Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 85593 

11See Antidumping and Countervailing Duty 

Proceedings: Assessment of Antidumping Duties, 68 

FR 23954 (May 6, 2003). 12See Order, 51 FR 17784. 

dumping margin exists for the period 

May 1, 2021, through April 30, 2022: 

Exporter/manufacturer 

Weightedaverage 

dumping 

margin 

(percent) 

Borusan Mannesmann Boru 

Sanayi ve Ticaret A.S./ 

Borusan Istikbal Ticaret T.A.S 5.27 

Disclosure 

Commerce intends to disclose the 

calculations performed in connection 

with these final results of review to 

parties in this review within five days 

after public announcement of the final 

results or, if there is no public 

announcement, within five days of the 

date of publication of this notice in the 

Federal Register, in accordance with 19 

CFR 351.224(b). 

Assessment Rates 

Commerce shall determine, and U.S. 

Customs and Border Protection (CBP) 

shall assess, antidumping duties on all 

appropriate entries of subject 

merchandise in accordance with the 

final results of this review. For Borusan, 

we calculated importer-specific 

assessment rates on the basis of the ratio 

of the total amount of dumping 

calculated for each importer’s examined 

sales and the total entered value of those 

sales in accordance with 19 CFR 

351.212(b)(1). Where an importerspecific assessment rate is de minimis 

(i.e., less than 0.5 percent), the entries 

by that importer will be liquidated 

without regard to antidumping duties. 

For entries of subject merchandise 

during the POR produced by Borusan 

for which it did not know its 

merchandise was destined for the 

United States, we will instruct CBP to 

liquidate unreviewed entries at the allothers rate if there is no rate for the 

intermediate company(ies) involved in 

the transaction.11

Commerce intends to issue 

assessment instructions to CBP no 

earlier than 35 days after the date of 

publication of the final results of this 

review in the Federal Register. If a 

timely summons is filed at the U.S. 

Court of International Trade, the 

assessment instructions will direct CBP 

not to liquidate relevant entries until the 

time for parties to file a request for a 

statutory injunction has expired (i.e., 

within 90 days of publication). 

Cash Deposit Requirements 

The following cash deposit 

requirements for estimated antidumping 

duties will be effective upon publication 

of this notice for all shipments of 

circular welded carbon steel standard 

pipe and tube products from Turkey 

entered, or withdrawn from warehouse, 

for consumption on or after the date of 

publication as provided by section 

751(a)(2) of the Act: (1) the cash deposit 

rate for the companies subject to this 

review will be equal to the companyspecific weighted-average dumping 

margin established in the final results of 

the review; (2) for merchandise exported 

by producers or exporters not covered in 

this review but covered in a prior 

completed segment of the proceeding, 

the cash deposit rate will continue to be 

the company-specific rate published in 

the completed segment for the most 

recent period; (3) if the exporter is not 

a firm covered in this review, a prior 

review, or the original investigation, but 

the producer has been covered in a prior 

completed segment of this proceeding, 

then the cash deposit rate will be the 

rate established in the completed 

segment for the most recent period for 

the producer of the merchandise; (4) the 

cash deposit rate for all other producers 

or exporters will continue to be 14.74 

percent, the all-others rate established 

in the less-than-fair-value investigation 

of this proceeding.12 These cash deposit 

requirements, when imposed, shall 

remain in effect until further notice. 

Notification to Importers 

This notice serves as a final reminder 

to importers of their responsibility 

under 19 CFR 351.402(f)(2) to file a 

certificate regarding the reimbursement 

of antidumping duties prior to 

liquidation of the relevant entries 

during this POR. Failure to comply with 

this requirement could result in 

Commerce’s presumption that 

reimbursement of antidumping duties 

occurred and the subsequent assessment 

of double antidumping duties. 

Notification Regarding Administrative 

Protective Order (APO) 

This notice also serves as a reminder 

to parties subject to APO of their 

responsibility concerning the 

destruction or return of proprietary 

information disclosed under APO in 

accordance with 19 CFR 351.305(a)(3), 

which continues to govern business 

proprietary information in this segment 

of the proceeding. Timely written 

notification of the destruction or return 

of APO materials or conversion to 

judicial protective order is hereby 

requested. Failure to comply with the 

regulations and terms of an APO is a 

sanctionable violation. 

Notification to Interested Parties 

We are issuing and publishing this 

notice in accordance with sections 

751(a)(1) and 777(i)(1) of the Act, and 19 

CFR 351.221(b)(5). 

Dated: December 1, 2023. 

Abdelali Elouaradia, 

Deputy Assistant Secretary for Enforcement 

and Compliance. 

Appendix—List of Topics Discussed in 

the Issues and Decision Memorandum 

I. Summary 

II. Background 

III. Scope of the Order 

IV. Changes Since the Preliminary Results 

V. Discussion of the Issues 

Comment 1: Whether Commerce Must 

Account for Borusan’s Cost Recovery 

Pursuant to Statute 

Comment 2: Whether Commerce Must 

Perform the Export Subsidy Offset in the 

Final Results 

Comment 3: Whether Commerce’s 

Application of its Differential Pricing 

Methodology is Contrary to Law 

VI. Recommendation 

[FR Doc. 2023–26937 Filed 12–7–23; 8:45 am] 

BILLING CODE 3510–DS–P 

DEPARTMENT OF COMMERCE 

National Institute of Standards and 

Technology 

[Docket No.: 230831–0207] 

Request for Information Regarding the 

Draft Interagency Guidance Framework 

for Considering the Exercise of MarchIn Rights 

AGENCY: National Institute of Standards 

and Technology, Department of 

Commerce. 

ACTION: Notice; Request for Information 

(RFI). 

SUMMARY: The National Institute of 

Standards and Technology (NIST) seeks 

comments on the Draft Interagency 

Guidance Framework for Considering 

the Exercise of March-In Rights, which 

reviews the factors that an agency may 

consider when deciding whether to 

exercise march-in rights. NIST requests 

information from the public on the 

proposed version of this guidance 

document to ensure that it is clear, and 

its application will both fulfill the 

purpose of march-in rights and uphold 

the policy and objectives of the BayhDole Act. The information received in 

response to this RFI will inform NIST 

and the Interagency Working Group for 

Bayh-Dole (IAWGBD) in developing a 


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85594 Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 

1National Center for Science and Engineering 

Statistics. Survey of Federal Funds for Research and 

Development, 2021. Available at: https://

ncses.nsf.gov/surveys/federal-funds-researchdevelopment/2021. 

2Rights to Federally Funded Inventions and 

Licensing of Government Owned Inventions, 86 

Federal Register 35, https://

www.federalregister.gov/d/2020-27581. 

3Rights to Federally Funded Inventions and 

Licensing of Government Owned Inventions, 88 

Federal Register 17730, https://

www.federalregister.gov/d/2023-06033. 

final framework document that may be 

used by an agency when making a 

march-in decision. NIST will hold at 

least one informational webinar 

explaining the Draft Interagency 

Guidance Framework for Considering 

the Exercise of March-In Rights and how 

the public can submit comments. 

Details about the informational 

webinar(s), including dates, times and 

any registration requirements, will be 

announced at https://www.nist.gov/tpo/ 

policy-coordination/bayh-dole-act. 

DATES: Comments must be received by 

5 p.m. Eastern time on February 6, 2024 

to be considered. Written comments in 

response to the RFI should be submitted 

according to the instructions below. 

Submissions received after that date 

may not be considered. 

ADDRESSES: Comments may be 

submitted by electronic submission via 

the Federal eRulemaking Portal. 

1. Go to www.regulations.gov and 

enter NIST–2023–0008 in the search 

field. 

2. Click the ‘‘Comment Now!’’ icon, 

complete the required fields. 

3. Enter or attach your comments. 

Please submit comments only and 

include your name and/or your 

organization’s name (if any) in your 

submission. Comments containing 

references, studies, research, and other 

empirical data that are not widely 

published should include copies of the 

referenced materials. 

All submissions, including 

attachments and other supporting 

materials, will be a matter of public 

record. Relevant comments will 

generally be available on the Federal 

eRulemaking Portal at https://

www.Regulations.gov. NIST will not 

accept comments accompanied by a 

request that part or all of the material be 

treated confidentially because of its 

business proprietary nature or for any 

other reason. Therefore, do not submit 

confidential business information or 

otherwise sensitive, protected, or 

personal information, such as account 

numbers, Social Security numbers, or 

names of other individuals. 

FOR FURTHER INFORMATION CONTACT: 

Mojdeh Bahar, Associate Director for 

Innovation and Industry Services, 

National Institute of Standards and 

Technology, 100 Bureau Drive, 

Gaithersburg, MD 20899, (301) 975– 

2340 or by email to mojdeh.bahar@

nist.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Federal Government invests 

approximately $115B each year in 

extramural research and development at 

universities, non-profits, and small and 

large businesses.1 This results in the 

creation of thousands of inventions 

annually. The University and Small 

Business Patent Procedures Act of 1980, 

Public Law 96–517 (as amended), 

codified at title 35 of the United States 

Code (U.S.C.) 200 et seq., commonly 

known as the ‘‘Bayh-Dole Act’’ or 

‘‘Bayh-Dole,’’ governs these inventions 

made with Federal assistance. The 

Bayh-Dole Act outlines the rights of 

persons, nonprofit organizations, and 

small business firms (‘‘contractors’’), 

and, as set forth in Executive Order 

12591, all contractors regardless of size 

and to the extent permitted by law, in 

‘‘any invention of the contractor 

conceived or first actually reduced to 

practice in the performance of work 

under a funding agreement’’ (‘‘subject 

invention’’) as well as rights retained by 

the government. One such right is the 

funding agency’s right to require the 

contractor, an assignee, or exclusive 

licensee of a subject invention to grant 

a license to a responsible applicant or 

applicants, upon terms that are 

reasonable under the circumstances, 

and if the contractor, assignee, or 

exclusive licensee refuses such request, 

to grant a license itself (35 U.S.C. 203). 

This right, referred to as ‘‘march-in,’’ 

can only be exercised if the agency 

determines that: 

(1) action is necessary because the 

contractor or assignee has not taken, or 

is not expected to take within a 

reasonable time, effective steps to 

achieve practical application of the 

subject invention in such field of use; 

(2) action is necessary to alleviate 

health or safety needs which are not 

reasonably satisfied by the contractor, 

assignee, or their licensees; 

(3) action is necessary to meet 

requirements for public use specified by 

Federal regulations and such 

requirements are not reasonably 

satisfied by the contractor, assignee, or 

licensees; or 

(4) action is necessary because the 

agreement required by section 204 has 

not been obtained or waived or because 

a licensee of the exclusive right to use 

or sell any subject invention in the 

United States is in breach of its 

agreement obtained pursuant to section 

204. 

NIST has been delegated 

responsibility by the Secretary of 

Commerce to promulgate regulations 

concerning the management and 

licensing of federally funded inventions. 

On January 4, 2021, NIST published a 

notice of proposed rulemaking (NPRM) 

in the Federal Register (86 FR 35) 2

requesting public comments on several 

proposed changes to the Bayh-Dole 

regulations at 37 CFR parts 401 and 404, 

including a provision related to marchin rights which stated that march-in 

‘‘shall not be exercised exclusively 

based on the business decisions of the 

contractor regarding the pricing of 

commercial goods and services arising 

from the practical application of the 

invention.’’ In connection with that 

provision and other proposed changes, 

NIST received over 81,000 public 

comments and was directed through 

Executive Order 14036 to consider not 

finalizing the provision on march-in 

rights and product pricing in the 

proposed rule. In the Final Rule 

published in the Federal Register (88 

FR 17730) 3 on March 24, 2023, NIST 

did not finalize this provision but stated 

its intent to engage with stakeholders 

and agencies with the goal of 

developing a comprehensive framework 

for agencies considering the use of 

march-in. 

NIST has been working with the 

IAWGBD which regularly meets to find 

agency consensus on policy and 

procedures related to the 

implementation of the Bayh-Dole 

regulations, to draft this framework. The 

objectives for the Draft Interagency 

March-In Guidance Framework are to: 

• Provide clear guidance to an agency 

on the prerequisites for exercising 

march-in, and, if those prerequisites are 

met, on facts to be gathered by the 

agency and factors to consider in 

determining whether to march-in. 

• Ensure that decisions to exercise 

march-in support the policy and 

objectives of Bayh-Dole. 

• Encourage the consistent and 

predictable application of the Bayh-Dole 

Act’s march-in authority. 

• Balance the need to incentivize 

industry investment in the development 

and commercialization of subject 

inventions with the need to promote 

public utilization of subject inventions. 

II. Request for Information 

NIST publishes this notice to seek 

comments on the Draft Interagency 

Guidance Framework for Considering 

the Exercise of March-in Rights, 

included with this RFI as Appendix A. 


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All responses that comply with the 

requirements listed in the DATES and 

ADDRESSES sections of this RFI will be 

considered. 

The following list of topics covers the 

major areas about which NIST seeks 

information. The listed areas are not 

intended to limit the topics that may be 

addressed by respondents so long as 

they address the proposed march-in 

framework, including, but not limited 

to, sections or questions that are 

confusing or need additional context or 

explanation; additional sub-questions 

that would assist an agency in 

answering the major questions outlined 

in the framework; specific challenges 

posed by the framework as written; and 

other recommended improvements. 

Responses may include any topic 

believed to have implications for 

decision making related to march-in, 

regardless of whether the topic is 

included in this document. 

NIST is specifically interested in 

receiving input from the public 

pertaining to the following questions: 

(1) After reading through the 

framework and example scenarios, if 

needed, how could the guidance about 

when an agency might want to exercise 

march-in and the factors that an agency 

might consider be made clearer? 

(2) The framework contains many 

terms which have specific meanings 

under Bayh-Dole or in technology 

development and commercialization. 

Are the definitions provided at the 

beginning of the framework easy to 

understand? Do they aid in your ability 

to interpret the framework? 

(3) How could the framework be 

improved to be easier to follow and 

comprehend? 

(4) Does this framework sufficiently 

address concerns about public 

utilization of products developed from 

subject inventions, taking into account 

the fact that encouraging development 

and commercialization is a central 

objective of the Bayh-Dole Act? 

(5) The framework is not meant to 

apply to just one type of technology or 

product or to subject inventions at a 

specific stage of development. Does the 

framework ask questions and capture 

scenarios applicable across all 

technology sectors and different stages 

of development? How could any gaps in 

technology sectors or stages of 

development be better addressed? 

Authority: 35 U.S.C. 203, 206; DOO 

30–2A. 

Alicia Chambers, 

NIST Executive Secretariat. 

Appendix A 

Draft Interagency Guidance Framework for 

Considering the Exercise of March-In Rights 

Table of Contents 

Definitions 

Introduction to March-in Rights & 

Framework 

Does Bayh-Dole Apply? 

Ownership and Licensing 

Is a Statutory Criterion Met? 

Would March-In Support the Policy & 

Objective of Bayh-Dole, Considering The 

Specific Case And Broader Context? 

Scenarios & Examples 

Definitions 

When used within this framework, 

including the introduction, the terms listed 

below should be interpreted as defined 

below: 

Agency—Any executive agency as defined 

in section 105 of title 5, and the military 

departments as defined by section 102 of title 

5. For purposes of this framework, and in 

accordance with 35 U.S.C. 203 ‘‘agency’’ 

shall refer to the agency or agencies under 

whose funding agreement the subject 

invention was made. 

Head of Agency—The head of the agency 

is the Department Secretary or in the case of 

DOD, the Secretary of that particular military 

branch. For independent agencies (e.g., NSF, 

NRC, NASA, etc.) the agency head is the 

highest-ranking member within the agency, 

such as the Director or Administrator. 

Contractor—‘‘Contractor’’ is defined under 

Bayh-Dole as ‘‘any person, small business 

firm, or nonprofit organization that is a party 

to a funding agreement.’’ (35 U.S.C 201(c)). 

Executive Order 12591 expanded this 

definition to include ‘‘any business firm 

regardless of size.’’ Throughout this 

document, unless indicated otherwise, 

‘‘contractor’’ may include contractors as well 

as subcontractors and assignees, including 

inventor(s) or Third Party Assignees 

following agency approval of a request to 

waive rights. 

Funding Agreement—Any contract, grant, 

or cooperative agreement entered into 

between any Federal agency, other than the 

Tennessee Valley Authority, and any 

contractor for the performance of 

experimental, developmental, or research 

work funded in whole or in part by the 

Federal Government. Such term includes any 

assignment, substitution of parties, or 

subcontract of any type entered into for the 

performance of experimental, developmental, 

or research work under a funding agreement 

as herein defined. 

Practical Application—To manufacture in 

the case of a composition or product, to 

practice in the case of a process or method, 

or to operate in the case of a machine or 

system; and, in each case, under such 

conditions as to establish that the invention 

is being utilized and that its benefits are to 

the extent permitted by law or Government 

regulations available to the public on 

reasonable terms. 

Product—Consistent with 35 U.S.C. 204, 

‘‘product’’ includes ‘‘any products 

embodying the subject invention or produced 

through the use of the subject invention.’’ For 

purposes of this framework, ‘‘product’’ may 

also include a service when that service 

requires the use of the subject invention. 

Shelving—When an entity holds a patent 

or has a license to make, use, or sell an 

invention, but they do not develop, use, or 

sell that invention (or a product embodying 

the invention) or seek out third parties to do 

so for an extended period of time. 

Subject Invention—Any invention of the 

contractor conceived or first actually reduced 

to practice in the performance of work under 

a funding agreement: Provided, that in the 

case of a variety of plant, the date of 

determination (as defined in section 41(d)[1] 

of the Plant Variety Protection Act (7 U.S.C. 

2401(d)) must also occur during the period of 

contract performance. Bayh-Dole governs the 

rights and obligations surrounding subject 

inventions; therefore, only subject inventions 

are subject to march-in under Bayh-Dole. 

Other terms used throughout this 

framework should be read consistent with 

the definition within the Bayh-Dole statute 

and regulations (35 U.S.C. 201, 37 CFR 401). 

Introduction to March-In Rights & 

Framework 

Under the University and Small Business 

Patent Procedures Act of 1980, more 

commonly known as the ‘‘Bayh-Dole Act’’ or 

‘‘Bayh-Dole,’’ the government allows 

recipients of federal research funding to 

retain rights to inventions conceived or first 

actually reduced to practice under a federal 

funding agreement (‘‘subject inventions’’). 

The government, however, retains certain 

rights and imposes certain obligations on the 

contractor, including the authority to 

‘‘march-in.’’ March-in allows the agency to 

require the contractor, or an exclusive 

licensee to grant a license to the subject 

invention in any field of use to a responsible 

applicant or applicants. If they refuse, then 

the agency may itself grant a license. 

However, the agency can only exercise 

march-in rights in four specific 

circumstances, the criteria of which are 

specified in the statute (35 U.S.C. 203): 

(1) action is necessary because the 

contractor or assignee has not taken, or is not 

expected to take within a reasonable time, 

effective steps to achieve practical 

application of the subject invention in such 

field of use; 

(2) action is necessary to alleviate health or 

safety needs which are not reasonably 

satisfied by the contractor, assignee, or their 

licensees; 

(3) action is necessary to meet 

requirements for public use specified by 

Federal regulations and such requirements 

are not reasonably satisfied by the contractor, 

assignee, or licensees; or 

(4) action is necessary because the 

agreement required by section 204 has not 

been obtained or waived or because a 

licensee of the exclusive right to use or sell 

any subject invention in the United States is 

in breach of its agreement obtained pursuant 

to section 204. 


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4This represents a summary of the march-in 

procedures. For a full description, see 37 CFR 

401.6. 

5A transcript shall be made and available at cost 

to the contractor, though this requirement can be 

waived upon agreement by the agency and the 

contractor. 

6All portions of the march-in proceeding are 

closed to the public and are held confidential (35 

U.S.C. 202(c)(5)). 

To date, no agency has exercised its right 

to march-in. Several agencies have 

considered march-in previously but have 

either declined to exercise it or worked with 

the parties to find an alternative solution to 

achieve the desired objectives. March-in is an 

important tool for agencies, but that tool is 

accompanied by potentially significant 

positive and negative ramifications. 

Therefore, in addition to the statutory criteria 

discussed above, the agency should carefully 

consider all circumstances and consequences 

and ensure that its march-in decision is 

consistent with the policy and objectives of 

Bayh-Dole. The policy and objectives are 

enumerated in the Bayh-Dole Act at 35 U.S.C. 

200: 

It is the policy and objective of the 

Congress to use the patent system to promote 

the utilization of inventions arising from 

federally supported research or development; 

to encourage maximum participation of small 

business firms in federally supported 

research and development efforts; to promote 

collaboration between commercial concerns 

and nonprofit organizations, including 

universities; to ensure that inventions made 

by nonprofit organizations and small 

business firms are used in a manner to 

promote free competition and enterprise 

without unduly encumbering future research 

and discovery; to promote the 

commercialization and public availability of 

inventions made in the United States by 

United States industry and labor; to ensure 

that the Government obtains sufficient rights 

in federally supported inventions to meet the 

needs of the Government and protect the 

public against nonuse or unreasonable use of 

inventions; and to minimize the costs of 

administering policies in this area. 

The exercise of march-in rights is just one 

tool that may be available to the government 

and use of march-in should be considered in 

the context of all tools at the agency’s 

disposal to address situations. 

Regulatory Procedures for March-In 

If the agency has reason to believe that the 

exercise of march-in rights could be 

warranted (i.e., one of the four criteria appear 

to exist and there is reason to believe that the 

invention in question is subject to BayhDole), then it can initiate the procedures for 

march-in under 37 CFR 401.6.4

First, the agency must notify the contractor 

in writing of the circumstances it believes 

warrants march-in and request an informal 

consultation and information so that the 

agency and the contractor can understand the 

nature of the issue and may consider possible 

alternatives to march-in. At the end of this 

informal consultation, the agency will 

provide written notice to the contractor of its 

decision whether to continue with formal 

march-in procedures based on the available 

information. 

If the agency decides to move forward with 

formal march-in proceedings, the contractor 

is permitted to submit information and an 

argument opposing use of march-in. If that 

submission raises a genuine dispute over 

material facts upon which the march-in is 

based, the head of the agency or his or her 

designee will undertake fact-finding or refer 

fact-finding to another agency official (the 

‘‘fact-finder’’). If the agency proceeds with 

fact-finding, the agency should permit the 

contractor to appear with counsel, submit 

evidence, present witnesses, and confront 

witnesses or experts presented by the 

agency.5 6 The fact-finder will then prepare or 

adopt written findings of fact, which will be 

sent to the contractor. The contractor will be 

given the opportunity to submit arguments 

or, if requested, present oral arguments 

before the agency head or designee makes a 

decision. 

At this point, the head of the agency or 

designee will make a determination based on 

the written findings of facts; information and 

arguments submitted by the contractor; any 

other information in the administrative 

record; and the policy and objectives of the 

Bayh-Dole Act. 

Agencies shall develop an appeals 

procedure pursuant to 37 CFR 401.11(c). It is 

recommended that the appeal be decided by 

the head of the agency or by his or her 

designee who is at a level above the person 

who made the determination. Additionally, a 

contractor, inventor, assignee, or exclusive 

licensee adversely affected by a march-in 

decision may appeal that decision in the 

United States Court of Federal Claims (35 

U.S.C. 203(b)). 

About This Framework 

While the decision to exercise march-in 

rights lies ultimately with the head of the 

agency or his or her designee, this framework 

details facts the agency may seek and the 

considerations that the agency may use in 

making these decisions. 

When determining whether to exercise 

march-in rights, the agency may consider a 

variety of facts but must assess three 

overarching questions: (1) whether Bayh-Dole 

applies to the invention(s) at issue; (2) 

whether any of the statutory criteria for 

exercising march-in applies under the 

circumstances; and (3) whether the exercise 

of march-in rights would support the policy 

and objectives of Bayh-Dole. This framework 

will explore each of these topics in more 

depth and includes some, though not 

necessarily all, of the questions and factors 

the agency may weigh when considering 

march-in. 


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7 iEdison is ‘‘an interagency online reporting 

system for recipients of federal funding agreements 

to report subject inventions to the federal funding 

agency and complete other reporting as required by 

the Bayh-Dole Act and its implementing 

regulations.’’ Available at https://www.nist.gov/ 

iedison. 

8 If an invention is reported to the agency as a 

subject invention, it will be assumed that it is a 

subject invention. If a contractor contends an 

invention is not a subject invention, then they 

would be given the opportunity to provide evidence 

to raise this as a ‘‘genuine dispute over a material 

fact’’ under 37 CFR 401.6(3–5). 

9 If an invention is funded by multiple agencies, 

the funding agencies should notify one another and 

attempt to work together to come to one unified 

government determination on whether march-in is 

warranted. 

10Typically, this can be found near the beginning 

of the patent application and/or patent in the 

specification describing the invention. 

11 Government funding may be listed in an 

acknowledgment in a publication but not contribute 

to the conception or first actual reduction to 

practice of any invention. (37 CFR 401.1(a)(2)). 

Further analysis may be warranted to determine if 

an invention is a subject invention subject to BayhContinued 

When reviewing this framework, it is 

important to remember that march-in 

considerations are extremely fact-dependent 

and any decision to exercise march-in will be 

made based on the totality of all 

circumstances. Nothing in this framework 

should be treated as a mandate that an 

agency exercise its march-in right, as a 

requirement that an agency collect facts to 

answer every question posed here, or as a 

limitation on the facts and questions an 

agency can consider. Rather, it provides a 

more comprehensive outline of the factors 

that an agency may weigh when determining 

whether to exercise march-in rights. 

Information Gathering 

Much of the information discussed in this 

framework may be easily accessible through 

records maintained by the agency, such as 

the iEdison system, and agencies should 

make efforts to compile information from 

these sources when possible.7 However, 

some information will need to be obtained 

through additional searches (e.g., the United 

States Patent and Trademark Office (USPTO) 

or grants and contracts databases), 

discussions with the contractor, information 

requested from or through the contractor, or 

other means. Some information sought in this 

framework may not be discovered until later 

steps in the process, and the facts and 

landscape may shift during march-in 

proceedings. Therefore, it should be noted 

that, if at any time during the process, the 

agency decides that it does not wish to 

exercise march-in rights, it may terminate the 

proceedings. 

Given that the contractor is responsible for 

monitoring its licensees and exclusive 

licensees and that the agency only has direct 

relationships with its contractors (as opposed 

to that contractors’ licensees, or sublicensees), the agency will correspond and 

interact with the contractor as it assesses 

march-in. When requesting certain 

information, the contractor is expected to 

engage with and gather information from its 

licensees or other outside parties as needed. 

Some information relevant to this framework 

may not be available until later in the 

process, and the facts or underlying 

circumstances may shift while the agency is 

assessing a march-in request. If at any time 

during the process, the agency decides 

march-in is not warranted, it may terminate 

the proceedings. 

Does Bayh-Dole apply? 

Because Bayh-Dole only governs subject 

inventions, as a threshold consideration, 

agencies should determine whether a marchin assessment is directed to a ‘‘subject 

invention.’’ Under Bayh-Dole, the 

government cannot march-in and issue 

licenses to any U.S. patent. Government use 

of march-in rights is limited to these 

inventions funded by the government. In 

many cases, march-in requests are directed 

to patents that acknowledge government 

funding, and that acknowledgement can be 

an indication of a subject invention. 

However, whether an invention is a subject 

invention can be a complex and factintensive inquiry. For example, some patents 

that acknowledge government funding will 

not meet the statutory definition of a ‘‘subject 

invention’’ (e.g., those under a funding 

agreement made primarily for educational 

purposes). Agencies evaluating march-in may 

consider these questions in assessing 

government funding for purported subject 

inventions: 

I. Was the invention(s) in question reported 

to the government as a subject invention(s)? 8

If there are products at issue, do they embody 

a subject invention or are they produced or 

performed through use of a subject 

invention? 

A. What purported subject invention(s) are 

relevant to this march-in analysis? If 

available, collect the iEdison Invention 

Report Number, Date Reported to Agency, 

Title Election Status, and reported Funding 

Agreements.9

B. What patent application(s) and/or 

patent(s) are associated with the subject 

invention(s)? All available, associated patent 

numbers and patent application numbers 

should be made part of the agency record. 

II. Is this invention an unreported subject 

invention? 

A. Do unreported patent applications and/ 

or patents covering the invention 

acknowledge federal funding? 10

B. Do publication(s) exist that cover the 

invention? If so, does the acknowledgement 

section(s) reference government funding? 11 If 


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Does Bayh-Dole Apply? 

Are the Inventions Reported as Subject Inventions? Are the Inventions Unreported Subject Inventions? 

'()7 

Is a Statutory Criterion Met? 

Effective Steps to Achieve Alleviate Health or Safety Public Use Specified by Domestic Manufacturing NonPractical Application Needs Federal Regulations Compliance 

'()7 

Would March-In Support the Policy & Objectives of Bayh-Dole? 

Would March-In Achieve Desired Is There a Better Alternative Solution? What are the Wider Implications & Do 

Objective? They Conflict with Bayh-Dole Objectives? 
85598 Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 

Dole, but references to relevant publications can be 

useful in this analysis. 

12A contractor or licensee may be given the 

opportunity to dispute a finding that an invention 

is an unreported subject invention by raising it as 

a ‘‘genuine dispute over the material facts’’ under 

401.6(3–5). 

so, what funding agreements were listed as 

supporting the research described in the 

publication? 

C. Did the contractor receive any funding 

agreements related to the invention and 

conducted by an inventor listed on the 

invention and/or patents? If available, note 

all funding agreements for the contractor 

relevant to the subject matter of the invention 

and work done by the relevant inventor. 

D. What are the approved scientific aims 

under the listed funding agreements? 

1. If available, the funding agreement, 

including the Scope of Work which might 

relate to the subject invention, should be part 

of the agency record. 

Note that the agency may request input 

from a program manager, legal counsel, and/ 

or subject matter expert, and analyze 

publications, patent applications, or issued 

patents to help identify potential overlaps 

with the scientific aims of a funding 

agreement(s). 

E. Based on the information gathered in 

this section, can the agency confirm whether 

each invention relevant to the march-in 

assessment was ‘‘conceived or first actually 

reduced to practice in the performance of 

work under a funding agreement?’’ 12

Ownership and Licensing 

To evaluate march-in, agencies should also 

determine the contractors and licensee(s) 

that currently have rights to the subject 

invention and are involved in activities like 

research and development (R&D) or 

manufacturing, marketing, and selling 

products. The march-in assessment will often 

center on the scope and extent of what these 

parties are doing in an effort to understand 

the full scope of efforts undertaken to 

practice the subject invention. The totality of 

this information will allow agencies to 

understand the relevant stakeholders and 

their current actions. 

I. Which owners are listed for each subject 

invention, patent application and/or patent 

relevant to this march-in analysis in USPTO 

records and other sources? 

II. Which license(s) cover the subject 

invention, associated patent application(s), 

and/or patent(s)? If available, note which 

subject invention(s), patent application(s), 

and/or patent(s) are covered by each license; 

whether the license is exclusive or nonexclusive; and the field of use. 

Is a statutory criterion met? 

The statute only authorizes march-in in 

four statutorily defined circumstances (35 

U.S.C. 203(a)), therefore, agencies must 

assess whether at least one of these 

circumstances applies before proceeding. To 

that end, and depending on the details of a 

march-in consideration, agencies may 

consider some of the following questions: 

Criterion 1. Action is necessary because the 

contractor or assignee has not taken, or is not 

expected to take within a reasonable time, 

effective steps to achieve practical 

application of the subject invention in such 

field of use. 

This criterion focuses on the steps that 

contractors have taken to develop and 

achieve practical application of the subject 

invention. For example, if a contractor or 

licensee has stopped further work on the 

subject invention and the contractor and/or 

licensee has refused to restart work and 

rejects requests to license the subject 

inventions, that could suggest limited 

opportunities to commercialize the subject 

invention into new products. Stalled product 

development could be an indication of 

conflict with the objectives of the Bayh-Dole 

Act to encourage utilization and 

commercialization of federally funded 

inventions. To assess the steps contractors 

and licensees are taking to commercialize 

these subject inventions, agencies should 

assess if the subject invention is licensed and 

whether there is a product embodying the 

invention on the market. If the contractor has 

not licensed the invention, or if no product 

exists, agencies may need to further assess 

whether march-in is warranted. 

If the contractor or licensee has 

commercialized the product, but the price or 

other terms at which the product is currently 

offered to the public are not reasonable, 

agencies may need to further assess whether 

march-in is warranted. Whether action may 

be needed to meet the needs of the 

Government or protect the public against 

nonuse or unreasonable use of the subject 

invention may include consideration of 

factors that unreasonably limit availability of 

the invention to the public, including the 

reasonableness of the price and other terms 

at which the product is made available to 

end-users. 

Agencies may also consider the 

circumstances surrounding the patent status, 

any licenses and/or offers to license, and the 

products themselves—however, some of 

those issues may be better addressed through 

other statutory march-in criteria, other 

provisions in the Bayh-Dole Act, or different 

government authorities. 

It should be noted that given the nature of 

this criterion, the questions the agency asks 

may vary depending on the stage of 

development as well as whether the 

contractor is licensing the technology for 

development and commercialization or 

intends to develop and commercialize the 

resulting product directly. 

I. When determining whether to exercise 

march-in under this criterion, the agency will 

first assess which of the following categories 

best describes the current stage of 

development for the subject inventions and/ 

or products and answer the corresponding 

questions. 

A. The subject invention is not licensed, 

and the contractor has no plans to develop 

or commercialize, itself. Complete Section II. 

B. The subject invention is licensed, or the 

contractor is developing the subject 

invention with plans to directly 

commercialize it. Complete Section III. 

C. The product is commercialized. 

Complete Section IV. 

II. In considering whether this criterion 1 

applies to a subject invention that is not 

licensed and the contractor has no plans to 

develop or commercialize itself, the agency 

may assess: 

A. What actions has the contractor taken to 

license the subject invention (for example, is 

it evaluating licensing offers, or seeking out 

interested licensees)? 

B. Have the contractor and any potential 

licensee(s) reached mutually agreeable 

license terms? 

1. If yes, then why is the subject invention 

not licensed? 

2. If no, has the contractor offered to 

license the subject invention under 

commercially reasonable terms? Are there 

companies that want to license but the 

contractor will not agree to terms offered? 

C. Is there an indication the contractor 

would decline to license the subject 

invention even if a potential, responsible 

license applicant was presented? 

D. Is there a valid reason (technical, legal, 

or otherwise) that explains why the 

contractor has stopped licensing efforts? 

What is that reason? 

E. Are there concerns about the contractor 

shelving the subject invention(s) without 

justification and not committing to 

discernable steps on re-engaging in its 

licensing? 

III. In considering whether this criterion 1 

applies to a licensed subject invention or a 

subject invention that is being developed or 

commercialized by the contractor, the agency 

may assess: 

A. What steps are needed to bring the 

product to market? Is the contractor or the 

licensee taking these steps or planning to 

take these steps within a reasonable 

timeframe? 

1. If the invention is licensed but the 

licensee is not taking steps to bring it to 

market, has the contractor attempted to 

address the matter with the licensee? Are 

there appropriate product development 

milestones in the License Agreement? Are 

there unmet milestones the contractor could 

enforce? If not, are there other steps the 

contractor can take under the terms of the 

license to ensure development? 

2. What is the degree of investment, time, 

and regulatory requirements needed to bring 

the product to market? 

B. Is regulatory approval needed or 

pending? 

1. If yes, is the contractor and/or licensee 

seeking regulatory approval? If approval was 

denied, what were the reasons and will 

further approval be sought, for example after 

additional data is collected? 

C. If the licensee or contractor is not 

intending to manufacture the product, have 

they identified manufacturers? 

1. If a potential manufacturer(s) has been 

identified, have the manufacturer and 

contractor(s)/licensee(s) reached mutually 

agreeable license terms? 

a. If yes, when will manufacturing begin? 

b. If no, has the contractor(s)/licensee(s) 

offered to license the subject invention for 

manufacturing under commercially 

reasonable terms? Are there manufacturers 

who desire a license, but the contractor(s)/ 

licensee(s) has not agreed to terms offered? 

2. If a potential manufacturer has not been 

identified, what actions has the contractor(s) 


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13Pursuant to 35 U.S.C 202(a)(ii) some agencies 

may have issued Determinations of Exceptional 

Circumstances (DECs) amending the standard 

patent rights clauses of their funding agreements to 

include broader domestic manufacturing 

obligations than those enumerated in 35 U.S.C. 204. 

Agencies who have issued such DECs should refer 

to those DECs to determine the extent of the 

government’s rights when contractors are 

noncompliant with the manufacturing obligations 

under the DEC. For example, DOE’s 

‘‘DETERMINATION OF EXCEPTIONAL 

CIRCUMSTANCES UNDER THE BAYH–DOLE ACT 

TO FURTHER PROMOTE DOMESTIC 

MANUFACTURE OF DOE SCIENCE AND ENERGY 

TECHNOLOGIES’’ does not specify any government 

march-in rights, but requires contractors to ‘‘convey 

to DOE, upon written request from DOE, title to any 

subject invention, upon a breach’’ of their U.S. 

Competitiveness provision. 

or licensee(s) taken to identify potential 

manufacturers? 

D. Is there a valid reason (technical, legal, 

or otherwise) that explains why the 

contractor or licensee has stopped 

development or commercialization efforts? 

What is that reason? 

E. Are there concerns about the contractor 

or licensee shelving the subject invention(s) 

without justification and not committing to 

discernable steps on re-engaging in its 

development? 

VI. In considering whether this criterion 1 

applies to a product that is being 

commercialized, the agency may assess: 

A. Is the contractor or licensee marketing 

or selling to end-users or consumers in the 

U.S.? If not, why? 

B. Has the product utilizing the subject 

invention been sold or offered for sale in the 

U.S. using distribution channels (e.g., 

retailer, wholesaler, through a regulated 

intermediary, or direct to consumer) used for 

similar products? 

C. How does the availability of the product 

benefit the public, and how is the public 

harmed by limited availability of the 

product? 

D. At what price and on what terms has the 

product utilizing the subject invention been 

sold or offered for sale in the U.S.? 

a. Has the contractor or licensee made the 

product available only to a narrow set of 

consumers or customers because of high 

pricing or other extenuating factors? Has the 

contractor or licensee provided any 

justification for the product’s price or 

background on any extenuating factors which 

might be unreasonably limiting availability of 

the subject invention to consumers or 

customers? 

Criterion 2. Action is necessary to alleviate 

health or safety needs which are not 

reasonably satisfied by the contractor, 

assignee, or their licensees. 

In considering march-in based on criterion 

2, agencies will seek a clear picture of the 

health or safety need that is not being 

reasonably satisfied. The agencies can also 

assess what it would take to better or fully 

meet the need and will evaluate how marchin could address the health or safety need. 

I. What is the health or safety need to be 

addressed? What is the scope of the health 

or safety need? How long is the health or 

safety need anticipated to last? 

II. Has the agency consulted with other 

agencies resulting in agreement on unmet 

health or safety needs and/or other necessary 

actions? 

III. How does the subject invention or the 

product at issue address the unmet health or 

safety need? 

IV. What is necessary to resolve the health 

or safety need? 

A. Greater quantity or quality of a specific 

product? 

B. Different or additional ways to access 

the product? 

C. More options to access similar, but not 

identical, products? (For example, if the 

contractor manufactures one dosage of a drug 

but a new use is identified that requires a 

much lower or higher dosage). 

D. Greater access through additional uses 

of another existing product? 

V. Is the contractor or the licensee 

exploiting a health or safety need in order to 

set a product price that is extreme and 

unjustified given the totality of 

circumstances? 

A. For example, has the contractor or 

licensee implemented a sudden, steep price 

increase in response to a disaster that is 

putting people’s health at risk? 

It should be noted that in reviewing this 

question, the agency is not limited to 

reviewing price increases; the initial price 

may also be considered if it appears that the 

price is extreme, unjustified, and exploitative 

of a health or safety need. 

VI. How would march-in address the 

health or safety need? Are there other 

products, or other potential alternatives to 

march-in, that would address the health or 

safety need, in whole or in part? 

VII. Has the contractor been consulted 

about options, short of march-in, to address 

the unmet need? 

Criterion 3. Action is necessary to meet 

requirements for public use specified by 

Federal regulations and such requirements 

are not reasonably satisfied by the contractor, 

assignee, or licensees. 

Under criterion 3, agencies will evaluate 

whether any Federal regulations relate to the 

use of products commercialized from the 

subject invention. They will assess whether 

the contractor(s) and/or licensee(s) have 

taken reasonable steps to address any needs 

related to these Federal regulations, 

including making the subject invention 

available to all who require it. 

I. Does a Federal regulation expressly 

require the subject invention to be used in or 

in combination with another product (if the 

subject invention is commercially available)? 

If a Federal regulation does not expressly 

require such use, does a Federal regulation in 

practice effectively require the use of the 

subject invention in order to satisfy a 

regulatory requirement? 

II. Is the subject invention already available 

to those who require it under the regulation? 

A. If not, is there evidence that the 

contractor(s) or licensee(s) is restricting 

access or imposing barriers to access? 

III. How does the subject invention address 

the need? 

IV. Do other current technologies address 

the issue? If so, what are those technologies? 

V. Has the contractor contacted the agency 

that issued the regulation for assistance? 

VI. How much time is required to meet 

public use requirements by Federal 

regulation? 

VII. Has the contractor been specifically 

consulted about addressing the public use 

requirement? 

Criterion 4. Action is necessary because the 

agreement required by section 204 has not 

been obtained or waived or because a 

licensee of the exclusive right to use or sell 

any subject invention in the United States is 

in breach of its agreement obtained pursuant 

to section 204. 

This criterion relates to 35 U.S.C. 204 and 

requires that exclusive licenses to use or sell 

in the U.S. include an agreement that 

products embodying subject inventions be 

manufactured substantially in the U.S.13 The 

requirement for such an agreement may be 

waived by the agency under whose funding 

agreement the invention was made upon a 

showing by the small business firm, nonprofit 

organization, or assignee that reasonable but 

unsuccessful efforts have been made to grant 

licenses on similar terms to potential 

licensees that would be likely to manufacture 

substantially in the U.S. or that under the 

circumstances domestic manufacture is not 

commercially feasible. Broadly, agencies will 

evaluate if § 204 applies, request specific 

details on where any products are being 

manufactured, and determine if a 

manufacturing waiver is required and if a 

request to waive the preference for U.S. 

industry has been granted. 

I. Are the prerequisites triggering the 

agreement required under section 204 

present? 

A. Has the contractor granted an exclusive 

license to use or sell any subject invention 

in the United States? 

II. Did the contractor’s exclusive license 

agreement require that any products 

embodying the subject invention or produced 

through the use of the subject invention be 

manufactured substantially in the U.S.? 

A. If no, can the agreement be amended to 

incorporate the agreement required by 

section 204? 

B. If no, was a request for waiver of the 

preference for U.S. industry submitted to the 

agency(ies)? Was the request granted and 

under what terms? 

III. Are products embodying the subject 

invention or produced through the use of the 

subject invention being manufactured under 

that exclusive license? 

A. If yes, in what countries are those 

products being manufactured? 

B. Taking the manufacturing locations of 

all components of the product into 

consideration, would the product be 

considered to have been manufactured 

substantially in the U.S.? 

IV. If the answers to II and/or III above are 

no, was a request for waiver of the preference 

for U.S. industry submitted to the 

agency(ies)? 

A. If yes, was the waiver request granted? 

1. If so, what were the terms of the waiver 

(subject inventions covered, duration, 

countries or facilities wherein products can 

be manufactured, field of use, etc.)? 

2. If the waiver request was submitted but 

denied, why was it denied? 


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B. If no, has the agency contacted the 

contractor under its enforcement authorities 

of the terms and conditions of the funding 

agreement to demand that a waiver request 

be submitted? 

Would march-in support the policy & 

objective of Bayh-Dole, considering the 

specific case and broader context? 

The Bayh-Dole regulations under 37 CFR 

401.6(a)(6) state that ‘‘[t]he consistency of the 

exercise of march-in rights with the policy 

and objectives of 35 U.S.C. 200 shall also be 

considered. The Bayh-Dole Act emphasizes 

‘‘utilization of inventions arising from 

federally funded research and development’’ 

and the ‘‘commercialization and public 

availability of’’ those inventions. The 

foundation of Bayh-Dole’s policies and 

objectives reflect two themes (among others): 

promoting the development of new products 

in the U.S. and their availability to end-users 

or consumers in the U.S. Accordingly, 

agencies evaluating march-in should 

prioritize both policy goals—incentivizing 

U.S. innovation and promoting access to the 

fruits of that innovation in the U.S. 

Determining whether an individual march-in 

decision would advance or impede these 

goals may be a complex and fact-specific 

assessment. Agencies should also weigh how 

an individual march-in decision could 

impact the broader policy objectives for U.S. 

competitiveness and innovation. 

I. Would march-in help achieve practical 

application, alleviate health or safety needs, 

meet public use requirements, or meet 

manufacturing requirements? 

This section of the framework is intended 

to inform the agency’s assessment of the 

practical value of exercising march-in, 

specifically in terms of increasing 

accessibility of the subject invention(s)—what 

would happen if a contractor, licensee, or the 

agency issued (or tried to issue) a new 

license(s) to the subject invention(s)? How 

likely is it that march-in would solve the 

problem identified by those seeking it? Could 

other interested and willing licensees 

practice the subject invention in sufficient 

time to address the problem? An absence of 

other interested licensees could weigh 

against march-in. Agencies may also need to 

consider whether there is intellectual 

property (beyond the subject invention(s)) 

that could possibly prevent other licensees 

from making the product or offering the 

service in question. A complicated 

intellectual property landscape could reduce 

the likelihood of successful licensing and 

weigh against march-in. To that end, 

agencies reviewing march-in may ask some of 

these questions: 

A. Is there another willing and able 

licensee or is it likely that one could be 

found? 

1. How long would it take another 

licensee(s) to start producing and marketing 

the covered product? How long would it take 

before another licensee(s) could satisfy 

existing demand for the product? At what 

price would another licensee(s) be able to 

make the product available to the public? 

2. What steps, if any, could or should the 

agency or the existing contractor(s) take to 

identify other willing licensee(s) under the 

circumstances? 

B. What intellectual property, in total, is 

needed to make the product in question? 

Does making the product or performing the 

service also require use of intellectual 

property that was not government funded 

and is not subject to Bayh-Dole? 

1. For example, if only one of several 

patents necessary to produce a product is 

subject to march-in, that likely weighs 

against march-in, since other licensees would 

need separate permission to use several other 

patents before they could make the product. 

On the other hand, if all the intellectual 

property needed to produce the product is a 

subject invention(s), that might result in a 

different licensee being able to produce 

product quickly or efficiently. 

C. When do the patents subject to the 

march-in evaluation expire? 

1. Will the patents expire before the marchin process is completed and another licensee 

is able to bring a product to market? Consider 

the remaining patent life in relation to the 

timeline for march-in proceedings, federal 

court appeals, transfer of know-how and 

build out of product manufacturing 

capability, and/or any necessary regulatory 

approvals. If the patent term is likely to end 

before the march-in process concludes and 

before a new licensee could bring a product 

to market, these factors weigh against a 

decision to exercise march-in rights. 

D. Is the product or service subject to 

regulatory exclusivity, such as those 

provided by the FDA? If so, how much time 

remains in the period of exclusivity? 

E. If march-in is requested in response to 

an emergency or an urgent public health or 

safety issue—how long is the emergency or 

issue expected to last? Consider if the marchin process would take longer than the 

emergency is expected to last, as that could 

weigh against march-in. 

F. If march-in is requested based on the 

criterion of domestic manufacturing— 

1. Is the contractor willing to submit a 

request to waive the preference for U.S. 

industry? Consider whether the agency 

would grant a waiver, if requested. 

G. Would a determination to march-in 

promote utilization of this subject invention? 

Would it protect the public against non-use 

or unreasonable use of this subject invention? 

1. Would march-in have an impact on 

public availability of the benefit of the 

invention in the short and long-term? 

The situation and pertinent facts may 

evolve with time. Agencies may revisit these 

questions—e.g., whether there is another 

willing and able licensee—and defer a 

march-in determination in the event 

appropriate licensees emerge. Another 

possible circumstance that could affect 

march-in analysis includes another product 

coming to market during the pendency of the 

march-in process that displaces the market 

for product that is the subject of march-in. 

II. Are there other ways to address the 

identified problem, and can those 

alternatives be pursued instead of or in 

parallel with any march-in proceedings? 

During review of march-in, more 

expeditious resolutions may be identified, 

and agencies should weigh viable 

alternatives when making march-in 

decisions. However, just because there may 

be alternative resolutions to the problem that 

prompted march-in consideration, that does 

not mean exercise of march-in rights is 

inappropriate. 

A. Are there other alternatives available to 

address the problem identified? How 

effective are the alternatives (or how likely is 

it that other alternatives would solve the 

problem), and how effective are the 

alternatives in comparison to march-in? 

B. If the subject invention is licensed, what 

efforts have or can the contractor(s) and/or 

licensee(s) take to solve the problem? 

C. Are the contractor and its licensee(s) 

willing to take action to remedy the matter 

without the agency exercising march-in? 

D. Is there a problem such as anti-trust 

activity, fraud, or bankruptcy, that would be 

best addressed by other federal or state 

governmental authorities? 

E. Is there patent litigation pending or 

other legal actions or concerns regarding the 

patents associated with the subject 

invention? Consider whether other legal 

processes (e.g., a challenge to the validity of 

the patent, licenses being revoked) may allow 

another manufacturer to bring the product to 

market more quickly, as that could weigh 

against use of march-in. 

F. Is there another federal agency taking 

action that would resolve underlying issues 

without the use of march-in? 

III. What are the wider implications of use 

of march-in? 

At its core, the Bayh-Dole Act focuses on 

U.S. innovation and the commercialization 

of inventions that arise from federally funded 

R&D—all with an eye towards advancing the 

interests of the American public. Prior to 

exercising march-in, funding agencies should 

consider both the practical impact and the 

potential impact on the broader R&D 

ecosystem. To that end, agencies may 

consider questions such as: 

A. Would march-in protect the public 

against nonuse or unreasonable use of subject 

inventions? 

1. Consider ways to ensure that any use of 

march-in achieves the intended outcomes 

and does not have broad and unintended 

consequences on U.S. competitiveness and 

innovation. 

2. Consider whether march-in would send 

a clear signal to industry so other contractors 

and licensees can rely on that agency’s prior 

decisions to avoid similar issues in the 

future. 

B. Consider whether march-in would 

increase public availability of federally 

funded inventions and foster support for the 

federal research enterprise. 

C. Would exercise of march-in rights here 

promote competition without unduly 

encumbering future R&D? Would it impact 

competition and R&D more broadly? For 

example, would there be a decrease in the 

number of applicants for federal funding? 

D. Would exercise of march-in impact 

utilization of subject inventions more 

broadly? 

1. Would march-in have an impact on U.S. 

competitiveness and innovation? 

2. Would prospective licensees likely avoid 

future collaborations with federally funded 

research institutions, organizations, small 

businesses, and investigators? For example, 


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would there be a decline in the number of 

collaborations with the federal laboratory? 

Would an agency’s practice result in a 

decline in the number of collaborations? 

Agencies may answer both questions post 

facto, and cannot be predicted. However, if 

an agency has had a similar effort that had 

impacted the number or quality of 

collaborators, they could extrapolate the 

effect. Agencies should consider the potential 

chilling effect on the agencies’ existing 

relationships with industry and ability to 

address Administration priorities. 

E. Consider whether input from other 

agencies would be helpful to understand the 

ramifications of a march-in decision, e.g., the 

State Department, Office of the U.S. Trade 

Representative, or Department of Commerce 

as to any diplomatic or trade implications or 

the United States Patent and Trademark 

Office as to any intellectual property 

implications. 

Scenarios & Examples 

This section of the framework presents a 

variety of hypothetical scenarios where 

march-in could emerge. These examples and 

the subsequent discussion showcase how an 

agency might apply this framework, 

considering certain factors and questions, in 

assessing march-in. 

In an actual march-in analysis, an agency 

would consider the relevant facts and 

questions, explore the relevant Bayh-Dole 

statutory march-in criteria, and evaluate any 

feasible alternatives before making a 

determination of whether to exercise marchin. However, for clarity and brevity, when 

discussing these scenarios, please assume the 

following: 

1. The agency establishes or has 

established that Bayh-Dole applies to the 

subject invention(s). 

2. Only Bayh-Dole subject inventions are 

needed to successfully manufacture the 

product (i.e., no additional intellectual 

property licensing would be needed). 

3. Although the agency considers the 

relevant factors and answers relevant 

questions within the framework, only one 

criterion and certain illustrative facts and 

circumstances may be addressed in the 

discussion of each scenario. 

These scenarios are hypothetical and 

should not be read or inferred to reference a 

particular invention, product, contractor, or 

licensee. Further, nothing in the discussions 

of these scenarios should be interpreted as an 

obligation upon the agency to exercise 

march-in. As stated previously, march-in 

decisions are extremely fact-dependent and 

the agency would consider the totality of 

circumstances in a real-life situation, 

whereas these scenarios only address select 

issues. 

Scenario 1 

Background: A biotech company has 

partnered with a U.S. government-funded 

university to develop treatments for 

autoimmune skin diseases. The company was 

granted an exclusive license to a governmentfunded patent owned by the university. The 

patent claims a new compound that has 

shown promise in pre-clinical trials for 

psoriasis. The company has also separately 

developed another psoriasis treatment and 

that second treatment—which recently 

received FDA approval—was developed 

solely by the company without any 

government support. Once the company 

secured FDA approval for that second 

treatment, it appears to have stopped all 

work on the patented compound that was 

invented by the government-funded 

university. A second company has 

approached both parties for a license to the 

university-owned patent, but its request was 

denied, so the second company has asked the 

government funding agency to march-in and 

require the university to grant it a license to 

the university patent. 

Discussion: 

Statutory Criteria—In this scenario, it 

appears the contractor and licensee may not 

be taking effective steps to achieve practical 

application of the subject invention in such 

field of use (Statutory Criterion 1). Before 

proceeding, the agency would seek 

information from the contractor to confirm 

whether the current licensee has in fact 

stopped development of the subject 

invention. If so, the agency would continue 

this inquiry to determine if the licensee is 

inappropriately shelving the technology. 

To make this determination, the agency 

would explore the questions detailed in 

Statutorily Defined March-In Criteria; 

Criterion 1; Section III. It appears the licensee 

might have ceased development of the 

subject invention in favor of another 

competing technology (Statutorily Defined 

March-in Criteria, Criterion 1, III, A). The 

agency would then ask whether there was a 

valid, technical reason that the licensee 

stopped development (Section III, B). For 

example, if the licensee obtained poor results 

in clinical trials, that could justify halting 

work and weigh against march-in. However, 

the fact that there is another interested 

licensee suggests the subject invention holds 

clinical promise, and that could weigh in 

favor of march-in. 

The agency would also ask whether the 

contractor has taken steps to remedy this 

situation and whether the contractor’s 

agreement with the licensee includes 

milestones or other diligence provisions that 

would allow the contractor to terminate the 

license and ‘‘clawback’’ the technology. If the 

contractor intends to enforce ‘‘clawback’’ 

provisions to terminate the license and seek 

other licensees, or if it intends to enforce 

milestones within the license to push further 

development of the university-patented 

invention, these factors could weigh against 

march-in. If the license in question did not 

contain such provisions or the contractor was 

unwilling to exercise its rights, then these 

circumstances could weigh in favor of marchin. 

Policy & Objectives of Bayh-Dole—As part 

of this analysis, the agency would also look 

at whether exercising march-in rights would 

achieve the desired outcome and support the 

policy and objectives of Bayh-Dole. First, the 

agency would consider whether march-in 

would promote utilization and protect 

against non-use of this subject invention 

(Would March-In Support the Policy & 

Objective of Bayh-Dole; Section I). Here, the 

agency would analyze whether the second 

company that sought a license pursuant to 

march-in was a reasonable applicant (Section 

I, E). In other words, would that company be 

capable of bringing the product to market? If 

a viable and qualified company was 

interested in restarting development work 

but being denied the opportunity, that would 

weigh in favor of march-in. However, if that 

second company, on its face, lacked any of 

the experience or resources necessary to 

bring a new psoriasis treatment to market— 

and if the agency was unlikely to find 

another qualified and interested licensee (for 

example, because the product failed clinical 

trials)—these factors and circumstances 

would weigh against march-in. The agency 

would also look at timing factors, like the 

remaining patent life compared to the time 

required to complete march-in proceedings, 

exhaust appeals, and further develop the 

technology—as a short remaining patent term 

could weigh against march-in (Section I, B, 

1). Second, the agency would consider 

whether there are viable alternatives (Section 

II), like the contractor clawing-back the 

existing license and issuing one to a new 

developer. Finally, the agency would assess 

the wider implications of exercising marchin (Section III). This would depend in large 

part on further factual development 

referenced above. But if there is a valid 

reason why this licensee stopped work, then 

march-in here seems unlikely to advance the 

goals of Bayh-Dole. But if this is a case of a 

licensee is impermissibly shelving a subject 

invention to preserve the market position of 

a competing product, march-in here could 

deter similar actions by others in the future. 

Scenario 2 

Background: An advanced manufacturing 

startup that received Phase I and Phase II 

SBIR grants is working on improved 3–D 

printing technology for construction 

materials. The startup is regularly attending 

conferences and showcasing its prototypes 

and it recently closed a successful Series A 

funding round with several venture investors 

who have a history of success in the relevant 

markets. But it has been several years since 

the startup launched and it is not yet offering 

a commercial product or service. The startup 

also holds a portfolio of five governmentfunded patents directed to its technology. A 

large, established construction company is 

looking to launch a 3–D printing initiative 

and it has asked the government funding 

agency to march-in and grant it a license to 

the startup’s patent portfolio. The established 

construction company claims the startup is 

impermissibly shelving the subject invention 

by not launching a product or service, yet, 

and the established company contends it has 

the resources and funding on hand to bring 

this technology to market quickly—making it 

a preferred licensee. 

Discussion: 

Statutory Criteria—In this scenario, it 

appears the contractor is taking steps to 

achieve practical application of the subject 

invention (Statutorily Criterion 1). The 

agency would likely start its analysis by 

discussing the contractor’s plans to develop 

or license the invention (Statutorily Defined 

March-in Criteria, Criterion 1, I–III). Here, the 

contractor seems to be actively developing 


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the technology and preparing to market it in 

at least one field of use. It has recently raised 

additional funds that would support further 

development and product launch. The mere 

fact that a potential competitor might be able 

to bring a subject invention to market more 

quickly than the contractor does not mean 

the contractor is impermissibly shelving a 

subject invention. On the other hand, if there 

are indications that the startup is delayed 

because it is devoting all its resources to 

develop to unrelated technology, that could 

weigh in favor of march-in. The agency may 

also monitor the continued progress of the 

contractor in developing this technology to 

improve construction material 

manufacturing. 

Policy & Objectives of Bayh-Dole—The first 

part of this analysis looks at whether marchin would promote utilization and protect 

against shelving or non-use of this invention 

(Would March-in Support the Policy & 

Objective of Bayh-Dole; Section I). Here, it 

appears the contractor is still actively 

developing this technology and not shelving 

it, which would weigh against march-in, 

even though other licensees might also be 

able to bring this technology to market. The 

agency may also consider if there are other 

steps it, or the contractor, could take to speed 

development—if that is warranted (Section 

II). Finally, the agency may consider the 

wider implications of exercising march-in 

(Section III). For example, the Bayh-Dole Act 

includes the objective of ‘‘encourage[ing] 

maximum participation of small business 

firms in federally supported research and 

development efforts.’’ March-in here could 

deter future small businesses from engaging 

in federally supported R&D, if they thought 

larger competitors would be able to easily 

leverage march-in requests to step in and take 

over development and commercialization. 

Scenario 3 

Background: The Federal Highway Safety 

Administration has identified a growing 

safety concern in which traffic accidents 

have risen 27% due in large part to drivers’ 

inability to see traffic signs early enough to 

act accordingly. Having evaluated the 

growing number of incidents, it has been 

determined that the issue is the visibility of 

the traffic signs in lighting extremes (glare 

from bright sunshine during the day or lack 

of visibility of the signage during low light 

hours). Subject to a grant provided by the 

government, a contractor has developed a 

new retroreflective coating for traffic signs 

that improves the visibility of the signs by as 

much as 75% both during bright daylight 

without glare and at night by enhancing the 

indirect reflection of automobile headlights 

off the signage. The contractor is a mediumsized company that is seeking to grow, based 

on this new patented technology, but they are 

unable to keep up with demand for their new 

material from signage manufacturers who are 

receiving significant increases in demand 

from state Departments of Transportation 

(DOTs) seeking to improve or replace their 

signage. To date the contractor has only 

agreed to license its patent to one sign 

manufacturer. Others have sought licenses 

and been rejected. Several manufacturers 

have approached the government funding 

agency seeking assistance in licensing the 

patented material to manufacture and 

incorporate the material into the signs they 

sell to the state DOTs. 

Discussion: 

Statutory Criteria—First, the agency would 

investigate the scope of the unmet health and 

safety need and how this subject invention 

addresses that need (Statutorily Defined 

March-In Criteria; Criterion 2; Sections I–III). 

Based on this fact pattern, it seems more of 

the retroreflective coating product is needed 

to satisfy an unmet safety need (Section IV) 

and it could significantly impact, though not 

completely alleviate, the safety concerns 

(Section V). The agency may, for example, 

seek additional data to understand how 

much the new coating has actually improved 

safety and how many accidents have been 

prevented due to use of this coating. If there 

is strong evidence of a steep drop in 

accidents, that could weigh more in favor of 

march-in. However, if there’s not yet 

sufficient evidence that the improved 

visibility is positively impacting driver 

safety, march-in may at the very least be 

premature. The agency would also consult 

with the contractor and gather additional 

information as to why it has been denying 

licenses (Section VI). Perhaps the contractor 

has a valid reason, e.g., limited worldwide 

access to necessary raw materials, or it may 

have a concrete plan to increase production 

in the near future; these factors could weigh 

against march-in. Likewise, the contractor 

and the agency may be able to work out a 

plan or timeline for addressing the safety 

need without march-in. However, if the 

contractor cannot present a rationale to 

refuse more licenses and it has no 

discernable plan to meet increasing demand, 

then that could weigh in favor of march-in. 

Policy & Objectives of Bayh-Dole—The 

agency would also need to determine 

whether march-in would alleviate the health 

or safety need (Would March-In Support the 

Policy & Objective of Bayh-Dole; Section I). 

In this case, the answer likely depends on the 

further factual development referenced 

above. For example, if the raw materials 

necessary to make this new coating are in 

very short supply—and the contractor is 

already using all the available raw 

materials—then march-in would be unlikely 

to alleviate the health or safety need by 

increasing coating production. The agency 

would also consider the relevant timelines 

(Section I, C). For example, if the contactor 

would be able to satisfy all outstanding state 

DOT orders within the year and march-in 

proceedings are likely to take longer, that 

would weigh against march-in. The agency 

would also explore other alternatives to 

address traffic safety in parallel (Section II, 

A). For example, are there other products that 

could support the market need while the 

contractor increases its production capacity? 

Alternatives need not be superior to the 

subject invention to be a consideration 

weighing against march-in. Finally, the 

agency would consider the wider 

implications of march-in. For example, 

would march-in here deter smaller or 

medium sized businesses from 

commercializing subject inventions, out of 

fear that they would lose exclusivity or 

patent protection to larger companies with 

more capacity (Section III, B–C)? 

Scenario 4 

Background: A small pharmaceutical 

startup that has received extensive 

government funding developed a monoclonal 

antibody that currently is the only treatment 

for a rare disease. That company holds all of 

the patents covering the antibody, its use, 

and the methods of manufacturing—and each 

of those patents contains a clause 

acknowledging government funding as 

required by the regulations. The startup does 

all its manufacturing at a plant in California, 

and severe rainfall caused substantial 

flooding that compromised the 

manufacturing plant. The plant will need 

substantial repairs, and it is unclear if and 

when the company will be able to resume 

production. Even if the company can resume 

production, it will take four months after the 

repairs to complete manufacturing a batch of 

the antibody. A rare disease patient group 

has asked the government to march-in and 

issue licenses to all of the patents necessary 

to make and use the antibody. 

Discussion: Given the urgent need, marchin would be among a range of options the 

agency would likely consider for resolving 

this problem and promptly getting treatment 

into the hands of patients. 

Statutory Criteria—In this scenario, it 

appears there may be health needs that are 

not being reasonably satisfied by the 

contractor (Statutory Criterion 2). The agency 

would first ask the contractor for information 

to confirm the basic facts—that the company 

has ceased manufacturing the treatment in 

question due to flooding and return to 

operations is uncertain. If that is the case, the 

agency would continue its inquiry to assess 

whether march-in would alleviate the unmet 

health need, exploring questions detailed in 

Statutorily Defined March-In Criteria; 

Criterion 2. In this scenario, more treatment 

for this rare disease is needed (Section III; 

IV,A). 

From there, the agency would likely need 

more information to assess whether march-in 

could feasibly address the problem. For 

example, does the contractor have a back-up 

plan for manufacturing, and if so, how long 

would it be before the contractor can start 

delivering treatment to patients (Section VI)? 

If there’s no back-up plan, that could weigh 

in favor of march-in. Likewise, the lack of 

clarity about if and when the contractor will 

resume manufacturing suggests a potentially 

prolonged unmet health need, which could 

also weigh in favor of march-in (Section VII). 

The agency would also consider whether 

there are other manufacturers—‘‘responsible 

applicants’’—that could quickly manufacture 

this (or another) product with FDA approval 

to treat the rare disease. If yes, then marchin might help address the health need; but, 

if no other manufacturers are willing to make 

the product in question or utilize the subject 

invention, then march-in may not provide a 

solution (Section V). 

Policy & Objectives of Bayh-Dole—As part 

of this analysis, the agency would also look 

at whether exercising march-in would 

achieve the desired outcome and support the 

policy and objectives of Bayh-Dole (Would 


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March-In Support The Policy & Objective Of 

Bayh-Dole; Section I). The agency would 

likely focus on whether there are other 

responsible applicants interested in 

manufacturing the product in question or 

practicing the subject invention to treat the 

rare disease (Section I, E). The agency would 

also look at timing considerations like the 

remaining term of the relevant patents, the 

time required for any regulatory approvals of 

new products or manufacturing facilities, and 

the potential length of a march-in proceeding 

and any appeals. Very lengthy timelines 

could weigh against march-in and towards 

more expeditious solutions. If all of the 

patents involved in making this treatment are 

subject inventions, that could weigh in favor 

of march-in as it is less likely other 

intellectual property would stand in the way 

of other manufacturers (Section I, B; II). 

Finally, the manufacturing problems in this 

scenario seem largely outside of the 

contractor’s control. That suggests march-in 

would be unlikely to resolve non-use or 

unreasonable use of subject inventions in the 

future, although it could deter other future 

collaborators from developing subject 

inventions, weighing against march-in 

(Section III). 

Scenario 5 

Background: A water filtration company 

has an exclusive license from a governmentfunded university to patents covering a 

subject invention for point-of-use water 

purification technology. The company 

manufactures a small device, which can be 

used to remove organic contaminants like 

pesticides in households that get their 

drinking water from wells. Ten years ago, a 

certain pesticide became very popular 

because it was safe for native U.S. pollinators 

but effective at combatting an invasive beetle 

destroying crops nationwide. But recent 

studies have shown a ten-fold increase in 

pediatric cancers that is connected to 

drinking groundwater contaminated with 

that pesticide. The water filtration company’s 

point-of-use purification device is uniquely 

able to remove even trace amounts of that 

pesticide. As a result, demand has spiked. 

However, the company has not increased its 

manufacturing pace, so the price of the 

devices has jumped 1000% in the past three 

months. The combination of the limited 

supply and increased prices has resulted in 

a health emergency that cannot be adequately 

addressed without expanding capacity. Three 

other manufacturers and a dozen rural 

community groups have asked the 

government funding agency to march-in and 

issue licenses to increase supply and reduce 

cost of the specialized filters. 

Discussion: Given the pressing need, 

march-in would be among a range of options 

the agency would likely consider for 

resolving this problem promptly and 

protecting children. 

Statutory Criteria—In this scenario, it 

appears that march-in may alleviate a health 

or safety need that, at this time, is not 

reasonably being satisfied by the contractor 

or its licensee (Statutory Criterion 2). First, 

the agency would seek to confirm underlying 

information, including about the health or 

safety need. For example, the agency would 

consult with experts and appropriate 

agencies, seek available information about 

how the pesticide contributes to pediatric 

cancer, and investigate how (and how 

effectively) this purification device removes 

the pesticide (Statutorily Defined March-In 

Criteria; Criterion 2; Sections I–III). The 

agency would also confirm basic facts with 

the contractor, including whether it is 

refusing to ramp up manufacturing and how 

much the price has increased. All of this 

would be with an eye toward mitigating the 

risk of pediatric cancer, which in this 

scenario would appear to require an 

increased supply and accessible filtration 

devices (Section IV). The agency would 

likely assess whether the contractor is in fact 

exploiting the health or safety need to set a 

product price that is egregious within the 

U.S. market and unjustified given the totality 

of circumstances (Section IV, E). If the 

evidence suggests this 1000% increase was 

an intentional act by the company to ‘‘cashin’’ on this newly discovered health and 

safety need, that would weigh in favor of 

march-in. However, if the entire market has 

seen similar price increases and there is a 

compelling justification for such a high price, 

e.g., a shortage of essential raw materials is 

making increased production impossible, 

that would weigh against march-in. 

Policy & Objectives of Bayh-Dole—The 

agency would similarly need to assess the 

practical impact of march-in on the unmet 

need and carefully evaluate all alternatives 

(Would March-In Support the Policy & 

Objective of Bayh-Dole). For example, if the 

pesticide stays in the water supply long term 

and there’s no indication other solutions will 

become available very soon, that would 

weigh in favor of march-in. If farmers are no 

longer using the pesticide in question and it 

dissipates quickly, then the demand for 

filters could subside soon, weighing against 

march-in. Additionally, the fact that there are 

already other interested manufacturers 

suggests march-in could increase production 

by these entities soon, weighing in favor of 

march-in. However, the agency would need 

to examine the capability of the prospective 

licensees and manufacturers and be 

comfortable these are ‘‘reasonable 

applicants’’ that could get a product to 

market (Section I, E). Here again, the agency 

would also consider possible alternatives, 

like other technologies to protect children 

(Section II). For example, perhaps another 

agency has already banned the pesticide and 

that, combined with an alternative filtration 

technology, could bring the pesticide levels 

to a safe percentage within the year, weighing 

against march-in. Finally, the agency would 

analyze the wider implications of march-in to 

ensure consistency with Bayh-Dole policy 

and objectives (Section III). The agency may 

determine that exercising march-in rights 

would have a meaningful positive impact on 

child health, increase confidence that 

federally funded inventions are available to 

improve the lives of Americans, result in 

increased competition, and set an example of 

actions by contractors or licensees that are 

‘‘off limits.’’ The agency may determine those 

factors outweigh any negative impacts on 

investments in future federal R&D, given the 

apparent bad-faith actions of the contractor 

(Sections III, A, 2; III, 3). 

Scenario 6 

Background: In the early stages of a 

respiratory virus pandemic, a consumer 

goods company working under a government 

contract developed improved face masks that 

filter out 99% of that virus’ particles. The 

contractor filed for a patent on its mask 

technology, and it reported the subject 

invention and associated patent application 

to the government. During a three-week 

window, several experts published studies 

confirming that the virus spreads easily and 

rapidly through airborne transmission. The 

following week, the consumer goods 

company increased the price of its masks 

100%, and it continued to raise the price 

over the course of a month, resulting in a 

400% price increase. The company has also 

sent letters to other mask manufacturers, 

flagging the pending patent application and 

promising to file lawsuits against any 

infringers as soon as the patent issues. Trade 

associations representing frontline healthcare 

workers asked the government funding 

agency to march-in and issue licenses to 

those other manufacturers to bring down the 

price of the masks. 

Discussion: Given the urgent need, marchin would be among a range of options the 

agency would likely consider for resolving 

this problem promptly and protecting 

frontline workers. 

Statutory Criteria—In this scenario, it 

appears there could be actions that promote 

nonuse or unreasonable use of the subject 

invention (Criterion 1) as well as health and 

safety needs that are not being reasonably 

satisfied by the contractor (Statutory 

Criterion 2). The agency would first ask the 

contractor for information to confirm the 

basic facts—for example, that the contractor 

has increased price 400%, how that increase 

compares to prices for other masks, how that 

price point compares to the cost of 

developing and manufacturing the masks, 

that the contractor has filed for patents, and 

that it is threatening to file suit against 

competing manufacturers when a patent 

issues. Based on that, the agency could 

continue its inquiry to assess whether marchin would alleviate an unmet health need and/ 

or ensure the benefits of the mask are 

available to the public on reasonable terms, 

exploring questions detailed in Statutorily 

Defined March-In Criteria; Criterion 1 and 2. 

In this scenario, more affordable masks are 

needed and it may be that more mask 

production would bring down the price 

(Section III; IV, E). The agency would likely 

need more information to assess whether the 

contractor is exploiting the health or safety 

need in setting a product price that is 

egregious within the U.S. market and 

unjustified given the totality of 

circumstances and/or whether the masks are 

available on reasonable terms (Section IV, E). 

By rapidly increasing the price of masks and 

threatening other manufacturers with 

litigation during an urgent public health 

need, the contractor seems focused on 

keeping prices unusually high while not 

satisfying demand. This could weigh in favor 

of march-in. But the agency would need 

additional information, for example, to 

understand the unmet need, how march-in 

would impact it, and why the contractor is 


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responding this way. Are other mask 

manufacturers charging similarly high prices 

under the circumstances, all to fund facility 

expansion? If so, that would weigh against 

march-in (Section IV, E). Is there a strong 

connection between mask usage (or mask 

availability) and public health benefit? Does 

this mask provide unique benefits over 

others? Stronger evidence the masks resolve 

a health need could weigh more in favor of 

march-in, whereas tangential evidence of 

unique benefits could weigh against marchin (Section III). Is there a legitimate reason 

not to license other manufacturers for this 

mask, e.g., they lack capacity or capability? 

Answers to those questions could justify the 

contractor’s actions and weigh against marchin (Section IV, E). 

Policy & Objectives of Bayh-Dole—The first 

part of this analysis looks at whether marchin would promote utilization and protect 

against non-use of the subject invention 

(Would March-In Support The Policy & 

Objective Of Bayh-Dole Section I). The 

agency would need to understand whether 

other manufacturers are ‘‘responsible 

applicants’’ that would be interested and 

willing to make the masks in question 

(Section I, E). The agency would also likely 

want to understand the impact of the 

pending patent application and threat of 

(possible) litigation on the other 

manufacturers (I, B; II, E). If the other 

manufacturers are actually deterred from 

making the product, then that could weigh in 

favor of march-in. However, if other 

manufacturers do not believe valid patents 

are going to issue on this subject invention, 

and those manufacturers are willing to 

immediately start manufacturing masks, that 

could weigh against march-in. The agency 

would also consider whether other action 

might be warranted—for example, the agency 

purchasing or manufacturing the masks itself 

at a lower price (Section II, A). Whether 

march-in would protect the public against 

non-use or unreasonable use of subject 

inventions more broadly likely depends on 

similar facts (Section III). However, in a 

situation of a pressing health or safety need, 

where a contractor is artificially keeping 

supply low while demand for a product is 

high or artificially increasing the price, 

march-in could deter others from similar 

actions in the future without impacting 

contractors and licensees who act in good 

faith to bring products to market and meet 

market demand (Section III, A, 2). 

Scenario 7 

Background: The Department of 

Transportation has been working with 

industry to develop the requirements and 

technologies for vehicle-to-everything (V2X) 

communications. This technology will allow 

vehicles to automatically communicate with 

each other basic safety messages including 

location, direction of travel, speed, and other 

relevant information that can serve to reduce 

traffic accidents. Additionally, the 

technology will allow vehicles to receive 

messages from networked roadside units that 

can warn a driver about work zones or traffic 

accidents miles ahead of them along their 

current path of travel or road conditions such 

as icy or wet roads. The National Highway 

Traffic Safety Administration (NHTSA) 

within the U.S. Department of Transportation 

is responsible for the Federal Motor Vehicle 

Safety Standards and the regulatory 

requirements that all automobiles must 

satisfy to be sold in the U.S. NHTSA has 

issued a regulation that requires the 

inclusion of a transceiver capable of 

transmitting and receiving such messages in 

all new automobiles. A contractor under 

government funding developed a technology 

essential to the operation of such transceiver 

but to date has refused to license the 

technology to any auto manufacturers, 

instead insisting that it can supply the entire 

automotive industry with the required 

equipment. Auto manufacturers have 

approached the government seeking 

assistance in getting a license to manufacture 

the equipment because the contractor has 

failed to satisfy industry demand. 

Discussion: 

Statutory Criteria—In this scenario, it 

appears that march-in may help meet 

requirements for public use specified by a 

federal regulation (Statutory Criterion 3). The 

federal regulation in question for this marchin analysis requires inclusion of a transceiver 

capable of transmitting and receiving basic 

safety messages in all new automobiles. The 

agency would need to investigate whether 

the contractor is meeting the industry’s need 

in order to comply with this regulation and 

determine whether the contractor is 

restricting access or imposing barriers 

(Statutorily Defined March-In Criteria; 

Criterion 3, II, A). The agency would discuss 

the issue with the contractor, and if the 

contractor is in fact unwilling to license the 

technology, the agency would likely discuss 

whether and how the contractor plans to 

individually meet the current or future needs 

(Section VI). If the contractor has discernable 

plans, the agency may choose to set certain 

timeframes or thresholds that the contractor 

must meet to avoid march-in. The agency 

may also assess whether the contactor is 

willing to license the subject invention on 

commercially reasonable terms—if it is 

refusing prospective licensees because it will 

only accept unreasonably high royalties, that 

could weigh in favor of march-in (Section II, 

A). If it is open to reasonable licensing offers, 

that cuts the other way. The agency would 

also need to explore whether there are other 

technologies that do or could also address 

this same need (Section IV). If the 

contractor’s invention is the only one that 

could address this need, and the company 

cannot offer a plan to provide adequate 

supply and meet the regulatory requirements, 

these factors would weigh in favor of marchin. Whereas, if there are alternatives that 

could meet or implement the regulatory 

requirements, that would weigh against 

march-in. 

Policy & Objectives of Bayh-Dole—The 

agency would assess the practical impact of 

march-in on regulatory compliance, carefully 

evaluate alternatives, and look at the broader 

context (Would March-In Support the Policy 

& Objective of Bayh-Dole). For example, the 

direct interest from auto manufacturers 

suggests that march-in might increase 

production of the subject invention, since 

there are already interested licensees (Section 

I). Although the agency may also want to 

look at timelines; for example, if these 

technologies have short life cycles and there 

is likely to be more advanced technology to 

meet the regulatory requirements within the 

year, that could weigh against march-in. 

Likewise, the agency would continue to look 

at viable alternatives that are already 

available to meet the regulatory needs and 

could be relevant to avoid march-in (Section 

II). Finally, the agency would review the 

broader impacts and policy and objectives of 

Bayh-Dole (Section III). The agency may 

determine, because the contractor cannot 

meet the industry need, that the negative 

impacts on future R&D and utilization are 

minimal and decide to exercise march-in. 

Scenario 8 

Background: A government-funded 

university, after years of both broad and 

targeted marketing efforts, executed an 

exclusive license for a new compound 

demonstrated effective in Phase III clinical 

trials for treating Alzheimer’s disease with a 

large Swiss pharmaceutical company active 

in drug development and the manufacture of 

proprietary medicines. The new compound 

was government-funded in its initial stages of 

development. The terms of the exclusive 

license did not reference the Bayh-Dole 

regulations and requirement for U.S. 

manufacturing unless waived by the 

government. The exclusive licensee has 

begun manufacturing limited quantities of 

the active pharmaceutical ingredient (API) of 

the compound at its existing facilities in 

Switzerland prior to FDA approval. The 

Swiss company has no manufacturing 

facilities in the U.S. The government-funded 

university self-reported to the funding agency 

the deficiency in the terms of the exclusive 

license and reported the status of 

manufacturing the API. The governmentfunded university has not requested a waiver. 

The head of the agency has asked about 

possible use of march-in rights. 

Discussion: 

Statutory Criteria—In this scenario, it 

appears that the contractor did not include 

the agreement terms required by 35 U.S.C. 

204 in its exclusive license agreement 

(Statutorily Defined March-in Criterion 4). 

The agency would review the facts of the 

case to ensure that the U. S. industry 

preference under § 204 was triggered. Based 

on the facts presented, the contractor 

exclusively licensed the right to use or sell 

a product embodying the subject invention 

(Statutorily Defined March-In Criteria; 

Criterion 2, Section IV, A & C). The agency 

would need to confirm that the exclusive 

license included the right to use or sell in the 

U.S. (Section IV, B), and would need to 

confirm whether the preference for U.S. 

industry applies. Assuming § 204 is triggered, 

under this scenario the exclusive license 

does not include a provision requiring 

products to be manufactured substantially in 

the U.S. (Section I, C). The scenario provides 

that the licensee intends to manufacture only 

in Switzerland, but the agency would want 

to have the contractor confirm that the 

licensee has no U.S. manufacturing facilities 

(Section I, F). Finally, the scenario provides 

that the contractor has not requested a waiver 


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Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 85605 

of the preference for U.S. industry (Sections 

I, C, 1; I, F, 1). These facts, without more and 

if not remedied, would collectively weigh in 

favor of march-in. 

Policy & Objectives of Bayh-Dole—Next the 

agency will consider Bayh-Dole’s policy and 

objectives in its march-in assessment. As part 

of this analysis, the agency should consult 

with the contractor and determine whether 

the license agreement could be amended to 

include the preference for U.S. industry and 

whether the current licensee would be 

willing and able to manufacture substantially 

in the U.S. Perhaps the agency could even 

assist in identifying potential U.S. 

manufacturers (Would March-In Support the 

Policy & Objective of Bayh-Dole Section II, 

A–C). If the contractor and current licensee 

agree to a U.S. manufacturer or 

manufacturing facilities, this would weigh 

against exercising march-in. If they refused, 

that could weigh in favor of march-in. The 

agency should also consider whether, if the 

contractor had submitted a waiver, a waiver 

would have been granted; and it should 

inquire as to whether the contractor, 

following a notice of non-compliance by the 

agency, submits a domestic manufacturing 

waiver request (Section I, D). In this scenario, 

it appears the contractor conducted extensive 

marketing to find a licensee; suggesting it 

was difficult to line up a manufacturer 

anywhere in the world. If the agency, for 

example, finds that the contractor offered this 

technology for license under similar terms to 

companies who were likely to manufacture 

in the U.S., but none of those manufacturers 

were interested, then the agency may 

consider granting a domestic manufacturing 

waiver and decide not to march-in. If the 

contractor refused to apply for a waiver, that 

could weigh in favor of march-in. As part of 

this assessment, the agency could likewise 

consider whether there is another 

prospective licensee able to manufacture 

substantially in the U.S. (Section I, E). 

Finally, the agency would consider the wider 

implications of march-in, including whether 

exercising march-in—if the contractor 

refused to amend its license, seek a waiver, 

or relocate manufacturing—would send a 

message that the U.S. industry preference 

provisions of the Bayh-Dole Act will be 

enforced (Section III, A, 2). 

[FR Doc. 2023–26930 Filed 12–7–23; 8:45 am] 

BILLING CODE 3510–13–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

[RTID 0648–XD497] 

Pacific Island Fisheries; Marine 

Conservation Plan for the Pacific 

Insular Area for the Commonwealth of 

the Northern Mariana Islands; Western 

Pacific Sustainable Fisheries Fund 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Notice of agency decision. 

SUMMARY: NMFS announces approval of 

a Marine Conservation Plan (MCP) for 

the Commonwealth of the Northern 

Mariana Islands (CNMI). 

DATES: This agency decision is effective 

from the publication of this notice 

through August 3, 2026. 

ADDRESSES: You may obtain a copy of 

the MCP, identified by NOAA–NMFS– 

2023–0150, from the Federal eRulemaking Portal, https://

www.regulations.gov and type NOAA– 

NMFS–2023–0150 in the Search box 

(note: copying and pasting the FDMS 

Docket Number directly from this 

document may not yield search results), 

or from the Western Pacific Fishery 

Management Council (Council), 1164 

Bishop St., Suite 1400, Honolulu, HI 

96813, telephone 808–522–8220, 

https://www.wpcouncil.org. 

FOR FURTHER INFORMATION CONTACT: 

Keith Kamikawa, Sustainable Fisheries, 

NMFS Pacific Islands Regional Office, 

808–725–5177. 

SUPPLEMENTARY INFORMATION: Section 

204(e) of the Magnuson-Stevens Fishery 

Conservation and Management Act 

(Magnuson-Stevens Act) authorizes the 

Secretary of State, with the concurrence 

of the Secretary of Commerce 

(Secretary), and in consultation with the 

Council, to negotiate and enter into a 

Pacific Insular Area fishery agreement 

(PIAFA). A PIAFA would allow foreign 

fishing within the U.S. Exclusive 

Economic Zone (EEZ) adjacent to 

American Samoa, Guam, or the CNMI. 

The Governor of the Pacific Insular Area 

to which the PIAFA applies must 

request the PIAFA. The Secretary of 

State may negotiate and enter the PIAFA 

after consultation with, and concurrence 

of, the applicable Governor. 

Before entering into a PIAFA, the 

applicable Governor, with concurrence 

of the Council, must develop and 

submit to the Secretary a 3-year MCP 

providing details on uses for any funds 

collected by the Secretary under the 

PIAFA. NMFS is the designee of the 

Secretary for MCP review and approval. 

The Magnuson-Stevens Act requires 

payments received under a PIAFA to be 

deposited into the United States 

Treasury and then conveyed to the 

Treasury of the Pacific Insular Area for 

which funds were collected. 

In the case of violations by foreign 

fishing vessels in the EEZ around any 

Pacific Insular Area, amounts received 

by the Secretary attributable to fines and 

penalties imposed under the MagnusonStevens Act, including sums collected 

from the forfeiture and disposition or 

sale of property seized subject to its 

authority, shall be deposited into the 

Treasury of the Pacific Insular Area 

adjacent to the EEZ in which the 

violation occurred, after direct costs of 

the enforcement action are subtracted. 

The Pacific Insular Area government 

may use funds deposited into the 

Treasury of the Pacific Insular Area for 

fisheries enforcement and for 

implementation of an MCP. 

Federal regulations at 50 CFR 665.819 

authorize NMFS to specify catch limits 

for longline-caught bigeye tuna for U.S. 

territories. NMFS may also authorize 

each territory to allocate a portion of 

that limit to U.S. longline fishing vessels 

that are permitted to fish under the 

Fishery Ecosystem Plan for Pelagic 

Fisheries of the Western Pacific (FEP). 

Payments collected under specified 

fishing agreements are deposited into 

the Western Pacific Sustainable 

Fisheries Fund (SFF), and any funds 

attributable to a particular territory may 

be used only for implementation of that 

territory’s MCP. An MCP must be 

consistent with the Council’s FEPs, 

must identify conservation and 

management objectives (including 

criteria for determining when such 

objectives have been met), and must 

prioritize planned marine conservation 

projects. 

At its 194th meeting held in March 

2023, the Council reviewed and 

concurred with the MCP prepared by 

the Governor of the CNMI. This MCP 

was approved on June 20, 2023 and 

became effective on August 4, 2023 and 

is currently in effect (88 FR 39831). 

However, after the MCP was approved 

by NMFS in June 2023, the CNMI 

Department of Land and Natural 

Resources (DLNR) submitted an 

application to PIRO to use funds from 

the Western Pacific SFF to implement 

the MCP. NMFS staff determined that 

the projects described in the CNMI’s 

application were not within the scope of 

the MCP currently in effect. This 

prompted the CNMI to develop a 

revised MCP that better addresses the 

needs of the CNMI and DLNR. The 

Council reviewed and concurred with 

the updated MCP at its 196th meeting in 

September 2023. Then on October 2, 

2023, the Governor of the CNMI 

submitted the new MCP to NMFS for 

review and approval. The revised MCP 

contains the following seven 

conservation and management 

objectives: 

1. Improve fisheries data collection 

and reporting; 

2. Conduct resource assessment, 

monitoring, and research to gain a better 

understanding of marine resources and 

fisheries; 


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