[Bayh-dole-regulations] PhRMA, BIO submissions on NIST Regs

James Love james.love at keionline.org
Wed Apr 7 04:54:46 PDT 2021


https://www.regulations.gov/comment/NIST-2021-0001-18079

The Pharmaceutical Research and Manufacturers of America (PhRMA). As
expected, PhRMA thinks that NIST has not been restrictive enough as regards
march-in rights, and wants consideration of prices banned altogether. PhRMA
wants licensees consulted in march-in proceedings, and more time to
respond. PhRMA wants to narrow the definition of a subject invention when
there is co-funding. (See submission by Abinader above on same topic,
different view). PhRMA wants to relax sanctions for non-reporting of
federal funding.

https://www.regulations.gov/comment/NIST-2021-0001-17950

Biotechnology Innovation Organization (BIO). “The proposed rule should make
clear that a march-in determination under 35 USC §203(a)(1) may be based
only on conduct that is attributable to the contractor or assignee, whereas
a determination under 35 USC §203(a)(2)-(3) may additionally be based on
conduct that is attributable to the licensee.” BIO is asking that the
obligation to bring an invention to “practical obligation” and make
products “available to the public on reasonable terms” not apply to
licensees.
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