Mylan Pharmaceuticals, Inc. v. Thompson
United States Court of Appeals for the Federal Circuit
268 F.3d 1323 (2001)
Mylan Pharmaceuticals sought FDA approval of a generic version of a drug through an Abbreviated New Drug Application (ANDA). Bristol-Myers Squibb, holder of the corresponding brand-name drug's New Drug Application, obtained a newly issued patent (U.S. Patent No. 6,150,365) and had it listed in the FDA's "Orange Book" of patents covering approved drugs, a listing that under the Hatch-Waxman Act can trigger an automatic delay in final approval of a competing generic's ANDA. Mylan sued the Secretary of Health and Human Services, the FDA, and Bristol-Myers Squibb, seeking a declaration that the '365 patent was improperly listed and an order requiring its delisting from the Orange Book so that Mylan's ANDA could receive final approval.
Whether a generic drug manufacturer commits patent infringement by filing an Abbreviated New Drug Application for purposes of marketing a product claimed in the patent prior to the expiration of the patent.