WIPO IGC Negotiations on Genetic Resources and Associated Traditional Knowledge, 73003-73006 [2023-23387]
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Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices
Conference on Intellectual Property and
Genetic Resources: ‘‘Substantive
articles’’ (Articles 1 through 9) from
WIPO/GRTKF/IC/43/5 Chair’s Text of a
Draft International Legal Instrument
relating to Intellectual Property, Genetic
Resources and Traditional Knowledge
associated with Genetic Resources:
Intergovernmental Committee on
Intellectual Property and Genetic
Resources, Traditional Knowledge and
Folklore: Forty-Third Session (wipo.int),
as revised in the Special Session of the
Intergovernmental Committee on
Intellectual Property and Genetic
Resources, Traditional Knowledge and
Folklore, 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, and can be found
here: www.wipo.int/meetings/en/doc_
details.jsp?doc_id=620066.
General Information on the
Diplomatic Conference on Intellectual
Property and Genetic Resources can be
found here: www.wipo.int/diplomaticconferences/en/genetic-resources/
index.html.
Note that documents for all WIPO IGC
meetings can be found here:
www.wipo.int/meetings/en/
topic.jsp?group_id=110&items=10.
WIPO Publication: Intellectual
Property and Genetic Resources,
Traditional Knowledge and Traditional
Cultural Expressions can be found here:
www.wipo.int/edocs/pubdocs/en/wipo_
pub_933_2020.pdf.
WIPO Publication: Protect and
Promote Your Culture A Practical Guide
to Intellectual Property for Indigenous
Peoples and Local Communities can be
found here: www.wipo.int/publications/
en/details.jsp?id=4195.
WIPO Webinar Series: How to Protect
and Promote Your Culture can be found
here: www.wipo.int/tk/en/protect_and_
promote.html. These webinars focus on
intellectual property (IP) tools that can
be used to protect and promote
traditional knowledge (TK) and
traditional cultural expressions (TCEs).
Documents describing key issues
related to protecting traditional cultural
expressions (TCE)/folklore and
traditional knowledge (TK) can be found
here: www.wipo.int/tk/en/igc/
issues.html.
Presentations on Indigenous and
Local Community Experiences can be
found here: www.wipo.int/tk/en/igc/
panels.html. See also Indigenous
Peoples and Local Communities’
Engagement: www.wipo.int/tk/en/
engagement.html.
IGC Related Seminars, on intellectual
property and genetic resources, on IP
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and traditional knowledge, and on IP
and traditional cultural expressions can
be found here: www.wipo.int/tk/en/igc/
related_seminars.html.
Views from Speakers at the Seminar
on Intellectual Property and Traditional
Cultural Expressions, on June 8 and 9,
2017, can be found here: www.wipo.int/
tk/en/news/tk/2017/news_0009.html.
P. Jaszi, ‘‘Protecting traditional
cultural expressions—some questions
for lawmakers,’’ WIPO Magazine, dated
August 2017, can be found here:
www.wipo.int/export/sites/www/wipo_
magazine/en/pdf/2017/wipo_pub_121_
2017_04.pdf.
Information on how to participate in
the IGC, including virtually, can be
found here: www.wipo.int/tk/en/igc/
participation.html. Note that
organizations requesting to be
accredited as an observer at the IGC
must complete an accreditation form
and submit it to WIPO at least 60 days
prior to the first session that it wishes
to attend.
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.
[FR Doc. 2023–23386 Filed 10–23–23; 8:45 am]
BILLING CODE 3510–16–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO–C–2023–0019]
WIPO IGC Negotiations on Genetic
Resources and Associated Traditional
Knowledge
United States Patent and
Trademark Office, Department of
Commerce.
ACTION: Notice and request for
comments.
AGENCY:
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.
SUMMARY:
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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®
portable document format or Microsoft
Word® 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 benefitsharing as well as the protection of TK
and traditional cultural expressions
(TCEs).
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
DATES:
1 WIPO currently has 193 Member States
(www.wipo.int/members/en/).
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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.
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
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/igcmandate-2024-2025.pdf.
3 See Article 2 in Home | Convention on
Biological Diversity (cbd.int) (www.cbd.int). The
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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.
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
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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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.’’
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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.’’
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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
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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
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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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English, or if not, accompanied by an
English translation. Comments
submitted to the Commission should
include only information that you wish
to make available publicly. If you wish
the Commission to consider information
that you believe is exempt from
disclosure under the Freedom of
Information Act, a petition for
confidential treatment of the exempt
information may be submitted according
SUMMARY:
E:\FR\FM\24OCN1.SGM
24OCN1
]]>Agencies
[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.
[[Page 73006]]
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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