Why Don't We Enforce Existing Drug Price Controls? The Unrecognized and Unenforced Reasonable Pricing Requirements Imposed upon Patents Deriving in Whole or in Part from Federally Funded Research

Article by Peter S. Arno and Michael H. Davis

This Article discusses drug pricing in the context of federally funded inventions. It examines the “march-in” provision of the Bayh-Dole Act, a federal statute that governs inventions supported in whole or in part by federal funding. It discusses technology-transfer activity as a whole and the often-conflicting roles of the government, academia, and industry. The Article discusses the mechanisms of the Bayh-Dole Act and examines its legislative history. It notes that the Act has had a powerful price-control clause since its enactment in 1980 that mandates that inventions resulting from federally funded research must be sold at reasonable prices. The Article concludes that the solution to high drug prices does not involve new legislation but already exists in the unused, unenforced march-in provision of the Bayh-Dole Act.


About the Author

Peter S. Arno. Professor of Epidemiology and Social Medicine, Albert Einstein College of Medicine/Montefiore Medical Center. Ph.D., Economics 1984, Graduate Faculty of the New School for Social Research.

Michael H. Davis. Professor of Law, Cleveland State University College of Law; Registered to Practice Before the U.S. Patent & Trademark Office in Patent Matters. J.D. 1975, Hofstra Law School; LL.M 1979, Harvard Law School.

Citation

75 Tul. L. Rev. 631 (2001)