ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC

Before Lourie, Chen, and Cunningham. Appeal from the Patent Trial and Appeal Board.

Summary: Presumption of obviousness based on overlapping ranges applied where a prior-art reference disclosed an element in the claimed range that was similar but not identical to the claimed element.

Amneal petitioned for inter partes review of Almirall’s patent. The challenged claims recite methods of skin treatment using topical formulations of compounds in certain concentrations. These compounds include a copolymer called A/SA, which acts as a thickening agent. Amneal argued that the challenged claims were obvious over a patent publication called Garrett in view of either two secondary references. With one exception, Garrett discloses each claimed compound in concentrations that encompass, overlap with, or abut the concentrations claimed. The exception is that Garrett does not teach using A/SA as its thickening agent; instead, the preferred thickening agent in Garrett is a polymer in a class called carbomer. Each secondary reference discloses using A/SA as a thickening agent in concentrations that overlap with the claimed concentrations. The Board applied a presumption of obviousness based on overlapping ranges and found that Almirall did not overcome that presumption. It therefore held the challenged claims unpatentable. Almirall appealed.

On appeal, Almirall argued that the Board erred in presuming obviousness based on overlapping ranges. Specifically, it argued that Garrett does not disclose ranges for A/SA thickeners and therefore no single reference discloses all of the claimed ranges. The Court disagreed. It cited the Board’s factual findings of similarity between Garrett’s carbomer thickeners and the claimed A/SA thickeners, noting expert testimony that supported those findings. Separately, the Court noted that the case does not depend on overlapping ranges but is simply a case of substituting one known thickening agent for another. It held there was substantial evidence that a person of ordinary skill in the art would have been motivated to combine Garrett with either of the secondary references to arrive at the claims with a reasonable expectation of success. Accordingly, the Federal Circuit affirmed the Board’s obviousness determination.

Editor: Paul Stewart

Written by: Joshua C. Loader & Justin J. Gillett