11th Circuit Rules that the Scope of Orphan Drug Exclusivity is Determined by the Rare Disease or Condition Designation, Not the Approved Indication
Recently, the Eleventh Circuit sided with Florida-based Catalyst Pharmaceuticals Inc., holding that the U.S. Food and Drug Administration’s interpretation of the Orphan Drug Act is contrary to the plain language of the statute. Catalyst Pharm., Inc. v. Becerra. The court found that the FDA unlawfully infringed on an exclusivity period it awarded to Catalyst for…