By Dr. Deepti Malhotra & Dr. Malathi Lakshmikumaran
Biological diversity or biodiversity encompasses the entire species of plants, animals and microorganisms, including variability and their immense ecosystems[See Endnote 1]. India is one of the megadiverse countries with hotspots of biological diversity and associated traditional knowledge on plants and animals ranging from crop plants with wild relatives to native plants to farm livestock [See Endnote 2]. There are four biodiversity hotspots in India [See Endnote 3]. India, as one of the members of the Conservation on Biological Diversity (CBD) since 1994 abides by its three objectives, which are “conservation of biodiversity, sustainable use of its components, and fair and equitable sharing of benefits arising out of the use of these resources”. Considering Article 6 and Article 15 of the CBD, India regulates access to biological resources under its national biodiversity strategy and action plan under the Biological Diversity Act, 2002 [See Endnote 4] (hereinafter the ‘Act’), and its corresponding Biological Diversity Rules, 2004[See Endnote 5] (hereinafter the ‘Rules’), which came into force on 1st of July 2004 [See Endnote 6].
Despite the existence of said Act and Rules for over a decade now, it has been brought to the notice of the Ministry of Environment, Forest and Climate Change (hereinafter the “Ministry”) by the National Biodiversity Authority (hereinafter the “NBA”) that there are a large number of entities/persons (hereinafter the “Applicants”) who are not fully aware of the provisions under the Act namely, Sections 3, 4, 6 and 20[See Endnote 7], but are desirous to comply with the same. In consideration of the same and to give an opportunity to Applicants to comply with the Act, in exercise of the powers bestowed by Section 48 of the Act, the Ministry felt that there is a requirement to provide an opportunity to such entities/persons who are required to obtain prior approval for undertaking activities under the aforesaid Sections, including access to biological resources, namely,
- obtaining any biological resource occurring in India or knowledge associated thereto for research or for commercial utilization or for bio-survey and bio-utilization;
- transferring the results of any research relating to any biological resources occurring in, or obtained from, India for monetary consideration;
- applying for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India;
- transferring any biological resources or knowledge associated thereto occurring in, or obtained from, India for which an approval from NBA has been granted, for monetary consideration;
that relate to past activities as specified above and consequently, released an Office Memorandum (hereinafter the “OM”) on September 10, 2018, giving 100 days for all Applicants to regularize past non-compliance. The NBA has been directed that within the 100 days from the date of issuance of the OM it shall take decisions, including course of action for matters related to the past non-compliance.
The OM directs the NBA to hear all such cases where prior approval under Sections 3, 4, 6 or 20 of the Act was required but the Applicants did not apply or obtain the same by filing of the requisite forms - Form I, Form II, Form III, and Form IV. These approvals are required for the following activities:
- approval of the NBA for access to biological resources and associated knowledge for research or for commercial utilization: Form I, under Section 3 of the Act and Rule 14 of the Rules;
- approval of the NBA for transferring results of research, relating to biological resources obtained from India, for monetary consideration to foreign nationals, companies and Non-Resident Indians (NRIs): Form II, under Section 4 of the Act and Rule 17 of the Rules;
- approval of the NBA for applying for a patent or any other intellectual property right based on research on biological material and knowledge obtained from India: Form III, under Section 6 of the Act and Rule 18 of the Rules; and
- approval of the NBA for persons who have been granted approval for access to biological resources and associated knowledge, but who intend to transfer the accessed biological resource or knowledge to any other person or organization: Form IV, under Section 20 of the Act and Rule 19 of the Rules.
However, it is to be noted that before passing any such order/decision, the NBA shall take into consideration scientific evidence of damage that might have been caused. Further, the OM directs that the NBA shall ensure that only those cases are regularized which would have been otherwise approved in the event the concerned Applicants had applied for prior approval as directed under the Act.
Importantly, the OM gives an opportunity to all the Applicants falling within the purview of Section 3(2)[See Endnote 8] of the Act to get absolved of all the violations pertaining to Sections 3, 4, 6, or 20 of the Act, that might have been caused due to their past activities. For Applicants falling under Section 7 of the Act, i.e., a citizen of India or a body corporate, association or organisation which is registered in India, the State Biodiversity Board (SBB) is the competent authority for regularising the non-compliance with the requirement of giving prior intimation to the SBB for obtaining biological resources for commercial utilisation or bio-survey and bio-utilisation. Importantly, for the Indian applicants, even the prior intimation requirement under section 7 is not applicable for accessing biological resources for research per se. Further, access to germplasms for conventional breeding is also exempt under the definition of commercial utilization under Section 2 of the Act[See Endnote 9]. Another exemption is to applicants under Protection of Plant Varieties and Farmers' Rights Act, 2001, who are not required to obtain an approval from the NBA. However, all persons and entities, even Applicants falling under Section 7 of the Act, are required to apply at the NBA for prior approval by filing Form III before the date of grant of the corresponding application to obtain IPR[See Endnote 10] such as applications for Patents in India or any other foreign jurisdiction, and the OM extends the privilege to past violations under the Act.
Therefore, in view of the limited time-period accorded by the Ministry, it is recommended that all Applicants may make applications / representations before the NBA for regularisation of past non-compliances within the 100 days period permitted by the OM. The NBA has been implementing the OM in the right spirit as can be seen from the large number of applications that have been considered and approved in the decisions of 48th[See Endnote 11] and 49th [See Endnote 12] NBA meetings.
[The authors are Senior Patent Analyst and Executive Director, respectively, in IPR Practice Team, Lakshmikumaran & Sridharan]
- Section 2 (b) of Biodiversity Act, 2002: “biological diversity” means 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;
- Section 3(2) of Biodiversity Act, 2002: The persons who shall be required to take the approval of the National Biodiversity Authority under sub-section (1) are the following, namely:- (a) a person who is not a citizen of India; (b) a citizen of India, who is a non-resident as defined in clause (30) of section 2 of the Income-tax Act, 1961 ; (c) a body corporate, association or organization- (i) not incorporated or registered in India; or (ii) incorporated or registered in India under any law for the time being in force which has any non-Indian participation in its share capital or management.
- Section 2(f) of Biodiversity Act, 2002: “commercial utilization” means end uses of biological resources for commercial utilization such as drugs, industrial enzymes, food flavours, fragrance, cosmetics, emulsifiers, oleoresins, colours, extracts and genes used for improving crops and livestock through genetic intervention, but does not include conventional breeding or traditional practices in use in any agriculture, horticulture, poultry, dairy farming, animal husbandry or bee keeping;