DCT

2:24-cv-08809

Azurity Pharma Inc v. Annora Pharma Private Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-08809, D.N.J., 08/28/2024
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign corporation, and also cites Defendant's continuous business contacts with New Jersey and history of engaging in patent litigation in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic vancomycin hydrochloride oral solution constitutes an act of infringement of seven patents related to liquid formulations of the drug.
  • Technical Context: The technology concerns stable, ready-to-use liquid oral formulations of vancomycin, an antibiotic used to treat serious intestinal infections, which provides an alternative to solid capsules for patients with difficulty swallowing.
  • Key Procedural History: The litigation was triggered by a July 15, 2024 notice letter from Annora to Azurity, informing Azurity of its ANDA filing seeking approval to market a generic version of Azurity's FIRVANQ® product. The complaint notes a dispute over the terms of confidential access to the ANDA, which may indicate that the precise details of the accused formulation are a central issue.

Case Timeline

Date Event
2014-03-14 Earliest Priority Date ('028, '046, '946, '947, '948, '949, '692 Patents)
2019-12-03 U.S. Patent No. 10,493,028 Issued
2020-06-23 U.S. Patent No. 10,688,046 Issued
2021-03-30 U.S. Patent Nos. 10,959,946, 10,959,947, 10,959,948, 10,959,949 Issued
2023-05-02 U.S. Patent No. 11,638,692 Issued
2024-07-15 Annora sends Notice Letter to Azurity regarding ANDA filing
2024-08-28 Complaint Filing Date

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

U.S. Patent No. 10,493,028 - “Composition and Method for Vancomycin Oral Liquid”

Issued December 3, 2019

The Invention Explained

  • Problem Addressed: The patent background describes the difficulty of administering solid oral dosage forms of vancomycin (e.g., capsules) to pediatric and geriatric populations and the challenges associated with compounding oral solutions from vancomycin powder intended for injection, which is described as cumbersome, time-consuming, and prone to contamination. (’028 Patent, col. 5:1-50).
  • The Patented Solution: The invention is a non-sterile, stable liquid formulation of vancomycin hydrochloride created by combining a pre-measured powder with a specifically formulated liquid solution containing excipients such as a buffering agent, sweetener, flavoring agent, and preservative. (’028 Patent, col. 2:25-43, 60-68). This solution is designed to be homogenous and stable for at least 30 days at both ambient and refrigerated temperatures, improving patient compliance and safety over traditional compounding methods. (’028 Patent, col. 2:25-30).
  • Technical Importance: The invention provides a standardized, shelf-stable oral liquid product that avoids the inconsistencies and contamination risks of ad-hoc pharmacy compounding, thereby improving accessibility for patients unable to swallow capsules. (’028 Patent, col. 5:50-65).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims, but Claim 1 is the first independent composition claim.
  • Essential elements of Independent Claim 1:
    • A non-sterile stable liquid formulation for oral administration, consisting of:
    • (a) 0.1-0.4% w/v anhydrous citric acid,
    • (b) water,
    • (c) 0.1-0.3% w/v sucralose,
    • (d) 0.01-0.1% w/v of a flavoring agent,
    • (e) 0.08-0.2% w/v sodium benzoate,
    • (f) 0.0001-0.0003% w/v of a dye, and
    • (g) vancomycin hydrochloride,
    • wherein the formulation is homogenous and stable for at least 30 days at ambient and refrigerated conditions, has a pH of 2.5-4.5, and a vancomycin concentration of 25-50 mg/ml.
  • The complaint makes general allegations of infringement without specifying any claims, a common practice in initial ANDA complaints.

U.S. Patent No. 10,688,046 - “Composition and Method for Vancomycin Oral Liquid”

Issued June 23, 2020

The Invention Explained

  • Problem Addressed: The ’046 Patent addresses the same technical problems as the ’028 Patent, namely the drawbacks of solid dosage forms and the challenges of extemporaneous compounding of vancomycin oral liquids. (’046 Patent, col. 5:3-50).
  • The Patented Solution: The patent describes a stable liquid formulation of vancomycin composed of specific excipients designed to ensure stability and palatability. The solution is explicitly described as homogenous and stable for at least two weeks at ambient and refrigerated temperatures. (’046 Patent, Abstract; col. 10, claim 1). The described kit components in Figure 1 illustrate a system for combining the active pharmaceutical ingredient with a pre-formulated diluent. (’046 Patent, Fig. 1).
  • Technical Importance: As with the ’028 Patent, this technology provides a reliable, ready-to-use oral liquid vancomycin, which is particularly significant for treating C. difficile infections in vulnerable patient populations who cannot use solid dosage forms. (’046 Patent, col. 5:51-65).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims, but Claim 1 is the first independent composition claim.
  • Essential elements of Independent Claim 1:
    • A non-sterile stable liquid formulation for oral administration, consisting of:
    • (a) 0.1-0.4% w/v citric acid,
    • (b) water,
    • (c) a sweetener that is sucralose,
    • (d) 0.02-0.08% w/v sodium benzoate,
    • (e) 20-60 mg/ml vancomycin hydrochloride, and
    • (f) flavoring agent,
    • wherein the formulation is homogenous and stable for at least 2 weeks at ambient and refrigerated temperature and has a pH of 2.5-4.5.
  • The complaint makes general allegations of infringement without specifying any claims.

U.S. Patent No. 10,959,946 - “Composition and Method for Vancomycin Oral Liquid”

Issued March 30, 2021

  • Technology Synopsis: This patent, part of the same family, also discloses stable, non-sterile liquid formulations of vancomycin hydrochloride designed for oral administration. The invention focuses on providing a ready-to-use solution with specific excipients that ensure stability and homogeneity, addressing the problems associated with compounding from powders intended for injection. (’946 Patent, col. 1:21-2:20).
  • Asserted Claims: The complaint does not specify, but representative independent claims include Claim 1 (a non-sterile stable liquid formulation) and Claim 2 (a liquid solution).
  • Accused Features: The Annora ANDA Product is accused of infringing the ’946 Patent. (Compl. ¶¶53-54).

U.S. Patent No. 10,959,947 - “Composition and Method for Vancomycin Oral Liquid”

Issued March 30, 2021

  • Technology Synopsis: This patent also covers non-sterile, stable oral liquid formulations of vancomycin. The claims cover specific combinations of buffering agents, sweeteners, preservatives, and flavoring agents that provide a stable and palatable alternative to compounded solutions or solid dosage forms. (’947 Patent, col. 1:21-2:20).
  • Asserted Claims: The complaint does not specify, but representative independent claims include Claim 1 (a non-sterile stable liquid formulation) and Claim 5 (a non-sterile stable liquid formulation with a different combination of excipients).
  • Accused Features: The Annora ANDA Product is accused of infringing the ’947 Patent. (Compl. ¶¶58-59).

U.S. Patent No. 10,959,948 - “Composition and Method for Vancomycin Oral Liquid”

Issued March 30, 2021

  • Technology Synopsis: This patent claims stable oral liquid formulations of vancomycin, focusing on specific compositions of excipients. The claimed solution is characterized by its stability for at least one week at ambient and refrigerated temperatures and a defined pH range, providing a reliable product for treating infections like C. difficile. (’948 Patent, col. 1:21-2:20).
  • Asserted Claims: The complaint does not specify, but representative independent claims include Claim 1 (a non-sterile stable liquid formulation with a specified list of buffering agents) and Claim 5 (a non-sterile stable liquid formulation with a specified list of preservatives).
  • Accused Features: The Annora ANDA Product is accused of infringing the ’948 Patent. (Compl. ¶¶63-64).

U.S. Patent No. 10,959,949 - “Composition and Method for Vancomycin Oral Liquid”

Issued March 30, 2021

  • Technology Synopsis: This patent continues the theme of stable oral liquid vancomycin formulations. The claims are directed to specific compositions defined by their components, including a buffering agent, sweetener, preservative, and flavoring agent, to ensure stability and homogeneity for at least one week. (’949 Patent, col. 1:21-2:20).
  • Asserted Claims: The complaint does not specify, but representative independent claims include Claim 1 (a non-sterile stable liquid formulation) and Claim 7 (a method of treating C. difficile).
  • Accused Features: The Annora ANDA Product is accused of infringing the ’949 Patent. (Compl. ¶¶68-69).

U.S. Patent No. 11,638,692 - “Composition and Method for Vancomycin Oral Liquid”

Issued May 2, 2023

  • Technology Synopsis: As the most recent patent in the asserted family, this patent also claims stable oral liquid formulations of vancomycin. It continues to protect specific combinations of excipients intended to create a reliable, ready-to-use product, addressing the known issues with other forms of vancomycin administration. (’692 Patent, col. 1:21-2:20).
  • Asserted Claims: The complaint does not specify, but representative independent claims include Claim 1 (a non-sterile stable liquid formulation) and Claim 5 (a non-sterile stable liquid formulation with a different list of preservatives).
  • Accused Features: The Annora ANDA Product is accused of infringing the ’692 Patent. (Compl. ¶¶73-74).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Annora Pharma Private Ltd.’s proposed generic vancomycin hydrochloride oral solution, identified as the "Annora ANDA Product" associated with ANDA No. 218168. (Compl. ¶2).

Functionality and Market Context

The complaint alleges that the Annora ANDA Product is a generic version of Azurity's FIRVANQ® product, an FDA-approved antibacterial for treating Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus. (Compl. ¶¶2, 13). By filing an ANDA, Annora has represented to the FDA that its product has the same active ingredient, route of administration, dosage form, and strength as FIRVANQ®, and is bioequivalent. (Compl. ¶38). The product is intended for commercial manufacture, use, and sale in the United States upon FDA approval. (Compl. ¶37).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for analysis of specific infringement allegations. It makes general allegations that Annora's ANDA product, if approved and marketed, would infringe at least one claim of each of the asserted patents, either literally or under the doctrine of equivalents. (Compl. ¶¶44, 49, 54, 59, 64, 69, 74). No claim charts or specific mapping of accused product features to claim elements are provided. This level of detail is common for initial complaints in ANDA litigation, where the primary act of infringement is the filing of the ANDA itself under 35 U.S.C. § 271(e)(2).

  • Identified Points of Contention:
    • Scope Questions: A primary question will be whether the specific formulation detailed in Annora's ANDA falls within the scope of the asserted claims. Many of the independent claims use the transitional phrase "consisting of" to introduce the list of excipients (e.g., ’028 Patent, claim 1; ’046 Patent, claim 1), which is highly restrictive. The presence of any additional, unlisted excipients in Annora's formulation may create a viable argument for non-infringement.
    • Technical Questions: The asserted patents claim specific stability characteristics (e.g., "stable for at least 30 days at ambient and refrigerated temperature conditions" in claim 1 of the '028 patent). A key technical question will be whether the Annora ANDA Product, as formulated, meets these specific, quantitative stability and pH limitations recited in the claims.

V. Key Claim Terms for Construction

  • The Term: "consisting of"

    • Context and Importance: This term appears in the preambles of the independent composition claims of the lead patents (e.g., ’028 Patent, claim 1; ’046 Patent, claim 1) and is used to introduce the list of required formulation components. This term is legally significant as it is "closed" language, meaning the claimed formulation must not contain any ingredients other than those explicitly recited. Practitioners may focus on this term because if Annora's formulation contains any additional excipients not listed in the claim (e.g., a different buffering agent, a second sweetener, a processing aid), it would likely fall outside the literal scope of the claim.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent does not appear to offer an explicit definition that would broaden the standard, restrictive meaning of "consisting of." A party might argue that trace impurities should not be considered additional components that would defeat infringement.
      • Evidence for a Narrower Interpretation: The patent claims consistently list specific components with specific weight/volume percentages. The structure of Claim 1 of the ’028 Patent, for instance, exhaustively lists components (a) through (g), suggesting a closed and complete composition. The use of this term strongly supports a narrow interpretation where infringement requires the absence of any other material components.

  • The Term: "stable for at least 30 days" (and similar stability limitations)

    • Context and Importance: This limitation, found in claims such as Claim 1 of the ’028 Patent, defines a required functional property of the formulation. The dispute will likely turn on the technical evidence from stability studies of Annora's product. The definition of "stable" is critical; the patent specification provides context by referencing microbial assay values, impurity levels, and specific testing conditions. (’028 Patent, col. 9:16-47).
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party might argue that "stable" allows for minor, commercially acceptable degradation over the 30-day period, as long as the product remains safe and effective.
      • Evidence for a Narrower Interpretation: The patent provides specific, quantitative stability data in its examples (e.g., Example 2 tables showing % vancomycin remaining). (’028 Patent, col. 16-18). A party could argue that "stable" should be construed in light of these examples to require meeting similar or identical performance benchmarks, thus narrowing the term to a specific, high-performance standard.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if Annora's ANDA is approved, its commercial activities, including use directed by its proposed labeling, will induce and contribute to infringement by others. (Compl. ¶¶44, 49, 54, 59, 64, 69, 74).
  • Willful Infringement: The complaint alleges that Annora had "actual and constructive knowledge" of the asserted patents prior to filing its ANDA and acted with "specific intent to infringe." (Compl. ¶¶45, 50, 55, 60, 65, 70, 75). This forms the basis for a claim of willful infringement.

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

  • A core issue will be one of compositional scope: given the use of the highly restrictive term "consisting of" in key independent claims, does Annora's proposed generic formulation contain only the specifically recited excipients, or does it include any additional components that would place it outside the literal scope of the claims?
  • A central evidentiary question will be one of functional performance: does the stability data for Annora’s proposed product, as contained in its confidential ANDA submission, demonstrate that it meets the quantitative stability and pH requirements (e.g., "stable for at least 30 days") defined and claimed in the patents-in-suit?
  • A procedural and substantive question is how the parties' dispute over confidential access to the ANDA (Compl. ¶¶39-41) will be resolved, as the details of Annora’s formulation contained within that submission are essential for Azurity to develop its infringement contentions and for the court to ultimately adjudicate the dispute.