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Almirall, LLC v. Amneal Pharms. LLC

Almirall, LLC v. Amneal Pharms. LLC

United States Court of Appeals for the Federal Circuit

March 14, 2022, Decided

2020-2331

Opinion

 [*268]  Lourie, Circuit Judge.

Almirall, LLC ("Almirall") appeals from the final written decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board (the "Board") holding that claims 1-8 of U.S. Patent 9,517,219 (the "'219 patent") would have been obvious over the cited prior art at the time the alleged invention was made.1 See Amneal Pharms. LLC v. Almirall, LLC, No. IPR2019-00207, 2020 Pat. App. LEXIS 12502, 2020 WL 2833274 (P.T.A.B. May 29, 2020) ("Decision"). For the reasons provided below, we affirm.

Background

Almirall owns the '219 patent, which relates to methods of treating acne or rosacea with dapsone formulations that include an acrylamide/sodium [**2]  acryloyldimethyl taurate copolymer ("A/SA") thickening agent and the solvent diethylene glycol monoethyl ether ("DGME"). Dapsone can be used for treating various dermatological conditions. '219 patent, col. 1 ll. 19-23. DGME allows compositions to be prepared with increased solubilized concentrations of dapsone. Id. at col. 2 ll. 48-50. A polymeric viscosity builder such as an A/SA agent can minimize the intensity of yellowing of the composition. Id. at col. 2, ll. 54-61. It can also influence dapsone crystallization by reducing the particle size and minimizing a gritty feel upon application. See id.

Adapalene is a compound used for treating dermatological conditions, sometimes in combination with dapsone. See Decision 2020 Pat. App. LEXIS 12502, [WL] at *18. The '219 patent includes 62 generalized composition embodiments, '219 patent, col. 6 l. 58—col. 12 l. 40, and eight specific example formulations, id. at col. 12 l. 42-col. 15 l. 33. Several of the examples are described as including adapalene.

Independent claims 1 and 6 read as follows:

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28 F.4th 265 *; 2022 U.S. App. LEXIS 6416 **; 2022 U.S.P.Q.2D (BNA) 252; 2022 WL 760555

ALMIRALL, LLC, Appellant v. AMNEAL PHARMACEUTICALS LLC, AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, Appellees, ANDREW HIRSHFELD, PERFORMING THE FUNCTIONS AND DUTIES OF THE UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor

Prior History:  [**1] Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2019-00207, IPR2019-01095.

Disposition: AFFIRMED.

CORE TERMS

skill, formulations, gelling, composition, dapsone, ordinary person, adapalene, ranges, thickening, overlapping, argues, carbomer, reasonable expectation, expert testimony, concentration, copolymer, discloses, pharmaceutical, teaches, substantial evidence, comprising, combine, acne, prior art, dermatological, substitution, predictable, interchangeable, viscosity, treating

Administrative Law, Judicial Review, Standards of Review, Substantial Evidence, Patent Law, US Patent & Trademark Office Proceedings, Appeals, Jurisdiction & Review, De Novo Review, Infringement Actions, Burdens of Proof, Nonobviousness, Evidence, Prima Facie Obviousness, Inferences & Presumptions, Elements & Tests, Prior Art, Claims, Claim Language, Elements & Limitations, Fact & Law Issues, Predictability