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About

Editor-in-Chief,   Anatole Krattiger

Editorial Board

Concept Foundation

PIPRA

Fiocruz, Brazil

bioDevelopments-   Institute

CHAPTER NO. 3.8   The TRIPS Agreement and Intellectual Property in Health and Agriculture
Editor's Summary, Implications and Best Practices

Krattiger A, RT Mahoney, L Nelsen, JA Thomson, AB Bennett, K Satyanarayana, GD Graff, C Fernandez and SP Kowalski. 2007. Editor’s Summary, Implications and Best Practices (Chapter 3.8). From the online version of Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices. MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.

© 2007. A Krattiger et al. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.

Editor's Summary

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) applies to all WTO members. Establishing minimum levels of protection for the intellectual property of fellow WTO members, TRIPS covers five broad issues:

1) how basic principles of the trading system and other international IP agreements should be applied
2) how to adequately protect IP rights
3) how countries should adequately enforce those rights in their own territories
4) how IP disputes can be settled between Members of the WTO
5) special transitional arrangements for the introductory period of the new system

This chapter focuses on the effects of TRIPS on health and agriculture in developing countries, highlighting the WTO programs that seek to enhance IP capacities in the developing world. It offers detailed discussions relating to TRIPS and compulsory licensing, the Doha Declaration, biological organisms, plant-related intellectual property, the Convention on Biological Diversity (CBD), traditional knowledge, technology transfer, and IP capacity building.

Of particular interest is the discussion of the Doha Declaration, which responded to concerns about TRIPS potentially constricting access to patented medicines in developing countries. The Declaration emphasizes that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health, and it reaffirms the right of Members to use, to the full, the provisions of the TRIPS Agreement that provide flexibility for this purpose. The Declaration makes it clear that each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency and that public-health crises, including those relating to HIV/AIDS, tuberculosis, malaria, and other epidemics, can represent such circumstances. Under TRIPS, therefore, compulsory licensing and government use without the authorization of the rights holder are allowed, though these are subject to conditions aimed at protecting the legitimate interests of the rights holder. Some of these conditions are relaxed in cases of emergency, public non-commercial use or when compulsory licenses are employed to remedy practices that were judged anticompetitive by a legal process. For countries that lack the manufacturing capacity to produce their own drugs under compulsory licensing, paragraph six of the Doha Declaration allows for these licenses to be used to import generic versions of the needed drugs.

With regard to agriculture, TRIPS Article 27.3(b)) allows governments to exclude some kinds of inventions from patenting, for example, plants, animals and “essentially” biological processes (but micro-organisms, and non-biological and microbiological processes have to be eligible for patents). However, plant varieties have to be eligible for protection either through patent protection or a system created specifically for the purpose (“sui generis”), or a combination of the two.

Other important TRIPS Articles, directly relating to capacity building, that the chapter mentions include Article 7, Article 66.2 and Article 67. Article 7 reflects the objective that the transfer of technology should be promoted by the protection of IP rights. Some developing countries have expressed the view that more needs to be done to implement this concept. Article 66.2 obligates developed countries to provide incentives for the transfer of technology to developing countries. Article 67 obligates developed country World Trade Organization (WTO) Members to provide, on request and according to mutually agreed terms and conditions, technical and financial cooperation and assistance to developing countries for preparing laws and regulations for the protection and enforcement of IP rights.

This chapter illustrates the very broad impact that the TRIPS Agreement has on intellectual property in health and agriculture, and those interested in the other aspects mentioned above will want to consult this Handbook chapter to benefit from its detailed overview and analysis.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

  • The TRIPS Agreementestablishes minimum levels of IP rights protection and enforcement; in particular, patents shall be available for all technology fields.
  • Various exceptions and limitations to patent rights are allowed, including for tackling public health problems. Plant and animal inventions and “essentially” biological processes may be excluded from patenting, but micro-organisms and non-biological and microbiological processes have to be eligible for patents.
  • Geographical indications are protected under the TRIPS Agreement as a separate category of IP rights.
  • The Doha Declaration on the TRIPS Agreement for public health, memorialized as an amendment to the Agreement on December 6, 2005, provides options for accessing essential medicines under specific criteria. It is important to understand the implications of this amendment, and to know how such access, if needed, can be implemented.
  • Least-developed country Members of WTO have until the beginning of 2016 to provide for the protection and enforcement of patents and rights in undisclosed information with respect to pharmaceutical products. They have up to July 2013 to implement other provisions of the TRIPS Agreement that have not already been put in place, in both cases without prejudice to the possibilities of a further extension of the transition periods.

For Senior Management (university president, R&D manager, etc)

  • In accordance with the TRIPS Agreement, protection and enforcement of IP rights should be available in more than 100 developed and developing countries. The fundamental harmonization of IP rights protection, which is the basis of TRIPS, will facilitate IP related transactions.
  • Article 66.2 of the TRIPS Agreement obligates developed countries to provide incentives for the transfer of technology to least–developed country Members.
  • Article 67 obligates developed country WTO Members to provide, on request and according to mutually agreed terms and conditions, technical and financial cooperation and assistance to developing countries for preparing laws and regulations for the protection and enforcement of IP rights.

For Scientists

  • TRIPS, although not directly applicable to your daily activities, will influence how your institution does business, specifically, how it handles intellectual property. This, in turn, will reach you via university IP policies and guidelines.

For Technology Transfer Officers

  • The TRIPS Agreement sets the basic levels of IP protection for your country. Inevitably, your institution will implement IP guidelines and policies consistent with the TRIPS provisions, and so knowledge of these provisions will become increasingly important.
  • Harmonization of international IP rights protection pursuant to the TRIPS Agreement should facilitate and stimulate international IP transactions, licensing and technology transfer. View this as an opportunity for building partnerships with colleagues from around the world.

Krattiger A, RT Mahoney, L Nelsen, JA Thomson, AB Bennett, K Satyanarayana, GD Graff, C Fernandez and SP Kowalski. 2007. Editor’s Summary, Implications and Best Practices (Chapter 3.8). From the online version of Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices. MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.

© 2007. A Krattiger et al. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.