Waxman/Hatch Reforms Preserve Declaratory Judgment “Reasonable Apprehension” Test – Court
This article was originally published in The Pink Sheet Daily
Executive Summary
Newark, N.J. federal judge rejects Dr. Reddy’s argument that the Medicare Rx law’s generic drug reform provisions were intended to create a “case or controversy” when an ANDA filer is not sued for infringement within 45 days.