IP Provisions in Bilateral

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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

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Overview

• From TRIPS to Bilateral Regional Trade
  Agreements ( FTAs )
• Impact of FTAs in the area of public health some
  examples
• Conclusions

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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)

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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

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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)

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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

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Example 2 patentability criteria

• US FTAs introduce notion of  utility 
• Potentially broader than EPOs  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

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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

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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

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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

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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?

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Contact

• Christoph Spennemann
• Legal Expert
• Intellectual Property Team
• Division on Investment and Enterprise (DIAE)
• UNCTAD
• E-mail Christoph.Spennemann_at_unctad.org
• Tel [phone]
• Fax [phone]
• http//www.unctad.org/tot-ip