Clinicaltrials-dot-Gov-HHS-15Sep2023 From the memo: This memo provides a request that the Department of Health and Human Services (HHS), working through the National Institutes of Health (NIH), use its rulemaking authority for ClinicalTrials.Gov to include data on the costs of human… Continue Reading
Update: S.2333 passed Senate HELP today on a 17-3 bipartisan vote, with the delinkage study included. On Thursday, July 20, 2023, the Senate HELP Committee will consider a bill to reauthorize the Pandemic and All-Hazards Preparedness and Response Act (PAHPA).… Continue Reading
KEI provided these comments to the Senate HELP Committee staff on July 10, 2023, regarding a draft bill dealing with pandemic preparation and response. The specific issue KEI was asked to comment on concerned the proposal by Senator Sanders for… Continue Reading
KEI Comments in response to the Office of Science and Technology Policy (OSTP) Request for Information (RFI), regarding National Priorities for Artificial Intelligence, as noticed on May 23, 2023 in the Federal Register, 88 FR 34194. July 7, 2023 Knowledge… Continue Reading
KEI-NTIA-AI-Accountability-RFC KEI response to NTIA request for comments on AI Accountability Policy, expressing concerns over trade agreement provisions which limit the transparency of source code and algorithms RE: Notice by the National Telecommunications and Information Administration on 04/13/2023, Document Citation:… Continue Reading
KEI-USPTO-fees18may2023 Testimony of James Love Representing Knowledge Ecology International (KEI) regarding the opportunities to use differential USPTO fees to achieve additional social objectives USPTO Patent Public Advisory Committee Public Hearing on the Proposed Patent Fee Schedule May 18, 2023 Introduction… Continue Reading
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
NIH-rejection-Xtandi-marchin-21march2023 This is an appalling decision. The worst is this quote: “practical application is evidenced by the “manufacture, practice, and operation” of the invention and the invention’s “availability to and use by the public….” This is what 35 USC 201(f)… Continue Reading
I’m in a two day meeting in Geneva on new approaches to affordable monoclonal antibodies (mAbs), and it made me think of a provision found in some bills that have been proposed or introduced in the U.S. Congress to force… Continue Reading