INTELLECTUAL PROPERTY RIGHTS AND THE PROTECTION OF BIOLOGICAL MATERIALS

This article is written by Sonali Patade of 2^nd Semester of Jitendra Chauhan College of Law, an intern under Legal Vidhiya

ABSTRACT

Intellectual Property Rights (IPR) play a pivotal role in the protection of biological materials, encompassing everything from genetically modified organisms to traditional medicinal products. This study explores the intersection of IPR with biological innovation, addressing challenges like patent eligibility criteria, ethical concerns in bioprospecting and genetic manipulation, biodiversity conservation, and international legal frameworks. It emphasizes the importance of IPR in incentivizing innovation, promoting fair benefit-sharing, and fostering sustainable development. Key international agreements such as the Convention on Biological Diversity (CBD) and the Nagoya Protocol are discussed, alongside India’s legislative enactments aimed at safeguarding biodiversity and indigenous knowledge. The role of the judiciary in adjudicating disputes and ensuring equitable outcomes amidst global dynamics is also highlighted through notable case studies.

Keywords

Intellectual Property Law, Biopiracy, Bioprospecting, Traditional Knowledge, Patent, Biodiversity Conservation, Bioprospecting, Convention of Biological Diversity, TRIPs, Access and Benefit Sharing.

INTRODUCTION

Intellectual Property Rights (IPR) form a cornerstone of modern legal frameworks, playing a pivotal role in protecting innovations across diverse industries, including the intricate domain of biological materials. At its essence, IPR refers to legal rights granted to individuals or entities over creations of the mind, encompassing patents, trademarks, copyrights, and trade secrets. In the realm of biological materials, these rights assume a particularly nuanced and multifaceted character, as they seek to balance the interests of innovators, consumers, and society at large. This introductory exploration aims to dissect the intricate interplay between IPR and biological materials, examining how these rights navigate the complexities of scientific discovery, ethical considerations, commercial interests, and global biodiversity conservation efforts.

The protection of biological materials under IPR spans a broad spectrum of innovations, from genetically modified organisms (GMOs) and hybrid seeds in agriculture to biotechnological breakthroughs in medicine and healthcare. These innovations often represent significant investments of time, resources, and expertise, driving economic growth and technological progress. Consequently, robust IPR regimes are essential not only for incentivizing continued innovation but also for ensuring fair competition and equitable access to benefits derived from these advancements. However, the application of IPR to biological materials is not without its challenges and controversies.

One of the fundamental challenges lies in defining the scope of what constitutes intellectual property in the biological realm. Unlike inventions or artistic works, biological materials often involve living organisms or natural compounds that may have existed long before human discovery or manipulation. This raises complex questions about the extent to which such materials can be owned, controlled, and commercialized without impeding scientific research or infringing on traditional knowledge and community rights. Striking a balance between encouraging innovation and respecting ethical boundaries is thus a critical endeavor for policymakers, legal scholars, and stakeholders alike.

Moreover, the global nature of biological innovation complicates matters further, as legal frameworks vary significantly between jurisdictions. International treaties and agreements, such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Convention on Biological Diversity (CBD), aim to harmonize standards while addressing the unique challenges posed by biological resources. These agreements seek to ensure that benefits derived from the use of genetic resources and traditional knowledge are shared equitably, particularly with indigenous communities and developing countries that are often rich in

Furthermore, the rapid pace of technological innovation in biotechnology and genetic engineering continues to outpace the development of regulatory frameworks and ethical guidelines. Issues such as gene editing, synthetic biology, and the patenting of genes raise profound ethical dilemmas regarding the ownership of life itself and the implications for future generations. As such, ongoing dialogue and collaboration among scientists, policymakers, ethicists, and civil society are essential to ensure that IPR regimes evolve responsibly to meet the challenges and opportunities presented by advances in biological sciences.

WHY IS IT IMPORTANT TO PROTECT BIOLOGICAL MATERIALS THROUGH INTELLECTUAL PROPERTY LAW?

Biological materials dose not only include plants and animals but also pathogenic microorganisms, animal products, human products, genetically modified organisms, viral vectors, etc. In a capitalist world, corporations and individuals seek to derive monetary benefits from such biological materials. These biological and natural resources are regularly capitalized by sectors like pharmaceuticals, cosmetics, agriculture and even academics for research and knowledge transfer. Even Biotechnology which refers to denote the use of living organisms for the production of goods has evolved to encompass techniques ranging from traditional tribal practices to sophisticated genetic modifications and bioinformatics. This progression underscores the integral role of biological materials in advancing scientific and industrial innovations. In this process, many rights associated with biological materials are prone to violation, and therefore, the Intellectual Property Law and the protection of biological materials need to complement each other to devise a balance and solution to the threats. [1]

Using IPR for the protection of biological materials offers numerous benefits, including:

1. Incentivizing Innovation: IPR provides creators and inventors with exclusive rights to their discoveries. This exclusivity encourages investment in research and development (R&D) by ensuring that innovators can gain financial rewards from their efforts.[2]
2. Promoting Commercialization: IPR protection allows innovators to commercialize their discoveries without fear of unauthorized copying or exploitation by competitors. This promotes the transfer of technology from the lab to the market, driving economic growth and job creation.[3]
3. Ensuring Fair Return on Investment: By protecting biological materials, IPR ensures that innovators receive a fair return on their investment. This encourages continued investment in R&D, particularly in costly and risky biotechnological research.[4]
4. Fostering Collaboration and Licensing: IPR facilitates collaboration between researchers, companies, and institutions. Licensing agreements allow innovators to share their technology while retaining control over its use, leading to synergistic partnerships and accelerated innovation.[5]
5. Supporting Ethical and Responsible Use: IPR frameworks often include provisions for ethical considerations, such as access to genetic resources and benefit-sharing with local communities. This ensures that biological materials are used responsibly and sustainably, respecting biodiversity and indigenous knowledge. [6]
6. Contributing to Global Public Health: IPR protection encourages the development of new medicines, vaccines, and agricultural technologies that address global health challenges and food security issues. These innovations can improve quality of life and save lives worldwide.[7]

BIODIVERSITY CONSERVATION

The realm of intellectual property rights (IPR) intersects significantly with biodiversity conservation, particularly in safeguarding biological materials essential for industries like pharmaceuticals, cosmetics, and agriculture. Researchers harness biological and natural resources to develop these products across industries, often seeking legal protections such as patents or technology transfers under IPR. However, this utilization can lead to over-exploitation of resources, posing threats to biodiversity and indigenous community rights. The intersection of biodiversity conservation and IPR necessitates a balanced approach to prevent conflicts and ensure sustainable development. There are many ways in which these effects can be felt.[8] Some of them are:

• Biopiracy

One of the most pressing concerns within this relationship is biopiracy, where bioresources are exploited for profit without fair compensation to the communities that preserve them or acknowledgment of their traditional knowledge. This practice disregards local rights and can lead to significant conflicts between industry and indigenous groups. International frameworks like the Nagoya Protocol aim to address biopiracy by establishing mechanisms for equitable access and benefit-sharing, ensuring communities are involved in biodiversity utilization processes.[9]

• Bioprospecting

In contrast, bioprospecting involves responsibly exploring biological resources for innovative solutions to human challenges. This approach encourages scientific discovery and economic growth while respecting environmental sustainability. However, it also raises concerns about resource depletion and monopolization through patents, necessitating regulatory safeguards to prevent over-exploitation and ensure equitable sharing of benefits.[10]

• Traditional Knowledge

Local communities often hold valuable traditional knowledge about the use of biological resources for medicinal or cultural purposes. Appropriation of this knowledge without proper recognition or compensation can undermine community livelihoods and cultural integrity. Initiatives like India’s Traditional Knowledge Digital Library (TKDL) catalog traditional knowledge to prevent its misappropriation and protect community interests.[11]

INTERNATIONAL AGREEMENTS AND LEGAL FRAMEWORKS

Internationally, two key frameworks address the protection of biological materials and associated intellectual property rights:

Convention on Biological Diversity (CBD):

• The CBD is a multilateral treaty aimed at promoting the conservation of biodiversity, sustainable use of its components, and fair and equitable sharing of benefits arising from genetic resources. It was adopted at the Earth Summit in Rio de Janeiro in 1992 and entered into force in 1993.[12]
• The CBD establishes principles and guidelines for access to genetic resources and the fair and equitable sharing of benefits derived from their use. It emphasizes the importance of respecting the sovereignty of nations over their own biological resources.[13]
• The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization is a supplementary agreement to the CBD, which provides a framework for implementing the CBD’s third objective regarding access to genetic resources and benefit-sharing.[14]

Trade-Related Aspects of Intellectual Property Rights (TRIPS):

• TRIPS is an international agreement administered by the World Trade Organization (WTO), which sets down minimum standards for many forms of intellectual property (IP) regulation, including patents.[15]
• TRIPS requires WTO member countries to provide protection for plant varieties either by patents or by an effective sui generis system, or a combination thereof.[16]
• It provides certain flexibilities for developing countries to adopt measures to protect public health and nutrition, and to promote agricultural production and food security.[17]
• TRIPS also mandates that patents can be granted in any area of technology, as long as the inventions are new, involve creativity, and are suitable for industrial use.[18]

Access and Benefit-Sharing (ABS):

• ABS is a crucial concept within the framework of the Convention on Biological Diversity (CBD), designed to ensure fairness in the utilization of genetic resources and traditional knowledge.[19]
• It aims to promote conservation while ensuring that benefits derived from these resources are shared equitably between countries providing the resources and those using them.[20]
• ABS involves granting access to genetic resources and traditional knowledge in exchange for a fair share of benefits, such as monetary compensation, technology transfer, or capacity building. This approach recognizes genetic resources as the collective heritage of indigenous and local communities, who have preserved them across generations. [21]
• The Nagoya Protocol, established under the CBD, mandates countries to establish national ABS frameworks to govern access to genetic resources. It emphasizes obtaining prior informed consent from providers and aims to balance scientific and commercial interests with the rights of indigenous peoples and local communities.[22]

LEGISLATIVE ENACTMENTS IN INDIA

India is renowned for its vast biological diversity and abundant natural resources, encompassing unique flora and fauna native to its land. The country also hosts numerous indigenous communities and tribes that have safeguarded traditional knowledge across generations, deeply intertwined with local ecosystems for sustenance, medicinal practices, and spiritual beliefs.

Simultaneously, India stands as a rapidly growing economy, emphasizing collaboration between industry and academia to explore and research its natural resources, aiming to harness their commercial potential. Given these dynamics, it is crucial for India to establish a stringent and inclusive legal framework that protects its biological diversity. This necessitates integrating provisions into intellectual property rights (IPR) laws and other legislation, ensuring a delicate balance between safeguarding natural resources and preventing monopolistic exploitation.

Such a legal regime would not only preserve India’s rich biodiversity and indigenous knowledge but also foster sustainable development and equitable benefit-sharing, thereby supporting both conservation efforts and economic growth in harmony. Below are few legislations:

1. Indian Patents Act, 1970: This act provides for the patenting of inventions, including biological materials and processes related to them. Section 3(j) of the Patents Act specifically excludes certain types of biological materials from patentability, such as plants and animals in whole or any part thereof other than microorganisms.[23]
2. Protection of Plant Varieties and Farmers’ Rights Act, 2001 (PPV&FR Act): This legislation aims to set up a robust system to safeguard plant varieties, farmers’ rights, and plant breeders, using a unique system designed specifically for protecting plant varieties apart from patents.[24]
3. Biological Diversity Act, 2002: This act was enacted to provide for conservation of biological diversity, sustainable use of its components, and fair and equitable sharing of benefits arising out of the use of biological resources and associated knowledge.[25]
4. Environment (Protection) Act, 1986: This act provides for the protection and improvement of the environment and includes provisions relevant to the conservation and sustainable use of biological resources.[26]
5. Food Safety and Standards Act, 2006: This act regulates the manufacture, storage, distribution, sale, and import of food to ensure safety and quality. It may apply to biological materials used in food products.[27]
6. Traditional Knowledge Digital Library (TKDL): While not a statute, the TKDL is an initiative of the Indian government to prevent the misappropriation of traditional knowledge by documenting and digitizing traditional medicinal knowledge and other traditional knowledge.[28]
7. National Biodiversity Authority (NBA): Established under the Biological Diversity Act, 2002, the NBA plays a crucial role in regulating access to biological resources and ensuring fair and equitable sharing of benefits arising from their use.[29]
8. Customs Act, 1962: This act empowers customs authorities to regulate the import and export of goods, including biological materials, to prevent illegal trade and ensure compliance with relevant regulations.[30]
9. Wildlife (Protection) Act, 1972: While primarily focused on the protection of wildlife, this act also has implications for the use and conservation of biological resources.[31]
10. Trademarks Act, 1999: This act provides for the registration and protection of trademarks, which can include biological materials used in commerce.[32]
11. Copyright Act, 1957: The Copyright Act provides protection for original literary, artistic, musical, and other creative works, which can include biological materials in certain forms.[33]

ROLE OF INDIAN JUDICIARY

The judiciary plays a crucial role in interpreting and enforcing IPR laws to strike a balance between fostering innovation and safeguarding biological materials. By adjudicating disputes, setting precedents, and interpreting international agreements like the Nagoya Protocol, the judiciary shapes the legal landscape to promote responsible biotechnological advancements while protecting the rights of indigenous communities and ensuring fair benefit-sharing from biological resources. In the recent decades there have been several high-profile cases, where traditional knowledge and indigenous practices intersected with commercial interests. These cases highlight the judiciary’s pivotal role in adjudicating disputes and ensuring equitable outcomes amidst complex global dynamics.

Turmeric Patent Case[34]

Turmeric, a staple herb in India renowned for its medicinal properties, became the center of controversy when the University of Mississippi Medical Center was granted a US patent in 1995 for its wound healing properties. Despite turmeric’s widespread use in Indian households for generations, the patent claimed novelty in using turmeric powder orally and topically for wound healing. The Indian Council for Scientific and Industrial Research (CSIR) contested this patent, providing extensive evidence from ancient texts in Sanskrit, Urdu, and Hindi that documented turmeric’s medicinal uses dating back centuries. The United States Patent and Trademark Office (USPTO) eventually revoked the patent, acknowledging that turmeric’s healing properties were widely known and not novel, thus safeguarding India’s traditional knowledge.

Neem Patent Case[35]

Similarly, the neem tree, revered in India for its medicinal and agricultural benefits, faced patent challenges when W.R. Grace and the US Department of Agriculture filed a patent in the European Patent Office (EPO) for a method using neem oil to control fungi on plants. The Research Foundation for Science, Technology and Ecology (RFSTE) and international allies opposed the patent, citing ancient Indian Ayurvedic texts that detailed neem’s therapeutic uses. The EPO ultimately revoked the patent, recognizing that the methods claimed were already known and utilized in India for centuries, emphasizing the importance of prior art and traditional knowledge protection in patent disputes.

Basmati Patent Case[36]

Basmati rice, renowned for its aromatic qualities, became the subject of contention when the US granted a patent to RiceTec Inc. for certain strains of Basmati rice that allegedly enhanced yield and quality. The Indian government and advocacy groups contested the patent’s claims, arguing that Basmati rice varieties had been cultivated and refined by farmers in India and Pakistan over centuries. Although the patent was narrowed to specific claims related to grain characteristics, the case highlighted broader concerns about biotechnological patents and the implications for traditional agricultural practices.

CHALLENGES

Obtaining patents, copyrights, or trademarks for biological products presents several unique challenges due to the nature of biological materials and their intersection with intellectual property law. “According to J.D. Houvener, founder and CEO of Bold IP, an examiner may attempt to reject a biotechnology patent application by asserting that the scientist’s invention is merely a replication of something naturally occurring in nature. The argument would be that the scientist has created an obvious variation of what already exists in nature, which would not qualify for patent protection. This issue is particularly pronounced in cases involving genetically modified organisms, tissues, and cells.[37]

Regarding novelty, the primary challenge lies in demonstrating that the biotechnological product or process being patented is genuinely new and not merely a natural occurrence. The inventor must also prove that their invention is the first of its kind worldwide to perform the specified action.

While any technological innovation can potentially be patented, the patentability of biological materials often sparks debate. Some contend that biological materials are discoveries and thus ineligible for patents. Others argue that certain biological materials are inventions created by humans, hence deserving of patent protection.

Another aspect that complicates biotechnological inventions is that biological materials have the ability to reproduce themselves. This means that a biological material might be patentable in its current form, but its subsequent changes or developments raise questions about whether the original patent covers these alterations or not.

In some jurisdictions, the patentability of living organisms, particularly genetically modified organisms (GMOs), can be contentious. There may be specific regulations or ethical considerations surrounding the patenting of living organisms, especially if they are deemed to have intrinsic value or rights.

There are also ethical concerns related to biopiracy, where biological resources or traditional knowledge of indigenous communities are exploited without proper authorization or benefit sharing agreements. Patent offices and international treaties increasingly address these issues to protect indigenous rights and biodiversity.[38]

CONCLUSION

In conclusion, the protection of biological materials through Intellectual Property Rights is essential for balancing innovation with ethical and sustainable use. IPR incentivizes research and development in biotechnology, pharmaceuticals, and agriculture by granting creators exclusive rights and ensuring fair returns on investments. However, the exploitation of biological resources without equitable benefit-sharing can lead to conflicts, especially concerning indigenous rights and biodiversity conservation. International agreements like the CBD and the Nagoya Protocol provide frameworks for responsible access to genetic resources and traditional knowledge, emphasizing prior informed consent and fair benefit-sharing. In India, robust legislative measures such as the Biological Diversity Act and the Protection of Plant Varieties and Farmers’ Rights Act aim to protect biodiversity while promoting economic growth. The judiciary plays a crucial role in interpreting IPR laws and adjudicating disputes to strike a balance between fostering innovation and safeguarding biological diversity. Moving forward, it is imperative to strengthen international cooperation and regulatory frameworks to ensure that biological materials are used responsibly for the benefit of all stakeholders, including future generations.

REFERENCES

• Jakob Edler, Hugh Cameron and Mohammad Hajhashem, THE INTERSECTION OF INTELLECTUAL PROPERTY RIGHTS AND INNOVATION POLICY MAKING – A LITERATURE REVIEW, World Intellectual Property Organization Report (Jul. 5, 2025, 3:00 PM), https://www.wipo.int/edocs/pubdocs/en/wipo_report_ip_inn.pdf
• National Institute of health, http://www.techtransfer.nih.gov/partnerships/licensing-faqs#:~:text=A%20biological%20materials%20license%20is,protection%20will%20not%20be%20obtained. (Jul. 5, 2024, 4:47 PM)
• Jakob Edler, Hugh Cameron and Mohammad Hajhashem, THE INTERSECTION OF INTELLECTUAL PROPERTY RIGHTS AND INNOVATION POLICY MAKING – A LITERATURE REVIEW, World Intellectual Property Organization Report (Jul. 5, 2025, 3:00 PM), https://www.wipo.int/edocs/pubdocs/en/wipo_report_ip_inn.pdf
• Arya Senapati, Relationship between Intellectual Property Rights and Biodiversity Conservation, Law Sakho (Jul. 7, 2024, 6:32 PM), https://blog.ipleaders.in/ipr-and-biodiversity/#:~:text=The%20Indian%20Patents%20Act%2C%201970,preventing%20the%20loss%20of%20biodiversity.
• Suvarna Pandey, Biopiracy related to Traditional Knowledge & Patenting issues, S. Majumdar & Co. (Jul. 8, 2024, 4:30 PM), https://www.birac.nic.in/webcontent/dib.pdf
• Arya Senapati, Relationship between Intellectual Property Rights and Biodiversity Conservation, Law Sakho (Jul. 7, 2024, 6:32 PM), https://blog.ipleaders.in/ipr-and-biodiversity/#:~:text=The%20Indian%20Patents%20Act%2C%201970,preventing%20the%20loss%20of%20biodiversity.
• Rahul Yadav, Bio-diversity issues with Intellectual property rights: Special reference to India, Research Gate (Jul. 7, 2024, 5:14 PM)
• Arya Senapati, Relationship between Intellectual Property Rights and Biodiversity Conservation, Law Sakho (Jul. 7. 2024, 6:32 PM), https://blog.ipleaders.in/ipr-and-biodiversity/#:~:text=The%20Indian%20Patents%20Act%2C%201970,preventing%20the%20loss%20of%20biodiversity.
• Indian Patents Act, 1970 § 3(j), No. 39, Acts of Parliament, 1970 (India).
• Protection of Plant Varieties and Farmers’ Rights Act, 2001 (PPV&FR Act), No. 53, Acts of Parliament, 2001 (India).
• Biological Diversity Act, 2002, No. 18, Acts of Parliament, 2002 (India).
• Environment (Protection) Act, 1986, No. 29, Acts of Parliament, 1986 (India).
• Food Safety and Standards Act, 2006, No. 34, Acts of Parliament, 2006 (India).
• Traditional Knowledge Digital Library (TKDL), https://www.tkdl.res.in/tkdl/langdefault/common/Abouttkdl.asp?GL=Eng
• National Biodiversity Authority (NBA), http://nbaindia.org/content/22/2/1/aboutnba.html
• Customs Act, 1962, No. 53, Acts of Parliament, 1962 (India).
• Wildlife (Protection) Act, 1972, No. 53, Acts of Parliament, 1972 (India).
• Trademarks Act, 1999, No. 47, Acts of Parliament, 1999 (India).
• Copyright Act, 1957
• Saipriya Balasubramanian, Traditional Knowledge and Patent Issues: an overview of Turmeric, Basmati, Neem cases, Singh & Associates (Jul. 8, 2014, 3:00 PM), https://www.manupatrafast.in/NewsletterArchives/listing/SAIPTech%20Singh%20Associates/2017/Mar/IPTech%20March17.pdf
• Carly Klein, The complications around patenting biotechnology, Labiotech (Jul.8, 2024, 3.37 PM)  https://www.labiotech.eu/in-depth/biotechnology-patents-intellectual-property/
• Suvarna Pandey, Biopiracy related to Traditional Knowledge & Patenting issues, S. Majumdar & Co. (Jul. 8, 2024, 4:30 PM), https://www.birac.nic.in/webcontent/dib.pdf

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[1] Jakob Edler, Hugh Cameron and Mohammad Hajhashem, THE INTERSECTION OF INTELLECTUAL PROPERTY RIGHTS AND INNOVATION POLICY MAKING – A LITERATURE REVIEW, World Intellectual Property Organization Report (Jul. 5, 2025, 3:00 PM), https://www.wipo.int/edocs/pubdocs/en/wipo_report_ip_inn.pdf

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] National Institute of health, http://www.techtransfer.nih.gov/partnerships/licensing-faqs#:~:text=A%20biological%20materials%20license%20is,protection%20will%20not%20be%20obtained.

(Jul. 5, 2024, 4:47 PM)

[6] Jakob Edler, Hugh Cameron and Mohammad Hajhashem, THE INTERSECTION OF INTELLECTUAL PROPERTY RIGHTS AND INNOVATION POLICY MAKING – A LITERATURE REVIEW, World Intellectual Property Organization Report (Jul. 5, 2025, 3:00 PM), https://www.wipo.int/edocs/pubdocs/en/wipo_report_ip_inn.pdf

[7] Ibid.

[8] Arya Senapati, Relationship between Intellectual Property Rights and Biodiversity Conservation, Law Sakho (Jul. 7, 2024, 6:32 PM), https://blog.ipleaders.in/ipr-and-biodiversity/#:~:text=The%20Indian%20Patents%20Act%2C%201970,preventing%20the%20loss%20of%20biodiversity.

[9] Suvarna Pandey, Biopiracy related to Traditional Knowledge & Patenting issues, S. Majumdar & Co. (Jul. 8, 2024, 4:30 PM), https://www.birac.nic.in/webcontent/dib.pdf

[10] Arya Senapati, Relationship between Intellectual Property Rights and Biodiversity Conservation, Law Sakho (Jul. 7, 2024, 6:32 PM), https://blog.ipleaders.in/ipr-and-biodiversity/#:~:text=The%20Indian%20Patents%20Act%2C%201970,preventing%20the%20loss%20of%20biodiversity.

[11] Rahul Yadav, Bio-diversity issues with Intellectual property rights: Special reference to India, Research Gate (Jul. 7, 2024, 5:14 PM)

[12] Arya Senapati, Relationship between Intellectual Property Rights and Biodiversity Conservation, Law Sakho (Jul. 7. 2024, 6:32 PM), https://blog.ipleaders.in/ipr-and-biodiversity/#:~:text=The%20Indian%20Patents%20Act%2C%201970,preventing%20the%20loss%20of%20biodiversity.

[13] Ibid.

[14] Ibid.

[15] Ibid.

[16] Ibid.

[17] Ibid.

[18] Ibid.

[19] Ibid.

[20] Ibid.

[21] Ibid.

[22] Ibid.

[23] Indian Patents Act, 1970 § 3(j), No. 39, Acts of Parliament, 1970 (India).

[24] Protection of Plant Varieties and Farmers’ Rights Act, 2001 (PPV&FR Act), No. 53, Acts of Parliament, 2001 (India).

[25] Biological Diversity Act, 2002, No. 18, Acts of Parliament, 2002 (India).

[26] Environment (Protection) Act, 1986, No. 29, Acts of Parliament, 1986 (India).

[27] Food Safety and Standards Act, 2006, No. 34, Acts of Parliament, 2006 (India).

[28] Traditional Knowledge Digital Library (TKDL), https://www.tkdl.res.in/tkdl/langdefault/common/Abouttkdl.asp?GL=Eng

[29] National Biodiversity Authority (NBA), http://nbaindia.org/content/22/2/1/aboutnba.html

[30] Customs Act, 1962, No. 53, Acts of Parliament, 1962 (India).

[31] Wildlife (Protection) Act, 1972, No. 53, Acts of Parliament, 1972 (India).

[32] Trademarks Act, 1999, No. 47, Acts of Parliament, 1999 (India).

[33] Copyright Act, 1957

[34] Saipriya Balasubramanian, Traditional Knowledge and Patent Issues: an overview of Turmeric, Basmati, Neem cases, Singh & Associates (Jul. 8, 2014, 3:00 PM), https://www.manupatrafast.in/NewsletterArchives/listing/SAIPTech%20Singh%20Associates/2017/Mar/IPTech%20March17.pdf

[35] Ibid.

[36] Ibid.

[37] Carly Klein, The complications around patenting biotechnology, Labiotech (Jul.8, 2024, 3.37 PM)  https://www.labiotech.eu/in-depth/biotechnology-patents-intellectual-property/

[38] Suvarna Pandey, Biopiracy related to Traditional Knowledge & Patenting issues, S. Majumdar & Co. (Jul. 8, 2024, 4:30 PM), https://www.birac.nic.in/webcontent/dib.pdf

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