US Seeks Comments on WIPO Genetic Resources Treaty

Summary

Last year the World Intellectual Property Organization (WIPO), under a threat of a vote, accelerated negotiations on an international legal instrument related to intellectual property (IP) and genetic resources (GRs). The Diplomatic Conference, a body with a mandate to adopt a new international treaty, will convene in the first half of 2024. The United States government has expressed concerns about both the – currently-negotiated provisions and the forced move to a final negotiating stage, but it is engaging in the process. To that end, the United States Patent and Trademark Office (USPTO) on October 24 issued a request for comments with a deadline for comments of January 22, 2024.

Biotechnology, life sciences, and innovative pharmaceuticals industries are likely to be impacted by the final treaty, especially due to its intention to harmonize the disclosure of genetic resources and associated traditional knowledge in patent applications. The treaty is also intended to create a harmonized approach to genetic resources-associated traditional knowledge, which includes know-how, 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.

The USPTO seeks and encourages views from patent filers to help form its position with regards to the final stage of negotiations. This consultation is the moment to get involved as it will be difficult to affect the direction of these multilateral negotiations later.

Background

According to WIPO, the objectives of the legal instrument are to enhance the patent system with regard to genetic resources and associated traditional knowledge, and to prevent patents from being granted for inventions that are not novel or inventive with regards to genetic resources and associated traditional knowledge. Draft texts include a mandatory disclosure requirement (Article 3) where the claimed invention in a patent is based on genetic resources or associated traditional knowledge; the draft articles also include an option to revoke patents where a party has acted with fraudulent intent in connection with the disclosure requirement of Article 3 (Article 6).

Genetic resources include medicinal plants, agricultural crops, and animal breeds. Although genetic materials in their natural form are not patentable, inventions developed based on them, mostly in modern scientific research, are eligible for patent protection. In some instances, uses of genetic resources are associated with the traditional knowledge of indigenous people and tribes. Genetic resources and traditional knowledge have been addressed in the Convention on Biological Diversity in the Nagoya Protocol, as well as in the new Marine Biodiversity Treaty. During negotiations for the new treaty, Marine Genetic Resources (MGR) proved to be a stumbling block due to divergent views regarding how benefit-sharing should work. Experts pointed to the potential monetary value of MGR in drug development as fuel for the disagreement.

A Special Session of the negotiating body (Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, IGC) took place in September 2023 and was immediately followed by a Preparatory Committee, whose mandate is to finalize preparations for the Diplomatic Conference. These recent discussions were unproductive, and disagreements prevailed. Therefore, the fate and final wording of the new treaty is far from certain.

In the past, both India and the U.S. pushed against moving this file to the final stages as they deemed it not ready and prone to failure or an unfavorable result. More recently, under a threat of a vote by the African Group, the U.S. and Japan disassociated themselves from the acceleration decision in July 2022, rather than block it entirely. Other delegations, notably the U.K., joined the consensus while criticizing both the immaturity of the negotiating texts and the forceful process. The U.S. is looking to adopt a reasonable approach and genuinely consider the proposal. This means that comments gathered by the USPTO will be particularly important to formulating a final negotiating position for the U.S.

If concluded in the first half of 2024, the proposed WIPO treaty is sure to have an effect on research and development that utilizes genetic resources and traditional medicine, and will likely impact patent applications and grants. The USPTO comment period will run from October 24, 2023 to January 22, 2024. Akin is available to advise clients on draft comments and potential implications of the treaty.