(Update: The NIH provided a response to our comments on July 16, 2018) Below are comments sent by KEI, UACT and HealthGap, regarding a proposed exclusive license to Morphiex Biotherapeutics, an entity for which little is known. The license concerns… Continue Reading
FOR IMMEDIATE RELEASE April 5, 2018 kim.treanor@keionline.org (202)-332-2670 Six organizations are asking Department of Health and Human Services Secretary Alex Azar to take actions to lower the price of eteplirsen, a drug sold under the brand name Exondys 51, to… Continue Reading
On March 21, 2018, KEI asked the NIH to investigate the failure of James Griffin, the Dana-Farber Cancer Institute and Novartis to disclose millions of dollars in NIH grants related to two patents for the leukemia drug midostaurin, marketed by… Continue Reading
Bayh-Dole cases involving royalty free or march-in rights 1997 Cellpro case This was a strong case involving two competing medical devices, both invented on NIH grants, and a bad ending. The NIH rejection of the Cellpro march-in request led to… 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
Attached is a letter sent on September 14, 2017 to Andrew Bremberg, an Assistant to the President and the Director of the Domestic Policy Council at the White House, and Keagan Lenihan, a Senior Adviser to HHS Secretary Tom Price, regarding Zinbrytra (INN: daclizumab), a drug to approved by the FDA to treat multiple sclerosis. (PDF version here)
Bayh-Dole Act and difference between March-In Rights and the world wide royalty free rights in patents KEI Briefing Note 2017:1 When the United States federal government funds research that results in patents, it obtains rights, either directly or through contracts,… Continue Reading
Context and history, and areas of current work. Bayh-Dole timeline Timeline regarding Bayh-Dole march-in right requests Timeline regarding Bayh-Dole royalty-free requests Bayh-Dole Act confidentiality provisions timeline Licensing NIH owned patents and data, including KEI comments on proposed exclusive licenses, 2015… Continue Reading