Bayer Shering Pharma AG v. Lupin, Ltd.

Case Name: Bayer Shering Pharma AG v. Lupin, Ltd., 676 F.3d 1316 (Fed. Cir. April 16, 2012) (Circuit Judges Newman, Plager and Bryson presiding; Majority Opinion by Bryson; Dissenting Opinion by Newman) (Appeal from S.D.N.Y., Gardephe, J.)

Drug Product and Patent(s)-in-Suit: Yasmin^®(dihydrospirorenone); U.S. Patent No. 5,569,652 ("the '652 patent")

Nature of the Case and Issue(s) Presented: Defendants filed an ANDA seeking to commercially manufacture and market generic Yasmin, an oral contraceptive for women. The '652 patent claimed a method of using dihydrospirorenone to achieve three effects simultaneously, one of them being the contraceptive effect. Defendants moved to dismiss the case on the pleadings pursuant to Fed. R. Civ. P. 12(c) because the intended use of the their generic product, based on the FDA-approved label for Yasmin, was directed only to achieving the contraceptive effect, and not the other effects. The district court granted defendants' motion because the FDA-approved label did not mention the other effects outside of the contraceptive effect.

On appeal, Bayer argued that the FDA did approve the use of dihydrospirorenone to achieve the other two effects because these effects are mentioned in the "Pharmacodynamics" subsection of the "Clinical Pharmacology" section. The Federal Circuit affirmed the district court's ruling of non-infringement because the FDA-approved label for Yasmin does not instruct the use of Yasmin to achieve the three effects simultaneously.

Why Lupin Prevailed: The Court relied on the fact that the "Indications and Usage" section of the label states only that "Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive." The "Indications and Usage" section failed to mention the other effects claimed in the '652 patent. Thus, the FDA-approved label did not instruct a patient or doctor to infringe the method claims in the '652 patent.

The Federal Circuit rejected Bayer's argument that the discussion in the "Pharmadynamics" subsection was sufficient to show that the use of dihydrospirorenone would achieve the other effects. The Court reasoned that while the "Indications and Usage" section requires the support of scientific evidence of the safe and effective use of the drug, the "Pharmadynamics" section does not. Further, the evidence in the "Pharmadynamics" section only relates to in vitro and animal studies, and lacks any evidence regarding clinical effects. Thus, the "Pharmadynamics" section does not provide doctors with a sufficient summary of dihydrospirorenone's other effects.

The Federal Circuit further found that to practice the claimed method in the '652 patent, the FDA would have had to approve the use of dihydrospirorenone to achieve the three effects simultaneously. The FDA only approved the use of dihydrospirorenone to achieve one effect, i.e., its contraceptive effect, as that was the only effect supported with evidence of its safe and effective use. Therefore, the FDA label does not recommend or suggest a safe and effective use for the combined effects in the '652 patent, and the defendants do not infringe.

In her dissent, Judge Newman stated that the Court's holding was in error because the portion of the FDA label in which a product's properties are described is irrelevant to whether the patent is infringed by sale or use of the product. Instead, "[t]he infringement question is whether sale or use of the generic equivalent of the Yasmin product, in accordance with the representations in the ANDA with respect to FDA approval for the generic equivalent of Yasmin, infringes the '652 patent." Judge Newman took issue with the fact that neither the district court, nor the Federal Circuit, conducted a standard infringement analysis given the posture of the case-the district court dismissed the complaint on the pleadings under Fed. R. Civ. P. 12(c), thereby denying the patentee the opportunity to put forward its proofs and litigate infringement in the proper Hatch-Waxman context.