Making Therasense of the Inequitable Conduct Doctrine


In a split in its decision (6-1-4), the Federal Circuit’s May 25, 2011 en banc opinion in Therasense, Inc. v. Becton, Dickinson and Co. attempts to unify the patch work of opinions on inequitable conduct, which is a judicially-created doctrine rooted in the U.S. Supreme Court’s cases on the doctrine of "unclean hands" where egregious conduct had occurred.1 (Full decision). The Federal Circuit emphasized that the previous assertions of the inequitable conduct doctrine based on its precedent have "plagued not only the courts but also the entire patent system."2

The majority opinion of the Federal Circuit in Therasense tries to balance the importance of patent applicants being honest in dealings with the United States Patent Office ("Patent Office") with the appropriate standard of review in determining whether inequitable conduct has actually occurred. As the Federal Circuit explained, the "low standards for intent and materiality" created by its previous opinions "have inadvertently led to many unintended consequences" including "increased adjudication cost and complexity, reduced likelihood of settlement, burdened courts, strained PTO resources, increased PTO backlog, and impaired patent quality[.]" Therefore, the Federal Circuit finally intervened to tighten the standard and redirect the application of the inequitable conduct doctrine to benefit the public and the patent system by protecting against “egregious misconduct, including perjury, the manufacture of false evidence, and the suppression of evidence."3

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