June 2011

Spotlight Info

In Therasense, Inc. v. Becton, Dickinson & Co., Nos. 08-1511, -1512, -1513, -1514, -1595 (Fed. Cir. May 25, 2011) (en banc), the Federal Circuit, sitting en banc, vacated the district court’s finding of unenforceability due to inequitable conduct and announced tightened standards for both the intent and materiality prongs of the inequitable conduct analysis.  The Court outlined the historical divergence of inequitable conduct from the doctrine of unclean hands and the fluctuations of the standards for intent and materiality.  Citing numerous issues of unintended consequences, the majority chose to “now
tighten[] the standards for finding both intent and materiality in order to redirect a doctrine that has been overused to the detriment of the public.”  Slip op. at 24.  First, as to intent, the Court held that an accused infringer must prove by clear and convincing evidence that the patentee acted with the specific intent to deceive the PTO, noting that the gross negligence and “should have known” standards are insufficient. Moreover, the Court dismissed the “sliding scale” to infer intent from materiality, instead holding that the district court should weigh the evidence of intent to deceive independent of its analysis of materiality.   Second, with respect to materiality, the Court held that, as a general matter, the materiality required to establish inequitable conduct is but-for materiality such that the district court must determine whether the PTO would have allowed the claim if it had been aware of the undisclosed reference.  Finally, the Court carved out an exception to the but-for materiality test for affirmative egregious misconduct, such as filing an unmistakably false affidavit.  Accordingly, the Court vacated the district court’s opinion and remanded for proceedings consistent with the new standard for inequitable conduct.  See the full summary in this issue.