How does the Hatch-Waxman Act affect patent infringement related to regulatory approval?
The Hatch-Waxman Act, codified in part as 35 U.S.C. 271(e), provides a safe harbor for certain activities that would otherwise be considered patent infringement. According to the MPEP: “Congress legislatively overruled Roche Products v. Bolar Pharmaceuticals, 733 F.2d 858, 221 USPQ 937 (Fed. Cir. 1984) as to products covered by 35 U.S.C. 271(e) and provided…
Read More