ProAir® HFA (albuterol sulfate)
Case Name: Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S., Civ. No. 24-4404 (SRC), 2024 WL 3966314 (D.N.J. Aug. 28, 2024) (Chesler, J.)
Drug Product and Patent(s)-in-Suit: ProAir® HFA (albuterol sulfate); U.S. Patents Nos. 8,132,712 (“the ’712 patent”), 9,463,289 (“the ’289 patent”), 9,808,587 (“the ’587 patent”), 10,022,509 (“the ’509 patent”), 10,022,510 (“the ’510 patent”), 10,086,156 (“the ’156 patent”), 10,561,808 (“the ’808 patent”), 10,695,512 (“the ’512 patent”), 11,395,889 (“the ’889 patent”)
Nature of the Case and Issue(s) Presented: Teva holds the NDA for ProAir® HFA and Deva filed an ANDA seeking FDA approval to market a generic version. Teva listed the nine patents-in-suit in the FDA’s Orange Book. Teva sued Deva alleging infringement of the patents-in-suit. Teva’s complaint asserts two counts of patent infringement for each of the nine patents, one for infringement under 35 U.S.C. § 271(e)(2), and one for declaratory judgment of infringement based on the expected future marketing of Deva’s ANDA product. Deva moved to dismiss the complaint for lack of subject matter jurisdiction, based on two arguments: (i) none of the nine patents claims a drug, therefore no act of infringement has taken place under 35 U.S.C. § 271(e); and (ii) the complaint does not allege sufficient immediacy to trigger declaratory judgment jurisdiction. The motion was denied-in-part and its decision was reserved-in-part.
Why Teva Prevailed: As to the declaratory judgment claims, Deva argues that the complaint alleged “no more than a vague possibility that, at some unknown future point in time, the FDA may approve Deva’s ANDA and Deva may begin to market an infringing product.” Those allegations fail to meet the immediacy standard necessary for declaratory judgment jurisdiction set forth in Federal Circuit, specifically Glaxo Inc. v. Novopharm Ltd., 110 F.3d 1562 (Fed. Cir. 1997). Teva responded by arguing that the complaint established two required elements: Deva had made meaningful preparation for infringing activity by filing its ANDA; and the facts pled made plausible the inference that Deva refused to change the course of its actions in the face of litigation. The court found that the complaint alleges “sufficient facts to support the finding that there is a definite and concrete infringement dispute between parties with adverse legal interests, which is real and substantial, and which could be resolved by the issuance of a declaratory judgment.” While there may not be a formula for determining whether the controversy alleged has sufficient immediacy to warrant the issuance of a declaratory judgment, “the Supreme Court directed district courts to consider the usefulness of the declaratory judgment remedy and the fitness of the case for resolution, when deciding to exercise discretion to declare the rights of litigants.” This consideration was adopted in Federal Circuit jurisprudence. Given no indication from Deva that, upon FDA approval, it would not proceed to market, there is more than sufficient allegations to demonstrate that an actual controversy subject to judicial resolution exists between the parties.
As to the 35 U.S.C. § 271(e)(2) allegations, Deva argued that in view of another case, Teva v. Amneal, where the court decided that the same patents did not claim drugs and were improperly listed in the Orange Book, no subject matter jurisdiction could exist. That case is on appeal and Teva asked, and the court agreed, to wait until the Federal Circuit has decided the pending appeal in that case.
