Digest of Allergan, Inc. v. Sandoz Inc., No. 2014-1275 (Fed. Cir. Aug. 4, 2015) (precedential). On appeal from E.D. Tex. Before Lourie, Linn, and Hughes.
Procedural Posture: Appellants-defendants appealed final judgment of infringement and validity. CAFC affirmed.
- Obviousness: The district court properly held that the asserted claims were not obvious. When a claimed composition falls within a range disclosed by the prior art, the patentee bears the burden of production to show that there would not have been any motivation to select the claimed composition from the range. Ample evidence supported the district court’s factual finding that the prior art taught away from using 200 ppm BAK in a bimatoprost formulation, even though that amount was within the range disclosed in the prior art. The record also supported the district court’s finding that the claimed formulation exhibited unexpected results in the form of previously unknown and unexpected properties of a new and nonobvious formulation.
- Written Description: The district court properly held certain claims not invalid for lack of written description. The specification disclosed the particular ingredients as one of the best modes of the invention, and one of ordinary skill in the art could recognize the claimed formulation in the specification. Although the specification did not describe the claimed clinical profile limitations, these features were inherent properties of the formulation and therefore did not need to be described.
- Enablement: The district court properly held claims not invalid for lack of enablement. The disclosures in the specification of in vivo and in vitro data, and a constructive example showing certain results, demonstrated utility and permitted a skilled artisan to make and use the claimed invention without undue experimentation. Appellants’ assertion that a finding of nonobviousness meant the claims could not have been enabled was incorrect, as the obviousness inquiry turns on the prior art while the enablement inquiry turns on the specification.
- Infringement: The district court correctly found literal infringement. The accused product had a pH of 6.8–7.2 during shelf life, satisfying the claim limitation “pH of about 7.3,” which the parties had agreed should be construed as “pH of approximately 7.3.”