The U.S. Court of Appeals for the Federal Circuit recently held that filing a Paragraph IV certification for an Orange Book listed method-of-use patent was not an act of infringement when an NDA holder’s FDA-approved labeling did not include an indication for every use limitation in the asserted Orange Book patent. Bayer Schering Pharma AG v. Lupin, Ltd, et al., Case Nos. 11-1143; -1228 (Fed. Cir., Apr. 16, 2012) (Bryson, J.) (Newman, J., dissenting).

In 2010, the defendants submitted ANDAs to market a generic form of Bayer’s Yasmin® oral contraceptive. The defendants filed Paragraph IV certifications for each of the three Orange Book listed patents, but Bayer brought suit alleging infringement under § 271(e)(2)(A) for only one of those patents. Both independent claims of the patent essentially require a method of achieving simultaneous contraceptive, anti-androgenic and anti-aldosterone effects in a female patient in need thereof. The FDA-approved label provides an indication of safe and effective use of the drug “for oral contraception.”

The district court granted the defendants’ motions for judgment of non-infringement on the pleadings because FDA had not approved the three simultaneous uses of the drug. The district court reasoned that infringement under § 271(e)(2)(A) for a method-of-use patent could only occur if the FDA had approved the use claimed in the patent under the patent-holder’s NDA. Here, Bayer’s NDA labeling only provided an indication for use as an oral contraceptive, but mentioned the other two effects in a separate section. Bayer appealed.

Judge Bryson, writing for the majority, affirmed the district court and its reasoning. The Court rejected Bayer’s arguments and purported evidence that the FDA had actually approved all three uses claimed in the patent due to observed being discussed in the label. First, the Court found that FDA labeling regulations made clear that Yasmin® was not approved for anti-androgenic and anti-aldosterone effects because there was no recommendation or suggestion for safe and effective administration of the drug for these purposes. Second, the Court found that Bayer’s evidence was insufficient to prove that the FDA approved all three simultaneous uses, let alone in female patients in need thereof. To the contrary, the majority concluded that even the declaration testimony of a former FDA official only showed that the contraceptive use was “approved,” while the other effects were listed in the label merely as “pertinent” to human use.

Judge Newman, in dissent, opined that the majority and the district court failed to subject Bayer’s claims to a “standard infringement analysis.” According to Judge Newman, whether the generic would infringe is a question of fact that “cannot be resolved on pleadings by adverse inference or assumption.”