Timeline regarding Bayh-Dole royalty-free requests

For a general timeline of the Bayh-Dole Act, see this page.

1999. September 3. Ralph Nader, James Love, and Robert Weissman requests the NIH Director Harold Varmus, M.D., to use royalty-free rights and give the WHO access to several U.S. government funded medical inventions including ddI, ddC and FddA, d4T, 3TC and ritonavir.

1999. October 21. NIH Director Harold Varmus, M.D., rejected the proposal by Ralph Nader, James Love, and Robert Weissman regarding the use of royalty-free rights to the WHO on several U.S. government funded medical inventions, but welcomed “further discussions with WHO on what can be done to assist developing countries with health care needs.”

2001. September 5. The NIH used its authority to use march-in and royalty-free rights over patents on stem cell lines resulting from publicly funded research and held by the Wisconsin Alumni Foundation (WARF) as leverage to secure an open license on those patents. The NIH press release on this case is available here and the agreement between the NIH and Wicel is available here.

2007. January 5. Essential Inventions requests Robert Portman, Director The Office of Management and Budget, to use royalty-free rights over patents related to stavudine/d4T, an HIV drug marketed by Bristol Myers Squibb under the trade name Zerit; and ritonavir, an HIV drug marketed by Abbott Laboratories under the trade name Norvir.

2012. October 25. AMSA, KEI, PIRG, and UAEM asks the NIH Director Francis Collins to use march-in rights and royalty-free rights over patents related to ritonavir, a HIV drug marketed by Abbott under the brand name Novir.

2013. March 18. The NIH held a conference call with AMSA, KEI, PIRG, and UAEM regarding their October 25, 2012, march-in and royalty free request over patents related to HIV drug ritonavir.

2013. November 1. The NIH Director Francis Collins rejects the ritonavir march-in and royalty-free request filed by AMSA, KEI, PIRG, and UAEM on October 25, 2012.

2016. January 14. KEI and UACT submit a march-in and royalty-free rights request to the HHS Secretary Sylvia Mathews Burwell, DoD Secretary Ashton Carter, and the NIH Director Francis Collins over patents related to enzalutamide, a prostate cancer drug marketed under the brand name Xtandi by the Japanese pharmaceutical company Astellas.

2016. June 20. NIH Director Francis Collins rejects the Xtandi march-in and royalty-free request filed by KEI and UACT on January 14, 2016.

2017. April 29. KEI and UACT appealed the NIH Xtandi march-in and royalty-free decision to the HHS Secretary Tom Price, requesting that the Trump Administration reevaluate the January 14, 2016 request.

2017. June 7. NIH Director Francis Collins rejects the Xtandi march-in and royalty-free appeal filed by KEI and UACT on April 29, 2017, despite an explicit request that the appeal not be fielded by his office.

2017. September 14. KEI submit a march-in and royalty-free request to Andrew Bremberg, an Assistant to the President and the Director of the Domestic Policy Council at the White House, and Keagan Lenihan, a Senior Adviser to HHS Secretary Tom Price, over patents related to daclizumab, a multiple sclerosis drug co-marketed by Biogen and AbbVie by under the brand name Zinbrytra.

2018. March 2. Biogen and Abbvie announced a voluntary withdrawal of Zinbryta from the market, noting concerns about the drug’s evolving benefit/risk profile.