This Article is written by Nameera Meraj, of Aligarh Muslim University.
Traditional Knowledge (TK) represents the cumulative body of knowledge, practices, and innovations developed by indigenous and local communities over generations. In India, communities actively preserve and transmit such knowledge through systems like Ayurveda, agriculture, biodiversity conservation, and cultural traditions.
However, globalization and the expansion of intellectual property (IP) regimes have exposed TK to exploitation, particularly through biopiracy, the unauthorized commercial use of biological resources and associated knowledge without consent or compensation.
India has responded to this challenge through a combination of legislative safeguards and defensive IP mechanisms, positioning itself as a global leader in TK protection. Yet, the persistence of biopiracy highlights the need for a more nuanced and community-centric legal framework.
Understanding Biopiracy
Biopiracy refers to the misappropriation of biological resources and traditional knowledge by individuals or corporations, typically through the patent system, without recognizing or compensating the original knowledge holders. This phenomenon stems from the incompatibility between modern intellectual property regimes, which emphasize novelty and individual ownership, and traditional knowledge systems, which communities collectively hold, transmit across generations, and often leave undocumented.
Biopiracy involves the unauthorized extraction and commercial exploitation of biological resources and associated traditional knowledge, without fairly compensating indigenous or local communities.
- Traditional Knowledge (TK):
According to the World Intellectual Property Organization, Traditional Knowledge includes “knowledge, know-how, skills, and practices that communities develop, sustain, and pass on from generation to generation, often forming part of their cultural or spiritual identity.
- Genetic Resources:
Under the Convention on Biological Diversity, “genetic resources” means genetic material of actual or potential value.
- Access and Benefit Sharing (ABS):
The concept of ABS, recognized under the Nagoya Protocol, refers to the fair and equitable sharing of benefits arising from the utilization of genetic resources with the provider communities.
Legal Framework for Protection in India
India follows a multi-layered legal approach to protect TK, combining biodiversity laws with intellectual property regulations.
The Biological Diversity Act, 2002, serves as the cornerstone of this framework. It regulates access to biological resources through the National Biodiversity Authority (NBA) and mandates prior approval for foreign entities. It also incorporates the principle of Access and Benefit Sharing (ABS), ensuring that local communities receive a share of benefits arising from commercialisation.
The Patents Act, 1970 (as amended in 2005) plays a crucial role in preventing biopiracy. Section 3(p) explicitly excludes traditional knowledge from patentability, while mandatory disclosure requirements ensure transparency regarding the source of biological materials.
A significant innovation in India’s approach is the Traditional Knowledge Digital Library (TKDL), which documents traditional medicinal knowledge and makes it accessible to patent examiners worldwide. By establishing TK as prior art, it has successfully prevented numerous wrongful patents.
Additionally, laws such as the Geographical Indications of Goods Act, 1999 and the Protection of Plant Varieties and Farmers’ Rights Act, 2001, provide indirect protection by safeguarding community-based products and farmers’ rights.
Case laws
India’s legal framework has been shaped by landmark cases that exposed the vulnerabilities of traditional knowledge.
In the Turmeric Patent Case (University of Mississippi Medical Center v. USPTO, 1995),a patent granted in the United States for turmeric’s wound-healing properties was successfully challenged by India’s Council of Scientific and Industrial Research (CSIR). The patent was revoked after evidence of prior use in Indian traditional medicine was presented.
Similarly, in the Neem Patent Case (European Patent Office, 2000),a patent granted to foreign entities for neem-based fungicides was revoked on the grounds that such uses were already well known in India.
Another significant case is Basmati Rice Patent (RiceTec Inc. v. USPTO), where attempts to patent certain rice strains were contested by India, highlighting concerns over geographical and cultural misappropriation.
These cases demonstrate the importance of documentation and legal vigilance in combating biopiracy.
International Legal Framework
At the global level, TK protection is addressed through multiple legal instruments. The Convention on Biological Diversity (1992) recognizes state sovereignty over biological resources and promotes protection of traditional knowledge. The Nagoya Protocol (2010) establishes a framework for fair and equitable benefit-sharing.
The TRIPS Agreement allows member states to adopt sui generis systems for plant variety protection, indirectly supporting TK protection. The UN Declaration on the Rights of Indigenous Peoples (2007) affirms the rights of communities over their knowledge systems.
A major recent development is the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge (2024), which introduces mandatory disclosure requirements in patent applications, strengthening global efforts against biopiracy.
Challenges and Structural Limitations in Protecting Traditional Knowledge
While India has emerged as a global leader in defensive protection of traditional knowledge (TK), particularly through mechanisms such as the TKDL, the existing framework suffers from deep structural limitations that hinder its effectiveness in delivering tangible benefits to indigenous and local communities.
A primary concern lies in the documentation gap. The TKDL largely focuses on codified systems such as Ayurveda, Unani, and Siddha, leaving vast reservoirs of folk and tribal knowledge undocumented. Since much of this knowledge is transmitted orally across generations, it remains highly susceptible to misappropriation and biopiracy.
Closely linked to this is the challenge of identifying rightful knowledge holders. India does not formally recognize “indigenous peoples” as a legal category in the TK context, instead using the broader term “local communities.” Given the collective and evolving nature of TK, identifying specific rights holders becomes legally complex.
Another major limitation is the failure of benefit-sharing mechanisms under the Biological Diversity Act, 2002. Although the law mandates equitable sharing of benefits, its implementation has been weak due to bureaucratic delays, lack of transparency, and limited awareness among communities.
India’s framework is also criticized for its over-reliance on defensive protection. While it effectively prevents wrongful patents, it does not grant communities positive, enforceable rights to commercially exploit their knowledge.
Further, the fragmentation of legal provisions across multiple statutes creates administrative inefficiencies and weakens enforcement. The absence of a dedicated sui generis law tailored to the unique nature of TK remains a critical gap.
Finally, a widespread lack of awareness at the grassroots level continues to undermine the effectiveness of legal protections, leaving communities vulnerable to exploitation.
Recent Legislative and Policy Developments (Post-2022)
Since 2022, India has witnessed a significant shift in its approach to governing traditional knowledge, moving from a purely protective stance toward a framework that attempts to balance community rights with ease of doing business.
The Protection of Traditional Knowledge Bill, 2022, introduced by Shashi Tharoor as a Private Member’s Bill, represents an important attempt to create a dedicated legal regime for TK.The Bill proposes that ownership of traditional knowledge within a state vests in the government, a provision that has attracted criticism for potentially undermining community autonomy. It also introduces the concept of “Knowledge Societies,” requiring communities to formally register as legal entities to act as custodians of their knowledge. Furthermore, it envisages the establishment of a National Authority on Traditional Knowledge (NATK) and corresponding State Boards, along with a centralized docketing system. The Bill mandates benefit-sharing agreements and proposes the creation of a National Traditional Knowledge Fund to support practitioners. However, concerns remain regarding its centralized structure and its impact on grassroots empowerment.
A more immediate and impactful reform is the Biological Diversity (Amendment) Act, 2023, which significantly modifies the earlier 2002 framework. One of its most debated features is the decriminalization of offences, replacing imprisonment with monetary penalties ranging from ₹1 lakh to ₹1 crore. The amendment also introduces exemptions for AYUSH practitioners and users of codified traditional knowledge, removing the requirement for prior approval and benefit-sharing in certain cases. While this aims to promote ease of doing business, it raises concerns about weakening safeguards for local communities. Additionally, the amendment streamlines patent procedures by requiring NBA approval only before patent grant, rather than at the application stage. It also allows the NBA to negotiate benefit-sharing on behalf of communities, potentially reducing the role of local Biodiversity Management Committees.
At the international level, the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge (2024) marks a landmark development. By introducing mandatory disclosure requirements for patent applicants regarding the origin of genetic resources and associated TK, the treaty strengthens global safeguards against biopiracy and aligns with India’s long-standing demands for greater transparency in the international IP system.
Conclusion
The protection of traditional knowledge in India reflects a dynamic interplay between law, culture, and economic policy. While India has developed one of the most advanced defensive frameworks in the world, significant challenges remain in ensuring that these protections translate into real benefits for communities. The recent legislative developments indicate a shift toward reform, but their long-term impact will depend on how effectively they balance commercialization with community rights. Ultimately, safeguarding traditional knowledge requires not only legal innovation but also a commitment to equity, inclusivity, and cultural preservation.
Frequently Asked Questions
What is biopiracy?
Biopiracy refers to the unauthorized commercial use of biological resources or traditional knowledge without compensating the original communities.
How does India protect traditional knowledge?
Through laws like the Biological Diversity Act, the Patents Act, and mechanisms such as the TKDL.
What is the significance of the TKDL?
It documents traditional knowledge and prevents wrongful patents by establishing pror art.
What is new in the 2023 amendment?
It introduces decriminalization, exemptions for AYUSH practitioners, and streamlined patent procedures.
References
World Intellectual Property Organization (WIPO), Traditional Knowledge (WIPO, Geneva), available at: https://share.google/VF1XNL4xxPDWHWuiW (last visited Apr. 2026).
Convention on Biological Diversity, 1992, Art. 2 https://share.google/TaPeOdHWAEILMDf4V (last visited Apr. 2026).
Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, 2010 https://share.google/RfxNRVRQZUjH9DW4x (last visited Apr. 2026).
The Patents Act, 1970 (as amended in 2005), § 3(p) https://share.google/grT7dIC1DrgcdqEor (last visited Apr. 2026).
Traditional Knowledge Digital Library (TKDL), Government of India, available at: https://share.google/lAKlzsLiMoi6CnGZ7 (last visited Apr. 2026).
