Sciele Pharma Inc. v. Lupin Ltd.

April 09, 2012

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Case Name:  Sciele Pharma Inc. v. Lupin Ltd., Case No. 2012-1118 (Fed. Cir. Feb. 6, 2012) (Circuit Judges Lourie, Prost, and Moore; Order on Motion by Lupin) (Appeal from D. Del., Kugler, J.).  (Preliminary injunctions - District Court's failure to make findings on defendant's obviousness defense results in vacatur of a preliminary injunction). 

Drug Product and Patent(s)-in-Suit: Fortamet® (metformin hydrochloride); U.S. Patent Nos. 6,099,859 and 6,866,866

Nature of the Case and Issue(s) Presented:  Lupin moved the Federal Circuit for a stay, pending disposition of its appeal, of the preliminary injunction entered against it.  Because the district court failed to make an independent assessment of Lupin's obviousness defense and apply the proper burden of proof, the Federal Circuit vacated the injunction and remanded the matter for a proper analysis.

Why Lupin Prevailed:  The district court's order imposing the preliminary injunction failed to address Lupin's obviousness arguments-it made no findings of fact nor conclusions of law on this issue.  While acknowledging that Lupin had raised an obviousness defense, the district court nonetheless found that Lupin failed to raise a substantial question that its obviousness argument was likely to succeed at trial because the referenced prior art was before the examiner during the prosecution of the patent-in-suit.  The Federal Circuit found that the district court's failure to make adequate findings prevented it from engaging in a "meaningful review" of Lupin's obviousness defense.  "Absent appropriate findings, the normal course is to vacate the district court's decision and remand the matter for a proper analysis." 

Ryan M. Schultz


Pronouns: he/him

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