L. 96-517, December 12, 1980) is United States legislation permitting ownership by contractors of inventions arising from federal government-funded research.

Sponsored by senators, Birch Bayh of Indiana and Bob Dole of Kansas, the Act was adopted in 1980, is codified at 94 Stat.

[9]: 3 These patents had accumulated because after World War II, the government under President Harry S. Truman decided to continue and even ramp up its spending on research and development, on the basis of Vannevar Bush's famous report entitled, "Science The Endless Frontier", which stated: "Scientific progress is one essential key to our security as a nation, to our better health, to more jobs, to a higher standard of living, and to our cultural progress.

[8][12]: 10–14  A report by the Government Accountability Office found that "Those seeking to use government-owned technology found a maze of rules and regulations set out by the agencies in question because there was no uniform federal policy on patents for government-sponsored inventions or on the transfer of technology from the government to the private sector.

[14] By 1978, over seventy universities and research organizations had negotiated an IPA with HEW or with the National Science Foundation.

[15] In the 1970s, faculty at Purdue University in Indiana had made important discoveries under grants from the Department of Energy, which did not issue Institutional Patent Agreements.

[19] The Department of Commerce has delegated to the National Institute of Standards and Technology to promulgate implementing regulations for Bayh–Dole.

Similarly, an invention is not a subject invention if it arises in closely related research outside the "planned and committed activities" of the federally funded project, and the closely related research does not "diminish or distract from the performance" of the federally funded project.

[26] The judges affirmed the common understanding of US Constitutional law that inventors automatically own their inventions, and contractual obligations to assign those rights to third parties are secondary.

Roche, that purchased the startup soon thereafter, introduced the first commercially successful HIV tests, which embodied the PCR technology of the Stanford's patents.

Furthermore, none of the eight policy objectives of the Bayh–Dole Act encourages or condones less stringent application of the patent laws to universities than to other entities.The government's march-in right is one of the most contentious provisions in Bayh–Dole.

It allows the funding agency, on its own initiative or at the request of a third party, to effectively ignore the exclusivity of a patent awarded under the act and grant additional licenses to other "reasonable applicants".

CellPro argued that the march-in provisions were created for this situation, especially because (in its view) availability of essential medical technology was at stake.

The NIH denied this claim[33] citing: In In the Case of NORVIR, the NIH received requests[34] from Essential Inventions in January 2004, and other members of the public and members of the United States Congress,[35] to exercise march-in rights for patents owned by Abbott Labs covering the drug ritonavir, sold under the trade name Norvir, a prescription drug used in the treatment of HIV infection.

[35] The NIH cited: In In the Case of Xalatan the NIH received a request[37] from Essential Inventions in January 2004 to adopt a policy of granting march-in licenses to patents when the patent owner charged significantly higher prices in the United States than they did in other high income countries, on the basis of Pfizer's glaucoma drug being sold in the United States at two to five times the prices in other high income countries.

In 2009, Genzyme rationed the drug to less than a third of the recommended dose as a result of manufacturing problems and FDA sanctions, but did not anticipate being able to meet the market needs until late 2011.

The NIH additionally required regular updates from Mount Sinai School of Medicine, the patent holder, which agreed to not seek injunctions for potentially infringing products being sold during the shortage.

[41] On October 25, 2012, the NIH received a petition on behalf of a coalition of public interest groups to exercise its march-in rights against AbbVie over its antiretroviral drug ritonavir (sold under the name Norvir).

On October 25, 2013, NIH denied the petition[42] stating that, as in 2004 when similar pricing and availability issues regarding the same drug were raised and discussed at public hearings, the NIH'S role in the case was limited to compliance with the Bayh–Dole Act and that "... the extraordinary remedy of march-in is not an appropriate means of controlling prices of drugs broadly available ...".

Several studies tried to understand, what were the effects of the Act on patenting by university researchers and on technology transfer from academia to industry.