SUPPLEMENTARY INFORMATION:

WIPO is a specialized United Nations agency based in Geneva, Switzerland, that focuses on intellectual property. Established in September 2000, the WIPO Intergovernmental Committee (IGC) ^[1] serves as a forum where WIPO Member States ^[2] and accredited observers can discuss and address the intellectual property issues that arise in the context of access to GRs as well as the protection of traditional knowledge (TK) and traditional cultural expressions (TCEs). The IGC operates in accordance with a mandate ^[3] determined by the WIPO General Assembly.

At its Fifty-Fifth (30th Extraordinary) Session, held in Geneva on July 14-22, 2022, the WIPO General Assembly decided to convene a diplomatic conference to conclude an International Legal Instrument Relating to Intellectual Property, Genetic Resources, and Traditional Knowledge Associated with Genetic Resources.

The diplomatic conference occurred on May 13-24, 2024, at WIPO Headquarters in Geneva, Switzerland. On May 24, 2024, WIPO Member States adopted the Treaty. The text of the adopted Treaty is different in several respects from the proposed text ^[4] that served as the starting point for negotiations at the diplomatic conference.

Article 3 of the Treaty mandates that patent applicants disclose the origin/source of a GR, or associated traditional knowledge (ATK) provided by Indigenous Peoples or local communities, in certain circumstances. In particular, the disclosure requirement is triggered where a claimed invention is “based on” a GR or ATK, which requires satisfaction of a two-part test: (1) the GR or ATK “must have been necessary for the claimed invention”; and (2) “the claimed invention must depend on the specific properties of” the GR or ATK. Among its 22 articles, the Treaty covers several other topics, including treaty objectives, definitions, exceptions and limitations, non-retroactivity, sanctions and remedies for noncompliance, relationship with other international agreements, and review and potential revision of Treaty text.

For additional context, the text of the Treaty can be found on the WIPO website at: https://www.wipo.int/​edocs/​mdocs/​tk/​en/​gratk_​dc/​gratk_​dc_​7.pdf. WIPO's “informal summary” of the Treaty can be found at: https://www.wipo.int/​edocs/​mdocs/​mdocs/​en/​gratk_​dc/​gratk_​dc_​exsum.pdf.

The Treaty is open for signature by any eligible Member State of WIPO for one year after its adoption ( i.e., up to May 23, 2025).^[5] The act of signing does ( printed page 5828) not make a Member State a party to ( i.e., bound by) the Treaty. Rather, signing qualifies the signatory Member State to proceed to ratification, acceptance, or approval and creates an obligation for the Member State to refrain from acts that would defeat the object and purpose of the Treaty.^[6] To become a party to the Treaty, a Member State must undertake a separate step of ratification or accession.^[7]

The Treaty will enter into force three months after it is ratified or acceded to by 15 Contracting Parties.^[8] Thereafter, Treaty provisions will apply in any Member State of WIPO that is or subsequently becomes a Contracting Party to the Treaty. This means, for example, that the Treaty's required disclosure of the origin/source of GRs/ATK will apply to all patent applicants who file an application in a Contracting Party, including those applicants who come from countries that have not ratified or acceded to the Treaty.

Within the U.S. Government, the USPTO, based on authority delegated by the U.S. Department of State, takes the lead in the WIPO IGC among other Federal agencies and coordinates and develops U.S. positions on issues before the WIPO IGC.

Request for Information

The USPTO welcomes Tribal input on any issues relevant to this Notice and is particularly interested in comments responsive to the questions below. The USPTO also has issued in this issue of the Federal Register a notice entitled, “Request for Comments and Testimony on the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge,” which is directed to the general public (“public FRN”). Tribes may also provide comments responsive to the questions or participate in the public hearing described in the USPTO's public FRN regarding the Treaty.

Questions for Comment

When submitting written comments, please identify yourself and either your Tribal Government, or that you are a Native Hawaiian or other Pacific Islander. If you are a representative, please identify yourself and for whom you are speaking. Commenters need not respond to every question and may provide relevant information, even if not responsive to a particular question.

1. In your view, should the United States sign and become a party to the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge? In your response, please identify and explain your reasons in detail, including legal, policy, and any other considerations.

2. In your view, please explain whether the Treaty is consistent or inconsistent with existing U.S. law, including tribal treaties and other federal law. In your response, please explain your legal reasoning and identify the provisions of the Treaty that are consistent or inconsistent with U.S. law.

3. If, in your view, the Treaty is inconsistent with existing U.S. law, please identify and explain the change(s) to U.S. law necessary for compliance with the Treaty. In doing so, please describe any impacts of adopting such change(s).

4. In your view, please explain whether the Treaty is consistent or inconsistent with existing U.S. international obligations, including treaties, free trade agreements, and other international agreement(s). In your response, please explain your legal reasoning and identify the provision(s) of the Treaty that are consistent or inconsistent with specific U.S. international obligations.

5. Please indicate whether and, if so, how GRs and ATK may be protected by existing U.S. law(s). In doing so, please explain your legal reasoning and identify the specific law(s) by which GRs and ATK may be protected.

6. Please indicate whether and, if so, how GRs and ATK may be protected by tribal treaties, tribal customary law and protocols, tribal codes, or in other ways. In doing so, please explain your legal reasoning and identify the specific provision(s) of the identified ways by which GRs and ATK may be protected.

7. If the United States does not become a party to the Treaty, please identify any Treaty or other provision(s) you believe should be incorporated in U.S. patent or other law for protection of GRs and ATK. In your response, please explain the reason(s) for and any impact(s) of, incorporating those provisions in U.S. patent or other law.

8. In your view, please identify and explain any impact(s) of implementing the Treaty on domestic and global innovation, including both tribal and non-Indigenous innovation.

9. Based on your experiences with other countries that require patent applicants to disclose the source or origin of GRs or ATK, please identify and explain any possible impact(s) of Treaty implementation in the United States.

10. In your view, please identify and explain any impact(s) of implementing or not implementing the Treaty on the Tribal Nations and other Indigenous Peoples located in the U.S.

90 FR 5827