Background and the current situation

The TRIPS Agreement requires a review of Article 27.3(b), which deals with whether plant and animal inventions should be covered by patents, and how to protect new plant varieties.

The discussion now has an additional focus. Paragraph 19 of the 2001 Doha Declaration says the TRIPS Council should also look at the relationship between the TRIPS Agreement and the UN Convention on Biological Diversity and at the protection of traditional knowledge and folklore. Most recently discussed are proposals on disclosing the source of biological material and associated traditional knowledge.

Last updated: November 2008

This backgrounder has been prepared by the Information and Media Relations Division of the WTO Secretariat to help the public understand the main issues. It is not an official interpretation of the WTO agreements or members’ positions; and because of the need to simplify and summarize, it cannot cover all nuances or all points of the debate in detail. These can be found more precisely in the documents cited

> Follow developments and find all documents here

> Groups in the TRIPS negotiations

> Go to: Convention on Biological Diversity website
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Article 27.3(b), explained

As a whole, 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 should generally cover all fields of technology.

Broadly speaking, part (b) of paragraph 3 (i.e. 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.

Latest: On 21 April 2011, Director-General Pascal Lamy circulated a 6-page report on his consultations on two issues mandated by the 2005 Hong Kong Ministerial Conference: extending to other products the higher level of protection for geographical indications beyond wines and spirits (“GI extension”); and proposals dealing with the relationship between the WTO’s intellectual property (TRIPS) agreement and the UN Convention on Biological Diversity, including what is sometimes called biopiracy. On both issues delegations differ in interpreting the 2001 mandate — whether these are negotiations — as well as the substance. Mr Lamy has chaired the consultations as director-general, not chairperson of the Trade Negotiations Committee.

He concluded that members’ views continue to diverge on both issues but that discussions underscore the benefits of understanding more fully how countries’ own intellectual property systems work — the scope of protection for geographical indications in practice in various countries, and the “practical and operational context” of the existing patent mechanisms for disclosing the origins of genetic material and any associated traditional knowledge used in inventions.

Before Doha

The review of Article 27.3(b) began in 1999 as required by the TRIPS Agreement. The topics raised in the TRIPS Council’s discussions include:

how to apply the existing TRIPS provisions on whether or not to patent plants and animals, and whether they need to be modified
the meaning of effective protection for new plant varieties (i.e. alternatives to patenting such as the 1978 and 1991 versions of UPOV — the International Union for the Protection of New Varieties of Plants). This has included the flexibility that should be available, for example to allow traditional farmers to continue to save and exchange seeds that they have harvested
how to handle moral and ethical issues, e.g. to what extent invented life forms should be eligible for protection
how to deal with the commercial use of traditional knowledge and genetic material by those other than the communities or countries where these originate, especially when these are the subject of patent applications
how to ensure that the TRIPS Agreement and the UN Convention on Biological Diversity (CBD) support each other

The Doha mandate

The 2001 Doha Declaration made it clear that work in the TRIPS Council under the reviews (Article 27.3(b) or the whole of the TRIPS Agreement under Article 71.1) and on outstanding implementation issues should cover: the relationship between the TRIPS Agreement and the UN Convention on Biological Diversity (CBD); the protection of traditional knowledge and folklore; and other relevant new developments that member governments raise in the review of the TRIPS Agreement.

It adds that the TRIPS Council’s work on these topics is to be guided by the TRIPS Agreement’s objectives (Article 7) and principles (Article 8), and must take development issues fully into account.

The debate

The discussion in the TRIPS Council has gone into considerable detail with a number of ideas and proposals for dealing with these complex subjects.

More recently, the topic has been the subject of informal consultations chaired by the WTO director-general or by one of his deputies. The present debate focuses on how the TRIPS Agreement relates to the Convention on Biological Diversity (the last two of the topics listed above). The ideas put forward include (the documents containing the proposals and the director-general’s report can be found here):

Disclosure as a TRIPS obligation: A group represented by Brazil and India and including Bolivia, Colombia, Cuba, Dominican Republic, Ecuador, Peru, Thailand, and supported by the African group and some other developing countries, wants to amend the TRIPS Agreement so that patent applicants are required to disclose the country of origin of genetic resources and traditional knowledge used in the inventions, evidence that they received “prior informed consent” (a term used in the Biological Diversity Convention), and evidence of “fair and equitable” benefit sharing.
Disclosure through WIPO: Switzerland has proposed an amendment to the regulations of 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. Failure to meet the requirement could hold up a patent being granted or, when done with fraudulent intent, could entail a granted patent being invalidated.
Disclosure, but outside patent law: The EU’s position includes a proposal to examine a requirement that all patent applicants disclose the source or origin of genetic material, 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 United States has argued that the Convention on Biological Diversity’s 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 disclosing of any commercial application of genetic resources or traditional knowledge.

In July 2008, a group of WTO members called for a “procedural decision” to negotiate three intellectual property issues in parallel: two geographical indications issues, and the “disclosure” proposal (see document TN/C/W/52 of 19 July 2008). But members remain divided over this idea.

‘Patentable inventions’

In general, inventions eligible for patenting must be new, involve an inventive step (or be non-obvious) and be capable of industrial application (or be useful). Article 27 also lists inventions which governments do not have to make eligible for patent protection.