No Liability For Induced Infringement Where Drug Label Does Not Instruct the Patented Method Of Use

This article previously appeared in Last Month at the Federal Circuit, May, 2012.

Judges: Newman (dissenting), Plager, Bryson (author)

[Appealed from S.D.N.Y., Judge Gardephe]

In Bayer Schering Pharma AG v. Lupin, Ltd., Nos. 11-1143, -1228 (Fed. Cir. Apr. 16, 2012), the Federal Circuit affirmed the district court's dismissal of Bayer Schering Pharma AG and Bayer HealthCare Pharmaceuticals, Inc.'s (collectively "Bayer") claims for infringement of a method-of-use patent in two ANDA cases.

Bayer produces and markets Yasmin®, an oral contraceptive containing the active ingredient drospirenone. The FDA-approved label for Yasmin® states in the Indications and Usage section that "Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive." Slip op. at 12. The Pharmacodynamics subsection of the Clinical Pharmacology section of the label recites that drospirenone "is a spironolactone analogue with antimineralocorticoid activity. . . . Preclinical studies in animals have also shown that drospirenone has antiandrogenic activity." Id. at 13.

Bayer had listed three patents in the FDA's Orange Book in connection with Yasmin®, including U.S. Patent No. 5,569,652 ("the '652 patent"). The '652 patent claims a method of use for simultaneously achieving three effects: an antiandrogenic effect, an antialdosterone effect (also known as an antimineralocorticoid effect), and a contraceptive effect in a premenopausal or menopausal female patient. Defendants filed ANDAs with the FDA to market generic versions of Yasmin®. The ANDAs track the original NDA and seek FDA approval for the use of generic versions of Yasmin® for oral contraception. Bayer filed a complaint against defendants Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc. (collectively "Watson") and Sandoz, Inc. ("Sandoz") in 2008, and a complaint against Lupin, Ltd. and Lupin Pharmaceuticals, Inc. (collectively "Lupin") in 2010, alleging infringement of the '652 patent. The district court entered a judgment of noninfringement based on the pleadings in favor of Watson and Sandoz, holding that because the FDA had not approved the use of Yasmin® for the simultaneous treatment of the three conditions as claimed in the '652 patent, Bayer could not state a claim for patent infringement. Based on that ruling, Bayer and Lupin stipulated to, and the district court entered, final judgment of noninfringement in Bayer's suit against Lupin.

In a consolidated appeal...