ProAir® HFA (albuterol sulfate)
Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, No. 2024-1936, 2024 WL 5176737 (Fed. Cir. Dec. 20, 2024) (Circuit Judges Prost, Taranto, and Hughes presiding; Opinion by Prost, J.) (Appeal from D.N.J., 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: ProAir HFA was approved by FDA in 2004 “for the treatment or prevention of bronchospasm with reversible obstructive airway disease in adults and children 12 years of age or older.” ProAir HFA combines albuterol sulfate (the active ingredient) with a propellant, ethanol, and an inhaler device to administer the drug. FDA approved ProAir HFA as a drug because the primary mode of therapeutic action comes from albuterol sulfate. Teva listed nine patents in FDA’s Orange Book as covering ProAir HFA. The five patents-in-suit claim a dose counter, which lets the patient know how many doses remain in the inhaler’s canister, or components thereof.
Amneal filed an ANDA seeking approval to make and sell a generic version of Teva’s drug that contained paragraph IV certifications against all nine Orange Book-listed patents. Teva sued Amneal alleging patent infringement and subsequently amended its complaint to sue for infringement of only the five patents-in-suit. Amneal filed antitrust counterclaims, among others, seeking an order requiring Teva to delist the five patents that it asserted against Amneal. Teva moved to dismiss Amneal’s delisting counterclaims and Amneal cross-moved for a motion for judgment on the pleadings on the ground that Teva improperly listed the asserted patents. The district court denied Teva's motion, granted Amneal's motion, and ordered Teva to delist the five asserted patents. Teva appealed the district court’s interlocutory delisting order, and the Federal Circuit affirmed.
Why Amneal Prevailed: The Federal Circuit summarized Teva’s argument on appeal as follows:
ProAir HFA metered-dose inhaler, the approved NDA product in this case, has various features including an active ingredient, a dose counter, and a canister (which Amneal does not dispute). Teva’s patents at issue here have claims to the dose-counter and canister parts of a metered-dose inhaler. Since Teva’s ProAir HFA has features claimed by these patents—the dose counter and canister—Teva’s argument is that it properly listed its patents in the Orange Book.
Teva relied on the FDCA’s broad definition of the word “drug” to argue that any component of an article that can treat disease meets the statutory definition of a “drug.” The Federal Circuit rejected Teva’ arguments and interpretation of the FDCA as allowing for the listing of far more patents than Congress had indicated. It further rejected Teva’s argument that a patent claiming any component of a drug is listable, finding that “to qualify for listing, a patent must claim at least what made the product approvable as a drug in the first place—its active ingredient.”
Teva conflated the terms “infringe” and “claims.” They are two distinct requirements and accepting Teva’s interpretation would lead to statutory redundancy. “The more natural reading is that, in order to be listed, a patent must both claim the drug and be infringed by the NDA product.” Claims and infringement have different analytical focal points: infringement is assessed by examining a particular thing or series of acts that exists out in the world; and, in contrast, determining what is claimed requires examining the intrinsic meaning of the written patent document, informed by extrinsic evidence about how a skilled artisan would understand the words of the written instrument. Second, one can infringe a patent without literally meeting all of the claim elements, e.g., via the doctrine of equivalents. Third, a product that is infringing can, and often does, contain additional features beyond what the patent claims. Fourth, the adequate written description of Section 112 does not apply to the entirety of an infringing product. Thus, contrary to Teva’s position, what a patent claims and what infringes a claim are distinct concepts.
Next, Teva relied on two definitions for the word “drug” in the FDCA. The first is “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” The second is “articles intended for use as a component of any article specified in clause ... .” Teva therefore argued that the FDCA defines any part of something used to treat a disease as a drug. The Federal Circuit rejected this argument, finding instead that for a patent to claim the drug for which the applicant submitted the application, such a patent must claim at least the active ingredient identified in the application. Drugs and devices have different pathways to market approval. An applicant seeks premarket approval for a drug by submitting an NDA or ANDA. Before 1976, devices did not require premarket approval. Since then, devices have three levels of oversight with different premarket approval requirements, depending on the level of risk associated with using the device. These distinct pathways mean that a product may be regulated as a drug or a device, but not both, and while a single product may simultaneously satisfy the linguistic elements of two definitions of drug and device, it is not possible for the FDA to give simultaneous effect to both. The FDCA uses a specific term for the part of a drug that supplies the chemical action or metabolization that treats disease—the active ingredient. And it is the presence of this active ingredient that makes a product approvable as a drug.
“To list a patent in the Orange Book, that patent must, among other things, claim the drug for which the applicant submitted the application and for which the application was approved. And to claim that drug, the patent must claim at least the active ingredient. Thus, patents claiming just the device components of the product approved in an NDA do not meet the listing requirement of claiming the drug for which the applicant submitted the application.”
