DCT

1:20-cv-00006

Almirall LLC v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00006, N.D. W. Va., 01/09/2020
  • Venue Allegations: Venue is based on Defendant's incorporation and principal place of business in West Virginia, rendering it "at home" in the district.
  • Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's ACZONE® Gel constitutes an act of infringement of a patent covering a method of using the topical formulation.
  • Technical Context: The technology concerns a specific topical pharmaceutical formulation of dapsone, an anti-inflammatory and antibacterial agent, for the treatment of skin conditions such as acne vulgaris.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Mylan's Paragraph IV certification asserting that Almirall's patent is invalid, unenforceable, or will not be infringed. Subsequent to the filing of this complaint, the U.S. Patent and Trademark Office issued an Inter Partes Review Certificate on September 26, 2022, cancelling all claims (1-8) of the patent-in-suit. This post-filing event is dispositive of the infringement claim.

Case Timeline

Date Event
2012-11-20 ’219 Patent Priority Date
2016-02-24 FDA Approval for Plaintiff's ACZONE® NDA
2016-12-13 U.S. Patent No. 9,517,219 Issued
2019-11-26 Plaintiff receives Defendant's Paragraph IV Notice Letter
2020-01-09 Complaint Filed
2022-09-26 USPTO issues Inter Partes Review Certificate cancelling all claims

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,517,219 - "Topical Dapsone and Dapsone/Adapalene Compositions and Methods for Use Thereof"

  • Patent Identification: U.S. Patent No. 9,517,219, entitled "Topical Dapsone and Dapsone/Adapalene Compositions and Methods for Use Thereof," issued December 13, 2016 (the "’219 Patent").

The Invention Explained

  • Problem Addressed: The patent's background section describes challenges with topical dapsone formulations. Specifically, it notes that adding emollients or oils to counteract the drying effect of dapsone can cause the active ingredient to precipitate out of the composition, reducing efficacy and stability ('219 Patent, col. 2:26-34).
  • The Patented Solution: The invention claims to solve this problem through a composition that uses diethylene glycol monoethyl ether as a solubilizing agent to support a higher concentration of dissolved dapsone, combined with a specific type of "polymeric viscosity builder" (an acrylamide/sodium acryloyldimethyltaurate copolymer). This combination is described as improving the composition's aesthetics by reducing the particle size and "gritty" feeling, while also minimizing the yellowing that can occur with solubilized dapsone ('219 Patent, col. 2:49-61).
  • Technical Importance: The formulation aims to provide a stable, effective, and aesthetically pleasing high-concentration dapsone gel, thereby improving patient compliance and therapeutic outcomes for common skin conditions ('219 Patent, col. 1:40-54).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the ’219 Patent (Compl. p. 6, ¶(a)). All eight claims of the patent were cancelled in a 2022 inter partes review proceeding. The key independent claims at the time of filing were Claims 1 and 6.
  • Independent Claim 1: A method for treating acne vulgaris or rosacea by administering a topical composition comprising:
    • about 7.5% w/w dapsone;
    • about 30% w/w to about 40% w/w diethylene glycol monoethyl ether;
    • about 2% w/w to about 6% w/w of a polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer; and
    • water.
  • Independent Claim 6: A method for treating acne vulgaris or rosacea by administering a topical composition comprising the same ingredients as Claim 1, but with the polymeric viscosity builder present at a specific concentration of "about 4% w/w."
  • The complaint makes general allegations covering all claims and does not reserve rights to specific dependent claims (Compl. ¶35).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendant Mylan's generic dapsone gel, 7.5% drug product, as described in Abbreviated New Drug Application (ANDA) No. 213847 (the "ANDA Product") (Compl. ¶¶1-2).

Functionality and Market Context

  • The ANDA Product is a topical pharmaceutical preparation for the treatment of acne vulgaris (Compl. ¶31). The complaint alleges that Mylan's ANDA seeks approval for a generic version of Almirall's ACZONE® Gel, 7.5% and relies on data demonstrating the bioequivalence of the two products (Compl. ¶¶24-25). The complaint does not provide specific details regarding the formulation or excipients of the ANDA Product itself.

IV. Analysis of Infringement Allegations

The complaint is a notice pleading filed under the Hatch-Waxman Act and does not contain a detailed claim chart or specific factual allegations mapping elements of the Mylan formulation to the patent's claim limitations. The central allegation is that the submission of the ANDA, which seeks FDA approval to market the ANDA Product for a use claimed in the ’219 Patent, constitutes a statutory act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶33). The use of the ANDA product by physicians and patients for treating acne vulgaris would allegedly directly infringe the method claims of the patent (Compl. ¶32).

The complaint does not provide sufficient detail for a tabular analysis of the infringement allegations.

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Technical Questions: A primary factual question, unaddressed in the complaint, is the precise composition of Mylan's ANDA product. The infringement analysis would depend entirely on whether Mylan's formulation contains the specific solubilizer and polymeric viscosity builder within the concentration ranges required by the asserted claims.
    • Scope Questions: Had the patent remained valid, a likely point of contention would be the scope of the term "polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer." The court would have to determine if Mylan's chosen thickening agent, whatever it may be, falls within the construction of this limitation.

V. Key Claim Terms for Construction

  • The Term: "about 30% w/w to about 40% w/w diethylene glycol monoethyl ether"

  • Context and Importance: This limitation defines the concentration of the key solubilizing agent. The term "about" is a frequent subject of claim construction, and its interpretation would be critical in determining whether a Mylan formulation with a concentration slightly outside the specified 30-40% range could still be found to infringe.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification discusses various concentration ranges, such as "about 25% w/w to about 40% w/w" and "about 30% w/w to about 40% w/w," suggesting some flexibility ('219 Patent, col. 5:58-63). Parties favoring a broader scope might argue these disclosures indicate the endpoints are not absolute.
    • Evidence for a Narrower Interpretation: The patent's examples test specific concentrations of 30%, 35%, and 40% ('219 Patent, Tables 2, 4). Parties favoring a narrower scope could argue that these embodiments, tied to achieving specific results like avoiding precipitation, suggest that "about" should be construed narrowly to encompass only minor variations that preserve the invention's stated advantages.

  • The Term: "polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer"

  • Context and Importance: This term defines a required excipient in the formulation. The infringement analysis hinges on whether the thickening agent in Mylan's ANDA Product meets this definition. Practitioners may focus on this term because the choice of an alternative, non-infringing thickener is a common design-around strategy in pharmaceutical formulation.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent identifies this copolymer as one type of "polymeric viscosity builder" and notes that "useful compositions include dapsone and/or adapalene in a polymeric viscosity builder" ('219 Patent, col. 2:46-48), potentially suggesting the specific copolymer is an exemplary, not exclusive, agent.
    • Evidence for a Narrower Interpretation: The independent claims expressly recite this specific copolymer. Further, Example 5 discloses a composition using "Sepineo P 600," a commercial embodiment of this copolymer, which could be used to argue the claim is tied to this specific chemical structure and its properties ('219 Patent, Table 7).

VI. Other Allegations

  • Indirect Infringement: The complaint is premised on a theory of induced infringement. The statutory act of infringement is Mylan's filing of the ANDA under § 271(e)(2) (Compl. ¶33). The underlying tortious act that would occur upon approval is inducement, as Mylan's product label would allegedly instruct physicians and patients to "use... the ANDA Product" to treat acne vulgaris, a method claimed by the ’219 Patent (Compl. ¶¶31-32).
  • Willful Infringement: The complaint does not explicitly allege willful infringement. It does, however, request a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶40). The basis for this allegation is not detailed in the pleading.

VII. Analyst’s Conclusion: Key Questions for the Case

The resolution of this case is dictated by a single, dispositive procedural event that occurred after the complaint was filed. The key questions that defined the dispute at its inception have been rendered moot.

  1. A core issue is now one of mootness: with all asserted claims of the ’219 Patent cancelled by the USPTO in an inter partes review, there is no longer an enforceable patent right upon which an infringement claim can be based. The case cannot proceed on the merits of infringement.

  2. A secondary question, had the patent survived, would have been one of claim construction: could the term "polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer" be construed to read on the specific excipient used in Mylan's ANDA product?

  3. A final question would have been evidentiary: what is the actual, complete formulation of Mylan's generic product? The answer to this factual question, which would be obtained through discovery, would have been necessary to perform the infringement analysis against the construed claims.