We have several pages related specifically to the U.S. Bayh-Dole Act here.
KEI efforts to address pricing and other public interest issues in more than 30 different NIH licensing cases, involving both patents and data rights, are here: http://keionline.org/nih-licenses
KEI lawsuit against the NIH related to the license of CD30 CAR T patents to Gilead: https://www.keionline.org/kei-v-nih
Our work on the Sanofi/Army Zika vaccine license is here. https://keionline.org/zika-army
Our work on licensing cases from other U.S. Government agencies is here: https://www.keionline.org/other-USG-licenses
KEI efforts related to the failures to disclose Bayh-Dole rights: https://www.keionline.org/bayh-dole/failure-to-disclose
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: https://keionline.org/xtandi
The work on government funded CRISPR inventions is here: http://keionline.org/crispr
The Fabrazyme patent disputes are here: https://keionline.org/fabry
The 2004 and 2012 ritonavir cases are here: https://keionline.org/ritonavir
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 Wisconsin June 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
- Federal Executive Orders relating to Federally-funded Inventions