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."
Rather, a POSA need only have a "reasonable expectation of success in developing [the claimed invention]." Allergan, Inc. v. Sandoz, Inc., 726 F.3d 1286, 1292 (Fed. Cir. 2013). Here, the patentee broadly claimed the use of 4-AP to achieve blood levels having any "therapeutic effect."
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.
. Relying on Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1293 (Fed. Cir. 2013), the Board concluded that Infineum's unexpected results evidence was not meaningful in view of the fact that Toshikazu "provide[d] a strong reason to use low levels of molybdenum in combination with an organic ashless nitrogen-free friction modifier." Decision, 2019 WL 5806946, at *14.
Id. at *13 (quoting J.A. 825). Relying on Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1293 (Fed. Cir. 2013), the Board concluded that Infineum's unexpected results evidence was not meaningful in view of the fact that Toshikazu "provide[d] a strong reason to use low levels of molybdenum in combination with an organic ashless nitrogen-free friction modifier." Decision, 2019 WL 5806946, at *14.
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.
“[T]he problem motivating the patentee may be only one of many addressed by the patent's subject matter.” Id. at 420; see Janssen Pharm., Inc. v. Teva Pharm. USA, Inc., 97 F.4th 915, 929 (Fed. Cir. 2024) (“A motivation ‘may be found in many different places and forms.'” (quoting Allergan, Inc. v. Sandoz, Inc., 726 F.3d 1286, 1292 (Fed. Cir. 2013)). “What matters is the objective reach of the claim.” KSR, 550 U.S. at 419.
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.”).