

Summary Report ...................................................................................... 321 

Resolution .................................................................................................. 367 

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Table des matières 

Congrès (Boston, 6 – 11 septembre, 2008) 

I. Les questions à l’ordre du jour ........................................................... 5 

II. Q202: L’influence des questions de santé publique 

sur les droits exclusifs de brevet ........................................ 9 

Orientation de travail ............................................................................ 19 

Rapports des Groupes: 

Afrique du Sud ................................................................................................. 261 

Allemagne ....................................................................................................... 147 

Argentine ........................................................................................................ 35 

Australie .......................................................................................................... 41 

Autriche .......................................................................................................... 51 

Belgique .......................................................................................................... 55 

Brésil .............................................................................................................. 63 

Bulgarie .......................................................................................................... 69 

Canada .......................................................................................................... 73 

Chine .............................................................................................................. 81 

Colombie ........................................................................................................ 87 

Danemark ....................................................................................................... 93 

Egypte ............................................................................................................ 105 

Equateur.......................................................................................................... 99 

Espagne .......................................................................................................... 269 

Estonie ............................................................................................................ 113 

Etats-Unis d’Amérique ....................................................................................... 317 

Finlande .......................................................................................................... 117 

France ............................................................................................................ 123 

Hongrie .......................................................................................................... 173 

Indonésie ........................................................................................................ 179 

Irlande ............................................................................................................ 183 

Israël .............................................................................................................. 189 

Italie ............................................................................................................... 193 

Japon ............................................................................................................. 199 

Malaisie .......................................................................................................... 211 

Mexique .......................................................................................................... 215 

Norvège ......................................................................................................... 227 

Pays-Bas .......................................................................................................... 221 

Pérou .............................................................................................................. 231 

Philippines ....................................................................................................... 237 

Portugal .......................................................................................................... 245 

République de Corée ........................................................................................ 253 

Royaume-Uni ................................................................................................... 309 

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Singapour ....................................................................................................... 257 

Suède ............................................................................................................. 277 

Suisse ............................................................................................................. 287 

Thaïlande ........................................................................................................ 295 

Turquie ............................................................................................................ 301 

Rapport de synthèse ............................................................................... 335 

Résolution .................................................................................................. 371 

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Inhaltsverzeichnis 

Kongress (Boston, 6. – 11. September, 2008) 

I. Die Fragen der Tagesordnung ............................................................. 5 

II. Q202: Auswirkungen von Fragen der Volksgesundheit 

auf exklusive Patentrechte .................................................. 9 

Arbeitsrichtlinien ..................................................................................... 27 

Gruppenberichte: 

Ägypten .......................................................................................................... 105 

Argentinien ...................................................................................................... 35 

Australien ........................................................................................................ 41 

Belgien ........................................................................................................... 55 

Brasilien .......................................................................................................... 63 

Bulgarien......................................................................................................... 69 

China ............................................................................................................. 81 

Dänemark ....................................................................................................... 93 

Deutschland ..................................................................................................... 159 

Ecuador .......................................................................................................... 99 

Estland ............................................................................................................ 113 

Finland ............................................................................................................ 117 

Frankreich ....................................................................................................... 123 

Indonesien ....................................................................................................... 179 

Irland .............................................................................................................. 183 

Israel .............................................................................................................. 189 

Italien ............................................................................................................. 193 

Japan ............................................................................................................. 199 

Kanada ........................................................................................................... 73 

Kolumbien ....................................................................................................... 87 

Malaysia ......................................................................................................... 211 

Mexiko ............................................................................................................ 215 

Niederlande .................................................................................................... 221 

Norwegen ....................................................................................................... 227 

Österreich ....................................................................................................... 51 

Peru ................................................................................................................ 231 

Philippinen....................................................................................................... 237 

Portugal .......................................................................................................... 245 

Republik Korea................................................................................................. 253 

Schweden ....................................................................................................... 277 

Schweiz .......................................................................................................... 287 

Singapur ......................................................................................................... 257 

Spanien .......................................................................................................... 269 

Südafrika ........................................................................................................ 261 

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Thailand .......................................................................................................... 295 

Türkei .............................................................................................................. 301 

Ungarn ........................................................................................................... 173 

Vereinigtes Königreich ....................................................................................... 309 

Vereinigte Staaten von Amerika ......................................................................... 317 

Zusammenfassender Bericht ................................................................ 351 

Entschliessung........................................................................................... 375 

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YEARBOOK 2008 / I - AIPPI

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