2010 Fabrazyme March-In Request

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

Government Funded Inventions

We have several pages related specifically to the U.S. Bayh-Dole Act here. KEI efforts to address pricing and other public interest issues in more than 30 different NIH licensing cases, involving both patents and data rights, are here: http://keionline.org/nih-licenses KEI… Continue Reading

KEI Publications

KEI publishes research and commentary in a variety of journals, periodicals, books and other independent publishing platforms. In-house, KEI presents information in blogs, correspondence and reports, as well as in occasional KEI research notes and papers. Timelines (several) Timelines regarding… Continue Reading

2018: Briefing note on NIH proposed license to Gilead for CD-30 CAR T technology

Contact: Kim Treanor 202-332-2670; kim.treanor@keionline.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

2017: NIH non-response response to KEI and MSF comments on the proposed exclusive license of Zika vaccine patents to PaxVax

(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

KEI Comment on GOP proposal to eliminate the Orphan Drug Tax Credit

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.

Continue Reading

Following KEI request for investigation, Cold Spring Harbor Labs says 7 patents require correction to disclose federal funding

Summary:

  • After KEI filed a complaint with the NIH, Cold Spring Harbor Laboratory (CSHL) corrected a failure to disclose funding of at least 7 patented inventions, including one patent for the drug Sprinraza.
  • Since 2012, when federal funding was relevant to an invention, CSHL failed to make a disclosure on a filed patent more than half the time.

Continue Reading