We are happy to bring you yet another guest post in our SpicyIP Fellowship applicant series. Madhulika Vishwanathan brings our attention to the Dec 18th announcement of the final version of the Guidelines for Processing of Patent Applications relating to Traditional Knowledge and Biological material. Prashant had earlier commented on the draft guidelines here.
Madhulika is a qualified Indian patent agent, with a Masters in Pharmacology from UDCT, Mumbai. She formerly worked in the patent cell of a biotech company in Mumbai. She provides a brief critique on these new guidelines which advocate enhanced standards of patentability. She writes, "It is unclear as to why these separate guidelines have been issued, when traditional knowledge protection has been adequately afforded by Section 3(p) and existing standards of novelty and obviousness. In the absence of a patent conducive environment, inventions are not commercialized, no sharing of economic benefits occurs, and the consumer and holder of the resource gain nothing."
Traditional knowledge patent applications: Need for deliberation
The Indian patent office recently released guidelines for processing of patent applications relating to traditional knowledge which are essentially similar to the draft guidelines issued a month back. The guidelines begin by detailing various provisions of the patent act associated with traditional knowledge. It goes on to emphasize the importance of seeking approval from the national biodiversity authority before making any patent application and also disclosing the source and geographical origin of biological material used. The guidelines also mandate a declaration on Form-1 that the necessary permission from the competent authority should be submitted before patent grant. Furthermore, the guidelines also specify that traditional knowledge related applications should be appropriately screened by examiner in accordance with International patent classification. The guidelines also enumerate several guiding principles for examination of traditional knowledge applications which redefine standards of substantive patent laws.
Guiding principle 1 heightens the threshold for novelty and implies that if a plant is known in the prior art for treatment of disorder X then the claims related to purified extracts, isolated actives of the plant are already anticipated. The rest of the guiding principles redefine the standards for obviousness/inventive step. Accordingly combinations of plants which are each individually known to provide the same therapeutic effect do not meet this enhanced threshold for obviousness. The guiding principles do not take into account an unexpected synergistic effect wherein the combination may produce an effect far greater than the sum of their individual effects.
Similarly, a combination of ingredients for treatment of a disease is presumed to be obvious if even one of the ingredients is known to be effective in treating the disease. Furthermore arriving at optimal workable ranges of traditionally known ingredients is not considered inventive. Finally generic disclosures of multiple ingredients known to have the same therapeutic effect can impugn the inventiveness of a specific disclosure.
The worlds of traditional knowledge and patents have been considered to be mutually exclusive since traditional knowledge denotes community interests and patent rights denote personal monopoly. Traditional knowledge refers to a long standing practice within communities. Traditional knowledge evolved over a period of time may be interspersed with knowledge gaps. Innovations which bridge these knowledge gaps add substantial value and transform it into meaningful applications. Natural products play a dominant role in the discovery of leads for the development of drugs for the treatment of human disease. A large majority of allopathic drugs (artemisin, vincristine) are derived from or modeled after natural product leads.
Such enhanced threshold for novelty and obviousness will impede patenting of quality inventions resulting from existing traditional knowledge base (with appropriate permission from competent authorities and material transfer agreements). Moreover most of the research in Central government laboratories and other academic institutions revolve around ethnomedicine. These substantive patent guidelines for traditional knowledge might serve as a disincentive for research in these areas. Benefit sharing methodologies along with material transfer agreements will protect the rights of owners of traditional knowledge and also contribute to meaningful research.
Development of Jeevani is a good example of equitable benefit sharing between resource holders. As noted in the WIPO report, "in South India the medicinal knowledge of the Kani tribes led to the development of a sports drug named Jeevani, an anti-stress and anti-fatigue agent, based on the herbal medicinal plant arogyapaacha. Indian scientists at the Tropical Botanic Garden and Research Institute (TBGRI) used the tribal know-how to develop the drug. The knowledge was divulged by three tribal members, while the customary rights to the practice and transfer of certain traditional medicinal knowledge within the Kani tribes are held by tribal healers, known as Plathis. The scientists isolated 12 active compounds from arogyapaacha, developed the drug Jeevani, and filed two patent applications on the drug. The technology was then licensed to the Arya Vaidya Pharmacy, Ltd., an Indian pharmaceutical manufacturer pursuing the commercialization of Ayurvedic herbal formulations. A trust fund was established to share the benefits arising from the commercialization of the TK-based drug.
By hindering the grant of patents, traditional knowledge is not harnessed adequately and this neither benefits the owner of the traditional resource nor the end user. Section 3(p) of Indian patent act along with existing standards of novelty and obviousness are adequate to prevent expropriation of traditional knowledge. Separate guidelines for evaluating traditional knowledge related patent applications are thus redundant and only add to the ambiguity.