DCT

2:25-cv-13775

Azurity Pharma Inc v. MSN Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:

  • Case Identification: 2:25-cv-13775, D.N.J., 07/25/2025

  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant MSN Pharmaceuticals Inc. maintains its principal place of business in the state.

  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's FLEQSUVY® oral suspension product constitutes an act of infringement of patents related to stable liquid pharmaceutical formulations of baclofen.

  • Technical Context: The technology at issue involves liquid oral suspensions of the muscle relaxant baclofen, developed as a stable and palatable alternative for patients, such as children and the elderly, who have difficulty swallowing solid pills.

  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' notification to Plaintiff of their ANDA submission. The complaint was filed within the statutory 45-day window, triggering a potential 30-month stay of FDA approval for the generic product. The complaint also describes a pre-litigation dispute regarding allegedly unreasonable confidentiality restrictions proposed by Defendants for access to the technical details of their ANDA filing.

Case Timeline

Date Event
2016-09-09 Priority Date for '696 and '246 Patents
2022-05-10 '696 Patent Issued
2022-09-20 '246 Patent Issued
2025-06-XX Defendants' ANDA Notice Letter Sent to Plaintiff
2025-07-25 Complaint Filed

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

U.S. Patent No. 11,324,696 - Suspensions and Diluents for Metronidazole and Baclofen, Issued May 10, 2022

The Invention Explained

  • Problem Addressed: The patent's background describes the challenge faced by patients who cannot swallow solid medications like tablets or capsules, a common issue in pediatric and geriatric populations (Compl. ¶20; ’696 Patent, col. 4:1-11). Extemporaneously compounded liquid formulations often suffer from poor stability, non-uniform drug concentration, and unpleasant taste, which can lead to inaccurate dosing and patient non-compliance (’696 Patent, col. 4:12-19).
  • The Patented Solution: The invention provides a specific liquid pharmaceutical composition for oral administration that is designed to be stable and homogenous over time. The formulation uses a precise combination of excipients—including hydroxyethyl cellulose as a thickener, a citrate buffer to control pH, simethicone emulsion to reduce foaming, and sucralose as a sweetener—to suspend the active ingredient, baclofen, in water (’696 Patent, Abstract; col. 3:26-34). This specific recipe aims to ensure consistent dosage and improve palatability compared to ad-hoc compounded alternatives (’696 Patent, col. 4:26-32).
  • Technical Importance: The claimed formulation offers a standardized, ready-to-use liquid oral solution that overcomes the key drawbacks of both solid dosage forms and pharmacy-compounded liquids, thereby improving the safety and efficacy of baclofen administration for vulnerable patient populations (’696 Patent, col. 4:51-61).

Key Claims at a Glance

  • The complaint alleges infringement generally, but such actions typically center on the independent claims. The only independent claim is Claim 1.
  • Claim 1 recites a liquid pharmaceutical composition with the following essential elements:
    • 5 mg/ml of baclofen or a salt thereof
    • 0.12% (w/v) of citric acid (anhydrous)
    • 0.5% (w/v) of hydroxyethyl cellulose
    • 5% (w/v) of propylene glycol
    • 0.15% (w/v) of simethicone emulsion (30%)
    • 0.1% (w/v) of sodium benzoate
    • 0.2% (w/v) of sucralose
    • water
    • A pH between 3.0 and 6.0
    • A stability requirement wherein the composition retains less than +/-5% variation of baclofen concentration for at least 30 days when stored at room temperature, as measured by a USP assay.

U.S. Patent No. 11,446,246 - Suspensions and Diluents for Metronidazole and Baclofen, Issued September 20, 2022

The Invention Explained

  • Problem Addressed: The patent addresses the same underlying issue as the ’696 Patent: the need for a reliable oral liquid dosage form of baclofen for patients with dysphagia (’246 Patent, col. 4:1-11). For a condition like spasticity, inconsistent dosing from unstable liquid formulations can lead to poor control of muscle spasms, pain, and stiffness (’246 Patent, col. 5:7-16).
  • The Patented Solution: This patent claims a method of treating spasticity by administering the specific baclofen formulation detailed in the patent. Rather than claiming the composition itself, this patent protects the act of using that specific, stable, and homogenous liquid formulation for its intended therapeutic purpose (’246 Patent, Abstract; Claim 1). The invention thus links the technical advantages of the formulation directly to a clinical application.
  • Technical Importance: By claiming the method of treatment, the patent provides a different scope of protection than a pure composition patent. It aims to cover the end-use of a generic product that is formulated in the same specific manner, connecting the formulation's technical properties to its prescribed medical use (’246 Patent, col. 4:51-61).

Key Claims at a Glance

  • The complaint’s allegations are general. The only independent claim is Claim 1.
  • Claim 1 recites a method of treating spasticity by administering a liquid oral pharmaceutical composition, where the composition includes the exact same list of ingredients, concentrations, pH, and stability requirements as Claim 1 of the ’696 Patent.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendants' proposed generic version of Azurity's FLEQSUVY® product, which is the subject of Abbreviated New Drug Application (ANDA) No. 220553 submitted to the FDA (Compl. ¶2).

Functionality and Market Context

  • The "ANDA Product" is described as a generic oral suspension of baclofen (Compl. ¶2). The complaint alleges that by filing the ANDA, Defendants have necessarily represented that their product has the same active ingredient as and is bioequivalent to Plaintiff's FLEQSUVY® product (Compl. ¶30).
  • The intended function of the ANDA Product is for the treatment of spasticity resulting from conditions such as multiple sclerosis, which is the FDA-approved indication for FLEQSUVY® (Compl. ¶20). The complaint alleges that Defendants intend to commercially manufacture and sell the ANDA product in the United States upon receiving FDA approval (Compl. ¶28).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or a detailed element-by-element analysis of infringement. Instead, it bases its infringement allegations on the statutory framework of the Hatch-Waxman Act, where the submission of an ANDA is itself an act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶40, 45). The core allegation is that the product described in ANDA No. 220553, if approved and marketed, would infringe one or more claims of the patents-in-suit (Compl. ¶41, 46). The complaint notes that Defendants have not provided access to the technical details of the ANDA product, stating that Defendants' notice letter contained only a conclusory statement of non-infringement (Compl. ¶36-37).

No probative visual evidence provided in complaint.

Identified Points of Contention

  • Factual Question: The central dispute will be whether the specific formulation detailed in the confidential ANDA No. 220553 contains every ingredient at the exact concentrations required by the asserted claims. This includes not only the chemical components but also the functional limitations, raising the question of whether the ANDA product meets the claimed pH range and stability profile ("less than +/-5% variation... for at least 30 days").
  • Scope Question: For the '246 Patent's method claim, a key question will be whether the proposed labeling for the ANDA product instructs or encourages physicians and patients to administer the drug for the "treatment of spasticity," which may support a finding of induced infringement.

V. Key Claim Terms for Construction

The Term: "simethicone emulsion (30%)"

(asserted in Claim 1 of both patents)

  • Context and Importance: This term specifies not only the ingredient (simethicone emulsion) but also the concentration of the active simethicone within the raw material emulsion. The infringement analysis may turn on whether the simethicone emulsion used in the ANDA product is a 30% concentration. Practitioners may focus on this term because any deviation by the defendant could form a basis for a non-infringement argument, raising questions about the materiality of the parenthetical "30%".
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Narrower Interpretation: The explicit recitation of "(30%)" in the claim language suggests a specific choice by the inventors. The patent’s examples also specify the use of a "30%" simethicone emulsion, potentially limiting the scope to this exact concentration (’246 Patent, col. 9:52-53).
    • Evidence for a Broader Interpretation: The specification describes the function of simethicone emulsion as minimizing foam formation during manufacturing and storage (’246 Patent, col. 5:27-35). A party could argue that this functional purpose is the core of the invention and that other commercially available concentrations of simethicone emulsion that achieve the same result should be considered equivalent.

The Term: "retains less than +/-5% variation of baclofen concentration measured by a USP assay for at least 30 days"

(asserted in Claim 1 of both patents)

  • Context and Importance: This functional limitation defines the required stability of the composition. The dispute will likely focus on the precise methodology and conditions under which this stability is tested. Practitioners may focus on this term because "a USP assay" could refer to multiple testing protocols, and the calculation of "variation" could be debated.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Narrower Interpretation: Defendants may argue that the scope of this limitation is defined by the specific testing conditions and results disclosed in the patent's examples (’246 Patent, Tables 3-6). Any deviation in testing protocol could be argued to place an accused product outside the claim scope.
    • Evidence for a Broader Interpretation: The patent states a general objective of improving homogeneity and stability (’246 Patent, col. 4:26-32). Plaintiff may argue that the term "a USP assay" should be given its plain meaning, encompassing any standard, recognized USP protocol for measuring drug concentration, and that the +/-5% threshold is the critical, defining feature.

VI. Other Allegations

Indirect Infringement

The complaint alleges that upon FDA approval, Defendants’ commercial sale of the ANDA Product with its proposed labeling will induce infringement of the '246 method patent by directing healthcare providers and patients to use the product for the patented method of treating spasticity (Compl. ¶46). The basis for intent is Defendants' alleged knowledge of the patents prior to filing the ANDA (Compl. ¶47).

Willful Infringement

The complaint does not contain a formal count for willful infringement. However, it alleges that Defendants had "actual and constructive knowledge" of the patents-in-suit prior to filing their ANDA and possessed "specific intent to infringe" (Compl. ¶42, 47). These allegations lay the groundwork for a potential future claim for enhanced damages, and the prayer for relief requests a finding that this is an "exceptional case" under 35 U.S.C. § 285 (Compl. Prayer for Relief ¶E).

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

  • A primary issue will be one of factual correspondence: does the precise formulation disclosed in Defendants’ confidential ANDA No. 220553 meet every quantitative and functional limitation of the asserted claims, particularly the specific excipient percentages and the claimed stability profile of less than +/-5% variation over 30 days?
  • A threshold procedural question will be one of access to evidence: the dispute over the confidentiality terms for accessing the ANDA file, as described in the complaint, must be resolved before the technical merits of the infringement allegations can be fully developed and litigated.
  • For the '246 method patent, a central question will be one of induced infringement: does the proposed product labeling submitted with the ANDA provide sufficient direction to users to practice the claimed "method of treating spasticity," thereby establishing Defendants' intent to induce infringement by third parties?