Post- Therasense Inequitable Conduct: a Pharmaceutical Perspective

Abstract

This article explores the policies behind and recent changes to the inequitable conduct defense in US patent law. Recognizing problems with the doctrine, the Federal Circuit clarified and heightened the underlying materiality and intent to deceive standards for inequitable conduct in its landmark Therasense decision in 2011. The doctrine underwent further reform later that year with the enactment of the America Invents Act, which, among other changes, created a supplemental examination mechanism by which a patentee can obtain PTO consideration of previously nondisclosed information and, subject to some limitations, inoculate itself from inequitable conduct challenges relating to the prior nondisclosure. This article discusses the present and future practical impact of these changes on patent litigation involving the pharmaceutical industry.