DCT

3:20-cv-00343

Almirall LLC v. Zydus Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:20-cv-00343, D.N.J., 01/09/2020
  • Venue Allegations: Venue is alleged based on Defendant Zydus USA’s incorporation in New Jersey and its regular and established place of business within the district.
  • Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to market a generic 7.5% dapsone gel constitutes an act of infringement of a patent covering the formulation of Plaintiff’s branded ACZONE® Gel product.
  • Technical Context: The technology concerns topical pharmaceutical formulations for treating dermatological conditions like acne, specifically focusing on methods to achieve a high concentration of an active ingredient in a stable and cosmetically acceptable gel.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a Paragraph IV Notice Letter from Defendants in November 2019, which asserted that the patent-in-suit was invalid and/or would not be infringed. Inter Partes Review (IPR) proceedings were previously filed against the patent-in-suit at the U.S. Patent and Trademark Office (IPR2019-00207 and IPR2019-01095). These proceedings ultimately concluded with a certificate issued on September 26, 2022, confirming the cancellation of all claims of the patent.

Case Timeline

Date Event
2012-11-20 U.S. Patent No. 9,517,219 Priority Date
2016-02-24 FDA approves Almirall’s ACZONE® New Drug Application (NDA)
2016-12-13 U.S. Patent No. 9,517,219 issues
2018-11-06 IPR proceeding (IPR2019-00207) filed against the '219 patent
2019-06-07 IPR proceeding (IPR2019-01095) filed against the '219 patent
2019-11-26 Almirall receives Defendants’ Paragraph IV Notice Letter (on or about)
2020-01-09 Complaint Filing Date
2022-09-26 IPR Certificate issues, cancelling all claims of the '219 patent

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, "Topical Dapsone and Dapsone/Adapalene Compositions and Methods for Use Thereof," issued December 13, 2016.

The Invention Explained

  • Problem Addressed: The patent’s background section explains that creating effective topical compositions of the anti-inflammatory agent dapsone is difficult because efforts to make them less drying by adding emollients can cause the dapsone to precipitate, reducing the product's effectiveness ('219 Patent, col. 2:27-34).
  • The Patented Solution: The invention addresses this problem by using a specific combination of ingredients: a high concentration of a solubilizing agent (diethylene glycol monoethyl ether) and a "polymeric viscosity builder." This combination is described as enabling a high concentration of dapsone (e.g., 7.5%) to remain solubilized in a stable composition that also possesses improved aesthetics, such as a less "gritty" feel upon application ('219 Patent, col. 2:46-61).
  • Technical Importance: This formulation strategy allowed for the development of a high-strength topical dapsone product that could deliver a therapeutic dose while remaining stable and cosmetically suitable for patient use ('219 Patent, col. 2:49-54).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the ’219 patent (Compl. ¶42; Prayer for Relief (a)). The patent contains two independent method claims, Claim 1 and Claim 6.
  • Independent Claim 1 recites the following essential elements:
    • 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;
    • water; and
    • wherein the composition does not comprise adapalene.
  • The complaint does not explicitly reserve the right to assert dependent claims, but its general allegation covers all claims.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' "generic dapsone gel, 7.5% drug product," which is the subject of Abbreviated New Drug Application (ANDA) No. 214019 submitted to the FDA (Compl. ¶1-2).

Functionality and Market Context

  • The complaint alleges that the Zydus ANDA Product is a generic version of Plaintiff's ACZONE® Gel, 7.5%, and that the ANDA filing contains data to demonstrate its bioequivalence (Compl. ¶31-32). The product is intended for use by physicians and patients for the treatment of acne vulgaris (Compl. ¶38). The filing of the ANDA itself, seeking approval to market this generic product prior to the expiration of the ’219 patent, is the statutory act of infringement alleged in this Hatch-Waxman action (Compl. ¶40).

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart. The infringement theory is based on the statutory infringement defined in 35 U.S.C. § 271(e)(2), where the submission of an ANDA for a drug claimed in a patent is an act of infringement. The allegations suggest that the proposed label for the ANDA product will instruct for an infringing use, and the product's formulation will meet the composition limitations of the asserted claims.

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 Zydus ANDA seeks approval to market the ANDA Product for use by physicians and patients for the treatment of acne vulgaris. ¶38 col. 15:40-16:2
...comprising administering to a subject...a topical pharmaceutical composition comprising: about 7.5% w/w dapsone; The accused product is identified as a "dapsone gel, 7.5% drug product." ¶2 col. 16:3-5
...about 30% w/w to about 40% w/w diethylene glycol monoethyl ether; The complaint does not specify the concentration of this excipient in the ANDA product, but alleges the product is a generic version of and bioequivalent to the ACZONE® product, which is covered by the patent. ¶32 col. 16:6-7
...about 2% w/w to about 6% w/w of a polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer; and water; The complaint does not provide specific details on the excipients in the ANDA product, but relies on the allegation that it is a generic, bioequivalent version of the patented product. ¶32 col. 16:8-11
...wherein the topical pharmaceutical composition does not comprise adapalene. The complaint describes the ANDA Product solely as a "dapsone gel, 7.5%," which does not suggest the presence of the excluded ingredient adapalene. ¶2 col. 16:12-13
  • Identified Points of Contention:
    • Technical Questions: A central factual question, not answerable from the complaint alone, is whether the precise formulation of the Zydus ANDA product meets every compositional limitation of the asserted claims. The complaint relies on the alleged bioequivalence between the generic and branded products to support an inference of infringement, rather than providing direct evidence of the ANDA product's composition (Compl. ¶32).
    • Scope Questions: The interpretation of the term "about" as it applies to the concentration of each claimed ingredient could become a key issue. The court would need to determine the permissible range of deviation from the recited percentages for a finding of literal infringement.

V. Key Claim Terms for Construction

  • The Term: "about"
  • Context and Importance: This term qualifies every quantitative limitation in the asserted claims (e.g., "about 7.5%," "about 30% w/w to about 40% w/w"). The scope of this term is therefore critical to the infringement analysis, as it dictates how closely the Zydus formulation must match the claimed concentrations. Practitioners may focus on this term because even small differences in formulation could be dispositive of infringement if "about" is construed narrowly.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification frequently uses "about" when describing concentration ranges, such as "about 5% w/w to about 10% w/w dapsone" ('219 Patent, col. 5:40-41), which may suggest the patentee did not intend the claim values to be rigid endpoints but to encompass standard manufacturing tolerances.
    • Evidence for a Narrower Interpretation: The claims recite specific numerical values and ranges, such as "about 7.5% w/w dapsone" and "about 30% w/w to about 40% w/w diethylene glycol monoethyl ether" ('219 Patent, col. 16:5-7). The specificity of these numbers, tied to a commercially successful formulation, could be used to argue that "about" should be interpreted narrowly to mean very little deviation from the recited values.

VI. Other Allegations

  • Indirect Infringement: The complaint asserts method-of-treatment claims. The infringement allegation is necessarily one of induced infringement under 35 U.S.C. § 271(b). The complaint alleges that Zydus is seeking approval to market its product for the treatment of acne vulgaris (Compl. ¶38) and that this use constitutes a method claimed by the patent (Compl. ¶39). The basis for inducement would be the instructions and indications on the ANDA product's proposed label, which would allegedly encourage physicians and patients to perform the infringing method.
  • Willful Infringement: The complaint does not explicitly allege "willful infringement." However, it does request a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶47). The factual basis for this request would likely be Defendants' knowledge of the ’219 patent, which is listed in the FDA's Orange Book, and the act of filing an ANDA with a Paragraph IV certification despite this knowledge.

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

  • A core issue for this litigation, arising after the complaint was filed, is the viability of the patent itself. The subsequent cancellation of all claims of the '219 patent in IPR proceedings is a dispositive event. A key question is how the district court case proceeded and was ultimately resolved in light of the parallel and ultimately successful invalidity challenge at the U.S. Patent and Trademark Office.
  • Setting aside the patent’s validity, a central evidentiary question would have been one of compositional identity: does the formulation in Zydus's ANDA, whose specific details are not disclosed in the complaint, contain every ingredient within the claimed concentration ranges? The case would depend on whether Zydus's product formulation literally meets the limitations of the claims, particularly given the potential dispute over the scope of the term "about."