KEI Response to Questions from USTR on Special 301 – March 5, 2021
Author: KEI Staff
Some industry submissions for USTR’s 2021 Special 301
(More on the USTR Special 301. link) Attached are links to several of the industry submissions for the 2021 USTR Special 301 list. The Docket: USTR-2020-0041 PhRMA 2021 Special 301 Review Comment, and Correction to Comment BIO 2021 Special 301… Continue Reading
KEI Roundtable on Pathways to Scale Up Manufacturing Capacity for COVID-19 Vaccines – 19 February 2021
KEI roundtable on pathways to scale up manufacturing capacity for COVID-19 vaccines Friday, 19 February 2021 14h00 UTC to 16h00 UTC 15h00 CET to 17h00 CET 09h00 EST to 11h00 EST On Friday, 19 February 2021, KEI will host a… Continue Reading
Draft of EU export restriction for COVID-19 vaccines
The European Commission-Curevac Advance Purchase Contract for a COVID-19 Vaccine
The European Commission has released a redacted version of a contract with Curevac for a COVID-19 vaccine. The vaccine uses mRNA technology, similar to the Pfizer and Moderna vaccines. The contract is severely redacted in some areas, but some information… Continue Reading
KEI comments to FDA on Prospective Exclusive Patent License for Diagnostic for SARS, SARS-CoV-2, Other Viruses, Bacteria and Bacterial Serovar, to Advion
To: Ken Millburne Technology Transfer Program Food and Drug Administration Via email: Kenneth.millburne@fda.hhs.gov From: James Love Knowledge Ecology International 1621 Connecticut Avenue NW, Suite 500 Washington, DC 20009 https://keionline.org Date: November 30, 2020 Re: Prospective Grant of an Exclusive Patent… Continue Reading
Regeneron $450 million contract with Advanced Technology International has Patent Rights Clause that Narrows Government Rights in Patented Inventions
A contract between Regeneron and Advanced Technology International (ATI) involving $450 million in taxpayer funding uses the “Other Transactions Authority” or OTA, to avoid Bayh-Dole safeguards on patent rights. ATI is entering into purchase agreements on behalf of the Department… Continue Reading
Three Moderna contracts disclosed in 2020 Q3 10-Q SEC filing
Moderna has attached three COVID-19 related contracts as exhibits to its SEC 10-Q form for the quarterly period ending in October 2020. The first is the contract between the Department of Health and Human Services (HHS) and Moderna for the… Continue Reading
Regeneron failed to disclose BARDA funding in their REGN-COV2 patent
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
KEI comments on the FDA Orange Book
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