Litigation
Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc.
reversed and remandedCV 83-4312
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Patents at issue (1)
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Summary
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).
Case overview & background
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