In an en banc decision, Therasense, Inc. v. Becton, Dickinson & Co., Nos. 08-1511, -1512, -1513, -1514, -1595 (Fed. Cir. May 25, 2011), the United States Court of Appeals for the Federal Circuit has tightened the standards for both prongs of the inequitable conduct defense—materiality and intent to deceive—and, in doing so, rejected the “sliding scale” approach to materiality and intent.  As a result, both elements must be established independently of each other.  Moreover, the specific intent to deceive must be “the single most reasonable inference able to be drawn from the evidence,” and materiality is to be analyzed under a “but-for” standard.  In light of the Federal Circuit’s decision, inequitable conduct becomes more difficult to establish, with potentially significant consequences for both litigation [1] and patent prosecution.[2]

Recognizing “the problems created by the expansion and overuse of the inequitable conduct doctrine,” the Court reiterated the basic elements of an inequitable conduct defense—misrepresentation or omission of material information with the specific intent to deceive the U.S. Patent and Trademark Office (“PTO”), both of which must be proved by clear and convincing evidence—noting that the standards for intent to deceive and materiality have fluctuated over time. The Court identified its previous low standards for meeting the intent requirement (gross negligence or even negligence) and its earlier broad view of materiality (using a “reasonable examiner” standard based on the PTO’s 1977 amendment to 37 C.F.R. § 1.56). The Court referred to “[f]urther weakening the showing needed to establish inequitable conduct” when it placed intent and materiality together on a “sliding scale.” Per the Court, this change conflated, and diluted, the standards for both intent and materiality.

To read further, please click here.

______________________________________

[1]             The additional step in an inequitable conduct analysis—weighing the equities to determine whether the applicant’s conduct before the U.S. Patent and Trademark Office (“PTO”) warrants rendering the entire patent unenforceable—was not addressed by the Federal Circuit; nonetheless, it remains part of a district court’s analysis.