2017 KEI asks HHS to use Bayh-Dole rights in Zinbryta patent (drug for multiple sclerosis), September 15, 2017.
Pages on the 2012-2013 NIH Request October 15, 2013. 15 frequently asked questions about the 2012 ritonavir March-In petition /node/1815 October 8, 2013. Congress asked to hold hearings on NIH failure to address abuses of government financed medical inventions /node/1805… Continue Reading
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 the drug in a timely… Continue Reading
This page has some broken links, due to some issues with our hosting company. The issues should be fixed soon.—– We have a page on Bayh-Dole march-in and royalty free cases here. KEI efforts to address pricing and other public… Continue Reading
We have a briefing note on this license here: 2018: Briefing note on NIH proposed license to Gilead for CD-30 CAR T technology
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
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)
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:
Workshop: Patents, the Public Interest and Two New Medical Technologies: Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), Chimeric Antigen Receptors (CAR) technologies
On September 15th, 2017, Knowledge Ecology International will be hosting a workshop on: “Patents, the Public Interest and Two New Medical Technologies: CRISPR and CAR T.”
If you are unable to attend in person, a livestream of the event will be available here