Indian Indigenous Knowledge And Patent Rights - Case Studies In Bioprospecting
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Category: Intellectual Property
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INDIAN INDIGENOUS KNOWLEDGE AND PATENT
RIGHTS: CASE STUDIES IN BIOPROSPECTING
Sai Lakshmi. S & K. Adhitya, VIT School of Law, Chennai.
ABSTRACT
The convergence of Indian Indigenous Knowledge and bioprospecting with patent rights is a key area to explore, exhibiting deep significance in cultural, legal, and ethical contexts. Bioprospecting, promising trade and medicinal returns, tends to result in exploitative practices overlooking the contributions made by Indigenous groups. Indian law, in the form of the Indian Patents Act and the Biological Diversity Act, is intended to protect traditional knowledge from biopiracy, but serious issues in implementation and enforcement persist. Significant case studies involving Neem, Turmeric, and Basmati rice reflect the complexity of defending Indigenous knowledge from spurious patent claims by foreign companies.
The creation of the Traditional Knowledge Digital Library (TKDL) is an anticipatory measure to prevent biopiracy, although it does not formally provide Indigenous communities with ownership rights. To increase protection for Indigenous knowledge, community engagement in decisionmaking and enhancing benefit-sharing agreements must be ensured. In addition, tackling systemic issues in patent systems and calling for international legal reforms are vital to ensure fair recognition of Indigenous inputs. This research stresses the importance of a collective effort in safeguarding Indigenous knowledge and ensuring ethical bioprospecting to achieve fair and sustainable results for all involved stakeholders. Keywords: Indigenous Knowledge; Bioprospecting; Patent Rights; Biopiracy; Traditional Knowledge Digital Library; Benefit-Sharing.
1. INTRODUCTION
Bioprospecting is the search for plants, animals, and microbial species for academic, pharmaceutical, biotechnological, agricultural, and other industrial purposes. In the prospect of finding patentable products, inventors have led expeditions into the wild and dark to scout commercially viable genetic material1. The core of the Indigenous community lies in their rooted practices and knowledge which often lies within their close-knit company. Lack of awareness among the community has led to unjust exploitation by people who tend to call themselves ‘inventors’, and take away the knowledge that was guarded for generations. Patent rules governing biological resources seek to regulate the ownership and commercialisation of inventions generated from natural sources. The Indian Patents Act of
1970 (as revised in 2005), the Biological Diversity Act of 2002, and international accords such
as the Convention on Biological Diversity (CBD) and the Nagoya Protocol all contribute to India's legal framework controlling patents and biological resources. These laws aim to combat biopiracy, ensure equitable benefit-sharing, and protect indigenous knowledge through systems like as the Traditional Knowledge Digital Library (TKDL), which records traditional medical knowledge to prevent unauthorised patents. However, there still exists friction as foreign corporations knowingly or unknowingly step into the boundaries of traditional knowledge and try to patent it. At times, it even proved to be successful, and this calls for action in order to protect what is truly ours. The purpose of this study is to investigate the interaction between indigenous knowledge, bioprospecting, and patent rights in India.
This study will look at major case studies to better understand the challenges and legal mechanisms involved in preserving traditional knowledge. It will also consider policy recommendations to improve the protection of indigenous knowledge while encouraging sustainable and ethical bioprospecting techniques. The scope of this study includes an examination of existing Indian and international legal frameworks, the role of indigenous groups in biodiversity protection, and case studies
1 Padma Nambisan, Biodiversity and Sharing of Biological Resources, AN INTRODUCTION TO ETHICAL,
SAFETY AND INTELLECTUAL PROPERTY RIGHTS ISSUES IN BIOTECHNOLOGY, ACADEMIC
PRESS, 189 – 209 (2017).
exhibiting conflicts and settlements in patent rights associated with bioprospecting. By highlighting these factors, this study hopes to add to the continuing discussion about the fair and ethical use of indigenous knowledge in scientific and commercial applications.
2. LITERATURE REVIEW
Vandana Shiva in her journal has quoted that “Bioprospecting is a sophisticated form of Biopiracy” which nothing but takes away every last bit of knowledge that is available to the poor and creates a community that is surrounded by poverty even though providing compensation to some individuals as mere eye-wash2. On the whole, there is a lack of recognition and acknowledgement of the contributions of indigenous societies to the discovery of new medicines that have benefited humanity, which is important to validate indigenous knowledge systems. The importance of biodiversity conservation for the health of the 80% of the world's population that relies on medicinal plants for primary healthcare is often overlooked, with the focus being on the value for industrialized nations3.
In ‘Traditional Knowledge Digital Library: A Distinctive Approach to protect and promote Indian indigenous medicinal treasure’, the authors worked on the relationship between traditional knowledge and intellectual property rights. Reports of many medicinal plants and certain practices like yoga being wrongly patented necessitate the requirement to have a systematized database that will contain all the records about indigenous knowledge4.
3. INDIGENOUS KNOWLEDGE AND BIOPROSPECTING
Globalisation has opened the market systems which provide both opportunities as well challenges to Indigenous communities. Through the dissemination of knowledge, the world has benefitted from getting to know the varied benefits that knowledge has to offer and at the same, the benefits are eroded due to the commercialisation of the same knowledge which
2 Vandana Shiva, Bioprospecting as Sophisticated Biopiracy, 32 THE UNIVERSITY OF CHICAGO PRESS,
307-313 (2007).
3 Katy Morn et al., Biodiversity Prospecting: Lessons and Prospects, 30 ANNUAL REVIEW OF
ANTHROPOLOGY, 505 – 526 (2001).
4 Saikat Sen & Raja Chakraborty, Traditional Knowledge Digital Library: a distinctive approach to protect and promote Indian indigenous medicinal treasure, 106 CURRENT SCIENCE, 1340 – 1342 (2014).
causes conflicts. The majority of times, it so happens that the products even lose their significance as the focus is now on how to commodify and market them. There are many variants of herbal medicines and cosmetics available in the market, which boast their medicinal abilities as mere unique selling propositions to garner attention towards their products. Healing practices which look into community well-being and spirituality are reduced to a business process. Once, the products reach the consumer's ears, the clout behind the same tends to increase and then comes the pressure of demand which in turn leads to more production. However, the demand further tends to make people forget the rich value it holds consequently, with many pseudo products taking its place. This tends to cause disrepute to the product as well apart from disrupting the biodiversity. Ms.
Vandana Shiva, an Indian scientist and activist, launched a project named ‘Navdanya’, to raise awareness about the unique properties of the seeds and crops. She educated the farmers about how to conserve their produce and linked it to how to get away with climate change as the homogenisation of the crops was dangerous. She also believed that multinational businesses plundered the biological resources of poorer countries without seeking their approval or sharing the rewards. In her 1997 book, Biopiracy: The Plunder of Nature and Knowledge, she claimed that these techniques amounted to biological larceny. Her other works in this context also highlight how the corporate domination of genetic resources5. Another cause affecting indigenous knowledge is rapid westernisation and urbanisation which tends the masses to alter their life which severs them from their nativity and its practices.
The international framework of laws such as TRIPS, have pressured developing nations to conform to Western-style patent systems, often at the expense of indigenous knowledge protection6. The question of ethical consideration also finds a place when it comes to the use of indigenous knowledge primarily for laying the foundation of fairness. Hence, as Dutfield has pointed out in ‘Intellectual Property, Biogenetic Resources and Traditional Knowledge’ it is imperative to follow protocols to ensure that a basic level of give and take is followed. To ensure that Indigenous groups are informed about the use of their knowledge and have the
5 The Information Architects of Encyclopaedia Britannica, Vandana Shiva, ENCYCLOPEDIA BRITANNICA,
https://www.britannica.com/facts/Vandana-Shiva.
IIED
Briefing, Protecting traditional knowledge from the grassroots up (2009), https://www.iied.org/sites/default/files/pdfs/migrate/17067IIED.pdf .
opportunity to negotiate fair terms, corporations and researchers must obtain Prior Informed Consent (PIC) from the community before accessing indigenous knowledge or biological resources. Equitable Benefit-Sharing Agreements (EBSAs) ensure that communities receive both financial and non-financial benefits, such as infrastructure, educational resources, or healthcare support. Another aspect that has to be given importance is the community should not be passive onlookers but rather active participants in the management of resources. The Convention on Biological Diversity and Nagoya Protocol encourage such participatory approaches but require stronger enforcement mechanisms7.
4. PATENT LAWS AND BIOPROSPECTING IN INDIA
The aspect of indigenous knowledge alongside the varied biodiversity riches, makes the legal framework dynamic having political, economic and cultural influences over it. The Indian Patent Act, of 1970, as originally enacted, excluded the patenting of life forms altogether, reflecting a protectionist and public welfare-oriented policy. The Act was amended in 2002 and 2005 to comply with India's obligations under the TRIPS Agreement (Trade- Related Aspects of Intellectual Property Rights), which mandates patent protection in all fields of technology, including biotechnology. However, India maintained safeguards. Section 3(j) of the Act expressly excludes the “plants and animals in whole or any part thereof other than microorganisms” from patentability, along with “essentially biological processes for production or propagation of plants and animals”8.
The exclusion, however, confused what comes under the ambit of ‘micro-organisms’. The Biological Diversity Act (BDA), 2002, was passed by India to combat biopiracy and safeguard traditional knowledge. Under the 1992 Convention on Biological Diversity (CBD), which places a strong emphasis on sovereign rights over biological resources, this law was a direct reaction to global concerns. The BDA creates a three-tiered structure that includes local Biodiversity Management Committees, State Biodiversity Boards, and the National Biodiversity Authority (NBA). 7 UNEP, Cultural and Spiritual Values of Biodiversity, https://proyectodeautonomia. wordpress. com/wpcontent/uploads/2018/04/1999-posey-cultural_spiritual_thebible. pdf .
8 The Patents Act, 1970, Act No. 39 of 1970, - Reference to Section 3.
In accordance with the TRIPS, CBD and Nagoya Protocol, the Act mandates benefit-sharing mechanisms, ensuring that local communities are compensated for their knowledge and resources and any person seeking a patent based on Indian biological resources must obtain prior approval from the NBA9. Nevertheless, there also lies bureaucratic hurdles in the system and unclear terms of benefit sharing10.
5. CASE STUDIES
With the revelation of new knowledge, there came new challenges on how to safeguard the knowledge that originally belonged to our country. • Neem case Neem's antifungal and pesticidal qualities have been utilised for ages by Indian farmers and traditional healers. A U. S. -based corporation, W. R. Grace, and the U. S. Department of Agriculture were granted a patent in the 1990s for a process of extracting neem oil that has antifungal properties. Under the leadership of individuals such as Vandana Shiva, Indian activists, scientists, and environmentalists contested the patent before the European Patent Office (EPO), claiming that the usage of neem was not new or creative because it was customary knowledge. Since there was prior art in Indian agricultural and medical practices, the EPO invalidated the patent in 2000, stating that the approach was not novel.
This case emphasised the requirement of proper documentation11. • Turmeric case A similar situation involved the spice turmeric (Curcuma longa), which has a long history in
Indian medicine and cooking. A U.S. patent (No. 5,401,504) for the application of turmeric in wound healing was awarded to two scientists of Indian descent at the University of Mississippi Medical Centre in 1995. But for millennia, Ayurvedic writings have extensively recorded these 9 Krishna Ravi Srinivas, Protecting Traditional Knowledge Holders' Interests and Preventing Misappropriation— Traditional Knowledge Commons and Biocultural Protocols: Necessary but Not Sufficient?, 19 IJCP (2012).
10 Harry Jonas et al., Community Protocols and Access and Benefit Sharing, 12 RIS, 49 – 76 (2010).
11 Vandana Shiva, Special Report: Golden Rice and Neem: Biopatents and the Appropriation of Women's
Environmental Knowledge, 29 WOMEN’S STUDIES QUARTERLY, 12 – 23 (2001).
applications. In their legal challenge, the Council of Scientific and Industrial Research (CSIR) presented recorded proof of turmeric's long-standing medicinal use from ancient Sanskrit writings and medical treatises. For lack of innovation, the United States Patent and Trademark Office (USPTO) revoked the patent in 1997. This highlighted on scripting all knowledge and practice that lies unscripted12. • Basmati case The worldwide patent regimes' shortcomings in honouring the cultural and geographic origins of agricultural goods were further highlighted by the Basmati rice patent dispute. Under the title "Basmati rice lines and grains," the USPTO awarded Patent No. 5,663,484 to RiceTec Inc. , a U. S. -based corporation, in 1997 for an aromatic rice strain that resembles Indian Basmati.
The Indian government and civil society organisations objected, claiming that RiceTec was trying to monopolise a term associated with South Asian history and had only crossed existing Indian and Pakistani Basmati types. The USPTO eliminated multiple claims that connected the rice to the term "Basmati" as a result, partially rescinding the patent13. • Hoodia and Arogyapacha The South African Council for Scientific and Industrial Research (CSIR) owned a patent on the Hoodia cactus, which the San people of Southern Africa traditionally used to stifle hunger during protracted hunts. Pharmaceutical companies were granted licenses to use the patent. International criticism resulted from the San people's initial lack of consultation and compensation. A benefit-sharing arrangement was eventually struck, acknowledging the San as possessing important knowledge14.
Similarly, Arogyapacha (Trichopus zeylanicus travancoricus), a plant utilised by the Kani tribal people in Kerala to maintain their energy and endurance, is an analogous case in India. The
12 Anusree Bhowmick et al., A Brief Review On The Turmeric Patent Case With ItsImplications On The
Documentation On The Documentation Of Traditional Knowledge, 1 NDC – E- BIOS, 83 – 88 (2021). 13 Kasturi Das, Protection of Geographical Indications: An Overview of Select Issues with Particular Reference to India, SSRN ELECTRONIC JOURNAL (2007).
14 Roger Chennells, Traditional Knowledge And Benefit Sharing After The
Nagoya Protocol: Three Cases From South Africa, 9 LEAD, 165 – 183.
plant was used to create the medication Jeevani by the Tropical Botanic Garden and Research Institute (TBGRI), which also signed a commercial licensing contract. Crucially, a trust fund was established to distribute a percentage of the revenues to the Kani tribe. Although frequently praised as an example of benefit-sharing, subsequent criticisms contend that the Kani had little say in decision-making, which raises questions regarding the definition and allocation of "benefit15. " India changed its legal systems in response to these bioprospecting instances in order to better protect biodiversity and traditional knowledge. To catalogue traditional medical knowledge in ways that patent examiners around the world can access, the Traditional Knowledge Digital Library (TKDL) was established.
More than 250 patent applications based on Indian traditional knowledge have been blocked by the TKDL as of 202316. Through these cases, India has pushed for TRIPS revisions that would require patent applicants to provide proof of prior informed permission and the source of biological materials. India has used its experiences to push for greater acknowledgement of traditional knowledge in international forums, even if suggestions to reform TRIPS are still being discussed.
6. CHALLENGES AND CONTROVERSIES IN PROTECTING INDIGENOUS
KNOWLEDGE
Biopiracy v. Bioprospecting
A fundamental controversy in protecting indigenous knowledge lies in differentiating biopiracy
from bioprospecting. Bioprospecting, in theory, refers to the scientific exploration of biological resources for commercial or medicinal applications, often with ethical agreements on benefitsharing. In contrast, biopiracy refers to the unauthorized appropriation of indigenous resources or knowledge without compensating or acknowledging the original custodians. Cases like the Neem and Turmeric patents granted in the U.S. exemplify biopiracy, where companies sought exclusive rights over traditional uses of plants that had been known for centuries in India. Such incidents underscore the loopholes in global patent laws, where
15 C.R. Bijoy, Access And Benefit Sharing From The Indigenous Peoples’ Perspective:
The Tbgri-Kani ‘Model, 3 LEAD, 3 – 19. 16 Ijinu TP, Access and Benefit Sharing in Indigenous Knowledge Stewardship and Sustainable Development, BIODIVERSITY CONSERVATION THROUGH ACCESS AND BENEFIT SHARING, 163 – 185, (2023).
companies claim novelty and industrial applicability without considering the vast historical record of indigenous use. The challenge lies in creating mechanisms that allow ethical bioprospecting while preventing biopiracy—ensuring that commercial benefits derived from traditional knowledge are shared equitably with Indigenous communities17. • The Role of TKDL India created the Traditional Information Digital Library (TKDL), a library of recorded traditional medical information, mostly from Ayurvedic, Unani, and Siddha systems, to fight biopiracy. To prevent erroneous patents on existing knowledge, the TKDL gives patent examiners access to prior art about traditional knowledge around the globe. Over 250 patent applications have been revoked or prevented by the TKDL since its founding in countries including the US, Europe, and Japan.
However, the TKDL does not grant indigenous groups ownership rights, even though it is a prophylactic measure against biopiracy. Critics contend that although it shields traditional knowledge from outside exploitation, it does not grant the communities that have been conserving it for generations any legal recognition or financial advantages. • Integration of oral traditions into patent systems The fact that a large portion of indigenous knowledge does not have written documentation makes it extremely difficult to preserve. Indigenous spiritual knowledge, farming methods, and medical practices are frequently transmitted orally throughout generations. However, because patent systems depend on written records and concrete evidence of innovation, oral traditions have a hard time being accepted as prior art.
For example, while the TKDL has documented many practices from ancient texts, millions of knowledge systems remain undocumented, particularly those of tribal and rural communities. Without formal records, these communities face difficulty proving ownership when corporations patent similar knowledge. Additionally, legal definitions of “novelty” and “inventiveness” favour modern scientific methodologies, often disregarding holistic and 17 Gurdial Singh Nijar, Incorporating Traditional Knowledge in an International Regime on Access to Genetic Resources and Benefit Sharing: Problems and Prospects, 21 EUROPEAN JOURNAL OF INTERNATIONAL LAW, 457 – 475 (2010).
traditional approaches. This leads to an asymmetry where corporations can modify traditional knowledge slightly and claim patents, while indigenous groups struggle to assert their claims under Western IP regimes18. Many researches have shown that a possible solution to this problem is collective ownership. • Issues with Benefit Sharing Even when patents or commercial products derive from indigenous knowledge, fair benefitsharing remains a critical issue. The Convention on Biological Diversity (CBD, 1992) and its Nagoya Protocol (2010) stress that access to genetic resources and traditional knowledge should come with prior informed consent (PIC) and mutually agreed terms (MAT) to ensure fair compensation. However, in practice, benefit-sharing agreements are often inadequate or poorly implemented.
Furthermore, corporations often negotiate directly with government bodies rather than indigenous groups, excluding the true knowledge holders from discussions. The legal and bureaucratic hurdles in accessing benefits discourage many communities from engaging in IP claims. To address this, there needs to be greater legal empowerment of indigenous groups, ensuring their active participation in decision-making and resource management19.
7. CONCLUSION
The intersection of indigenous knowledge, bioprospecting, and patent rights in India presents a complex challenge that requires a multi-faceted approach for resolution. While legal frameworks such as the Indian Patents Act, the Biological Diversity Act, and international agreements like the Nagoya Protocol have provided a foundation for protecting traditional knowledge, significant gaps remain in implementation, enforcement, and benefit-sharing mechanisms. Addressing these gaps is crucial to ensuring that indigenous communities receive rightful recognition and compensation for their invaluable contributions. One crucial step forward is to increase community participation in decision-making processes.
Indigenous organisations must be able to actively participate in negotiations, patent 18 Carlos M Correa, Issues and options surrounding the protection of traditional knowledge, QUNO, 2 – 25. Dr. Rakesh Shah, Access and Benefit Sharing of Biological Resources,
IGNFA
https://www.ignfa.gov.in/document/biodiversity-cell-ntfp-related-issues1.pdf.
discussions, and benefit-sharing agreements. Legal reforms should provide clearer standards for gaining Prior Informed Consent (PIC) and Equitable Benefit-Sharing Agreements (EBSA), ensuring that commercial enterprises use traditional knowledge ethically and transparently. Furthermore, documenting oral traditions remains a significant difficulty. The expansion of the Traditional Knowledge Digital Library (TKDL) should include procedures for recording and validating orally conveyed knowledge. Creating community-led archives and incorporating contemporary technology to archive indigenous practices can help prevent biopiracy while preserving the validity of traditional knowledge systems. Global advocacy is another critical stage.
India must continue to advocate for international patent law reforms that demand disclosure of the origin of biological resources and verification of informed permission. This would prevent multinationals from unfairly claiming patents for indigenous knowledge. Furthermore, promoting sustainable bioprospecting strategies can help strike a balance between commercial research and biodiversity conservation. Promoting ethical relationships among scientists, industries, and indigenous populations can boost innovation while also maintaining cultural and environmental sustainability. Finally, protecting indigenous knowledge necessitates a collaborative effort that incorporates legal, technological, and ethical considerations.
Strengthening indigenous rights, improving documentation tactics, implementing stronger rules, and supporting sustainable bioprospecting will contribute to a future in which traditional knowledge is honoured, preserved, and properly shared.