1. IP Provisions in Bilateral & Regional Trade Agreements and Public Health ICTSD/QUNO Dinner Discussion on IPRs in Bilateral & Regional Trade Agreements & Public Health 4 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
Tel: ++41 (0)
Fax: ++41 (0)