Bolar Pharmaceutical Co., Inc.

Roche sued Bolar for patent infringement of U.S. Patent No. 3,299,053, covering flurazepam hydrochloride (DALMANE), after Bolar conducted pre-expiration testing to obtain FDA approval. The district court held Bolar's testing was de minimis/experimental and not infringement, but the Federal Circuit reversed and remanded, holding that the testing infringed under 35 U.S.C. § 271(a). The decision led to the Bolar exemption and 35 U.S.C. § 271(e)(1).