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Bayer Pharma AG v. Watson Laboratories, Inc.

Evidence Disfavoring Combination Was Not “Teaching Away” From It

Bayer Pharma AG v. Watson Laboratories, Inc., 2017 U.S. App. LEXIS 21705 (Fed. Cir. Nov. 1, 2017) (Lourie, MOORE, O’Malley) (D. Del.: Sleet) (3 of 5 stars)

Fed Cir reverses bench judgment of non-obviousness in Hatch-Waxman case. The case involved Bayer’s patent for a formulation of an erectile-dysfunction (ED) treatment, vardenafil (branded name Levitra), as an oral disintegrating tablet (sold by Bayer as Staxyn). The district court clearly erred in concluding that Watson had failed to show a motivation to formulate ED drugs as oral disintegrating tablets (ODTs), as the record included numerous references describing such formulations, each of which the district court failed to consider. The opinion discusses these references, and analyzes Bayer’s counterarguments, concluding that the record clearly showed a motivation to formulate vardenafil ODT. The opinion also analyzes various other limitations, finding clear error in the district court’s finding of no motivation to employ technology reaching those limitations. That some of this technology had not yet been FDA-approved did not negate an “otherwise apparent motivation to formulate a product.” Op. at 16 (citing Allergan, 7266 F.3d 1286 (Fed. Cir. 2013)). And while the district court did not err in finding that some of the combinations would have led to “bitter taste and increased bioavailability,” such did not rise to the level of teaching away from the combination—the combination would still have been productive, even if disfavored, per Mouttet, 686 F.3d 1322 (Fed. Cir. 2012). The opinion notes that Bayer had presented objective evidence of nonobviousness (copying and unexpected results), but “weighing all four Graham factors” the claims were obvious.

KEYWORDS: OBVIOUSNESS (NO); HATCH-WAXMAN; MOTIVATION TO COMBINE