WIPO OPEN FORUM ON THE SPLT MARCH 1 – 3, 2006

1. WIPO OPEN FORUM ON THE SPLTMARCH 1 – 3, 2006 EXCEPTIONS TO PATENT RIGHTS Alain GALLOCHAT Advisor for intellectual property at the French Ministry for Higher Education and Research Representative of AIPPI

2. The principle: Art. 28 TRIPs Agreement • The patent grants to the patentee an exclusive right, that to exclude non authorized persons from • making, using, offering for sale, selling, or importing for these purposes the patented product • using the patented process, and using, offering for sale, selling, or importing for these purposes the product obtained directly by that process.

3. Exceptions to the principle • Authorized by Law: Art. 30 of the TRIPs Agreement «Exceptions to rights conferred » • Authorized by a Court or by an Administrative body: Art. 31 of the TRIPs Agreement «Other use without authorization of the right holder »

4. The exceptions: Art 30 TRIPs Agreement (1) • Exceptions to Rights Conferred: 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.

5. The exceptions: Art 30 TRIPs Agreement (2) • A balanced position: the legitimate interests of the patent owner / the legitimate interests of third parties • REMINDER • a patent represents a balanced position: the legitimate interests of the inventor / the legitimate interests of the Society

6. Exceptions to the principle // experimental use // • Statute of the exemption: • non statutory exemption • Australia, Canada, USA, New-Zealand • Switzerland • statutory exemption • European Union • Japan, Korea, Mexico, Norway

7. Which exceptions? (1) • Private use of the invention (France: Art. L. 613-5 IPC « Acts done privately and for non-commercial purposes » ) • Acts done to satisfy idle curiosity or for strictly philosophical inquiry (USA – Roche v Bolar) • Specific use of the invention: • France: art. L. 613-5 IPC « 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 ».   • Japan: art. 69.3 Patent law concerning « medicines prepared in accordance with the prescriptions of physicians or dentists » 

8. Which exceptions? (2) • Experimental use: falls within the scope of Art. 30 of TRIPs Agreement • Divergence among the countries • the USA: common law; « patent infringement does not extend to use that is done for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry »  (Bolar) • Japan: art. 69.1 of the patent law « The effects of the patent right shall not extend to the working of the patent right for the purposes of experiment or research ».

9. Which exceptions? (3) • European Union • Nothing in the EPC • Possibly in a future « Community patent Regulation » • National laws: UK Patents Act [s. 60(5)], German Patent Act (s.11.2), French IPC (art. L. 613-5) « The effects of the patent shall not extend to acts done for experimental purposes relating to the subject matter of the patented invention ».

10. Experimental use • Which kind of experimental use? • improvements • regulatory requirements • clinical trials

11. Experimental use: improvements (1) • Improvements: which kind of improvements? • new applications of a patented product • new process for preparing a product (either patented or not) • new pharmaceutical presentation of a patented product • Improvements: which conditions? • non-commercial purpose • increase in the general knowledge  dependant patent for the improvement, with a possible compulsory license

12. Experimental use: improvements (2) • Position of some countries: • generally accepted by the majority of the countries (see in particular the German Clinical Trials II justifying such improvements) • specific approach in the USA: Madey v Duke University (CAFC 2002) « the Common law rule does not immunize any conduct that is in keeping with the alleged infringer’s legitimate business, regardless of commercial implication » [Duke’s argument: use was exempt because it was limited to research and educational purposes]

13. Experimental use: regulatory requirements (1) • Acts done in order to get an administrative (regulatory) approval: mainly for, but not limited to, medicines; do they fall under the exemption? • Great diversity of situations: • no: United-Kingdom [as a result of a Monsanto v Stauffer decision – 1985 / Lord Justice Dillon opinion] • yes, but limited: • Germany: probably no in case of bioequivalency testing and yes when producing new knowledge • France: the act of filing an application for getting an administrative approval is not an infringement per se [Supreme Court – 1998 – Promedica v Allen]; unclear concerning the trials supporting such application [infringement according to the Supreme Court, non infringement according to two decisions - 2001 & 2002 - from lower Courts involving Science Union]

14. Experimental use: regulatory requirements (2) • yes: the USA [ Restoration Act 1984 / Hatch- Waxman Amendments  « Bolar exception » • 35USC 271(e) « use of a patented invention solely for purposes reasonably related to gathering data to support an FDA application for generic versions of patented drug does not constitute infringement » • « Bolar exception applicable to medical devices [Eli Lilly v Medtronic - 1989]

15. Experimental use: clinical trials (1) • Trials supporting an application for getting an administrative approval for medicines (visa) • Situation in some countries: do such trials fall within the exemption? • the USA: yes as a result of « Bolar exception », but only when clinical trials are performed to obtain such approval • France: yes if the trials are performed on the patent subject-matter and on an experimental basis, or if they fall within the new French Public Health Code (generic drugs)

16. Experimental use: clinical trials (2) • Germany: yes in case of trials performed to find new applications [Clinical Trials I – 1995] and in case of trials performed to find the best form for a substance with the same indication as in the patent [Clinical Trials II – 1998]; in both cases, increase of knowledge. No in case the trials are performed merely to prove that the product works [German Constitutional Court – 2000]. • United-Kingdom: yes as a result of Monsanto decision ifthe trials are performed either i) to discover something new, or ii) to test an hypothesis, or iii) to confirm that the subject-matter works in different conditions, or iv) to confirm that the subject-matter can be manufactured.

17. Experimental use / AIPPI • AIPPI resolution at the Tokyo Congress (April 5 – 12, 1992) « AIPPI is in favor of the authorization of the experimental use of a patented invention by the third parties because of the potential importance of such use for technical progress  »

18. Experimental use / OECD • OECD undergoing survey on « Research use of patented knowledge » by the Working Party on Innovation and Technology Policy • meeting in Paris on December 12-14, 2005 • international conference in Madrid on May 18-19, 2006

19. Other use without authorization of the right holder:Art 31 TRIPs Agreement (1) • Compulsory licenses: • for improvements: in case of improvements resulting from experimental use of a patented invention and enabling the public to get access to a patented improvement (substantial technical progress and economic interest, …)

20. Other use without authorization of the right holder:Art 31 TRIPs Agreement (2) • for specific needs: public health, others (national defence) • exemple of the French law: art L. 613-15 IPC (compulsory license in the interest of public health), • applicable to medicines, process, medical apparatus, ex vivo diagnosis method • in case of unsufficient quantity, quality, too high price, unfair behaviour, …

21. As a conclusion • Concept of experimental use and compulsory licenses: • to be approved on its principle: • already provided in the TRIPs Agreement • a need to fulfil the balanced situation private interest (inventor, patentee) / public interest • to be clearly delimited and clarified • need of harmonization throughout the countries in the world • legal concept of an exception to be narrowly interpreted by the Courts

22. Thank you for your attention… alain.gallochat@recherche.gouv.fr