WIPO Committee Pursues Global Governance of Inventions Using Genetic Resources
Wednesday, October 21, 2009
The World Intellectual Property Organization (the “WIPO”), is one of several international organizations at the epicenter of a debate over whether the patentability and regulation of inventions created from genetic resources and/or traditional knowledge will be globally governed or will be determined on a case-by-case basis as a result of free-market contractual negotiations within the context of national laws and regulatory systems. As a result of a recent WIPO decision, a WIPO committee will spend the next two years developing an international legal instrument on the subject that will be considered at the 2011 WIPO General Assembly. The outcome could have significant global governance implications on transnational pharmaceutical and other companies that depend on new genetic resources or traditional knowledge about plants and other indigenous materials to create innovative products.
On October 1, 2009, the last day of the 47th series of meetings of the WIPO General Assemblies, WIPO Member States adopted a Decision creating a new mandate for its Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (the “IGC”) (the “Decision”). The two-year mandate states that the IGC will “without prejudice to the work pursued on other fora, continue its work and undertake text-based negotiations with the objective of reaching agreement on a text of an international legal instrument (or instruments) which will ensure the effective protection of genetic resources, traditional knowledge, and traditional cultural expressions.” In the Decision, the IGC is requested to submit to the 2011 WIPO General Assembly the text (or texts) of an international legal instrument (or instruments) that will ensure the effective protection of genetic resources, traditional knowledge, and traditional cultural expressions. During the 2011 WIPO General Assembly, the General Assembly will decide whether to convene a Diplomatic Conference to consider adoption of the proposed text (or texts).
To ensure the timely submission of a proposed “international legal instrument,” the Decision contains an Annex that sets forth a clearly defined IGC work program, including, in addition to the 15th session of the IGC scheduled for December 2009, four sessions of the IGC and three inter-sessional working groups during 2010-2011.
The World Trade Organization’s Council for Trade-Related Aspects of Intellectual Property Rights (the “TRIPS Council”) is another forum in which discussions are taking place regarding the appropriate method of ensuring that sources of genetic resources and traditional knowledge, often located in developing countries, are adequately informed about the commercial potential of their resources or knowledge, consent to their use in the production of a new product, and are appropriately compensated for their use in a commercially successful product.
The TRIPS Council, which is open to all members of the WTO, is responsible for administering the WTO Agreement on the Trade-Related Aspects of Intellectual Property Rights (the “TRIPS Agreement”), which deals with international standards concerning the availability, scope, use, enforcement, acquisition, maintenance, and dispute management of intellectual property rights. Presently, Article 27 of the TRIPS Agreement, which contains exclusions from patent protection, does not exclude patents on products which include genetic resources or traditional knowledge obtained in the absence of compliance with international or national legislation on the subject, including failure to obtain the prior informed consent of the country of origin or the community concerned and failure to reach agreement on conditions for the fair and equitable sharing of benefits arising from their use.
Many developing countries consider the absence in the TRIPS Agreement of an exclusion for patent protection relating to products resulting from alleged “biopiracy” creates a conflict with the Convention on Biological Diversity (the “CBD”).
On February 8, 2006, the Secretariat of the TRIPS Council produced a Note titled “The Relationship Between the TRIPS Agreement and the Convention on Biological Diversity” (the “TRIPS Council Note”). In the TRIPS Council Note, the Secretariat summarized the issues raised and points made in the TRIPS Council’s work on three items: the review of the provisions of Article 27.3(b) of TRIPS; the relationship between the TRIPS Agreement and the CBD; and the protection of traditional knowledge and folklore.
First, the TRIPS Council Note explains the position of the proponents of a national-based approach-- that concerns about the equitable sharing of benefits arising from the use of genetic resources and traditional knowledge could be most effectively addressed through tailored national solutions outside the intellectual property system. In accordance with the CBD, countries could incorporate into their national legislation requirements for the conclusion of contracts between the authorities competent to grant access to genetic resources and any related traditional knowledge and those who wish to make use of such resources and knowledge.
Opponents of a consensual, bilateral contracting method have offered three proposals for disclosure requirements in patent applications involving the use of genetic resources and traditional knowledge.
Under a “TRIPS disclosure proposal,” the TRIPS Agreement would be amended to oblige WTO members to require that an applicant for a patent relating to biological materials or to traditional knowledge provide the following information, as a condition of acquiring patent rights:
1. the source and country of origin of the biological resource and of the traditional knowledge used in the invention;
2. evidence of prior informed consent from the authorities under the relevant national regime; and
3. evidence of fair and equitable benefit sharing under the relevant national regime.
Under this “TRIPS disclosure proposal” it would be mandatory for WTO members to have the proposed disclosure requirements in their national laws and regulations. These requirements would be obligatory for patent applicants applying for patents whenever they use genetic resources and/or associated traditional knowledge in their inventions.
Under the second, so-called “PCT disclosure proposal,” the regulations under the Patent Co-operation Treaty (the “PCT”) of WIPO would be amended so as to explicitly enable the national patent legislation of contracting parties to the PCT to require the declaration of the source of genetic resources and traditional knowledge in patent applications. Unlike the TRIPS disclosure proposal, the PCT disclosure proposal would be permissive, explicitly enabling Members to incorporate it into their national laws and regulations. This means of disclosure has the advantage of leaving Members with adequate flexibility to develop efficient national legislation according to their needs.
Finally, under the “mandatory disclosure proposal,” each country would accept an obligation to require all patent applicants to disclose information on the country of origin or source of genetic resources used in the invention which patent applicants know or have reason to know. Also, if the applicant is aware that the invention is directly based on traditional knowledge, there could be a requirement on the applicant to declare the specific source of traditional knowledge associated with the genetic resources. If a patent were to be erroneously granted due to a violation of the disclosure requirement, it would be up to each country to decide how it would provide for sanctions. This mandatory disclosure proposal, though less comprehensive than the TRIPS disclosure proposal, would also require a new article in the TRIPS Agreement.
The TRIPS Council Note sets forth the following concerns of those WTO members who believe that a national-based, free-market contractual approach that relies on bilateral negotiations is preferable to a global governance approach that would rely on international organizations to regulate the inappropriate use of genetic resources and traditional knowledge through patent protection:
• Proposals for new patent disclosure requirements would add new uncertainties into the patent system; impose significant administrative burdens on nations; undermine the role of the patent system in promoting innovation; and undermine potential benefit-sharing.
• Mandatory disclosure requirements requiring evidence of the sharing of benefits would be burdensome on patent offices since patent examiners do not have the necessary legal and technical competence to determine the correctness of the evidence provided or the fairness and equity of complicated benefit sharing arrangements.
• Instead of singling out patent applications and trying to deal with them through new patent disclosure requirements that may negatively affect technological development, a more appropriate solution would be to strengthen national regimes outside the patent systems in order to take a comprehensive, holistic approach and address all instances of commercialization of misappropriated resources and/or traditional knowledge that need to be addressed.
• Since the resources and knowledge related to an invention may multifaceted and the process of inventing sometimes involves different raw materials, including compounds extracted from plants, it would be difficult to determine the closeness of the relationship between the claimed invention and the relevant genetic resources or traditional knowledge that would trigger the necessity to disclose origin or source.
• The CBD leaves it to each country to establish its own system for controlling access to genetic resources and benefit sharing, without being prescriptive about how this should be done.
• Only contractual obligations that establish the rights and obligations of the entities involved prior to any access to genetic resources could ensure that prior informed consent and the sharing of benefits are achieved.
• Work at the international level might be better focused on a limited number of issues that are likely to attract consensus such as disclosure of source or origin and not on evidence of prior informed consent and benefit sharing.
Regardless of the merits of these arguments, by adopting the Decision, the members of WIPO have instructed the IGC to draft one or more international legal instruments designed to ensure the effective protection of genetic resources, traditional knowledge, and traditional cultural expressions. Thus, it appears that an amendment to the TRIPS Agreement or the PCT may be forthcoming for consideration by the 2011 WIPO General Assembly, a development that most likely would favor the prospects for global governance of patents to the detriment of national sovereignty and free market principles.
Jim Kelly is the President of Solidarity Center for Law and Justice, P.C., a public interest civil and human rights law firm based in Atlanta, Georgia. The opinions expressed herein are his own.