(Update: The NIH provided responses to our comments on April 5, 2021 – 86 FR 10092 Response and 86 FR 10081 Response) On Friday March 5, 2021, Knowledge Ecology International (KEI) submitted comments to the National Institute of Health (NIH)… Continue Reading
On September 12, 2019, Knowledge Ecology International (KEI), Union for Affordable Cancer Treatment (UACT), Universities Allied for Essential Medicines (UAEM), Social Security Works (SSW), and Clare Love filed an appeal with the National Institutes of Health (NIH). The signatories appealed… Continue Reading
On June 25, 2018, plaintiff KEI filed a memorandum in opposition to a motion to dismiss filed by defendants NIH et al. The opposition cites the declaration of KEI Director James Love. The original KEI complaint is here: https://www.keionline.org/27669 The… Continue Reading
On February 14, the NIH was asked what the budget was for the Phase 1 clinical trial of the anti-CD30 CAR T technology that is the subject of a proposed exclusive patent license to Kite/Gilead. The clinicaltrials.gov identifier for the… 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
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.