The district court found the asserted claims not invalid as obvious, reasoning that Sandoz presented substantially the same arguments and evidence in an earlier dispute with Allergan in which we held that claim 4 of the '149 patent recited an efficacy limitation that is neither suggested nor inherent in any prior art in the record. J.A. 74-76; see also Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1293-94 (Fed. Cir. 2013). Relying on that precedential decision, the court found that all asserted claims recited analogous efficacy limitations, neither suggested nor inherent in prior art produced by Sandoz.

On appeal, the Federal Circuit found the '463 patent, which claimed the timolol/ brimonidine combination, invalid as obvious. See Allergan, Inc. v. Sandoz Inc. ("Combigan® I Appeal"), 726 F.3d 1286, 1294 (Fed. Cir. 2013). However, unlike the '463 patent, claim 4 of the '149 patent contained the additional limitation that the "daily number of doses of brimonidine be reduced from 3 to 2 times a day without loss of efficacy."

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.

The determination of obviousness is a legal conclusion based on underlying facts. Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1290-91 (Fed. Cir. 2013). After a bench trial, we review the district court's factual findings for clear error and its conclusions of law de novo. Honeywell Int'l, Inc. v. United States, 609 F.3d 1292, 1297 (Fed. Cir. 2010).

The determination of obviousness is a legal conclusion based on underlying facts. Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1290-91 (Fed. Cir. 2013). After a bench trial, we review the district court's factual findings for clear error and its conclusions of law de novo.

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.”).

Allergan and Sandoz both appealed the Court's ruling to the Federal Circuit. See Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286 (Fed. Cir. 2013). On appeal, the Federal Circuit reversed-in-part, finding that the asserted claims of the '463 patent were invalid as obvious.

Allergan and Sandoz both appealed the Court's ruling to the Federal Circuit. SeeAllergan, Inc. v. Sandoz Inc. , 726 F.3d 1286 (Fed.Cir.2013). On appeal, the Federal Circuit reversed-in-part, finding that the asserted claims of the '463 patent were invalid as obvious.

SANDOZ INC., et al., petitioners, v. ALLERGAN, INC.Case below, 726 F.3d 1286. Petition for writ of certiorari to the United States Court of Appeals for the Federal Circuit denied.

This court has previously "consider[ed] the failure of others to obtain FDA approval as relevant objective indicia of non-obviousness." Allergan, Inc. v. Sandoz Inc. , 726 F.3d 1286, 1291 (Fed. Cir. 2013). None of the FDA, the district court, the panel majority, nor the defendant Teva, identified any teaching or suggestion by the FDA (or anyone else) of the Narcan ® composition and method.