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The criterion of bioequivalence of two drugs in infringement cases may differ from the requirements used for drug approval by the FDA. In  Adams  v . Perrigo ,  1   the Federal Circuit examined three different sets of criteria for judging bioequivalence. The statistical properties of those criteria are explored and evaluated. Our results support the appellate court’s decision to impose less stringent requirements for bioequivalence in infringement cases.

Case comment: Adams v . Perrigo and the appropriate criterion for bioequivalence in patent infringement cases