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.

制药诉讼通常始于仿制药公司提交申请，要求其仿制药获得 FDA 的批准。该申请由马里兰地区的 FDA 收到。根据 Hatch-Waxman 法案，“提交”是专利侵权的法定行为。在后续的 Hatch-Waxman 诉讼中确定地点可能很复杂，因为 Hatch-Waxman 诉讼通常涉及针对许多仿制药申请人的同时和独立诉讼。Hatch-Waxman 原告可能会合理地尝试在一个地方法院合并诉讼；Hatch-Waxman 案中的被告可能会合理地拒绝在原告首选地点进行合并。最近的最高法院和联邦巡回法院判例法缩小了 Hatch-Waxman 原告的审判地点选择范围。