KEI Comment to NIST on the Bayh-Dole Letter to the Washington Post and the Legislative History of the Act

KEI submitted comments to the National Institute of Standards and Technology (NIST) issued a Request for Information regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593) regarding the 2002 Bob Dole and Birch… Continue Reading

NIST Draft Guidance on Exercising March-in Rights

The National Institute of Standards and Technology (NIST) issued a Request for Information on December 8, 2023 regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593). The request follows a nearly year-long interagency… Continue Reading

KEI Comment to NIST on Bayh-Dole Rights and Cases of Mixed Patent Landscapes

KEI submitted comments to the National Institute of Standards and Technology (NIST) in response to the Request for Information regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593) concerning Bayh-Dole rights and the… Continue Reading

25 Members of Congress Ask HHS Secretary to Act on Xtandi Request

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

Letter to Secretary of HHS Xavier Becerra regarding Xtandi march-in case from Robert Sachs and Clare Love

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

Senators Tillis and Blackburn’s February 24, 2022 Letter to HHS Opposing the Use of Bayh-Dole March-in Rights

(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

Clare Love, Robert Sachs and Eric Sawyer respond to Astellas Feb 9 Statement on Xtandi Bayh Dole march in and government use case

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

December 15th 10AM – Briefing on Xtandi March-in Request

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