Glaxo Group Limited, et al. v. Apotex, Inc. (Fed. Cir.)

July 29, 2004 on 11:12 am | In Caselaw |

Glaxo Group Limited, et al. v. Apotex, Inc.
Federal Circuit, July 27, 2004
Before SCHALL, GAJARSA, and DYK, Circuit Judges.
Opinion for the court filed by Circuit Judge GAJARSA.
Opinion concurring-in-part and dissenting-in-part filed by Circuit Judge DYK.

Apotex, Inc. (“Apotex”) appeals the judgment of the United States District Court for the Northern District of Illinois, which found that Apotex’s filing of an Abbreviated New Drug Application (“ANDA”) for a generic version of the antibiotic Ceftin® willfully infringed U.S. Patent No. 4,562,181 (the “’181 patent”) and U.S. Patent No. 4,820,833 (the “’833 patent”) owned by Glaxo Group Limited and SmithKline Beecham Corp. (collectively “Glaxo”). Glaxo Group Ltd. v. Apotex, Inc., 268 F. Supp. 2d 1013 (N.D. Ill. 2003). While we affirm the district court’s determination that Apotex’s ANDA infringes the ’181 and ’833 patents pursuant to 35 U.S.C. § 271(e)(2), and also affirm that the patents at issue are not invalid, we reverse the district court’s finding that Apotex’s ANDA filing constituted willful infringement. We hold that the mere filing of an ANDA cannot constitute an act of willful infringement compensable by attorney’s fees under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act.

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