NIH
2012-2013-nih-march-in-request-for-ritonavir
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
2010 Fabrazyme March-In Request
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
Government Funded Inventions
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
Licensing NIH owned patents and data, including KEI comments on proposed exclusive licenses
(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
NIH wants to give Gilead a new, government subsidized monopoly on CAR T technology, this one for CD-30 proteins.
NIH Director Dr. Francis Collins falsely asserts Bayh-Dole safeguards do not address excessive pricing abuses
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
2017: NIH non-response response to KEI and MSF comments on the proposed exclusive license of Zika vaccine patents to PaxVax
(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
KEI asks HHS to use Bayh-Dole rights in Zinbryta patent (drug for multiple sclerosis)
Attached is a letter sent on September 14, 2017 to Andrew Bremberg, an Assistant to the President and the Director of the Domestic Policy Council at the White House, and Keagan Lenihan, a Senior Adviser to HHS Secretary Tom Price, regarding Zinbrytra (INN: daclizumab), a drug to approved by the FDA to treat multiple sclerosis. (PDF version here)
2017: Kymriah, the Novartis $475,000 CAR T treatment, received 50 percent Orphan Drug tax credit on trials
Missing in the reporting on the Novartis price for Kymriah, its new $475,000 CAR T treatment, is that Novartis received an Orphan Drug designation in February 3, 2015, and sequently received a tax credit subsidy from the United States equal to 50 percent of the cost of qualifying clinical trials.
From the FDA database on Orphan Designations:
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=463114