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Abstract

This Note examines the changing role of declaratory judgment actions in challenging patents upon generic entry and evaluates alternative regulatory schemes to the FDA's current system of patent enforcement in the drug approval setting. Part I reviews the Federal Circuit's recent decisions regarding generic drug entry, focusing on how the courts justify declaratory judgments in the current system and when a "controversy" exists to create Article III jurisdiction. Part II examines the complex system of regulating generic drug entry and how attempts to stop the exploitation of loopholes have resulted in a patchwork of regulation by various parties. It challenges the current regulatory scheme with alternative regulatory mechanisms of discretion by courts, litigation by subsequent-filers, legislative changes by Congress, and antitrust policing by the FTC. Part III hypothesizes that a likely increase in litigation will force courts to become more active in the regulation of patent rights in relation to generic drug entry, especially in light of the recently liberalized standing requirements, and draws attention to the competing goals of the Hatch-Waxman Act that courts must remember to balance.