Bayh-Dole

Context and history, and areas of current work.

• Bayh-Dole timeline
  • Timeline regarding Bayh-Dole march-in right requests
  • Timeline regarding Bayh-Dole royalty-free requests
  • Bayh-Dole Act confidentiality provisions timeline
• Licensing NIH owned patents and data, including KEI comments on proposed exclusive licenses, 2015 to 2019.
• Licensing by U.S. government agencies, other than NIH
• March-in and royalty-free rights under Bayh-Dole
• Failures to disclose U.S. government rights in patents.
• Reasonable pricing clause
• U.S. Government-Funded Inventions
• Bayh-Dole Act, US Manufacturing Waivers

Some current controversies

• Litigation: KEI v. NIH et al.
• 2019, January 10. KEI Comments Regarding the NIST Special Publication 1234 Draft Green Paper on Return on Public Investment
• 2018, November 30. NIH Director Dr. Francis Collins falsely asserts Bayh-Dole safeguards do not address excessive pricing abuses.
• 2018, March 16. KEI Briefing Note 2018:1. Bayh-Dole Obligations to Disclose Federal Funding in Patented
  Inventions
• 2017. July 21. House Appropriations rejects Kaptur amendment (allow competition for gov funded drugs if prices higher than reference countries)
• 2017, July 17. Senate Armed Services Committee directive on use of Bayh-Dole rights for DoD funded drugs.
• 2017, June 6. KEI asks the Department of Health and Human Services to adopt a policy on licensing CRISPR patents
• 2016, December 17. KEI comments to NIST on Bayh-Dole Act Regulations.
• 2016, September 23. Differences between the march-in, royalty free right, and government use options
• 2016, September 17. NIH Waivers for U.S. Manufacturing Requirements for Federally-Funded Drugs

A few older pages

• 2012, August 24. Birch Bayh’s competing interests and evolving views
• 2009, September 2.Some general notes on the Bayh-Dole Act. (A bit dated now, but still has some useful background.)
• 2001, March 28. Letter to US Secretary of Health and Human Services Tommy Thompson regarding access to NIH funded patents
• 2001, March 28. Letter from Ralph Nader, James Love and Robert Weissman to HHS Secretary Tommy Thompson, regarding WHO right to use NIH funded inventions
• 2001, July 6. Letter from DHHS Secretary Tommy G. Thompson letter to Ralph Nader Regarding WHO rights to use inventions funded by the NIH
• 1999, October 21. Letter from Dr. Varmus rejecting “standardized transfer of manufacturing and distribution rights to the WHO or any other nonprofit organization”
• 1999, September 3. Letter to NIH asking that WHO have right to use NIH funded inventions
• 1980, September 23. Views of Representatives Jack Brooks and Toby Moffett on Bayh-Dole Act, HOUSE REPORT NO. 96-1307 (Part II), SEPT. 23, 1980