The Convention on Biological Diversity (CBD), ratified by 159 member countries in 1992, plays a pivotal role in the conservation of biological diversity, sustainable utilization of bio-resources, and equitable sharing of benefits from their use. The CBD emphasizes each nation's right to devise its own environmental policies and methods for utilizing and exploiting bio-resources, while ensuring the protection of environments in other national jurisdictions with Patent and Indian Biodiversity Act
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Indian Patents Act and Indian Biodiversity
The Indian Patents Act, a crucial piece of legislation in India's intellectual property regime, establishes the framework for granting patents while also integrating considerations for the protection of bio-resources and traditional knowledge. This Act outlines the balance between promoting innovation and safeguarding the country's rich biodiversity and indigenous knowledge
Non-Patentable Traditional Knowledge
Section 3(p): This section plays a pivotal role in protecting traditional knowledge, which is an integral part of India's cultural and natural heritage.
By declaring inventions related to traditional knowledge as non-patentable, the Act prevents the commercial exploitation and patenting of knowledge that has been passed down through generations within communities in India.
This provision serves as a barrier against biopiracy and unauthorized commercialization of ancient wisdom.
Restrictions on Patenting Life Forms
Section 3(j): In recognition of the ethical, environmental, and cultural concerns associated with the ownership of life forms, this section prohibits the patenting of plants, animals, and essentially biological processes for their production or propagation.
This includes seeds, varieties, species, and even methods of agriculture and horticulture. The rationale behind this restriction is to prevent monopolization over biological resources that are crucial for food security and ecological balance.
Disclosure Requirements
Section 10(4)(ii): Transparency and accountability are key in the use of biological materials. This section mandates the disclosure of the source and geographical origin of the biological material used in the patent application. This requirement serves multiple purposes:
Conservation of Biodiversity: It helps in tracking the use of biological resources and ensuring their sustainable utilization.
Protecting Indigenous Rights: It acknowledges and protects the rights of indigenous communities over their resources and knowledge.
Compliance with International Agreements: It aligns with international treaties like the Budapest Treaty, which India is a party to, ensuring that biological materials are deposited in internationally recognized repositories.
Consequences of Non-Disclosure
Invalidation of Patent Rights: If an inventor fails to disclose the source and origin of biological material, the patent can be invalidated. This provision ensures that inventors cannot bypass the ethical and legal requirements concerning the use of biological resources.
Pre- and Post-grant Opposition: Sections 25(1)(j) and 25(2)(j) allow for opposition to the grant of a patent if there is non-disclosure or misrepresentation of the source of biological material. This acts as a check against the misuse of biological resources and protects the interests of the resource custodians.
Invalidation and Opposition Grounds
Anticipation by Traditional Knowledge: Sections 64(p) and 64(q), along with sections 25(1)(k) and 25(2)(k), provide grounds for invalidation or opposition of a patent if the invention is already known through traditional knowledge. This is crucial in a country like India, where a rich heritage of indigenous knowledge exists, often undocumented in formal literature.
Gap in Benefit Sharing Mechanisms
Despite these robust provisions, a notable gap in the Indian Patents Act is the absence of a mechanism for benefit sharing from inventions derived from Indian biological resources and associated knowledge. This is a critical area that needs attention, as it involves the ethical aspect of compensating and acknowledging the contributions of local communities and indigenous people who have been the custodians and creators of traditional knowledge and biological resources.
CBD and the Biodiversity Act of India, 2002
The Convention on Biological Diversity (CBD) and the Biological Diversity Act of India, 2002, collectively form a comprehensive framework for the conservation, sustainable use, and equitable sharing of benefits arising from the utilization of biological resources. India, as a signatory to the CBD, has integrated these global principles into its national legislation through the Biological Diversity Act (BDA), which encompasses a wide range of provisions to protect and manage its rich biodiversity
Provisions of the Biological Diversity Act
The Biological Diversity Act (BDA) of India aims to conserve, sustainably utilize, and equitably share benefits from the utilization of India's biological resources and associated knowledge. Key definitions under the Act include:
Benefit Claimers: This term is significant in the context of the BDA as it recognizes and empowers those individuals or communities who have traditionally conserved biological resources. These claimers not only conserve but also possess knowledge and information about the use of these resources. They are often the unsung heroes who play a vital role in sustaining ecosystems and have invaluable indigenous knowledge.
Biological Diversity: The BDA defines this as the variability among living organisms and their ecological complexes. This includes diversity within species, between species, and of ecosystems. The Act acknowledges the complexity of biodiversity, encompassing everything from genetic diversity within a species to the variety of ecosystems.
Biological Resources:Under the Act, these are broadly categorized as plants, animals, microorganisms, and their parts and genetic material, excluding value-added products. The exclusion of human genetic material is particularly notable, reflecting ethical considerations.
Bio-survey and Bio-utilization: These terms refer to the systematic survey or collection of species, genes, and components of biological resources. This encompasses a range of activities from basic research to the commercial application of biological resources
Commercial Utilization: The Act defines this as the end uses of biological resources for commercial purposes, like pharmaceuticals, food additives, and cosmetics. It specifically excludes conventional breeding or traditional practices, acknowledging the need to balance commercial interests with the preservation of traditional practices.
Fair and Equitable Benefit Sharing: Benefits determined by the National Biodiversity Authority (NBA) under section 21. This principle mandates that benefits arising from the use of biological resources and associated knowledge must be shared in a fair and equitable manner. This is crucial for ensuring that the communities providing these resources are duly compensated and acknowledged.
Research: efined as the systematic study of biological resources, this includes technological applications that use biological systems or derivatives to develop or modify products or processes.
State Biodiversity Board: Each Indian state has a Biodiversity Board, which plays a critical role in regulating the use of biological resources within the state and ensuring compliance with the Act’s provisions.
Sustainable Use: This is defined as the utilization of biological diversity in a way that does not lead to its long-term decline, ensuring that it can meet the needs of both current and future generations.
Value-Added Products: Products derived from biological resources that are processed to the point that their original biological nature is unrecognizable or physically inseparable.
Regulatory Framework
Section 3: This section addresses the need for foreign entities, including non-resident Indians (NRIs), to obtain approval from the National Biodiversity Authority (NBA) for accessing India’s biological material and associated knowledge. This provision ensures that any exploitation of India's biological resources by foreign parties is regulated and that benefits arising from such use are equitably shared.
Section 7: It mandates that Indian citizens or organizations intending to use biological resources for commercial purposes must provide prior intimation to the State Biodiversity Board. This ensures that local resources are not exploited without oversight and that benefits are shared with local communities.
Impact and Significance
The BDA represents a significant step in the protection and sustainable management of India’s biodiversity. By integrating the principles of the CBD into national law, it provides a legal framework for the conservation of biological diversity, sustainable use of its components, and fair and equitable sharing of benefits. The Act plays a critical role in recognizing and protecting the rights of indigenous communities and local populations, who have been the traditional stewards of these resources. It also establishes a regulatory mechanism to control access to biological resources and associated knowledge, ensuring that such access is subject to equitable benefit-sharing agreements.
Benifit Sharing under Biodiversity Act
Benefit sharing, as articulated in Section 21 of the Biological Diversity Act (BDA) of India, is a fundamental component that underpins the equitable distribution of benefits derived from the use of biological resources. The National Biodiversity Authority (NBA) plays a crucial role in overseeing and implementing these provisions. Let's explore the various aspects of benefit sharing in greater detail:
Joint Ownership of Intellectual Property Rights
Collaborative Rights: This approach involves granting joint ownership of intellectual property rights (IPRs) related to biological resources to the NBA, benefit claimers, or both. This ensures that local communities or individuals who have contributed to the development of a product or process through their traditional knowledge or resources get a share in the IPRs.
Empowerment through IPRs: It allows communities to have a stake in the profits and decision-making processes related to the commercialization of products or technologies derived from their resources.
Technology Transfer
Access to Technologies: The NBA can facilitate the transfer of new technologies, especially those that are relevant to the conservation and sustainable use of biodiversity, to benefit claimers.
Capacity Building: Technology transfer can also include training and capacity building for local communities, enabling them to utilize these technologies for their benefit.
Setting up Production and R&D Units
Local Development: Establishing production, research, and development units in areas where biological resources are sourced can lead to economic development and job creation in these regions.
Community Engagement: This can also ensure that local communities are directly involved in and benefit from the commercialization of their resources.
Involving Indian Scientists, Benefit Claimers, and Local People in R&D
Participatory Research: Involving local communities, scientists, and benefit claimers in research and development activities related to biological resources ensures that the research is grounded in local knowledge and needs.
Knowledge Exchange: This collaboration can lead to a more sustainable and culturally sensitive approach to biodiversity research and product development.
Establishing a Venture Capital Fund
Financial Support: Setting up a venture capital fund can provide the necessary financial resources for benefit claimers to start their own ventures related to the sustainable use of biological resources.
Entrepreneurship Promotion: Such funds can help in nurturing local entrepreneurship and innovation in the field of biodiversity.
Monetary and Non-Monetary Compensation
Direct Financial Benefits: Monetary compensation to benefit claimers can include a share in the profits generated from the commercial use of biological resources or traditional knowledge.
Non-Monetary Benefits: These can include improvements in local infrastructure, healthcare, education, and other community development projects as a form of benefit sharing.
Holistic Approach to Benefit Sharing
The comprehensive approach to benefit sharing under the BDA is not just about compensating local communities but also about creating a sustainable model where the use of biological resources benefits all stakeholders. This includes respecting and preserving traditional knowledge, fostering innovation, and ensuring that the economic benefits derived from biodiversity are distributed fairly.
The Biological Diversity Act of India, 2002, aligns with international conventions and addresses local needs and conditions. It not only protects biodiversity and traditional knowledge but also ensures that the exploitation of these resources, whether for research or commercial purposes, is conducted in a responsible and sustainable manner.