March-in and Royalty Free cases under Bayh-Dole

Bayh-Dole cases involving royalty free or march-in rights


Cellpro case

Ventana Medical Systems, Inc (later a division of Roche Diagnostics) petitioned the U.S. Department of Energy to use the government’s rights in University of California patents and the exclusive licensed, Vysis. The relevant patent was “841 patent” related to blocking DNA which is used in most in-situ hybridization (ISH) assays to chromosomal DNA. The technology used to identify gene sequences was developed entirely at the Energy Department Laboratory and transferred to the University of California. An exclusive license was granted to Vysis, a subsidiary of Abbott laboratories that makes genetic tests for cancer, prenatal disorders, microarrays, and other equipment used by medical and biotechnology researchers. The parties settle the dispute, after a 30-month fact-finding process determination with DOE, with the Ventana/Roche obtaining a license.


DHHS used its authority to exercise March-In rights for 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. September 5, 2001, “National Institutes of Health and WiCell Research Institute, Inc., Stem Cell Research Agreement,” . Memorandum of Understanding between WiCell Research Institute, Inc. and Public Health Service.


Ritonavir case

2004, Latanoprost (Xalatan) case

Centers for Disease Control threatened to use March-In rights to issue compulsory licenses on patents on reverse genetics, which are needed to manufacture vaccines for avian flu.


Essential Inventions requested Robert Portman, Director of the Office of Management and Budget, to take steps to develop and accept alternative competitive sources of supply for federal procurement of two HIV-AIDS medicines: stavudine/d4T and ritonavir. Due to public funding for the development of both drugs, the US government has a royalty free, nonexclusive, worldwide statutory license to the patents for each product. On March 1, 2007, Essential Inventions met with OMB officials, and extended the proposal to include the AIDS drug emtricitabine (Emtriva).

Fabrazyme case




Additional links

KEI Briefing Note 2017:1. Bayh-Dole Act and difference between March-In Rights and the world wide royalty free rights in patents

Feb. 24, 2017 Compulsory Licensing Workshop – Panel Discussion, Bayh-Dole Act