Unknown and Unexpected Properties of New Pharmaceutical Formulation Constitute Objective Evidence of Nonobviousness

Author: Yieyie Yang, Ph.D.
Editor: Jeff T. Watson

In Allergan, Inc. v. Sandoz Inc., No. 14-1275 (Fed. Cir. Aug. 4, 2015), the Federal Circuit affirmed the district court’s holding of nonobviousness.  The asserted claims recite a formulation for treating open angle glaucoma and ocular hypertension comprising 0.01% bimatoprost and 200 ppm benzalkonium chloride (“BAK”), which fall within prior art ranges. The Court concluded that the district court did not clearly err in finding that Allergan had produced ample evidence of teaching away and unexpected results to support a conclusion of nonobviousness.

Particularly, the Court noted that the prior art taught minimizing BAK in ophthalmic formulations to avoid safety problems.  The prior art also taught that BAK would not increase the permeability of bimatpoprost, but might instead decrease it.  The Court thus concluded that the prior art taught away because it “criticized, discredited, or otherwise discouraged” the use of 200 ppm BAK in a bimatoprost formulation.

The Court also found that the claimed formulation exhibited unexpected results.  Whereas the prior art taught that 200 ppm BAK would have no impact on the permeability of bimatoprost or decrease it, the inventors determined that the opposite was true—that 200 ppm BAK enhanced the permeability of bimatoprost.  Accordingly, the Court concluded that “the previously unknown and unexpected properties of a new and nonobvious formulation” constituted additional, objective evidence of nonobviousness. Therefore, the Court affirmed the district court’s holding that the asserted claims would not have been obvious.

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