EU concept paper on relationship between TRIPs and Convention on biological diversity and protection of traditional knowledge and folklore

October 21, 2002

Geneva, 18 Oct 2002

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EXECUTIVE SUMMARY

This text addresses the issues dealt with under Paragraph 19 of the Doha Declaration, which instructs the TRIPS Council to continue the review of Article .3(b) TRIPS, and to examine the relationship between TRIPS and CBD and the protection of Traditional Knowledge (TK) and folklore, and other relevant new developments. It reflects the EC's stated willingness to commit to this process in a spirit of openness, with the aim of finding ways of interpreting and implementing the TRIPS Agreement in a way to support the objectives of the CBD.

The review of Article .3(b)

This review deals, stricto sensu, with the patentability of biotechnological inventions and the protection of plant varieties. This subject has an important link with development issues in agriculture, so the development dimension must be fully taken into account.

The European Communities and their member States (hereinafter "the EC") see no reason to amend Article .3(b) as it now stands. The TRIPS Agreement allows Members sufficient flexibility to modulate patent protection as a function of their needs, interests or ethical standards. In this connection Article .3(b) - in conjunction with Article .2 (exclusion from patentability of inventions the commercial exploitation of which is necessary to protect ordre public or morality) and Article .1 (patentability criteria) - provides considerable leeway.

The EC have already indicated that they are prepared to discuss certain technical issues related to Article .3(b). However, in the EC's view, trying to clarify the definitions of technical terms such as "micro-organism" in the TRIPS Council may not be the best way forward. Firstly, because it would be extremely difficult to agree on precise definitions in that context, and, secondly, because it is questionable whether more precise definitions are really necessary, given that they would reduce the flexibility of WTO Members.

The relationship between the TRIPS Agreement and the CBD

>From a legal perspective there is no conflict between the CBD and the TRIPS Agreement. However, it would be wrong to put on end to all discussion by saying that, in the absence of legal incompatibility, there cannot be a problem with the implementation of both Agreements. There is considerable interaction between both agreements, so TRIPS and CBD can and should be implemented in a mutually supportive way. The TRIPS Council should focus on ways and means of doing this.

At national level, sound regulation (through legislation or administrative or policy measures) on access and benefit-sharing (ABFS) under the CBD is essential to guarantee legal security for all parties involved and to protect the rights of providers of genetic resources. Further details can be settled through contractual arrangements. Legislation/policy measures and contracts are complementary instruments for ensuring fair implementation of the CBD.

Further synergies between the implementation of these agreements can be worked out at international level by ensuring policy coherence in all forums which deal with issues relevant to the interplay between TRIPS, the CBD and the FAO International Treaty on Plant Genetic Resources for Food and Agriculture. In this respect the Bonn Guidelines on Access to Genetic Resources and Benefit-sharing adopted at the 6th Conference of the Parties in The Hague on 19 April 2002 are an important evolution.

Disclosure of origin

The EC agree to examine and discuss the possible introduction of a system, such as for instance a self-standing disclosure requirement, that would allow Members to keep track, at global level, of all patent applications with regard to genetic resources for which they have granted access. The EC see merit in a system that would ensure transparency and would allow the authorities of countries granting access to their resources to keep track of patent applications linked to the use of these resources.

Under such a system, the information to be provided by patent applicants should be limited to information on the geographic origin of genetic resources or TK used in the invention, while such a disclosure requirement should not act, de facto or de jure, as an additional formal or substantial patentability criterion. Legal consequences to the non-respect of the requirement should lie outside the ambit of patent law.

Protection of TK

Preventive approaches to avoid misappropriation of traditional knowledge and to stimulate the sharing of benefits could be dealt with by the TRIPS Council. We need to explore methods of documenting and sharing information on TK, such as databases and registers, in order to allow patent examiners to take them into account in prior art searches. When TK is used as a basis for further innovations, disclosure of the original TK from which inventions are derived would be an important way of ensuring that holders of traditional knowledge share in the benefits.

The EC support further work towards the development of an international sui generis model for legal protection of TK in WIPO. At this stage, the TRIPS Council is not the right place to negotiate a protection regime for a complex new subject matter like TK or folklore. This is an issue where the WTO should ideally be able to build on the work done by the WIPO Intergovernmental Committee on Intellectual Property, Genetic Resources, Traditional Knowledge and Folklore. Depending on the outcome of the WIPO process, the TRIPS Council will have to determine whether this result warrants further work in the WTO.

Effective sui generis protection of plant variety rights

The absence of a definition of this concept means that Members have a considerable degree of flexibility in determining how their legislation meets the standard of effectiveness, thus allowing them to design a protection regime that is appropriate to their specific national situation. Although the UPOV Convention meets the standard of effectiveness in Article .3(b), other protection models may be equally effective.

This paper explores the criteria that any regime establishing rights over plant varieties must fulfil (for example, a clear definition of the protectable subject matter and the conditions for granting protection, the availability of enforcement procedures, etc.).

Farmers' rights and farmers' exemptions

Farmers' exemptions (i.e. exceptions to plant variety rights or patents allowing farmers to save, use, exchange or sell seeds of protected varieties or seeds) can, under certain circumstances, be justified under Article .3(b) of the TRIPS Agreement, or under Article 30 of the TRIPS Agreement. The special situation of least developed or developing countries could be addressed by specific exceptions allowing subsistence farmers or small farmers to save, replant, exchange, share and resell seed, provided they do not use the commercial denomination of the variety. Farmers with significant commercial interests should remain subject to more stringent rules.

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