Ventana Medical Systems, Inc., march-in request 1999. February 10. Jonathan Cohen, Director of Intellectual Property for Ventana Medical Systems, Inc., sends letter to Paul A. Gottlieb, Esq., Assistant General Counsel for Technology Transfer and Intellectual Property at the U.S. Department… Continue Reading →
For a general timeline of the Bayh-Dole Act, see this page. 1980. December 12. The Bayh-Dole Act was enacted into law as part of Public Law 96-517, including Section 203 that provide march-in rights. 1984. November 8. The Bayh-Dole statute was… Continue Reading →
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 →
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
2017 KEI asks HHS to use Bayh-Dole rights in Zinbryta patent (drug for multiple sclerosis), September 15, 2017.
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)
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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 →