And, although we recognize that obtaining specific results or outcomes in a population of patients could have been one motivation for modifying the protocol—indeed, it seems that it was Janssen's motivation—the motivation analysis does not look only to the data the patentee found significant. Cf. KSR, 550 U.S. at 420, 127 S.Ct. 1727; Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1292 (Fed. Cir. 2013) ("There is no requirement in patent law that the person of ordinary skill be motivated to develop the claimed invention based on a rationale that forms the basis for FDA approval."). While we do not make an initial finding about the level of background information a POSA would require to be motivated to modify an existing dosing regimen for a psychiatric patient in need of treatment, it is different from (and almost certainly less demanding than) the level of information desired by a POSA in deciding whether to redesign a Phase III clinical trial to obtain approval for a dosing regimen's use across a population of patients of varying weights.

And, although we recognize that obtaining specific results or outcomes in a population of patients could have been one motivation for modifying the protocol-indeed, it seems that it was Janssen's motivation-the motivation analysis does not look only to the data the patentee found significant. Cf. KSR, 550 U.S. at 420; Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1292 (Fed. Cir. 2013) (“There is no requirement in patent law that the person of ordinary skill be motivated to develop the claimed invention based on a rationale that forms the basis for FDA approval.”).

After a bench trial, appellate review of the district court's factual findings is for clear error, and conclusions of law receive de novo review. Allergan, Inc. v. Sandoz Inc. , 726 F.3d 1286, 1290 (Fed. Cir. 2013) (citation omitted). Invalidity of an issued patent must be shown by clear and convincing evidence.

To prove obviousness, a party must show that a skilled artisan would have been motivated to combine the prior art teachings to create the claimed treatment method with a reasonable expectation of success. SeeAllergan, Inc. v. Sandoz Inc. , 726 F.3d 1286, 1291 (Fed. Cir. 2013). The improvement over prior art must be "more than the predictable use of prior art elements according to their established functions."