Documents from NIH Freedom of Information requests

ACTIV Partnership Records Records received via the KEI-NIH Freedom of Information Act (FOIA) lawsuit regarding an April 17, 2020 FOIA request for records relating to the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, the private-public partnership announced by the… 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

KEI Reaction to Astellas Comment Regarding Public and Private Sector Contributions to the Development of Xtandi

(More on the Xtandi case here: https://www.keionline.org/xtandi2021) Astellas has issued a statement, dated February 9, 2022, on the Bayh-Dole Act and the petition to exercise march-in and government use rights in the prostate cancer drug Xtandi. It was brought to… 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

Harvard academics letter supporting use of US government rights in Xtandi patents to remedy price discrimination against US residents

On February 2, 2022, Drs. Ameet Sarpatwari, Aaron S. Kesselheim, Jerry Avorn, and Benjamin N. Rome of Harvard Medical School and Dr. Michael S. Sinha of Northeastern University and Loyola University sent a letter to HHS Secretary Xavier Becerra in… Continue Reading

Pfizer Agrees to International Reference Pricing in US Government Contract for COVID-19 Therapeutic

Published in an article by Sydney Lupkin of NPR, the Pfizer-US government contract for the COVID-19 therapeutic Paxlovid contains terms of interest in broader drug pricing discussions. The Pfizer contract includes a “Most Favored Nation Clause” (H.7), which provides that… Continue Reading