Lexology April 30, 2024
In Short
The Situation: On March 22, 2024, the Federal Trade Commission (“FTC”) filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the District of New Jersey (“Teva v. Amneal”), stating that the court should grant Amneal’s motion for judgment on the pleadings to compel Teva to de-list certain patents in the U.S. Food and Drug Administration’s (“FDA”) Orange Book for Teva’s ProAir HFA product.
Background: For many years, FDA has failed to respond substantively to requests from drug makers for clarity regarding which types of patents that cover drug-device combination products should be listed in the “Approved Drug Products with Therapeutic Equivalence...
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