Pleading Standards For Inequitable Conduct - Did Therasense Change The Rules?

In its recent Therasense opinion, the Federal Circuit "tightened the standards for finding both intent and materiality in order to redirect a doctrine that has been overused to the detriment of the public," because "the inequitable conduct doctrine has plagued not only the courts but the entire patent system." Therasense, Inc. v. Becton-Dickinson & Co., 649 F.3d 1276, 1289-90 (Fed. Cir. 2011) (en banc). This tightened standard severed the "sliding-scale" link between intent and materiality – intent to deceive cannot be inferred from materiality alone – established that "but-for" materiality is generally required, and clarified that clear and convincing evidence of deceptive intent means that a specific intent to deceive the PTO must be "the single most reasonable inference able to be drawn from the evidence." Id. at 1290-91. The Therasense opinion altered the substantive elements of inequitable conduct, and has also led to a flurry of challenges to inequitable conduct defenses and counterclaims at the pleading stage. A number of recent opinions have discussed whether and how Therasense changed the standards for pleading, not just proving, inequitable conduct.

Under Federal...