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Proposed changes to rules governing the commercialization of technologies developed with federal funding prompts significant stakeholder feedback.
On Jan. 4, 2021, the National Institute of Standards and Technology (NIST) published for notice and comment proposed rulemaking regarding “Rights to Federally Funded Inventions and Licensing of Government Owned Inventions (1).” These regulations relate to the operation of the Bayh-Dole Act, which encourages technology transfer and commercialization of inventions made under research grants from the federal government. The law has always had its detractors, but the COVID-19 pandemic has raised the temperature on the issues of drug pricing, compulsory licensing, patent waivers, and federal march-in rights. These considerations are relevant to the changes NIST is proposing, and the comments—estimated to be more than 1800—reflect the passions the topic has engendered.
Kevin E. Noonan is a partner with McDonnell Boehnen Hulbert & Berghoff LLP and co-chair of the firm’s Biotechnology & Pharmaceuticals Practice Group.
eBook: Regulatory Sourcebook
When referring to this article, please cite it as K. Noonan, “NIST Proposes Clarifications to Bayh-Dole March-in Rights Regulations," BioPharm International’s Regulatory Sourcebook eBook (October 2021)