Azurity Pharma Inc v. Novitium Pharma LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Azurity Pharmaceuticals, Inc. (Delaware)
  • Defendant: Novitium Pharma, LLC (Delaware)
  • Plaintiff’s Counsel: Saiber LLC
• Case Identification: 1:23-cv-00163, D.N.J., 10/03/2022
• Venue Allegations: Venue is based on Defendant’s principal place of business being located in New Jersey.
• Core Dispute: Plaintiff alleges that Defendant’s imminent manufacture and sale of a generic enalapril oral solution for its partner Bionpharma will infringe two patents related to stable, liquid pharmaceutical formulations of enalapril.
• Technical Context: The technology concerns ready-to-use liquid formulations of enalapril, an ACE inhibitor for treating hypertension, which is particularly significant for pediatric and geriatric patients who may have difficulty swallowing tablets.
• Key Procedural History: The complaint seeks a declaratory judgment of infringement. It notes that the same patents-in-suit have been asserted in prior litigations against the Abbreviated New Drug Application (ANDA) holder (Bionpharma Inc.) and the previous manufacturer (CoreRx, Inc.), suggesting a basis for Plaintiff’s allegation that Defendant had pre-suit knowledge of the patents and the infringement allegations.

Case Timeline

Date	Event
2016-03-18	Priority Date for ’023 and ’405 Patents
2021-06-22	U.S. Patent No. 11,040,023 Issues
2021-06-22	Azurity files suit against Bionpharma on ’023 Patent
2021-08-10	ANDA No. 212408 for the accused formulation is approved by FDA
2021-10-12	U.S. Patent No. 11,141,405 Issues
2021-10-15	Azurity files suit against Bionpharma on ’405 Patent
2021-12-01	Previous manufacturer CoreRx allegedly stops supplying the formulation
2022-04-01	Azurity files suit against CoreRx on ’023 and ’405 Patents
2022-06-01	Novitium is listed as the new manufacturer of the formulation (approx.)
2022-10-03	Complaint Filing Date

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

U.S. Patent No. 11,040,023 - "Enalapril Formulations"

• Patent Identification: U.S. Patent No. 11,040,023, titled “Enalapril Formulations,” issued on June 22, 2021 (the “’023 Patent”) (Compl. ¶12).

The Invention Explained

• Problem Addressed: The patent addresses the difficulty certain patient populations, such as children and the elderly, have in swallowing solid oral dosage forms like enalapril tablets (Compl. ¶15; ’023 Patent, col. 5:32-37). It notes that creating liquid versions by crushing tablets is problematic, leading to inaccurate dosing, rapid instability, and potential contamination (’023 Patent, col. 5:53-62).
• The Patented Solution: The invention is a stable, ready-to-use oral liquid formulation of enalapril that does not require reconstitution before administration (’023 Patent, Abstract; col. 6:3-8). The solution achieves stability through a specific combination of components, including a sweetener, a preservative, and water, where the formulation maintains a specified stability profile (e.g., ≥95% of initial enalapril) for at least 12 months under refrigerated conditions (’023 Patent, col. 2:33-39, Claim 1).
• Technical Importance: This technology provides a commercially prepared, stable liquid dosage form of a widely-used drug, which may enhance patient compliance and dosing accuracy for populations unable to ingest solid tablets (’023 Patent, col. 5:26-31).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 (Compl. ¶38).
• Claim 1 of the ’023 Patent recites:
  • A stable oral liquid formulation, consisting essentially of:
  • about 0.6 to about 1.2 mg/ml enalapril or a pharmaceutically acceptable salt or solvate thereof;
  • a sweetener;
  • a preservative, comprising sodium benzoate, a paraben or a mixture of parabens;
  • water; and
  • optionally a flavoring agent;
  • wherein the formulation is stable at about 5±3° C. for at least 12 months, defined as retaining about 95% or more of the initial enalapril amount with about 5% or less total impurities.

U.S. Patent No. 11,141,405 - "Enalapril Formulations"

• Patent Identification: U.S. Patent No. 11141405, titled “Enalapril Formulations,” issued on October 12, 2021 (the “’405 Patent”) (Compl. ¶17).

The Invention Explained

• Problem Addressed: The ’405 Patent addresses the same problem as the ’023 Patent: the lack of a stable, commercially-prepared, ready-to-use liquid enalapril formulation suitable for patients who cannot swallow tablets (’405 Patent, col. 5:32-37, col. 5:53-62).
• The Patented Solution: The patent describes a stable, oral liquid formulation of enalapril comprising enalapril, a preservative, and water (’405 Patent, Abstract). The claim structure allows for the optional inclusion of a buffer to maintain pH at or below 4.5, a sweetener, and a flavoring agent, while requiring the formulation to remain stable for at least 12 months under refrigeration (’405 Patent, Claim 1).
• Technical Importance: This invention offers another approach to a stable, ready-to-use liquid enalapril product, aiming to improve medication adherence and dosage precision for vulnerable patient groups (’405 Patent, col. 5:26-31).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 (Compl. ¶38).
• Claim 1 of the ’405 Patent recites:
  • A stable oral liquid formulation, consisting essentially of:
  • about 0.6 to about 1.2 mg/ml enalapril or a pharmaceutically acceptable salt or solvate thereof;
  • a preservative selected from a specific list including sodium benzoate and parabens; and
  • water;
  • wherein the formulation optionally comprises a buffer to maintain pH about 4.5 or below, a sweetener, and/or a flavoring agent;
  • wherein the formulation is stable at about 5±3° C. for at least 12 months, defined as retaining about 95% or more of the initial enalapril amount with about 5% or less total impurities.

III. The Accused Instrumentality

Product Identification

• The accused product is the "Novitium Formulation," identified as the subject of Bionpharma Inc.'s ANDA No. 212408 (Compl. ¶1).

Functionality and Market Context

• The Novitium Formulation is a generic, ready-to-use oral solution of enalapril maleate (Compl. ¶1, ¶10). The complaint alleges that Novitium is the new manufacturer of this formulation for Bionpharma, which was previously manufactured by CoreRx, Inc. (Compl. ¶9, ¶23). The lawsuit was filed as a declaratory judgment action based on allegations that Novitium is poised to manufacture, offer for sale, and sell the formulation in the United States prior to the expiration of the patents-in-suit (Compl. ¶1, ¶22).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or sufficient technical detail to construct a side-by-side comparison of the claim elements and the accused product. The infringement theory is presented in narrative form. It alleges that the "Novitium Formulation" is the same formulation as the "ANDA Formulation" that was the subject of prior litigation against other parties, and that this formulation is covered by at least claim 1 of the ’023 Patent and claim 1 of the ’405 Patent (Compl. ¶9, ¶38). The complaint alleges that Novitium has taken "concrete steps to infringe" and has made "substantial and meaningful preparations" to engage in commercial manufacture and sale (Compl. ¶22, ¶36).

No probative visual evidence provided in complaint.

• Identified Points of Contention:
  • The primary technical question for both patents will be establishing the precise composition of the Novitium Formulation, including its ingredients, their concentrations, and its pH level. The complaint does not provide these details, suggesting they will be a focus of discovery.
  • For both patents, a central legal question may be whether the accused formulation contains unlisted excipients that materially affect the invention's "basic and novel properties" of stability, which would be relevant to the claim term "consisting essentially of."
  • A key evidentiary question will concern the stability of the Novitium Formulation. The analysis will require determining whether the accused product meets the specific functional limitation of being "stable at about 5±3° C. for at least 12 months" as defined in the claims.

V. Key Claim Terms for Construction

• The Term: "consisting essentially of" (Claim 1 of the ’023 and ’405 Patents)

  • Context and Importance: This transitional phrase defines the scope of the claims as including the listed ingredients and any unlisted ingredients that do not materially affect the "basic and novel properties" of the invention. Practitioners may focus on this term because the infringement analysis will depend on whether any unlisted components in the Novitium Formulation are found to materially affect the formulation's stability, which the patents identify as a key characteristic.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specifications focus on achieving stability through a specific combination of components and pH control (’023 Patent, Abstract). A party could argue that this stability is the core novel property, and that common, inert excipients like flavoring or coloring agents do not materially affect it.
    • Evidence for a Narrower Interpretation: The specifications explicitly state that in some embodiments, the formulations do not contain certain common excipients like mannitol or silicon dioxide (’023 Patent, col. 4:2-4). A party could argue that this implies the "basic and novel properties" include achieving stability without such components, thereby narrowing the scope of permissible unlisted ingredients.

• The Term: "stable at about 5±3° C. for at least 12 months" (Claim 1 of the ’023 and ’405 Patents)

  • Context and Importance: This is a functional limitation that requires the accused product to meet a specific performance standard. Both claims further define this term as retaining "about 95% w/w or greater of the initial enalapril amount and about 5% w/w or less total impurity." The dispute will likely be evidentiary, centering on whether the accused formulation meets this precise quantitative threshold under the specified test conditions.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language of the claim provides a clear, quantitative definition of "stable," which could be argued as the sole criterion for interpretation.
    • Evidence for a Narrower Interpretation: The specifications provide extensive data tables showing degradation products (enalapril diketopiperazine and enalaprilat) under various conditions (’023 Patent, Tables A-2, B-2, C-2, D-2, E-2). A party may argue that these examples, which demonstrate stability well within the claimed 5% impurity limit, set a standard for what one of ordinary skill in the art would understand the term to mean in the context of the patent.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Novitium will induce infringement by intentionally encouraging direct infringement by others (e.g., Bionpharma) and will contributorily infringe by supplying a material component not suitable for substantial non-infringing use (Compl. ¶¶42-43, 53-54). The factual basis for these allegations rests on Novitium’s alleged role as the manufacturer for Bionpharma (Compl. ¶23).
• Willful Infringement: While the complaint does not contain a formal count for "willful infringement," it lays a foundation by alleging pre-suit knowledge. It claims Novitium was aware of the prior lawsuits involving the same patents against the ANDA holder and previous manufacturer (Compl. ¶¶26, 28, 30). The complaint further characterizes Novitium’s decision to become the manufacturer as an act in "blatant disregard for Azurity's patent rights" (Compl. ¶33).

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

• A central factual issue will be one of compositional identity: what are the precise ingredients, concentrations, and pH of the Novitium Formulation? As a declaratory judgment action filed prior to any apparent commercial launch, the case will depend heavily on discovery to establish the technical characteristics of the accused product.
• A core legal issue will be one of definitional scope: how will the term "consisting essentially of" be construed? The case may turn on whether any unlisted ingredients in the Novitium Formulation—once discovered—are found to materially affect the patented invention's basic and novel property of long-term stability.
• A key evidentiary question will be one of functional performance: does the Novitium Formulation meet the quantitative stability requirements defined in the asserted claims? This will likely involve a battle of expert testimony and competing data from accelerated and real-time stability studies.