Affirming-in-part a district court’s finding of validity, the U.S. Court of Appeals for the Federal Circuit held that a claimed method was not inherently obvious because defendants failed to argue the efficacy limitation was inherent to all prior art fixed combination products.  The Federal Circuit also reversed-in-part the district court’s finding of validity, holding that a claimed formulation was obvious in view of sufficient support to find a motivation to combine, notwithstanding the FDA’s approval process.  Allergan, Inc. v. Sandoz Inc., Case Nos. 11-1619, -1620, -1635, -1639 (Fed. Cir., May 1, 2013) (Prost, J.) (Dyk, J. concurring-in-part and dissenting in-part).

Allergan brought suit, under 35 U.S.C. § 271(e)(2)(A), against a group of generic-drug manufacturers including Sandoz, Apotex and Watson Laboratories, asserting infringement of four Orange Book-listed patents: U.S. Patent Nos. 7,642,258 (’258 patent); 7,320,976 (’976 patent); 7323,463 (the ’463 patent); 7,030,149 (’149 patent).  The four asserted patents were listed for Combigan®, a combination brimonidine and timolol eye-drop product used to treat glaucoma.  After a bench trial, the district court entered judgment finding each of the asserted claims of the four asserted patents valid.  The district court also granted summary judgment of non-infringement as to claims 1-3 of the ’149 patent, and the parties stipulated to infringement of the other asserted claims of the asserted patents.

The Federal Circuit disagreed with the district court’s finding that the asserted formulation claims of the ’463 patent were not invalid for obviousness due to secondary consideration of non-obviousness.  The Federal Circuit noted that the recited combination was not necessarily not obvious, notwithstanding the FDA’s lack of considering patient compliance improvement as a factor in its approval process and that “[m]otivation to combine may be found in many different places and forms; it cannot be limited to those reasons the FDA sees fit to consider in approving drug applications.”  The Federal Circuit further explained that Allergan had a “reasonable expectation of success” that using brimonidine and timolol together would be more effective than using them separately based upon the teachings in the prior art.  Moreover, the Federal Circuit did not find that secondary considerations in this case weighed heavily in the obviousness analysis.

The Federal Circuit, however, agreed with the district court’s finding that defendants failed to prove by clear and convincing evidence that method claim 4 of the ’149 patent would have been obvious. Claim 4 called for lowering the dosing of the drug from three times to twice a day, which the district court noted had a surprising result of retaining efficacy even when dosage was scaled back.  Notably, the Federal Circuit found that defendants had only argued the obviousness of the method over the prior art and “[did] not argue that this efficacy limitation [was] inherent to fixed combinations products [containing the two drugs], nor that a dose reduction without loss of efficacy would inherently flow from the obvious [composition].” 

Judge Dyk dissented from the Court’s holding with respect to claim 4 of the ’149 patent, arguing that a method claim is obvious if it merely claims the result of a treatment with an obvious composition.