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[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Notices]
[Pages 5828-5830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01090]

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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No.: PTO-C-2024-0048]

Request for Comments and Testimony on the World Intellectual 
Property Organization Treaty on Intellectual Property, Genetic 
Resources and Associated Traditional Knowledge

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Request for comments and notice of hearing.

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SUMMARY: The United States Patent and Trademark Office (USPTO), 
Department of Commerce, requests input from all interested parties on 
the World Intellectual Property Organization (WIPO) Treaty on 
Intellectual Property, Genetic Resources and Associated Traditional 
Knowledge (hereinafter, ``the Treaty'') adopted by WIPO Member States 
in Geneva, Switzerland on May 24, 2024. In particular, the USPTO 
welcomes written comments, and will hold a hybrid hearing, on whether 
the United States should sign and implement the Treaty and any impacts 
of taking those actions. 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.

DATES: Written comments must be received on or before March 18, 2025. 
The USPTO will also hold a hybrid hearing on this matter on April 29, 
2025, from 9 a.m.-12 p.m. and 1-4 p.m. eastern time (ET). If necessary, 
the hearing may continue on April 30, 2025. Any interested parties 
wishing to present oral testimony at the hearing must submit a written 
request for an opportunity to do so no later than April 22, 2025. 
Details on submitting such a request are provided below.

[[Page 5829]]

ADDRESSES: 

I. For Comment Submitters

    For reasons of Government efficiency, comments should be submitted 
through the Federal eRulemaking Portal at https://www.regulations.gov. 
To submit comments via the portal, enter docket number PTO-C-2024-0048 
on the homepage and select ``Search.'' The site will provide a search 
results page listing all documents associated with this docket. Find a 
reference to this request for information and select the ``Comment'' 
icon, complete the required fields, and enter or attach your comments. 
Attachments to electronic comments will be accepted in Adobe[supreg] 
portable document format or Microsoft Word[supreg] format. Because 
comments will be made available for public inspection, information that 
the submitter does not desire to make public, such as a personal 
address or phone number, should not be included.
    Visit the Federal eRulemaking Portal (www.regulations.gov) for 
additional instructions on providing comments via the portal. If 
electronic submission of comments is not feasible due to a lack of 
access to a computer and/or the internet, please submit comments by 
First-Class Mail or Priority Mail to: Michael Buckler, Patent Attorney, 
Mail Stop OPIA, U.S. Patent and Trademark Office, P.O. Box 1450, 
Alexandria, VA 22313-1450.

II. For All Hearing Attendees

    The hybrid hearing will be held in person in the Clara Barton 
Auditorium at the USPTO, 600 Dulany Street, Alexandria, Virginia 22314. 
The hearing will also be available in a virtual format for those 
wishing to attend remotely. Prior to the hearing, information on 
attendance will be posted on the Office of Policy and International 
Affairs (OPIA) section of the USPTO website, https://www.uspto.gov/ip-policy.

III. For Hearing Testifiers (Requests To Present Oral Testimony)

    All interested parties are invited to testify at the hearing. 
Anyone wishing to present oral testimony at the hearing must submit a 
request in writing no later than April 22, 2025. Requests to testify 
must be submitted by email to Michael Buckler at 
[email protected] or, if email submission is not feasible due 
to a lack of access to a computer and/or the internet, by First-Class 
Mail or Priority Mail as indicated above.
    Requests to testify should specify:
    1. The name of the person wishing to testify;
    2. The person's contact information (telephone number and email 
address);
    3. The organization(s) the person represents, if any;
    4. An indication of the amount of time needed for the testimony 
(not to exceed 5 minutes to allow time for follow-up questions);
    5. An indication of whether testimony will be provided in person or 
remotely; and
    6. A copy of your prepared remarks.

FOR FURTHER INFORMATION CONTACT: Michael Buckler, Patent Attorney, 
USPTO, Office of Policy and International Affairs (OPIA), at 
[email protected] (preferred) or 571-272-6024.

SUPPLEMENTARY INFORMATION: 

I. Background

    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\ is a 
Permanent Committee of WIPO where Member States \2\ and accredited 
observers can discuss and address intellectual property issues that 
arise in the context of access to genetic resources (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.
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    \1\ More information on the IGC may be found at: https://www.wipo.int/tk/en/igc.
    \2\ WIPO currently has 193 Member States. https://www.wipo.int/members/en/.
    \3\ The current ``IGC Mandate'', covering the biennium 2024/
2025, may be found at: https://www.wipo.int/export/sites/www/tk/en/igc/docs/igc-mandate-2024-2025.pdf.
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    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. On May 24, 2024, WIPO Member States adopted the 
Treaty on Intellectual Property, Genetic Resources and Associated 
Traditional Knowledge. 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.
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    \4\ That text (known as the ``Basic Proposal'') may be found at: 
https://www.wipo.int/edocs/mdocs/tk/en/gratk_dc/gratk_dc_3.pdf. In 
October 2023, following a Special Session and Preparatory Committee 
meeting of the IGC, the USPTO requested comments on draft text that 
subsequently became the ``Basic Proposal'' of the diplomatic 
conference. https://www.federalregister.gov/documents/2023/10/24/2023-23387/wipo-igc-negotiations-on-genetic-resources-and-associated-traditional-knowledge. Comments received by the USPTO 
helped inform positions taken by the United States at the diplomatic 
conference.
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    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. Likewise, 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 for one year after its adoption 
(i.e., up to May 23, 2025).\5\ The act of signing does 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\
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    \5\ According to WIPO, as of December 5, 2024, thirty-eight 
delegations had signed the Treaty: Algeria, Bosnia and Herzegovina, 
Brazil, Burkina Faso, Cabo Verde, Central African Republic, Chile, 
Colombia, Congo, C[ocirc]te d'Ivoire, Democratic People's Republic 
of Korea, Dominican Republic, Eswatini, Gambia, Ghana, Indonesia, 
Lesotho, Madagascar, Malawi, Marshall Islands, Morocco, Namibia, 
Nicaragua, Niger, Nigeria, Niue, Paraguay, Peru, Saint Vincent and 
the Grenadines, Sao Tome and Principe, Senegal, South Africa, Togo, 
United Republic of Tanzania, Uganda, Uruguay, Vanuatu, and Zimbabwe. 
https://www.wipo.int/export/sites/www/treaties/en/docs/pdf/gratk.pdf.
    \6\ See, e.g., Article 18 of the Vienna Convention on the Law of 
Treaties. https://legal.un.org/ilc/texts/instruments/english/conventions/1_1_1969.pdf.
    \7\ See WIPO Treaty on Intellectual Property, Genetic Resources 
and Associated Traditional Knowledge, Articles 12-13, 18. https://www.wipo.int/edocs/mdocs/tk/en/gratk_dc/gratk_dc_7.pdf.

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[[Page 5830]]

    The Treaty will enter into force three months after it is ratified 
or acceded to by 15 eligible 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.
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    \8\ According to WIPO, as of December 5, 2024, only Malawi had 
ratified or acceded to the Treaty.
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    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.
    In addition to this request for comments and notice of hearing, the 
USPTO will conduct a Tribal Consultation to seek input from Tribes on 
the Treaty. Additional details about the Tribal Consultation can be 
found in a notice published in this issue of the Federal Register.

II. Substantive Guidance on Comments and Testimony

    The USPTO welcomes any relevant, written comments or oral testimony 
on the topics described herein, particularly on the WIPO Treaty on 
Intellectual Property, Genetic Resources and Associated Traditional 
Knowledge, the text of which can be found on the WIPO website at: 
https://www.wipo.int/edocs/mdocs/tk/en/gratk_dc/gratk_dc_7.pdf.
    The USPTO is especially interested in responses to the questions 
below. However, commenters or testifiers need not respond to every 
question and may provide relevant information even if it is not 
responsive to a particular question. Comments and testimony should be 
as detailed as possible and provide all necessary information to enable 
an objective assessment of the views expressed, including specific 
references to: laws, regulations, and policy statements; executive, 
presidential, or other orders; administrative, court, or other 
determinations; and available data (and associated methodology) 
regarding purported and potential impacts of policy decisions.
    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 reasoning in detail, including legal and policy 
considerations.
    2. In your view, please explain whether the Treaty is consistent 
with existing U.S. patent law. In your response, please explain your 
legal reasoning and identify the provision(s) of the Treaty that you 
view as consistent or inconsistent with U.S. patent law.
    3. If, in your view, the Treaty is inconsistent with existing U.S. 
patent law, please identify and explain the change(s) to U.S. patent 
law necessary for compliance with the Treaty. In doing so, please 
describe any impact(s) of adopting such changes.
    4. In your view, please explain whether the Treaty is consistent 
with existing U.S. international obligations, including treaties, free 
trade agreements, and other binding international agreement(s). In your 
response, please explain your legal reasoning and identify any 
provision(s) of the Treaty that you view as consistent or inconsistent 
with specific U.S. international obligations.
    5. If the United States does not become a party to the Treaty, 
please identify any Treaty provision(s) you believe should be 
incorporated into U.S. patent law. In your response, please explain the 
reason(s) for and any impact(s) of incorporating the identified 
provision(s) into U.S. patent law.
    6. In your view, please identify and explain any impact(s) of 
implementing the Treaty in the United States on domestic and global 
innovation, including U.S. science and innovation leadership.
    7. In your view, please identify and explain any impact(s) of 
implementing the Treaty in the United States on businesses, consumers, 
investors, and the economy.
    8. 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.

III. Additional Information on Hearing

    Speaking slots are limited, and the USPTO may be unable to honor 
all requests. If more requests to provide oral testimony are received 
than time allows, requesters will be invited to submit written 
comments. Time slots will be a maximum of five minutes each to allow 
for follow-up questions on testimony or corresponding comments. 
Speakers providing testimony at the hearing should submit a written 
copy of their testimony for inclusion in the record of the proceedings 
no later than April 22, 2025. Speakers will have one week following the 
hearing to submit any supplemental materials referenced during their 
testimony. Such materials must be submitted by email to Michael Buckler 
at [email protected] or, if email submission is not feasible 
due to a lack of access to a computer and/or the internet, by First-
Class Mail or Priority Mail as indicated above.
    Before the hearing, an agenda of witness testimony will be sent to 
testifiers and posted on the OPIA section of the USPTO website, https://www.uspto.gov/ip-policy.
    If time allows, the USPTO may permit unscheduled testimony at the 
hearing.
    The hearing will be physically accessible to people with 
disabilities. Individuals requiring accommodation, such as sign 
language interpretation or other ancillary aids, should communicate 
their needs to the person listed in the FOR FURTHER INFORMATION CONTACT 
section of this notice at least seven business days prior to the 
hearing.
    A recording of the hearing will be posted on the OPIA section of 
the USPTO website, https://www.uspto.gov/ip-policy, as soon as possible 
after the hearing.
    A transcript of the hearing will be available on the OPIA section 
of the USPTO website, https://www.uspto.gov/ip-policy, as soon as 
possible after the hearing.

Derrick L. Brent,
Acting Under Secretary of Commerce for Intellectual Property and Acting 
Director of the United States Patent and Trademark Office.
[FR Doc. 2025-01090 Filed 1-16-25; 8:45 am]
BILLING CODE 3510-16-P
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