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 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
EU For an earlier survey, see: 2014:1 KEI Research Note: Recent European Union Compulsory Licenses. 2014-03-01 DG-Enterprise – data exclusivity prevents access to life saving drugs (in the EU), even in an emergency situation, 2012-07-31 Germany German Court Issues Compulsory… Continue Reading
(More on government funded inventions here) 2015 2015: NIH refuses to give information about principals in company seeking exclusive license to HCV patents 2016 2016: AAVMediated Aquaporin Gene Transfer To Treat Sjögren’s Syndrome 2016: Great Lakes Neuroscience and NIH exclusive… 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
Contact: Kim Treanor 202-332-2670; firstname.lastname@example.org January 5, 2018 The National Institutes of Health (NIH) has proposed an exclusive license with Gilead for certain patent applications for inventions that target CD-30 proteins and CAR T technologies. The proposed license is to… Continue Reading
KEI statement regarding Gilead’s Acquisition of Kite Pharma.
“Congress should require the NIH to enforce the Bayh-Dole obligation to make the Kite Pharma Chimeric Antigen Receptors Technologies (CAR T) treatments available to the public on reasonable terms.
KEI notes that Kite reported spending $317 million in R&D from 2012 to June 30, 2017, and is selling the company for $11.9 billion.
Today, KEI submitted comments to the Notice published in the Federal Register on October 5, 2016, entitled “Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers.” KEI’s comments addressed issues with the NIH’s processes for granting exclusive licenses, and transparency in those licenses, resulting data, trials, pricing, and revenue.
Kite Pharma is a California-based biopharmaceutical company working on various types of cell therapies for the treatment of cancer, in a bid to become the first pharmaceutical firm to gain successful FDA approval for this new class of cancer treatment.
Kite closely collaborates with the National Cancer Institute, which conducted significant early research into the forms of cell therapies that Kite is seeking to commercialize. NCI conducts clinical trials under Cooperative Research and Development Agreements (CRADAs) with Kite, and additionally has granted exclusive licenses on over a dozen patents to Kite on the same technologies.