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Exceptions - presentation IP law
9
Exceptions in International Patent Law
- Chandell Stienstra
- Tess Mulder
- Anouk van Tulder
- Jamie Karamat Ali
Introduction
International patent law
- Patent law
- Exceptions
- 'Should there be more room for exceptions in international patent law?'
Example
Conflicting interests
WIPO - Patent Flexibility
Chaper IV - PATENT EXCLUSIONS THAT PROMOTE PUBLIC HEALTH OBJECTIVES
Shamnad Basheer, Shashwat Purohit and Prashant Reddy
Chapter V - Exceptions and limitations in the health context
Professor Coenraad Visser
Exceptions - Health context
Exceptions
- Compulsory licenses
- Art. 5A (2) (4) Paris Convention
- Art. 31 TRIPS
- Individual prescriptions
- Parallel imports
- Regulatory exception
Compulsory licenses
- Correct abuse of rights
- Address national emergencies or situations of extreme urgency
- i.e. ensure proper access to medicines in developing and least developed countries
- i.e. improve export opportunities for generic pharmaceutical sectors in developing countries
Article 31 TRIPS - Other Use Without Authorization of the Right Holder
Article 31 of TRIPS
- Art. 31 (f)
- any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use
- Obstacle to developing and least developed countries
- Countries that have lack of or insufficiency of manufacturing capacity unable to produce patented medicines themselves
- Export disadvantages
More room = more balance
Argument
Discussion
- Current exceptions effective?
- Waiver Decision (2003)
- Article 31bis of TRIPS
Race Against Time: The Export of Essential Medicines to Rwanda
by Matthew Rimmer
- Short introduction
- WTO General Council Decision 2003
- Canada's Access to Medicines Regime
- Conclusion
Rwanda exception
Rwanda
Abstract
- Debate over patent law and access to essential medicine
- Waiver: First export under the WTO General Council Decision 2003 to Rwanda
- HIV/AIDS drug manufactured by Canadian manufacturer
Abstract
Debate
Patent Law
vs.
Access to essential medicines
Strong patent protection is necessary to promote research and development
VS.
Address health crises in poor countries
Arguments
WTO General Council Decision 2003
WTO General Council Decision 2003
- Agreement on implementing the paragraph of the Doha Declaration on the TRIPS and Public Health 2001
- Solution to compulsory licensing for member states without manufacturing capabilities
Waiver
Article 2
Article 2. The obligations of an exporting Member under Article 31(f) of the TRIPS Agreement shall be waived with respect to the grant by it of a compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s)
A breakthrough achievement?
NO!
Promise or Failure?
There is scope for further reform
'Pioneer' and 'path-finder'
However: the compulsory licensing provisions in CAMR have proved to be complex and troublesome
A Failure of CAMR
Conclusion
- WTO decision provides and imperfect model
- There is a gap between political symbolism and the practical efficacy
Conclusion
There should be a new effective international mechanism
The interest of both parties should be taken into account
Should international patent law offer more room for exceptions?
YES!
YES!
Abbott/Reichman
Art. 31bis TRIPS - Compulsory licensing
Power imbalance: developing countries & pharmaceutical industry lead negotiations
Abbott/Reichmann
International IP system that
aims at a high level of protection
Difficulties for developing countries to obtain essential medicines
Exception: art. 31bis
Far from optimal
Exception art. 31bis
Inter alia: developing countries are required to make a public notification of their intention to use the compulsory licensing scheme
Fear of criticism
limits usefulness of art. 31bis
Necessary to have more room for exceptions
More room for exceptions?
But will exceptions ever be optimal?
Article 31bis solution
Ho
- TRIPS Council came up with the Waiver because the poorest countries had less access to low-cost medicines than middle-income countries.
- The Waiver spawned great confusion
- Criticism
Concerns from developing countries
Criticisms
- (Developing) countries suggested the Waiver is ineffective: also raised their concerns with the TRIPS Council
- System should be low cost and easy to use
- Venezuela: ironic situation
No financial incentive
Secondly
- Under compulsory license only limited quantity allowed, thus not have large-scale production advantage
- Some countries were interested but dissuaded because of complexity
Economies of scale
And...
- 31bis scheme does not provide
- Generic companies: pricing low, sell high quantities. Not permitted under 31bis
- Licenses provided on country by country basis
- Regional trade agreement does not provide commercial incentive to generic companies
Current situation
- South Centre article (January 2019) about the current situation
- UN High Level Panel: amendment needed to streamline procedures
- Urgency not acknowledged by the international community
- Article 31bis is a step forward, but not the solution