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Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd.

No Bar Against Utilizing Inherency With an Obviousness Combination

Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd., __ F.3d __, 2019 WL 7202688 (Fed. Cir. Dec. 27, 2019) (O’Malley, REYNA, Chen) (D. Del.: Bryson) (2 of 5 stars)

Fed Cir affirms Hatch-Waxman judgment of obviousness. Perison’s patents relate to treating, with extended-release hydrocodone formulations, pain in patients with compromised liver functionality. The district court did not err in finding one limitation inherently present in Alvogen’s combination of references. Inherency is not limited to circumstances where all limitations save one are in a single reference. The opinion also reviews the record and finds no clear error in the district court’s obviousness findings. That the district court placed its discussion of objective indicia of nonobviousness after its discussion of obviousness was not incorrect because “the substance of the court’s analysis makes clear that it properly considered the totality of the obviousness evidence in reaching its conclusion.” Op. at 18. The opinion reviews the objective indicia record and finds no clear error. The opinion also rejects Persion’s contention that the obviousness determination was in tension with the district court’s analysis of written description (which the Fed Cir does not reach as moot), and criticizes Persion for selective quotation and omission of context in describing the district court’s analysis.

KEYWORDS: HATCH-WAXMAN; OBVIOUSNESS (YES); INHERENCY