A group of eight developing countries including India, Brazil, China, Cuba, Pakistan, Peru, Thailand and Tanzania (the ‘Disclosure Group’), have submitted a proposal to the World Trade Organisation (WTO) that a new provision should be inserted in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement).
The new provision would mandate additional disclosure obligations on patent applicants whenever the subject matter of a patent application is derived from or developed from biological resources, and/or its associated Traditional Knowledge (TK).
The patent application would have to disclose information on the following aspects:
- The country providing genetic resources and/or associated traditional knowledge used in the invention.
- The country of ‘origin’ of the resources, if different from the country providing such resources, if this is identifiable after reasonable inquiry.
- If the providing country has legislation requiring Prior Informed Consent (PIC) for access to those resources, evidence of such consent.
- Evidence of benefit-sharing with the provider of the resources.
According to the proposal, even after their applications are accepted, patent-holders would be obliged to disclose any new information regarding the source or origin of the resource, or of relevant access or benefit rules in the providing country, of which they become aware.
To ensure compliance, the proposed amendment would require member governments of the WTO to empower domestic authorities to deny and revoke patents “when the applicant has, knowingly or with reasonable grounds to know, failed to comply” with the disclosure requirements, or provided false information.
Such disclosure requirements, if incorporated into the TRIPS Agreement, could be particularly significant for countries like India that have a rich biological diversity and often provide the biological resources for research and commercial utilisation.
Biological diversity does not exist in isolation; on the other hand, wherever there is biological diversity, whether in India or in South America’s Amazon forests, there is invariably a rich heritage of traditional knowledge in relation to such resources developed by local and traditional communities. TK is knowledge developed through human observation and ingenuity -- whether through selecting crops for better productivity, developing products for protection of crops, or identifying medicinal properties and building a storehouse of traditional remedies.
Scientific research leading to patentable substances, especially in the biotechnology and pharmaceutical industry, often relies on TK in relation to a biological resource as the basis to identify useful plants and study them further to develop commercially viable products. The issue of how TK contributes to research and development has been the subject of some serious study in the recent couple of decades.
The basic consensus in most literature on this aspect is that TK and the use of biological resources by local communities plays a key role at several stages, ranging from the initial stage of identification of the uses of the biological resource to, sometimes, information on the precise dosage and preparation of a particular product or development of a process using the resource.
Legal protection for biological diversity and TK
International recognition of the principle that the source of biological resources and TK should be acknowledged, protected and rewarded is a recent phenomenon.
In 1989, the concept of farmers' rights was introduced by the Food and Agriculture Organisation (FAO) in its International Undertaking on Plant Genetic Resources. In 1992, the Convention on Biological Diversity (CBD), concluded at the Earth Summit, highlighted the need to have systems in place for access to biological resources and to promote and preserve traditional knowledge and the sharing of benefits arising from such access.
Two fundamental concepts enunciated under the CBD are:
- Prior Informed Consent (PIC) of the country providing the biological resource/ TK; and
- Benefit Sharing pursuant to the use of the biological resource and TK.
Pursuant to the commitments under the CBD, several countries have put in place regulatory mechanisms that seek to regulate access to and sharing of benefits arising from use of biological resources and TK associated from the same. India, for instance, has enacted the Biological Diversity Act.
One of the aspects that CBD recognises and emphasises is that both the country providing the resource and the country utilising the same need to put in place adequate regulatory mechanisms. Countries like India have consistently argued that one critical aspect on which countries utilising the resource need to have adequate legal mechanisms is in the field of patent law.
The argument is that patent law should be such that when a patent application is made in respect of a product made using biological resource and/or TK, the application should provide adequate information on the nature of prior uses of the resources/ TK, so that the patent examiner can assess the innovation made.
It is further argued that if such resources have been misappropriated—taken without following the legal procedures related to prior informed consent and benefit sharing—then, such an innovation should not be granted a patent.
At the WTO negotiations, pressure from developing countries resulted in the Doha Ministerial Declaration of 2000 specifically mandating, under Paragraph 12, that WTO members should consider the relationship between CBD and TRIPS. India and other developing countries including Brazil, Bolivia, Cuba, the Dominican Republic, Ecuador, Peru, Thailand, Venezuela and the African group of countries have made several submissions since 2000 arguing for disclosure requirements pursuant to the explicit mandate under the Doha Declaration. As explained above, such disclosure requirements pertain to the disclosure of PIC and benefit sharing in a patent application.
The recent proposal on Article 29bis is a culmination of the previous submissions. It states that the purpose is to establish “a mutually supportive relationship” between the TRIPS Agreement and the CBD. It is argued that the proposed disclosure requirements are essential to achieve the following broad objectives, among others:
- Prevent misappropriation of biological resources and TK associated with the same.
- Ensure credibility of the patent system by enabling the patent office to ascertain more effectively the prior art, i.e., prior knowledge and practices regarding the product in respect of which a patent application has been made, and the inventive step claimed in a particular patent application.
- Enhance the ability of countries to track patents granted on their biological resources and traditional knowledge.
- Ensure the principle of equity that a person should not be able to benefit from exploiting patents based on genetic resources or associated knowledge that have been acquired in contravention of any legislation governing access to the material.
Status of negotiations
Other developing countries, including Ecuador , Sri Lanka , Kenya , Colombia , Bolivia , Turkey and the Philippines have expressed support for the Disclosure Group's proposal on Article 29 bis . Among the developed countries, Norway and to some extent Switzerland and the European Community have expressed their willingness to explore some sort of language under TRIPS mandating disclosure requirements.
However the US, Japan , Korea , Australia , New Zealand and Canada have strongly opposed the proposal and, in general, the idea of a disclosure amendment to the TRIPS Agreement. Their argument is that a new disclosure requirement would not help prevent the issuance of “bad” patents that incorporate genetic resources without proper recognition of the source or access agreements.
The US also argues that the disclosure requirement could generate burdensome procedures and additional costs on patent offices. The US and Japan maintain that countries should develop their own databases for biological resources and TK, and use these as a basis for tracking and challenging any patents that may erroneously be granted on the basis of existing knowledge.
The implication of the argument made by US and Japan is that patent examiners should not be burdened with the responsibility of reviewing information on the origin of the material. Instead, these countries argue, biologically rich countries like India should develop their own internal databases, and when any patent is granted based on information extracted from such database, they can challenge the same in the country granting the patent.
The argument of the Disclosure Group has been that such a defensive mechanism will be ineffective in the absence of adequate linkages with the patent system. Further, a mechanism that emphasises litigation to challenge patents, rather than on due diligence at the stage of grant itself, would be an expensive proposition for most developing countries. Disclosure norms in the patent application, it is argued, will enable patent examiners to better assess the novelty and inventiveness involved in the application. It will also ensure that inventions based on non-compliance with regulations related to benefit-sharing and prior informed consent are not rewarded.
Countries like India acknowledge that adequate administrative mechanisms also need to be in place to enable effective searches in relation to TK by both patent applicants and patent examiners. The consolidation of databases such as India 's Traditional Knowledge Digital Library (TKDL) and China 's Traditional Chinese Medicines Database, are valuable tools. The point to be noted, however, is that they are not sufficient in themselves to cover the entire gamut of traditional knowledge. Disclosing the source of origin in the patent application would be a fundamental component for enabling searches that may be outside the scope of established databases.
Disclosure norms under Indian law
India 's Patent Act, 1970 has provisions that require disclosure of TK on the basis of which an invention is made. However, the law does not require evidence of PIC of the relevant authorities, or benefit-sharing with the relevant TK holder, to be disclosed in the patent application.
The Protection of Plant Varieties and Farmers' Rights Act (PPVFRA), 2001 has provisions requiring an applicant for plant breeders rights to disclose details of prior art, i.e., the existing knowledge and information on the resource that forms the basis for the application, and specifically the TK relating to the resource used in the application. The PPVFRA also mandates that an application for registration should contain evidence of PIC.
There is no requirement, however, for evidence of benefit-sharing and benefit-sharing is not a prerequisite for granting plant variety rights.
India 's Biological Diversity (IBD) Act, 2002 has detailed provisions on the mechanism of PIC and benefit-sharing that have to be followed by any person seeking access to biological resources and associated TK. However, concrete linkages between this Act and the Patent Act are yet to be put in place. For instance, the IBD Act states that consent from the National Biodiversity Authority is mandatory for grant of patent for any invention based on biological resources. The Patent Act however, is silent on this aspect. Guidelines and regulations under the IBD Act are yet being formulated. It remains to be seen how the two laws work together in practice.
Conclusion
The proposal for a new Article 29 bis to be incorporated into the TRIPS Agreement is a landmark development. However, this proposal is far from being turned into international law. Especially in view of the recent deadlock in WTO negotiations on the issue of industrial tariffs and domestic support for farm products between developing and developed countries, issues such as TRIPS would invariably take the backseat for the time being.
Meanwhile, it is important that India considers adequate legal frameworks within the country to protect its TK and biological resources, and have effective mechanisms for PIC and benefit-sharing. |
