Introduction
The National Institute of Standards and Technology (NIST) has released a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights under the Bayh-Dole Act. This framework outlines the factors agencies should consider when deciding to exercise march-in rights, allowing the government to intervene in commercializing inventions arising from federally funded research.
Background
- The Bayh-Dole Act governs inventions resulting from the $115 billion federal investment in extramural research and development.
- March-in rights empower agencies to intervene if a contractor fails to achieve practical application of a subject invention or address health, safety, or public use concerns.
Recent Developments
In response to proposed changes in 2021, NIST received over 81,000 public comments and decided not to finalize a march-in rights and product pricing provision. This Draft Interagency Guidance Framework aims to provide clear guidelines for agencies considering march-in rights.
Key Points
- Purpose of March-In Rights: Agencies may exercise march-in rights if a contractor fails to take adequate steps for practical application, address health or safety needs, meet public use requirements, or comply with specific agreements.
- NIST’s Role: Delegated by the Secretary of Commerce, NIST regulates federally funded inventions. The draft framework results from collaboration with the Interagency Working Group for Bayh-Dole.
- Public Input: NIST invites public comments on the draft framework, emphasizing clarity, fulfillment of march-in rights’ purpose, and alignment with Bayh-Dole Act objectives. Comments must be submitted by 5 p.m. Eastern on February 6, 2024.
- Framework Overview: The draft framework details information gathering, ownership and licensing considerations, and statutory criteria assessment for march-in decisions.
- Appeal Process: Agencies are required to develop an appeals procedure, and affected parties can appeal march-in decisions to the United States Court of Federal Claims.
Next Steps
- NIST will conduct an informational webinar to explain the draft framework and guide the public on submitting comments on Wednesday, December 13, 2023, at 1:00 pm Eastern. Visit the official webinar page for additional information, including a zoom link and dial-in information.
- Stakeholders are encouraged to provide input on topics such as the clarity of guidance, the comprehensibility of framework definitions, and improvements for broader applicability.
Conclusion
As NIST seeks public input, stakeholders and the public have a unique opportunity to shape the guidelines surrounding the exercise of march-in rights. The draft framework reflects NIST’s commitment to balancing the promotion of innovation and commercialization with public utilization of federally funded inventions.
See the official request for information for more information and to submit comments.
