[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
michael.buckler@uspto.gov 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
michael.buckler@uspto.gov (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 michael.buckler@uspto.gov 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]
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