Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC

Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, Civ. No. 23-20964 (SRC), 2024 WL 2923018 (D.N.J. June 10, 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”), 10,561,808 (“the ’808 patent”), and 11,395,889 (“the ’889 patent”)

Nature of the Case and Issue(s) Presented: Teva holds the NDA for ProAir HFA Inhalation Aerosol and listed the patents-in-suit in the FDA’s Orange Book as covering that product. Amneal filed an ANDA, containing a paragraph IV certification to the patents-in-suit, seeking to make and sell generic albuterol sulfate inhalation aerosol. Teva filed suit and Amneal’s Amended Answer alleged counterclaims for delisting the patents-in-suit from the Orange Book and for violations of U.S. antitrust laws. Teva brought a motion to dismiss all the counterclaims and Amneal cross-moved for judgment on the pleadings with respect to its delisting counterclaims. The court denied Teva’s motion and granted Amneal’s motion.

Why Amneal Prevailed: The delisting counterclaims. The Listing Statute authorizes the listing of three types of patents: drug substance patents, drug product patents, and method of use patents. Teva argued that the patents-in-suit were properly listed, drug product patents. Drug product patents have two requirements: (i) the patent must claim the drug for which the applicant submitted the application; and (ii) the patent must be directed to a drug substance or a drug product. The court found that the issue presented in this case centered on the interpretation of the first element and concluded that the patents-in-suit did not claim the drug for which Teva sought approval.

The patents-in-suit do not claim the active ingredient, albuterol sulfate. Teva responds that its NDA approval letter from the FDA references its drug as albuterol sulfate HFA Inhalation Aerosol. Therefore, according to the FDA, the drug for which the applicant submitted its NDA is “albuterol sulfate HFA Inhalation Aerosol.” The court did not find this argument compelling. The patents-in-suit claim components of a metered inhaler device, and do not claim or even mention albuterol sulfate or the ProAir HFA. While the court agreed with Teva that the term “drug” is defined by the statute broadly, “this determination does not suffice to establish that the Inhaler Patents claim the drug for which the applicant submitted the application.” The drug for which the applicant submitted the application is “albuterol sulfate HFA Inhalation Aerosol.”

Teva also argued that the patents-in-suit have been listed in the Orange Book as “drug product” patents. “Drug product is a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.” 21 C.F.R. § 314.3(b). The patents-in-suit do not claim the “finished dosage form” that is the subject of Teva’s NDA. While patents claiming devices or containers that are integral to the drug product or require prior FDA approval may be listed in the Orange Book, devices such as metered dose inhalers and transdermal patches, which are drug delivery systems used and approved in combination with a drug, do not meet those criteria.

The antitrust counterclaims. Teva argued that because its patents were properly listed in the Orange Book, any antitrust claim based on purported improper listing necessarily fails. Because the court concluded that Teva’s patents were not properly listed in the Orange Book as a matter of law, Teva’s argument does not support dismissal based on Rule 12. Next, Teva argued that even were the court to find that the listings were improper, given the Trinko doctrine, “antitrust law does not create a cognizable claim for Amneal based on purported improper listing in any event.” The court did not find the Supreme Court’s Trinko case to be analogous to the application of the Hatch Waxman Act in the instant case. The key attribute of the statutory provision at issue in Trinko was that it imposed the obligation to share its telephone network with competitors. The Listing Statute, in this case, does not impose any analogous obligation on the holder of an NDA; rather, the Listing Statute says nothing about competitors or other drug companies and speaks only about certain information that must be submitted to the FDA. In FTC’s amicus brief, relied on by the court, it stated, “Trinko is inapplicable because Amneal’s counterclaims are not an expansion of antitrust law, the FDA does not directly police the Orange Book, and the statutory amendment to add a delisting counterclaim does not transform a patent enforcement framework into an antitrust regulatory scheme.”

Teva also argued that Amneal’s counterclaim for sham litigation in violation of the Sherman Act fails to state a valid claim because it is unlikely to succeed at trial or summary judgment. As the Supreme Court stated in Twombly, “of course, a well-pleaded complaint may proceed even if it strikes a savvy judge that actual proof of those facts is improbable, and that a recovery is very remote and unlikely.”