Proposed international legal instrument relating to intellectual property, genetic resources, and traditional knowledge associated with genetic resources

The United States Patent and Trademark Office (USPTO) leads the U.S. delegation at the World Intellectual Property Organization (WIPO) as it considers a proposed international legal instrument relating to intellectual property (IP), genetic resources (GRs), and traditional knowledge associated with genetic resources (ATK). In July 2022, the WIPO General Assembly decided to convene a diplomatic conference no later than 2024 to conclude such an instrument.

The current draft text of the instrument would require contracting parties—that is, the countries and other intergovernmental organizations that accede to it—to impose a new international disclosure requirement on patent applicants. In particular, where the claimed invention is based on GRs or ATK, applicants would be required to disclose the source of them (for example, the country of origin). Importantly, this disclosure requirement would apply to all applicants seeking a patent within a contracting party’s jurisdiction, including foreign applicants not subject to the same disclosure requirement in their home jurisdictions.

2024 Diplomatic conference

The WIPO diplomatic conference will be held May 13–24, 2024, in Geneva, Switzerland. In preparation for it, the United States and representatives of other countries met at WIPO in September 2023 to discuss the substantive articles of the draft text. In addition, WIPO held meetings in September and December 2023 to discuss the modalities of the diplomatic conference. These WIPO meetings included discussion of the administrative and final provisions of the draft text and a number of ancillary topics, including the draft rules of procedure for the conference, the list of those invited to participate, the text of the draft letters of invitation, and other document or organizational questions relating to the diplomatic conference.

As of late 2023, the draft text continues to reflect the many divisions and differences of views among WIPO member states on key concepts and definitions, as illustrated by conflicting textual revisions proposed by WIPO member states during their September 2023 meetings. That limited negotiation resulted in only minor changes to the draft text thus far. This is because none of the many, often contradictory, proposed revisions received sufficient support from member states to be adopted.

Issues of discussion

The current draft text is nearly identical to a version that was drafted in 2019 by a previous chair of the WIPO Intergovernmental Committee (IGC) on Intellectual Property and GRs, Traditional Knowledge, and Folklore (Traditional Cultural Expressions), acting on his own authority and based on his interpretation of discussions between WIPO member states. The current draft text present a number of issues that likely will be the subject of negotiations at the upcoming diplomatic conference. These include:

  • The definition of “genetic resources” in the instrument
  • The required link between the claimed invention, on the one hand, and GRs or ATK, on the other hand, that will trigger mandatory disclosure
  • The content and scope of the mandatory disclosure
  • Any remedies or sanctions for non-compliance with the mandatory disclosure requirement and implications for patent rights
  • Exceptions and limitations to the mandatory disclosure requirement
  • How the instrument relates to other international agreements
  • Ongoing reviews of the instrument and potential extensions of the mandatory disclosure requirement in the future

Comments from U.S. stakeholders

On October 24, 2023, the USPTO published a Federal Register Notice soliciting comments from the public and IP stakeholders on these and other IGC-related issues. The deadline for comments was January 22, 2024. Comments received will help inform the U.S. government’s participation in ongoing WIPO IGC meetings and the planned May 2024 diplomatic conference.