On January 10, 2023, twenty-five Members of Congress sent a letter to HHS Secretary Xavier Becerra urging him to act on the Xtandi request, and to use the Bayh-Dole Act to lower the price of Xtandi (enzalutamide) for US patients.… Continue Reading
SecBecerra-18Nov2022-Sachs-Love-Xtandi November 18, 2022 Xavier Becerra Secretary Department of Health & Human Services Washington, DC Via Email: xavier.becerra@hhs.gov Dear Secretary Becerra: Today marks the one-year anniversary since the undersigned prostate cancer patients petitioned the Department of Health & Human Services… Continue Reading
(More on this topic here: https://www.keionline.org/xtandi2021) On February 24, 2022, Senators Thom Tillis and Marsha Blackburn sent a letter to HHS Secretary Xavier Becerra (PDF copy). The letter refers to “petitions to march-in on a pharmaceutical product purely based on… Continue Reading
This is a letter from the three prostate cancer patient petitioners to HHS Secretary Becerra and Acting NIH Director Tabak, regarding the February 9, 2020 statement by Astellas on the Bayh-Dole march in and government rights case. The patient’s letter… Continue Reading
Update: Video recording of the press briefing available here: https://www.youtube.com/watch?v=KwqUl7NLMXo) December 15th 10AM – Briefing on Xtandi March-in Request Supporters of the march-in petition to lower the cost of the prostate cancer drug Xtandi will host a virtual press conference… Continue Reading
On July 9, 2021, the Biden White House has issued an Executive Order on competition which includes opposition to the Trump effort to narrow Bayh-Dole march-in rights over pricing concerns. This is the first time since 1995 there has been… Continue Reading
PDF version here: KA-KEI-NIST-Standing-26March2021 More on the NIST proposed changes to the Bayh-Dole Regulations: https://www.keionline.org/35432 Kathryn Ardizzone Counsel, Knowledge Ecology International National Institute of Standards and Technologies Rights to Federally Funded Inventions and Licensing of Government Owned Inventions Docket No.:… Continue Reading
PDF version here:LGA-NIST-Subject-Invention-definition-26March2021 More on the NIST proposed changes to the Bayh-Dole Regulations. https://www.keionline.org/35432 Comments of Luis Gil Abinader of Knowledge Ecology International on the redefinition of “Subject Invention” to Narrow the Inventions to Which Government Rights Attach (Modify 37… Continue Reading
New: Biden White House Executive Order opposes change in Bayh-Dole March-In regulations. (KEI has an email list to discuss this issue here: http://lists.keionline.org/mailman/listinfo/bayh-dole-regulations_lists.keionline.org) The Department of Commerce’s National Institute of Standards and Technology (NIST) published on January 4, 2021, a… Continue Reading