Draft Interagency March-In Framework

Bethany Loftin

Interagency Policy & iEdison Specialist

Technology Partnerships Office
Bayh-Dole and NIST

• The University and Small Business Patent Procedures Act of 1980, or more 

commonly known as the “Bayh-Dole Act", was passed by Congress on 

December 12, 1980 (35 U.S.C. §§ 200-212)

• Applies to any contract, grant, or cooperative agreement from any federal agency for 

the performance of experimental, developmental, or research work

• Provides recipients of federal research funding the right to retain ownership of the 

inventions conceived or first actually reduced to practice under their federal funding 

agreements 

• Intended to promote utilization of inventions arising from federally supported R&D and 

encourage progression of inventions from the laboratories into the marketplace

• The Bayh-Dole Statute gives the Secretary of Commerce the authority to issue the 

Bayh-Dole Act’s implementing regulations

• Implementing regulations are found at 37 CFR Part 401

• This authority was delegated by the Secretary to the National Institute of Standards 

and Technology (NIST)
March-In Rights

Among the rights and 

obligations detailed in the 

Bayh-Dole Act are “march-in 

rights”

March-in rights allow a federal 

funding agency to require the 

Bayh-Dole contractor to issue a 

license and if they refuse, the 

agency can issue a license 

themselves (35 U.S.C. § 204)

The statute only allows the exercise of march-in 

rights in 4 circumstances:

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.
Requests for Clarity and the NPRM

• To date, no agency has exercised march-in rights. However, NIST has 

repeatedly been asked to provide additional clarity regarding whether price 

can be considered a factor that an agency may consider when deciding 

whether to march-in.

• On January 4, 2021, NIST published a Notice of Proposed Rulemaking that 

sought to streamline, update, and clarify several provisions of the Bayh-Dole 

regulations.

• Among the proposed changes, the NPRM sought to include the following 

provision: 

“March-in rights 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.”
NPRM to Final Rule

• NIST received over 81,000 comments on the NPRM 

-- with the majority on this particular provision.

• On July 9, 2021, President Biden signed Executive 

Order 14036, which directed the Secretary of 

Commerce, acting through the Director of NIST to 

“consider not finalizing any provisions on march-in 

rights and product pricing in the proposed rule.”

• On March 24, 2023, NIST issued a Final Rule based 

on that NPRM, but did not finalize the provision 

related to march-in rights and product pricing.

• In the Federal Register Notice accompanying the 

Final Rule, NIST committed to “engage with 

stakeholders and agencies with the goal of 

developing a comprehensive framework for 

agencies considering the use of march-in 

provisions.”

81,000 

Comments Fell 

into 3 

Categories:

Opposed the 

proposed 

change; 

supported 

march-in based 

on price

Requested 

further 

restriction; 

proposed 

removal of 

“exclusively” and 

“of the 

contractor”

Supported the 

proposed change
Whole-of-Government Approach

• Along with the Final Rule 

publication, DOC and HHS 

jointly announced a plan 

to take a more 

comprehensive, wholeof-government approach 

to review and provide 

clarity on March-in 

Authority.
Interagency Process

• NIST tasked the Interagency Working Group for Bayh-Dole (IAWGBD) with drafting an interagency 

framework that agencies could use when analyzing whether to exercise march-in rights

• The IAWGBD was formed in 2015 to discuss policy issues surrounding Bayh-Dole to find consensus and create consistency in the application of 

the Bayh-Dole regulations

• IAWGBD consists of nearly 120 members with representation from DOC, DHHS, DOE, DOD, NSF, DHS, DOT, DOJ, USDA, USAID, NASA, and the VA

• The IAWGBD convened a subcommittee of volunteers to work on the framework. The subcommittee 

drafted and edited the framework as well as scenarios to demonstrate how an agency might apply the 

framework 

• Representation on the subcommittee included NIST, NIH, DOE, NSF, CDC, Army/MRDC, DOD R&D, DHS, DOT, USAID, Air Force, NOAA, and NASA

• This draft framework was presented to the full IAWGBD and agencies were given the opportunity to 

provide feedback through several rounds of review until the IAWGBD came to consensus on a draft for RFI 

publication

• NIST sent the framework to OMB for formal interagency review before publishing in the Federal Register
Goals & Themes of the Framework

Goals

Clear Guidance 

on Prerequisites, 

Facts, Factors

Support Policy & 

Objectives of 

Bayh-Dole

Consistent and 

Predictable 

Application of 

Authority

Balance Industry 

Investment 

Incentive and 

Public Utilization 

Themes

Important 

Tool with 

Potential 

Ramifications

Cases are FactSpecific

Technology

Agnostic

Guidance & 

Suggestions –

Not Binding
Goals & Themes of the Framework

Themes

Important Tool 

with Potential 

Ramifications

Cases are FactSpecific

Technology

Agnostic

Guidance & 

Suggestions –

Not Binding

Goals

Clear Guidance 

on Prerequisites, 

Facts, Factors

Support Policy & 

Objectives of 

Bayh-Dole

Consistent and 

Predictable 

Application of 

Authority

Balance Industry 

Investment 

Incentive and 

Public Utilization 
• The draft framework asks the agencies to answer three questions in analyzing 

whether to exercise march-in rights: 

1. Does Bayh-Dole Apply?

• The invention(s) must be conceived or first actually reduced to practice in the 

performance of work under a federal funding agreement

2. Is a Statutory Criterion Met?

• Provides facts that an agency may gather, questions they may ask, and factors they may 

consider in determining whether one of the criterion required to march-in under the 

Bayh-Dole statute has been met.

• Broken down into 4 subsections – one for each statutory criterion

3. Would March-In Support the Policy & Objective of Bayh-Dole, 

Considering the Specific Case and Broader Context?

• The Framework concludes with 8 different example scenarios illustrating how 

an agency might use the framework when considering whether to exercise 

march-in rights.

Structure of the Framework
• Does Bayh-Dole Apply?

• Was the invention reported to the funding agency as a subject invention under Bayh- Dole?

• 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). 

• If it was not reported to the funding agency as a subject invention, further analysis will 

be needed by the agency. Agencies may consider

• Reviewing patent applications and patents

• Reviewing publications

• Review funding agreements

• Consulting with subject matter experts

• Etc.

• Ownership and Licensing 

• What parties are listed as owners of invention(s) and patent(s)?

• What current licenses exist that cover the invention(s)/patent(s)?

• Exclusive or nonexclusive

• Fields of Use

Does Bayh-Dole Apply?
Statutory 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

• For inventions not licensed or commercialized:

• Focuses on what steps the contractor has taken to further develop the invention and/or seek 

licensees and whether there are concerns that the contractor is shelving the subject 

invention(s) without justification and not committing to discernable steps on re-engaging in 

its licensing.

• For inventions licensed:

• Focuses on what steps the contactor and/or licensee is taking to progress the invention to 

manufacturing and/or commercialization and whether there are concerns that the contractor 

or licensee is shelving the subject invention(s) without justification and not committing to 

discernable steps to commercialize

• For inventions commercialized: 

• Focuses on whether the invention is being made available to the public on reasonable terms

• Pricing is addressed in this criterion -- specifically:

• At what price and on what terms has the product utilizing the subject invention been sold or 

offered for sale in the U.S.?

• 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?
Statutory Criterion 2

• Questions include:

• What the health or safety need is

• How this product addresses the need

• What is needed to address the need

• Possible alternatives

• Pricing is addressed in this criterion -- specifically:

• 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?

• 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? 

Action is 

necessary to 

alleviate 

health or 

safety needs 

which are 

not 

reasonably 

satisfied by 

the contract

or, assignee, 

or their 

licensees
Statutory Criterion 3

• Questions include:

• What the regulatory requirement is and whether or not the regulation 

expressly requires the product’s use (or use in combination with 

another product)

• How the invention addresses the requirement

• What other technologies address the need

• Whether this invention is available to those who need it to fulfil the 

requirement and if the contractor is imposing barriers or restricting 

access to the invention

• How much time is required under the regulation to meet the 

requirement

• An example might be if the National Highway Traffic Safety Administration 

(NHTSA) issued a regulation requiring cars have a certain functionality and 

the subject invention in question achieved that functionality, but not 

enough volume was being manufactured to fulfill the public’s need

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
Statutory Criterion 4

• Questions include:

• Whether the Preference for United States Industry under the 

regulations is triggered 

• Is there an exclusive license to use or sell in the United States?

• Whether the contractor and/or licensee are compliant with the 

Preference for United States Industry required in the statute

• Do exclusive licenses to use or sell in the United States include 

a requirement that products be manufactured substantially in 

the United States? 

• Are licensees compliant with that obligation?

• Whether there has been a waiver request submitted

• If yes, the outcome of that waiver request, if submitted

• If no, whether the agency has demanded a waiver request

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
Policy & Objective of Bayh-Dole, Considering 

the Specific Case and Broader Context

Questions seek to determine:

• Whether march-in would achieve the desired results, for example:

• Is there a willing and able licensee or is it likely that one could be found?

• What additional IP rights would be needed in order to make the product in question?

• Whether there are other alternatives that would address the issue, for 

example:

• What are the alternative technologies available and how effective are those alternatives?

• Is there another government action (e.g., anti-trust activity, fraud, bankruptcy, other 

federal or state governmental authorities, etc.) that would better address the problem?

• The broader implications of use of march-in, for example:

• Would exercise of march-in rights here promote competition without unduly encumbering 

future R&D?

• Would exercise of march-in impact utilization of subject inventions more broadly? 
Request for Information

• NIST published an RFI in the Federal Register on Friday, December 8th asking for 

feedback on the Draft Interagency Guidance Framework for Considering the 

Exercise of March-In Rights 

• The comment period will be open for 60-days from publication, closing at 5:00 

PM Eastern time on February 6, 2024

• NIST will then review all relevant comments received and present them to the 

IAWGBD for consideration to incorporate into a final document
Request for Information

• We welcome all comments, but we also ask certain specific questions in the RFI:

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?
How to Submit Comments

• You can submit comments directly from the Federal Register Notice by clicking 

the button that says “Submit a Formal Comment”
How to Submit Comments

• Complete the comment 

form and click the 

“Submit Comment” 

button at the bottom
How to Submit Comments

• You can also go to www.regulations.gov and enter NIST-2023-0008 in the search 

field. 
How to Submit Comments

• Complete the comment 

form and click the 

“Submit Comment” 

button at the bottom
Questions

• If you have further questions, you can feel free to reach out to Mojdeh 

Bahar at mojdeh.bahar@nist.gov

• Please continue to check our website at 

https://www.nist.gov/tpo/policy-coordination/bayh-dole-act available 

from the NIST TPO website for updates
Thank You!