Only Drugs Allowed: Federal Circuit Affirms Order To Delist Device Patents From the Orange Book

On December 20, 2024, the Federal Circuit affirmed a district court’s holding that five device patents had been improperly listed in the Orange Book by Teva Pharmaceuticals, Inc. as claiming a drug, and ordering that they be delisted.

The FDA’s Orange Book lists patents that a drug manufacturer has identified as claiming its drug and which it may assert when a generic manufacturer files an application for FDA approval of a generic equivalent. For any Orange Book-listed patent, a generic manufacturer may file a “Paragraph IV” certification stating that a brand company’s unexpired patent is either invalid or will not be infringed by its generic equivalent. A Paragraph IV certification typically gives a brand manufacturer the right to immediately sue a generic applicant for patent infringement, which in turn triggers an automatic 30-month stay of the FDA’s approval of the generic application. Orange Book listings therefore play a large role in patent infringement litigation between brand and generic manufacturers and can influence how quickly a generic medication comes to market. The Federal Circuit has noted that the 30-month stay may provide “significant incentives to improperly list patents in the Orange Book as purporting to claim the drug, even if they do not actually claim the drug.”

In the underlying case, Teva sued Amneal for infringing several patents Teva had listed in the Orange Book as claiming ProAir® HFA Inhalation Aerosol, and Amneal filed antitrust counterclaims alleging that Teva had improperly listed the patents at issue in the Orange Book. Specifically, the litigation involved five patents related to device components of the ProAir® HFA inhaler, such as the dose counter. Amneal argued that these patents did not claim albuterol sulfate, the active ingredient in ProAir® HFA. On June 10, 2024, the district court granted Amneal’s motion for judgment on the pleadings and ordered Teva to delist the five patents, on the grounds that the patents did not contain a claim for albuterol sulfate as required by statute. The Federal Circuit agreed to review the decision on an expedited basis.

The Federal Circuit conducted its own statutory analysis, interpreting the Orange Book listing provision (21 U.S.C. § 355(b)(1)(A)(viii)) as a narrow one: “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.” The court rejected an argument that the word “claim” equated to “products that infringe a patent” as inconsistent with the Orange Book statute, which identifies “infringing” and “claiming” as two different requirements. 21 U.S.C. § 355(b)(1)(A)(viii). The more natural interpretation, according to the court, is that a patent must both claim the drug and be infringed by the product. The court also rejected an argument, relying on the Federal Food, Drug, and Cosmetic Act’s (“FDCA”) definition of the word “drug,” that the language “claims the drug” in 21 U.S.C. § 355(b)(1)(A)(viii)(I) extends to any part of the product at issue. The court analyzed how drugs and devices have different regulatory regimes and approval pathways under the FDCA, which shows that a “drug” is a narrower class of medical product. Finally, the court rejected Teva’s request to vacate and remand the case for claim construction. The court noted that no claim in the patent requires the presence of an active drug, and that Teva’s proposed construction does not “particularly point out and distinctly claim what was approved—the ProAir® HFA with albuterol sulfate as the active ingredient.”

The district court’s order had been stayed pending the Federal Circuit’s opinion, and now that the stay is lifted, the opinion will have significant repercussions for both this case and other antitrust and patent cases. The district court’s order was one of the first instances of a court ordering a patent delisting in the context of antitrust claims, and the Federal Circuit’s opinion affirming that order is one of the first appellate court rulings on the issue. Furthermore, as reported in previous Client Alerts, this past year, the FTC has issued a series of warning letters to drug manufacturers about improperly-listed device patents. While the FTC scored early victories with the first round of letters, with some companies delisting patents and others agreeing to cap patient out-of-pocket costs on inhalers, in response to the second round of letters, manufacturers stood firm and refused to delist device patents. The Federal Circuit’s decision may therefore impact future activity from the FTC in this space.