Environment and Natural Resources Programme • Volume 2 • Number 3 • October 2008

Negotiations on disclosure of origin requirement under scrutiny

by Fleur Claessens

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Over the past decade, the misappropriation of genetic resources and traditional knowledge has emerged as an issue of global concern. Yet gaining international recognition for the need to effectively address such misappropriation and adequately protect traditional knowledge remains a major challenge for developing countries, which hold the majority of the world’s genetic resources and traditional knowledge.
The WTO Doha Ministerial Declaration (2001) requested the Trade Related Aspects of Intellectual Property Rights (TRIPS) Council to address the relationship between the Convention on Biological Diversity (CDB) and the WTO TRIPS Agreement. Since then, a debate has ensued over whether the TRIPS Agreement conflicts with the CBD, and whether a disclosure of origin requirement should be introduced into the former. Many developing countries, including Brazil, Pakistan, Thailand, Peru, India, the African Group and the group of least-developed countries (LDCs) have proposed amending the TRIPS Agreement to require patent applications to disclose the origin of genetic resources and associated traditional knowledge in inventions, as well as to provide evidence of prior informed consent and benefit sharing with communities with a view to combating biopiracy. Biopiracy refers to the misappropriation—generally by means of patents—of genetic resources and associated traditional knowledge. Their proposed amendment recognises the sovereign rights of states over their natural resources, and includes forfeiture of patent rights as a penalty for noncompliance.
However, many industrialised countries question the need for such amendment. Some consider the World Intellectual Property Organisation (WIPO) the appropriate forum to deal with these issues, particularly the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) established in 2001. Japan and the US – which is not a party to the CBD – do not regard the CBD and the TRIPS Agreement to be in conflict with each other, but understand both Agreements to deal with separate issues. In contrast, the EU, Norway and Switzerland are supportive of establishing disclosure of origin requirements at the international level, but not necessarily in the framework of the WTO. Norway was the first developed nation to favour the incorporation of a disclosure requirement in the TRIPS Agreement, yet it differs from developing countries on the legal consequences of the lack of disclosure, considering that non-compliance should not lead to the revocation of the patent.

Having ongoing parallel discussions on the protection of traditional knowledge within the WTO TRIPS Council, the WIPO IGC, the Food and Agriculture (FAO) International Treaty on Plant Genetic Resources for Food and Agriculture, and the CBD raises further questions of coherence between deliberations in these different fora and adds to the complexity of this technical debate. The discussions also reflect the highly political nature of the issue.

Countries generally agree that the misappropriation of genetic material can have severe consequences for indigenous people in terms of economic losses and access restrictions, which could stifle the preservation of culture and biodiversity. An international system of protection would give the legal possibility of asserting rights outside the domestic territory and would also ensure the recognition of TK within the international community.

The disclosure of origin and the certificate of origin

In order to combat the misappropriation of their resources and to minimise the granting of erroneous patents, several countries and regions apply disclosure of origin measures for patent applications for inventions derived from genetic resources at the national level. Here, there are two separate but related issues: the disclosure of origin certificate, and the disclosure requirement. A certificate of origin would serve as a type of passport or permit that would accompany the genetic resource along the whole chain of the access and benefit sharing (ABS) process. It could be verified at various points, particularly once the said resource left the provider country, ensuring the traceability of the genetic resources. A certificate of origin would be a practical way to implement the disclosure of origin requirement, but it would not have the same legal consequences as an official amendment to the TRIPS Agreement, making it a much looser and less effective measure.

In contrast, an amendment incorporating a disclosure of origin requirement would strengthen implementation and enforcement significantly as it would be linked to the WTO dispute settlement system. It would strengthen the process of verifying whether genetic resources were collected in accordance with national rules requiring consent, and whether the conditions for such consent were met. A disclosure of origin requirement has the potential to function as a bridge between national and international legislation as well as between the providers and users of resources to monitor trade and movement of resources in endeavours to protect and promote TK.

Discussions under the CBD have led to a process for adopting a certificate of origin system that would make the disclosure requirement operate effectively.

A disclosure of origin requirement is part of a broader system of measures to safeguard and protect TK, of which access and benefit sharing (ABS) embodies an important component. The concept of ABS was further crystallised by the CBD. It addresses the range of benefits that result from the commercialisation of genetic resources at different stages. These benefits can take various forms including: 1) financial compensation through royalties or fees; 2) stakes in equity or profit sharing; 3) commercial partnerships such as joint ventures; 4) scientific, social and/or environmental benefits; and/or 5) non-monetary benefits such as the sharing of research results or technology transfer. All these different modes of benefits are intrinsically linked.

Although the CBD advocates the preservation of TK by using mechanisms such as ABS, prior informed consent and disclosure of origin, some shortcomings remain. Since the convention only has an impact on genetic resources obtained after its adoption in 1992, the CBD’s effectiveness is significantly reduced. In particular, botanical gardens and seed banks have gathered up to one third of the world’s plant species, but remarkably the CBD does not demand that these banks adopt policies of prior obtained approval from the country of origin. As a result, these genetic resources can be subjected to further use and subsequent commercialisation without the requirement to share benefits with the source country.

Disclosure of origin requirement: where, what and how

To date, there is no agreement as to the form of an ideal disclosure of origin requirement, the necessity of such a regime, its form, objectives, and whether it should be adopted within the framework of WTO, CBD or WIPO.

Views vary as to the legal effect and practical consequences, whether disclosure should be mandatory or voluntary; and whether its materialisation could lead to an additional requirement to patentability, or if the requirement could be inserted as part of the grant/administrative procedure. Proposals have also included various options as to the consequences of non-compliance from revocation of the patent to sanctions outside the patent system.

Further, practical problems may arise in the implementation of a disclosure of origin requirement. How will national regimes be brought into compliance on prior informed consent and ABS on mutually agreed terms? How can patent officers be trained to deal with patentability issues in this area? Is it feasible to ask that all sources of knowledge and material be remunerated, no matter how minor and peripheral to the invention?

This brings with it the additional difficulty of tracing all countries of origin. Indeed, how would one deal with several nations that could all legitimately claim to be countries of origin of the same resource?

In addition, a disclosure requirement will not change the fact that so many resources and TK relevant to a patented invention can be acquired or learned without visiting any of the countries of origin or source. It follows that the measure will only be applicable to a small number of inventions. Although the pharmaceutical and agricultural seed industries have depended heavily on biogenetic resources and TK in the past, this does not mean that they will equally rely on such resources and knowledge in the future. Arguably, molecular biology and genetic engineering technologies will overtake natural products in drug, discovery, design, and development activities. At the same, TK is widely used, especially in the botanical medicine industry, as the basis for determining safety and efficacy, to develop agronomic practices for the cultivation of materials, and to guide the development of new products.

Final remarks

It is important that countries that have not done so already—in particular developing countries—set in motion the process of creating ABS rules, including prior informed consent and a disclosure of origin requirement in their domestic legislation. This will strengthen claims and proposals for a disclosure of origin requirement at the international level. In addition, the impact of special patent disclosure requirements, already introduced in national laws on the use of bio-prospecting and ABS, should be fully studied, as is the extent to which patent applicants already provide sources of information in their applications when materially relevant.

Furthermore, discussions would prove more fruitful if countries searching for solutions to protect traditional knowledge reach consensus on their objectives and goals: a long-term vision is a must. This equally applies to national regimes of protection. Without clear long term objectives, laws, sui generis systems, or policies are unlikely to be effective. The participation of indigenous peoples in identifying these objectives and solutions is of importance.

In the meantime, developing countries should also explore options, such as local collaborative projects, to promote collection and use of genetic resources with traditional uses. The T’ikapapa potato project in Peru, which brings together different sectors of society to promote the commercialisation of native potatoes, can serve as a good example.

A disclosure requirement, in the end, is only part of the solution to ensure that patents are granted in such a way that the invention furthers key objectives for the conservation of biological diversity, sustainable use of its components, and the achievement of social equity.

Fleur Claessens is Intellectual Property Programme Officer at ICTSD