DCT

1:17-cv-00663

Almirall LLC v. Taro Pharmaceutical Industries Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00663, D. Del., 06/01/2017
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant conducts substantial business in the United States, intends to market its product in Delaware, and has purposefully availed itself of the jurisdiction, including by filing counterclaims in prior Delaware cases.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking to market a generic version of Plaintiff’s ACZONE® Gel, 7.5%, constitutes an act of patent infringement under the Hatch-Waxman Act.
  • Technical Context: The technology concerns topical pharmaceutical formulations for treating dermatological conditions like acne, specifically focusing on creating a stable, high-concentration gel.
  • Key Procedural History: The complaint was filed within 45 days of Plaintiff’s receipt of Defendant’s Paragraph IV certification notice, triggering a 30-month statutory stay of FDA approval for the generic product. Significantly, subsequent to the filing of this complaint, the U.S. Patent and Trademark Office instituted Inter Partes Review (IPR) proceedings against the patent-in-suit. An IPR certificate issued on September 26, 2022, confirms that all claims of the patent (1-8) have been cancelled, a development that is dispositive for this litigation.

Case Timeline

Date Event
2012-11-20 ’219 Patent Priority Date
2016-02-24 FDA approves Allergan's ACZONE® Gel, 7.5% (NDA No. 207154)
2016-12-13 ’219 Patent Issue Date
2017-06-01 Complaint Filing Date
2018-11-06 IPR2019-00207 filed against the '219 Patent
2019-06-07 IPR2019-01095 filed against the '219 Patent
2022-09-26 IPR Certificate issues, cancelling all claims of the '219 Patent

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

  • Patent Identification: U.S. Patent No. 9,517,219, "Topical Dapsone and Dapsone/Adapalene Compositions and Methods for Use Thereof," issued December 13, 2016.
  • The Invention Explained:
    • Problem Addressed: The patent describes challenges with creating effective topical dapsone compositions. Specifically, dapsone, an anti-inflammatory agent, can precipitate out of solution when combined with emollients or oils, which are often necessary to counteract the drying effect of topical treatments on the skin (’219 Patent, col. 5:27-34). This precipitation reduces the drug's effectiveness and can create a "gritty" texture disliked by users.
    • The Patented Solution: The invention is a topical gel formulation that solves the stability and solubility problem by combining dapsone with a specific solubilizing agent, diethylene glycol monoethyl ether, and a specific "polymeric viscosity builder," an acrylamide/sodium acryloyldimethyltaurate copolymer (’219 Patent, col. 5:45-54). This combination allows for a higher concentration of dapsone (e.g., 7.5%) to remain dissolved and stable, improving dermal delivery and aesthetic feel (’219 Patent, col. 5:55-62).
    • Technical Importance: The formulation enables a stable, high-strength (7.5%), once-daily dapsone product, addressing issues of patient compliance and treatment efficacy that can arise with less stable or lower-concentration formulations requiring more frequent application (’219 Patent, col. 5:35-44).
  • Key Claims at a Glance:
    • The complaint does not specify which claims are asserted, alleging infringement of "one or more claims" (’219 Patent, Compl. ¶33). Independent claims 1 and 6 are the most relevant to the accused product.
    • Independent Claim 1 (Method of Treatment):
      • A method for treating acne vulgaris or rosacea
      • by administering a topical pharmaceutical 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.
      • A negative limitation: "wherein the topical pharmaceutical composition does not comprise adapalene."
    • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Defendant Taro’s proposed generic version of ACZONE® Gel, 7.5%, as described in its ANDA No. 210191 ("Taro's ANDA Product") (Compl. ¶1).
  • Functionality and Market Context: The complaint alleges that Taro’s ANDA Product is a topical gel containing 7.5% dapsone for the treatment of acne vulgaris (Compl. ¶¶1, 16). As a generic drug submitted through an ANDA, it is intended to be a bioequivalent and lower-cost alternative to Allergan's branded ACZONE® Gel (Compl. ¶20). The complaint notes that at the time of filing, Allergan had not been granted access to the confidential details of Taro's ANDA and thus could not provide a more specific description of the product's formulation (Compl. ¶27).

IV. Analysis of Infringement Allegations

The complaint makes general allegations of infringement without providing an element-by-element comparison of any asserted claim to the accused product. The following chart is based on the statutory requirement that a generic product seeking approval via an ANDA must have the same active ingredient, strength, and dosage form as the reference listed drug (Allergan's ACZONE® Gel, 7.5%), which Plaintiff asserts is an embodiment of the ’219 Patent.

No probative visual evidence provided in complaint.

’219 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating a dermatological condition selected from the group consisting of acne vulgaris and rosacea The proposed product label for Taro's ANDA Product will allegedly instruct physicians and patients to administer the product for the treatment of acne vulgaris. ¶34 col. 16:1-8
about 7.5% w/w dapsone Taro's ANDA Product is a generic version of ACZONE® Gel, 7.5%, and is therefore alleged to contain approximately 7.5% by weight of the active ingredient dapsone. ¶1, ¶17 col. 16:9
about 30% w/w to about 40% w/w diethylene glycol monoethyl ether The complaint does not specify the excipients in Taro's ANDA product, but alleges on information and belief that the product will infringe, implying it contains the claimed components. ¶33 col. 16:10-12
about 2% w/w to about 6% w/w of a polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer The complaint alleges on information and belief that the formulation of Taro's ANDA Product falls within the scope of the patent's claims, which would require the presence of this specific viscosity builder. ¶33 col. 16:12-15
wherein the topical pharmaceutical composition does not comprise adapalene The complaint does not address this negative limitation directly, but infringement would require that Taro's ANDA Product is a dapsone-only formulation and does not contain adapalene. ¶33 col. 16:16-17
  • Identified Points of Contention:
    • Compositional Questions: A central question, absent the subsequent IPR, would have been factual: does the precise formulation in Taro’s confidential ANDA meet every concentration range and compositional element of the asserted claims? The complaint, filed before discovery, relies on the presumption of equivalence rather than direct evidence (Compl. ¶27).
    • Scope Questions: The interpretation of the term "about" would be critical. The court would need to determine the permissible range of deviation from the specified concentrations (e.g., "about 7.5%") for a finding of literal infringement.

V. Key Claim Terms for Construction

  • The Term: "about"

    • Context and Importance: This term appears before every concentration in Claim 1. Its scope is central to determining infringement, as Taro’s formulation could have concentrations that are bioequivalent to Allergan's product but numerically outside a strict reading of the claimed ranges. Practitioners may focus on this term to dispute whether minor variations in Taro's manufacturing process take its product outside the claim scope.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification uses ranges throughout (e.g., "about 5% w/w to about 10% w/w," col. 5:66-67), suggesting the inventors did not intend for the numbers to be rigid endpoints.
      • Evidence for a Narrower Interpretation: The patent provides specific working examples with precise concentrations (e.g., 7.5% dapsone, 35% diethylene glycol monoethyl ether in Table 3), which could be used to argue that "about" means only a very narrow range of deviation from these successfully tested values.

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

    • Context and Importance: This defines a key excipient. The dispute will question whether Taro's product uses the exact same class of polymer. A different, non-infringing polymer that achieves a similar viscosity could be a viable design-around strategy for a generic manufacturer.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term is functional ("viscosity builder") and compositional ("comprising..."), which could be argued to cover any polymer that performs the viscosity-building function and includes the specified copolymer.
      • Evidence for a Narrower Interpretation: The patent links the invention's success to this specific type of builder, distinguishing it from others like carbomers (’219 Patent, Example 1, Table 1). An example in the specification identifies a specific commercial product, Sepineo P 600, which could be argued to limit the scope of the term to that product or its direct equivalents (’219 Patent, Table 7).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Taro will induce infringement by "knowingly and intentionally includ[ing] a product label and insert containing instructions for administering Taro's ANDA Product" to patients for the treatment of acne (Compl. ¶34). It is also alleged that Taro will contribute to infringement by selling its product to resellers, pharmacies, and healthcare professionals (Compl. ¶34).
  • Willful Infringement: The complaint does not contain an explicit allegation of "willful" infringement. However, it does allege that Taro knows of the ’219 Patent and that its actions will encourage infringement, which are factual predicates for a potential willfulness claim based on post-suit conduct (Compl. ¶34).

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

  1. Mootness due to Patent Invalidation: The central, dispositive issue in this case is the post-filing cancellation of all claims of the ’219 Patent in Inter Partes Review. With no valid patent claims to enforce, the Plaintiff's infringement action is rendered moot, and a judgment of non-infringement or dismissal is the necessary outcome.

  2. Definitional Scope: Had the patent remained valid, a core issue would have been one of definitional scope: how broadly would the term "about" be construed? The outcome of that construction would likely determine whether Taro's specific formulation, as detailed in its ANDA, literally infringes the patent's concentration ranges.

  3. Compositional Identity: An essential evidentiary question would have been one of compositional identity: does the excipient used by Taro as a viscosity builder fall within the scope of the claimed "polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer," or does it represent a non-infringing alternative?