[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
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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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