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

Robert H. Mermell Letter of Support for Government Use Request on Prostate Cancer Drug Xtandi

The Department of Health and Human Services (HHS) and National Institutes of Health (NIH) is currently reviewing whether to proceed with the request that the government use its rights in the prostate cancer drug Xtandi, in order to enable generic… 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

Xtandi Bayh-Dole Rights Case: Memorandum in Support of Prostate Cancer Patient Petition Asking HHS to Use the US Government’s Rights in Patents to Enable Generic Competition

(For more information, please see the Xtandi: 2021-2022 request page) A January 25, 2022 Knowledge Ecology International “Memorandum in support of the petition to HHS to exercise the march-in or paid up royalty right in patents on the prostate drug… Continue Reading

Eric Sawyer December 13, 2021 Petition to HHS on Xtandi March-in Case

On December 13, 2021, Eric Sawyer filed this petition with the Department of Health and Human Services, asking to join an outstanding march-in petition on the patents for the prostate cancer drug enzalutamide, sold under the brand name Xtandi by… Continue Reading

HHS Asked to Take Up March-in Request of Prostate Cancer Drug Xtandi

(Update: On December 15, 2021 KEI hosted a press briefing regarding the Xtandi march-in request. Video and details available here: https://www.youtube.com/watch?v=KwqUl7NLMXo) On November 18, 2021, Robert Sachs and Clare Love submitted a petition to the Secretary of Health and Human… Continue Reading