PTAB

IPR2019-01095

Mylan Pharmaceuticals Inc v. Almirall LLC

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1. Case Identification

2. Patent Overview

  • Title: Method for Treating a Dermatological Condition
  • Brief Description: The ’219 patent discloses methods for treating dermatological conditions like acne vulgaris and rosacea by administering a topical pharmaceutical composition. The composition comprises about 7.5% dapsone, a diethylene glycol monoethyl ether (ethoxydiglycol) solvent, and an acrylamide/sodium acryloyldimethyl taurate copolymer as a viscosity builder.

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 every element of the claimed invention. Garrett disclosed topical dapsone compositions for treating acne and rosacea, comprising dapsone within the claimed concentration range (5-10% w/w), water, and ethoxydiglycol in an overlapping range (10-30% w/w). Garrett also taught the use of various polymeric thickeners but did not specifically name the claimed acrylamide copolymer. Nadau-Fourcade remedied this by teaching that the claimed acrylamide copolymer is a "preferred" gelling agent for topical compositions containing water-insoluble active ingredients like dapsone, and that it is interchangeable with the Carbopol-type thickeners disclosed in Garrett.
    • Motivation to Combine: Petitioner contended that a person of ordinary skill in the art (POSITA) would combine Garrett and Nadau-Fourcade because both relate to topical formulations for water-insoluble drugs. A POSITA would have been motivated to substitute one of the general thickening agents taught in Garrett with the specific, preferred acrylamide copolymer taught by Nadau-Fourcade to achieve a stable and effective topical dapsone composition. This substitution was presented as a predictable choice between known, interchangeable alternatives for a desired function.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success. The components were known to be compatible, and their functions in topical formulations were well-understood. Replacing one known thickener (Carbopol) with another preferred, interchangeable thickener (acrylamide copolymer) would have been a routine formulation step with predictable results, particularly since Nadau-Fourcade taught its suitability for drugs like dapsone.

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

  • Prior Art Relied Upon: Garrett (WO 2009/061298) and Bonacucina ("Characterization and Stability of Emulsion Gels Based on Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer," a June 2009 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: As in Ground 1, Garrett provided the base formulation for a topical dapsone composition to treat acne and rosacea. Petitioner argued that the Carbopol-type thickeners disclosed in Garrett were known to produce "gritty" compositions and required a neutralization step (adding a base like sodium hydroxide) to function, adding manufacturing complexity. Bonacucina taught that the claimed acrylamide copolymer (under the trade name Sepineo P 600) was a "prime candidate" for topical gels, provided superior rheological properties, resulted in smooth compositions, and did not require a neutralization step.
    • Motivation to Combine: A POSITA would have been motivated to replace the Carbopol thickener of Garrett with the acrylamide copolymer taught in Bonacucina for several reasons: (1) to improve the final product's texture and patient feel by avoiding the "gritty" quality associated with Carbopol; (2) to simplify the manufacturing process by eliminating the need for a neutralization step; and (3) to create a more stable and aesthetically pleasing "gel-cream" composition, as taught by Bonacucina.
    • Expectation of Success: Petitioner asserted a high expectation of success. Bonacucina explicitly identified the claimed copolymer as a "prime candidate" for topical formulations, highlighting its favorable gelling properties and stability. Combining this superior thickener with the known dapsone formulation from Garrett was argued to be a straightforward path to an improved, yet obvious, composition with predictable benefits.

4. Key Claim Construction Positions

  • Petitioner proposed that the term "acne vulgaris," as used in claims 1, 5, 6, and 8, should be construed to mean "acne consisting of inflammatory or non-inflammatory lesions." This construction was based on the patent’s specification and the understanding in the art, ensuring that prior art references discussing the treatment of either type of acne lesion were directly applicable to the challenged claims.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial under §314(a) or §325(d) was not warranted. It was contended that this was the first time the ’219 patent was challenged and that the primary prior art references, Nadau-Fourcade and Bonacucina, were never considered by the examiner during the original prosecution. Furthermore, Petitioner asserted its combination rationales were more specific and compelling than the general arguments for functional equivalence made by the examiner.

6. Relief Requested

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