DCT

3:25-cv-02086

Nevakar Injectables Inc v. InfoRLife SA

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-02086, D.N.J., 03/26/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant WG Critical Care is a New Jersey entity with its principal place of business in the state, and Defendant InfoRLife is a foreign corporation subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ ready-to-use norepinephrine bitartrate injectable drug products infringe a patent directed to stable, antioxidant-free pharmaceutical compositions.
  • Technical Context: The technology concerns pharmaceutical formulations for injectable drugs, specifically aimed at creating ready-to-use products that have a long shelf-life without requiring dilution or the use of potentially allergenic antioxidants.
  • Key Procedural History: The complaint notes that the parties are involved in other litigation, including a pending patent infringement action in the same district involving different patents. Plaintiff Long Grove is identified as the exclusive licensee of the patent-in-suit. The complaint also refers to the prosecution history of the patent, stating that the patent examiner recognized that the bitartrate component of the drug could function as a claimed metal ion chelator.

Case Timeline

Date Event
2017-01-30 '996 Patent Priority Date
2021-11-19 Defendants' New Drug Application (NDA) Filing Date for Accused Product
2022-09-15 FDA Approval of Accused Product
2022-10-31 Defendants Allegedly Begin Offering to Sell the Accused Product
2023-05-04 Exclusive License Agreement for '996 Patent Granted to Long Grove
2025-03-11 U.S. Patent No. 12,245,996 Issues
2025-03-26 Complaint Filed

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

U.S. Patent No. 12,245,996 - "Norepinephrine Compositions and Methods Therefor"

  • Patent Identification: U.S. Patent No. 12,245,996, "Norepinephrine Compositions and Methods Therefor," issued March 11, 2025 (’996 Patent).

The Invention Explained

  • Problem Addressed: The patent’s background section describes problems with then-current norepinephrine formulations, which were typically sold as concentrates requiring dilution before use. This process created risks of microbial contamination and calculation errors (Compl. ¶22; ’996 Patent, col. 2:3-17). Furthermore, these formulations often contained sulfites as antioxidants, which can cause allergic reactions, and the diluted products had poor long-term stability ('996 Patent, col. 2:17-21).
  • The Patented Solution: The invention is a ready-to-inject norepinephrine composition that achieves storage stability without using conventional antioxidants ('996 Patent, Abstract). The solution involves controlling the pH to a specific acidic range (e.g., 3.7-4.3) and including a metal ion chelator and a tonicity agent, which together prevent significant degradation and isomerization of the active ingredient ('996 Patent, col. 4:31-40, 50-60).
  • Technical Importance: This approach allows for a premixed, ready-to-use injectable product, which can reduce the potential for medication errors and contamination in clinical settings while avoiding sulfite-based allergens ('996 Patent, col. 6:1-11).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims, with independent claim 1 identified as an example (Compl. ¶27, ¶29).
  • The essential elements of independent claim 1 are:
    • A sterile, storage-stable, ready-to-inject norepinephrine composition.
    • Comprising an aqueous solution with norepinephrine, a tonicity agent, and a metal ion chelator.
    • Norepinephrine concentration is ≤ 100 µg/ml.
    • At least 90% of the norepinephrine is the R-isomer.
    • The metal ion chelator is a bicarboxylic acid present in an amount between 1 µg/ml and 100 µg/ml.
    • The tonicity agent is from a group including a pharmaceutically acceptable salt.
    • The solution's pH is between 3.7 and 5.0.
    • The composition is "substantially antioxidant-free."

III. The Accused Instrumentality

Product Identification

  • The Accused Products are Defendants' "norepinephrine bitartrate in 0.9% sodium chloride solutions for intravenous administration," sold in 16 µg/ml, 32 µg/ml, and 64 µg/ml strengths (Compl. ¶15, ¶23).

Functionality and Market Context

  • The Accused Products are ready-to-use injectable pharmaceuticals approved for the "restoration of blood pressure in adult patients with acute hypotensive states" (Compl. ¶23).
  • According to the complaint, the product label states they contain sodium chloride as a tonicity agent, are "substantially free of an antioxidant," use norepinephrine in the R-configuration, and have a pH range of 3.4 to 4.0 (Compl. ¶24).
  • The products are alleged to be direct competitors to Plaintiffs' own commercial norepinephrine products (Compl. ¶20, ¶23).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

Claim Chart Summary

The complaint’s allegations for claim 1 are summarized below.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A sterile storage stable ready-to-inject norepinephrine composition, comprising: an aqueous pharmaceutically acceptable solution containing norepinephrine, a tonicity agent, and a metal ion chelator; The Accused Products are alleged to be sterile, ready-to-inject aqueous solutions containing norepinephrine, sodium chloride (a tonicity agent), and dissociated bitartrate anions (alleged to be a metal ion chelator). ¶33, ¶34, ¶36, ¶37 col. 21:48-52
wherein the composition contains the norepinephrine in an amount of equal or less than 100 µg/ml; The Accused Products contain norepinephrine in concentrations of 16, 32, or 64 µg/ml. ¶35 col. 21:53-55
wherein the norepinephrine is present as an R-isomer in an amount of at least at least 90% of total norepinephrine; The norepinephrine in the Accused Products is alleged to be present as an R-isomer in an amount of at least 90%. ¶35 col. 21:56-58
wherein the aqueous solution comprises the metal ion chelator in an amount of between 1 µg/ml and 100 µg/ml, and wherein the metal ion chelator is a bicarboxylic acid; The complaint alleges that "dissociated bitartrate anions" from the norepinephrine bitartrate API function as a metal ion chelator and are a bicarboxylic acid. ¶37 col. 21:59-62
wherein the tonicity agent is selected from the group consisting of a pharmaceutically acceptable salt...; The Accused Products contain sodium chloride, which is a pharmaceutically acceptable salt. ¶36 col. 21:63-65
wherein the pH of the aqueous solution is in a range of between 3.7-5.0...; The Accused Products are alleged to have a pH in this range. The product label states a range of 3.4 to 4.0, which overlaps with the claimed range. ¶38 col. 21:66-67
...and wherein the composition is substantially antioxidant-free. The Accused Products are alleged to be substantially antioxidant-free. ¶39 col. 21:67

Identified Points of Contention

  • Scope Questions: A primary point of contention may be whether the term "metal ion chelator," as recited in the claim alongside "norepinephrine" and "tonicity agent," can be construed to read on the bitartrate anion that is part of the active pharmaceutical ingredient (API) salt, or if it must be a separately added excipient. The complaint’s reliance on the patent’s prosecution history suggests this is a central dispute (Compl. ¶37).
  • Technical Questions: The complaint alleges the Accused Products have a pH "in a range of between 3.7-5.0" (Compl. ¶38), while citing a product label that specifies a pH range of 3.4 to 4.0 (Compl. ¶24). This raises the question of whether all manufactured batches of the Accused Product will have a pH that falls within the more restrictive range required by the claim.

V. Key Claim Terms for Construction

The Term: "metal ion chelator"

Context and Importance

The infringement theory hinges on this term. If the bitartrate anion from the API salt (norepinephrine bitartrate) is found to be the claimed "metal ion chelator," it may support infringement. If the term is construed to require a distinct excipient added separately from the API, the infringement case may be weakened. Practitioners may focus on this term because its definition determines whether an inherent component of the API can satisfy a separate claim limitation for an excipient.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The specification discloses that where norepinephrine is provided as the bitartrate salt, a separate buffer "can advantageously be omitted," suggesting the patent contemplates that the anion of the API salt can serve an additional function ('996 Patent, col. 6:35-38). The claim also requires the chelator to be a "bicarboxylic acid," a description that fits the chemical structure of bitartrate ('996 Patent, col. 21:62).
  • Evidence for a Narrower Interpretation: The claim lists "norepinephrine, a tonicity agent, and a metal ion chelator" as three distinct components of the solution ('996 Patent, col. 21:50-52). This linguistic structure could support an interpretation that three separate chemical entities must be present, where the bitartrate is part of the "norepinephrine" component and cannot also be the "metal ion chelator."

The Term: "substantially antioxidant-free"

Context and Importance

The Accused Products are described as "substantially free of an antioxidant" (Compl. ¶24). However, a potential defense could argue that bitartrate itself exhibits some antioxidant properties, raising a dispute over whether the product is truly "antioxidant-free."

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The patent provides a functional definition, stating that the term means the composition does not "include antioxidants in an amount effective to reduce degradation of total norepinephrine by at least 1% when stored over a period of at least three months at 25° C" ('996 Patent, col. 7:23-27). This sets a clear, measurable threshold and suggests that the mere presence of a compound with some antioxidant properties is not disqualifying, so long as it is not present in an "effective" amount.
  • Evidence for a Narrower Interpretation: A party could argue that the plain meaning of "free" implies a complete absence. They might also argue that if the bitartrate is providing the claimed stability, it is doing so through a combination of chelation and antioxidant effects, thereby failing to meet this limitation.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges that Defendants induce infringement by "instructing third parties," including contract manufacturers, to commit infringing acts (Compl. ¶32). The complaint does not, however, cite specific evidence such as product instructions or manuals that direct end-users to infringe.

Willful Infringement

  • The complaint alleges willful infringement, which would entitle Plaintiffs to enhanced damages (Compl. ¶42). The basis for willfulness is not explicitly stated, but the complaint's reference to prior litigation between the same parties may be used to argue Defendants had pre-suit knowledge of Plaintiffs' patent position (Compl. ¶14).

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

  • A core issue will be one of claim construction: can the claim term "metal ion chelator" be interpreted to cover the bitartrate anion of the active pharmaceutical ingredient, or must it be a distinct, separately added excipient? The outcome of this question, which will depend on the patent's specification and prosecution history, is central to the infringement analysis.
  • A key evidentiary question will be one of infringement-in-fact: assuming the claim is construed to cover the bitartrate anion, does that anion actually function as a metal ion chelator in the accused formulation to achieve the stability described in the patent, or is its presence merely incidental to the choice of API salt form?
  • A secondary factual question will be one of literal infringement: can Plaintiffs prove that the accused products, as sold in commerce, consistently possess a pH within the claimed 3.7-5.0 range, when the product's own label allows for a pH as low as 3.4?