How does the paragraph IV certification process relate to USPTO disclosures?
The paragraph IV certification process, typically associated with generic drug applications to the FDA, can generate information material to patentability that should be disclosed to the USPTO. According to MPEP 2015: “Consequently, to assist USPTO staff in evaluating patentability effectively and efficiently, the party receiving a paragraph IV certification should review such documents to determine…
Read MoreHow 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