Innovation is Under Threat

Innovation is Under ThreatLast Thursday, the Biden Administration released draft guidance outlining proposed factors that an agency may consider, including the “reasonableness of a product’s price,” when deciding whether to exercise its ‘march-in rights’ to federally funded inventions under the Bayh-Dole Act. According to the Bayh-Dole Coalition and other stakeholders, the proposal may deter public-private collaborations to advance new treatments and cures, and it will decimate confidence in the reliability of universities and federal laboratories as R&D partners, severely handicapping American innovation.   

Organizations like yours have until February 6, 2024 to respond to the proposed guidance – please see the links to the Federal Register below and a link that provides tips on how to submit comments.

INFORMATION RE: FEDERAL REGISTER NOTICE

The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) released for public comment its Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, a tool to help agencies evaluate when it might be appropriate to require licensing of a patent developed with federal funding.

The draft guidance seeks to help agencies work through a range of policy considerations relevant to a potential march-in decision, including price. The proposed guidance is now available in the Federal Register. Also available in pdf form here.

The 60-day comment period will close on Feb. 6, 2024, after which NIST will review and make publicly available all comments received, before finalizing the guidance.

Federal Register :: Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights

Submit a comment with this link

Tips for Submitting Effective Comments* from Regulations.gov


BioCT’s Legislative BreakfastPart of BioCT’s effort to promote the life sciences in Connecticut is a Legislative Breakfast, hosted at Alexion, on January 22nd. Register now to ensure your voice gets heard directly by CT policy makers. A full agenda and registration is hereInterested in sponsoring this event? Contact Jodie Gillon (jgillon@bioct.org) today.