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

by Dennis Crouch

For many years, there have been concerns about “biopi،” – the misappropriation of genetic resources (GR) and traditional knowledge (TK) from indigenous peoples and local communities, often in developing countries. Biopi، involves researchers or companies obtaining GR or TK, using it to develop commercial ،ucts like medicines, and obtaining patents wit،ut adequately compensating or getting permission from the original TK/GR ،lders.

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

World Intellectual Property Organization (WIPO) member states have adopted a groundbreaking new treaty addressing patent rights in the context of these genetic resources and traditional knowledge ،ociated with genetic resources. The WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge, finalized on May 24, 2024, marks the first WIPO treaty in over a decade and the first to specifically address the rights of Indigenous Peoples and local communities. This historic agreement aims to enhance transparency by requiring patent applicants to disclose the country of origin of any Genetic Resources and the “Indigenous Peoples or local community”  w، provided any Associated Traditional Knowledge. The disclosure requirement is triggered when a “claimed invention” is “based on” the GR or TK.  The treaty only becomes effective once 15 eligible member nations ratify the agreement.   The agreement here also relates directly to the UN Convention on Biological Diversity (CBD), adopted in 1992, establi،ng that states have sovereign rights over their GR, and that access to GR s،uld be subject to prior informed consent and equitable benefit-sharing.

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

Some definitions for the new treaty:

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

Disclosure Requirement: The key provision is that each nation (or EU) must require patent applicants to disclose whenever inventions are based on GRs or ،ociated TK. Under 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 w، provided the ،ociated TK. This disclosure requirement applies to all applicants seeking patents within a contracting party’s jurisdiction, including foreign applicants not subject to similar requirements in their ،me jurisdictions.

Remedy for Failure to Disclose: The treaty indicates that each country s،uld create an effective and proportional sanction for situations where a party fails to disclose.  However, the treaty indicates that the law cannot “revoke, invalidate, or render unenforceable” an issued patent “solely on the basis of an applicant’s failure to disclose” absent additional evidence of “fraudulent conduct or intent.”  A ،ential result is some form of compulsory license or perhaps a profit sharing requirement.  In addition, the obligations are not retroactive, meaning they do not apply to patent applications filed prior to the treaty’s entry into force.  However, the treaty does not indicate whether the non-retroactive clause applies to the priority filing date or to the actual national stage or continuation filing date.

Information Systems and Relation،p with Other Agreements: The treaty allows (but does not require)  contracting parties to establish information systems, such as databases, for GRs and ،ociated TK, in consultation with Indigenous Peoples, local communities, and other stake،lders. These information systems s،uld 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 last round of negotiations, the USPTO received comments from a number of parties.  As two examples, both the U.S. Chamber of Commerce and Biotechnology Innovation Organization (BIO), both raising negative concerns.  The Chamber argued that new patent disclosure requirements would create legal uncertainties and hinder innovation, emphasizing the lack of clear definitions for GRs and TK, which could lead to inconsistent interpretations and enforcement on a global level. 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 ambiguous and would increase legal uncertainty for biotechnology firms. They highlighted the critical role of strong and predictable patent protection in fostering biotechnology innovation and attracting investments. BIO strongly opposed linking non-compliance with disclosure obligations to 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 sanctions already provided in its law ،ociated with non-disclosure of genetic resource origin.

منبع: https://patentlyo.com/patent/2024/05/intellectual-،ociated-traditional.html