Clarity: A First Look at Therasense, Inc. v. Beckton Dickinson and Co.


The U.S. Court of Appeals for the Federal Circuit has called rampant allegations of inequitable conduct an "absolute plague." When successful, an allegation of inequitable conduct can unleash the "atomic bomb" of patent law. Specifically, a finding of inequitable conduct can render an entire patent unenforceable and create additional collateral damage. Applicants and prosecuting attorneys often feel compelled to engage in counterproductive activities to buttress against inequitable conduct allegations. These activities may include swamping the U.S. Patent and Trademark Office ("PTO") with marginally relevant or irrelevant prior art.

In Therasense, Inc. v. Beckton Dickson and Co. ("Therasense"), sitting en banc the U.S. Court of Appeals for the Federal Circuit addresses the difficult issue of inequitable conduct. In the opinion, the Federal Circuit "tightens" its standards for establishing the intent and materiality necessary for a finding of inequitable conduct. Importantly, the court outlines a new "but-for" test for determining materiality. By recalibrating the inequitable conduct standard, the Federal Circuit clarifies the expectations for attorneys and applicants and raises the bar for establishing this equitable defense.

This paper reviews the Federal Circuit's Therasense decision and discusses questions raised by the decision. These questions include the practical impact of Therasense on prosecuting attorneys, inventors, and anyone else owing a duty of candor to the PTO.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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