by Dennis Crouch
In a major decision clarifying the scope of Orange Book patent listings, the Federal Circuit has ruled that device patents must claim at least the active ingredient to be properly listed. Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, No. 24-1936, -- F.4th --, 2024 WL 2923018 (Fed. Cir. Dec. 20, 2024). The court rejected Teva's attempt to list patents covering only inhaler components, explaining that the listing statute requires patents to "claim the drug" - which means they must particularly point out and distinctly claim at least the active pharmaceutical ingredient.
[O]ur analysis of the numerous relevant statutory provisions and the relevant case law leads us to only one conclusion: 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.
The dispute centers on five Teva patents related to components of its ProAir HFA albuterol inhaler - specifically the dose counter and canister features. After Amneal filed an Abbreviated New Drug Application (ANDA) seeking approval for a generic version, Teva sued for patent infringement, triggering an automatic 30-month stay of FDA approval. Amneal counterclaimed seeking delisting of the patents from the Orange Book, arguing they did not properly "claim the drug" as required by 21 U.S.C. ยง 355(b)(1)(A)(viii). The district court granted Amneal's motion for judgment on the pleadings, ordering Teva to delist the patents because they "contain no claim for the active ingredient at issue, albuterol sulfate" but instead "are directed to components of a metered inhaler device." Teva appealed, and the Federal Circuit stayed the delisting order pending its review. However, the appellate panel now affirmed the delisting order.
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