Government Funded Inventions

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We have several pages related to the U.S. Bayh-Dole Act here.

KEI efforts to address pricing and other public interest issues in more than 22 different NIH licensing cases, involving both patents and data rights, are here:

Our work on the Sanofi/Army Zika vaccine license is here.

Xtandi is an Army and NIH funded invention, patented by UCLA. Our work on the efforts to get the Army or the NIH to use their march-in or royalty free license rights to obtain lower prices are collected here:

The work on government funded CRISPR inventions is here:

The Fabrazyme patent disputes are here:

The 2004 and 2012 ritonavir cases are here:

Many of the other disputes and commentary on government funded inventions are listed below.

  • 2012: NIH case: exclusive rights in regulatory test data are absolute, even where there are drug shortages
  • 2011: Survey of drug prices for 14 drugs with US government rights in patents listed in the FDA Orange Book
  • 2013 July 12, Senator Leahy (D-VT) Requests March-In To Ensure Availability of Genetic Testing for BRCA Mutations
  • 2009: CDC FOIA regarding intellectual property on avian flu intellectual property rights
  • 51 members of Congress have asked the NIH to use March-In rights to rein in high drug prices
  • 2016: Did Army do analysis to determine if public is better off with exclusive license to patent?
  • Update on our work on US government owned patents
  • Extending Bayh-Dole March-in rights
  • 2016: KEI comments to NIST on Bayh-Dole Act Regulations
  • Spinraza: KEI asks DHHS Office of the Inspector General (OIG) to investigate a failure to disclose federal funding in patents
  • Apple obtains compulsory license on patents owned by WARF, by District Court Judge in WisconsinJune 8, 2017.
  • Senator Angus King amendment to National Defense Authorization Act (NDAA) on federally funded drugs, vaccines
  • Senate Armed Services Committee directive on use of Bayh-Dole rights for DoD funded drugs
  • House Appropriations rejects Kaptur amendment (allow competition for gov funded drugs if prices higher than reference countries)
  • KEI and Médecins Sans Frontières propose contractual terms to protect access and affordability of Zika vaccine
  • Statutes mentioned in 35 USC 210 of the Bayh-Dole Act
  • Bayh-Dole Timeline