Broad Scope of Claims + Unpredictability of Art = Lack of Enablement

Pharmaceutical Resources, Inc. v. Roxane Laboratories, Inc., [2007-1093-1134](October 26, 2007)[MOORE, Michel, and Cote] NON-PRECEDENTIAL The Federal Circuit affirmed summary judgment that the claims of U.S. Patent Nos. 6,593,318 and 6,593,320 were invalid under 35 USC 112 for lack of enablement.
SIGNIFICANCE: The broad scope of the claims and the unpredictability of the art meant that the claims were not adequately enabled. It is important to claim what was actually invented.
BRIEF: LOF: Whether the subject matter of a patent claim satisfies the enablement requirement under 35 USC 112 is a question of law, reviewed de novo, based on underlying facts, reviewed for clear error. In re Wands set forth the eight factors to determine enablement: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. The Federal Circuit observed that Par sought extremely broad claims in an art it acknowledged was unpredictable, quipping "The motto, 'beware of what asks for,' might be applicable here." The specifications of the patents in suit discusses the unpredictability of the art. Further, the claims were, as as the district court found, extraordinarily broad. The Federal Circuit found that the claims cover any surfactant in any concentration, the claims and the specification suggesting that the claims encompass hundreds of possible surfactants. The Federal Circuit found that the number of inoperative combinations is significant when assessing the experimentation that an ordinary skilled artisan would need to practice the claimed invention. The Federal Circuit found that taking into account the broad scope of the claims, and the unpredictability of the art, Par evidence of enablement failed to establish a genuine issue of material fact to defeat summary judgment. The disclosure of only three working examples utilizing only one new surfactant, was not an enabling disclosure commensurate with the entire scope of the claims. Furthermore the affidavits from experts were conclusory. Finally, the evidence of experiments by the inventor actually supported a finding of lack of enablement because of the number of unsuccessful experiments.