Proveris v. Innovasystems: Redefining a Patented Invention Under § 271(E)(1): An Examination of the Federal Circuit’s Narrowing of the § 271(e)(1) “Safe Harbor” Exemption
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...