ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC 

U.S. Patent 9,517,219 relates to methods of treating acne or rosacea with dapsone formulations that include a specific thickening agent and solvent, and recites the negative limitation “wherein the topical pharmaceutical composition does not comprise adapalene.” Amneal filed a petition for inter partes review of the ’219 patent, arguing that claims 1–8 would have been obvious. The Board ultimately concluded that Amneal demonstrated by a preponderance of the evidence that claims 1– 8 of the ’219 patent are unpatentable and Almirall appealed. Almirall contends that the Board erred in presuming obviousness based on overlapping ranges. The CAFC notes that in the absence of evidence indicating that there is something special or critical about the claimed range, an overlap suffices to show that the claimed range was disclosed in—and therefore obvious in light of—the prior art, finds that the Board did not err in applying a presumption of obviousness of overlapping ranges.  Almirall also argues that the Board’s obviousness determinations were unsupported by substantial evidence because although the prior art does not indicate that any of its formulations include adapalene, more is needed for a disclosure of a negative claim limitation. After pointing out that a reference need not state a feature’s absence in order to disclose a negative limitation, the CAFC finds that it was reasonable for the Board to find that, in the context of the prior art, a skilled artisan would recognize that the reference discloses a complete formulation—excluding the possibility of an additional active ingredient, and concludes that the Board did not err in concluding that prior art discloses the negative adapalene claim limitation. The CAFC was also not persuaded that the Board erred in analyzing the evidence provided by Amneal and its impact on whether a skilled artisan would have had a reasonable expectation of success in combining these prior art teachings to achieve the claimed invention. Accordingly, the CAFC affirms.

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