1. TRIPS-Plus Pressures: Trade Agreements, and New Trade Policy Prof. Brook K. Baker OSI Kiev – IPRs & A2M, Sept. 16, 2009

2. What Do We Mean by TRIPS-Plus? IP rights/protection greater than what is required by TRIPS IP rights/protection greater than what is required by TRIPS Restrictions on use of TRIPS-compliant flexibilities Restrictions on use of TRIPS-compliant flexibilities Enhanced and costly enforcement requirements Enhanced and costly enforcement requirements U.S. and E.U. seeks TRIPS+ in bilateral/regional trade agreements – FTAs & EPAs U.S. and E.U. seeks TRIPS+ in bilateral/regional trade agreements – FTAs & EPAs Forum shifting & IPR ratchet Forum shifting & IPR ratchet

3. TRIPS-Plus Patenting Provisions Expand scope of patentability (new forms of existing chemical entities, new uses, new formulations, combinations, etc.) Expand scope of patentability (new forms of existing chemical entities, new uses, new formulations, combinations, etc.) Patenting of life-forms, plants, medical/surgical methods Patenting of life-forms, plants, medical/surgical methods Extend patent term for regulatory delays (patent and/or registration) Extend patent term for regulatory delays (patent and/or registration) Ban pre- and post-grant opposition and limit grounds for patent revocation Ban pre- and post-grant opposition and limit grounds for patent revocation Set low disclosure standard Set low disclosure standard

4. TRIPS-Plus Data Exclusivity and Patent/Registration Linkage TRIPS requires data protection, preventing unfair commercial use and unnecessary disclosures of registration-related data. TRIPS requires data protection, preventing unfair commercial use and unnecessary disclosures of registration-related data. US seeks TRIPS+ data exclusivity and patent/registration linkage. US seeks TRIPS+ data exclusivity and patent/registration linkage.

5. Data Exclusivity and Patent/Registration Linkage Data exclusivity prevents use of registration data (reference or reliance) for five years for new chemical entities Data exclusivity prevents use of registration data (reference or reliance) for five years for new chemical entities Require three years of additional D.E. for each new use/formulation Require three years of additional D.E. for each new use/formulation Link drug registration and patent status preventing registration of generic medicines whenever a patent claim is made Link drug registration and patent status preventing registration of generic medicines whenever a patent claim is made

6. TRIPS-Plus Limiting Flexibilities Ban parallel importation (nat’l exhaustion/contracts right rule only) Ban parallel importation (nat’l exhaustion/contracts right rule only) Limit compulsory licenses to public non- commercial use, emergencies, and competition cases only Limit compulsory licenses to public non- commercial use, emergencies, and competition cases only Restrict use of price controls, therapeutic formularies/reimbursement schemes Restrict use of price controls, therapeutic formularies/reimbursement schemes

7. TRIPS-Plus Enhanced Enforcement Enhanced enforcement Enhanced enforcement Criminal sanctions, border control Criminal sanctions, border control Anti-counterfeiting (recent forum shifting) Anti-counterfeiting (recent forum shifting) Enhanced remedies, i.e. mandatory injunctions, full & reasonable compensation Enhanced remedies, i.e. mandatory injunctions, full & reasonable compensation Investor rights to sue countries directly Investor rights to sue countries directly

8. E.U. Economic Partnership Agreements Also seek TRIPS-plus provisions: Also seek TRIPS-plus provisions: Patent term extensions Patent term extensions Data exclusivity up to 10 years plus 1 more Data exclusivity up to 10 years plus 1 more Enhanced enforcement/anti-counterfeiting measures Enhanced enforcement/anti-counterfeiting measures Agreements recently concluded with Caribbean countries and some SACU countries Agreements recently concluded with Caribbean countries and some SACU countries

9. Ripple Effects How do other countries and IP right holders benefit from bilateral and regional trade agreements? How do other countries and IP right holders benefit from bilateral and regional trade agreements? Art. 4: most-favoured-nation treatment. Art. 4: most-favoured-nation treatment.

10. Recent Developments New US Trade Policy Congressional Democrats eased IPR barriers to more affordable generic medicines (May 2007) Congressional Democrats eased IPR barriers to more affordable generic medicines (May 2007) Public health exception and additional limits on data exclusivity, in the text of the agreement Public health exception and additional limits on data exclusivity, in the text of the agreement No mandatory patent/registration linkage No mandatory patent/registration linkage No mandatory extensions of patent terms for regulatory delay No mandatory extensions of patent terms for regulatory delay Congress forced renegotiation of IP provisions in Peru, Panama, and Columbia FTAs Congress forced renegotiation of IP provisions in Peru, Panama, and Columbia FTAs

11. Additional Developments 2008 GAO Report finding that the U.S. trade policy does not implement the Doha Declaration and that if Congress wanted to implement Doha it must give clearer directives to the USTR. 2008 GAO Report finding that the U.S. trade policy does not implement the Doha Declaration and that if Congress wanted to implement Doha it must give clearer directives to the USTR. Congressional letters protesting USTR threats against Thailand for issuing CLs. Congressional letters protesting USTR threats against Thailand for issuing CLs.

12. Recent Developments Obama’s Trade Agenda President-Elect Obama on Trade: promise that no future bilateral agreements “will … prevent developing country governments from adopting humanitarian licensing policies to improve access to life-saving medications.” Key IP Provisions in Proposed New TRADE Act – New Rules for Global Economy [S. 3083/H.R. 6180] Assess the impact of intellectual property provisions in past trade agreements on access to medicines [Section 3(b)(8)] Future agreements must not include IP provisions that limit Doha Declaration flexibilities relating to access to medicines and issuance of compulsory licenses [Section 7(b)]. However, recent statements by new USTR Kirk and 2009 Special 301 Report quite problematic

13. Way Forward Eliminating TRIPS+ rules is essential Eliminating TRIPS+ rules is essential Pharma will not sit by quietly Pharma will not sit by quietly USTR and European trade negotiators need very specific instructions in order to change their approaches USTR and European trade negotiators need very specific instructions in order to change their approaches EECA countries should resist all TRIPS-plus measures in trade agreements or elsewhere. EECA countries should resist all TRIPS-plus measures in trade agreements or elsewhere. Activists must monitor trade negotiations Activists must monitor trade negotiations