The 2010 Fabrazyme NIH Bayh-Dole march-in case https://www.keionline.org/cl/bayh-dole/fabrazyme The 2014 FTC complaint regarding collusion between Shire and Sanofi. https://www.keionline.org/22538
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
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
In a reversal from the version that passed out of the Senate Finance Committee, the version of the tax bill that passed the Senate eliminated the requirement that the Orphan Drug tax credit be transparent as to taxpayer, drug and… Continue Reading
The Managers Amendment for the “Tax Cuts and Jobs Act” is available on the Senate Finance web page here: https://www.finance.senate.gov/imo/media/doc/11.20.17%20Tax%20Cuts%20and%20Jobs%20Act.pdf or here: 11.20.17 Tax Cuts and Jobs Act I was looking over the Orphan Drug Tax Credit (ODTC) language. The… Continue Reading
Statement by James Love, KEI Director, on GOP proposal to eliminate the Orphan Drug Tax Credit.
The GOP proposal to eliminate the Orphan Drug Tax Credit may create a new opportunity to reform the incentives for rare diseases, even if the tax bill fails or the tax credit survives. The GOP tax bill shows there is weaker support for the existing regime than many thought.
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:
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.
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