DCT

2:24-cv-09600

American Regent Inc v. Accord Healthcare Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-09600, D.N.J., 01/09/2025
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant conducts business in New Jersey, is registered as a drug manufacturer with the state, employs a sales force in the district, and has consented to venue for the purposes of this case.
  • Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking to market generic versions of Plaintiff's Tralement® and Multrys® drug products, constitutes an act of infringement of five patents related to trace element compositions for parenteral nutrition.
  • Technical Context: The technology involves injectable multi-trace element compositions formulated to provide essential nutrients such as zinc, copper, selenium, and manganese to patients who cannot receive oral or enteral nutrition.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Defendant's filing of ANDA No. 218656 with a Paragraph IV certification, asserting that the patents-in-suit are invalid or will not be infringed. Plaintiff was notified of the ANDA filing via a Notice Letter dated August 28, 2024. Two of the asserted patents, U.S. Patent Nos. 12,150,956 and 12,150,957, were listed in the FDA's Orange Book after Plaintiff filed its initial complaint.

Case Timeline

Date Event
2020-07-02 Patent Priority Date for '548, '022, '565, '956, and '957 Patents
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
2024-08-28 Defendant Sends Paragraph IV Notice Letter to Plaintiff
2024-11-26 U.S. Patent No. 12,150,956 Issues
2024-11-26 U.S. Patent No. 12,150,957 Issues
2025-01-09 Amended Complaint Filed

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's background section describes the short stability period (typically 24-48 hours) of parenteral nutrition (PN) solutions once trace elements are added. This short window necessitates frequent, costly, and time-consuming admixing procedures by healthcare providers and prevents the preparation of daily doses in larger, more efficient batches ('548 Patent, col. 2:5-30).
  • The Patented Solution: The invention provides a stable, injectable composition containing specific concentrations of zinc, copper, selenium, and manganese. When added to a parenteral nutrition solution, this composition allows the final admixture to remain stable for a significantly longer period (e.g., at least 3 to 14 days), reducing waste, cost, and the burden on caregivers and healthcare facilities ('548 Patent, Abstract; col. 2:46-58).
  • Technical Importance: By extending the stability of admixed parenteral nutrition, the invention enables more efficient batch preparation and enhances the quality of life for patients and caregivers by reducing the frequency of admixing and trips to healthcare facilities ('548 Patent, col. 2:35-44).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims, and Defendant’s pre-suit correspondence did not assert non-infringement defenses for claims 1-7, 9-10, or 12-58 (Compl. ¶35, ¶47). Independent claim 1 is representative.
  • The essential elements of independent claim 1 include:
    • An injectable composition comprising water,
    • about 60 µg of selenium,
    • 3,000 µg of zinc,
    • about 300 µg of copper,
    • and about 55 µg of manganese per 1 mL of the injectable composition,
    • wherein the injectable composition contains 0 µg per 1 mL to about 10 µg per 1 mL of iron, does not contain any vitamins, contains no added chromium, and no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL.
  • The complaint reserves the right to assert additional claims (Compl. ¶47).

U.S. Patent No. 11,975,022 - "Trace Element Compositions, Methods of Making and Use"

The Invention Explained

  • Problem Addressed: As a divisional of the application leading to the ’548 Patent, the ’022 Patent addresses the identical technical problem: the limited stability of parenteral nutrition solutions after the addition of trace elements ('022 Patent, col. 2:5-30).
  • The Patented Solution: The invention claims a method of providing trace elements to a patient by administering an injectable composition with the same specific concentrations of zinc, copper, selenium, and manganese described in the ’548 Patent. The claimed method leverages the extended stability of the composition to facilitate parenteral nutrition ('022 Patent, Abstract; col. 2:46-58).
  • Technical Importance: The technical importance is identical to that of the ’548 Patent, focusing on improving the efficiency of care and quality of life for patients requiring parenteral nutrition ('022 Patent, col. 2:35-44).

Key Claims at a Glance

  • Defendant's pre-suit correspondence did not assert non-infringement defenses for any claim of the patent (Compl. ¶35). Independent claim 1 is representative.
  • The essential elements of independent claim 1 include:
    • A method of providing trace elements to a patient in need thereof, comprising administering an injectable trace element composition to the patient,
    • the composition comprising 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 specified low or zero levels of iron, vitamins, added chromium, and aluminum.
  • The complaint reserves the right to assert additional claims (Compl. ¶54).

U.S. Patent No. 11,998,565 - "Trace Element Compositions, Methods of Making and Use"

  • Technology Synopsis: This continuation patent addresses the same technical problem of parenteral nutrition stability. It claims an injectable composition with specific concentrations of trace elements tailored for neonatal patients, including 1,000 µg of zinc, 60 µg of copper, 6 µg of selenium, and 3 µg of manganese per 1 mL ('565 Patent, Abstract; col. 4:31-36).
  • Asserted Claims: The complaint alleges infringement of one or more claims, and Defendant’s pre-suit correspondence did not assert non-infringement defenses for any claim of the patent (Compl. ¶35, ¶61). Independent claims include 1 and 19.
  • Accused Features: The specific formulation of Defendant's single-dose, 1 mL generic version of Multrys® is accused of infringing this patent (Compl. ¶42, ¶60-61).

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

  • Technology Synopsis: As a member of the same patent family, this patent concerns stable injectable compositions of trace elements for use in parenteral nutrition (Compl. ¶37).
  • Asserted Claims: The complaint does not identify specific asserted claims (Compl. Count IV).
  • Accused Features: Defendant's ANDA Products, including its generic versions of Tralement® and Multrys®, are accused of infringing this patent (Compl. ¶41-42, ¶67-68).

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

  • Technology Synopsis: This patent is also a member of the same family and relates to stable injectable trace element compositions for parenteral nutrition (Compl. ¶39).
  • Asserted Claims: The complaint does not identify specific asserted claims (Compl. Count V).
  • Accused Features: Defendant's ANDA Products, including its generic versions of Tralement® and Multrys®, are accused of infringing this patent (Compl. ¶41-42, ¶73-74).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant's generic drug products ("the ANDA Products") seeking FDA approval under ANDA No. 218656 as generic versions of Plaintiff's Tralement® and Multrys® products (Compl. ¶1, ¶41).

Functionality and Market Context

  • The complaint alleges, based on Defendant's notice letter, that the ANDA Products are injectable aqueous solutions with specific formulations of trace elements for parenteral nutrition (Compl. ¶42-43). The formulations are alleged to be:
    • A 1 mL generic version of Tralement® containing 3 mg of zinc, 0.3 mg of copper, 55 mcg of manganese, and 60 mcg of selenium (Compl. ¶42).
    • A 5 mL generic version of Tralement® containing 3 mg/mL of zinc, 0.3 mg/mL of copper, 55 mcg/mL of manganese, and 60 mcg/mL of selenium (Compl. ¶42).
    • A 1 mL generic version of Multrys® containing 1000 mcg of zinc, 60 mcg of copper, 3 mcg of manganese, and 6 mcg of selenium (Compl. ¶42).
  • The act of infringement alleged under 35 U.S.C. § 271(e)(2) is the submission of the ANDA itself to seek approval for commercial manufacture and sale prior to the expiration of the patents-in-suit (Compl. ¶46).

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 accused ANDA Products are aqueous injectable solutions for parenteral nutrition. ¶41-43 col. 10:10-14
...about 60 µg of selenium... The 1 mL generic Tralement® product is alleged to contain 60 mcg of selenium. ¶42 col. 11:15-25
...3,000 µg of zinc... The 1 mL generic Tralement® product is alleged to contain 3 mg (3,000 µg) of zinc. ¶42 col. 11:15-25
...about 300 µg of copper... The 1 mL generic Tralement® product is alleged to contain 0.3 mg (300 µg) of copper. ¶42 col. 11:15-25
...and about 55 µg of manganese per 1 mL of the injectable composition... The 1 mL generic Tralement® product is alleged to contain 55 mcg of manganese. ¶42 col. 11:15-25
...wherein the injectable composition... contains no added chromium... The complaint alleges the ANDA Products contain the same or equivalent ingredients as Tralement®, which does not contain chromium as an active ingredient. ¶41, ¶43 col. 14:45-53

'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 in need thereof, the method comprising administering an injectable trace element composition to the patient... The proposed labeling for the ANDA Products allegedly instructs medical practitioners to administer the products to patients for parenteral nutrition. ¶54 col. 3:15-21
...the injectable trace element composition comprising water, about 60 µg of selenium, 3,000 µg of zinc, about 300 µg of copper, and about 55 µg of manganese per 1 mL... The ANDA Products for generic Tralement® are alleged to contain these exact concentrations of the specified trace elements. ¶42, ¶54 col. 11:8-18
...wherein the injectable composition... contains no added chromium... The proposed ANDA products are alleged to be formulations that do not contain added chromium. ¶41, ¶43, ¶54 col. 14:40-47

Identified Points of Contention

  • Scope Questions: The infringement analysis for several elements in the ’548 and ’022 Patents may turn on the scope of the term "about." A central question will be whether the specific concentrations of copper, selenium, and manganese in the accused products, as manufactured, fall within the range implied by "about" as used in the claims. A further question relates to the negative limitation "no added chromium," specifically whether this term means only the absence of intentionally formulated chromium or if it extends to any detectable trace amount that may arise as an impurity from the manufacturing process or raw materials.
  • Technical Questions: The complaint's infringement theory appears to be a direct mapping of the accused product's alleged formulation onto the claim elements. A primary factual question for the court will be to confirm whether the chemical composition of Defendant's ANDA products is, in fact, as alleged in the complaint and as disclosed in the ANDA submission to the FDA.

V. Key Claim Terms for Construction

  • The Term: "about"

  • Context and Importance: This term's construction is critical for determining the scope of the claimed concentrations for copper, selenium, and manganese. Practitioners may focus on this term because its interpretation will define the boundaries of literal infringement; a narrow reading could potentially allow a generic product with slight formulation differences to avoid infringement, whereas a broader reading would cover a wider range of concentrations.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent specification discloses broad ranges for the concentrations of trace elements, such as "about 40 µg to about 400 µg of copper" per 1 mL of the composition ('548 Patent, col. 4:3-4). This language may support an interpretation that "about" is not limited to minor manufacturing tolerances around a specific value.
    • Evidence for a Narrower Interpretation: The patent provides a specific embodiment in Table 1 that lists the exact values of 300 µg of copper, 60 µg of selenium, and 55 µg of manganese ('548 Patent, col. 11:15-25). A party could argue that "about" should be construed narrowly in light of this precise example, covering only minor variations from these disclosed amounts.

  • The Term: "no added chromium"

  • Context and Importance: This negative limitation is central to distinguishing the invention from prior art. Its construction will determine whether the presence of any detectable chromium, even as an unintended impurity, removes the accused product from the scope of the claim.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation (i.e., "no added" refers to formulation): The patent's background discusses the reduction of recommended daily doses of trace elements like chromium and notes that in some instances it is "not typically needed" ('548 Patent, col. 1:45-50). Further, the patent's Table 3 describes the injectable composition as containing "no chromium at all," in contrast to prior art products that contain chromium, suggesting the term refers to its absence as a formulated, active ingredient ('548 Patent, col. 14:45-53).
    • Evidence for a Narrower Interpretation (i.e., "no added" means absolute absence): The plain language of the claim itself is "contains no added chromium." A party might argue that this requires the complete absence of chromium, regardless of its source, to avoid rendering the term superfluous.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement and contributory infringement on the basis that Defendant's proposed product labeling and instructions will actively encourage and instruct medical professionals and patients to administer the ANDA Products in a manner that directly infringes the asserted method claims (Compl. ¶47, ¶54, ¶61). It further alleges the products are not suitable for substantial non-infringing use (Compl. ¶48, ¶55, ¶62).
  • Willful Infringement: The complaint alleges willfulness based on Defendant's pre-suit knowledge of the patents-in-suit. This knowledge is alleged to have arisen, at the latest, from the date Defendant submitted its ANDA with the Paragraph IV certification, which requires an applicant to review the patents listed for the reference drug product (Compl. ¶50, ¶57, ¶64).

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

  • A core issue will be one of claim construction: how broadly will the court interpret the term "about" as it modifies the specific concentrations of trace elements in the asserted claims? The outcome of the literal infringement analysis will likely depend on whether this term is given a wider scope in light of the specification's broad ranges or a narrower one tied to the patent's specific embodiment.
  • A second key issue will be the scope of the negative limitation "no added chromium." The case may turn on a legal and factual determination of whether this term prohibits only the intentional inclusion of chromium as an active ingredient or if it also encompasses trace-level impurities that may be present from raw materials or the manufacturing process.
  • A central pillar of the dispute, as in most ANDA litigation, will be validity. Although not detailed in the complaint, Defendant's Paragraph IV certification asserts that the patents are invalid. The case will likely feature a significant technical debate over whether the specific combination and concentration of trace elements recited in the claims would have been obvious to a person of ordinary skill in the art at the time of the invention.