slide1 n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Christoph Spennemann, Legal Expert, IP Team Division on Investment and Enterprise UNCTAD PowerPoint Presentation
Download Presentation
Christoph Spennemann, Legal Expert, IP Team Division on Investment and Enterprise UNCTAD

Loading in 2 Seconds...

play fullscreen
1 / 12

Christoph Spennemann, Legal Expert, IP Team Division on Investment and Enterprise UNCTAD - PowerPoint PPT Presentation


  • 102 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Christoph Spennemann, Legal Expert, IP Team Division on Investment and Enterprise UNCTAD' - denise-conway


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
slide1

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

overview
Overview
  • From TRIPS to Bilateral & Regional Trade Agreements (« FTAs »)
  • Impact of FTAs in the area of public health: some examples
  • Conclusions
from trips to ftas 1
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)
from trips to ftas 2
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
from trips to ftas 3
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)
example 1 term of patent protection
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
example 2 patentability criteria
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
example 3 test data exclusivity de 1
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
example 3 test data exclusivity de 2
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
example 4 linkage of drug regulation patent status
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
conclusions
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?
contact
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