Judge Robinson Dismisses Infringement Claims Based on Patents Invalidated in Prior ANDA Litigation Under Doctrine of Collateral Estoppel, Denies Request to Stay Pending Appeal to Fed. Cir.

In Cephalon, Inc., et al. v. Impax Labs., Inc., C.A. No. 11-1152-SLR (D. Del.), Judge Robinson recently granted defendant-generic drug manufacturer’s motion to dismiss infringement claims based on patents asserted by plaintiffs that had previously been invalidated in prior ANDA litigation. Id. at 1. In this case, plaintiffs filed suit against defendant alleging infringement of four patents-in-suit arising out of defendant’s ANDA for a generic version of a drug used to treat pain in cancer patients. Id. at 1. In response to the complaint, defendant moved to dismiss claims for infringement based on two of the patents-in-suit on the grounds that the two patents had been addressed by the Court in previous ANDA litigation, and the Court found both patents invalid for lack of enablement. Id. at 1-2. Specifically, in the motion to dismiss, defendant argued that under the doctrine of collateral estoppel there was no reason to litigate any issues involving the two invalidated patents because “validity was actually litigated in the [prior ANDA] litigation, culminating with a final judgment of invalidity against plaintiffs.” Id. at 2. The Court agreed. Id. at 4. Citing the U.S. Supreme Court’s decision in Blonder-Tongue Laboratories, Inc. v. University of Illinois Foundations, 402 U.S. 313 (1971), the Federal Circuit’s decision in Abbott Labs. v. Andrx Pharma, Inc., 473 F.3d 1196, 1203 (Fed. Cir. 2007), and the Third Circuit’s decision in Jean Alexander Cosmetics, Inc. v. L’Oreal USA, Inc., 458 F.3d 244, 249 (3d Cir. 2006), the Court held that “collateral estoppel applies to bar the re-litigation of the invalid . . . patents.” Id. at 4. In addition to granting defendant’s motion to dismiss, the Court denied plaintiffs’ request to stay the instant litigation pending the Federal Circuit’s review of the Court’s decision in the prior ANDA litigation on appeal. Id. at 5. In denying that request, the Court noted that briefing in the appeal had only recently been completed, and that if the request were granted, the Court could not resolve the present dispute within the 30-month ANDA stay deadline. Id. at 5.


Cephalon, Inc., et al. v. Impax Labs., Inc., C.A. No. 11-1152-SLR (D. Del.)