Open Access. Powered by Scholars. Published by Universities.®

Law Commons

Open Access. Powered by Scholars. Published by Universities.®

Series

Faculty Scholarship

Duke Law

United States

2012

Food and Drug Law

Articles 1 - 1 of 1

Full-Text Articles in Law

Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai Jan 2012

Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai

Faculty Scholarship

The Hatch-Waxman Act of 1984 aims to strike a balance between the innovation incentives provided by patents and the greater consumer access provided by low-cost generic drugs. The legislation, which relies in part on an explicit link between the FDA drug approval process and the U.S. patent system, has been controversial, particularly because of the ways in which firms producing brand-name drugs have exploited that link to delay market entry of generics as long as possible. Voluminous scholarship has focused on so-called "pay-for-delay" settlements of patent litigation between brand name and generic firms.

In contrast, this Perspective uses the ...