By Memorandum Opinion entered by the The Honorable Sue L. Robinson in Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp., et al., Civil Action No. 14-1268-SLR (D.Del., May 18, 2016), the Court granted Defendants’ motion to dismiss Plaintiff’s first amended complaint pursuant to Federal Rule of Civil Procedure 12(b)(6) after finding that Plaintiff’s claims for indirect infringement failed to state a plausible claim for relief.  In reaching its conclusion, the Court, among other things, found that the Mitigare™ label does not infringe and is not a sufficient catalyst to constitute active steps to encourage direct infringement. Id. at 16-17.  The Court reasoned that (1) like the generic in AstraZeneca Pharmaceuticals LP v. Apotex Corp., 2010 WL 5376310 (D.Del., December 22, 2010) aff’d, 669 F.3d 1370 (Fed. Cir. 2012), Defendant specified that Mitigare™ is for the prevention of gout flares and warned that its drug is not indicated for the treatment of acute gout flares, and (2) allowing Takeda to proceed with its claims would be akin to allowing Takeda to expand the scope of its exclusivity over the treatment of gout with colchicine. Id. at 15.

A copy of the Memorandum Opinion is attached.