Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc.
United States Court of Appeals for the Federal Circuit
733 F.2d 858 (1984)
Relevant factsFree
Roche (plaintiff) held a patent on the sleeping drug Dalmane's active compound, flurazepam hydrochloride. Before the patent expired, Bolar (defendant) obtained the compound from a foreign manufacturer and began running the stability, dissolution, and bioequivalency tests it needed to file a generic drug application with the FDA. Roche sued for infringement. The district court found no infringement, reasoning that Bolar's use was de minimis and merely experimental. Roche appealed.
IssueFree
Whether the unlicensed use of a patented drug for testing and investigation necessary for FDA drug approval before the patent expires constitutes infringement.