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

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

KEI Comments on NIH Prospective Exclusive License to Gilead for HIV Treatment/Cure

(Update: On November 4, 2021, the NIH provided a response to our comments on the license.) On October 12, 2021, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the ““Prospective Grant of an Exclusive… Continue Reading

KEI Comments Regarding NIH Prospective License to Blue Water Vaccines for West Nile Vaccine

On September 27, 2021, Knowledge Ecology International (KEI) submitted the following comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of Exclusive Patent License: Chimeric Live-Attenuated Vaccine for West Nile Virus (WNV)” (86 FR 50722). The technology… Continue Reading

KEI Comments to the NIH on Exclusive License of AAV Technology to Children’s Medical Research Institute in Australia

Knowledge Ecology International (KEI) submitted comments on Wednesday July 14, 2021 to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Adeno-Associated Virus Polynucleotides, Polypeptides and Virions” (86 FR 34246). The rights to technology… Continue Reading