Letter from Secretary Xavier Becerra rejecting appeal of the NIH rejection of the Xtandi petition, February 5, 2024
xtandi march-in
NGO Letter to Biden Administration in Support of Xtandi Appeal
Today, eight non-governmental organizations sent the Biden Administration a letter of support for the administrative appeal of the request for the Department of Health and Human Services (HHS) to use its rights in the patents on the prostate cancer drug… Continue Reading
Thursday webinar on Bayh-Dole safeguards including Xtandi march in and government use petition, and federal government review of march in rights
(UPDATE: A recording of the event is available on our YouTube channel here: https://www.youtube.com/watch?v=_qFgm-dohuU) Date: Thursday April 20, 2023 Time: 1:30 PM to 3:00 PM EDT Knowledge Ecology International is hosting an online discussion of two Bayh-Dole safeguard related topics.… Continue Reading
Cancer patients file administrative appeal on NIH rejection of Xtandi march-in petition with Secretary of HHS Becerra
On March 23, 2023, three prostate cancer patients, Robert Sachs, Clare Love and Eric Sawyer, filed an administrative appeal of the NIH decision to reject petition that HHS use Federal rights in patents on Xtandi to address pricing discrimination against… 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
NIH responds to Sachs/Love letter on the Xtandi Bayh-Dole safeguards petition, to say, still reviewing
NIH has sent a letter, dated Dec 1, to Robert Sachs and Clare Love, regarding the longstanding petition to HHS to use the federal government’s rights in the patented inventions for enzalutamide, marketed by Astellas in the USA at prices 3 to… Continue Reading
Letter from 19 groups asking HHS to take action on the request that HHS use the federal government rights in patents on the prostate drug enzalutamide, marketed by Astellas under the brand name Xtandi.
Attached is a letter from 19 groups asking HHS Secretary Xavier Becerra to take action on the request that HHS use the federal government rights in patents on the prostate drug enzalutamide, marketed by Astellas under the brand name Xtandi.… Continue Reading
NIH Questioned about Xtandi and March-in Rights during Congressional Hearing
On Wednesday May 11, 2022, the National Institutes of Health (NIH) was asked about Xtandi and march-in rights during a Congressional hearing. The House Appropriations Committee held a hearing on the FY2023 Budget Request for the NIH, and Representative Mark… Continue Reading
Xtandi (INN enzalutamide) Timeline
Revised February 14, 2022 Early 2000 UCLA claims work that led to the development of enzalutamide began at UCLA in early 2000. 2005 May 13, 2005. Priority date for the three patents in the Xtandi Orange Book. Patents 7709517, 8183274… Continue Reading
Xtandi Petitioners Highlight Pfizer Practice of Reference Pricing in US Government Contracts
Following the publication of the US government contract with Pfizer for the COVID-19 therapeutic Paxlovid, the petitioners of the Xtandi government use request wrote to the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH)… Continue Reading