WIPO Adopts Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge

by Dennis Crouch

For many years, there have been concerns about “biopiracy” – the misappropriation of genetic resources (GR) and traditional knowledge (TK) by indigenous peoples and local communities, often in developing countries. Biopiracy involves researchers or companies obtaining TK or TK, using it to develop commercial products such as drugs, and obtaining patents without compensating or obtaining adequate permission from the original TK/GR holders.

Some well-known examples of alleged biopiracy include: patents on the wound-healing properties of turmeric, which were long known in India; patents related to neem tree extracts, also used for centuries in India; Japanese and US patents on extracts of the African “Hoodia” cactus, traditionally used by the San people to stave off hunger; and a US patent for the Amazonian ayahuasca vine, considered sacred and used in ceremonies by indigenous peoples. You can see a similar Sean Connery doing this in my image below.

The member states of the World Intellectual Property Organization (WIPO) have adopted a groundbreaking new treaty that addresses patent rights in the context of these genetic resources and traditional knowledge associated with genetic resources. WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, finalized on 24 May 2024, marks the first WIPO treaty in more than a decade and the first to specifically address the rights of indigenous peoples and local communities. This landmark agreement aims to increase transparency by requiring patent applicants to disclose the country of origin of any Genetic Resource and the “Indigenous People or local community” that provided any associated traditional knowledge. The disclosure requirement is triggered when a “claimed invention” is “based on” GR or TK. The treaty enters into force only after 15 eligible member states ratify the agreement. The agreement here is also directly related to the UN Convention on Biological Diversity (CBD), adopted in 1992, which stipulates that states have sovereign rights over their GR and that access to GR must be subject to prior informed consent and equal sharing of benefits.

We know that US patentees have a duty to disclose material informative of patentability, but this agreement takes things a substantial step further – requiring additional disclosures when the invention is based on a related GR or TK.

Some definitions for the new treaty:

1. Genetic resources (GR): “Genetic material of actual or potential value”, but not including “human genetic resources”. The definition generally includes material, regardless of origin, “containing functional heritage units”.
2. Traditional Knowledge (TK) related to Genetic Resources: This is not expressly defined within the agreement, but TK has previously been defined by WIPO to include “knowledge, knowledge, skills and practices that are developed, sustained and passed on from generation to generation. within a community, often forming part of its cultural or spiritual identity, including knowledge, practices, skills and innovations.
3. Based on: A claimed invention is “based on” GR or TK only if they “should have been necessary for claimed invention” and “the claimed invention must depend on the specific properties of the genetic resources and/or on traditional knowledge”. In this final version, the disclosure requirement was significantly weakened – an earlier draft would have required disclosure if GR/TK was “material to the development of the claimed invention.”

Disclosure Request: The key provision is that each nation (or EU) must require patent applicants to disclose whenever inventions are based on related GR or TK. According to Article 3, contracting parties must require applicants to disclose the country of origin or source of the GRs and the indigenous peoples or local community that provided the related TK. This disclosure requirement applies to all applicants seeking patents within the jurisdiction of a contracting party, including foreign applicants who are not subject to similar requirements in their home jurisdiction.

Remedies for failure to disclose: The treaty indicates that each country must create an effective and proportionate sanction for situations where a party fails to disclose. However, the treaty indicates that the law cannot “revoke, invalidate or render unenforceable” a patent issued “solely on the basis of the applicant’s failure to disclose” in the absence of additional evidence of “deceptive conduct or intent.” A possible outcome is some form of compulsory license or perhaps a profit-sharing requirement. Furthermore, the obligations are not retroactive, meaning they do not apply to patent applications filed before the entry into force of the treaty. However, the treaty does not indicate whether the non-retroactivity clause applies to the priority filing date or to the current national phase or continuation date of the filing.

Information Systems and Relationships with Other Agreements: The Treaty allows (but does not require) contracting parties to establish information systems, such as databases, for GRs and associated TKs, in consultation with indigenous peoples, local communities and other stakeholders. These information systems should be accessible to patent offices for search and examination purposes, subject to appropriate safeguards. The Treaty also emphasizes its mutually supportive implementation with other relevant international agreements.

Prior to this latest round of negotiations, the USPTO received comments from a variety of parties. As two examples, the US Chamber of Commerce and the Biotechnology Innovation Organization (BIO) both raise negative concerns. The Chamber argued that the new patent disclosure requirements would create legal uncertainty and hinder innovation, highlighting the lack of clear definitions of GRs and TK, which could lead to inconsistent interpretations and applications globally . The Chamber also questioned the need for a new treaty, suggesting that existing IP frameworks are sufficient. BIO similarly argued that the proposed obligations are unclear and would increase legal uncertainty for biotech firms. They emphasized the critical role of strong and predictable patent protection in driving biotech innovation and attracting investment. BIO strongly objected to linking non-compliance with disclosure obligations with sanctions such as patent invalidation or compulsory licensing.

A Spicy IP post by Praharsh Gour notes that the treaty would actually weaken Indian law by limiting the sanctions already provided in its law for not disclosing the origin of genetic resources.