Today KEI asked the Department of Commerce National Institute of Standards (NIST) to publish a notice in the Federal Register inviting comments on their Special Publication 1234, Draft Green Paper on Return on Public Investment, with an extended deadline. The… Continue Reading
KEI filed comments on the NIST Draft Green paper on the return from investment on federally funded R&D (See: https://www.keionline.org/29518). We expect the comment period to be extended, but filed this on January 9, 2018, as an initial submission. KEI-comments-NIST-SP-1234-ROI-9Jan2018… 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
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
In a recent exchange with Senator Durbin, NIH Director Francis Collins expressed his concern that the NIH would alienate potential collaborators if the NIH applied the march-in remedy to address excessive prices of drugs. Continue Reading
On August 5, 2016, KEI received a response from the Department of the Army to KEI and UACT’s January 14, 2016 request that the Army and the National Institutes of Health (NIH) exercise the governments’ rights in the patents for… Continue Reading
National Institutes of Health Declines to Exercise Authority to Lower Xtandi Price
The National Institutes of Health will not use its rights under the Bayh-Dole Act to end the monopoly on the expensive prostate cancer drug Xtandi and allow low-priced generic versions to compete on the market.
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