KEI Briefing Note 2021:3, The number of standard and material CRADAs executed by the NIH from 1985 to 2020 and the relationship to NIH reasonable pricing clause
Bayh-Dole Act
Kathryn Ardizzone, KEI Comment to NIST Regarding Proposal to Deny Members of the Public Standing to Appeal Government Licenses
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
Luis Gil Abinader NIST comments on the definition of Subject Invention, 26 March 2021
PDF version here:LGA-NIST-Subject-Invention-definition-26March2021 More on the NIST proposed changes to the Bayh-Dole Regulations. https://www.keionline.org/35432 Comments of Luis Gil Abinader of Knowledge Ecology International on the redefinition of “Subject Invention” to Narrow the Inventions to Which Government Rights Attach (Modify 37… Continue Reading
Comments on NIST Proposed Revisions to Bayh-Dole Act
(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 request for comments on changes in regulations related to the Bayh-Dole Act… Continue Reading
DARPA letter to KEI confirming investigation of Moderna for failure to report government funding in patent applications
On Friday, September 18, 2020, KEI received a letter from the Defense Advanced Research Projects Agency (DARPA) confirming that the agency was investigating Moderna for failure to report government funding in patent applications. The Financial Times and other outlets had… Continue Reading
KEI asks DOD to investigate failure to disclose DARPA funding in Moderna patents
(More on Moderna here: https://www.keionline.org/moderna) Luis Gil Abinader has taken a deep dive into Moderna’s surprising practice of never declaring government funding in its 126 patents and 154 patent applications, despite having had funding from multiple federal agencies. One outcome… Continue Reading
2020:3 KEI Research Note: Moderna failures to disclose DARPA funding in patented inventions
KEI receives seven new contracts for COVID 19 research from BARDA and DOD, including five using “Other Transactions Authority” that weaken or eliminate Bayh-Dole and FAR Safeguards
KEI has a number of outstanding requests under the United States Freedom of Information Act (FOIA) for contracts related to biomedical innovations to control or treat the COVID-19 pandemic. On Thursday, June 25, and Friday, June 26, we received a… Continue Reading
KEI Briefing Note 2020:2 The Federal Government’s Authority to Restrict or Eliminate Contractors’ Rights to Federally-Funded Inventions in “Exceptional Circumstances”
NIH Response to KEI Letter to Secretary Azar on Bayh-Dole Options for COVID-19-related Inventions
On April 6, 2020, KEI received a response from the National Institutes of Health (NIH) to a letter we sent to DHHS Secretary Alex Azar on March 13, 2020 regarding three areas in Section 202 of the Bayh-Dole Act that… Continue Reading