The US Federal Register has published a final rule for the “Concrete Masonry Products Research, Education, and Promotion Order.” (Link). The rule is being issued pursuant to Public Law 115-254, the FAA Reauthorization Act of 2018, which is described as… Continue Reading
On September 9, 2021, the Secretary of HHS, Xavier Becerra, pushed a 29 page report on proposals to address high drug prices. “Report To The White House Competition Council, on Comprehensive Plan for Addressing High Drug Prices. A Report in… Continue Reading
PDF version of letter to NIH. Failure2disclose-Doudna-patents-12oct2020 October 12, 2020 Michelle Bulls Director Office of Policy for Extramural Research Administration (OPERA) National Institutes of Health Via Email: michelle.bulls@nih.gov RE: Failures to disclose government funding associated with patents related to “Methods… Continue Reading
Robert Sachs filed this petition with DoD, asking to join an outstanding march-in petition on the patents for the prostate cancer drug enzalutamide, sold under the brand name Xtandi by Astellas. The petition asks that that march-in be granted on… Continue Reading
On July 9, 2021, the Biden White House has issued an Executive Order on competition which includes opposition to the Trump effort to narrow Bayh-Dole march-in rights over pricing concerns. This is the first time since 1995 there has been… Continue Reading
On June 28, 2021, KEI sent a memorandum to Gayle E Smith (State), Eric Lander (OSTP), Loyce Pace (HHS) and Samantha Power (USAID), asking the U.S. government to clarify that its sanctions against Cuba do not extend to activities and… Continue Reading
The comments focusing on geographic scope, pricing, manufacturing know-how and transparency. June 2, 2021 Daniel Lee, J.D., Technology Transfer and Patent Specialist, National Institute of Allergy and Infectious Diseases Technology Transfer and Intellectual Property Office Via daniel.lee5@nih.gov Re: Prospective Grant… Continue Reading
HouseOversight-UnsustainableDrugPrices-PartIII-2021 May 19, 2021 Rep. Carolyn B. Maloney Chairwoman of the Committee on Oversight and Reform U.S. House of Representatives Rep. James Comer Ranking Member of the Committee on Oversight and Reform U.S. House of Representatives Re: Request for statement… Continue Reading
KEI comment on the May 5, 2021 USTR statement to support negotiations on a waiver of TRIPS rules for COVID 19 vaccines. Attributed to James Love, KEI Director +1.202.361.3040, james.love@keionline.org KEI applauds the decision by President Biden and USTR Katherine… Continue Reading
KEI will host an online discussion of the new end of Trump term proposals to change Bayh-Dole regulations and Stevenson-Wydler Act statutes, on January 27, 2021, from 2pm to 4pm. To register for the event, send an email to bayh-dole-proposals@keionline.org… Continue Reading