On 18 March 2025, the World Trade Organization (WTO) published a communication (IP/C/W/719) by Brazil, India, and Peru entitled, “Revising discussions on the relationship between the TRIPS Agreement and Convention on Biological Diversity“. Brazil, India, and Peru have called for the inclusion of a mandatory disclosure requirement in the TRIPS Agreement based on a 2011 proposal (TN/C/W/59) by Brazil, China, Colombia, Ecuador, India, Indonesia, Peru, Thailand, the ACP Group and the African Group in 2011 to amend Article 29 of the TRIPS Agreement. The paper makes no explicit reference to digital sequence information (DSI).
While this topic was broached at the March 2025 TRIPS Council meeting, this topic will be addressed at the next TRIPS Council meeting (26-27 June 2025).
In the chapeau of the March 2025 paper, the demandeurs (Brazil, India, and Peru) articulated the interplay between traditional medical knowledge, modern medicine, traditional and complementary medicine use, the misappropriation of genetic resources, intellectual property, and biopiracy:
2. A WTO-WIPO-WHO joint study of 2020 titled ‘Promoting Access to Medical Technologies and Innovation’ notes the profound influence of traditional medical knowledge on modern medicine. With 88% of WHO members acknowledging traditional and complementary medicine use, international trade in these products is growing rapidly. However, the study notes that this has come on the back of the rampant misappropriation of genetic resources (GR) and associated traditional knowledge (TK). Some prominent examples of biopiracy include neem (India), turmeric (India), kava (Pacific Islands-Fiji and Vanuatu), ayahuasca (Brazil), quinoa (Peru), and hoodia (South Africa). Assessing the economic loss to developing countries due to biopiracy is a complex task involving multiple factors, such as the loss of intellectual property (IP) rights, restricted access to genetic resources, negative impact on traditional industries, and discouragement of research and development in the country of origin.
In relation to biodiversity, the co-sponsors of IP/C/W/719 quoted a WHO Global Report on Traditional and Complementary Medicine from 2019, “developing countries, especially those with rich biodiversity in Asia, Africa, and South America, supply approximately two-thirds of the plants used in western and global medical systems”.
Furthermore, the demandeurs noted:
While recent data is publicly unavailable, a 1999 report by the United Nations Development Program estimates that if a 2% royalty were charged on genetic resources developed by local innovators in the South, the North would owe over USD 300 million in unpaid royalties for farmers’ crop seeds and more than USD 5 billion in unpaid royalties for medicinal plants.
In the 719 paper, Brazil, India, and Peru described the Convention on Biological Diversity (CBD) and the Nagoya Protocol as having a “significant shortcoming” noting that the CBD and Nagoya Protocol do not “link these requirements with the patent system, resulting in the grant of erroneous patents to biopiracy-based inventions and lack of enforcement of the PIC and ABS commitments, particularly in a transboundary context.”
4. The CBD (1992) marked the first step towards recognising the sovereign rights of states over their biological resources. It conditioned access to biological resources and associated traditional knowledge with prior informed consent (PIC) and access and benefit sharing (ABS) with local communities, who are the rightful holders of such knowledge. The Nagoya Protocol, which came into force in 2014, further developed the legal framework established under the CBD to operationalise the requirements of PIC and ABS. A significant shortcoming of the CBD and Nagoya Protocol is that it does not link these requirements with the patent system, resulting in the grant of erroneous patents to biopiracy-based inventions and lack of enforcement of the PIC and ABS commitments, particularly in a transboundary context.
The 719 paper points to the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, adopted in May 2024, as the culmination of over two decades of work to address some of the shortcomings in the CBD and Nagoya Protocol.
6. The WIPO treaty requires patent applicants to disclose the source of the genetic resources and traditional knowledge on which their claimed invention is based. The disclosure requirement, if complied with by the applicant, would aid the patent office in conducting a prior art search. It would help prevent the patenting of inventions based on genetic resources and associated traditional knowledge that do not fulfil the requirements of novelty and inventiveness. Genetic resources and associated traditional knowledge obtained from one country are often used as a basis for seeking a patent in another. In such situations, the disclosure requirement would make the patent office the checkpoint to identify instances of transboundary utilisation of genetic resources and traditional knowledge.
While hailing the WIPO Treaty on IP, Genetic Resources and Associated Traditional Knowledge, the 719 demandeurs are cognizant that the WIPO treaty “does not offer recourse to international dispute settlement if states fail to establish the disclosure requirement under their domestic patent systems”. The demandeurs call for the amending of the TRIPS Agreement to integrate the mandatory disclosure requirement into the WTO’s institutional architecture, including its binding dispute settlement system.
7. While a progressive instrument, the WIPO treaty could be further strengthened by integrating these commitments under the TRIPS Agreement. First, the WIPO treaty does not offer recourse to international dispute settlement if states fail to establish the disclosure requirement under their domestic patent systems. Second, the WIPO treaty does not address the requirements to obtain PIC under mutually agreed terms (MAT). Hence, even though the treaty introduces the disclosure requirement, it does not provide for compliance with the ABS requirements. The WIPO treaty shifts the burden to ensure compliance on the government agencies and local communities of the provider country, who must monitor published patent applications worldwide to ensure compliance and enforce ABS through PIC under MAT. Thus, amending the TRIPS Agreement to integrate the mandatory disclosure requirement could subject this commitment to the WTO’s legal framework. Further, the TRIPS Agreement could build on the WIPO treaty to require evidence of PIC and benefit-sharing arrangements as a prerequisite for patent grant or commercialization, thereby reinforcing the PIC and ABS commitments.
In addressing the way forward, the demandeurs stressed that in the “context of protecting the legitimate rights of traditional communities and preventing misappropriation of genetic resources, the momentum gained from adopting the WIPO treaty must be channelled towards reviving negotiations on TRIPS-CBD linkage, thereby fostering greater harmony between the environmental, IP and trade regime” including the prevention of the “grant of erroneous patents”.
Brazil, India, and Peru have called the inclusion of a discussion on the relationship of the TRIPS Agreement and CBD as part of the mandate of the 14th Ministerial Conference of 2026.
In short, the demandeurs harken back to the TN/C/W/59 proposal by Brazil, China, Colombia, Ecuador, India, Indonesia, Peru, Thailand, the ACP Group and the African Group in 2011 to amend Article 29 of the TRIPS Agreement to introduce a mandatory disclosure requirement. The draft text is reproduced below.
ANNEX 1
AMENDMENT TO ARTICLE 29BIS, TRIPS, AS PROPOSED UNDER TN/C/W/59
Presented below is the draft amendment to the TRIPS Agreement proposed by the delegations of Brazil, China, Colombia, Ecuador, India, Indonesia, Peru, Thailand, the ACP Group and the African Group under (document TN/C/W/59) (2011).
Article 29bis
Disclosure of Origin of Genetic Resources and/or Associated Traditional Knowledge
1. For the purposes of establishing a mutually supportive relationship between this Agreement and the Convention on Biological Diversity, Members shall have regard to the objectives, definitions and principles of this Agreement, the Convention on Biological Diversity, and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, in particular its provisions on prior informed consent for access and fair and equitable benefit sharing.
2. Where the subject matter of a patent application involves utilization of genetic resources5 and/or associated traditional knowledge, Members shall require applicants to disclose: (i) the country providing such resources, that is, the country of origin of such resources or a country that hasacquired the genetic resources and/or associated traditional knowledge in accordance with theCBD; and, (ii) the source6 in the country providing the genetic resources and/or associated traditional knowledge. Members shall also require that applicants provide a copy of an Internationally Recognized Certificate of Compliance7 (IRCC). If an IRCC is not applicable in the providing country, the applicant should provide relevant information regarding compliance with prior informed consent and access and fair and equitable benefit sharing as required by the national legislation of the country providing the genetic resources and/or associated traditional knowledge, that is, the country of origin of such resources or a country that has acquired the genetic resources and/or associated traditional knowledge in accordance with the CBD.
3. Members shall publish the information disclosed in accordance with paragraph 2 of this Article jointly with the publication of the application or the grant of patent, whichever is made first.
4. Members shall put in place appropriate, effective and proportionate measures so as to permit effective action against the non-compliance with the obligations set out in paragraph 2 of this Article. Patent applications shall not be processed without completion of the disclosure obligations set out in paragraph 2 of this Article.
5. If it is discovered after the grant of a patent that the applicant failed to disclose the information set out in paragraph 2 of this Article, or submitted false and fraudulent information, or it is demonstrated by the evidence that the access and utilization of genetic resources and/or associated traditional knowledge violated the relevant national legislation of the country providing genetic resources and/or associated traditional knowledge, that is, the country of origin of such resources or a country that has acquired the genetic resources and/or associated traditional knowledge in accordance with the CBD, Members shall impose sanctions, which may include administrative sanctions, criminal sanctions, fines and adequate compensation for damages. Members may take other measures and sanctions, including revocation, against the violation of the obligations set out in paragraph 2.