Christoph Spennemann, Legal Expert, IP Team Division on Investment and Enterprise UNCTAD

1. IP Provisions in Bilateral & Regional Trade Agreements and Public Health ICTSD/QUNODinner Discussion on IPRs in Bilateral & Regional Trade Agreements & Public Health4 November 2009, Hotel Royal, Geneva Christoph Spennemann, Legal Expert, IP Team Division on Investment and Enterprise UNCTAD

2. Overview • From TRIPS to Bilateral & Regional Trade Agreements (« FTAs ») • Impact of FTAs in the area of public health: some examples • Conclusions

3. From TRIPS to FTAs (1) • TRIPS: introduction of minimum standards relevant to public health • Patents available for all areas of technology • Protection of pharmaceutical test data • But many flexibilities • Appropriate way of implementation (Art. 1 TRIPS) • Lack of definitions (e.g. invention, patentability criteria, « unfair commercial use ») • Exceptions (Art. 30 TRIPS)

4. From TRIPS to FTAs (2) • Since 1995: more than 250 bilateral & regional trade agreements among WTO Members • Not all of these have full IP chapters • Trend: strengthening of exclusive rights; loss of TRIPS flexibilities

5. From TRIPS to FTAs (3) • FTAs legitimate consequence of TRIPS Art 1 • DCs are often demandeurs • Market access to OECD • But hesitant on IP (e.g. Chile) • OECD countries push for stronger IP • Response to domestic industry • US Congress: public health safeguards in recent US FTAs (Colombia, Panama, Peru)

6. Example 1: term of patent protection • TRIPS: 20 years from filing date • US FTAs: obligation to adjust term for delays in • Patent granting procedure • Marketing approval procedure • Now optional under US – Peru for pharmaceuticals, not other sectors • TRIPS Art 27.1 non-discrimination does not prevent differentiation

7. Example 2: patentability criteria • US FTAs introduce notion of « utility » • Potentially broader than EPO’s « industrial application » • Business models • Research tools: safeguards in USPTO Guidelines & Federal Circuit case law, but no reference in FTAs • Patents on new uses of known products • US-Australia, Bahrain, Morocco, Oman • Process patents in US law  unclear in FTAs

8. Example 3: test data exclusivity (DE) (1) • TRIPS: strategically vague (« unfair commercial use ») • FTAs (mainly US): exclusive rights in test data  no reliance by drug regulatory authority • Impact on generic industry: • No bioequivalence during term of protection  full clinical trials dossier • Despite CLs & regulatory review exception: no regulatory approval prior to expiry of DE

9. Example 3: test data exclusivity (DE) (2) • US – Peru: modifications • E.g. subjects DE to Doha Declaration and TRIPS Art 31bis waivers (CL) • EU: opposite development • No DE in earlier FTAs; 10/11-year DE in recent proposals (Colombia, Ecuador, Peru) • EFTA: some FTAs include DE • Korea: compensatory liability option • Colombia: compensatory liability for agrochemicals only

10. Example 4: linkage of drug regulation – patent status • TRIPS: no provision  regulatory approval not concerned with patent status • EU & EFTA: no linkage • US FTAs: no regulatory approval prior to expiry of patent • Shifts enforcement from IP owner to state • Optional under new FTAs (Colombia, Peru, Panama) • Effective remedies for patent infringement litigation • Rewards for successful patent challenges

11. Conclusions • FTAs are legitimate consequences of TRIPS • FTA provisions on patents & regulated products shift balance in favor of IP holder • FTAs do not refer to checks & balances used by OECD countries (e.g. patentability guidelines, case law) • Recent adjustments in US FTAs respond to public health concerns • Initiated by US Congress • Role of developing countries?

12. Contact Christoph Spennemann Legal Expert Intellectual Property Team Division on Investment and Enterprise (DIAE) UNCTAD E-mail: Christoph.Spennemann@unctad.org Tel: ++41 (0) 22 917 59 99 Fax: ++41 (0) 22 917 01 94 http://www.unctad.org/tot-ip