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

733 F.2d 858 (1984)

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Nature of the Case

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Facts

P was the assignee of the rights in the '053 patent. One of the chemical compounds claimed in the '053 patent is flurazepam hydrochloride (flurazepam HCl), the active ingredient in P's successful brand name prescription sleeping pill 'Dalmane.' The patent had not yet expired and D obtained, from a foreign manufacturer, 5 kilograms of flurazepam HCl to form into 'dosage form capsules, to obtain stability data, dissolution rates, bioequivalency studies, and blood serum studies' necessary for a New Drug Application with the FDA. P filed a complaint seeking to enjoin D from using flurazepam HCl for any purpose whatsoever during the life of the '053 patent. The court held that D's use of the patented compound for federally mandated testing was not infringement of the patent because D's use was de minimis and experimental. P appealed.