2025 Federal Circuit IP Appeals: Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of New York, LLC, 124 F.4th 898 (Fed. Cir. 2024) (Prost, Taranto, Hughes)

Amneal applied for U.S. Food and Drug Administration (FDA) approval to market a generic version of Teva’s ProAir HFA drug — a combination product of albuterol sulfate (the active ingredient), a propellant, ethanol, and an inhaler. Teva sued Amneal for infringement under the Hatch-Waxman Act. Amneal counterclaimed, alleging that Teva had improperly listed certain patents in the FDA’s Orange Book.

By way of background, the Orange Book is an FDA publication where brand-name drug manufacturers can list patents that, according to the brand, cover a particular branded drug. To qualify for listing, the patent must, as relevant here, “claim the drug for which the applicant submitted the application.” When a generic drug company applies for approval to market a generic version of the branded drug, it must make one of four certifications with respect to the listed patents. As relevant here, if a listed patent has not yet expired and the generic company wishes to market its product before expiration, it must submit a “paragraph IV” certification stating that the patent is invalid or will not be infringed by the generic company’s drug product. The brand company may then initiate litigation under the Hatch-Waxman Act. If the brand company does so, the FDA will not finally approve the generic company’s application for at least 30 months.

The FDA does not substantively review patent information for accuracy before publishing it in the Orange Book. So, if a brand company improperly lists a patent, the generic company has no recourse with the agency. However, if the brand sues the generic applicant, the generic can file a “delisting” counterclaim on the ground that the patent listed in the Orange Book “does not claim … the drug for which the application was approved.”

In this case, Teva had nine nonexpired patents listed in the Orange Book for its ProAir HFA product. Five of those patents were directed to dose counters, which tell the user of the inhaler product how many doses remain in the inhaler’s canister. Amneal moved the district court to order Teva to delist those patents from the Orange Book because they “contain[ed] no claim for the active ingredient at issue, albuterol sulfate,” and were instead “directed to components of a metered inhaler device.” In other words, they did not “claim the drug for which the applicant submitted the application.” The district court agreed with Amneal, and Teva appealed.

The Federal Circuit affirmed, finding that Teva’s inhaler-device patents did not “claim the drug for which the applicant submitted the application” because they did not claim the active ingredient. The court rejected Teva’s three contrary arguments.

First, the court rejected Teva’s argument that a patent’s claim scope “is effectively coterminous with the products that infringe a patent.” In finding that argument “defective,” the court explained that the Hatch-Waxman Act’s “listing” provision “identifies infringing and claiming as two distinct requirements.” Under the statute, the court explained, a patent may be listed in the Orange Book only if it “claim[s] the drug” and would “be infringed by the NDA product.” The court further relied on distinctions in the Patent Act and Federal Circuit case law between a claim — which “particularly point[s] out and distinctly claim[s] the subject matter” of the invention — and infringement, which “occurs when others make, use, or sell the invention without authorization.”

Second, the court rejected Teva’s argument that its patents were listable so long as they claimed any part of Teva’s inhaler product. This argument synthesized two definitions of “drug” in the applicable statute to mean “any part of something used to treat a disease,” including device parts. While the court saw “some superficial appeal” in that argument, it found that when viewing the statute as a whole and “looking at how the FDA approves the many different medical products it regulates, it is apparent that a product regulatable and approvable as a drug contains an active ingredient.” The court contrasted the regulatory approval pathways for drugs and devices and noted that the “touchstone of the distinction between drugs and devices is that the former are ‘composed of complex chemical compounds or biological substances’ and the latter are ‘characterized more by their purely mechanical nature.’” Thus, to claim a drug, a patent must claim at least the active ingredient.

Finally, the court rejected Teva’s argument that the patents do in fact claim the active ingredient. For purposes of its analysis, the court assumed that the claims require the presence of “an active drug.” But that broad construction, the court said, allows “the presence of any active ingredient in any form.” Since, even under that construction, the patents did not “particularly point out and distinctly claim what was approved—the ProAir® HFA with albuterol sulfate as the active ingredient” — the patents were not eligible for listing in the Orange Book.

Related: 

Jazz Pharm., Inc. v. Avadel CNS Pharm., LLC, 136 F.4th 1075 (Fed. Cir. 2025) (reversing injunction prohibiting generic manufacturer from initiating new clinical trials for drug because that activity was permitted under the safe harbor of 35 U.S.C. § 271(e)(2), and remanding to district court to consider, in the first instance, whether submitting an ANDA or “paper NDA” for a drug claimed in any patent — as opposed to only patents listed in the Orange Book — is an act of infringement under 35 U.S.C. § 271(e)(2)).

This article appeared in the 2025 Federal Circuit IP Appeals: Summaries of Key 2025 Decisions report.