[Federal Register Volume 88, Number 204 (Tuesday, October 24, 2023)]
[Notices]
[Pages 73003-73006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23387]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No.: PTO-C-2023-0019]


WIPO IGC Negotiations on Genetic Resources and Associated 
Traditional Knowledge

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

ACTION: Notice and request for comments.

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SUMMARY: The United States Patent and Trademark Office (USPTO), 
Department of Commerce, requests public comments on certain text-based 
negotiations before the World Intellectual Property Organization (WIPO) 
Intergovernmental Committee (IGC) on Intellectual Property and Genetic 
Resources, Traditional Knowledge, and Folklore (Traditional Cultural 
Expressions). WIPO will organize a diplomatic conference to negotiate a 
treaty focusing on intellectual property (IP), genetic resources (GRs), 
and traditional knowledge (TK) associated with GRs no later than 2024. 
Public comments are requested regarding the negotiations on genetic 
resources and associated traditional knowledge.

DATES: The written comment period will begin on October 24, 2023, and 
end on January 22, 2024.

ADDRESSES: 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-2023-0019 on the homepage and click ``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 
click on 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 an 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: Paolo M. Trevisan, Patent 
Attorney, Mail Stop OPIA, U.S. Patent and Trademark Office, P.O. Box 
1450, Alexandria, VA 22313-1450.

FOR FURTHER INFORMATION CONTACT: Paolo M. Trevisan, Patent Attorney, 
USPTO, Office of Policy and International Affairs (OPIA), at 571-272-
7110.

SUPPLEMENTARY INFORMATION: WIPO is a specialized United Nations agency 
based in Geneva, Switzerland, that focuses on intellectual property. 
Established in September 2000, the WIPO IGC serves as a forum where 
WIPO Member States \1\ and accredited observers can discuss and address 
the intellectual property issues that arise in the context of access to 
GRs and benefit-sharing as well as the protection of TK and traditional 
cultural expressions (TCEs).
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    \1\ WIPO currently has 193 Member States (www.wipo.int/members/en/).
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    Since 2009, the WIPO IGC has been engaged in separate text-based 
negotiations on (1) an international legal instrument for the 
protection of genetic resources and associated traditional knowledge 
and (2) an international legal instrument for TK and TCEs. The United 
States understands the term ``international legal instrument'' in the

[[Page 73004]]

WIPO IGC mandate \2\ to include declarations, recommendations, best 
practices, toolkits, and other forms of ``soft law'' and actively seeks 
a practical outcome. WIPO also has the authority to initiate norm-
setting discussions and to propose international rules for adoption by 
a diplomatic conference or by another WIPO body. Thus the phrase 
``international legal instrument(s)'' could also include a treaty or 
international agreement, although there is no requirement that 
prescribes this particular outcome.
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    \2\ The current ``IGC Mandate'' may be found at: 
Intergovernmental Committee (IGC) (wipo.int) (www.wipo.int/tk/en/igc). The current IGC Mandate covers the biennium 2024/2025. https://www.wipo.int/export/sites/www/tk/en/igc/docs/igc-mandate-2024-2025.pdf.
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    During the 42nd and 43rd sessions of the WIPO IGC held in Geneva in 
2022, the IGC completed its designated sessions on Intellectual 
Property, Genetic Resources and Traditional Knowledge Associated with 
Genetic Resources for the 2022/2023 biennium. These sessions made some 
progress and achieved a level of convergence around document WIPO/
GRTKF/IC/43/4, the ``Consolidated Document Relating to Intellectual 
Property and Genetic Resources'' (the consolidated text). The 
consolidated text had been drafted and revised through negotiations 
between the WIPO Member States over an extended period of time, during 
multiple meetings of the IGC. This document reflected the many 
divisions and differences of views on key concepts and definitions 
among the participants to the sessions.
    The previous Chair of the IGC, Mr. Ian Goss of Australia, drafted 
document IPO/GRTKF/IC/43/5, the ``Chair's Text of a Draft International 
Legal Instrument Relating to Intellectual Property, Genetic Resources 
and Traditional Knowledge Associated with Genetic Resources'' (the 
Chair's text), on his own authority, based on his interpretation of 
discussions between Member States.
    The current Chair, Ms. Lilyclaire Bellamy of Jamaica, made the 
Chair's text available to Member States during IGC 43 as a text for 
discussion but not for negotiation. Both the Chair's text and the 
consolidated text include provisions for a mandatory disclosure 
requirement of the country of origin/source of genetic resource(s) in a 
patent application where the claimed invention is based on genetic 
resources. While the term GR is defined in the Convention on Biological 
Diversity (CBD) \3\ as ``all genetic material of actual or potential 
value,'' and that definition is used in the non-negotiated Chair's text 
with the footnote that it is '' . . . not intended to include ``human 
genetic resources''.'', the term GR has not been given an agreed 
definition in the consolidated text.
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    \3\ See Article 2 in Home [bond] Convention on Biological 
Diversity (cbd.int) (www.cbd.int). The United States is not a member 
of the CBD, but accepts these definitions for purposes of the work 
in the WIPO IGC.
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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, based on document WIPO/
GRTKF/IC/43/5 (the Chair's text) and any other contributions by Member 
States. The diplomatic conference is to be held in 2024.
    A Preparatory Committee of the Diplomatic Conference was convened 
in September 2023 to establish the procedures for the diplomatic 
conference and also consider ``administrative provisions and final 
clauses'' of the instrument drafted by the WIPO Secretariat (Articles 
10 through 23). A special session of the IGC was also convened in 
September 2023, preceding the Preparatory Committee, to close any 
existing gaps in ``substantive articles'' (Articles 1 through 9) of the 
Chair's text to the extent possible. The Preparatory Committee and 
special session concluded with the adoption of rules of procedure for 
the diplomatic conference but with only minor changes to the 
``substantive articles'' of the Chair's text and ``administrative 
provisions and final clauses'' from the WIPO Secretariat, reflecting 
the significant differences in interests between the parties involved, 
which will have to be addressed in further negotiations at next year's 
diplomatic conference.
    Within the U.S. Government, the USPTO, based on authority delegated 
by the State Department, takes the lead in the WIPO IGC among other 
Federal agencies and coordinates and develops U.S. positions on issues 
before the WIPO IGC. The text-based negotiations before the WIPO IGC 
include the protection of genetic resources and associated traditional 
knowledge. These negotiations may result in changes to requirements for 
filing patent applications and for challenging patent rights.
    The WIPO IGC will also continue its text-based negotiations on IP 
and the protection of TK and TCEs to the renewed mandate of the IGC for 
the biennium 2024/2025 as decided by the WIPO General Assembly at the 
64th Series of Meetings of the Assemblies of the Member States of WIPO 
held July 6-14, 2023.

Request for Comments

    This request for comments seeks public and stakeholder input to 
inform U.S. Government participation in the ongoing WIPO IGC meetings 
and in anticipation of a diplomatic conference to conclude an 
International Legal Instrument Relating to Intellectual Property, 
Genetic Resources and Traditional Knowledge Associated with Genetic 
Resources, expected to be held in 2024.
    In addition, this request for comments seeks input to inform the 
U.S. Government as it participates in the ongoing WIPO IGC meetings on 
TK/TCEs.
    The following is particularly useful in forming an understanding of 
the issues under discussion, and in answering the questions below.
    Both the Chair's text and the consolidated text include provisions 
for mandatory disclosure requirements of the country of origin or 
source of GR and associated TK (ATK) in a patent application where the 
claimed invention is based on GR. Article 29.1 of the TRIPS Agreement 
provides that TRIPS member countries must require a patent applicant to 
disclose the invention in a manner that is sufficiently clear and 
complete for the invention to be carried out by a person skilled in the 
art. The term ``disclosure requirements,'' which is expected to be 
addressed by the diplomatic conference, generally refers to additional 
requirements that would include the source or origin of the GR and 
associated TK as part of the patent application. Details of the 
disclosure requirements have not been agreed to as part of the Chair's 
text nor the consolidated text.
    These additional requirements to disclose the source or origin of 
the GR and associated TK as part of a patent application involve a 
number of issues that likely will be the subject of negotiations at the 
upcoming diplomatic conference, some of which are highlighted below.

A. Definition of Genetic Resources

    ``Genetic resources'' are defined in the Convention on Biological 
Diversity (CBD) as ``genetic material of actual or potential value'' 
wherein ``genetic material'' is defined as ``any material of plant, 
animal, microbial or other origin containing functional units of 
heredity.'' Agreement has yet to be reached by the

[[Page 73005]]

IGC on the definition of ``genetic resources'' in the Chair's text or 
the consolidated text.

B. Content of Disclosure

    The content of what is required to be disclosed in a patent 
application with respect to the mandatory disclosure requirements has 
been the topic of much debate in the IGC negotiations. Under different 
versions, patent applicants may be required to disclose:
     the country of origin of the GRs;
     the source of the GRs (for example, a gene bank that 
provided genetic material);
     the legal provenance of the GRs (the chain of custody 
pursuant to legal authority);
     the legal status of the GRs and/or ATK, such as compliance 
with any legal obligations relating to access and benefit-sharing or 
prior informed consent for accessing and using GRs; and
     a due diligence declaration that the applicant has 
complied with all applicable legal requirements concerning access to 
and use of GRs and/or ATK.
    Agreement has yet to be reached on the definition of ``content.''

C. Disclosure Triggers

    The application of patent disclosure requirements in the Chair's 
text and the consolidated text is dependent on a ``trigger'' or link 
between the claimed invention and relevant GRs or ATK--that is, the 
relationship with the subject matter of disclosure.
    The trigger may bring about or give rise to the disclosure 
requirements in response to various situations, such as:
     whether the GR/ATK is incidental or material to the 
development of the invention;
     whether the GR/ATK is necessary to assess, understand, 
replicate, or carry out the invention, or the GR/ATK is in effect only 
a vehicle for a separate innovative concept;
     whether the GR/ATK contributes to one earlier step in a 
chain of innovations that over time culminated in the invention, or is 
a direct input to the claimed inventive step;
     whether particular qualities of the GR/ATK are essential 
to the invention; and
     whether a GR/ATK is used in a particular embodiment or one 
example in a description of the invention, but is not indispensable to 
arrive at or replicate the invention as claimed.
    There has yet to be agreement on a definition of the ``trigger.''

D. Remedies and Sanctions

    Agreement has yet to be reached regarding the sanctions and/or 
remedies for non-compliance with the disclosure requirements. A wide 
range of remedies and sanctions for non-compliance is provided in the 
national laws of jurisdictions across the globe. These range from 
administrative sanctions to the denial, revocation or finding of 
unenforceability of a patent.
    Depending on the final form of this provision in the instrument 
which may result from the diplomatic conference, and its potential 
implementation in various countries, the sanctions could include 
rendering a patent unenforceable for non-compliance with the disclosure 
requirement. This could be analogous to the operation of the USPTO Rule 
56 (37 CFR 1.56) relating to inequitable conduct.

Request for Comments

    The USPTO welcomes any relevant comments on the topics described in 
this Request for Comments. However, the USPTO is particularly 
interested in comments responsive to the questions below. When 
responding to the questions, please identify yourself. Commenters need 
not respond to every question and may provide relevant information even 
if it is not responsive to a particular question.

Questions for Comment

Section I--Observations and Experiences

    1. Have you or any of your members, partners, co-workers, legal 
representatives or clients filed for patent protection in a 
jurisdiction that requires disclosure of the source of genetic 
resources and associated traditional knowledge in a patent application 
seeking protection for inventions based on genetic resources (hereafter 
``patent disclosure requirement'')? If yes, to the extent possible, 
please identify the jurisdiction(s) that required disclosure and 
describe the circumstances and your experiences associated with 
satisfying the patent disclosure requirement in that jurisdiction.
    2. How would you characterize the level of difficulty in complying 
with the aforementioned patent disclosure requirement? Please describe 
any anticipated or unanticipated problems that resulted or may result 
from the disclosure itself or the associated requirement for the 
disclosure.
    3. Please describe how your experiences with the patent disclosure 
requirement in the aforementioned jurisdiction or other jurisdictions 
across the globe affect your business. Where possible, please identify 
the jurisdiction as well as any relevant details of the patent 
disclosure requirement.
    4. Please identify any type of patent disclosure requirement, in 
the context of Genetic Resources and Traditional Knowledge, you believe 
is necessary and any benefits or detriments stemming from a patent 
disclosure requirement.
    5. Please identify any instances where you are aware of patent 
rights--yours, someone you represent or another party's--being impacted 
by the existence of a patent disclosure requirement, including but not 
limited to, any loss of rights, additional costs or other negative 
impacts.
    6. Please share whether or not the existence of a patent disclosure 
requirement was (or is) a consideration in pursuing patent protection 
on an invention in a given jurisdiction. Please provide details in 
relation to relevant technologies where this may be a consideration as 
well as alternative actions you took or would take in lieu of pursuing 
patent protection in the jurisdiction.

Section II--Need and Effectiveness of a Patent Disclosure Requirement 
for Genetic Resources and Traditional Knowledge

    7. Do you believe the patent system--through the use of a patent 
disclosure requirement in jurisdictions where such requirement exists--
has been an effective regulator of access and benefit sharing for 
genetic resources? Please explain.
    8. Do you believe that a patent disclosure requirement would enable 
interested groups to locate information on the use of a country's 
genetic resources? Please explain.
    9. Where a claimed invention is based on genetic resources, please 
identify the appropriate range of subject matter of genetic resources 
that should be within the scope of a disclosure requirement.
    10. Please comment on the effectiveness of the following options 
relating to disclosure of genetic resources and/or traditional 
knowledge associated with genetic resources in a patent application:
    a) Disclosure when genetic resource information is material to 
patentability.
    b) Voluntary disclosure of genetic resource information.
    c) Disclosure requirement if the genetic resource information is 
known.
    d) Mandatory disclosure requirement in all instances when an 
invention is based on genetic resources.
    e) Disclosure of access and benefit sharing compliance.

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    f) Compliance/non-compliance with a disclosure requirement.
    11. Please describe your views on what trigger mechanism should be 
used, if any, for a patent disclosure requirement pursuant to the 
Chair's text or the consolidated text.
    12. Please describe your views on what a patent applicant should be 
compelled to disclose in a patent application, in the context of a 
patent disclosure requirement.
    13. Please describe your views on whether a patent disclosure 
requirement should include provisions that impact the grant or the 
validity and enforceability of a patent in cases of non-compliance with 
a disclosure requirement.
    14. Please describe your views on the current working text for an 
International Legal Instrument Relating to Intellectual Property, 
Genetic Resources and Traditional Knowledge Associated with Genetic 
Resources, which has been approved for consideration by the Diplomatic 
Conference. Please describe recommendations, if any, for additions, 
deletions or changes that you would recommend to Articles 1 through 9 
(``substantive articles'') from the Chair's text and Articles 10 
through 23 (``administrative provisions and final clauses'') drafted by 
the WIPO Secretariat, including whether any language from the 
``consolidated text,'' a previous working text in these discussions, 
should be incorporated into or replace the current working text. These 
texts can be found at the links below:
    a) Current working text ``substantive articles'' (Articles 1 
through 9 from the WIPO IGC ``Chair's text''), as revised in the 
Special Session of the Intergovernmental Committee on Intellectual 
Property and Genetic Resources, Traditional Knowledge and Folklore, 
held in Geneva on September 4-8, 2023, is included as the Annex to 
document WIPO/GRTKF/IC/SS/GE/23/4 on the Decisions adopted by the 
committee on genetic resources and associated traditional knowledge, 
which can be found on the WIPO website, https://www.wipo.int/meetings/en/doc_details.jsp?doc_id=620066.
    b) Current working text ``administrative provisions and final 
clauses'' are contained in GRATK/PM/2, which can be found on the WIPO 
website, https://www.wipo.int/edocs/mdocs/diplconf/en/gratk_pm/gratk_pm_2.pdf, with a minor revision to delete ``to advise it on the 
matters referred to in Articles [7] and [9], and on any other matter'' 
in Article 11.2(e), as reflected in Summary Report of the Preparatory 
Committee, which can be found on the WIPO website, https://www.wipo.int/edocs/mdocs/diplconf/en/gratk_pm/gratk_pm_5.pdf.
    c) The latest consolidated text, contained in the Annex to document 
WO/GRTKF/IC/43/4, which can be found on the WIPO website, https://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_43/wipo_grtkf_ic_43_4.pdf.
    15. Please describe whether you believe any additional 
requirements, in particular a mandatory disclosure requirement relating 
to genetic resources and associated traditional knowledge, would 
negatively impact your patent filing strategy in overseas markets, your 
ability to protect innovation, or your business and investment 
strategy.

Section III--Need and Effectiveness of Sui Generis Exclusive Rights, 
Intellectual Property Rights, or Other Methods for Protecting 
Traditional Knowledge and Traditional Cultural Expressions

    16. Please describe your views and experiences regarding the use of 
sui generis exclusive rights to protect traditional knowledge and 
traditional cultural expressions.
    17. Please describe your views and experiences regarding the use of 
intellectual property rights to protect traditional knowledge and 
traditional cultural expressions.
    18. Please describe your views and experiences regarding the use of 
means or methods other than sui generis exclusive rights or 
intellectual property rights to protect traditional knowledge and 
traditional cultural expressions. Among other means and methods, this 
could include soft law, such as declarations, recommendations, best 
practices, toolkits, and voluntary codes of conduct.
    19. Please provide your recommendations regarding how best to 
address unauthorized uses of traditional knowledge or traditional 
cultural expressions.

Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2023-23387 Filed 10-23-23; 8:45 am]
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