Andrx Corp., a generic drug manufacturer, challenged theFood and Drug Administration’s failure to approve its abbreviated new drugapplication (ANDA) and to delist a drug patent owned by Biovail from an FDApublication known as the “Orange Book.” Following the recent decisionin Mylan Pharmaceuticals Inc. v. Thompson, 268 F.3d 1323 (Fed. Cir.2001), the Federal Circuit rejected Andrx’s argument that such relief was available in a declaratory judgment action brought under the patent laws. The Federal Circuit suggested in dicta, however, that such relief may lie under the Administrative Procedure Act (APA).
A drug manufacturer that develops a new drug must obtain approval from the FDA to market the drug by filing a new drug application(NDA). If the new drug or a method of using it is patented, that information is also supplied to the FDA. The FDA publishes the patent information in its Orange Book (the Approved Drug Product With Therapeutic Equivalence Evaluations publication). Before the Hatch-Waxman Act, a patentee could prevent a genericdrug manufacturer from making, using, offering to sell or selling the patenteddrug until the expiration of the full patent term.
