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THE RETURN OF THE PLAGUE: INEQUITABLE CONDUCT AFTER REGENERON V. MERUS
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Journal Article
THE RETURN OF THE PLAGUE: INEQUITABLE CONDUCT AFTER REGENERON V. MERUS
2018
Overview
In July 2017, the Federal Circuit decided Regeneron Pharmaceuticals Inc. v. Merus, where a split panel upheld the district court's decision to infer prosecution misconduct by Regeneron based on its subsequent litigation misconduct during the patent case, thus holding its patent unenforceable based on the doctrine of inequitable conduct. The decision raises new questions regarding the relevance of litigation misconduct to the unenforceability of a patent, which has traditionally been determined based upon evidence of misconduct before the U.S. Patent and Trademark Office (i.e., pre-litigation misconduct). The Regeneron decision also raises new questions regarding the standard of proof needed to establish inequitable conduct as a defense to patent infringement. In 2011, the Federal Circuit raised the bar for proving inequitable conduct in Therasense, Inc. v. Becton, Dickinson & Co., where an en banc panel held that clear and convincing evidence was needed to prove intent to deceive the USPTO, and that intent to deceive cannot be inferred by proving other elements of the defense. Prior to Therasense, claims of inequitable conduct were once so prevalent that the court wrote that the defense had \"become an absolute plague\" on patent litigation. By indicating that it is willing to consider litigation misconduct to infer a finding of inequitable conduct, the Federal Circuit appears to have expanded the scope of the doctrine, which may encourage defendants to raise inequitable conduct as a defense. If subsequent cases follow this expanded theory, the consequences could be far-reaching, exposing patent holders to a new wave of inequitable conduct charges. This Article examines the effect of Regeneron on the inequitable conduct defense and further discusses considerations for practitioners in light of the Federal Circuit's opinion in Regeneron.
Publisher
Santa Clara University
Subject
