KEI has asked the DHHS Office of Inspector General (OIG) to investigate a failure to disclose federal funding of patents on nusinersen, a drug developed by Ionis Pharmaceuticals (formerly known as Isis Pharmacetuicals) with BioGen, and sold under the trade name Spinraza.
A copy of the 22 page letter to OIG is available here.
Matt Richtel and Andrew Pollack explore the complex policy issues involved with the pricing of products based on taxpayer-funded inventions and research in a front page New York Times story published today.
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.
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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.
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(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) On May 18th, 2016 the NIH posted a notice on the Federal Register stating it is contemplating the grant of an exclusive license to Dimension… Continue Reading
(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) On April 22nd, 2016 the NIH posted a notice on the Federal Register stating it is contemplating the grant of an exclusive license to Dedalus… Continue Reading