Litigation is stayed pending appeal
Cephalon, Inc. and CIMA Labs, Inc. v. Sandoz Inc., Civ. No. 10-123-SLR, May 5, 2011. (amends 4/25/11 opinion)
Robinson, J. The Court granted plaintiff’s motion to stay litigation during the Federal Circuit appeal of the validity of the underlying patents.
This is a Hatch-Waxman litigation concerning fentanyl buccal tablets for the treatment of cancer pain. The defendant is the second generic filer with an unapproved ANDA FDA application. In an earlier litigation between plaintiff and the first generic filer, the Court found the underlying patents invalid for lack of enablement. That invalidity issue is pending before the Federal Circuit. Plaintiff moved the Court in the instant case to stay litigation pending the Federal Circuit’s review. The Court granted the motion. The Court reasoned that the Federal Circuit’s decision would simplify the issues for trial, and might obviate the need for a trial if the Court’s invalidity finding is upheld. The Court reasoned further, inter alia, that without an approved ANDA the defendant would suffer no prejudice because it could not enter the market.
