March 2, 2018

Case Name: Celgene Corp. v. Hetero Labs Ltd., 17-3387 (ES) (MAH), 2018 U.S. Dist. LEXIS 34025 (D.N.J. Mar. 2, 2018) (Salas, J.) 

Drug Product and Patents-in-Suit: Pomalyst® (pomalidomide capsules); U.S. Patents Nos. 8,198,262 (“the ’262 patent”), 8,673,939 (“the ’939 patent”), 8,735,428 (“the ’428 patent”), and 8,828,427 (“the ’427 patent”)

Nature of the Case and Issue(s) Presented: Defendants Mylan Pharmaceuticals, Inc., Mylan, Inc., and Mylan N.V. (together “Mylan”) moved to dismiss Plaintiff Celgene’s complaint for improper venue, lack of subject matter, and failure to state a claim. The court denied Mylan’s motion but opened limited discovery for venue related purposes.

Why Celgene Prevailed: The court first determined that, despite a split in how courts attribute the burden of proof in motions to dismiss for improper venue, Mylan, the party opposing venue, bore the burden of proof. Further, based on Mylan’s declarations, the court found sufficient evidence to demonstrate that Mylan did not reside in the District of New Jersey. But the court also found that Mylan had not met its burden of proving that it did not commit acts of infringement in the district. Mylan argued that it, by definition, had not committed an act of infringement, as Hatch-Waxman litigation contemplates acts of future, not past, infringement. The court disagreed, concluding that acts of infringement, in the Hatch-Waxman context, includes acts that the ANDA applicant non-speculatively intends to take if its ANDA is approved. Thus, Mylan had allegedly committed acts of infringement in the district. Finally, the court concluded that it did not have enough information to determine whether Mylan had a regular and established place of business in New Jersey. Accordingly, the court ruled that Celgene should be allowed to take limited venue-related discovery for the purpose of making this showing.

Because the court permitted venue-related discovery, it determined that the arguments that Celgene failed to state a claim upon which relief could be granted was moot for the time being. For this reason, the court denied the failure-to-state-a-claim portion of Mylan’s motion, but did so without prejudice so that Mylan could raise the issue again after discovery. Similarly, the court also denied Mylan’s motion to dismiss for lack of subject-matter jurisdiction, but did so without prejudice so that Mylan could raise the issue at a later date.