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.
A comment received via email:
“It is unfortunate that Patents Office has finalized the draft guidelines and has stuck to its draft position without engaging constructively in discussing objections on them.
They should have published the responses received and also have given reasons on why responses adverse to their draft position were rejected and draft opinion finalized by giving cogent reasons.
In absence of such an approach, the publication and circulation of the draft guidelines seems to have been treated by Patents office as a necessary evil that has to be undergone as a formality before thrusting what it has already decided to implement, come what may, as guiding principles; rather than using the circulation as a means for inducing a brain-storming to arrive at well reasoned position.
Patent office should be more sensitive to ensure that the guidelines serve to protect indigenous knowledge from being usurped as inventions; and to encourage refinement in indigenous knowledge by patentable inventions. Current guidelines are an unimaginative misguided discouragement that will hit indigenous knowledge as well as their stake-holders because in absence of continuous R&D, which can be sustained only through promising due rewards to it, field of commercial drugs will get automatically available only to chemical drugs manufacturers in absence of competition from refined traditional drugs. One can’t understand whether direction of Patents Office is to protect or to decimate traditional knowledge.”
– Dr. V.A. Savangikar
Long post, I hope it get through the word limit of comments.
The guidelines mention “country of source and geographical origin….” Patent office has not explained what it means by “country of source” and “geographical origin”. The biodiversity act as well as the patent act only mentions “source” and “geographical origin” which makes sense.
The patent act mentions that if the invention uses a biological material which cannot be described as prescribed under Sec 10(4), the written description requirement may be fulfilled by depositing the biological material with a depository and fulfilling other conditions, one of which is a reference to the “source” and “geographical origin” of the biological material.
The guidelines issued by the patent office requires every applicant to either give an affirmative or negative undertaking on F-1 which in my opinion is unwarranted if the invention(biological material) can be described satisfying Sec 10(4).
Another major issue with the guidelines is that it failed to bring out a clear nexus between the “nature of invention” and the requirement to disclose the source and origin of biological material.
For example, if my invention is about a process for refining sugar I use biological material (eg sugar cane, sugar beets, apples, oranges, or several other fruits) as a raw material. I might mention the farm/market from where I obtained my biological material, but how do I satisfy the “geographical origin” requirement? Geographical origin requirement must trace out the history/lineage of the material. In case of isolates of micro-organisms often the history of strains is obscure or extremely difficult to be traced out.
Additionally, I may have obtained a plant which is rich in high sugar content and that plant may be endemic to a particular region and only grown by tribals or a certain ethnic community, and I develop a process for refining sugar from the plant. If my process can only be applied to that plant, or if I claim any part of the plant itself, then there is a justification for such a requirement. Instead, if my process can be applied to any plant which has sugar content, this requirement doesn’t make any sense. In my opinion the patent office should have clearly brought out the nexus between the nature of invention and the requirement to disclose source and biological origin, which it failed to do in the present guidelines.
A more sensible approach would have been to insist on such requirement if the claims are directed to a product and which is a biological material, or if the claims are directed to a process which has the limitation of being only applied to that biological material. If the process is of general nature which can be applied to any biological material having similar characteristics, I fail to understand the logic behind this requirement.
Patent office seems to have issued draft guidelines for examination of biotechnology applications (http://www.ipindia.nic.in/). Needs a larger debate otherwise it may turn out to be senseless guidelines like the one issued on TK.