PTAB

IPR2019-00207

Amneal Pharmaceuticals LLC v. Almirall LLC

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1. Case Identification

2. Patent Overview

  • Title: Topical Dapsone Compositions for Treating Dermatological Conditions
  • Brief Description: The ’219 patent discloses methods for treating acne vulgaris or rosacea by administering a topical pharmaceutical composition. The composition comprises specific concentrations of dapsone (about 7.5% w/w), ethoxydiglycol (30-40% w/w), an acrylamide/sodium acryloyldimethyl taurate copolymer (2-6% w/w), water, and does not comprise adapalene.

3. Grounds for Unpatentability

Ground 1: Claims 1-8 are obvious over Garrett in view of Nadau-Fourcade.

  • Prior Art Relied Upon: Garrett (International Publication No. WO 2009/061298) and Nadau-Fourcade (International Publication No. WO 2010/072958).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Garrett taught nearly all limitations of the challenged claims, including a topical dapsone composition for treating acne and rosacea. Garrett disclosed overlapping concentration ranges for dapsone (5-10% w/w) and ethoxydiglycol (10-30% w/w), the use of water, and the absence of adapalene. The only element Garrett did not explicitly teach was the use of the specific claimed acrylamide copolymer as a thickening agent, instead suggesting known hydrophilic gelling agents like Carbopol. Nadau-Fourcade was alleged to supply this missing element by teaching that the claimed acrylamide copolymer is a "preferred" thickening agent for topical compositions containing water-insoluble drugs like dapsone.
    • Motivation to Combine: Petitioner contended a POSITA would combine Garrett and Nadau-Fourcade to select an optimal thickening agent for the dapsone formulation in Garrett. Garrett directs a POSITA to use known hydrophilic thickeners, and Nadau-Fourcade identifies the claimed copolymer as a preferred and interchangeable option for Carbopol-type thickeners in the context of stabilizing water-insoluble drugs. This created a simple and direct path to the claimed invention.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because both references focus on solving the same technical problem (formulating topical compositions for water-insoluble drugs). Nadau-Fourcade’s express preference for the claimed copolymer for this purpose would confirm its suitability and predictability when substituted into Garrett’s base composition.

Ground 2: Claims 1-8 are obvious over Garrett in view of Bonacucina.

  • Prior Art Relied Upon: Garrett (WO 2009/061298) and Bonacucina (a 2009 AAPS PharmaSciTech journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: As in the first ground, Garrett was asserted to disclose the base composition and method of treatment. The petition argued that Bonacucina provided the specific claimed acrylamide copolymer (Sepineo P 600) and the reasoning for its use. Bonacucina described this copolymer as a "prime candidate" for topical gels, noting its ability to form stable, aesthetically superior compositions that are "very pleasant for the touch and spread on the skin."
    • Motivation to Combine: A POSITA would be motivated to improve the formulation taught by Garrett by addressing known issues with its suggested thickeners. For example, Carbopol-based gels (like the prior art Aczone Gel 5%) were known to be "gritty" and required an undesirable neutralization step using a caustic base during manufacturing. Petitioner argued that Bonacucina taught that the claimed acrylamide copolymer solved these problems by providing a smooth texture and not requiring neutralization. This provided a clear motivation to substitute the thickener in Garrett with the superior one taught by Bonacucina.
    • Expectation of Success: A POSITA would have a high expectation of success because Bonacucina’s teachings directly addressed known formulation drawbacks of the thickeners in Garrett. The predictable improvements in texture and manufacturing simplicity would make the combination a straightforward and successful design choice.

4. Key Claim Construction Positions

  • Petitioner asserted that the term "acne vulgaris," found in claims 1, 5, 6, and 8, should be construed to mean "acne consisting of inflammatory or non-inflammatory lesions."
  • This construction was argued to be critical because it aligns the scope of the claims with the teachings of the prior art, particularly Garrett, which explicitly disclosed using dapsone compositions to treat both inflammatory and non-inflammatory acne.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued against discretionary denial under 35 U.S.C. §314(a), stating that the petition was the first challenge to the ’219 patent and was not a follow-on petition presenting a tactical delay.
  • Petitioner also contended that denial under 35 U.S.C. §325(d) was inappropriate. The core prior art references central to the petition’s arguments, Nadau-Fourcade and Bonacucina, were never before the examiner during original prosecution. Therefore, the patentability of the claims had never been tested against the specific combinations and motivations asserted in the petition.

6. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-8 of Patent 9,517,219 as unpatentable under pre-AIA 35 U.S.C. §103.