A few weeks ago, when India was featured in the 2025 USTR Section 301 Priority Watch List, Dr. Anson CJ explored the idea of whether India should come up with its own watch list to monitor biopiracy. Taking that idea forward, Achyuth B Nandan explains why the Biopiracy watchlist is the need of the hour and how it can be implemented in light of India’s Biodiversity Laws. Achyuth is an LLM candidate at Rajiv Gandhi School of Intellectual Property Law, IIT Kharagpur, specializing in intellectual property law. He is also an advocate registered with the Bar Council of Kerala. His previous post can be accessed here.
Operationalising India’s Biopiracy Watch List: A Strategic Proposal for Inclusive Global IP Accountability
By Achyuth B Nandan
Building on Dr. Anson CJ’s compelling call for India to create a Biopiracy Watch List, this piece argues that such a countermeasure should not be seen as a retaliatory gesture to India’s recurring placement on the USTR’s Special 301 Report, but rather as a legitimate diplomatic tool grounded in India’s biodiversity laws.
A well-structured, evidence-based biopiracy watchlist is the need of the hour, a vital step for biodiverse nations to collectively safeguard their genetic resources and traditional knowledge from systemic misappropriation. In this evolving landscape of global IP governance, India, with its long-standing leadership in Biodiplomacy, is uniquely positioned to take the lead and shape a more equitable and accountable regime.
Why the Biopiracy Watchlist Isn’t Another 301: Advancing CBD’s Ideals of Fairness and Equity
The Special 301 Report derives its authority from section 301 of the U.S. Trade Act of 1974, specifically under the “Omnibus Trade and Competitiveness Act of 1988,” which mandates the United States Trade Representative (USTR) to identify countries that deny adequate and effective protection of intellectual property rights or fair market access for U.S. entities relying on IP protection. Through this report, the USTR annually classifies countries into categories such as the “Priority Watch List” and “Watch List”, often triggering diplomatic pressure and potential trade consequences. The watch list system of the US is largely perceived as a selective scrutiny that disregards domestic policy considerations and the balance between IP enforcement and socio-economic development. As such, the Special 301 Report reveals the asymmetries in global IP governance, where developed countries unilaterally assess the adequacy of other nations’ IP laws without reciprocal accountability.
The most important distinction between the proposed biopiracy watchlist and the Special 301 Report lies in their fundamental purpose and operational approach. The Special 301 Report functions as an end in itself, with its main objective being selective, unilateral scrutiny that often results in shaming and judgment against countries, particularly those from the Global South. It is widely criticised for its lack of informed, expert, and empirically based inputs, thereby undermining its credibility and fairness.
In contrast, the biopiracy watchlist is not a dead-end mechanism. The instances it flags can be addressed on a post facto basis, allowing for prospective benefit-sharing, a core aspect of fairness and equity under the Convention on Biological Diversity (CBD). This prospective approach ensures that the watchlist acts as a constructive tool, facilitating ongoing dialogue and corrective measures rather than imposing punitive judgments. Just as the TRIPS Agreement and the intellectual property system play a crucial role in shaping international compliance, the CBD and the Nagoya Protocol framework are equally important for ensuring fair and equitable sharing of benefits arising out of the use of genetic resources and associated traditional knowledge. Bringing issues of non-compliance into public discourse is essential, not as a means of naming and shaming, but as a constructive tool to incentivise global adherence to user country obligations under these frameworks.
In the intellectual property system, international traction and compliance have been largely driven by the availability of reliable data and transparent monitoring mechanisms. In contrast, the biodiversity governance framework suffers from a significant gap in data availability and transparency, which hampers effective tracking and monitoring of genetic resources and associated traditional knowledge once they leave the territory of the source country. Addressing this data deficit is critical to strengthening compliance, facilitating benefit-sharing, and enhancing accountability within the global biodiversity regime. Thus, the biopiracy watchlist serves as a forward-looking instrument that upholds principles of fairness, equity, and collaborative governance, rather than merely functioning as a tool for unilateral condemnation.
What is the Legal Basis for a Biopiracy Watch List in India?
It is pivotal to emphasize that the well-reasoned proposal for a Biopiracy Watch List must be anchored in statutory authority rather than remain a hypothetical or rhetorical exercise. The statutory foundation for such a watch list finds support in Section 18(4) of the Biological Diversity (Amendment) Act 2023. This provision empowers the National Biodiversity Authority (NBA), acting on behalf of the Central Government, to take necessary measures to oppose the grant of intellectual property rights in any foreign jurisdiction concerning biological resources originating from or brought from India, including those deposited in repositories abroad, as well as associated traditional knowledge. This clause reflects a similar intent to the USTR’s Special 301 Report, but within the framework of genetic resources and traditional knowledge, thereby offering a clear legal basis for establishing an Indian Biopiracy Watch List. Similarly, Section 19(4) of the Biological Diversity Act mandates that approvals and rejections related to the use of biological resources and traditional knowledge in India must be published. The purpose of this provision is to reveal whether access to genetic resources has been obtained in compliance with the law or in violation of it. To enhance transparency, this requirement should also be extended to foreign patent applications. Therefore, these provisions equip the NBA to create a Biopiracy Watch List or a similar report, governed under the Biological Diversity Act.
Even though the NBA has not formally initiated such measures, a precedent for compiling biopiracy instances already exists. The Traditional Knowledge Digital Library (TKDL), a collaborative initiative between the CSIR and the Ministry of AYUSH, has documented and published a comprehensive list of biopiracy cases involving Indian traditional knowledge and biological resources. This compilation includes cases where patent claims were either modified, withdrawn, or rejected based on prior art evidence from TKDL, spanning jurisdictions such as the European Patent Office (EPO), United States Patent and Trademark Office (USPTO), and others. These documented outcomes from 2011 to 2023 demonstrate the practical utility of systematically tracking and challenging misappropriation of traditional knowledge through evidentiary support. (See fig)
TKDL Outcomes against Bio-Piracy based on the data downloaded from the TKDL website
But a downside of this data is that not all European Patent Office (EPO) outcomes listed by the TKDL (as shown in the table) as successes appear to have been triggered primarily or decisively by TKDL submissions. As highlighted by patent attorney Tufty the Cat, in several cases the cited TKDL evidence was either redundant or less influential than prior examiner-cited art, raising questions about the actual impact of TKDL in those instances. For example, in the widely circulated EP2251029 case involving milk as a laxative, the application had already faced multiple substantive objections based on non-TKDL prior art before any TKDL-related third-party observations were filed. Thus, while TKDL is an important defensive tool against biopiracy, overstatements regarding its efficacy risk undermining the credibility of evidence-based interventions. This further underscore the need for a robust, transparent, and verifiable biopiracy watchlist, one that is grounded in documented case analysis, legally significant outcomes, and an honest assessment of the role played by TK-related interventions. Such a system would be better aligned with international expectations of fairness and evidence-driven policy-making.
India’s Leadership in Biodiplomacy
India has emerged as a key player in global biodiversity governance, with early and sustained efforts in implementing the Convention on Biological Diversity (CBD) and establishing a national framework for biodiversity protection. Through proactive diplomacy and strategic engagement with international bodies such as the WTO, WIPO, and the TRIPS Council, India has consistently advocated for stronger protection of genetic resources and associated traditional knowledge. The creation of the Traditional Knowledge Digital Library has been a game changer, offering defensive protection against biopiracy and setting a global precedent. However, despite its significance, the Traditional Knowledge Digital Library has faced considerable criticism. While it was envisioned as a defensive mechanism to prevent the misappropriation of Indian traditional knowledge by foreign entities, its exclusive focus on cataloguing pre-existing literature without generating new knowledge has raised concerns, including potential copyright infringement. Moreover, the extent of its success in preventing biopiracy has often been exaggerated, as patent rejections are seldom solely attributable to its interventions. Notably, the Traditional Knowledge Digital Library’s indiscriminate opposition to patent applications has at times hindered Indian innovators from commercialising traditional knowledge, inadvertently stifling domestic innovation in the name of protection. Its sporadic withdrawal from opposition proceedings, combined with the lack of academic rigour in its approach, further dilutes its credibility and effectiveness despite being celebrated as a milestone measure in the context of traditional knowledge protection. Nevertheless, India’s contributions extend to shaping the agenda at the WIPO Intergovernmental Committee, ensuring that the interests of biodiversity-rich countries are at the forefront of global policy discussions.
Conclusion
It is noteworthy that India has long successfully leveraged arguments surrounding Genetic Resources and Traditional Knowledge (GRTK) as well as biopiracy concerns in its diplomatic efforts. Specifically, India has utilized these issues to counter calls for intellectual property (IP) standardization, particularly from IP-intensive Western nations. The threat of misappropriation of genetic resources and traditional knowledge has been strategically presented within key international fora, such as the World Intellectual Property Organization’s (WIPO) Intergovernmental Committee (IGC) and the TRIPS Council. Just as the Global South has already undergone the transition to comply with TRIPS obligations, it is now high time for the IP-intensive Global North to demonstrate reciprocal commitment by fully adhering to the CBD–Nagoya Protocol framework. In this context, a Biopiracy Watch List should not be viewed as a mere immediate response to IP challenges, but rather as a strategic and long-term diplomatic tool that could enhance India’s leverage by taking concrete steps towards safeguarding its biological and cultural resources.