Valeant Pharm. N. Am. LLC v. Mylan Pharm. Inc.

Jublia® (efinaconazole)

November 5, 2020

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Valeant Pharm. N. Am. LLC v. Mylan Pharm. Inc., 978 F.3d 1374 (Fed. Cir. Nov. 5, 2020) (Circuit Judges Newman, O’Malley, and Taranto presiding; Opinion by O’Malley, J.) (Appeal from D.N.J., Sheridan, J.) 

Drug Product and Patent(s)-in-Suit: Jublia® (efinaconazole); N/A

Nature of the Case and Issue(s) Presented: Plaintiffs owned the NDA covering Jublia, a drug that treated fungal infections (onychomycosis) of toenails. Defendant Mylan Pharmaceuticals Inc. (“MPI”) was a West Virginia corporation with a principal place of business in Morgantown, West Virginia. Defendant Mylan Inc. was a Pennsylvania corporation with a principal place of business in Canonsburg, Pennsylvania. Defendant Mylan Laboratories Ltd. (“MLL”) was an Indian corporation with a principal place of business in Hyderabad, India.

In June 2018, MPI sent from its West Virginia office to the FDA, located in Maryland, an ANDA seeking approval to market a generic version of Jublia®. On September 26, 2018, Plaintiffs filed suit against Defendants in the District of New Jersey alleging infringement of its patents throughout the United States and specifically in New Jersey. The following day, Plaintiffs filed an identical suit in the Northern District of West Virginia. Defendants moved to dismiss the New Jersey action for improper venue because, under § 1400(b), no Defendant resided in New Jersey, the only alleged act of infringement—submission of the ANDA—did not occur in New Jersey, and the Defendants did not have regular and established places of business in New Jersey. The district court agreed with Defendants, finding that the ANDA was submitted from West Virginia, rendering venue proper there. Valeant appealed and the Federal Circuit affirmed.

Why Defendants Prevailed: In its opinion, the Federal Circuit held that venue was still, always, proper in the state of incorporation. Moreover, the Federal Circuit also made clear that acts that were protected by the safe-harbor provisions in § 271(e), i.e. formulation development, manufacturing, etc., were non-infringing for all purposes, including venue.

In determining whether past or future acts of infringement gave rise to venue, the Federal Circuit held that “venue in Hatch-Waxman cases must be predicated on past acts of infringement—i.e., acts that occurred before the action alleging infringement was filed. And we hold those acts occur only in districts where actions related to the ANDA submission occur.”

Valeant argued that New Jersey was the proper venue because an ANDA submission is a “nationwide act of infringement.” But the Federal Circuit rejected this argument because no act related to MPI’s or MLL’s ANDA submissions occurred in New Jersey. Moreover, neither MPI or MLL was incorporated or resided in New Jersey. Plaintiffs’ relied on the Acorda case, where the Federal Circuit held that planned future acts were sufficient to justify the exercise of specific personal jurisdiction over a defendant in ANDA cases. But the Federal Circuit distinguished Acorda on the grounds that it did not address proper venue, rather it was “focused on the narrow constitutional question of whether minimum contacts were present for purposes of personal jurisdiction based on the ANDA submission.” As such, Acorda could not be stretched to reach the venue issues in the present matter.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

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