DCT

2:25-cv-02086

Nevakar Injectables Inc v. InfoRLife SA

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-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 subject to personal jurisdiction, and Defendant InfoRLife is a foreign corporation subject to personal jurisdiction that conducts business in the district.
  • Core Dispute: Plaintiffs allege that Defendants' ready-to-use norepinephrine bitartrate injection products infringe a patent directed to stable, antioxidant-free pharmaceutical compositions.
  • Technical Context: The technology concerns injectable drug formulations, specifically creating a storage-stable version of norepinephrine—a drug used to treat acute hypotension—that does not require dilution before use or the inclusion of potentially allergenic sulfite antioxidants.
  • Key Procedural History: Plaintiff Long Grove is the exclusive licensee of the patent-in-suit, with rights to enforce it. The complaint notes that the parties have been involved in prior patent litigation in the same district. The infringement theory relies in part on an interpretation of a claim term allegedly adopted by the Patent Examiner during the patent's prosecution.

Case Timeline

Date Event
2017-01-30 '996 Patent Priority Date
2021-11-19 Defendant InfoRLife Files New Drug Application (NDA) for Accused Product
2022-09-15 FDA Approves Accused Product
2022-10-31 Defendants Allegedly Commence Sale of Accused Product
2023-05-04 Exclusive License Agreement Between Plaintiffs
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"

The Invention Explained

  • Problem Addressed: The patent's background section describes problems with then-current norepinephrine formulations, which were supplied as concentrates that required dilution prior to intravenous infusion. This process created risks of microbial contamination and calculation errors during dilution ('996 Patent, col. 2:8-16). Additionally, some existing formulations contained sulfite antioxidants to ensure stability, which can cause severe allergic reactions in susceptible patients ('996 Patent, col. 2:17-21).
  • The Patented Solution: The invention is a ready-to-inject, storage-stable, and "substantially antioxidant free" norepinephrine composition ('996 Patent, Abstract). The stability is achieved through a specific combination of components: norepinephrine (primarily the active R-isomer), a tonicity agent, and a metal ion chelator, all maintained within a specific acidic pH range (e.g., 3.7 to 4.3) ('996 Patent, col. 4:32-40). This formulation is designed to minimize both degradation and isomerization (conversion to the less active S-isomer) over time, even when subjected to heat sterilization ('996 Patent, col. 4:50-60).
  • Technical Importance: This approach provides a ready-to-use formulation of a critical care drug, which can reduce the risk of handling errors and adverse patient reactions associated with dilution and antioxidant excipients ('996 Patent, col. 6:1-10).

Key Claims at a Glance

  • The complaint asserts infringement of independent claim 1 ('996 Patent, col. 21:49 - col. 22:1).
  • The essential elements of Claim 1 include:
    • A sterile, storage-stable, ready-to-inject norepinephrine composition.
    • An aqueous solution containing norepinephrine, a tonicity agent, and a metal ion chelator.
    • The norepinephrine concentration is equal to or less than 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 specified group including a pharmaceutically acceptable salt.
    • The pH of the solution is between 3.7 and 5.0.
    • The composition is substantially antioxidant-free.
  • The complaint alleges infringement of "one or more claims," reserving the right to assert additional claims (Compl. ¶27).

III. The Accused Instrumentality

Product Identification

  • The Accused Products are Defendants' norepinephrine bitartrate solutions in 0.9% sodium chloride, sold in three strengths: 4 mg (16 µg/ml), 8 mg (32 µg/ml), and 16 mg (64 µg/ml) in 250 mL infusion bags (Compl. ¶23). These products were approved under NDA No. 215700 (Compl. ¶15).

Functionality and Market Context

  • The Accused Products are ready-to-administer intravenous solutions for the "restoration of blood pressure in adult patients with acute hypotensive states" (Compl. ¶23). According to the complaint's description of their label, the products contain sodium chloride as a tonicity agent, have a pH range of 3.4 to 4.0, use the R-configuration of norepinephrine, and are "substantially free of an antioxidant" (Compl. ¶24). Defendants are alleged to have commenced manufacture, marketing, and sale of the products on or around October 31, 2022 (Compl. ¶25).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

12,245,996 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A sterile storage stable ready-to-inject norepinephrine composition, comprising: The Accused Products are alleged to be sterile, storage-stable, ready-to-inject norepinephrine compositions. ¶33 col. 21:49-50
an aqueous pharmaceutically acceptable solution containing norepinephrine, a tonicity agent, and a metal ion chelator; The Accused Products are alleged to be aqueous solutions containing norepinephrine, a tonicity agent (sodium chloride), and a metal ion chelator (bitartrate). ¶34, ¶36, ¶37 col. 21:51-53
wherein the composition contains the norepinephrine in an amount of equal or less than 100 µg/ml; The Accused Products are sold in concentrations of 16, 32, and 64 µg/ml, all of which are below the 100 µg/ml limit. ¶35 col. 21:54-55
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 the R-isomer, based on the product label and on information and belief. ¶24, ¶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 Accused Products allegedly contain dissociated bitartrate anions from norepinephrine bitartrate, which the complaint asserts functions as a bicarboxylic acid metal ion chelator based on the patent’s prosecution history. ¶37 col. 21:59-62
wherein the tonicity agent is selected from the group consisting of a pharmaceutically acceptable salt, glycerol, a sugar alcohol, and a sugar; and The Accused Products contain sodium chloride, which is a pharmaceutically acceptable salt and a tonicity agent. ¶36 col. 21:63-65
wherein the pH of the aqueous solution is in a range of between 3.7-5.0, and wherein the composition is substantially antioxidant-free. The Accused Products are alleged to have a pH in this range and to be substantially antioxidant-free. ¶38, ¶39 col. 21:66-col. 22:1
  • Identified Points of Contention:
    • Scope Questions: The primary dispute appears to be whether the bitartrate anion, which is part of the active ingredient salt (norepinephrine bitartrate), can satisfy the "metal ion chelator" limitation. The complaint's theory relies on an assertion about the prosecution history (Compl. ¶37), raising the question of whether the claim requires a separate, distinct excipient to function as the chelator, or if a component of the active ingredient itself can fulfill this role.
    • Technical Questions: The Accused Product's label specifies a pH range of 3.4 to 4.0, which only partially overlaps with the claimed range of 3.7 to 5.0 (Compl. ¶24; ’996 Patent, col. 22:1). This raises the evidentiary question of whether the Accused Products, as actually manufactured and sold, consistently have a pH that falls within the claimed range.

V. Key Claim Terms for Construction

  • The Term: "metal ion chelator"
  • Context and Importance: The definition of this term is central to the infringement analysis. The complaint's theory is that the bitartrate anion from the active ingredient itself functions as the claimed chelator. The defense will likely argue that the "metal ion chelator" must be a separate excipient added to the formulation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not explicitly define the term to exclude a counter-ion of the active ingredient. The complaint alleges that the patent's prosecution history supports its view that bitartrate can function as a bicarboxylic acid metal ion chelator within the meaning of the claims (Compl. ¶37).
    • Evidence for a Narrower Interpretation: The patent specification describes a method of preparation that includes "preparing an aqueous acidic buffer" and notes that this buffer "also includes a chelating agent," which may suggest the chelator is a distinct component of the buffer system ('996 Patent, col. 4:44-46). The examples of chelators provided, such as EDTA and various carboxylic acids, are typically used as separate excipients ('996 Patent, col. 8:55-60).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement by stating that Defendants instruct third parties, including contract manufacturers, to commit infringing acts (Compl. ¶32). The complaint does not, however, plead specific facts to support this, such as references to manufacturing instructions or other documents that would allegedly encourage infringement.
  • Willful Infringement: Willfulness is alleged in a conclusory manner (Compl. ¶42). The complaint does not plead facts indicating when or how Defendants allegedly became aware of the ’996 Patent, such as through a notice letter or knowledge of the patent application during its prosecution.

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

  • A core issue will be one of claim construction: can the term "metal ion chelator," as used in the patent, be construed to read on the bitartrate anion that is an integral part of the active pharmaceutical ingredient, or does the claim require a separate, added excipient? The resolution will depend heavily on the patent's specification and its prosecution history.
  • A key evidentiary question will be one of factual infringement: does the accused product, as sold, consistently meet the claimed pH range of 3.7 to 5.0? Given the product label discloses a pH range that extends below this claimed range (3.4 to 4.0), demonstrating infringement will require factual evidence beyond the label itself.