Texas A&M Vaccine Manufacturing Contract Shows that cGMP Manufacturing of COVID-19 Vaccines Can Start in Five Months 

A $265 million COVID-19 vaccine manufacturing contract between the Department of Health and Human Services (HHS) and the Texas A&M University System (TAMUS) to manufacture the Novavax and other COVID-19 vaccines demonstrates that a manufacturing facility can be retrofitted to… Continue Reading

$1.3 Billion Johnson & Johnson COVID-19 Vaccine Development Contract Contains Broad Redactions Relating to Public’s Rights in Inventions

On March 31, 2020, KEI received a copy of the contract between Johnson & Johnson (“J&J”) and the Department of Health and Human Services (HHS) for the development of J&J’s COVID-19 vaccine.The contract, which is now valued at $1.3 billion,… Continue Reading

License to NIH Spike Protein Technology Needed in COVID-19 Vaccines Demonstrates “Available to the Public on Reasonable Terms” Requirement

A March 21, 2021 New York Times article on vaccine access discusses how a technology invented and owned by the National Institutes of Health (NIH) is necessary to make several COVID-19 vaccines. The invention mentioned by the Times, titled Prefusion… Continue Reading

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

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

Exclusive License to NIH Invention Used in Lilly Antibody Treatment Contains Termination Clause and Government-Use Rights

KEI has reviewed an exclusive license between the National Institute of Allergy and Infectious Diseases (NIAID) and AbCellera Biologics (“AbCellera”) concerning a technology invented by NIAID that apparently is being used for the Eli Lilly (“Lilly”) antibody treatment for COVID-19… Continue Reading

Novavax and Inovio COVID-19 Vaccine Contracts Limit Prices Companies Can Charge for Their Products

One of the main objections to march-in rights and reasonable pricing clauses is the repeated assertion by NIH leadership that pharmaceutical companies would never agree to a partnership with the federal government that involves price constraints. This argument defies logic… Continue Reading

$1.8 Billion Sanofi Vaccine Contract Contains International Reference Pricing Clause, Preserves Standard IP and Data Rights

The contract awarding Sanofi Pasteur (“Sanofi”) 1.8 billion U.S. taxpayers’ dollars for the development and manufacture of a COVID-19 vaccine was posted in the Department of Health and Human Services (HHS) Electronic Reading Room on November 30, 2020. Overall, the… Continue Reading

$1 Billion Johnson & Johnson COVID-19 Contract Weakens IP and Data Protections for Taxpayers

On November 7, 2020, the Department of Health and Human Services (HHS) posted another COVID-19 vaccine contract: the $1 billion agreement between Janssen Pharmaceutical (a component of Johnson & Johnson (“J&J”)) and the U.S. government (through an intermediary called Advanced… Continue Reading

Regeneron COVID-19 Contract Weakens the Government’s Rights in Data

On November 5, 2020, Regeneron Pharmaceuticals published a redacted version of the contract awarding the company $450 million taxpayers’ dollars for the large-scale manufacture of Regeneron’s investigational COVID-19 antibody treatment. The contract uses Other Transactions Authority to weaken the U.S.… Continue Reading