Recently, the U.S. Court of Appeals for the Federal Circuit issued a precedential opinion in Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of New York, LLC, No. 2024-1936 (Dec. 20, 2024), affirming a district court’s delisting order of Teva’s asthma inhaler patents from the Orange Book.
Amneal filed an Abbreviated New Drug Application (ANDA) to market a generic version of Teva’s ProAir® HFA inhaler. In response, Teva sued Amneal for infringement of five patents, triggering a 30-month stay of FDA approval. Amneal counterclaimed seeking an order requiring Teva to delist the five patents, arguing that Teva improperly listed those patents in the Orange Book and delayed entry of generic products. The district court granted Amneal’s motion for judgment on the pleadings, ordering Teva to delist their patents as they “contain no claim for the active ingredient at issue, albuterol sulfate.” Teva appealed.
The Federal Circuit affirmed. Teva argued that the district court erred in interpreting the listing provision in the Orange Book Transparency Act (“OBTA”), which construed the provision to require device patents to claim at least the active pharmaceutical ingredient. Teva contended that the claimed invention must be listed if it “is found in any part of its NDA product,” arguing that the listing was proper because the ProAir® HFA inhaler’s features, specifically the dose counter and canister, were claimed in its patents. The Court rejected Teva’s challenge. The Court interpreted OBTA’s listing provision to require patents to particularly point out and distinctly claim “at least the active ingredient”, reasoning that a patent must claim the component that makes the “product approvable as a drug in the first place—its active ingredient” to qualify for listing. Hence, Teva could not list its patents solely because they claimed the dose counter and canister parts. Also, the Court rejected Teva’s broad interpretation of a “drug”, noting that such interpretation would result in an expansive listing of patents in the Orange Book, far beyond what Congress had intended. Based on these findings, the Court affirmed the delisting order.
