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."

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.

Accordingly, the Opinion and Order of the U.S. District Court for the District of New Jersey is Sandoz’s argument that the District Court erred by considering this Court’s earlier decisions in Allergan, Inc. v. Sandoz Inc. , 726 F.3d 1286 (Fed. Cir. 2013), and Allergan Sales, LLC v. Sandoz, Inc. , 717 F. App'x 991 (Fed. Cir. 2017), Appellant’s Br. 62–67, is mistaken. Indeed, the District Court was well within its discretion to consider those decisions concerning related patents to support its claim construction determination.

Because a thrice-weekly 40mg injection would result in a total weekly dose very close to that in the already-approved daily 20mg injection—120mg/week versus 140mg/week—the district court found a POSITA would have had a reasonable expectation of success in pursuing the thrice-weekly dose frequency in terms of effectiveness, patient adherence, and FDA approval. Id. at *19 (quoting Allergan, Inc. v. Sandoz Inc ., 726 F.3d 1286, 1291 (Fed. Cir. 2013) ("The potential for FDA approval also may properly be considered, as it was here, in determining whether one of ordinary skill would be motivated to develop a drug product and whether there was skepticism regarding the efficacy of such a product.") ). The district court gave appropriate weight to the testimony of Dr. Green regarding patient compliance with thrice-weekly administrations and the Rebif® regimen, noting that "[e]ven though Rebif® is a different MS drug with a different mechanism of action, ... those in the art would still be motivated to try dosing GA three times a week based on the higher rates of patient adherence to the Rebif® therapy."

Obviousness under 35 U.S.C. § 103 is a question of law based on underlying questions of fact. Allergan, Inc.v. Sandoz Inc. , 726 F.3d 1286, 1290 (Fed. Cir. 2013). Watson and Sandoz accept the legal framework under which they had to establish that, as of February 2008, a person of ordinary skill in the art would have had a reasonable expectation that the processes claimed would succeed in their (claimed) aims, a factual issue.

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.

“[T]he person of ordinary skill need only have a reasonable expectation of success of developing the claimed invention.” Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1292 (Fed.Cir.2013) (emphasis added). The ' 029 patent is not limited to compounds with a C1–amide group, such as bimatoprost or the broader class of compounds described in the ' 819 patent.