Magistrate Judge Christopher J. Burke recently issued a Report and Recommendation Granting-in-Part defendants Glenmark’s and Teva’s motions to dismiss. GlaxoSmithKline LLC, et al. v. Glenmark Generics Inc., USA, et al., C.A. Nos. 14-877-LPS-CJB, 14-878-LPS-CJB (D. Del. April 22, 2015). The patent in suit relates to carvedilol which belongs to a class of chemical compounds used to treat high blood pressure or hypertension. Id. at 2. Plaintiff received FDA approval of carvedilol also for treatment of chronic heart failure and began marketing and selling it under the brand name COREG®. Teva holds Abbreviated New Drug Application (“ANDA”) for generic carvedilol, and although it originally sought FDA approval for a use for its generic that was not covered by the patent, Teva eventually amended its label to include treatment for chronic heart failure. Id. at 4. Glenmark also holds an ANDA for generic carvedilol, but filed its ANDA with a “Section viii carve out,” excluding the portions of the label relating to the chronic heart failure indication. Id. Plaintiff alleges that Glenmark revised its label to include chronic heart failure, but later switched back to the previous of the label. Id. at 5.
Teva and Glenmark moved to dismiss under Fed. R. Civ. P. 12(b)(6) arguing that Plaintiffs’ claims for inducement and contributory infringement fail to adequately state a claim for a relief. Id. at 7. Judge Burke recommended the Court dismiss without prejudice Plaintiffs’ claims for inducement during the time Defendants’ labels did not contain the chronic heart failure indication. Id. at 8-11. In short, the complaint focused on “what Defendant knew or what they did not do (or, in some cases, what those other Defendants did). But, as the Federal Circuit has recognized, a claim for induced infringement requires more: ‘mere knowledge of possible infringement by others does not amount to inducement; specific intent and action to induce infringement must be proven.'” Id. at 9 (emphases in original) (quoting Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003). Judge Burke recommended the Court deny the motions as to inducement during the time the chronic heart failure indication was on the labels, and as to contributory infringement. Id. at 11-20.
UPDATE: On August 10, 2015, Chief Judge Stark overruled objections and adopted Judge Burke’s Report and Recommendation.