TRIPS+ provisions in FTAs and the implications for access to medicines

1. TRIPS+ provisions in FTAs and the implications for access to medicines Sanya Smith Third World Network 27 August 2005

2. Outline of presentation • TRIPS+ intellectual property provisions affecting generics in these FTAs • Effect of inclusion of intellectual property in investment chapter of FTAs

3. Existing US FTAs Focusing on US FTAs: • Australia • Bahrain • CAFTA • Chile • Jordan • Morocco • Singapore • Other US agreements: Cambodia, Lao, Vietnam

4. TRIPS+ IPR protection: summary of issues • Patentability • Patent term • Patent extensions • Limitations on oppositions • Protection of data • Linkage of data protection, marketing approval and patent term • Compulsory licences • Parallel importation

5. TRIPS+ IPR protection continued • Patentability: Extended to include: • Plants • Animals • New uses or methods of using a known product • New uses of a known product for the treatment of humans and animals Australia-US FTA, Morocco-US FTA

6. TRIPS+ IPR protection continued • Patent term: no requirement for 20 year pharmaceutical product patent protection for: • Non-WTO Members • Least developed WTO Members • Patent term extensions • If the patentee requests it, governments must provide an extension of the patent term to compensate the patentee for: • Unreasonable delays that occur in granting the patent • The marketing approval process causing unreasonable curtailment of the effective patent term Australia-US FTA, Bahrain-US FTA, CAFTA, Chile-US FTA, Morocco-US FTA, Singapore-US FTA

7. TRIPS+ IPR protection continued Limitations on oppositions • Third party cannot bring pre-grant opposition Article 15.9.5 Morocco-US FTA

8. TRIPS+ IPR protection continued Linkage of data protection, marketing approval and patent term • Marketing approval body to prevent marketing during the patent term • Weak patent situation • Effect on compulsory licences and government use • Loss of element of surprise as even applying for marketing approval must be notified to patentee Australia-US FTA, Bahrain-US FTA, CAFTA, Chile-US FTA, Morocco-US FTA, Singapore-US FTA • Extensions of the patent term must be provided for certain delays in marketing approval, see above.

9. TRIPS+ IPR protection continued • Compulsory licences • Very limited because have to implement measures to prevent anyone else from marketing the product during the term of the patent without the patentee’s consent, see above Australia-US FTA, Bahrain-US FTA, CAFTA, Chile-US FTA, Morocco-US FTA, Singapore-US FTA

10. TRIPS+ IPR protection continued • Compulsory licences continued • Limitations on grounds for compulsory licences, Australia-US FTA, Jordan-US FTA, Singapore-US FTA • Cannot force patent holder to transfer know how to manufacture the medicine when issue a compulsory licence Australia-US FTA, Singapore-US FTA

11. TRIPS+ IPR protection continued • Parallel importation • At a minimum, where patentee has limited importation (eg by contract), then parallel importation without the patentee’s consent is not possible Australia-US FTA, Morocco-US FTA, Singapore-US FTA

12. IP in investment chapters • IP is often included in investment chapters of US FTAs in the definition of investment • Content of obligations is defined by IP chapter • Provisions on expropriation apply to IP • Patents • Royalties • Safeguards re compulsory licences and patents • Investor-state dispute settlement applies to IP

13. Some options • If you sign an FTA: • Exclude IP and investment • If you include IP and investment, stay with the TRIPS minimum requirements (for WTO Members) • If you agree to TRIPS+ provisions, include safeguards re compulsory licensing etc

14. Countries planning US-FTAs • Already in negotiations • Oman • Panama • Thailand • UAE • Andean countries • FTAA • SACU • Proposed negotiations • ASEAN • MEFTA • Bilateral pressure outside of FTAs

15. Thank you