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Therasense and the Doctrine of Inequitable Conduct

By Scott R Miller and Manuel Nelson
October 28, 2010

Perhaps signaling an interest in revisiting the doctrine in its entirety, in April 2010, the Federal Circuit asked for briefing on six questions regarding the defense of inequitable conduct (“IC”) to patent infringement. Therasense, Inc. v. Becton, Dickinson & Co., 2010 WL 1655391 (Fed. Cir. Apr. 26, 2010). To date, the court has received more than 30 briefs from more than 100 amici curiae, presenting diverse and interesting proposals for the court's consideration. Oral argument is scheduled for Nov. 9, 2010.

The IC defense finds its roots in a trilogy of older Supreme Court cases including Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806 (1945). Presently, IC requires clear and convincing evidence that a person with a duty of candor owed to the PTO: 1) misrepresented (or failed to disclose) material information with 2) an intent to deceive or mislead. If sufficient materiality and intent are found, the court balances the equities to determine whether the conduct was sufficiently egregious to declare the subject patent(s) unenforceable.

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