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Last week, the Federal Circuit issued an opinion in <a href="https://cafc.uscourts.gov/opinions-orders/20-2331.OPINION.3-14-2022_1920940.pdf"><em>Almirall, LLC v. Amneal Pharmaceuticals LLC</em></a>, No. 2020-2331 (March 14, 2022), affirming the Board’s obviousness determination.

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Appellant Almirall owns the U.S. Patent No. 9,517,219 (the “’219 patent”), which discloses methods for treating acne or rosacea with a topical composition containing claimed concentrations or concentration ranges of: dapsone; an A/SA thickening agent; and DGME as a solvent. The claims at issue also recite that the composition does not include adapalene.

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Amneal petitioned for <em>inter partes</em> review, arguing claims 1-8 were obvious over either the combination of references identified as Garrett and Nadau-Fourcade or Garrett and a publication identified as Bonacucina. Garrett teaches topical dapsone treatment for skin conditions using carbomer thickening agents, rather than A/SA. Nadau-Fourcade describes topical compositions for dermatologic use and lists both carbomers and A/SA as exemplary thickening agents. Bonacucina presents research on specific A/SA compositions with self-gelling and thickening properties that are effective for topical administration.

The Board found a person of 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 to arrive at the composition claimed by the ’219 patent. The Board also found that Garrett teaches the negative adapalene claim limitation.

Almirall appealed, arguing the Board erred in presuming obviousness of the claimed component concentrations based on overlapping ranges between the ’219 patent and the prior art, and that the Board’s obviousness determinations were not supported by substantial evidence.

The Court rejected Almirall’s first argument, finding substantial evidence supported the Board’s conclusion. The Court further noted the outcome would be unchanged without the presumption of obviousness because this is simply a case of substituting one known gelling agent for another, subject to conventional experimentation.

The Court then rejected Almirall’s arguments that the Board erred in finding the claims obvious over either Garrett and Nadau-Fourcade (Ground 1) or Garrett and Bonacucina (Ground 2). First, the Court found it reasonable to conclude Garrett teaches the negative adapalene claim limitation, because a skilled artisan would read Garrett as disclosing a complete formulation and excluding the possibility of an additional active ingredient. Second, the Court found the record amply supported the conclusions that there would have been a motivation to combine and reasonable expectation of success on both Ground 1 and Ground 2. The Court thus affirmed the Board’s finding of invalidity.

CAFC Affirms Board’s Obviousness Finding for Acne Treatment

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