Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices 73003 

1WIPO currently has 193 Member States 

(www.wipo.int/members/en/). 

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 

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 

AGENCY: United States Patent and 

Trademark Office, Department of 

Commerce. 

ACTION: Notice and request for 

comments. 

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®

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 


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73004 Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices 

2The 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. 

3See Article 2 in Home | 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. 

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 

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 

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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Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices 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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73006 Federal Register / Vol. 88, No. 204 / Tuesday, October 24, 2023 / Notices 

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] 

BILLING CODE 3510–16–P 

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