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
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
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
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
We have several pages related specifically to the U.S. Bayh-Dole Act here. KEI efforts to address pricing and other public interest issues in more than 30 different NIH licensing cases, involving both patents and data rights, are here: http://keionline.org/nih-licenses KEI… Continue Reading
(More on government funded inventions here) 2015 2015: Virotas Biopharmaceuticals. KEI and Public Citizen ask NIH for safeguards in license for HCV patents, April 14, 2015. 2015: NIH refuses to give information about principals in company seeking exclusive license to… Continue Reading
In a hearing before the House Energy & Commerce Subcommittee on Health, Dr. Francis Collins, Director of the National Institutes of Health, explained the agency’s position on the Bayh-Dole rights and high drug prices. In the hearing, focused on the… Continue Reading
(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) On November 30, 2017, KEI has received a response from the National Institute of Allergy and Infectious Diseases regarding our previous joint comments with MSFon the proposed exclusive… Continue Reading