NIST Draft Guidance on Exercising March-in Rights

The National Institute of Standards and Technology (NIST) issued a Request for Information on December 8, 2023 regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593). The request follows a nearly year-long interagency… Continue Reading

KEI Comment to NIST on Bayh-Dole Rights and Cases of Mixed Patent Landscapes

KEI submitted comments to the National Institute of Standards and Technology (NIST) in response to the Request for Information regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593) concerning Bayh-Dole rights and the… Continue Reading

Prostate cancer patients ask Secretary Beccera to act on their appeal of rejection of the Xtandi march in and government use petititon

On December 19, 2023, three prostate cancer patients, Robert Sachs, Clare Love and Eric Sawyer, sent a letter to Secretary Becerra asking that he act on their appeal of the rejection of their petition, asking the federal government to use… Continue Reading

FTC asked to use its advocacy role in the Xtandi case

The U.S. Federal Trade Commission (FTC) mission “is protecting the public from deceptive or unfair business practices and from unfair methods of competition through law enforcement, advocacy, research, and education.” https://www.ftc.gov/about-ftc/mission The advocacy role of the FTC includes to “Advance… Continue Reading

Cancer patients file administrative appeal on NIH rejection of Xtandi march-in petition with Secretary of HHS Becerra

On March 23, 2023, three prostate cancer patients, Robert Sachs, Clare Love and Eric Sawyer, filed an administrative appeal of the NIH decision to reject petition that HHS use Federal rights in patents on Xtandi to address pricing discrimination against… Continue Reading

25 Members of Congress Ask HHS Secretary to Act on Xtandi Request

On January 10, 2023, twenty-five Members of Congress sent a letter to HHS Secretary Xavier Becerra urging him to act on the Xtandi request, and to use the Bayh-Dole Act to lower the price of Xtandi (enzalutamide) for US patients.… Continue Reading

NIH responds to Sachs/Love letter on the Xtandi Bayh-Dole safeguards petition, to say, still reviewing

NIH has sent a letter, dated Dec 1, to Robert Sachs and Clare Love, regarding the longstanding petition to HHS to use the federal government’s rights in the patented inventions for enzalutamide, marketed by Astellas in the USA at prices 3 to… Continue Reading

On Joe Allen’s claims that former Senators can provide authoritative statements on legislative intent decades after leaving office, especially when they worked as lobbyists

A recent blog published in IPWatchdog expresses outrage at accurate observations made by James Love, director of Knowledge Ecology International (KEI), that former Senators Birch Bayh and Bob Dole acquired financial ties to the pharmaceutical industry between the enactment of… Continue Reading