Whether 35 U.S.C. § 271(e)(4)(A) requires courts to issue overly broad injunctive orders that delay FDA approval of generic drug applications beyond the scope of actual patent infringement

QUESTION PRESENTED Congress created the Hatch-Waxman Act with the purpose of hastening the introduction of less-costly generic drugs while safeguarding the legitimate patent rights of innovator companies. The lower court’s interpretation of 35 U.S.C. § 271(e)(4)(A) — the remedy provision in the Hatch-Waxman Act —is contrary to this purpose because it requires blanket injunctions on FDA approval of generic drug applications that may be far broader in scope than the underlying infringement finding. It is also contrary to the general patent-law principle that injunctive relief must be tailored to the infringement and avoid blocking conduct not found infringing. The question presented is: Whether 35 U.S.C. § 271(e)(4)(A) requires courts to issue injunctive orders that are broader in scope than the underlying infringement, thereby delaying FDA approval of generic drug applications for indications that have not been found to infringe any valid patent.