Duane C. Marks
By reducing the scope of “patented inventions” within § 271(e)(1) to only inventions comporting with the “perfect product fit” analysis, Proveris has drastically altered the function of § 271(e)(1) and potentially impairs the ability of generic manufactures to fully utilize the ANDA process created in Title I of the Act. Adherence to Proveris’ “perfect product fit” rule risks establishing loopholes that potentially allows patent holders of pioneer drugs and medical devices to delay generic manufacturers from bringing less expensive generics to the market. This Note critiques the Federal Circuit’s recent narrowing of § 271(e)(1) in Proveris. Part I provides a historical overview of FDA regulations on drugs and medical devices, the promulgation of the Act, and judicial interpretations of § 271(e)(1). Part II furnishes an in-depth review of the Federal Circuit’s holding in Proveris, and discusses the reasons cited as supporting the court’s narrowing of § 271(e)(1). Part III analyzes the Federal Circuit’s “perfect product fit” test, found to control the scope of § 271(e)(1), and discusses how the “perfect product fit” test contradicts the judicial precedent cited by the court as supporting its holding. Part IV illustrates how Proveris operates contrary to Congress’s intention for the Act, and suggests a “sliding scale” analysis for Federal courts when faced with a § 271(e)(1) defense.