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A Panacea for Inequitable Conduct Problems or Kingsdown Version 2.0? The Therasense Decision and a Look into the Future of U.S. Patent Law Reform

Virginia Journal of Law and Technology
Fall 2011

Irving, Thomas L., MacAlpine Ph.D., Jill K.


For an alleged infringer, a judicial finding of inequitable conduct is the legal equivalent of a jackpot at the nickel slot machines in Las Vegas. The inequitable conduct defense was criticized in the recent Federal Circuit en banc decision of Therasense, Inc. v. Becton, Dickinson & Co., and the majority explicitly directed a “tighten[ing] of the standards” for proving inequitable conduct. This article by Finnegan attorneys Thomas Irving, Jill MacAlpine, Deborah Herzfeld, and law clerk Stacy Lewis analyzes the majority’s standards for materiality and intent, as well as the new “affirmative egregious misconduct” exception that may establish materiality per se. It also discusses the post-Therasense Federal Circuit and district court decisions to date; the interface of inequitable conduct and recently enacted U.S. patent law reform legislation; and the USPTO's proposed Rule 56 regulations. In spite of the majority’s valiant efforts in Therasense, inequitable conduct allegations in patent infringement litigation will probably not decline, just as they did not the last time an en banc Federal Circuit “fixed” the inequitable conduct problem in the Kingsdown case. Simply put, it is unlikely that Therasense will be the panacea to the “plague” of inequitable conduct accusations, although it can be hoped that the house will win more often. The article concludes with possible responses for practitioners going forward in a post-Therasense world. To read the complete article, please click here.