SCIELE PHARMA INC. v. LUPIN LTD.

No. 2012-1228.

684 F.3d 1253 (2012)

SCIELE PHARMA INC. (now known as Shionogi Pharma Inc.), Plaintiff-Appellee, and Andrx Corporation, Andrx Pharmaceuticals Inc. (doing Business as Watson Laboratories Inc.-Florida), Andrx Pharmaceuticals L.L.C., Andrx Laboratories (NJ) Inc., Andrx EU Ltd., and Andrx LABS L.L.C., Plaintiffs, v. LUPIN LTD. and Lupin Pharmaceuticals Inc., Defendants-Appellants, and Mylan Inc. and Mylan Pharmaceuticals Inc., Defendants.

United States Court of Appeals, Federal Circuit.

July 2, 2012.


Attorney(s) appearing for the Case

David B. Bassett , Wilmer Cutler Pickering Hale and Dorr LLP, of New York, NY, argued plaintiff-appellee. With him on the brief were David A. Manspeizer and Christopher R. Noyes; and Mark C. Fleming , of Boston, MA.

Douglass C. Hochstetler , Kelley Drye & Warren LLP, of Chicago, IL, argued for defendants-appellants. With him on the brief was Beth D. Jacob , of New York, NY. Of counsel was Clifford Katz.

Before LOURIE, PROST, and MOORE, Circuit Judges.


MOORE, Circuit Judge.

Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively Lupin) submitted an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration seeking approval to market a generic version of Fortamet, an extended-release tablet of metformin hydrochloride. Shionogi Pharma Inc.1 (Shionogi), which markets Fortamet, sued Lupin for patent infringement under 35 U.S.C. § 271(e)(2)(A) asserting, among others...

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