Trade-Related Aspects of Intellectual Property Rights
The World Trade Organisation’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), negotiated in the 1986-94 Uruguay Round, introduced intellectual property rules into the multilateral trading system for the first time.
Article 27 of the TRIPS Agreement defines which inventions governments are obliged to make eligible for patenting, and what they can exclude from patenting. Inventions that can be patented include both products and processes, and they generally cover all fields of technology.
Article 27.3(b) focuses on biotechnological inventions. It is currently under review in the TRIPS Council, as required by the TRIPS Agreement. Some countries have broadened the discussion to cover biodiversity and traditional knowledge. The Doha Declaration has linked these issues.
Broadly speaking, Article 27.3(b) allows governments to exclude some kinds of inventions from patenting, i.e. 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. For example, some countries have enacted a plant varieties protection law based on a model of the International Union for the Protection of New Varieties of Plants (UPOV).
The review of Article 27.3(b) began in 1999 as required by the TRIPS Agreement. Broadening the discussion, the 2001 Doha Declaration stated that work in the TRIPS Council, including under the reviews of Article 27.3 or of the whole of the TRIPS Agreement under Article 71.1 and under the Council's treatment of TRIPS implementation issues, should also look at: the relationship between the TRIPS Agreement and the Convention on Biological Diversity; the protection of traditional knowledge and folklore; and other relevant new developments that member governments raise in the review of the TRIPS Agreement. In undertaking this work, the TRIPS Council was to be guided by the objectives and principles set out in the TRIPS Agreement and to fully take into account the development dimension.
The topics raised in the TRIPS Council’s discussions include:
- how to apply the existing TRIPS provisions on patenting biotechnological inventions. The discussion has included the extent to which life forms should be patentable;
- the meaning of effective sui generis protection for new plant varieties (i.e. alternatives to patenting such as the 1978 and 1991 versions of the UPOV convention). This includes the questions of allowing farmers to continue to save and exchange seeds that they have harvested;
- how to deal with traditional knowledge, folklore and genetic material, and the rights of the communities where these originate. Among the key questions are: how to prevent patents being granted wrongly and whether to support the creation of databases to help patent examiners; to what extent existing intellectual property rights help to protect traditional knowledge and folklore and to what extent a special purpose (“sui generis”) law is desirable; and what is the right forum to develop this subject further;
- how to implement the TRIPS Agreement and the CBD together, and whether the TRIPS Agreement should be amended; in particular, whether patent applications should have to disclose the source and/or origin of the traditional knowledge or genetic material involved and provide evidence of the approval researchers and inventors have obtained to access such genetic resources and knowledge as well as of the arrangements for sharing benefits entered into with countries of origin and local communities.
In respect of this last issue, the main lines of argument within the discussions in the TRIPS Council concern:
- Disclosure as a TRIPS obligation: a number of developing countries want to amend the TRIPS Agreement so that patent applicants are required to disclose the source and country of origin of the biological resources and traditional knowledge used in the inventions, evidence that they received “prior informed consent”, and evidence of “fair and equitable” benefit sharing. They also refer to what they consider to be the weaknesses of alternative methods such as contracts and databases;
- Disclosure through WIPO: an amendment has been proposed to WIPO’s Patent Cooperation Treaty (and, by reference, WIPO’s Patent Law Treaty) so that domestic laws may ask inventors to disclose the source of genetic resources and traditional knowledge when they apply for patents;
- Disclosure, but with consequences outside patent law: a proposal to examine a requirement that patent applicants disclose the source or origin of genetic material as a subject in itself, with legal consequences of not meeting this requirement lying outside the scope of patent law;
- Use of national legislation, including contracts rather than a disclosure obligation: the argument being that the CBD objectives on access to genetic resources, and on benefit sharing, could best be achieved through national legislation and contractual arrangements based on the legislation, which could include commitments on disclosure;
- The African Group’s view: this wants the TRIPS Agreement to prohibit patenting of all life forms (plants, animals, micro-organisms) and wants “sui generis” protection for plant varieties to preserve farmers’ rights to use and share harvested seeds. It also proposes requirements on disclosure — including amending the TRIPS Agreement — similar to those in the developing country group proposal. The proposal also looks at possible areas of agreement and areas of divergence and proposes a decision in the TRIPS Council to confirm these. The group also proposes a draft decision on traditional knowledge designed to prevent “misappropriation”.
Since the September 2003 Cancún Ministerial Conference, the TRIPS Council has continued to discuss these issues, particularly the proposals on patent disclosure with a steady stream of papers submitted both on the substance of the debate and on how to proceed. The Hong Kong Ministerial Declaration of December 2005 (WT/MIN(05)/DEC) provides for the TRIPS Council to continue this work and for the General Council to report on it to the next Ministerial meeting.
Pursuant to paragraph 12(b) of the Doha Ministerial Declaration, work has proceeded on another track to deal with outstanding implementation issues, including the TRIPS-CBD issue, namely in the form of consultations under the auspices of the Director-General of the WTO. Paragraph 39 of the Hong Kong Ministerial Declaration calls for the Director-General of the WTO to further intensify this process and to report to each regular meeting of the TNC and the General Council. This issue is now explicitly referred to in the text of the Declaration on outstanding implementation issues, alongside that of the extension of the protection of geographical indications The General Council, at its meeting on 27-28 July 2006, supported a recommendation by Director-General Pascal Lamy to suspend the Doha negotiations.
Visit the WTO website...
Visit the TRIPS Gateway...