Commercialization of Genetic Resources: Leveraging Ex Situ Genetic Resources to Shape Downstream IP Protection

Abstract

Plant and microbial genetic resources exist in natural habitats and culture collections worldwide. Their scientific and economic value is rapidly gaining in importance, even though the laws governing them do not support ease of use. Genetic resources are subject to the overlapping jurisdiction of the Convention on Biological Diversity (CBD) and the Agreement on Trade Related Aspects of Intellectual Property (TRIPS). Neither of these regimes operates in a particularly access-friendly manner with respect to biological resources with imminent commercial potential. The CBD entitles countries to share benefits arising out of the use of resources originating in their territories. The scope, nature and duration of CBD obligations, and consequently of potential claims, are however often vague. Patent laws enacted under TRIPS, in a context of a strong growth market, fragmented patents and expensive product development, tend to function sub-optimally and allow formation of blocking patents and patent thickets. In combination, these regimes encourage a race to extract value by the beneficiaries of the entitlements created, which tends to diminish the ability to exploit high-value biological resources.

A change in the current system is unlikely, despite growing need facilitated accessibility and transferability of biological resources. However, intervention through contractual means is possible. The ex situ collections that hold genetic materials, operate as contractual points of articulation between countries of origin and recipients/prospective developers. In that capacity collections are in a position both to negotiate clarification of CBD obligations and, by virtue of their control over the biological materials, to impose IP-related conditions on recipients.

Against this conceptual background, the WHO Framework for Pandemic Influenza Preparedness (PIP) provides the opportunity for empiric analysis. The Framework’s goal is to facilitate availability of influenza-related medicines in the event of pandemics. Its IP treatment defaults to national patent laws. In the context of the influenza-related medicines industry, characterized by a strong growth market, narrow patents, and high-cost product development, national patent laws are unlikely to achieve the Framework’s goal of widespread availability of influenza-related drugs at affordable prices. To the contrary, it is more probable that one player would seek to monopolize all relevant technologies and emerge as single source, or, in the alternative, that a patent thicket would discourage development.

Would alternate IP treatment help mitigate this result and better achieve the PIP Framework’s objective? If so, what treatment would be appropriate for biological resources with imminent commercial prospects? This paper proposes the concept of “re-bundling” of IP rights: the prospective patentee would relinquish its entitlement to full exclusivity under patent law, in exchange for freedom to operate from a patent perspective plus access to other material recipients’ technology. The “re-bundling” could take the form of a patent pooling arrangement and would give multiple players a chance to participate in the market.

From a practical perspective, the patent pool would be mandated by the ex situ collection’s Material Transfer Agreement, under which genetic materials are transferred to prospective developers. It would leverage release of the biological materials against the agreement to “re-bundle” patent rights: the greater the value of the biological materials, the greater the incentive to join. And finally, coming full circle, in the optimal scenario, contractual certainty regarding CBD obligations could be obtained and would provide an added incentive to participate in a patent pool.

Keywords: Convention on Biological Diversity, patents, patent pools, biological resources, genetic resources, TRIPS, influenza, MTA

JEL Classification: O34