Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC
Authored by: Jeremy J. Gustrowsky
A recent Federal Circuit decision has big implications for pharmaceutical companies that make combination drug-device products, like inhalers. The court ruled that patents covering only the device components of a drug product—such as dose counters or canisters—cannot be listed in the FDA’s Orange Book unless they specifically claim the drug’s active ingredient. This means that simply having a patent on a part of an inhaler isn’t enough to delay generic competition if that patent doesn’t also cover the medicine itself.
The case centered on Teva’s ProAir® HFA inhaler, which uses albuterol sulfate as its active ingredient. Teva had listed five patents in the Orange Book that covered features of the inhaler device, but none of these patents specifically claimed albuterol sulfate. When Amneal Pharmaceuticals sought to market a generic version using the same active ingredient, Teva’s listed patents triggered a 30-month delay in FDA approval. Amneal challenged this, arguing that the patents should be delisted because they didn’t actually claim the approved drug.
The Federal Circuit agreed with Amneal and ordered Teva to remove its device patents from the Orange Book. The court explained that, under federal law, only patents that “particularly point out and distinctly claim” the drug’s active ingredient or its approved formulation can be listed. Patents that merely cover device components—even if those components are part of the approved product—do not meet this requirement. The court also rejected Teva’s argument that a patent can be listed if the approved product would infringe it, clarifying that “claiming” and “infringing” are not the same thing in patent law.
This decision clarifies that brand-name drug makers cannot use device patents to block generic competition for combination products unless those patents also claim the active drug ingredient. The ruling is likely to speed up the entry of generic inhalers and similar products, benefiting patients and payers by increasing access to lower-cost medicines.