The following Act of Parliament received the assent of the President on the 5th February, 2003, and is hereby published for general information: THE BIOLOGICAL DIVERSITY ACT, 2002 No. While it is clear that the term includes any Indian citizen, or a resident of India (as defined in the Income Tax Act, 1961), does it cover a foreign national operating outside India? 4Section 55(1) of BDA: “Whoever contravenes or to or abets 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 and where the damage caused exceeds tend lakh rupees such fine may commensurate with the damage caused, or with both”. Advisories On Banking And Financial Sectors, Khurana & Khurana, Advocates and IP Attorneys, Pharma- biotech- Patent Commercialisation. This would make the jurisdictional reach of Act worldwide, whereas Section 1(2) clearly states that the Act extends to the whole of India and not elsewhere! History. Objective of this act is to regulate the access to genetic resources and protection of biodiversity.

The Act provides mechanism for equitable sharing of benefits arising out of the use of traditional biological resources and knowledge. This act provides for establishment of statutory bodies such as National Biodiversity Authority, State Biodiversity Boards, National and State Biodiversity Funds, Biodiversity Management Committee etc. A careful reading of Section 6 reveals the truly wide mandate of the BDA with regard to IPR. For instance, Section 6 states that permission of the NBA is required when IPR is applied for research or information based on a biological resource obtained from India.

How does one determine any time frame after which a biological resource can be considered to be “occurring” in India? Alternatively, does the term “obtained” necessarily mean that the biological resource shall also be found to be “occurring” in India?

Understandably, it may be difficult for an Indian applicant to do so. Though the BDA came into being in 2002, it was only in 2004 when the Rules were notified, hence, for all practical purposes, the effective implementation date of the BDA is 2004. It is quite clear from the definition in Section 2(c) that the legislation is principally directed towards patenting of biological inventions, which puts an additional burden, largely regulatory in nature, on the Applicant to comply with. Can be reached at amitavo@khuranaandkhurana.com. For instance, use of any biological resource for validation purposes of a claimed product would fall within the ambit of NBA! As the objective of the NBA is to safeguard Indian biodiversity, will “obtaining” be limited to only those biological resources which are literally sourced from within India? The gravity of non-compliance with Section 6 of the BDA can be appreciated from Sections 55(1)4, 575 and Section 586 of the Act. 18 OF 2003 [5th February, 2003] An Act to provide for conservation of biological diversity, sustainable use of its

In conclusion, under current IPO practice regime, any Applicant using any biological resource (as defined under Section 2(c) of the BDA) is suggested that he seek NBA clearance at the earliest instance in order to ensure a timely and smooth prosecution progress. The term “no person” used in Section 6, sub-clause 1 can be broadly interpreted to include any natural or legal person irrespective of nationality. 3. (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”. Secondly, the application of the law is extra-territorial in that it is applicable upon IPR laws of other foreign countries also. Ans: B. The Biological Diversity Act of 2002 (BDA) is a piece of Indian legislation which came into being in response to compliance with the Convention on Biological Diversity (CBD), to which India is a ratified member. An Act 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. Firstly, it is to be noted that Section 6 is not limited to Indian citizens or Indian residents (as defined in the Income Tax Act, 1961). The definition of “biological resource” can be found in Section 2(c)2 of the BDA. Under current Indian Patent Office (IPO) practice, it is observed that for patent applications, which disclose any biological material, in the First Examination Report (FER), it is almost routine to come across an objection requiring clarification as to furnishing of NBA approval in the case of use of any biological resource obtained from India. Instead, it encompasses use of any such resource or knowledge thereof in any part of the application. All rights reserved. Biodiversity act 2002 President signature- 5th Feb 2003 Enforcement- 15th April 2004 1The Biodiversity act 20028/9/2015 2. Sustainable use of the components of biodiversity. Thirdly, it is interesting to note that the scope of the said section is not merely limited to biological material “occurring” in India. In another instance, Section 6 clearly states that no application for IPR rights is to be filed in any foreign country without prior NBA approval.

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