(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
(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
In a January 31, 2022 letter to Drew Hirshfeld, the Commissioner for Patents for the USPTO, and Janet Woodcock, the Acting Commissioner of the FDA, Senator Thom Tillis provides extensive criticism of the empirical work of the group I-MAK and… Continue Reading
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
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
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
On 13 December 2021, the Office of United States Trade Representative (USTR) posted the following request for public comment in relation to its 2022 Special 301 Review: Identification of Countries Under Section 182 of the Trade Act of 1974 noting… Continue Reading
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
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
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