DCT

1:20-cv-00975

Almirall LLC v. Perrigo Uk FINCO Ltd Partnership

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: *Almirall, LLC v. Perrigo UK FINCO Limited Partnership*, D. Del., 07/22/2020
  • Venue Allegations: Venue is alleged to be proper based on Defendant Perrigo having previously availed itself of the jurisdiction by participating in other lawsuits in the district, purposefully directing activities at residents of Delaware, and being "at home" in the jurisdiction.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's ACZONE® Gel, 7.5% constitutes an act of infringement of a patent covering topical dapsone compositions.
  • Technical Context: The technology relates to pharmaceutical gel formulations for treating dermatological conditions like acne, specifically focusing on creating stable, effective topical compositions of the active ingredient dapsone.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff Almirall's receipt of a Paragraph IV Notice Letter from Defendant Perrigo, which asserted that the patent-in-suit is invalid, unenforceable, or would not be infringed by Perrigo's proposed generic product. Notably, the patent-in-suit was the subject of two inter partes review (IPR) proceedings filed at the U.S. Patent and Trademark Office. These proceedings ultimately resulted in a certificate issued on September 26, 2022, confirming that all claims of the patent have been cancelled.

Case Timeline

Date Event
2012-11-20 ’219 Patent Priority Date
2016-02-24 FDA Approval of Plaintiff's ACZONE® NDA
2016-12-13 U.S. Patent No. 9,517,219 Issued
2018-11-06 *Amneal Pharmaceuticals LLC v. Almirall, LLC* Filed against '219 Patent
2019-06-07 *Mylan Pharmaceuticals Inc. v. Almirall, LLC* Filed against '219 Patent
2020-06-08 Plaintiff receives Defendant's Paragraph IV Notice Letter
2020-07-22 Complaint Filing Date
2022-09-26 IPR Certificate Cancelling All Claims of '219 Patent Issued

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,” Issued December 13, 2016

The Invention Explained

  • Problem Addressed: The patent describes the difficulty in creating effective topical compositions containing the anti-inflammatory agent dapsone. Specifically, dapsone has low solubility, and attempts to formulate it can lead to precipitation of the drug, while typical topical formulations can also act as drying agents, irritating the skin. (’971 Patent, col. 2:27-34).
  • The Patented Solution: The invention proposes a topical composition that uses a specific solubilizer—diethylene glycol monoethyl ether—to prepare compositions with higher concentrations of solubilized dapsone. (’971 Patent, col. 2:49-54). To counteract potential yellowing and dapsone crystallization caused by this solubilizer, the invention further incorporates a "polymeric viscosity builder," which improves the aesthetics and stability of the final gel product. (’971 Patent, col. 2:55-61).
  • Technical Importance: The claimed formulation aimed to provide a stable, high-concentration (e.g., 7.5%) dapsone gel with improved cosmetic properties (less "gritty" feel), enabling effective treatment of dermatological conditions like acne vulgaris. (’971 Patent, col. 2:59-61, col. 5:45-52).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" without specifying which ones (Compl. ¶31; Prayer for Relief (a)). The patent contains two independent method of treatment claims, 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;
    • wherein the topical pharmaceutical composition does not comprise adapalene.
  • Independent Claim 6: A method for treating acne vulgaris or rosacea by administering a topical composition comprising:
    • about 7.5% w/w dapsone;
    • about 30% w/w diethylene glycol monoethyl ether;
    • about 4% w/w of a polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer; and
    • water;
    • wherein the topical pharmaceutical composition does not comprise adapalene.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant Perrigo’s proposed generic "dapsone gel, 7.5% drug product" (the "ANDA Product"), for which Perrigo seeks FDA approval via Abbreviated New Drug Application No. 212657 (Compl. ¶1-2).

Functionality and Market Context

The complaint alleges that Perrigo's ANDA Product is a generic version of Almirall's ACZONE® Gel, 7.5%, a topical product used to treat acne vulgaris (Compl. ¶2, ¶18). The ANDA filing relies upon the ACZONE® New Drug Application (NDA) and contains data intended to demonstrate the bioequivalence of the ANDA Product to Almirall's approved product (Compl. ¶23). The act of infringement alleged is the submission of the ANDA itself, which seeks approval to market this generic product prior to the expiration of the ’219 patent (Compl. ¶31).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a full element-by-element infringement analysis. It does not identify specific claims asserted or map elements of any claim to features of the accused ANDA product. The infringement allegation is a statutory one under the Hatch-Waxman Act, 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 (Compl. ¶31).

The core of Almirall's infringement theory is that the use of Perrigo's ANDA Product, as described in its application to the FDA, will constitute a method of treatment as claimed in the ’219 patent (Compl. ¶30). The complaint asserts that Perrigo's ANDA seeks approval for a product to be used by physicians and patients for treating acne vulgaris, the same indication covered by the patent's method claims (Compl. ¶29). Infringement will therefore depend on whether the formulation detailed in Perrigo’s confidential ANDA contains the specific ingredients at the specific concentrations required by the claims of the ’219 patent.

Identified Points of Contention

  • Scope Questions: A central question is whether the formulation of Perrigo's proposed generic product, as defined in its ANDA, falls within the specific weight-by-weight percentage ranges recited in the independent claims for dapsone, diethylene glycol monoethyl ether, and the polymeric viscosity builder.
  • Technical Questions: A key factual dispute would concern the composition of Perrigo's gelling agent. The analysis would question whether it is, in fact, an "acrylamide/sodium acryloyldimethyl taurate copolymer" as required by the claims, or a different "polymeric viscosity builder" that falls outside the claim scope.

V. Key Claim Terms for Construction

Term: "polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer" (from Claim 1)

Context and Importance

The identity and composition of the viscosity builder is a central element of the claimed invention, distinguished from prior art thickeners like Carbopol. (’971 Patent, col. 10:45-59). The infringement analysis will depend on whether the gelling agent used in Perrigo's ANDA product meets this definition. Practitioners may focus on this term to determine if Perrigo designed around the patent by using a chemically distinct, non-infringing polymer.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The patent uses the general term "polymeric viscosity builder" in the summary, suggesting the specific copolymer is one example of a broader class. (’971 Patent, col. 2:45-47).
  • Evidence for a Narrower Interpretation: The claims explicitly recite a specific copolymer ("acrylamide/sodium acryloyldimethyl taurate copolymer"). (’971 Patent, col. 16:9-11). Furthermore, the patent discloses a specific commercial product, Sepineo P 600, as an example of such a builder, potentially limiting the scope to that product or its direct equivalents. (’971 Patent, col. 15, Table 7).

Term: "wherein the topical pharmaceutical composition does not comprise adapalene" (from Claim 1)

Context and Importance

This negative limitation is critical for defining the scope of the invention and distinguishing it from potential combination therapies. The patent discloses embodiments that do contain adapalene, but the asserted claims explicitly carve it out. (’971 Patent, col. 7:27-29, col. 16:13-14). Infringement requires that Perrigo's ANDA product is free of adapalene.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation (i.e., any amount is excluded): The plain language "does not comprise" suggests a complete absence of adapalene. Any detectable amount, even an impurity, could be argued to fall outside the claim.
  • Evidence for a Narrower Interpretation (i.e., excludes only therapeutic amounts): A defendant might argue that the term should be construed in the context of the patent to mean the composition does not contain a therapeutically effective amount of adapalene, potentially allowing for trace or incidental amounts. The patent discusses adapalene as an active ingredient, which could support this narrower reading. (’971 Patent, col. 6:1-4).

VI. Other Allegations

Indirect Infringement

The complaint does not contain a separate count for indirect infringement but requests a judgment that the commercialization of the ANDA Product will "induce, and/or contribute to infringement" (Prayer for Relief (d)). The factual basis for inducement is the allegation that Perrigo's ANDA Product is intended for treating acne vulgaris, and its product labeling will necessarily instruct physicians and patients to administer the gel in a manner that performs the patented method. (Compl. ¶29-30).

Willful Infringement

The complaint does not use the term "willful infringement" but alleges that the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285. (Compl. ¶38). The implicit basis for this allegation is Perrigo's act of filing the ANDA with a Paragraph IV certification, which demonstrates knowledge of the ’219 patent. (Compl. ¶24-25).

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

The subsequent cancellation of all claims of the '219 patent in inter partes review proceedings is a dispositive event for this litigation. However, analyzing the dispute as framed by the complaint at the time of its filing reveals two central questions:

  1. A threshold legal question concerns the impact of the parallel IPR proceedings, which were pending when the complaint was filed and ultimately invalidated the patent-in-suit, raising the primary issue of whether a live controversy exists.
  2. A core substantive issue would have been one of formulation scope: does the specific chemical composition of Perrigo's proposed generic product, as detailed in its confidential ANDA submission, meet every limitation of the asserted method claims, including the precise ingredient concentrations and the negative requirement that the formulation "does not comprise adapalene"?