Summary: CAFC reverses a finding of nonobviousness in a patent infringement case arising under the Hatch-Waxman Act.

Case: Galderma Labs., L.P. V. Tolmar, Inc., No. 2013-1034 (Fed. Cir. Dec. 11, 2013) (precedential). On appeal from D. Del. Before Newman, Bryson, and Prost.

Procedural Posture: Appeal from a patent infringement case arising under the Hatch-Waxman Act. The defendant challenged the district court finding that the claims of the asserted patents are not invalid as obvious. CAFC reversed.

  • Obviousness: The district court’s holding of nonobviousness was reversed and the asserted claims were held invalid as obvious. The asserted claims included both compound claims and claims directed to a method of acne treatment using aqueous gel or cream that contained 0.3% by weight of adapalene. The Federal Circuit held that in circumstances where a range is disclosed in the prior art, and the claimed invention falls within that range, “the burden of production falls upon the patentee to come forward with evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected results relative to the prior art; or (3) there are other pertinent secondary considerations.” The patentee failed to carry this burden.
  • Teaching Away: The Federal Circuit found clear error in the district court’s finding that the prior art taught away from a 0.3% adapalene composition where the prior art merely expressed a general preference for an alternative invention but did not criticize, discredit, or otherwise discourage investigation into the claimed invention. The Federal Circuit generally noted that teaching that a composition may be optimal or standard does not criticize, discredit, or otherwise discourage investigation into other compositions.
  • Unexpected Results: The district court likewise erred in its finding of unexpected results where the difference in effectiveness and tolerability of 0.3% adapalene was one of degree, not kind, from results of the prior art. The Federal Circuit stated that “where an unexpected increase in efficacy is measured by a small percentage, as here, and the evidence indicates that skilled artisans were capable of adjusting the percentage, the result constitutes a difference in degree, not kind.”
  • Commercial Success: The Federal Circuit found that the “mere fact that generic pharmaceutical companies seek approval to market a generic version of a drug, without more, is not evidence of commercial success that speaks to the non-obviousness of patent claims.” The court also assigned “minimal probative value” to evidence of commercial success because the blocking patents prevented a market entry of a 0.3% adapalene product by entities other than the patentee.

Newman, dissenting:

  • Obviousness: While acknowledging that “the question of obviousness here presented a close call,” the dissent faults the majority opinion for giving little deference to the district court’s findings and applying flawed procedural and substantive law.