Celgene Corp. v. Mylan Pharms., Inc.

Case Name: Celgene Corp. v. Mylan Pharms., Inc., No. 2021-1154, 2021 WL 5143311 (Fed. Cir. Nov. 5, 2021) (Circuit Judges Prost, Chen, and Hughes presiding; Opinion by Prost, J.) (Appeal from D.N.J., Salas, J.)

Drug Product and Patent(s)-in-Suit: Pomalyst® (pomalidomide); U.S. Patents Nos. 10,093,647 (“the ’647 patent”), 10,093,648 (“the ’648 patent”), and 10,093,649 (“the ’649 patent”)

Nature of the Case and Issue(s) Presented: Celgene filed a patent infringement case in May 2017, and defendants Mylan Pharmaceuticals Inc. (“MPI”) and Mylan N.V. moved to dismiss for improper venue and failure to state a claim. The district court denied the motion without prejudice so that the parties could engage in venue-related discovery. After two years of discovery, the defendants renewed their motion to dismiss. The court granted that motion, finding that Celgene failed to gather facts sufficient to show the presence of affiliated entities and employees in New Jersey. In other words, MPI did not have a “regular and established place of business” in New Jersey. Further, the court concluded that Celgene failed to state a claim upon which relief could be granted for Mylan N.V. In particular, because the complaint sought approval on behalf of MPI only, Celgene’s pleadings with respect to Mylan N.V. were simply too speculative and conclusory. Celgene appealed and the Federal Circuit affirmed the district court’s decision.

Why Mylan Prevailed: The Federal Circuit first addressed whether Defendants committed acts of infringement in New Jersey. For the purposes of the Hatch-Waxman Act, the Federal Circuit explained that “it is the submission of the ANDA, and only the submission, that constitutes an act of infringement.” In other words, the Federal Circuit rejected Celgene’s argument that it should rely on contemplated future acts of infringement that might occur after approval of the ANDA product.

Celgene next argued that infringement for venue purposes included all acts that were sufficiently related to the ANDA submission, including the submission of the paragraph IV notice letter to Celgene’s headquarters in New Jersey. But the Federal Circuit explained that the infringing ANDA submission and the notice letter were different things. Importantly, the ANDA applicant could not send the notice letter until after the FDA had confirmed receipt of the ANDA.

The Federal Circuit next addressed whether Defendants had a regular and established place of business in New Jersey. There was no argument that MPI or Mylan N.V. had any fixed, physical presence in New Jersey. Instead, Celgene argued that venue was proper through (i) places associated with Mylan employees or (ii) places associated with Mylan affiliates.

As to the former, Celgene pointed to a handful of homes of Mylan employees in New Jersey. Mylan presented evidence, though, that it did not require or instruct employees to live in New Jersey, pay for the homes, require employees to store materials in their homes or in New Jersey, or pay for secretarial or support staff to work at the homes. As to the latter argument, Celgene argued that a defunct entity, Mylan Laboratories Inc. (“MLI”) had a physical office in New Jersey. MLI was dissolved in 2017, was a Delaware corporation with an office in New Jersey and, through a chain of ownership, was indirectly wholly owned by MPI. The Federal Circuit found, however, that MLI’s presence could not be imputed to MPI for purposes of venue because there was no evidence demonstrating that MPI abused the corporate form.

The Federal Circuit next turned to the dismissal of Mylan N.V. It was undisputed that Mylan N.V. did not sign or submit the ANDA. The Federal Circuit concluded that Celgene’s allegations were directed to the defendants as a group and that Celgene did not plead facts showing a plausible inference of liability as to Mylan N.V.