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
On Friday, September 18, 2020, KEI received a letter from the Defense Advanced Research Projects Agency (DARPA) confirming that the agency was investigating Moderna for failure to report government funding in patent applications. The Financial Times and other outlets had… Continue Reading