PDF version here: KA-KEI-NIST-Standing-26March2021 More on the NIST proposed changes to the Bayh-Dole Regulations: https://www.keionline.org/35432 Kathryn Ardizzone Counsel, Knowledge Ecology International National Institute of Standards and Technologies Rights to Federally Funded Inventions and Licensing of Government Owned Inventions Docket No.:… Continue Reading →
On March 11th 2021, Biolyse Pharma (“Biolyse”) issued a statement publicly indicating their capacity to manufacture a COVID-19 vaccine and their intent to apply for a compulsory license in Canada. Biolyse is a Canadian manufacturer of cancer drugs based out… Continue Reading →
New: Biden White House Executive Order opposes change in Bayh-Dole March-In regulations. (KEI has an email list to discuss this issue here: http://lists.keionline.org/mailman/listinfo/bayh-dole-regulations_lists.keionline.org) The Department of Commerce’s National Institute of Standards and Technology (NIST) published on January 4, 2021, a… Continue Reading →
On Friday, 20 November 2020, the World Trade Organization (WTO) convened an informal, virtual meeting of the TRIPS Council to discuss a proposal (IP/C/W/669) co-sponsored by Eswatini, India, Kenya, and South Africa for a waiver from certain provisions of the… Continue Reading →
Regeneron Pharmaceuticals failed to disclose U.S. government funding in a patent that claims antibodies against COVID-19. The obligation to acknowledge U.S. government funding in patents is required under an existing contract between Regeneron and the Biomedical Advanced Research and Development… Continue Reading →
On Friday, 16 October 2020, members of the World Trade Organization’s (WTO) TRIPS Council held a three hour debate on the proposal (IP/C/W/669) first tabled by India and South Africa for a waiver from certain provisions of the TRIPS Agreement… Continue Reading →
(More on KEI’s work on coronavirus here: https://www.keionline.org/coronavirus, and on Moderna, here: https://www.keionline.org/moderna) Oct 8, 2020 Moderna’s statement on intellectual property matters during the COVID-19 pandemic is very good, and should be matched by every manufacturer of a therapeutic, vaccine… Continue Reading →
These are the KEI comments on the questions raised by the FDA in the 85 FR 33165 and 85 FR 33169 Federal Register notices. KEI-comments-FDAOrange Book-31aug2020 KEI comments to the FDA relating to the Approved Drug Products With Therapeutic Equivalence… Continue Reading →
KEI Research Note: 2020-4: The current and potential role of biomedical research mandates 2020 The current and potential role of biomedical research mandates. Progress in biomedical research depends upon funding. This funding comes from a variety of public sector, non-profit… Continue Reading →
Below is a letter from several individuals and groups, asking that NIAID not grant exclusive rights in a HIV patent license for South Africa, India and other low income countries. (PDF version here) The license is to RNAceuticals, a firm… Continue Reading →
