Introduction

To meet the obligations under the Convention on Biological Diversity also known as Biodiversity Convention, India enacted The Biological Diversity Act, 2002 [hereinafter termed as "the Act"]. The present article is an effort to provide the context and summarize main provisions and stipulations under the Act.

The objective of the Act is "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." India is amongst the foremost developing nations to initiate the process of identification of its vast biodiversity, formulating guidelines for sharing of knowledge and use of it biodiversity, and setting up the National Biodiversity Authority to facilitate the same. The Act aims at striking a balance between a regulated and fair use of the country's biodiversity.

The National Biodiversity Authority (NBA) was established as per the provisions of the Act in 2003 at Chennai, under the Ministry of Environment and Forests, Government of India. The same was followed by State Biodiversity Boards (SBB) in 28 States along with 31,574 Biological Management Committees (for each local body) across India1. The NBA consists of a Chairperson, five non-official and ten ex-officio members to be appointed by the Central Government to represent various Ministries. The prime objective of NBA is to account for, maintain/conserve biodiversity and ensure sustainable use of India's rich biodiversity and associated knowledge.

The NBA, inter alia, deals with matters relating to requests by foreign individuals, institutions or companies for access to India's biological resources and transfer of results of research to any foreigner. The SBBs constituted by the State Governments deal with all matters relating to access by Indians for commercial purposes. The institutions of self-governments set up Biodiversity Management Committees (BMCs) in their respective areas for conservation, sustainable use, documentation of biodiversity and chronicling of knowledge related to biodiversity.

Under Section 2(b) "biological diversity" is defined as the variability among living organisms from all sources and the ecological complexes of which they are part, and includes diversity within species or between species and of eco-systems. Further, as per Section 2(c), "biological resources" means plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value, but does not include human genetic material.

Section 3 of the Act stipulates that all foreign entities, including foreign individuals, non-residents or body corporate, shall get approval from the NBA prior to obtaining any biological resource occurring in India or knowledge associated thereto for research or for commercial utilization or for bio-survey and bio-utilization.

Section 4 prohibits transfer of results of any research relating to any biological resources occurring in, or obtained from India, to any person who is not a citizen of India or a citizen of India who is non-resident as per Income Tax Act or a body corporate not registered in India or having non-Indian participation in its share capital or management.

With regards to Intellectual Property Rights (IPR) vis-à-vis Biological Resource, Section 6 of the act stipulates that-

(1) No person shall apply for IPR protection in or outside India for any invention based on research or information on a biological resource obtained from India without obtaining the previous approval of the NBA before making such application.

Provided that if a person applies for a patent, permission of the NBA may be obtained after the acceptance of the patent but before the sealing of title patent by the patent authority concerned.

Provided that the NBA shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof.

(2) The NBA may, while granting the approval under this section, impose benefit sharing fee or royalty or both or impose conditions including the sharing of financial benefits arising out of the commercial utilization of such rights.

(3) The provisions of this section shall not apply to any person making an application for any right under any law relating to protection of plant varieties enacted by Parliament.

(4) Where any right is granted under law referred to in sub-section (3), the concerned authority granting such right shall endorse a copy of such document granting the right to the National Biodiversity Authority.

Accordingly, before applying for IPR protection for an invention based on research or information regarding biological resource obtained from India, the applicant is first required to obtain approval from the NBA. However, in case of patent protection, said permission or approval from NBA can be obtained any time before recordal of patent at the respective patent authority in India or outside India. Further, the provision is not applicable for registration under Plant Varieties Act. However, the concerned authority while granting such registration is required to provide a copy of the same to the NBA.

In view of the "NBA approval" required for IPR protection, especially for patents, we have observed that under the current Indian Patent Office (IPO) practice, the Controller as a routine inserts a requirement in the first examination report (office action) for furnishing of NBA approval in the case of use of any biological resource obtained from India. Accordingly, the applicant needs to comply with this extra requirement if the invention is based on or has even a mention of the biological resource obtained from India in its specification.

The NBA plays a vital role in achieving the objectives of the Biological Diversity Act. The functions and powers of the NBA are lined out in Section 18 of the Act, which stipulates that:

(1) It shall be the duty of the NBA to regulate activities referred to in sections 3, 4 and 6 and by regulations issue guidelines for access to biological resources and for fair and equitable benefit sharing.

(2) The NBA may grant approval for undertaking any activity referred to in sections 3, 4 and 6.

(3) The NBA may (a) advise the Central Government on matters relating to the conservation of biodiversity, sustainable use of its components and equitable sharing of benefits arising out of the utilization of biological resources; (b) advise the State Governments in the selection of areas of biodiversity importance to be notified under sub-section (1) of section 37 as heritage sites and measures for the management of such heritage sites; (c) perform such other functions as may be necessary to carry out the provisions of this Act.

(4) The NBA may, on behalf of the Central Government, take any measures necessary to oppose the grant of intellectual property rights in any country outside India on any biological resource obtained from India or knowledge associated with such biological resource which is derived from India.

So as to enforce the regulations prescribed Sections 2, 4 and 6 of the Act, the penalties are given under Section 55(1), which is self explanatory: Whoever contravenes or abets to the contravention of the provisions of section 3 or section 4 or section 6 shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to ten lakh rupees [1 million INR] and where the damage caused exceeds ten lakh rupees such fine may commensurate with the damage caused, or with both.

Thus, while restrictions are there, the same also facilitate sustainable use and informed sharing of knowledge relating to India's biological recourses. In today's time when commercialization has penetrated each walk of life and innumerable resources which were unrecognized as resources only a few decades back, legislations such as Biological Diversity Act place checks and balances over uses and knowledge sharing of a biological resource and protecting it from excessive/harmful misuse in future.

Footnote

1. https://en.wikipedia.org/wiki/Biological_Diversity_Act,_2002

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