Introduction
In a world where intellectual property (IP) has emerged as an influential resource in international trade and innovation, the protection of Traditional Knowledge (TK) -the accumulated wisdom, skills, and practices, honed over generations in indigenous and local communities- represents a novel legal challenge. But TK is not exclusive to India. Similar traditional knowledge systems are found in nations like Bolivia and Peru, which have implemented sui generis regimes to acknowledge and safeguard them through community-based legal frameworks. This article argues that while India has made commendable efforts through legislative and institutional tools to defend traditional knowledge, current legal structures remain inadequate in granting proactive and enforceable rights to indigenous communities.
Understanding Traditional Knowledge & IP Limitations
Traditional knowledge is largely passed down orally, is held collectively, and is deeply embedded in community practices. It encompasses a wide range of activities, including Ayurveda, Siddha medical, agricultural and environmental practices. However, TK is typically excluded from standard intellectual property coverage, which is designed to reward uniqueness, innovation, and originality. The reason is because TK is not covered by conventional IP rules mainly because it fails to meet the common standards of identifiable authorship, innovative step, and novelty. This exception complicates obtaining intellectual property protection for remedies that have been in the public domain for years. For instance, even if a tribal healer develops a unique approach using traditional drugs, it becomes challenging to demonstrate originality and fulfil the weight of proof documentary, scientific, or clinical.
This mismatch has resulted in several incidents of theft, in which businesses or scholars get patents for ideas based on long-standing traditional practices without properly acknowledging or compensating the source communities. Such tactics have been dubbed "biopiracy." One well-known instance is the turmeric patent case, in which a U.S. university received a patent on the turmeric's ability to heal wounds. The patent was only withdrawn following CSIR's (Council of Scientific and Industrial Research) intervention and submission of contemporary medical journal publications and ancient Sanskrit literature.
Indian Legal and Institutional Framework
Recognizing the need to counter biopiracy and to assert sovereignty over its traditional resources, India has developed several legal and institutional mechanisms.
1. The Traditional Knowledge Digital Library (TKDL)
One of the most effective Indian solutions has been the establishment of the Traditional Knowledge Digital Library (TKDL) in 2001. The TKDL, a collaborative endeavour of the Council of Scientific and Industrial Research (CSIR) and the Ministry of AYUSH, preserves traditional medical knowledge in languages and formats so that patent claims based on previous art are not allowed.
TKDL has aided in the rejection, withdrawal, or adjustment of over 250 patent applications worldwide based on Indian TK (TKDL, Annual Report 2023).
2. Patent Act, 1970 (as amended)
According to Section 3(p) of the Indian Patents Act of 1970, inventions that are “an aggregation or duplication of known properties of traditionally known components” are not patentable. This provision clearly aims to prevent patents for non-novel TK-based ideas.
Furthermore, Section 10(4)(d) requires disclosure of the geographical origin and source of biological material employed in innovations.
3. Biological Diversity Act, 2002
Notably, the Biological Diversity Act of 2002 regulates access to biological resources and related traditional knowledge (TK). Foreign entities are obliged to seek prior consent from the National Biodiversity Authority (NBA) before exploiting Indian genetic resources or associated information.
The Act seeks equitable benefit-sharing with the local community and prohibits misappropriation under the Access and Benefit Sharing (ABS) system. Although the regulation gives communities more control, there are still implementation issues. Communities frequently lack awareness of their rights, and many benefit-sharing agreements are postponed or not implemented.
Landmark International and Indian Cases
1. Turmeric Patent Case- In 1995, the U.S. Patent and Trademark Office (USPTO) issued a patent to the University of Mississippi for wound healing with turmeric. This was challenged by the Council of Scientific and Industrial Research (CSIR), who presented ancient Sanskrit manuscripts and other evidence testifying to use of turmeric for the same in Indian traditional medicine.
The patent was revoked in 1997, making it one of the first successful international challenges based on traditional knowledge (Gupta, 2002).
2. Neem Patent Case- The European Patent Office (EPO) had issued a patent for a neem oil-based antifungal product to W.R. Grace & Co. Indian government agencies and NGOs presented an opposition, demonstrating that neem's pesticidal activity was a common knowledge in Indian agriculture for centuries. In 2000, the EPO cancelled the patent, admitting the absence of novelty owing to earlier traditional use.
These decisions not only protected Indian TK but also established precedents for the acknowledgment of oral and collective knowledge in patent oppositions.
TK holders worldwide often face difficulties navigating legal systems rooted in unfamiliar norms of individual ownership and commercial exploitation of individual property and commercialization. For instance,
Ayahuasca (US Plant Patent No. 5,751): Granted to American Loren Miller in 1986 for a plant long used by Amazonian shamans. Despite public protests and revocation in 1999, the patent was controversially reinstated in 2001.
Hoodia (P57): Indigenous San communities of southern Africa traditionally used the Hoodia cactus to suppress hunger. CSIR patented P57 and licensed it to global pharma companies without consulting the San, who later secured a benefit-sharing agreement in 2002.
International Law: PCT, WIPO, and FTAs
Traditional knowledge is not automatically recognised or protected by the WIPO-administered Patent Cooperation Treaty (PCT), even if it simplifies the process of submitting patent applications across several countries, unless it is specifically included as prior art in the application. The PCT does not require benefit-sharing or provide protections for mandating disclosure of the source of genetic resources or traditional knowledge. Communities are forced to rely on national laws or contest patents separately in each jurisdiction consequently, which is expensive and unworkable for most TK holders. To address this, several governments have advocated for an international legal framework established by WIPO's Intergovernmental Committee on Intellectual Property and Genetic Resources, which contains draft clauses requiring mandatory disclosure of origin and prior informed permission. However, the implementation of such policies has met pushback from industrialised countries due to perceived constraints on innovation and commerce.
As a possible alternative, bilateral accords and Free Trade accords (FTAs) might contain sections that recognise TK rights and ensure reciprocal enforcement of benefit-sharing commitments. India, for example, might include similar provisions in its FTAs with significant trading partners to improve cross-border enforcement.
Ongoing Challenges in TK Protection
Despite these measures, significant legal and practical gaps remain in the protection of traditional knowledge in the legal protection of TK:
1. Absence of Positive Protection
India must shift from primarily defensive mechanisms like TKDL to establishing positive rights that recognize traditional knowledge as a living, evolving form of innovation. Countries like Peru and Bolivia have adopted sui generis systems that recognize collective ownership, allowing communities to license and derive royalties from TK-based products. India could explore similar frameworks to empower local communities legally and economically. Positive protection would also mean legal recognition of customary laws and internal governance structures of indigenous groups as valid frameworks for TK management, rather than forcing alignment with Western IP paradigms.
As noted by WIPO, positive protection involves “the creation of legal rights that empower communities to prevent others from using their TK or to control its use” (WIPO, 2022).
2. Documentation vs. Oral Traditions
TKDL includes mostly codified knowledge (Ayurveda, Unani, Siddha, etc.) and usually leaves out oral traditions and local practices. Much of tribal and folk knowledge is still unrecorded and at risk.
“Many tribal communities are wary of documenting knowledge due to fears of exploitation,” says Anil Gupta. (Gupta, 2015). An implementation of community-led documentation projects with clear safeguards and benefit-sharing provisions to ensure transparency and trust could lead to better outreach within tribal communities to instil confidence.
3. Mechanisms of Benefit Sharing and Consent
Although the Biological Diversity Act provides for benefit sharing, it has been inadequately implemented. There is limited awareness of rights among most communities, and there is a lack of transparency regarding calculations and distribution of benefits.
As per a 2020 CAG Report on the NBA, several benefit-sharing agreements were delayed or not enforced.
4. International Jurisdiction Issues
Even if India blocks a patent locally, it cannot necessarily prevent misappropriation outside unless steps are taken proactively in every other jurisdiction. This is why international cooperation is necessary. Moreover, the Patent Cooperation Treaty does allow a more streamlined application process across multiple countries, it still does not inherently protect TK unless cited as prior art.
Bilateral or Multilateral treaties enforcing mutual recognition clauses in FTAs could help ensure enforcement of TK protections globally.
Global Models & India’s Role
India led the way at WIPO in calling for a Binding International Legal Instrument on TK. But talks have remained deadlocked owing to differences between developed and developing countries as to the nature and scope of protection. India contends that "misappropriation of TK without benefit-sharing is a form of cultural and economic injustice" (WIPO Intergovernmental Committee on IP and Genetic Resources, 2019).
India has been a strong supporter of a binding international legal instrument on traditional knowledge through the Intergovernmental Committee of WIPO. An increasing consensus on the need for prior informed consent and disclosure of origin for patents containing TK is reflected in the most recent draft wording from 2024. But developed nations still resist legally enforceable commitments.
Some nations, like as Peru and Bolivia, have implemented sui generis (custom) methods to safeguard TK. India might consider implementing similar community-based protection mechanisms that allow local groups to license and manage rights to their knowledge systems.
Recommendations & The Way Forward
To ensure that the law truly keeps up with indigenous wisdom, India must:
1. Develop a sui generis legislation that empowers communities with enforceable rights over TK, including mechanisms for licensing, royalties, and dispute resolution.
2. Enlarge TKDL to cover additional oral and region-specific knowledge systems with the help of local knowledge holders.
3. Enhance grassroot level awareness and capacity building to ensure that communities comprehend and can implement their rights according to the Biological Diversity Act.
4. Strengthen international cooperation in terms of bilateral and multilateral arrangements for mutual recognition of TK protection and application of benefit-sharing obligations.
Conclusion
Traditional knowledge, which is deeply embedded in India's cultural and ecological legacy, continues to confront threats from modern intellectual property frameworks that prioritise human invention above wisdom. However, behind India's advances, such as the TKDL and changes in patent law, lies a much brighter future as India develops a more community-centred, rights-based approach that ensures indigenous knowledge is not only protected against theft but also respected, valued, and fairly rewarded.
To truly protect and uplift indigenous knowledge, India must champion a strategic global agenda which leads negotiations at WIPO for binding treaties, embedding TK clauses in FTAs, and adopting community-driven legal models. Only through such multi-level coordination can traditional knowledge be preserved not just as heritage, but as a vital contributor to equitable innovation in the global IP system.
References
• Council of Scientific and Industrial Research. (2023). TKDL Annual Report. https://www.csir.res.in
• Gupta, A. (2002). Rewarding Traditional Knowledge and Contemporary Grassroots Creativity: The Role of Intellectual Property Protection. IIMA Working Paper.
• World Intellectual Property Organization (WIPO). (2022). Intellectual Property and Traditional Knowledge. https://www.wipo.int/tk/en/
• WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources. (2019). Negotiating Text for an International Legal Instrument.
• Comptroller and Auditor General (CAG) of India. (2020). Performance Audit on the Functioning of the National Biodiversity Authority.
• Patents Act, 1970 (India), Sections 3(p), 10(4)(d).
• Biological Diversity Act, 2002 (India), Sections 3, 6, 21.
• Traditional Knowledge Digital Library, Biopiracy Cases, TKDL, https://www.tkdl.res.in/tkdl/LangDefault/Common/Biopiracy.asp?GL=Eng (last visited June 10, 2025).
• [WIPO IGC, Draft Articles on the Protection of Traditional Knowledge (2024)].
• TKDL, Biopiracy Cases, https://www.tkdl.res.in/tkdl/LangDefault/Common/Biopiracy.asp?GL=Eng (last visited June 10, 2025)].
• [World Intellectual Property Organization (WIPO), Intellectual Property and Traditional Knowledge, https://www.wipo.int/tk/en/ (2022)].
• Anil K. Gupta, Rewarding Conservation of Biological and Genetic Resources and Associated Traditional Knowledge and Contemporary Grassroots Creativity, Indian Institute of Management Ahmedabad Working Paper No. 2003 01 06 (Jan. 2003), https://www.iima.ac.in/sites/default/files/rnpfiles/2003-01-06AnilKGupta.pdf
• [WIPO, Patent Cooperation Treaty: FAQs,
https://www.wipo.int/pct/en/faqs/faqs.html].
• [WIPO, Draft Articles on the Protection of Traditional Knowledge (2024), https://www.wipo.int/meetings/en/details.jsp?meeting_id=75203].
• [Comptroller and Auditor General (CAG) of India, Performance Audit on the Functioning of the National Biodiversity Authority (2020)].
Disclaimer: The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
Authors:
Mohit Porwal, Associate Partner
Krupa Vyas, Associate
Mr. Shubham Naphade, Intern