BioPharm International - October 2021

BioPharm-October 2021-Regulatory-Sourcebook

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26 BioPharm International eBook October 2021 NIST Proposes Clarifications to Bayh-Dole March-in Rights Regulations Proposed changes to rules governing the commercialization of technologies developed with federal funding prompts significant stakeholder feedback. O n Jan. 4, 2021, the National Institute of Standards and Technology (NIST) pub- lished for notice and comment proposed rulemaking regarding "Rights to Federally F u n d e d I n v e n t i o n s a n d L i c e n s i n g of Government Owned Inventions" (1). These regula- tions 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—ref lect the passions the topic has engendered. THE BAYH-DOLE ACT AND MARCH-IN RIGHTS The Bayh-Dole Act was enacted as the University and Small Business Patent Procedures Act of 1980, Public Law 96-517 (as amended), and codified at Title 35 of the United States Code (U.S.C.) §200 et seq. The law specifies the policies Congress intended to encourage "utilization" (i.e., commercialization) of inventions by small businesses, non-profit organizations, and universities supported in whole or part by grants from the federal government (§200). It permits each such entities ("con- tractors") to elect to retain title to inventions made as a result of the funded work (§202), subject to disclosure and notification to the funding agency and to provisions that in exceptional circumstances permit the federal government to retain title; the KEVIN E. NOONAN is a partner with McDonnell Boehnen Hulbert & Berghoff LLP and co-chair of the firm's Biotechnology & Pharmaceuticals Practice Group. KEVIN E. NOONAN Regulatory Sourcebook BioBusiness TEROVESALAINEN - STOCK.ADOBE.COM

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