Senju Pharma. Co. v. Lupin, Ltd., No. 13-1630 (Fed. Cir. 2015)
Annotate this CaseSenju sued defendants for infringement of the reexamined 045 patent, alleging constructive infringement under the Hatch-Waxman Act, 98 Stat. 1585. Defendants counterclaimed seeking a declaratory judgment of noninfringement and invalidity. The patent relates to gatifloxacin, an aqueous liquid pharmaceutical eye drop composition, with added disodium edetate. Seven prior art patents were alleged as the basis for the obviousness determination, each containing some of the same chemistry as the claimed invention. There are several prior patent infringement suits involving the same chemistry and the same 045 patent. The district court adjudged the claims infringed but invalid for obviousness. The Federal Circuit affirmed. The district court properly applied a presumption of validity, considering both the evidence of obviousness and the evidence of unexpected results, to find clear and convincing evidence of invalidity; it was not clear error for the court to conclude that the unexpected results evidence that Senju relied upon during reexamination did not withstand scrutiny by Lupin’s experts and the court.
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