Matthew Makowski

Volume 89.7
Toward a Centralized Hatch-Waxman Venue
Matthew Makowski
B.S. 2012, American University; Ph.D. 2018, Radboud University; J.D. Candidate 2023, The University of Chicago Law School.

I would like to thank, in particular, Professor Jonathan Masur for his consistently excellent supervision and Comments Editors Brian Bornhoft and Jaston Burri for improving this Comment at every stage of the editing process. I would also like to thank Professor William Hubbard and the editors and staff of the University of Chicago Law Review for their helpful advice, insight, and feedback.

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 Hatch- Waxman 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.