On October 24, 2023, the US Patent and Trademark Office (“USPTO”), which is a component of the Department of Commerce, published two notices in the Federal Register seeking input from Tribal Nations regarding intellectual property (“IP”) protection of “genetic resources, traditional knowledge and/or traditional cultural expressions.”

The First Notice explains that the USPTO is seeking comments on negotiations in advance of a meeting regarding these topics to be held at a specialized agency within the United Nations, the World Intellectual Property Organization (“WIPO”) Intergovernmental Committee (“IGC”) on Intellectual Property and Genetic Resources, Traditional Knowledge, and Folklore (Traditional Cultural Expressions).¹ The First Notice sets out 19 questions for Tribes and their representatives, with hopes of eliciting formal input on how IP protects genetic resources and traditional knowledge.² The written comment period ends Monday, January 22, 2024.

The Second Notice explains that the USPTO is hosting a formal Tribal Consultation in January 2024 and requests written comments in advance of the 2024 WIPO IGC meeting. Notice of Tribal Consultation Meetings and Request for Comments.³ The USPTO is involved in discussions in the WIPO IGC, along with other federal agencies, and is responsible for leading the development of U.S. positions on the WIPO IGC. The Tribal Consultation meetings intend to advance the federal government’s policies toward and relationships with Tribal governments, and to provide the USPTO insight into the positions Tribes take on how the agency should define certain terms and phrases. The first online meeting, for federally recognized Tribal Nations, will be held on Tuesday, January 16, 2024. The second online meeting, for state-recognized Tribes, Native Hawaiians, and their representatives and intertribal organizations, will be held on Friday, January 19. Written comments in response to this notice must be received by Friday, February 23, 2024

More details on the two notices follow:

First Notice

The First Notice explains that the WIPO IGC has been negotiating (1) “an international legal instrument for the protection of genetic resources and associated traditional knowledge”; and (2) “an international legal instrument” for traditional knowledge and traditional cultural experiences.”⁴ Following two sessions of the WIPO IGC that were held in Geneva in 2022, the IGC drafted a “Consolidated Text” that reflects differences on key concepts and definitions between and among participating member states.⁵The prior chair of the IGC independently drafted the “Chair’s Text” based on discussions with member states.⁶ The Chair’s Text and Consolidated Text both include provisions for mandatory disclosure of the country of origin/source of a genetic resource in a patent application where the claimed invention is based on genetic resources.⁷ But the two texts differ on the definition of “genetic resources.” The Chair’s Text uses the definition from the Convention on Biological Diversity: “all genetic material of actual or potential value,” with a footnote stating that the definition is “not intended to include ‘human genetic resources,’” while the term genetic resources “has not been given an agreed definition in the consolidated text."⁸

The First Notice further explains that a “Preparatory Committee of the Diplomatic Conference was convened in September 2023 to establish the procedures for the [2024] diplomatic conference.” It also states that these “negotiations may result in changes to requirements for filing patent applications and for challenging patent rights.” WIPO is set to organize a diplomatic conference to negotiate a treaty focusing on IP rights, genetic resources, and traditional knowledge no later than 2024. To prepare for discussions about patent filings, the USPTO requests comments on observations and experiences of Tribes or Tribal members when filing for patent protection of genetic resources and associated traditional knowledge. It also seeks input as to whether a new patent disclosure requirement for genetic resources and traditional knowledge is warranted. The written comment period ends on Monday, January 22, 2024.

Second Notice

The Second Notice explains that in preparation for the WIPO IGC meeting, the USPTO will hold two virtual Tribal consultations.⁹ The Second Notice provides 18 questions for Tribes, requesting (for example) an explanation of any current means used to protect traditional cultural expressions and recommendations as well as real-world examples of how to protect genetic resources and traditional cultural expressions.¹⁰ The Second Notice explains that the Commerce Department’s Tribal Consultation and Coordination Policy “requires that the Department . . . engage in meaningful dialogue with Tribes regarding policies that have Tribal implications” and that these meetings will help inform the USPTO prior to the WIPO IGC meeting.¹¹

Importantly, the Second Notice emphasizes that the terms “genetic resources,” “traditional knowledge,” and “traditional cultural expressions” have not been given agreed-upon definitions in the WIPO IGC, and that how to define them is thus up for discussion.¹² The Second Notice additionally explains that “possible attributes of” traditional knowledge “might include, but are not limited to, knowledge that is passed from generation to generation, in fixed or unfixed form, and linked with the national or social identity of Indigenous Peoples and local communities” or “might include know-how, skills, innovations, practices, teachings, and learning.”¹³ And it explains that what is in the “public domain” is a “fundamental concept in the WIPO IGC[’s]” discussion of traditional cultural expression and traditional knowledge.¹⁴ At the same time, it states the importance of “defining the boundary between the interests of holders of exclusive rights and the ability of others, including the public, to access and use the subject matter to be protected,” because “[e]ach type of intellectual property—patent, trade secret, trademark, and copyright—recognizes a form of public domain.”¹⁵ Before the WIPO IGC meeting, the USPTO hopes to have aid from Tribes in refining these terms by seeking comments and holding two webinars in January 2024.