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Mapping Biopiracy In The Ip Landscape

Author: LawSphereX

Category: Property & Real Estate

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MAPPING BIOPIRACY IN THE IP LANDSCAPE

Isha Gupta, Asian Law College, Noida

ABSTRACT

Over the past two decades, multinational corporations have been capitalizing on the traditional knowledge and resources of indigenous communities around the world by patenting them. This paper delves into the key area of dispute - “biopiracy” and examines how the concept of biopiracy can illuminate current and future challenges within the intellectual property rights (IPR) framework, both domestically and internationally. Biopiracy is an emergent term that refers to the appropriation and patenting of genetic resources and Traditional Knowledge and practices, thereby imposing restrictions on their use through intellectual property laws. These practices can exacerbate inequalities as bio-pirates carry out their operations under a veil of legality i. e. , the international patent system. India, a treasure trove of traditional knowledge is home to a diverse range of cultures and customs.

However, the ordeals in enforcing the intellectual property rights in foreign countries make it challenging for India to prevent biopiracy. But India has still made significant strides in protecting its Traditional Knowledge and has successfully challenged several patents and emerged as a protector of its ancient knowledge and practices. This article elucidates the dynamics behind the current stalemate while providing a template for moving forward. Further, it makes an effort to highlight the threat posed by biopiracy and how industrialized nations have wrongfully exploited Traditional Knowledge without due recognition or compensation to indigenous communities and to their knowledge.

By examining the biopiracy allegations in the context of national and international agreements, the article distinguishes rhetoric from reality and concludes with advocating on some suggestions and recommendations which can help in protecting Traditional Knowledge against the menace of biopiracy. Keywords: Biopiracy; Traditional Knowledge; Intellectual Property Rights (IPR); Patents I.

Introduction

Intellectual property rights (IPRs), especially patents, have emerged in recent decades as a key issue in developments across the various fields including law, economics, and the biosciences. and as part of the burgeoning bioeconomy. This paper attempts to examine the concept of “biopiracy”, which evolved to challenge various aspects of the rubric for intellectual property rights pertaining to the ownership and apportioning of benefits from ‘genetic resources’ derived from the world’s biodiversity. Numerous instances of biopiracy have been documented worldwide, including plants like the Neem Tree, Rosy Periwinkle, Hoodia cactus, Enola Bean and Turmeric. The concept of piracy is a central theme running through the international discourse on patent rights. The term “biopiracy” emerged in the early 1990s as a way to question the practice of bioprospecting.

It was first appeared in 1993 in a Communiqué1 by the Rural Advancement Foundation International (RAFI), which has since changed its name to the Action Group on Erosion, Technology and Concentration (ETC). The ETC Group continues to be an active voice in the biopiracy discourse, and its most current definition of biopiracy is: “the appropriation of the knowledge and genetic resources of farming and indigenous communities by individuals or institutions who seek exclusive monopoly control (patents or intellectual property) over these resources and knowledge. ”2 Another prominent figure involved in the early deployment of the term was Vandana Shiva, an Indian scholar, environmental activist and anti - globalization advocate.

She has published a book entitled Biopiracy: The plunder of nature and knowledge3 in 1997, which referred to Biopiracy as the use of intellectual property systems to legitimize the exclusive ownership and control over biological resources and biological products that have been used over centuries in non-industrialized cultures.

1 RAFI Communiqué, December 1993 RAFI, 2 (1993),

https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.etcgroup.org/sites/ww w.etcgroup.org/files/publication/564/01/raficom35comupdates.pdf&ved=2ahUKEwiBtK- Wv9eJAxWx1zgGHQwwCpUQFnoECBkQAQ&sqi=2&usg=AOvVaw1I3u0SjHN6df7v9OencWLF.

2 ETC Group, https://www.etcgroup.org/issues/patents-biopiracy (last visited Nov. 12, 2024).

3 VANDANA SHIVA, BIOPIRACY

THE PLUNDER OF NATURE AND KNOWLEDGE (South End Press 1997).

We can visualize the concept of “Biopiracy" by aforementioned definitions as the unauthorized use of genetic resources and associated traditional knowledge without permission. “Traditional knowledge”, passed down through generations in indigenous and rural communities, is deeply rooted in their connection to local biodiversity,4 that is, plants, fungi, animals, genes and other endemic biological materials. 5 In these cultures the communities often consider biodiversity and knowledge as a common heritage which contributes to their well-being. The unauthorized appropriation of this knowledge i. e. , biopiracy, can be facilitated by the global intellectual property rights which may not adequately address or sanction such practices.

The important treaties regulating traditional knowledge are unclear, and have generated considerable friction and ambiguities regarding how to interpret international contracts involving IPRs. The approach to patenting natural elements involves demonstrating the elements of nature as inventions which have been significantly altered. In applying for a patent, an invention must be useful, novel and non-obvious, thereby, inventors must show their contribution to the natural element is substantial enough to secure the patent protection. We need to broaden our understanding of biopiracy for a deeper understanding of how to address biopiracy effectively. To develop a more complete picture of the term’s influence in challenging conventional notions we move beyond the current narrow readings. In order to do so this paper will proceed in three parts majorly to map the current scenario.

Firstly, discussing the nexus between Biopiracy and Intellectual Property Rights. Then deeper understanding of Biopiracy from Indian Perspective following with some case studies and finally concluding with some suggestions that may help in combating the practice of Biopiracy and a way forward. II.

Nexus between Biopiracy and IPR The focus has shifted from cultivating, gathering, or harvesting the biomaterial itself to extracting and commercializing the genetic information contained within them. In this context, the plant's genetic information, rather than its physical form, holds significant value.

4 T. APTE, A SIMPLE GUIDE TO INTELLECTUAL PROPERTY RIGHTS, BIODIVERSITY AND

TRADITIONAL KNOWLEDGE, (Kalpavriksh, GRAIN, and IIED 2006).

5 L. GRENIER, WORKING WITH INDIGENOUS KNOWLEDGE

A GUIDE FOR RESEARCHERS, ( International Development Research Centre 1998).

Intellectual property rights is a promissory realm that is crucial in this process, allowing for the protection and commercialization of this valuable information. 6 IPRs play a vital role in defining what constitutes an invention and, consequently, what is patentable. This system sets lines of separation around invention and knowledge. In a number of instances of biopiracy, these normative boundaries between nature and knowledge are challenged. The bioeconomy promotes a specific view of nature, where natural elements can be considered inventions if they have been sufficiently modified. To obtain a patent, inventors must demonstrate significant human intervention to prove that their invention is both novel and non-obvious, meaning it differs from existing knowledge.

This process involves explicitly acknowledging the source of ideas from the public domain while highlighting the inventive step that makes the invention patentable. While an invention typically needs to be useful, novel and non-obvious to be patentable, countries like Japan, the United States, and Europe grant patents for plant varieties, which often lack novelty. Indigenous communities possess extensive knowledge regarding the medicinal properties of plants, passed down through generations with incremental improvements. Despite some documentation, its interpretation is cumbersome due the use of local scripts and this often hinders the accessibility of this knowledge. This disparity in documentation can lead to situations where patents are granted to individuals who do not traditionally own this knowledge, allowing them to reap the profits.

7 Biopiracy is mitigated when corporations obtain agreements for bio-prospecting and permission to transfer biological materials and know-how from indigenous or rural communities. The dominant paradigm often views biopiracy as "bad patents" obtained without the consent or benefit-sharing agreements of the communities holding traditional knowledge and safeguarding biodiversity. 8

6 BRON PARRY, TRADING THE GENOME

INVESTIGATING THE COMMODIFICATION OF BIO- INFORMATION, (Columbia University Press 2004). 7 Meeta Biswal and Debidutta Biswal, Issues relating to traditional knowledge systems and intellectual property rights, FOOD AND AGRICULTURAL ORGANIZATION ( Nov. 13 2024, 1:16 AM), https://www.fao.org/4/XII/0911-A3.htm.

8 IKECHI MGBEOJI, GLOBAL BIOPIRACY

PATENTS, PLANTS AND INDIGENOUS KNOWLEDGE, (University of British Columbia Press 2006).

The international legal framework for biodiversity conservation includes various agreements and conventions, with Convention on Biological Diversity (CBD)9 being the most prominent. It is one of the major environmental initiatives to come out of the celebrated 1992 Rio Earth Summit, signed in 1992 and ratified by 196 countries10 which explicitly recognizes the important role of traditional knowledge and practices of indigenous communities in biodiversity conservation and sustainable development. Article 1 explains the primary goals of the convention, that is, to conserve biodiversity, use its components sustainably, and ensure the fair and equitable sharing of benefits derived from the use of genetic resources. This includes providing appropriate access to genetic resources, transferring relevant technologies, and providing adequate funding.

11 While Article 2 of the CBD ambiguously defined genetic resources as "genetic material of actual or potential value"; this definition lacks clarity. 12 The United Nations Declaration on the Rights of Indigenous Peoples13, adopted in 2007, recognizes the importance of respecting indigenous knowledge, cultures, and traditional practices for sustainable and equitable development. Article 31 of the Declaration recognizes that indigenous people have the right to maintain, protect, control and develop their intellectual property over their cultural heritage, traditional knowledge and traditional cultural expressions. The Member States are obligated to take effective measures and work with indigenous communities to recognize and protect their rights effectively.

14 The Nagoya Protocol, adopted in 201015, supplements the CBD by providing a framework for accessing genetic resources and ensuring the fair and equitable sharing of benefits derived from

9 Convention on Biological Diversity, Secretariat of the Convention on Biological Diversity, (1993),

https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.cbd.int/doc/legal/cbden.pdf&ved=2ahUKEwjM0peOydeJAxXeTGwGHXgKCqoQFnoECD4QAQ&sqi=2&usg=AOvVaw0Qz6d9- 4rfVn0CvzOKNEpg.

10 CONVENTION ON BIOLOGICAL DIVERSITY, https://www.cbd.int/youth/0003.shtml (last visited Nov. 13,

2024).

11 CONVENTION ON BIOLOGICAL DIVERSITY,

https://www.cbd.int/convention/articles/default.shtml?a=cbd-01 (last visited Nov. 13, 2024).

12 CONVENTION ON BIOLOGICAL DIVERSITY,

https://www.cbd.int/convention/articles/default.shtml?a=cbd-02 (last visited Nov. 13, 2024).

13 United Nations Declaration on the Rights of Indigenous Peoples, (2007),

https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.un.org/esa/socdev/unp fii/documents/DRIPS_en.pdf&ved=2ahUKEwinspSHzdeJAxUuSGwGHbuJHZwQFnoECBoQAQ&usg=AOvV aw1ZzK9KMPSap9DfwLzlDoSQ.

14 BIOCULTURAL HERITAGE, https://biocultural.iied.org/un-declaration-rights-indigenous-peoples (last

visited Nov. 13, 2024).

15 UNITED NATIONS TREATY COLLECTION,

https://treaties. un. org/pages/ViewDetails. aspx? src=TREATY&mtdsg_no=XXVII-8-b&chapter=27&clang=_en (last visited Nov. 13, 2024). their use. Article 5 of the Protocol focuses on the Fair and Equitable Benefit-Sharing, stating that "Each Party shall take legislative, administrative or policy measures, as appropriate, with the aim of ensuring that benefits arising from the utilization of genetic resources that are held by indigenous and local communities, in accordance with domestic legislation regarding the established rights of these indigenous and local communities over these genetic resources, are shared in a fair and equitable way with the communities concerned, based on mutually agreed terms... Benefits may include monetary and non-monetary benefits, including but not limited to those listed in the Annex.

"16 This appears to suggest that Access and Benefit Sharing (ABS) agreements, which define the fair and equitable sharing of benefits from genetic resource utilization, may involve joint ownership or licensing provisions for intellectual property rights. The World Intellectual Property Organization (WIPO), in collaboration with the ABS Capacity Development Initiative, has provided guidance on how intellectual property issues arise within such agreements. However, the Nagoya Protocol doesn’t cover patents. To fill this gap, a new treaty was agreed upon at a conference in Geneva, by more than 190 nations on 24 May 2024. The Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge17 aims to prevent the commercial exploitation of traditional knowledge by ensuring that patent applications disclose any involvement of such knowledge.

It also allows countries to establish databases of information on genetic resources and associated traditional knowledge, in consultation with indigenous people, local communities, and other stakeholders. In India, there is a well-structured legal regime for the protection of traditional knowledge. The Patents Act, 1970 allows the patent office to reject patent applications for inventions based on traditional knowledge or obtained from communities claiming custody over such knowledge. 18 Traditional knowledge associated with biological resources are protected by the Biological Diversity Act, 2002. The Act mandates that prior informed consent from local communities and the State Biodiversity Board is necessary before accessing genetic materials or related

16 Patenting natural products (part 4):biopiracy, SIMMONS & SIMMONS (Nov. 13, 2024, 2:13 AM),

https://www.simmons-simmons.com/en/publications/ckgupgad9dd9s0997ec6fupy6/patenting-natural-productspart-4-biopiracy.

17 World Intellectual Property Organization (WIPO),

https://www.wipo.int/pressroom/en/articles/2024/article_0007.html (last visited Nov. 13, 2024).

18 The Patents Act, 1970, § 3 (p), No. 39, Acts of Parliament, 1970 (India).

traditional knowledge. Additionally, the Act enables the sharing of benefits derived from the use of traditional knowledge. In 2001, the Council of Scientific and Industrial Research (CSIR) and the Ministry of Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) created the Traditional Knowledge Digital Library (TKDL) to digitally preserve traditional knowledge from various fields, including handicrafts, agriculture, and medicine. By making traditional knowledge accessible in a digital format, the TKDL plays a crucial role in India's efforts to combat biopiracy by protecting its ancient knowledge from misappropriation and exploitation. India, in compliance with its TRIPS obligations, has enacted the Geographical Indications of Goods (Registration and Protection) Act, 1999, which came into effect in 2003.

This act provides for the registration and protection of geographical indications (GIs) associated with goods. GIs identify goods with specific geographical origins and unique qualities or reputations. By enabling the registration and protection of GIs linked to traditional knowledge, this Act safeguards the use of such knowledge. The Indian government, further recognizing the importance of intellectual property rights, introduced the National IPR Policy in 2016. This policy aims to promote the creation, commercialization, and protection of intellectual property assets. To achieve this, the government established the Cell for IPR Promotion and Management (CIPAM) under the aegis of Department for Promotion of Industry and Internal Trade (DPIIT).

The policy encourages researchers in public funded academic and R&D institutions in IPR creation linking it to research funding and career progression. 19 India's efforts to combat biopiracy are significant and ongoing. III.

India’s account on Biopiracy Given the rich biodiversity of India including four prominent biodiversity hotspots and over 47,00020 recorded species of flora, many of which are endemic, India is highly prone to biopiracy. The effectiveness of traditional medicine systems and the potential lack of awareness

19 Bency Baby T and Timmakkondu Narasimman Kuppusami Suriyaprakash, Intellectual Property Rights:

Bioprospecting, Biopiracy and Protection of Traditional Knowledge - An Indian Perspective, INTECHOPEN (Aug. 26, 2021), https://www. intechopen. com/chapters/78249. 20 UNITED NATIONS DEVELOPMENT PROGRAMME, https://www. undp. org/india/india-biodiversityawards-2018 (last visited Nov. 13, 2024). at patent offices make it easier for outsiders to obtain patents on products derived from traditional medical practices. Biopiracy hampres the livelihoods of communities and farmers who have invested their time, care, hard work and knowledge in preserving their heritage. The exploitation of this knowledge by corporations and individuals for profit has led to the misappropriation of valuable resources and practices. India, with its rich biodiversity and traditional knowledge, is particularly susceptible to biopiracy.

Numerous medicinal plants, such as turmeric, neem, aloe-vera, jamun, ashwagandha, and others, have been targeted by biopirates. However, India has actively fought against biopiracy and has successfully revoked several patents granted internationally. Table 1 : List of some Patents based on Traditional Indian Knowledge S. No. Name Indigenous Use Patent No. Purpose

1. Anar

[Punica granatum] Anti diarrheal and wormicidal US Patent 541173321 Anti - viral agent JP911066122 Grey Hair dyeing composition

2. Amla [Phyllanthus

emblica] To prevent grayness of hair

3. Kala Jeera

[Nigella sativa] Treatment of Jaundice, Halitosis and skin diseases US Patent 604283423 US Patent 565398124 Herbal composition for diabetes and method of treatment Use of nigella sativa to increase immune function

5. Tulsi [Ocimum

sanctum] Treatment of skin diseases US Patent 626499526 Herbal composition for reducing inflammation

6. Kali Mirch [Piper nigrum]

Dermatopathy, Used in the preparation of pipla US Patent 634653927 US Patent 553650628 Treatment of skin conditions Use of piperine to increase the bioavailability of nutritional compounds

7. Imli

[Tamarindus indica] Fruit Drink US Patent 547479129 Beverages using tamarind extract

8. Sharifa

[Annona squamosa] Treatment of inflammation, constipation, urinary infection and infertility US Patent 476271630 US Patent 595549731 insecticidal active compound obtained from pulverized annona squamosa extract.

Novel acetogenins isolated from Annona squamosa

10. Adrak

[Zingiber officinale] In rheumatism and inflammation of the liver US Patent 627417733 Method of preparing an extract from Zingiber officinale for antiinflammation and anti-platelet aggregation The issue of bio-piracy is touching threatening horizons at a fast pace because the western countries are seeking to patent crucial traditional and indigenous products. Recently, the growing interest in Ayurveda in western part of the globe, especially Europe and the United States has heightened this concern. Additionally, Geographical Indications (GIs) are under threat from biopirates due to the limitations of domestic regulations in international markets. The need for efficient international regulations, particularly within the World Trade Organization’s Agreement on Trade Related Aspects of Intellectual Property (TRIPS) framework, is evident to protect these valuable assets.

34 The time is ripe and suitable for genuine efforts from the Government, Non Government Organization (NGO)’s, scientists and publishers to protect India's valuable traditional wealth in order to keep highly ambitious pharmaceutical and biotechnological firms in bounds. So far, the Traditional Knowledge Digital Library (TKDL) is a significant step towards preserving, promoting, and disseminating traditional knowledge and using it as ‘Prior Art’35 to challenge illegitimate patent claims. Moreover, 324 patent applications have been either dropped, withdrawn or altered in response to prior art evidence found within the TKDL database. 36 Currently, the TKDL database contains over 4. 54 lakh formulations from texts of traditional systems of India including Ayurveda, Unani, and Siddha. Nevertheless, the following paradigmatic cases studies from India discussed below showcase

33 GOOGLE PATENTS, https://patents.google.com/patent/US6274177B1/en (last visited Nov.13, 2024).

34 Madhu Verma, et al., India- Victim of Bio-Piracy, 4 IAJPR 329, 330 (2014).

35 WIPO INTELLECTUAL PROPERTY HANDBOOK 19 (WIPO Publication No. 489 2004).

36 TKDL, https://www.tkdl.res.in/tkdl/LangFrench/common/Abouttkdl.asp?GL=Eng (last visited Nov. 13,

2024). that patents play a central role in biopiracy activities.

1. Turmeric (Curcuma longa)

Turmeric, a widely used spice in Indian cuisine, has long been recognized for its medicinal properties, including wound healing. It has been used in India for ages to treat burns and wounds. However, in 1995, the United States Patent and Trademark Office (USPTO) issued a patent (US 5401504) to two non -resident Indians linked with University of Mississippi Medical Center for "Use of Turmeric in Wound Healing”. 37 The Indian government, supported by the Council for Scientific and Industrial Research (CSIR), challenged this patent, arguing that the medicinal properties of turmeric were wellknown in Ayurvedic medicine and thus lacked novelty. Their challenge was reinforced by factual proofs of Traditional Knowledge, including ancient Sanskrit texts and a 1953 publication in the Journal of the Indian Medical Association.

After taking into consideration all the debates, in August 1997, the USPTO revoked the patent granted to the University of Mississippi Medical Centre on the basis of lacking the novelty. 38 In the turmeric case, a patent based on Indian traditional Knowledge was successfully contested for the first time, leading to a landmark decision. The US Patent Office cancelled this patent in 1997 after concluding that there was no originality and that the information about the patent had been well-known in India for a long time.

2. Neem (Azadirachta indica A. Juss)

The Neem case refers to a legal dispute between India and the US regarding the patenting of the Neem tree and its medicinal properties by several US-based corporations in the 1990s. In 1994, the European Patent Office (EPO) granted a patent to the US company named W.R. Grace for a method of using hydrophobic extracted Neem oil as fungal control on plants (EPO 436257).39 This was despite the fact that neem has been used for centuries in India as a natural pesticide and its properties are well-documented in traditional Indian medicine. This patent to

37 GOOGLE PATENTS, https://patents.google.com/patent/US5401504A/en (last visited Nov.13, 2024).

38 Johny Soloman Raj and Swaraj Singh Raghuvanshi, Nature of IPR Protection given by Law in Turmeric Case, SSRANA & CO. ( Apr. 18, 2022), https://ssrana.in/articles/nature-of-ipr-protection-given-by-law-in-turmericcase/.

39 GOOGLE PATENTS, https://patents.google.com/patent/EP0436257B1/en (last visited Nov.13, 2024).

W.R. Grace raised concerns about the misappropriation of traditional knowledge and its exploitation for commercial gain. The Indian government subsequently challenged the Neem patent granted by the EPO to a US based company, arguing that the fungicidal properties of Neem were already well-known in India and that the patent infringed upon traditional knowledge of India. After a long legal battle, the EPO revoked the patent in 2000, recognizing the prior use of neem in India and that the patent granted to W.R. Grace lacked novelty and inventive step.40

3. Basmati Rice (Oryza sativa Linn.)

The Basmati rice case involved a legal dispute between India and the United States over the ownership and recognition of Basmati rice as a Geographical Indication (GI). In 1997, RiceTec Inc. , a Texas-based company, obtained a patent (US 5663484)41 from USPTO on Basmati rice lines and grains. India objected to this, arguing that Basmati rice is indigenous to India and that RiceTec's patent amounted to biopiracy. India's Research Foundation for Science, Technology, and Ecology (RFSTE) in order to challenge the validity of the awarded patent, filed an appeal in the Supreme Court of India in public interest, prompting the Indian government to file a "Request for Re-examination". India filed a petition challenging RiceTec's patent application seeking to prevent RiceTec from obtaining a patent on Basmati rice.

The Indian government argued that Basmati rice is a traditional Indian product with a distinct aroma, taste, and cooking quality which had been cultivated in India for centuries. The government expressed concerns that the patent would monopolize the production and export of Basmati rice, impacting the livelihoods of Indian farmers adversely. The USPTO initially granted RiceTec a patent on Basmati rice, but only on certain aspects of its cultivation and not on the rice itself. The patent granted to RiceTec excluded the core components of Basmati rice, such as its grain characteristics, taste, and aroma. The decision by the USPTO was widely criticized in India, and the Indian government filed an appeal. In 2001, the Indian government succeeded in revocation of the patent granted to RiceTec after the USPTO reviewed the case.

The USPTO recognized that Basmati rice was a product indigenous to India and that the use of the term "Basmati" on RiceTec's products was

40 Tarun Khurana and Tanya Saraswat, The Neem Patent Case, MONDAQ (Nov. 13, 2024, 4:29 AM),

https://www.mondaq.com/india/patent/1286020/the-neem-patent-case#authors.

41 GOOGLE PATENTS, https://patents.google.com/patent/US5663484A/en (last visited Nov.13, 2024).

misleading to consumers. This decision was a significant victory for India in protecting its traditional knowledge and geographical indications.42

4. Ashwagandha - The Indian Ginseng (Withania somnifera)

In 2001, American and Japanese companies filed patent applications for formulations and extracts of Ashwagandha. The Japanese firm, Pola Chem Tech, sought a patent for a topical skin ointment regarding cosmetic purposes and to promote fertility, while the US based New England Deaconess Hospital obtained a patent relating to its use to alleviate the symptoms regarding arthritis. Further, in 2006, Natreon Inc., an American multinational company filed a patent application in EPO for Ashwagandha's use in treating various conditions like stress, depression, insomnia and convulsions titled ―Method of Treatment or Management of Stress ( EP 1906980)43.

Out of several patents granted in favour of Ashwagandha, India was successful in revoking only one, providing evidence from the Traditional Knowledge Digital Library (TKDL) and some ancient documents dating back to 12th century to demonstrate the long-standing use of Ashwagandha in traditional Ayurvedic medicine. The European Patent Office (EPO) recognized India's claims and revoked the patent, highlighting the importance of protecting traditional knowledge and preventing biopiracy. As a result of the breathless efforts, on 25th march 2010, EPO decided to dismiss the American’s firm claims over the Indian Ginseng. 44 IV. The Way Forward The adverse effects of bio-piracy on biodiversity can be significant and long-lasting as it is an over-exploitation of biological resources and associated traditional knowledge, leading to a loss of biodiversity.

By theft of traditional knowledge from indigenous communities, biopiracy disrupts their livelihoods and erodes valuable cultural and ecological wisdom. Moreover, these unlawful practices often result in social injustice and economic inequality by exploiting genetic materials and associated traditional knowledge without the consent or fair compensation of the communities from which they are taken. 42 Shahnaz Kaushar, Bio-piracy in India: A practice of patenting traditional knowledge for profit, 1 IPR J. MNLU 54, 58-59 (2023).

43 GOOGLE PATENTS, https://patents.google.com/patent/EP1906980A2 (last visited Nov.13, 2024).

44 Madhu Verma, supra note 34, at 332.

The negative consequences of biopiracy highlight that there is a dire need of modification or amendments in international and national regulations to safeguard interests of indigenous and local communities and prevent the privatization of global knowledge and resources. Government should negotiate and make amendments in the current regulating legal framework including TRIPS, Biodiversity bill, Seed bill and Patent bill as these are enforced in a hurry to comply with global standards, in order to protect traditional knowledge, indigenous innovations, and biodiversity. In India, to address the lack of IPR awareness among professionals, the government should implement widespread awareness programs and workshops to make people well versed with IP protection.

Government should reinforce the non-governmental organizations, legal organizations, scientistic societies and publishers of scientific journals to prioritize and publicize research related to traditional knowledge. Geographical Indications (GIs) only protect a limited number of exported commodities and do not safeguard the rights of creators to use, share, and preserve their knowledge. To prevent the widespread theft of our plants and traditional knowledge, we need a genuine `sui generis' system which is able to protect the collective, community-based innovations embedded in traditional knowledge as a shared societal resource. Patents should not be permissible for genetic resources because by definition, patents do not cover naturally occurring material as they already exist in nature lacking the element of novelty.

Patent law's evolution is hindered by inconsistencies between countries, leading to varying levels of protection. There's a consensus that patent law must adapt to societal issues and increasing globalization and its forth-coming changes. The fundamental question for the global communities is how to reshape patent law to maximize its benefits for society as a whole, rather than primarily serving the interests of individuals, mostly few industrialized nations. This necessitates clearly defined patent regulations and adjustments. Furthermore, regulations should offer enhanced protection to individuals in both developed and developing nations. Developing countries and indigenous groups should prioritize the preservation and protection of their cultural heritage as the most important public policy goal. The patent rights so-formed should be in coherency with this goal.

V. Conclusion

To foster social, economic, and cultural progress, it's essential to encourage intellectual creativity. Intellectual property rights, in all their forms, are crucial for safeguarding traditional cultural expressions. It seems quite clear that biopiracy has significantly altered the rules governing access to and benefit-sharing from genetic resources. Several efforts have been undertaken by governmental organizations (e. g. WTO's Committee on Trade and Environment, Conference of the Parties to the CBD) but due to competing interests of the attending parties progress has been hindered. To address this issue, alternative solutions have been proposed, including protecting traditional knowledge through trade secrets, databases, origin disclosure, and specific agreements. These approaches aim to safeguard traditional knowledge without solely relying on the CBD or TRIPS agreements.

Certainly, no single solution can completely eradicate biopiracy, a combination of approaches can lead to a more equitable sharing of benefits and better conservation of biodiversity. Biopiracy involves exploiting traditional knowledge without acknowledging or compensating the communities who created and maintained it. Thus, this practice infringes upon the rights of indigenous groups and the fair use of natural resources. India has taken steps to address this issue through initiatives like the Traditional Knowledge Digital Library, but more has to be done to protect traditional knowledge and ensure that communities receive due recognition and compensation. It is essential that the international community establish a legal framework that safeguards traditional knowledge and prevents the theft of biodiversity.

Applicants for patents for natural products should be mindful of these issues and consider seeking expert advice. The rapid evolution of intellectual property law in recent years has highlighted the urgent need to address biopiracy on a global scale. While existing international mechanisms and national legislation aim to mitigate biopiracy, there should be a collective responsibility from governments, NGOs, corporations, and communities to nurture innovation based on traditional knowledge for the benefit of mankind within the framework of intellectual property rights.