DCT

2:25-cv-16422

American Regent Inc v. Cipla USA Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-16422, D.N.J., 10/09/2025
  • Venue Allegations: Venue is based on Defendant Cipla USA, Inc. maintaining its principal place of business in New Jersey, thereby residing in the district. Defendant Cipla Limited is a foreign corporation and may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Multrys® injectable drug constitutes an act of infringement of five patents related to trace element compositions for parenteral nutrition.
  • Technical Context: The technology concerns stable, injectable solutions containing specific trace elements (zinc, copper, selenium, manganese) used to supplement parenteral nutrition for patients, including vulnerable neonatal and pediatric populations, who cannot receive nutrition orally or enterally.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a Paragraph IV Notice Letter from Defendants, which stated that Defendants are seeking FDA approval to market a generic version of Multrys® prior to the expiration of the patents-in-suit listed in the FDA's Orange Book. No prior litigation or post-grant proceedings are mentioned in the complaint.

Case Timeline

Date Event
2020-07-02 Earliest Patent Priority Date (Provisional App. 63/047,708)
2020-07-02 FDA Approval of Plaintiff's New Drug Application for Multrys®
2023-10-17 U.S. Patent No. 11,786,548 Issues
2024-05-07 U.S. Patent No. 11,975,022 Issues
2024-06-04 U.S. Patent No. 11,998,565 Issues
2024-11-26 U.S. Patent No. 12,150,956 Issues
2024-11-26 U.S. Patent No. 12,150,957 Issues
2025-09-17 Date of Defendants' Paragraph IV Notice Letter
2025-10-09 Complaint Filing Date

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

U.S. Patent No. 11,786,548 - "Trace element compositions, methods of making and use"

The Invention Explained

  • Problem Addressed: The patent describes a need for injectable trace element compositions for parenteral nutrition (PN) that are stable for longer periods than the typical 24-48 hours. Existing solutions require frequent admixing, which is time-consuming, expensive, and creates waste. Further, available multi-element products are not easily customizable and may contain higher-than-recommended doses of certain elements. (’548 Patent, col. 1:46-2:45).
  • The Patented Solution: The invention provides a stable injectable composition containing specific concentrations of zinc, copper, selenium, and manganese that can be added to PN solutions. This extended stability (e.g., "about at least 3 days to about 14 days") is intended to reduce the frequency of admixing, decrease costs, and improve the quality of life for patients and caregivers. (’548 Patent, Abstract; col. 2:46-3:5).
  • Technical Importance: By creating a trace element additive that allows for longer stability in PN bags, the invention reduces waste from discarded admixtures and mitigates potential drug supply shortages. (’548 Patent, col. 2:31-40).

Key Claims at a Glance

  • The complaint does not specify which claims are asserted, alleging infringement of "one or more claims" (Compl. ¶48). Independent claim 1 is presented here as representative.
  • Essential elements of Independent Claim 1, a composition claim, include:
    • An injectable composition comprising water
    • about 60 µg of selenium per 1 mL
    • 3,000 µg of zinc per 1 mL
    • about 300 µg of copper per 1 mL
    • about 55 µg of manganese per 1 mL
    • contains 0 µg to about 10 µg of iron per 1 mL
    • does not contain any vitamins
    • contains no added chromium
    • contains no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL
  • The complaint reserves the right to assert additional claims, including dependent claims (Compl. ¶48).

U.S. Patent No. 11,975,022 - "Trace element compositions, methods of making and use"

The Invention Explained

  • Problem Addressed: The background section of the patent, which is substantially identical to that of the ’548 Patent, identifies the short stability of existing parenteral nutrition admixtures with trace elements as a key problem leading to cost, waste, and logistical burdens for healthcare providers and patients. (’022 Patent, col. 1:46-2:45).
  • The Patented Solution: The patent describes a method of using a stable injectable trace element composition to provide essential nutrients to a patient. The composition's extended stability allows for less frequent preparation of PN solutions, thereby addressing the problems of waste and high costs associated with short-term-stable admixtures. (’022 Patent, Abstract; col. 2:46-3:5).
  • Technical Importance: The described method offers a more efficient and cost-effective way to manage parenteral nutrition for patients, improving quality of life and reducing the strain on healthcare resources. (’022 Patent, col. 2:31-40).

Key Claims at a Glance

  • The complaint does not specify which claims are asserted (Compl. ¶55). Independent claim 1 is presented here as representative.
  • Essential elements of Independent Claim 1, a method claim, include:
    • A method of providing trace elements to a patient in need thereof, comprising administering an injectable trace element composition to the patient
    • wherein the composition comprises water, about 60 µg of selenium, about 3,000 µg of zinc, about 300 µg of copper, and about 55 µg of manganese per 1 mL
    • wherein the composition contains 0 µg to about 10 µg of iron per 1 mL
    • wherein the composition does not contain any vitamins, contains no added chromium, and contains no aluminum or aluminum not to exceed 6 µg per 1 mL
  • The complaint reserves the right to assert additional claims, including dependent claims (Compl. ¶55).

U.S. Patent No. 11,998,565 - "Trace element compositions, methods of making and use"

  • Technology Synopsis: This patent, sharing a common specification with the previously analyzed patents, addresses the problem of short stability in parenteral nutrition admixtures containing trace elements (’565 Patent, col. 1:46-2:45). It provides a stable injectable composition with specific amounts of zinc, copper, selenium, and manganese, designed to reduce waste and admixing frequency (’565 Patent, Abstract).
  • Asserted Claims: The complaint alleges infringement of one or more unspecified claims (Compl. ¶62).
  • Accused Features: The accused features are the formulation and intended use of Defendants' ANDA Product, which is alleged to be a generic version of Plaintiff's Multrys® drug (Compl. ¶¶ 42-44, 61).

U.S. Patent No. 12,150,956 - "Trace element compositions, methods of making and use"

  • Technology Synopsis: This patent addresses the technical challenge of limited stability in parenteral nutrition solutions after trace elements are added (’956 Patent, col. 1:46-2:45). The invention is a method of using a stable injectable trace element composition with defined concentrations of key elements to improve efficiency and reduce costs in parenteral nutrition therapy (’956 Patent, Abstract).
  • Asserted Claims: The complaint alleges infringement of one or more unspecified claims (Compl. ¶69).
  • Accused Features: The infringement allegations target the formulation of Defendants' ANDA Product and its intended administration to patients, as instructed by its proposed labeling (Compl. ¶¶ 42-44, 68).

U.S. Patent No. 12,150,957 - "Trace element compositions, methods of making and use"

  • Technology Synopsis: This patent describes trace element compositions for parenteral nutrition that solve the problem of short-term stability common in existing admixtures (’957 Patent, col. 1:46-2:45). The patented solution is a stable, injectable formulation of zinc, copper, selenium, and manganese, which allows PN bags to be prepared less frequently, reducing waste and cost (’957 Patent, Abstract).
  • Asserted Claims: The complaint alleges infringement of one or more unspecified claims (Compl. ¶76).
  • Accused Features: Infringement is alleged based on the composition of Defendants' ANDA Product, which seeks to be a generic equivalent of Plaintiff's Multrys® drug (Compl. ¶¶ 42-44, 75).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' proposed generic "Trace Elements Injection 4* USP" product, for which they submitted ANDA No. 220424 to the FDA ("the ANDA Product") (Compl. ¶1, 43).

Functionality and Market Context

  • The ANDA Product is an injectable solution intended to provide trace elements for patients requiring parenteral nutrition (Compl. ¶1, 23). The complaint alleges the ANDA Product is a generic version of Plaintiff's Multrys®, containing the same or equivalent ingredients and intended for the same therapeutic uses (Compl. ¶42). According to a notice letter cited in the complaint, the ANDA Product formulation is "zinc 1,000 mcg/mL, copper 60 mcg/mL, manganese 3 mcg/mL, and selenium 6 mcg/mL" in single-dose vials (Compl. ¶43). Plaintiff's Multrys® is described as the "first and only FDA-approved multi-trace element injection for neonatal and pediatric patients weighing less than 10 kg," positioning the ANDA product as a direct competitor in this market (Compl. ¶22).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’548 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An injectable composition comprising water... The ANDA Product is an injectable composition comprising water for injection (Compl. ¶¶ 42-43). ¶42-43 col. 3:57-60
about 60 µg of selenium, ... about 3,000 µg of zinc, about 300 µg of copper, and about 55 µg of manganese per 1 mL The complaint alleges the ANDA product contains 6 µg/mL of selenium, 1,000 µg/mL of zinc, 60 µg/mL of copper, and 3 µg/mL of manganese. ¶43 col. 10:1-10
contains 0 µg per 1 mL to about 10 µg per 1 mL of iron The complaint alleges the ANDA product contains the "same or equivalent ingredients" as Multrys®, for which the patent discloses an iron limit. ¶42 col. 15:47-16:44
does not contain any vitamins The ANDA product is alleged to be a trace element injection equivalent to Multrys®, which does not contain vitamins. ¶42-43 col. 45:1-7
contains no added chromium The ANDA Product is alleged to be a trace element injection equivalent to Multrys®, for which the patent discloses no added chromium. ¶42-43 col. 14:49-54
no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL The ANDA product is alleged to be equivalent to Multrys®, for which the patent discloses an aluminum limit. ¶42 col. 17:59-18:10

’022 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of providing trace elements to a patient... comprising administering an injectable trace element composition to the patient... Defendants' proposed package insert for the ANDA product allegedly instructs medical practitioners to administer the product to patients. ¶55 col. 4:56-65
wherein the composition comprises... about 60 µg of selenium, ... about 3,000 µg of zinc, about 300 µg of copper, and about 55 µg of manganese per 1 mL... The complaint alleges the ANDA product contains 6 µg/mL of selenium, 1,000 µg/mL of zinc, 60 µg/mL of copper, and 3 µg/mL of manganese, which will be administered per the proposed label. ¶43, 55 col. 10:1-10
wherein the composition contains... no added chromium... The ANDA product is alleged to be a trace element injection equivalent to Multrys®, for which the patent discloses no added chromium. ¶42-43 col. 14:49-54
  • Identified Points of Contention:
    • Technical & Scope Questions: The complaint alleges the ANDA product contains 1,000 µg/mL of zinc, 60 µg/mL of copper, 3 µg/mL of manganese, and 6 µg/mL of selenium (Compl. ¶43). This raises the question of how this formulation can infringe representative independent claims, such as Claim 1 of the ’548 and ’022 Patents, which recite significantly different concentrations (3,000 µg/mL zinc, 300 µg/mL copper, 55 µg/mL manganese, and 60 µg/mL selenium). Analysis will likely focus on whether infringement can be established under the doctrine of equivalents, or whether the plaintiff will assert other patent claims (e.g., ’548 Patent, claim 27) that more closely recite the formulation disclosed for the ANDA product.

V. Key Claim Terms for Construction

  • The Term: "about" (e.g., "about 3,000 µg of zinc")
    • Context and Importance: This term's construction is critical for determining the scope of the claimed concentration ranges and assessing literal infringement. Practitioners may focus on this term because there is a substantial numerical difference between the concentrations recited in representative claims (e.g., 3,000 µg/mL of zinc in claim 1 of the ’548 Patent) and those alleged for the accused product (1,000 µg/mL of zinc) (Compl. ¶43). The scope of "about" will determine if such differences can be bridged.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification states that numerical parameters are "to be understood as being modified in all instances by the term 'about'" and are "approximations that may vary" (’548 Patent, col. 5:35-40).
      • Evidence for a Narrower Interpretation: The specification explicitly describes different formulations for adult/pediatric versus neonatal patients, with distinct concentration values that align with the different values in the claims versus the accused product (’548 Patent, col. 3:25-36). This could support an argument that the term "about" was not intended to be so broad as to encompass a completely different, separately described embodiment.
  • The Term: "no added chromium"
    • Context and Importance: This negative limitation is central to distinguishing the claimed invention from prior art that included chromium. The dispute will likely concern whether the presence of any trace amount of chromium in the final ANDA product, even as an impurity from raw materials or the manufacturing process, falls within the claim scope. The distinction between "no added chromium" and "containing no chromium" will be a key issue.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patentee’s choice of the word "added" may suggest an intentional act of including chromium as a listed ingredient, which would exclude unintentional trace contaminants.
      • Evidence for a Narrower Interpretation: The specification discusses chromium as a potential impurity and sets specific, low limits for it in certain embodiments (’548 Patent, col. 14:46-54, Table 4). This could be used to argue that the patentee considered the presence of even small amounts of chromium and intended to exclude it, whether added intentionally or not. The use of different phrasing for iron ("contains 0 µg... to about 10 µg") versus chromium ("no added chromium") in the same claim suggests the patentee intended different scopes for each limitation (’548 Patent, col. 45:51-57).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement on the basis that Defendants' proposed package insert and instructions will encourage and direct medical practitioners and patients to administer the ANDA Product in a manner that infringes the asserted method claims (Compl. ¶¶ 48, 55). Contributory infringement is alleged on the grounds that the ANDA Product is especially adapted for an infringing use and is not a staple article suitable for substantial non-infringing use (Compl. ¶¶ 49, 56).
  • Willful Infringement: Willfulness is alleged based on Defendants' knowledge of the patents-in-suit, which the complaint claims existed at least from the date Defendants submitted their ANDA with a Paragraph IV certification (Compl. ¶¶ 51, 58). The complaint asserts the case is "exceptional" and seeks an award of attorneys' fees (Compl. ¶¶ 52, 59).

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

  • A core issue will be one of technical mismatch and claim scope: given the significant quantitative differences between the accused product's formulation (e.g., 1,000 µg/mL zinc) and the formulation recited in representative independent claims (e.g., "about 3,000 µg/mL" zinc), can infringement be proven? The case may depend on the construction of the term "about" for literal infringement or, more plausibly, on a fact-intensive analysis under the doctrine of equivalents.
  • A key strategic question will be one of claim selection: will the litigation focus on the representative claims analyzed here, or will the Plaintiff pivot to other asserted claims within the patents that more closely match the neonatal formulation of the accused ANDA product? The answer will shape the entire infringement and validity dispute.
  • A central evidentiary question will concern the negative limitation "no added chromium." The resolution of this issue may require discovery into Defendants' manufacturing processes and supply chain to determine if any trace amounts of chromium are present and whether their presence constitutes "adding" chromium as understood within the context of the patent.