India is a unique nation with a time-tested continuous civilization with abundant biological resources despite myriad disruptions in the form of natural calamities, foreign invasions and the like, resulting in creation of vast repositories of knowledge either in written form or verbal tradition or even in encrypted form, perpetuated through generations for all available domains. The idiosyncratic effort of India embracing all the diversities through “Vasudhaiba Kutubumkam” was however, renounced for a brief period due to foreign invasion of an unprecedented nature, resulting in protectionism. Since the 90s, India started opening up yet again and began merging its capabilities with the rests of the world while being a signatory to several treaties under the auspices of the World Trade Organization (WTO). However, in this process, it also safeguarded its own capacities and resources, considered as imperative especially in the aftermath of the disputes over patenting the likes of neem and turmeric.
India signed the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement under the WTO for the transfer of technologies from the signatory developed nations after duly addressing the standards, enforcement and dispute settlement in order to create a sound technological niche. As a minimum standards agreement, TRIPS allows Members to provide more extensive protection of IP (Intellectual Property) as desired, as well as liberty to determine appropriate method of implementing the provisions of the Agreement within the legal system and practice of its member countries, resolving trade disputes over IP, and in assuring WTO members the latitude to achieve its members’ domestic policy objectives. Thus was created the Protection of Plant Varieties and Farmers’ Rights Act (PPV&FRA) giving IP (intellectual property) protection for seed companies for the seeds developed by them, as well as ensuring the rights to farmers for their traditionally conserved varieties; SICLDR (Semiconductor Integrated Circuits Layout-Design Registry), with its corresponding non-patentability under Section 3 of the Indian Patent Act as amended. Likewise, any act of patenting of any traditional knowledge was also barred through Section 3(p).
Correspondingly, as one of the early bird countries to legislate on Biological Diversity, the BD (Biological Diversity) Act was drafted and enacted in 2002 with the main purpose of ensuring legal implementation of the CBD (Convention of Biological Diversity) provisions, as a result of the 1992 Rio Summit (United Nations Conference on Environment and Development), to which India was a signatory.
One of the fundamental principles of the CBD as well as the BD Act, 2002, was the preservation of the diversity of flora and fauna in the country and the associated knowledge of its use. This was considered to be the sovereign property belonging to India. The three main objectives of the CBD enacted by the Biodiversity Act are: to conserve biological diversity along with the traditional knowledge of its use, to promote its sustainable use and to ensure equitable sharing of any benefits arising out of the use of this biological diversity and traditional knowledge.
For implementing the BD Act, 2002, the NBA (National Biodiversity Authority) was established by the Central Government in 2003. The NBA is a Statutory, Autonomous Body performing facilitative, regulatory and advisory functions for the Government of India in tandem with SSBs (State Biodiversity Boards) on issues of conservation, sustainable use of biological resources and fair and equitable sharing of benefits arising out of the use of biological resources, established by the Central Government in 2003 to implement India’s Biological Diversity Act, 2002.
The Biological Diversity Act (2002) mandates implementation of the provisions of the Act through a decentralized system with the NBA focusing on advising the Central Government on matters relating to the conservation of biodiversity, sustainable use of its components and equitable sharing of benefits; and advising the State Governments in the selection of areas of biodiversity importance to be notified under Sub-Section (1) of Section 37. The NBA considers requests by granting approval or otherwise for undertaking any activity referred to in Sections 3, 4 and 6 of the Act.
Thus, the NBA basically ensures that any exploitative effort from any individual or body corporate using the biological resources of the country is deterred, and forges a mandatory benefit sharing with all the stake holders, failing which, may resort to criminal prosecution. Regarding this, it must be noted that the provisions are equally applicable to any Applicant, irrespective of their residency status i.e. an Indian Applicant using a biological material from within the political boundary of India would be equally treated as an Applicant(s) of foreign residency, and would face similar legal consequence for failing to abide by the Act. Regarding its objectives, the NBA keeps a vigilant eye on patenting activities and sends intimations/ warnings/ notices to Applicants in case anything contrary is found.
The activities that come under the purview of the NBA, include applying for Intellectual Property Rights for inventions based on any research or information on a biological resource obtained from India, generally applicable for all the applicants irrespective of their residency; accessing of biological resources occurring in or obtained from India and/ or associated traditional knowledge for research, commercial utilization, bio-survey or bio-utilization, applicable for any Non-Indian, NRI (Non-Resident Indian), foreign entity or Indian entity having non-Indian participation in share capital or management, with a special provision in case the applicant is a Trader/ Manufacturer/ Company; transferring the results of research; Transferring of biological resources/ knowledge already accessed in the manner as prescribed, to a third party, applicable to any person who obtained approval of the NBA for accessing biological resources occurring in or obtained from India and/ or associated traditional knowledge for research, commercial utilization, bio-survey or bio-utilization, to Indians/ non-Indians or entities; conducting of non-commercial research or research for emergency purpose outside India by Indian Researchers/ Government Institutions, as per regulation 13 of ABS Guidelines, 2014, applicable exclusively to Indian Researchers/ Government Institutions; depositing of microorganism in non-Indian repository for claim of novel species, applicable only for the Indian Scientist/ Researchers; and registering collaborative research projects involving transfer or exchange of biological resources or information relating thereto between institutions, including Government sponsored institutions of India, and such institutions in other countries; against standard fees and/ or agreement executed with the NBA.
Therefore, NBA not only ensures a mandatory benefit sharing wherein said benefit is generated out of the legitimate exploitation of the biological resources, but also it keeps a track of the R&D activities, which may extend to the source entity of the Biological material as well apart from the Applicant of a patent application dealing with biological material; as well as implementation of the Nagoya Protocol (Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity), an international agreement aiming at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way enforced since October 12, 2014, asking permission from the researchers regarding whether or not to treat certain information as confidential or open source.
However, despite all these efforts, to a great many researchers mostly of Indian origin, NBA appears as a deterrent to their patenting activities, primarily due to its capacity of restricting only those inventors who are using biological material(s) from India. As natural dynamics doesn’t follow politics, and a species that is endemic to India is actually endemic to the Indian sub-continent, not merely restricted to the political boundary of today’s India, and as a statutory body like the NBA may only follow the political boundary when it comes to implementation and enforcement of any Act, the provision of the NBA may easily be bypassed by simply importing the same biological material from any of the neighboring countries in legitimate ways. Given the global village we are now citizens of, it may be impossible to restrict such import, which may result in revenue loss rather than a gain, unemployment, and last but not the least, a depressed number of patents in the biotechnology and pharmaceutical domain. In addition, the NBA generally executes an agreement of benefit sharing with the applicant(s) of a Patent Application or a Patentee; the clauses of said agreement are not settled amicably taking the parties into confidence. Even the percentage of benefit sharing is decided unilaterally through some parameters hitherto unknown to others including the Applicants, giving rise to the allegation of arbitrary determination of said percentage. To address several grievances of the likes as stated in the earlier paragraphs, GoI tabled the Biological Diversity Act Amendment Bill, 2021, and referred it to a JPC (Joint Parliamentary Committee) in order to amend certain provisions of the BD Act, 2002. The amendment generally aims to make scientific research and use of biological diversity for traditional medicines, by reducing the pressure on wild medicinal plants i.e. plants growing in-situ, by encouraging the cultivation of medicinal plants, i.e. ex-situ conservation of medicinal plants, increasing the farming of medicinal plants, increasing the scope of the AYUSH system (the traditional medicine systems either originated or in practice in India like Ayurveda, Yoga, Unani, Siddha and Homoeopathy), facilitating fast-tracking of the research patent application process, transfer of research results by utilising the biological research resources available in India, without compromising the objectives of the Nagoya Protocol, promoting the voluntary access and benefit sharing of resources.
Thus, the amendment would allow people practising traditional Indian systems of medicine like vaids, hakims, registered AYUSH practitioners, companies making medicinal products, to continue their business without needing to take permission from the National Biodiversity Authority (NBA) for the use of biological resources. The second significant point addressed through this amendment is the expansion of the NBA composition by incorporating several ex-officio members from different central government ministries, thus, bringing the biodiversity into national policymaking. The third point is regarding administration of the NBA, putting more impetus to the position of the Secretary, NBA. The position is upgraded to member secretary with more power, in order to match the signatory authority of the Chairman, NBA such that the signature of either the Chairperson or the Member Secretary would be enough to pass orders. This may eliminate the overlap between these two positions, with the environment ministry seeing the secretary as its representative in the Authority, while considering the chairperson at par to an outside council.
Further, if a seed company or a farmers’ group has an approval or a right granted under the PPV&FRA, then similar permissions are not needed under the BD Act, 2002. However, the amendment is opposed on the ground that the corporate or foreign interests could use the loophole of permissions given to traditional medicine and use it for commercial purposes, without sharing of benefits with the conservers of biodiversity. In addition, concerns have been raised as the bill was referred to a JPC, instead of simply putting it before the parliament.
In sum, the BD Act is designed to protect Indian bio-resources from exploitation by anyone, and to share the benefit of its legitimate exploitation. However, while doing so, even the effort of a legitimate exploitation is getting affected resulting in lesser number of patents in a domain, which has already been heavily restricted through non-patentable section 3(c), 3(d), 3(e), 3(h), 3(i), 3(j), 3(p) in tandem with Section 10 of the Indian Patent Act. Thus, although perfectly drafted as argued by many proponents of the BD Act, 2002, sometime, “perfect is the enemy of good”, therefore, a streamlined protocol may be designed by the GoI taking the entire stakeholders into confidence while at the same time enforcing faster decision making. As benefit sharing is mandated only when there is any benefit, and very few patents are actually commercialized, at least, the benefit sharing part may easily be replaced by a mandated increased tax on the revenue earned from the commercialization of inventions in the pharmaceutical and/ or biotechnology domain(s).
