In CIMA Labs Inc. v. Mylan Pharmaceuticals, Inc., C.A. No. 10-625-LPS (D. Del. Apr. 18, 2011), Judge Stark granted the plaintiffs’ motion to stay pending resolution of the PTO’s reexaminations of the patents-in-suit.
The plaintiffs held patents covering orally-disintegrating clozapine tablets in certain dosages. In July 2010, the plaintiffs initiated this Hatch-Waxman patent infringement action against the defendants after the defendants filed an ANDA seeking approval to market a generic orally-disintegrating clozapine product. Id. at 1-2.
Judge Stark noted that “[w]hether or not to stay litigation pending reexamination by the PTO of the patents-in-suit is a matter left to the Court’s discretion” and typically requires an evaluation of three factors: “(1) whether a stay will simplify the issues and trial of the case, (2) whether discovery is complete and a trial date has been set, and (3) whether a stay would unduly prejudice or present a clear tactical disadvantage to the non-moving party.” Id. at 4.
Applying these factors, Judge Stark found that (1) a stay would simplify the issues and trial of the case because, inter alia, all disputed claims “currently stand rejected in the reexaminations[,]” id. at 5-6, (2) no discovery had taken place and no “milestone dates” had been set (“the instant lawsuit is in its infancy”), id. at 6-7, and (3) “a stay would impose no undue prejudice to Mylan sufficient to outweigh the other considerations[,]” id. at 7. On balance, the court found that these factors “tip the interests against proceeding at this time with this litigation.” Id. at 7-8.