26 BioPharm International eBook October 2021 www.biopharminternational.com
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
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