[Ip-health] Note on the Roundtable on March-in for Patents on Federally-funded Inventions, October 6, 2021 from 2pm to 4pm EST.

James Love james.love at keionline.org
Wed Oct 6 05:51:02 PDT 2021


Details of the event are here:  https://www.keionline.org/36565

The march-in roundtable today begins at 2pm eastern time. The objective is
to deepen understanding of how march-in rights have been or can be used (or
not used).

The relevance now is heightened by the earlier NIST proposal to gut
march-in rights when prices are unreasonable. More than eighty thousand
persons opposed the NIST rule, and opposition to the rule was expressed in
a July White House Executive Order on competition and in a September HHS
report on drug pricing. (See: https://www.keionline.org/35432 and
https://www.keionline.org/36417)

The roundtable will review more than a dozen earlier cases at the NIH, DOE
and DOD, and discuss the current case involving the patents on the prostate
cancer drug enzalutamide (Xtandi). The discussion will also consider
several other potential candidates for march-in, including products for
COVID-19 (including but not limited to remdesivir, REGN-COV2 and
molnupiravir), cancer, spinal muscular atrophy (SMA), multiple sclerosis
(MS) and other diseases and conditions.

Among the issues to be explored are the grounds that make sense from a
practical and policy point of view, the challenges in making the current
law and regulations on march-in rights work, and how the march-in rights
work with other federal laws, including the more general government use
provisions of 28 USC 1498-the government’s royalty free rights in
federally-funded inventions-, competition law and the modifications of
march-in rights under the growing use of OTA R&D funding contracts.

This is an informal and interactive moderated format, with a number of
experts in the field, and participants will be free to ask questions.

This event will take place via Zoom, and requires prior registration at
march-in at keionline.org

The web page on the event (https://www.keionline.org/36565) explains more
about the questions to be explored.

Background documents

https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/

https://www.hhs.gov/about/news/2021/09/09/hhs-secretary-xavier-becerra-releases-bold-proposal-lower-prescription-drug-costs.html


KEI’s Timeline on Bayh-Dole Act:
https://www.keionline.org/bayh-dole/bayh-dole-timeline

Previous march-in cases

1997. NIH. Cellpro v Johns Hopkins.

1999. DOE. Ventana Medical System v University of California.

2001. NIH. WARF. Stem cell patents

2002. DOE. Berkeley Heart Lab v University of California.

2004. NIH. Norvir/ritonavir, Essential Inventions v Abbott.

2004. NIH. Xalatan, Essential Inventions v. Columbia University and Pfizer.

2006. CDC/NIH. pressure to more openly license reverse genetics patents for
avian flu vaccine manufacturing.

2010. NIH. Fabrazyme case. Joseph M. Carik, Anita Hochendoner, and Anita
Bova v Mount Sinai School of Medicine at NYU.

2012. NIH. Norvir/ritonavir.  The American Medical Students Association
(AMSA), Knowledge Ecology International (KEI), U.S. Public Interest
Research Group (PIRG) and the Universities Allied for Essential Medicines
(UAEM) v Abbott.

2016. NIH and DOD. Xtandi. KEI and UACT v University of California.

2017. NIH. Zinbryta/daclizumab. KEI v Biogen.

2017. DoD NDAA Directive from Senate Armed Services Committee. 115TH
Congress, 1st Session, 2017, Senate Report 115–125. National Defense
Authorization Act for Fiscal Year 2018. Report to accompany S. 1519, on
page 173. July 10, 2017.

2019. DOD. Xtandi/enzalutamide. Clare Melvin Love and David Reed v.
University of California.

2020. NIH. Remdesivir. State Attorney General's v Gilead.

2021. DOD. Robert Sachs, to join Love and Reed petition on
Xtandi/enzalutamide.


-- 
James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
http://www.keionline.org <http://www.keionline.org/donate.html>
twitter.com/jamie_love


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