Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc.

Research pharmaceutical company Roche Products, Inc. (“Roche”) (plaintiff) obtained the ‘053 patent for the prescription sleeping drug, Dalmane, including patent claims for the drug’s chemical compound, flurazepam hydrochloride. Prior to the expiration of the patent, Bolar Pharmaceutical Company, Inc. (“Bolar”) (defendant) began taking the necessary steps to manufacture and market a generic version of Dalmane, including obtaining 5 kilograms of flurazepam hydrochloride from a foreign manufacturer, to form into “dosage form capsules, to obtain stability data, dissolution rates, bioequivalency studies, and blood serum studies” needed for a New Drug Application to the Food and Drug Administration (“FDA”). Roche claimed that Bolar’s use of the patented drug for testing purposes was a violation of patent law and filed suit in the U.S. District Court for the District of New Jersey. The New Jersey district court temporarily enjoined Bolar from using flurazepam hydrochloride for any purpose during the life of the ‘053 patent. The case was then transferred to the U.S. District Court for the Eastern District of New York on Bolar’s motion. The New York district court denied Roche’s motion for a permanent injunction and held that Bolar’s use of the flurazepam hydrochloride did not infringe on Roche’s patent because Bolar’s use of the compound was de minimis and for experimental purposes. Roche appealed.