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

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

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

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

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

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 Au stralia-US FTA, Bahrain-US FTA, CAFTA, Chile-US FTA, Morocco-US FTA, Singapore-US FTA

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

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.

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

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

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

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

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

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

Thank you