Digest of Par Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., No. 2014-1391 (Fed. Cir. Dec. 3, 2014) (precedential). On appeal from D. Md. Before O’Malley, Wallach, and Hughes.

Procedural Posture: Par Pharmaceutical appealed the district court’s finding that its patent to methods of use of nanosized formulations of the drug megestrol acetate is invalid as obvious. CAFC vacated and remanded.

  • Obviousness: Inherency. The district court incorrectly applied CAFC’s law on inherency in the context of its obviousness determination. Inherency may supply a missing claim limitation in an obviousness analysis, but its use “must be carefully circumscribed in the context of obviousness.” CAFC held that “to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis—the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” The district court ignored the claim limitations at issue and did not require TWi to present sufficient evidence to prove inherency under this standard. CAFC remanded for further analysis on this ground.
  • Obviousness: Motivation to Combine. The district court did not err in finding a motivation to combine megestrol with nanoparticle technology due to the known viscosity and interpatient variability problems with micronized megestrol. The motivation to combine the teachings of prior art does not have to be the same as the likely motivation of the inventors, and does not need to be the best available option, but only a suitable option from which the prior art did not teach away.
  • Obviousness: Reasonable Expectation of Success. The district court did not err in finding that TWi proved a reasonable likelihood of success in combining megestrol with nanoparticle technology. “Reasonable expectation of success” does not require absolute certainty of it.
  • Obviousness: Teaching Away. The prior art did not teach away when it merely cautioned about a potentially negative effect, and there was no evidence in the record that such negative effect actually occurred.
  • Obviousness: Objective Indicia of Nonobviousness. The district court properly considered the objective indicia before reaching its ultimate conclusion of obviousness.
  • Obviousness: Unexpected Results. Unexpected results do not have to be derived explicitly from the motivation to combine to be relevant. The district court did not err in considering the relevance of the unexpected results in weighing the importance of those results, and in concluding that they were insufficient to alter the court’s obviousness conclusion.
  • Obviousness: Long-Felt Need. The district court correctly found an equivocal statement that “the use of the [Megace ES] formulation may be preferable to [Megace OS]” insufficient to establish long-felt need that would overcome its obviousness determination.