Citations

Full opinion text

Opinion for the court filed by LOURIE, Circuit Judge.

Opinion concurring in part and concurring in the result in part filed by BRYSON, Circuit Judge.

LOURIE, Circuit Judge.

Alphapharm Pty. Ltd. and Genpharm, Inc. (collectively, “Alphapharm”) and My-lan Laboratories, Inc., Mylan Pharmaceuticals, Inc., and UDL Laboratories, Inc. (collectively, “Mylan”) appeal from the final judgment of the United States District Court for the Southern District of New York. On September 20, 2006, the court granted a motion by plaintiff and patentee Takeda Chemical Industries, Ltd. and its affiliate Takeda Pharmaceuticals North America, Inc. (collectively, “Takeda”) to find the case relating to Hatch-Waxman challenges made by Alphapharm and My-lan in connection with Takeda’s U.S. Patent 4,687,777 (“the '777 patent”) to be exceptional and to award attorney fees. Takeda Chem. Indus., Ltd. v. Mylan Labs., Inc., 459 F.Supp.2d 227 (S.D.N.Y.2006) (“September Opinion”). On March 21, 2007, the court quantified the attorney fees, expenses, and expert fees, awarding Takeda $11,400,000 from Mylan and $5,400,000 from Alphapharm, with interest. Takeda Chem. Indus., Ltd. v. Mylan Labs., Inc., Nos. 03-8253, 04-1966, 2007 WL 840368 (S.D.N.Y. Mar. 21, 2007) (“March Opinion”). Because we conclude that the district court did not clearly err in finding that this was an exceptional case because of the misconduct of Mylan and Alphapharm and did not abuse its discretion in awarding attorney fees, we affirm.

BACKGROUND

The '777 patent covers the anti-diabetic drug pioglitazone, for which Takeda has enjoyed commercial success under the name ACTOS®. Alphapharm and Mylan are two generic drug companies that sought approval to produce generic versions of pioglitazone under the Hatch-Waxman Act. That legislation provides the mechanism for a generic drug company to file an abbreviated new drug application (“ANDA”). An ANDA announces the intention of the filer to sell a bioequivalent form of a drug when approved by the FDA, and the filer makes a certification regarding existing patents covering the drug and its use. 21 U.S.C. § 355(j) (2006). Both Mylan and Alphapharm chose to make certifications pursuant to 21 U.S.C. § 355