Alza Corp. v. Mylan Labs., Inc.

Alza Corp. (“Alza”) appeals from the district court’s judgment, after a bench trial, of noninfringement and invalidity of claims 1-3, 11, 13 and 14 of U.S. Patent No. 6,124,3551 (“the ’355 patent”) in favor of Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc. (collectively, “Mylan”). Alza Corp. v. Mylan Labs., Inc., 388 F. Supp. 2d 717 (N.D.W. Va. 2005) (“Alza II”). The infringement arose from Mylan’s filing of two Abbreviated New Drug Applications (“ANDAs”) for a generic version of the once-a-day extended release formulation of the anti-incontinence drug oxybutynin, id. at 720, which Alza has been marketing as Ditropan XL®. Id. at 738. This court has jurisdiction pursuant to 28 U.S.C. § 1295(a)(1). For the reasons stated below, we affirm the district court’s judgment of noninfringement and invalidity.

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