Fighting against biopiracy: does the obligation to disclose in patent applications truly help?

• Author: de Werra, Jacques

ABSTRACT

In the global fight against biopiracy, one of the key issues is to prevent the grant and exploitation of patents on traditional knowledge and genetic resources by requiring that patent applicants for inventions involving traditional knowledge and genetic resources disclose the source of those resources and provide evidence that the prior informed consent of the local owners of such resources has been obtained and that benefit-sharing agreements have been entered into with those owners.

This Article argues that a legal discussion of biopiracy should analyze the obligation to disclose the use of traditional knowledge and genetic resources in an invention beyond the sanctions that are attached in case of violation of such obligations as previously discussed at the international level. These issues should be addressed in light of the key objectives to be achieved: to ensure the effective sharing of benefits resulting from the use of such resources with the local communities that own them, and to implement appropriate mechanisms for this purpose. In the course of the analysis, this Article adopts an interdisciplinary approach by referring to rules governing the legal protection of tangible and intangible cultural property in order to explore the extent to which they could be used as models for a regime of protection against the misappropriation of traditional knowledge and genetic resources. This approach is inspired by the similarity between biopiracy and the misappropriation of cultural property goods, which constitutes a kind of "cultural piracy." This Article concludes that balanced, flexible, and interdisciplinary solutions are required in order to ensure that the interests of local communities are protected without unduly threatening the interests of their commercial partners.

TABLE OF CONTENTS I. INTRODUCTION II. ORIGINS AND LIMITS OF THE OBLIGATION TO DISCLOSE A. Origins B. Limits III. MOVING FROM TRANSPARENCY TO BENEFIT SHARING A. Are There Lessons To Be Learned from the Legal Protection of Tangible Cultural Property? 1. Relevant Aspects of the Legal Protection of Tangible Cultural Property 2. Are There Analogies to the Protection of Traditional Knowledge from Misappropriation? B. Potential Modalities for Sharing Benefits with the Communities 1. Co-Ownership of Patents 2. Compulsory Licensing Scheme for the Use of Traditional Knowledge? C. Implementation of the Benefit Sharing System 1. Efficient Enforcement and Dispute Resolution System 2. Flexible Approach IV. CONCLUSION I. INTRODUCTION

In the global fight against biopiracy, (1) one of the most important issues--as identified in the report entitled The Protection of Traditional Knowledge: Draft Objectives and Principles; (2) prepared under the auspices of the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore-is to "[p]reclude the grant of improper [intellectual property] rights to unauthorized parties." (3) More specifically, the goal is to

curtail the grant or exercise of improper intellectual property rights over traditional knowledge and associated genetic resources, by requiring, in particular, as a condition for the granting of patent rights, that patent applicants for inventions involving traditional knowledge and associated genetic resources disclose the source and country of origin of those resources, as well as evidence of prior informed consent and benefit-sharing conditions have been complied with in the country of origin. (4) According to the Draft Traditional Knowledge Principles, "[t]raditional knowledge shall be protected against misappropriation." (5) To accomplish this,

legal means should be provided to prevent ... false claims or assertions of ownership or control over traditional knowledge, including acquiring, claiming or asserting intellectual property rights over traditional knowledge-related subject matter when those intellectual property rights are not validly held in the light of that traditional knowledge and any conditions relating to its access. (6) Various countries have formulated proposals advocating the inclusion of such a disclosure obligation in a variety of international patent law conventions. (7) Others have adopted, or are discussing, national regulations to the same end. (8) Three different proposals for implementing this obligation at the international level can currently be identified: (9) (1) the TRIPS Disclosure Proposal; (10) (2) the PCT Disclosure Proposal; (11) and (3) the Mandatory Disclosure Proposal. (12)

The most protective of the three is the TRIPS Disclosure Proposal, which was proposed primarily by Brazil and India, with assistance from other countries. (13) Under its terms, a patent can be granted only if the patent application includes information regarding or evidence of (1) the source of the invention, its country of origin, and the countries of origin of the biological resources and traditional knowledge used in the invention; (2) the obtainment of prior informed consent from the authorities under the relevant national regime; and (3) fair and equitable benefit sharing under the relevant national regime. 14 If a patent applicant violates these obligations, the potential sanctions could include the revocation of the patent, the narrowing of the scope of the patent, and the "full or partial transfer of the rights to the invention ... where full disclosure would have shown that another person or community or governmental agency is the inventor or part inventor." (15) The TRIPS Disclosure Proposal is meant to be formally implemented in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) (16) at Article 29bis. (17)

The PCT Disclosure Proposal, authored by Switzerland, IS is based on a proposed amendment to the Regulations under the Patent Cooperation Treaty (PCT Regulations). (19) Under this amendment, national patent law could (20) require a patent applicant to declare the source of genetic resources and traditional knowledge in a patent application. (21) The absence of compliance by the patent applicant with the formal requirement could lead to the denial of the application by the relevant patent office. (22) However, if the applicant's failure to disclose the source of the invention or the submission of false information was discovered after the granting of the patent, the patent's validity would only be affected if it was found that the applicant had fraudulent intentions. (23) In such a case, sanctions outside of patent law could also be imposed. (24)

The third proposal, the Mandatory Disclosure Proposal, was made by the European Union. Pursuant to this proposal, each country shall "require all patent applicants to disclose information on the country of origin or source of genetic resources used in the invention which applicants know or have reason to know." (25) Under this proposal, the failure or refusal of the patent applicant to provide the required information would terminate the processing of the patent application. (26) However, after the grant of the patent, the sanction imposed on an applicant who provided incorrect or incomplete information would lie outside of patent law. (27) Each country would retain the ability to determine the sanctions it would impose in the case of a violation of the disclosure requirement. (28) As expressed in a submission of the European Union, this proposal supposes that

[m]eaningful and workable sanctions should be attached to the provision of incorrect or incomplete information. Where it is proved that the patent applicant has disclosed incorrect or incomplete information, effective, proportionate and dissuasive sanctions outside the field of patent law should be imposed on the patent applicant or holder.... For reasons of legal certainty, the submission of incorrect or incomplete information should not have any effect on the validity of the granted patent or on its enforceability against patent infringers. It must be left to the individual Contracting State to determine the character and the level of these sanctions, in accordance with domestic legal practices and respecting general principles of law. (29)

Among the three options mentioned above, the TRIPS Disclosure Proposal is obviously the most protective of the interests of local communities due to its extensive reach. (30) Indeed, it presupposes the creation of a benefit-sharing agreement between the applicant and the relevant stakeholders. Therefore, if one were to try to answer the question raised in the title of this Article as to whether the obligation to disclose truly helps communities, (31) one might conclude that the TRIPS Disclosure Proposal would be the most effective because it requires the patent applicant to prove benefit sharing with communities when filing a patent application. However, in spite of its appeal, the TRIPS Disclosure Proposal seems unlikely to be implemented at the global level because of the opposition it faces in political spheres and the delicate legal issues that it raises. (32)

On this basis, the goal of this Article is to assess whether the obligation to disclose the use of traditional knowledge and of associated genetic resources (hereinafter jointly referred to as "traditional knowledge") in an invention truly helps communities that create and own traditional knowledge. For this purpose, the Article focuses on whether the obligation to disclose (resulting in particular from the PCT Disclosure Proposal and the Mandatory Disclosure Proposal), as well as the sanctions attached to a violation, provide a suitable legal framework for allowing effective benefit sharing for communities.

In view of this focus, the Article does not comprehensively discuss the other complex issues relating to the implementation of the obligation to disclose, such as the so-called trigger of the disclosure (33) (i.e., what connection must exist between the traditional...