• Pleading Standards for Inequitable Conduct Claims: Motions for Leave to Amend and Motions to Dismiss after Therasense, Inc. v. Becton, Dickinson & Co.
  • October 14, 2013
  • Law Firm: Young Conaway Stargatt Taylor LLP - Wilmington Office
  • Several decisions from judges in the District of Delaware have addressed the pleading standard for inequitable conduct in the years following Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 127 (Fed. Cir. 2011). For example, in a report and recommendation authored by Magistrate Judge Burke and adopted by Judge Stark,the Court held that an assertion of inequitable conduct must be plead with “facts allowing for the reasonable inference of ‘but-for’ materiality.” Wyeth Holdings Corp. v. Sandoz, Inc., C.A. No. 09-955-LPS-CJB, 2012 U.S. Dist. LEXIS 26912, *18- 19 n.6 (D. Del. Feb. 3, 2012). Materiality must then be plead with particularity, including “the specific who, what, when, where, and how of the material misrepresentation or omission,” as required by Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1328 (Fed. Cir. 2009). As Magistrate Judge Burke explained, the “single most reasonable inference” language from Therasense set forth the “evidentiary standard that must be satisfied at the proof stage, not a pleading standard.” Wyeth, 2012 U.S. Dist. LEXIS 26912, *22. At the pleading stage, the requirements of Exergen apply, and parties bringing inequitable conduct claims need only set forth sufficient facts to satisfy two prongs: (1) “but-for” materiality and (2) specific intent to deceive. This Trend Watch provides summaries of post-Therasense decisions from the District of Delaware that applied the pleading standard in the context of motions for leave to amend and motions to dismiss. Addressing first the cases in which inequitable conduct claims were allowed to proceed, we further address those cases in which inequitable conduct claims were not allowed.