In Sciele Pharma Inc. v. Lupin Ltd., No. 12-1228 (Fed. Cir. July 2, 2012), the Federal Circuit vacated the district court's issuance of a preliminary injunction stopping the sale of a generic drug product and remanded the case to the district court for further proceedings.
Shionogi Pharma Inc. ("Shionogi"), previously known as Sciele Pharma Inc., markets Fortamet, an extended-release tablet of metaformin hydrochloride. Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively "Lupin") submitted an ANDA to the FDA, seeking approval to market a generic version of Fortamet. Shionogi sued Lupin for patent infringement, asserting, inter alia, U.S. Patent No. 6,866,866 ("the '866 patent") directed to Fortamet formulations with certain peak dosage limitations.
After expiration of the thirty-month stay, the FDA gave final approval to Lupin's ANDA, and Lupin launched its generic version of Fortamet "at risk." Shionogi moved for a preliminary injunction and a recall of Lupin's generic products. The district court granted the motion without addressing Lupin's obviousness arguments, and Lupin appealed. The Federal Circuit vacated the preliminary injunction and remanded the case, directing the district court to "make appropriate findings and conduct an appropriate obvious analysis in the first instance." Slip op. at 6. On remand, the district court reinstated the injunction and Lupin again appealed.
In the instant appeal, the Federal Circuit first addressed the appropriate presumption of validity and burden of proof. Lupin argued that the presumption of validity should not attach because claims that had been cancelled in response to an obviousness rejection were erroneously included in the issued patent. Shionogi argued that there should be a heightened presumption of validity because the prior art references were before the PTO during prosecution.
Judges: Lourie, Prost, Moore (author)| [Appealed from D. Del., Judge Kugler] |
This article previously appeared in Last Month at the Federal Circuit, August, 2012.
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