Should WIPO handle biodiversity and traditional-knowledge issues?

There is concern among developing countries about WIPO handling biodiversity and traditional-knowledge issues in view of the strong influence wielded by IPR holders (predominantly big business interests from the US, Europe and Japan) on the organisation.

Chee Yoke Ling

ONE fundamental issue for developing countries to determine is whether to support the patenting of life forms (wild and domesticated genetic resources, human parts and genes in whole and in part).

The original rationale of patent law was to reward inventions as opposed to discoveries. This is reflected in Article 27.1 of the TRIPS Agreement with the established patentability criteria of novelty, involving an inventive step and being capable of industrial application (though each term is not defined and left to national law).

The most controversial provision now is Article 27.3(b) of the TRIPS Agreement, which obliges WTO member states to provide for the patenting of microorganisms, micro-biological processes and non-biological processes. Members may exclude from patentability plants and animals which are not considered to be technologically improved varieties. But there must be protection of plant varieties, either by patents or by an effective sui generis system or any combination of these. The advent of biotechnology, especially genetic engineering, is the impetus behind this move. 

A number of options are open for the review of Article 27.3(b) at the WTO’s TRIPS Council. (See box.)

The independent Commission on Intellectual Property Rights established by the UK government strongly supports a restrictive definition of microorganisms to exclude naturally occurring ones (though some scientists argue that even genetically modified microorganisms should be excluded), and calls for the TRIPS Council review to ‘preserve the right of countries not to grant patents for plants and animals, including genes and genetically modified plants and animals’. It should be noted, however, that bilateral and regional free trade agreements with the US are already leading to intellectual property (IP) extension to cover plants and animals in a number of developing countries. A stark example is the US-Singapore free trade agreement that provides for patents on animals and plants.

Access and benefit-sharing

The obligations under TRIPS can have adverse impact on the use of biological and genetic resources and the distribution of benefits arising therefrom. IP protection in the current TRIPS regime may well deprive the countries providing the biological and genetic resources and the providers of traditional knowledge on the use of such resources, of their fair share of the benefits.

The fair and equitable sharing of benefits is one of the objectives of the Convention on Biological Diversity (CBD), and the implementation of intellectual property right (IPR) obligations has to be consistent with the objectives of the CBD. This is contained in Article 16(5) of the CBD.

On the issue of traditional knowledge that is associated with biological resources (in agriculture and medicinal uses), there have been growing  concerns  over the past few years regarding ‘biopiracy’ by developed-country institutions and corporations.

In 2000 WIPO established an Inter-governmental Committee on Intellectual Property, Genetic Resources, Traditional Knowledge and Folklore (IGC) to work on this critical issue. This came after two years of what WIPO itself describes as ‘extensive fact-finding and wide-ranging consultations’. This role for WIPO was facilitated by developments at the CBD.

The Africa Group in the CBD had wanted to set up a working group to examine the relationship between IPRs and the CBD, including the relationship between TRIPS and the CBD. This was rejected by developed countries, led by the US (a non-Party to the CBD). As a result, the WTO and then WIPO were gradually asked to work on more and more IP aspects of the CBD since they were the ‘competent’ bodies on IP.

The IGC is supposed to discuss IP issues that arise in the context of (i) access to genetic resources and benefit-sharing; (ii) protection of traditional knowledge, whether or not associated with those resources; and (iii) the protection of expressions of folklore.

The developing countries that are Parties to the CBD expected WIPO to explore alternative and innovative options for protection of traditional knowledge. However, the studies done by the WIPO Secretariat seem to have been narrowed to attempts to fit this accumulation and wealth of knowledge into the current IP regime. There are concerns that this approach will not provide sufficient protection to traditional knowledge and its holders (especially communities that hold communal knowledge), and may in fact perpetuate the phenomenon of ‘biopiracy’.

Meanwhile, the IGC as a discussion forum to deal with numerous papers and studies by the Secretariat, does not have any negotiation or decision-making authority. Critics, both governments and NGOs, are concerned that the IGC process is a detraction from the work that needs to be done to deal with biopiracy and the protection of traditional knowledge. Some of them are even against WIPO taking on these issues as the organisation is currently a creature of and for the interests of IPR holders, predominantly big business interests from the US, Europe and Japan. 

Protecting new plant varieties

TRIPS in Article 27.3(b) gives WTO member states the option of a sui generis system of protection (rather than patents) for plant varieties. This is to the interest of developing countries. However, there is strong pressure from developed countries to limit the choice of sui generis systems.

These countries want the International Convention for the Protection of New Varieties of Plants (UPOV) to be the only option. TRIPS makes no reference to UPOV, a convention that was drawn up a few decades ago as a special kind of IP system for commercial plant breeders and the Parties to which are mostly industrialised countries. In the last UPOV revision of 1991, these rights have become more ‘patent-like’.

Moves to get countries to join UPOV are very clearly ‘TRIPS-plus’, since TRIPS does not define ‘effective sui generis system’ in Article 27.3(b) for plant varieties protection. WTO members have been repeatedly assured that the absence of a definition and the absence of any mention of UPOV both indicate sufficient flexibility.

In reality, the UPOV Secretariat has been aggressively conducting ‘technical assistance’ programmes in developing countries to promote UPOV as the choice for TRIPS implementation. It has even criticised some countries’ attempts to develop a sui generis model. A number of countries have joined UPOV in the last 10 years.

In the last two years, bilateral and regional free trade agreements, especially with the US, have become a new tool to require developing countries to join UPOV 1991.

Interestingly, the Director-General of WIPO also heads UPOV, which is a matter of concern and potential conflict of interests as WIPO is also working on the protection of traditional knowledge and on access and benefit-sharing. UPOV 1991 has tilted the balance against the interests of small farmers and created ‘patent-like’ rights for commercial plant breeders.

Meanwhile, the FAO International Treaty on Plant Genetic Resources for Food and Agriculture that was concluded in November 2001 has entered into force this year. It is an international agreement that strives to balance the interests of commercial producers (especially the large corporations) and rights of small farmers. It sets up a multilateral access and benefit-sharing system for the genetic resources covered by the Treaty, and does not allow patents over those resources.

Given these various important treaties and processes that most governments have subscribed to, it is absolutely crucial for developing countries to coordinate at the national level and among themselves at the international level. This is to ensure strong like-minded understandings and positions for negotiations, and a reinforcement of those positions in the various processes. Coordination would also assist national implementation of the different treaties in ways that best serve sustainable development and the public interest.

COVER 10 (BOX)

Options for reviewing TRIPS Article 27.3(b)

THE first option is to reject patenting of life forms as a matter of principle, requiring an amendment to Article 27.3(b) to be made. This is a position taken by the Africa Group in the WTO. Then alternative systems of rewarding innovation, in accordance with the objectives and principles of the Convention on Biological Diversity, can be promoted. These include fair and equitable sharing of benefits (monetary and/or non-monetary), prior informed consent of the country of origin, and respect for the rights of indigenous and local communities to their traditional knowledge.

The FAO International Treaty on Plant Genetic Resources for Food and Agriculture which just entered into force this year provides for a multilateral system of access and benefit-sharing that protects farmers’ rights and does not permit IPR claims on the genetic resources covered by the Treaty.

The second option is the position of several developed countries, especially the US, which is to maximise the expansion of patents. (Their national laws allow for the patenting of gene sequences, human genes, even business methods. They want to globalise these standards to capture extra-territorial markets.) The EU is not as openly ambitious but essentially favours expansion (though in some countries there are some public and parliamentary objections to the patenting of life forms).

The third option is to restrict as much as possible the patentability of life forms and clarify the interpretation of the three patentability criteria under TRIPS. Thus discoveries, including those gleaned with the use of modern biotechnology tools and processes, are not patentable.

The fourth option is to put in place additional requirements for patentability. These ‘disclosure requirements’ comprise information on the country of origin of a genetic resource, prior informed consent from the country of origin, and evidence of a fair and equitable sharing of benefits. A group of developing countries including Brazil, India, Cuba, Ecuador, Peru, Thailand and Venezuela have been actively promoting this at the TRIPS Council. A checklist of issues was submitted to the March 2004 Council meeting for further work.

More details on ‘Elements of the obligation to disclose the source and country of origin of the biological resources and/or traditional knowledge used in an invention’ were submitted to the September 2004 meeting.

Developing countries were successful in obtaining the 2001 Doha Declaration on the TRIPS Agreement and Public Health that was a global affirmation of rights and flexibilities under TRIPS. Similar efforts could be considered for other areas of public and developmental importance.