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Statements in Clinical Pharmacology section do not induce YASMIN patent infringement – CAFC

On April 16, 2011, the Court of Appeals for the Federal Circuit affirmed that Sandoz, Watson and Lupin do not infringe U.S. Patent No. 5,569,652 listed against Bayer’s YASMIN (drosperione + ethinyl estradiol) product. The District Court below had granted the ANDA applicants’ motions for judgment on the pleadings under Rule 12(c) of the Federal Rules of Civil Procedure. Claim 11 of the ‘652 Patent reads as follows:

11 A method of simultaneously achieving, during premenopause or menopause, a contraceptive effect, an anti-androgenic effect, and an antialdosterone effect in a female patient in need thereof comprising administering an effective amount of dihydrospirorenone and an effective amount of an estrogenic compound, wherein said effective amount of dihydrospirorenone is effective to simultaneously achieve a gestagenic effect, anti-androgenic effect, and an anti-aldosterone effect in said female patient.

The ‘652 patent thus generally relates to a method of simultaneously achieving contraception (a gestagenic effect), treating acne (an anti-androgenic effect) and acting as a diuretic (an antialdosterone effect). The Indications and Usage section of the YASMIN label reads as follows:

Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.

The FDA-approved YASMIN label also discloses, in the Clinical Pharmacology section, that drosperinone

…is a spironolactone analogue with antimineralocorticoid activity. Preclinical studies in animals and in vitro have shown that drospirenone has no androgenic, estrogenic, glucocorticoid, and antiglucocorticoid activity. Preclinical studies in animals have also shown that drospirenone has antiandrogenic activity.

The Indications and Usage section of the ANDA applicants’ labels used the same language as that of YASMIN. The ANDA applicants submitted that they were only seeking approval for the unpatented oral contraception use and not for the combination of uses claimed in the ‘652 patent. The Court noted that the issue in the case was a narrow one – did the FDA approve YASMIN to simultaneously obtain all three effects claimed in the ‘652 patent?

Majority

Justices Plager and Bryson, relying on previous decisions of the Court in Warner-Lambert Co. v. Apotex Corp. and Allergan, Inc. v. Alcon Laboratories , Inc. answered this question in the negative, holding that while the YASMIN label does mention anti-mineralocorticoid and anti-androgenic activity, it does so in a way that would not recommend or suggest to physicians that the drug is safe and effective for the three simultaneous uses. Evidence that the FDA was aware that YASMIN could cause the effects claimed in the ‘652 patent was not sufficient. That certain effects are described in the Clinical Pharmacology section of the label does not mean that these effects are approved for safety and efficacy by the FDA. Since the ANDA applicants were seeking approval solely for the unpatented contraception use, the ANDA applicants cannot be held liable for infringement of the ‘652 patent.

Dissent

Justice Newman, in dissent, held that the infringement analysis under the Hatch-Waxman scheme is not restricted to the uses in the Indications and Usage section of the relevant labels. The analysis for artificial infringement under section 271(e)(2)(A) is the traditional infringement analysis. Since all  facts alleged in Bayer’s complaint are to be taken as true and in light of expert evidence that ““significant proportion of drospirenone and ethinyl estradiol prescriptions are written with the intent of producing three pharmacological effects”, Justice Newman held that Bayer’s claim should not have been struck at the pleading stage.

A copy of the opinion may be found here.