The Biological Diversity Act (the BD Act) was enacted with the objective to provide for conservation of Biological Diversity, sustainable use of its components and fair and equitable sharing of the benefits arising out of the use of biological resources, knowledge and for matters connected therewith or incidental thereto. One of the provisions under the BD Act (section 6) relates to seeking prior permission from National Biodiversity Authority (NBA) before applying for any intellectual property right, if the invention is based on any research or information on a biological resource obtained from India. Hence, if a patent right is sought by an applicant, then permission is required from NBA, before the patent could be granted, if the invention is based on Indian biological resource. If the invention is not based on Indian biological resource, then permission is not required under Section 6 of the BD Act.

However, in a recent Patent Office decision, the extent of scope of applicability of this provision of the BD Act seems to have been extended. During examination of the patent application, an objection was raised, asking the applicant to submit information regarding geographical source and origin of the biological material (beta carotene and lycopene) used in the invention, and if the biological resource is obtained from India then seeking a permission from NBA. The Applicant submitted that the biological material was not procured from India and that such materials mentioned in the specification were for research and had been sourced from commercial sources in Switzerland, Spain and China and no part of such beta carotene and lycopene were being procured from India. Accordingly, the Applicant was of the view that permission under Section 6 of the BD Act was not applicable. The Controller, however, held that the submissions of the Applicant was not satisfactory as it is a well-known fact that both the components are available from natural sources, which are grown in India on a large scale. He further held that Section 83(a) of the Patents Act states that patents are granted to encourage invention and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay. The Controller further held that Section 83(g) of the Act states that patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public.

The Controller thereafter reasoned that in case a patent application comprising biological materials, which are extensively grown and produced in India is granted, and if the raw material are imported from outside India at a time of large scale commercial production, then it is not clear whether that product would be available to the public at a reasonable price or not. Therefore, the Controller held that the intent of the Act as prescribed under sub-clauses (a) and (g) of Section 83 of the Patents Act is not fulfilled. Accordingly, necessary permission from the National Biodiversity Authority (NBA) would have to be taken, and since no such approval from NBA had been taken, the Application was rejected on this ground. It may be noted that the case was rejected for lack of inventive step as well, which is not under consideration here.

Section 6 of the BD Act imposes the liability of seeking permission from NBA, only if the invention is based on any research or information on a biological resource obtained from India, and not for conditions relating to working a patented invention. For working a patented invention based on a biological resource obtained from India, other provisions (Section 3, 4 and 7 of the BD Acct) are applicable, which govern the conservation of Indian biodiversity    and necessary permission required for the same. Since the invention was not based on a biological resource obtained from India, although it could have been obtained, still imposing a requirement under Section 6 might not have been appropriate. It would be pertinent to note here that, the applicant was an Indian entity, and still obtained biological resources from outside India, although such material was abundantly available in India, might have been at the back of the Controller's mind while issuing a rejection for not complying Section 6 of the BD Act.

When there are checks and balances, both under the Patents Act and the BD Act, for working of a patented invention in India, and to avoid abuse of monopoly, how far the extension of applicability of Section 6 of the BD Act was justifiable in rejecting a patent application, when the invention was not based on Indian biological resource? It might take some more time and a few decisions by the Courts of India, before the muck of linking of various IP rights and the provisions of BD Act could be clear.

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