Almirall, LLC v. Amneal Pharmaceuticals, LLC, No. 20-2331 (Fed. Cir. 2022)Annotate this Case
Almirall’s patent relates to methods of treating acne or rosacea with dapsone formulations that include an acrylamide/sodium acryloyldimethyl taurate copolymer (A/SA) thickening agent and the solvent diethylene glycol monoethyl ether (DGME), which allows compositions to be prepared with increased solubilized concentrations of dapsone. A polymeric viscosity builder such as an A/SA, can minimize the yellowing of the composition and can reduce the particle size, and minimize a gritty feel upon application. The Almirral patent includes 62 generalized composition embodiments and eight specific example formulations.
On inter partes review, the Patent Trial and Appeal Board agreed that claims 1–8 would have been obvious over prior art at the time the alleged invention was made. The Federal Circuit affirmed. The Board’s decision sets forth factual findings of similarity between carbomers and A/SA agents that support its conclusion that prior art discloses a range for each component of the composition that either fully encompasses or overlaps/abuts the ranges and amounts for those components recited in the challenged claims, sufficient to create a presumption of obviousness. The court upheld the Board’s analysis of whether a skilled artisan would have had a reasonable expectation of success in combining prior art teachings to achieve the claimed invention.