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Full-Text Articles in Law
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, Michael Henry Davis, Peter S. Arno
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, Michael Henry Davis, Peter S. Arno
Law Faculty Articles and Essays
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 …
Rare Diseases, Drug Development And Aids: The Impact Of The Orphan Drug Act, Michael Henry Davis, Peter S. Arno, Karen Bonuck
Rare Diseases, Drug Development And Aids: The Impact Of The Orphan Drug Act, Michael Henry Davis, Peter S. Arno, Karen Bonuck
Law Faculty Articles and Essays
In this article, we examine the Orphan Drug Act with an eye toward its contribution to the public interest, using AIDS drugs to illustrate many of the central points. The major policy question is, How, if at all, can the act be used to meet the legislative goal of stimulating drug development for small patient populations without resulting in prices that make drugs inaccessible?