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

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

KEI letter to Brian Nelson, Office of Terrorism and Financial Intelligence, regarding exceptions to sanctions for medical products

KEI is sending this letter to the Administration today, regarding measures we would like to see undertaken to make the humanitarian exceptions to sanctions work better.  This is a neglected area of policy failure, although there is evidence that the Biden administration… Continue Reading

KEI comments on NIH proposed exclusive license to Neogene Therapeutics CRISPR-Engineered T Cell Therapies for the Treatment of Cancer

November 10, 2021 Andrew Burke, Ph.D. Senior Technology Transfer Manager, NCI Technology Transfer Center, Email: andy.burke@nih.gov. Re: Prospective Grant of an Exclusive Patent License: Development and Commercialization of CRISPR-Engineered T Cell Therapies for the Treatment of Cancer to Neogene Therapeutics… Continue Reading

KEI Comments on the Medicines Patent Pool/Merck License for Molnupiravir

(For more resources, please see our page on molnupiravir.) The Medicines Patent Pool (MPP) and Merck Sharp & Dohme (“MSD” or “Merck”) have announced a voluntary license for the generic manufacture and sale of molnupiravir. A joint press release from… Continue Reading

Countries included in the Merck/molnupiravir voluntary license with generic suppliers

(For more resources, please see our page on molnupiravir.) According to Brook Baker, these are the countries included in the Merck voluntary license to generic suppliers Afghanistan, Algeria, Angola, Bangladesh, Belize, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon,… Continue Reading