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Better Late than Never: How the U.S. Government Can and Should Use Bayh-Dole March-In Rights to Respond to the Medicines Access Crisis

38 Pages Posted: 7 Mar 2017 Last revised: 24 Mar 2017

Jennifer Penman

Indiana University Robert H. McKinney School of Law

Fran Quigley

Indiana University Robert H. McKinney School of Law

Date Written: March 6, 2017

Abstract

The Bayh-Dole Act of 1980 allowed private patenting of inventions discovered with federally-funded research. Congress balanced that significant benefit to private entities by empowering the government to “march in” and grant a license to another manufacturer when the license holder has not made the invention available to the public on reasonable terms. Bayh-Dole also allows march-in when necessary to alleviate health or safety needs. Remarkably, federal agencies have not once exercised these rights since Bayh-Dole’s passage, even in the face of significant problems with access to medicines discovered with federal funding. This article argues that the current medicines pricing and access crisis, highlighted by the inaccessibility of an effective prostate cancer drug discovered by government funding, calls for the U.S. agencies to finally fulfill the terms of the Act.

Keywords: Bayh-Dole Act, march-in, medicines

Suggested Citation

Penman, Jennifer and Quigley, Fran, Better Late than Never: How the U.S. Government Can and Should Use Bayh-Dole March-In Rights to Respond to the Medicines Access Crisis (March 6, 2017). Available at SSRN: https://ssrn.com/abstract=2928019

Jennifer Penman

Indiana University Robert H. McKinney School of Law ( email )

530 West New York Street
Indianapolis, IN 46202
United States

Fran Quigley (Contact Author)

Indiana University Robert H. McKinney School of Law ( email )

530 West New York Street
Indianapolis, IN 46202
United States

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