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

Open Letter to Biden Administration on Increased Transparency of Clinical Trial Costs

On Monday January 31, 2022, Knowledge Ecology International (KEI) Doctors Without Borders/Médecins Sans Frontières (MSF) USA, Doctors for America, the Drugs for Neglected Diseases Initiative, Professor Chris Morten of Columbia Law School, and 33 supporting organizations sent a letter to… Continue Reading

Three areas in Section 202 of the Bayh-Dole Act that require action to ensure sufficient rights in patents on coronavirus relevant inventions

For more on KEI’s work on COVID-19, see keonline.org/coronavirus. As the US and other governments begin to expend large amounts of money on research and development related to the control, prevention and treatment of the coronavirus pandemic, there are important… Continue Reading

DHHS Listening Session on WHA 2018: Comment on Agenda Item 11.7 Preparation for the third High-level Meeting of the General Assembly on the Prevention and Control of Non-Communicable Diseases, to be held in 2018

On Friday May 11, 2018, the Department of Health and Human Services (DHHS) held its annual listening session in advance of the upcoming Seventy-First World Health Assembly. Comments were limited to 2 minutes, with no time set aside for a… Continue Reading