Orange Book Listed Patents Must Claim Approved Drug's Active Ingredient: Federal Circuit


In Teva Branded Pharma. Prods R&D, Inc. v. Amneal Pharma. of NY, LLC, the US Court of Appeals for the Federal Circuit affirmed the district court’s order requiring a branded pharmaceutical company to delist patents from the Orange Book because those patents claimed components of the drug delivery system rather than the drug’s active ingredient.

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