India recently asked the global community for comments on its “Draft Guidelines for Processing of Patent Applications Relating to Traditional Knowledge and Biological Material.” BIO was very active in their support of the goals of the Convention on Biological Diversity and “believes that a practical and workable Access and Benefit Sharing regime will benefit both the owner and the user of genetic resources and help countries to utilize their resources to develop their economies.” BIO has issued its own “Guidelines for Members Engaged in Bioprospecting” and has urged the global community to use its “Suggested Model Material Transfer Agreement” to ensure both access to the innovator and benefit to the holder of that knowledge and/or resource. In reviewing India’s Draft Guidelines, BIO sees several problematic provisions.
The first problem occurs with the Guidelines creating another separate screening process to ensure patent applications do not claim traditional knowledge. While on its face this seems innocuous, India Patent Law already provides a process for analyzing patentability claims which should already include reviewing traditional knowledge. In fact, the United States and the European Union already protect India’s traditional knowledge using existing prior art review processes so it is unclear why India would have to create a separate procedure to do the same instead of using existing infrastructure.
Another problem occurs when the Draft Guidelines begin to redefine substantive patentability standards. Guiding Principle 1 removes from patentability isolation of active ingredients from plants with associated traditional knowledge. This is out of step with the European Patent Office, the USPTO, the JPO and the majority of patent offices around the world. The policy rationale also seems confusing as the identification of the specific ingredient is novel and non-obvious and the community is still free to use the plant as they always have regardless of the patent.
Guiding principles 2-6 require a heightened standard of obviousness than most jurisdictions, disregards the possibility that the prior art “may not provide a reasonable expectation of success”, and disregards the fact that assessments of inventive step are entirely fact-dependent.
Finally, source and geographical origin requirements ignore the realities of bioprospecting. For biotechnology inventions, the majority of bioprospecting is done by university professors that collect samples and conduct the basic research. Small biotechnology companies later acquire the knowledge and sometimes the active ingredient itself without understanding where the original sample was obtained. Further the small biotechnology companies have no way of knowing whether the access of the sample was done on “mutually agreed terms” and in accordance with the law of the country. Requiring patent applicants to disclose source and geographical origin when they were not involved in the bioprospecting “pose[s] unacceptable risks for patent applications and undermine[s] the incentives of the patent system to promote research and innovation in the biotechnology sector.”
BIO has always advocated that “an effective ABS regulatory system, based on mutually agreed terms between the provider and user of genetic resources, which may include terms relating to future intellectual property rights based on use of such resources, is the best mechanism to ensure furtherance of the ABS objectives of the Convention of Biological Diversity.” In other words, regulating access of traditional knowledge and genetic resources should focus on promoting research, economic development, and the sharing of benefits from the holder of the resource and the consumer. India’s proposed Draft Guidelines does not meet this mark. When a patent is not granted, inventions are not commercialized, no sharing of economic benefits occurs, and the consumer and holder of the resource gains nothing.