Pharmaceutical litigation often begins when a generic drug company files an application to have its generic drug approved by the FDA. That application is received by the FDA in the District of Maryland. To “submit” it is a statutory act of patent infringement under the Hatch-Waxman Act. Establishing venue in subsequent Hatch-Waxman litigation can be complex because HatchWaxman litigation often involves simultaneous and independent lawsuits against many generic applicants. A Hatch-Waxman plaintiff might reasonably attempt to consolidate litigation in a single district court; Hatch-Waxman defendants might reasonably resist consolidation in the plaintiff’s preferred venue. Recent Supreme Court and Federal Circuit case law has narrowed venue options for Hatch-Waxman plaintiffs. This Comment argues for an interpretation of Hatch-Waxman’s statutory act of patent infringement and the patent venue rules that moves toward a centralized venue for Hatch-Waxman litigation in the District of Maryland.
"Toward a Centralized Hatch-Waxman Venue,"
University of Chicago Law Review: Vol. 89:
7, Article 4.
Available at: https://chicagounbound.uchicago.edu/uclrev/vol89/iss7/4