India Traditional Knowledge and Biological Material Draft Guidelines: Biotech Industry Provides Input

Draft Guidelines

Given the importance of protections for basic biotechnology inventions to the survival of the biotechnology sector in India, BIO has reviewed the Guidelines and has identified specific questions, and areas for improvement.

Screening for Traditional Knowledge (TK)

The Draft Guidelines indicate that Indian law has provisions for the protection of TK and biological resources pre-patent, during patenting and post-patent. The Guidelines further direct examiners and controllers to ensure screening of patent applications pertaining to TK. The purpose of a separate screening process for TK is not clear given that the India Patent Law already provides a process for analyzing the patentability of claims. Such a screening process has the potential to create/add to, the patent application processing backlogs which will be burdensome to applicant. Moreover, BIO is concerned that a special procedure for assessing “TK” given the ambiguity associated with what can be considered TK can create significant delays in patent examination. BIO is concerned that this may not be a mere process of classifying inventions, but rather could lead to determinations about the nature of the invention that may have a substantive impact on patent examination without a fair and effective system for enforcing the rights and adjudicating disputes. For example, it is unclear whether a determination that an invention is or is not based on TK would have any effect on whether currently publicly available information declared to be “TK” would be considered to withdrawn from the public domain. In addition, such a determination may lead to an unintended result that TK rights are in conflict with or would be perceived to be superior in effect or operation than those provided under patents, copyrights, trademarks, trade secrets, plant variety protection or other intellectual property protection systems to other products. BIO urges that all applications should be treated on a case-by-case basis, as indicated under the Indian Patents Act, for novelty, inventive step, sufficiency of description, etc.

Guiding Principle 1- Assessing Novelty

Guiding principle 1 stipulates that if a subject matter relates to extracts/alkaloids and/or isolation of active ingredients of plants which are inherently present in plants, such claims cannot be considered novel when the use of the plants is known as part of TK. Such an assessment of novelty is at odds with other major patent offices including the European Patent Office (EPO), US Patent and Trademark Office (USPTO) and Japan Patent Office (JPO). In each of these jurisdictions, lack of novelty requires that the claimed substance have the exact chemical structure as that previously existing in the prior art. Moreover, in most jurisdictions, the isolation of an active/functional component from its natural environment is patent-eligible and is (or can be) novel and non-obvious. As an example, the isolation of the anti-malarial drug quinine from the bark of the cinchona tree, which was known to Amazonians to treat fever, could give rise to a patent covering isolated quinine, because the identification of the specific active ingredient and the process to isolate it is considered novel and non-obvious. Such a patent would not prevent the continued use of the cinchona tree bark to treat fever.

Guiding Principles 2-6- Assessing inventive step

These five guiding principles reflect a stronger presumption of obviousness than what exists in most jurisdictions. In particular, the guiding principles seem to disregard the possibility that the art may not provide a reasonable expectation of success. In most jurisdictions, the motivation to combine two products is not indicative that a person of ordinary skill in the art will have a reasonable expectation of achieving the desired result. The assessment of inventive step is fact- dependent and should be assessed on a case by case basis. A one-size fits all approach set through general guidance has the potential to prevent patents on innovative biotechnology products, thereby stifling innovation in this sector. BIO members file patent applications in most Patent Cooperation Treaty (PCT) countries in the hopes of launching key products in those markets. Such divergent protections between key markets would create problems for biotechnology companies and may affect business decisions with respect to those products. In addition, such a strict approach to patentability is likely to discourage research and development activities in the area of biotechnology in India.

Section 17- Source and Geographical Origin

India’s Patents Act and the Draft Guidance require applicants to disclose the source and geographical origin of biological materials used to make an invention that is the subject of a patent application. These special disclosure requirements impose unreasonable burdens on patent applicants, subjecting valuable patent rights to great uncertainty. While the Guidance requires that an objection be raised to conform with the requirements, under the Indian law, the failure to identify the geographical source of a biological material and its origin may be a basis for opposition or revocation proceedings. However, the necessary relationship to the patented invention is not clear and their impact is inherently retroactive in effect. For example, companies often have obtained samples or materials from universities or in partnership with universities or depositories. Identifying the source of these materials may be impossible as many may have been obtained decades prior to eventual use and filing of a patent application. These requirements pose unacceptable risks for patent applicants and undermine the incentives of the patent system to promote research and innovation in the biotechnology sector.

Moreover, such requirements do not further the objectives of the CBD, which we understand to be the intended objective. Instead, 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 CBD. This approach should apply for all uses of genetic resources, whether those uses are subject to intellectual property rights or not.