Sciele Pharma v. Lupin was decided on July 1, 2012 on appeal from the District of Delaware. The district court granted plaintiff Sciele a preliminary injunction prohibiting defendant Lupin from “further importation and sales of its generic [product].” Lupin appealed.
The Federal Circuit vacated the preliminary injunction and remanded.
“In deciding whether to grant a preliminary injunction, a district court assesses four factors: (1) a reasonable likelihood of success on the merits; (2) irreparable harm if an injunction is not granted; (3) a balance of hardships tipping in its favor; and (4) the injunction’s favorable impact on the public interest.” To demonstrate a likelihood of success on the merits, a patentee “must show that, in light of the presumptions and burdens that will inhere at trial on the merits: (1) the patentee will likely prove that the accused infringer infringes the asserted patent; and, (2) the patentee’s infringement claim will likely withstand the accused infringer’s challenges to the validity and enforceability of the patent.”
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The Federal Circuit held that “Lupin’s obviousness arguments…, considered in light of the prosecution history and the correct standard of proof, raise[d] a substantial question of invalidity.” Because the district court incorrectly concluded that Lupin failed to raise a substantial question of invalidity regarding the asserted claims, it “abused its discretion by issuing a preliminary injunction enjoining Lupin from selling its generic product.”
Sciele Pharma Inc. v. Lupin Ltd., 684 F.3d 1253 (Fed. Cir. 2012)