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

KEI Comments to NIH on Exclusive License to TeraImmune for T-cell Therapy for Multiple Sclerosis

(Update: The NIH provided a response to our questions and comments on February 28, 2022) On February 9, 2022, Knowledge Ecology International (KEI) filed comments with the National Institutes of Health regarding the “Prospective Grant of Exclusive Patent License: Development… 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

Brazil, Egypt, Japan, Netherlands, South Africa, and Thailand comprise the bureau of WHO’s Intergovernmental Negotiating Body (INB) to draft and negotiate a WHO convention,agreement or other international instrument on pandemic prevention, preparedness and response

On 1 December 2021, the special session of the World Health Assembly adopted a decision launch intergovernmental negotiations to draft and negotiate a WHO convention,agreement or other international instrument on pandemic prevention, preparedness and response; this signaled the intent of… 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

EB150: Statement of Knowledge Ecology International KEI on the Global strategy and plan of action on public health, innovation and intellectual property

On Saturday, 29 January 2022,Knowledge Ecology International (KEI) delivered the following statement on the Global strategy and plan of action on public health, innovation and intellectual property at the 150th session of the World Health Organization’s Executive Board. Access to… Continue Reading