On February 6, 2024, KEI submitted comments to the National Institute of Standards and Technology (NIST) regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (88 FR 85593). This set of comments outlined that the draft… Continue Reading
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
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 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
(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
Comments on the Proposal to Eliminate Unreasonable Prices as a Standalone Basis for March-in Rights (Modify 37 CFR § 401.6) KEI Briefing Note 2021:1 March 18, 2021 James Love (Note: The contents of this briefing note were submitted to the… Continue Reading
On November 5, 2020, Regeneron Pharmaceuticals published a redacted version of the contract awarding the company $450 million taxpayers’ dollars for the large-scale manufacture of Regeneron’s investigational COVID-19 antibody treatment. The contract uses Other Transactions Authority to weaken the U.S.… Continue Reading
Regeneron Pharmaceutical recently applied for Emergency Use Authorization of its investigational COVID-19 treatment, REGN-COV2, after Donald Trump said that it cured him of COVID-19, suggesting that Regeneron expects to cash in on the treatment. Taxpayers, however, are funding 80 percent… Continue Reading
A House coronavirus stimulus bill contains a provision concerning the use of Other Transactions Authority to fund COVID-19 diagnostics. The provision appears to authorize the Department of Homeland Security (DHS) to award $2.2 billion to private sector companies to develop… Continue Reading