KEI Briefing Note 2018:1. Bayh-Dole Obligations to Disclose Federal Funding Government oversight of under-reporting U.S. federal rights in patents. 1994. June 15, 1994, Inspector General Report to HHS on the under-reporting of federal funding of inventions at the Scripps Research… Continue Reading
Bayh-Dole cases involving royalty free or march-in rights 1997 Cellpro case This was a strong case involving two competing medical devices, both invented on NIH grants, and a bad ending. The NIH rejection of the Cellpro march-in request led to… Continue Reading
KEI has appealed the NIH/NCI decision to proceed with the proposed exclusive license of anti-CD30 CAR T to Gilead, following an email of January 25, 2018 from Dr. David Lambertson of NCI rejecting all of KEI’s substantive suggestions and objections. KEI… Continue Reading
Public and Private Sector Funded Research for Fabry’s Disease KEI Research Note 2010:2 23 July 2010 Introduction Fabry’s disease is a rare genetic multisystemic disorder associated with progressive lipid accumulation and cell damage, leading to a variety of aliments, including… Continue Reading
On February 14, the NIH was asked what the budget was for the Phase 1 clinical trial of the anti-CD30 CAR T technology that is the subject of a proposed exclusive patent license to Kite/Gilead. The clinicaltrials.gov identifier for the… Continue Reading
Pages on the 2012-2013 NIH Request November 1, 2013. NIH rejects March-In petition, also rejects proposed rules on pricing of and access to government funded inventions. October 15, 2013. 15 frequently asked questions about the 2012 ritonavir March-In petition October… Continue Reading
On February 9, 2018, the Trump Administration released a paper by the Counsel of Economic Advisers (CEA) on drug pricing. The paper on pricing was thought to have been led by economist Tomas Philipson, appointed to the CEA by President… Continue Reading
(More on compulsory licensing here.) This is a non-exhaustive set of provisions in US statutes that are used to for non-voluntary use of patented inventions. 28 U.S.C. 1498 – Patent and copyright cases (a) Whenever an invention described in and… Continue Reading
More on Fabry here: https://keionline.org/fabry NIH rejects Fabrazyme March-In Petition December 7, 2010. Press release from Fabry patients: DHHS denies patient’s march-in request to end Genzyme’s rationing of treatment for Fabry Disease citing that FDA rules block manufactures from supplying… Continue Reading