Request for CMS to provide a Bayh-Dole Section 202 license and a 28 USC 1498 authorization and consent to use three patents listed in the FDA Orange Book for the cancer drug enzalutamide

Letter from KEI, UACT and UAEM to Chiquita White Brooks-Lasure, Administrator of the Office of the Administrator, Centers for Medicare and Medicaid Services, at HHS, asking that CMS to provide a Bayh-Dole Section 202 license and a 28 USC 1498… Continue Reading

Prostate cancer patients ask Secretary Beccera to act on their appeal of rejection of the Xtandi march in and government use petititon

On December 19, 2023, three prostate cancer patients, Robert Sachs, Clare Love and Eric Sawyer, sent a letter to Secretary Becerra asking that he act on their appeal of the rejection of their petition, asking the federal government to use… Continue Reading

FTC asked to use its advocacy role in the Xtandi case

The U.S. Federal Trade Commission (FTC) mission “is protecting the public from deceptive or unfair business practices and from unfair methods of competition through law enforcement, advocacy, research, and education.” https://www.ftc.gov/about-ftc/mission The advocacy role of the FTC includes to “Advance… Continue Reading

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

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