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."
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.
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. Motivation to combine may be found in many different places and forms; it cannot be limited to those reasons the FDA sees fit to consider in approving drug applications.Allergan, Inc. v. Sandoz Inc. , 726 F.3d 1286, 1292 (Fed. Cir. 2013). While FDA approval may be relevant to the obviousness inquiry, see id. at 1291–92, a lack of FDA approval cannot negate an otherwise apparent motivation to formulate a product.
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.
To prove obviousness, a party must show that a person having ordinary skill in the art (PHOSITA) would be motivated to combine the claimed combinations with a reasonable expectation of success. Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1291 (Fed.Cir.2013). Evidence of obviousness, especially when that evidence is proffered in support of an “obvious-to-try” theory, is insufficient unless it indicates that the possible options skilled artisans would have encountered were “finite,” “small,” or “easily traversed,” and “that skilled artisans would have had a reason to select the route that produced the claimed invention.”
To prove obviousness, Watson must show that a PHOSITA would be motivated to combine the claimed combinations with a reasonable expectation of success. Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1291 (Fed. Cir. 2013). Evidence of obviousness, especially when that evidence is proffered in support of an "obvious-to-try" theory, is insufficient unless it indicates that the possible options skilled artisans would have encountered were "finite," "small," or "easily traversed," and "that skilled artisans would have had a reason to select the route that produced the claimed invention."
To prove obviousness, Watson must show that a PHOSITA would be motivated to combine the claimed combinations with a reasonable expectation of success. Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1291 (Fed.Cir.2013). Evidence of obviousness, especially when that evidence is proffered in support of an “obvious-to-try” theory, is insufficient unless it indicates that the possible options skilled artisans would have encountered were “finite,” “small,” or “easily traversed,” and “that skilled artisans would have had a reason to select the route that produced the claimed invention.”
To prove obviousness, Defendants must show that a person skilled in the art would be motivated to combine the claimed combinations with a reasonable expectation of success. Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1291 (Fed. Cir. 2013). Evidence of obviousness, especially when that evidence is proffered in support of an "obvious-to-try" theory, is insufficient unless it indicates that the possible options skilled artisans would have encountered were "finite," "small," or "easily traversed," and that skilled artisans would have had a reason to select the route that produced the claimed invention.