Pfizer’s March 18, 2022 opposition to the KEI request for a compulsory license in Dominican Republic for Paxlovid.

On March 18, 2022, Pfizer filed a 45 page opposition to the KEI application for a compulsory license on Paxlovid patents in the Dominican Republican. This is the Pfizer filing, and KEI’s unofficial translation. Pfizer-opposition-DR-CL-18March2022.pdf Translation-Pfizer-opposition-KEI-CL-Paxlovid-18march2022.pdf The December 3, 2021… Continue Reading

KEI comments to USTR and the Trade Policy Staff Committee (TPSC) on Trade related aspects of public goods

https://www.regulations.gov/comment/USTR-2021-0021-0120 Trade related aspects of public goods Submission to USTR and the Trade Policy Staff Committee (TPSC) James Love, KEI March 8, 2022 Introduction One can think of the economy as including both public and private goods, each valued by… 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

KEI Reaction to Astellas Comment Regarding Public and Private Sector Contributions to the Development of Xtandi

(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

Senator Tillis Letter to FDA and USPTO Asking for a Study of Relationship between Patents and Drug Prices

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