NIH Questioned about Xtandi and March-in Rights during Congressional Hearing

On Wednesday May 11, 2022, the National Institutes of Health (NIH) was asked about Xtandi and march-in rights during a Congressional hearing. The House Appropriations Committee held a hearing on the FY2023 Budget Request for the NIH, and Representative Mark… Continue Reading

KEI Comments Regarding NIH Prospective Exclusive License to Georgetown University for Pancreatic Cancer Diagnostic

On April 28, 2022, Knowledge Ecology International (KEI) provided comments on the latest National Institutes of Health (NIH) Federal Register notice concerning licensing, the “Prospective Grant of an Exclusive Patent License: Development of Diagnostic for Imaging and Early Detection of… Continue Reading

Documents from NIH Freedom of Information requests

ACTIV The National Institutes of Health (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership, to develop treatments and vaccines. Coordinated by the Foundation for the National Institutes of Health (FNIH), with the NIH and sibling agencies in the… Continue Reading

KEI Comments Regarding NIH Exclusive License to Syncopation for CAR T Therapy

Knowledge Ecology International (KEI) filed comments with the National Institutes of Health (NIH) on March 16, 2022 regarding the “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Chimeric Antigen Receptor T-Cell Therapies (CAR-T) That are Specific to… Continue Reading

Senators Tillis and Blackburn’s February 24, 2022 Letter to HHS Opposing the Use of Bayh-Dole March-in Rights

(More on this topic here: https://www.keionline.org/xtandi2021) On February 24, 2022, Senators Thom Tillis and Marsha Blackburn sent a letter to HHS Secretary Xavier Becerra (PDF copy). The letter refers to “petitions to march-in on a pharmaceutical product purely based on… Continue Reading

Clare Love, Robert Sachs and Eric Sawyer respond to Astellas Feb 9 Statement on Xtandi Bayh Dole march in and government use case

This is a letter from the three prostate cancer patient petitioners to HHS Secretary Becerra and Acting NIH Director Tabak, regarding the February 9, 2020 statement by Astellas on the Bayh-Dole march in and government rights case. The patient’s letter… Continue Reading

Senators Warren and King, and Representative Doggett ask HHS Secretary Becerra to Move Forward on Xtandi March-in and Government Use Rights (Existing Bayh-Dole Safeguards)

Senators Elizabeth Warren (D-MA) and Angus King (I-ME) and Representative Lloyd Doggett (D-TX) wrote Secretary of HHS Xavier Becerra on February 17, 2022, urging him to move forward with the march-in petition by Robert Sachs, Clare Love and Eric Sawyer,… 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