The U.S. Court of Appeals for the Federal Circuit has long been concerned with the implications of inequitable conduct. As early as 1984, the court stated that “inequitable conduct has been overplayed, is appearing in nearly every patent suit, and is cluttering up the system.”1 The charge of inequitable conduct has been described as “an absolute plague.”2 A combination of expansion of discovery along with the severe consequences that come with a successful charge of inequitable conduct have turned it into a significant litigation strategy. Since a finding of inequitable conduct regarding any claim of a patent renders the entire patent unenforceable, it is unsurprising that at least one study has estimated that 80 percent of patent infringement suits contain an inequitable conduct allegation.3 Additionally, patentees are so worried about the possibility of inequitable conduct that they have deluged the U.S. Patent and Trademark Office (PTO) with prior art references, many of them trivial or useless, in an effort to cover their bases.

Attempting to rein in these abuses, the Federal Circuit granted en banc review in Therasense Inc. v. Becton Dickinson & Co. to address the standards of inequitable conduct. The majority opinion, by Chief Judge Randall Rader, and joined by Judges Pauline Newman, Alan Lourie, Richard Linn, Kimberly Moore, and Jimmie Reyna, has tightened the standards for both the intent and materiality prongs of the inequitable conduct test.

The Facts of ‘Therasense’

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