Almirall, LLC v. Amneal Pharmaceuticals LLC et al. (USPTO as Intervenor)
Docket No. 2020-2331 (IPR2019-00207, -01095 (https://cafc.uscourts.gov/opinions-orders/20-2331.OPINION.3-14-2022_1920940.pdf)
LOURIE, CHEN, CUNNINGHAM
March 14, 2022
Brief Summary: Board IPR FWD finding Almirall’s method of treatment claims obvious affirmed (e.g., “overlapping ranges”, negative limitation need not be disclosed by prior art).
Summary: Almirall appealed PTAB (“Board”) final written decision (FWD) holding claims 1-8 of US 9,517,219 directed to methods for using daposone formulations to treat dermatological conditions (e.g., acne, rosacea using 2-6% “of a polymeric viscosity builder” and not comprising adapalene”) would have been obvious over the combination of two PCT applications (“Garrett” and “Nadau-Fourcade”) and/or a publication (“Bonacucina”). The FC panel explained that “the Board’s decision hinged on whether a person of ordinary skill in the art would have found it obvious to substitute an A/SA agent taught by Nadau-Fourcade or Bonacucina for the carbomer gelling agent in Garrett’s formulations to arrive at the claimed composition” while “Garrett does not teach using an A/SA agent as its polymeric viscosity builder” and “identifies five other preferred gelling agents, including Carbopol®”. The Board determined that the combination of references “teach or suggest every claim limitation and that a person of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to incorporate Nadau-Fourcade’s A/SA gelling agent into Garrett’s dapsone formulations.” The Board also relied on expert testimony to find that “Carbopol® and Sepineo® ‘perform the same function and are interchangeable’ and that ‘such a substitution was routine and predictable because such thickening agents were known for use in topical compositions with water insoluble drugs’” (e.g., “good reasons to pursue a replacement for Carbopol®…Carbopol® was known to have drawbacks… Sepineo®’s advantages would have motivated a person of skill to replace Carbopol® with Sepineo®” with a reasonable expectation of success; “overlapping ranges”). The FC panel also explained that “[t]he Board also agreed with Amneal that Garrett teaches the negative adapalene claim limitation” (e.g., “it is not Garrett’s mere silence as to the presence of adapalene, but its disclosure of complete dapsone formulations to treat acne in its absence that suggests that adapalene is not included in Garrett’s formulations”). Almirall argued in this appeal that “the Board erred in presuming obviousness based on overlapping ranges” as the presumption relied on multiple references but it “applies only when a single reference discloses all claimed ranges” (Iron Grip, FC 2004). Amneal argued that “structurally and functionally similar compounds can establish a prima facie case of obviousness” (Valeant, FC 2020; Anacor, FC 2018) and “the obviousness inquiry is flexible and does not require that all elements be shown in a single reference.” The FC panel explained that “[a] prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art” (In re Peterson, FC 2003) unless “there is something special or critical about the claimed range” (E.I. du Pont, FC 2018), and found no error with the Board’s decision. Alimirall also argued that the Board “failed to account for the negative adapalene claim limitation” but the FC panel explained that “a reference need not state a feature’s absence in order to disclose a negative limitation” (AC Techs., FC 2019) and “it was reasonable for the Board to find that, in the context of Garrett, a skilled artisan would recognize that the reference discloses a complete formulation—excluding the possibility of an additional active ingredient” (Novartis, FC 2022; “It is undisputed that Garrett discloses dapsone formulations that lack adapalene.”) The FC panel also concluded that “[t]he record demonstrates that A/SA copolymers would have been predictable design choices that a person of ordinary skill would have considered for development of topical dapsone formulations” (KSR, US 2007) and would have had a reasonable expectation of success in doing so (OSI Pharms., FC 2019). The Board decision was therefore affirmed.