On April 19, 2018, KEI filed a lawsuit against the National Institutes of Health (NIH) to block or invalidate an exclusive license of patents on a new chimeric antigen receptor T-cell (CAR T) therapy to Gilead Sciences. A copy of… Continue Reading
FOR IMMEDIATE RELEASE April 5, 2018 kim.treanor@keionline.org (202)-332-2670 Six organizations are asking Department of Health and Human Services Secretary Alex Azar to take actions to lower the price of eteplirsen, a drug sold under the brand name Exondys 51, to… Continue Reading
On March 21, 2018, KEI asked the NIH to investigate the failure of James Griffin, the Dana-Farber Cancer Institute and Novartis to disclose millions of dollars in NIH grants related to two patents for the leukemia drug midostaurin, marketed by… Continue Reading
On March 29, 2018, KEI asked the NIH to investigate the failure of the University of Pennsylvania and Daniel J. Rader to report NIH funding relating to 6 patents in the FDA Orange Book for the drug Juxtapid (INN lomitapide).… Continue Reading
1994. The 1994 NIH Report on CRADAs and the Reasonable Pricing Clause 1994. September 8. James Love. Pricing of Drugs Developed with Public Funds. Comments Presented to the Second NIH CRADA Forum. 1995. April 11. NIH Notice Rescinding the Reasonable… Continue Reading
In the attached letter dated March 14, 2018 to Secretary of the Department of Health and Human Services (DHHS) Alex Azar, KEI is asking for an investigation into a failure to report NIH funding on US patent 7,964,580. This is… Continue Reading
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