DCT

2:24-cv-01169

American Regent Inc v. RK Pharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-01169, D.N.J., 02/28/2024
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because the defendants maintain regular and established places of business in the state and submitted the Abbreviated New Drug Application (ANDA) from VGYAAN's Skillman, New Jersey, location.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an ANDA to the FDA, seeking approval to market generic versions of Plaintiff's Tralement® and Multrys® products, constitutes an act of patent infringement.
  • Technical Context: The technology involves stable, injectable multi-trace element compositions used for parenteral nutrition in patients who cannot receive adequate nutrition orally or enterally.
  • Key Procedural History: This is a Hatch-Waxman Act lawsuit initiated after Defendants sent a "Notice Letter" dated January 23, 2024, informing Plaintiff of their ANDA filing containing a Paragraph IV Certification. The complaint notes that Plaintiff was unable to access the full ANDA to assess non-infringement claims due to a dispute over the terms of a proposed confidential access agreement.

Case Timeline

Date Event
2020-07-02 Plaintiff's NDA for Tralement® and Multrys® approved by FDA
2020-07-02 '548 Patent Priority Date
2023-10-17 '548 Patent Issue Date
2024-01-23 Defendants send Paragraph IV Notice Letter to Plaintiff
2024-02-28 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

  • Issued: October 17, 2023.

The Invention Explained

  • Problem Addressed: The patent describes that when trace elements are added to parenteral nutrition solutions, the resulting admixture has a short stability period (typically 24-48 hours), requiring frequent, costly, and time-consuming preparation under aseptic conditions ( '548 Patent, col. 2:4-17). Furthermore, existing combination products often contain higher doses of elements than needed, making them difficult to customize for individual patient requirements ( '548 Patent, col. 2:50-55).
  • The Patented Solution: The invention provides a stable, injectable trace element composition that can be added to parenteral nutrition, allowing the final admixture to remain stable for a longer period ('548 Patent, col. 2:46-52). This solution, comprising specific concentrations of zinc, copper, selenium, and manganese, reduces waste and the burden on healthcare providers by enabling the preparation of parenteral nutrition in larger batches less frequently ('548 Patent, Abstract; col. 2:34-44).
  • Technical Importance: The patented composition aims to improve patient quality of life and reduce healthcare costs by creating a more stable and customizable method for providing essential trace elements in parenteral nutrition ('548 Patent, col. 2:34-44).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the '548 patent, and notes that Defendants' notice letter failed to provide non-infringement positions for claims 1-2, 4-6, 9-19, 21-43, and 46-56 (Compl. ¶39). Independent claim 1 is representative of the asserted composition claims.
  • Independent Claim 1: 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 of the injectable composition.
  • The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶47).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the generic drug products described in the Defendants' Abbreviated New Drug Application (ANDA) No. 218537, which seek approval as generic versions of Plaintiff's Tralement® and Multrys® products (Compl. ¶¶1, 41).

Functionality and Market Context

  • Based on the Defendants' notice letter, the complaint alleges the ANDA Products include a single-dose, 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). This formulation is intended to provide trace elements for parenteral nutrition in adult and pediatric patients (Compl. ¶29).
  • The defendants are alleged to be a "vertically integrated" group of companies engaged in all phases of the generic pharmaceutical business (Compl. ¶¶16, 18). A screenshot from the RK Pharma website is provided to support this allegation, describing how the addition of VGYAAN and Archis adds to the group's "product portfolio as well as front-end capabilities" (Compl. ¶18, p. 5). The ANDA Products are intended to be commercially manufactured and sold as lower-cost, bioequivalent alternatives to the Plaintiff's branded products upon FDA approval (Compl. ¶1).

IV. Analysis of Infringement Allegations

The infringement allegations for the 1 mL generic Tralement® version are based on information disclosed in the Defendants' notice letter, as the Plaintiff states it was unable to review the full ANDA prior to filing (Compl. ¶¶40, 42).

11,786,548 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 solution alleged to be a generic version of Plaintiff's aqueous-based Tralement® product. ¶41 col. 3:1-5
about 60 µg of selenium, The ANDA Product is alleged to contain 60 mcg of selenium per 1 mL. ¶42 col. 12:21
3,000 µg of zinc, The ANDA Product is alleged to contain 3 mg (or 3,000 µg) of zinc per 1 mL. ¶42 col. 12:15
about 300 µg of copper, and The ANDA Product is alleged to contain 0.3 mg (or 300 µg) of copper per 1 mL. ¶42 col. 12:17
about 55 µg of manganese per 1 mL of the injectable composition, The ANDA Product is alleged to contain 55 mcg of manganese per 1 mL. ¶42 col. 12:19
wherein the injectable composition ... contains no added chromium... The complaint alleges the ANDA Product is a generic version of Tralement®, which is an embodiment of the patent that does not contain added chromium. ¶32, ¶41 col. 2:45-49
  • Identified Points of Contention:
    • Scope Questions: A central question may be the interpretation of the term "about" as it modifies the quantities of selenium, copper, and manganese. The Defendants' product is alleged to contain precise amounts (e.g., 60 mcg of selenium), and any deviation in the actual formulation could lead to a dispute over whether it falls within the scope of "about 60 µg."
    • Technical Questions: The complaint's infringement theory relies heavily on the allegation that the ANDA Products are "generic versions" of Plaintiff's commercial embodiments and contain the "same or equivalent ingredients" (Compl. ¶41). A key evidentiary question will be whether discovery confirms that the ANDA product composition meets the negative limitations of claim 1, such as containing "no added chromium" and having iron and aluminum levels below the claimed maximums. Plaintiff’s stated inability to review the ANDA itself underscores that these allegations are based on the notice letter and assumptions of bioequivalence (Compl. ¶40).

V. Key Claim Terms for Construction

  • The Term: "about"

    • Context and Importance: This term governs the scope of the claimed concentrations for selenium, copper, and manganese. Its construction will be critical to determining literal infringement, as even minor deviations in the accused product's formulation from the recited values could place it outside the claim's scope if the term is construed narrowly.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification states that numerical parameters are "approximations" and should be understood as being modified by the term "about" ( '548 Patent, col. 5:32-38). This suggests the patentee intended some flexibility beyond exact numerical values.
      • Evidence for a Narrower Interpretation: The patent provides tables with highly specific target values, such as "60 µg Se/mL" in Table 1, without the "about" modifier ( '548 Patent, col. 12:21). A party could argue that "about" should be interpreted narrowly to mean only the degree of variability expected from standard rounding or measurement techniques in the art.

  • The Term: "no added chromium"

    • Context and Importance: This negative limitation is a key feature distinguishing the invention from prior art that may have included chromium. Practitioners may focus on this term because the infringement analysis will depend on whether this requires the complete absence of detectable chromium or merely its exclusion as an intentionally formulated ingredient.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation (i.e., allowing for trace impurities): The specification distinguishes this term from impurity limits. For example, Table 4 provides a specific "Control Threshold" for chromium as a potential impurity (1.0 µg/mL), separate from the claim's requirement of "no added chromium" ( '548 Patent, col. 16:33). This suggests "no added" refers to the formulation's recipe, not an absolute absence of the element.
      • Evidence for a Narrower Interpretation (i.e., requiring near-zero levels): The background explains that "daily doses of chromium are not typically needed" ('548 Patent, col. 2:47-48), suggesting a clear intent to eliminate it. An argument could be made that any amount of chromium beyond unavoidable background levels present in the raw materials would violate this limitation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if the ANDA is approved, Defendants will induce infringement by instructing medical practitioners, through the product's package insert, to administer the product in an infringing manner. It also alleges contributory infringement, stating the ANDA Products are especially made for use in infringing the patent and are not suitable for substantial non-infringing use (Compl. ¶¶47-48).
  • Willful Infringement: While not pleaded as a separate count for willfulness, the complaint alleges that the RK Pharma Group has had knowledge of the '548 patent since at least the date it submitted the ANDA (Compl. ¶50). It further alleges the case is "exceptional" and seeks an award of attorneys' fees under 35 U.S.C. § 285, which is often associated with findings of willful infringement or other litigation misconduct (Compl. ¶51).

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

  • A core issue will be one of "evidentiary confirmation": As the infringement allegations are based on a notice letter rather than direct analysis of the ANDA, a central question is whether discovery will confirm that the defendants' product composition, including its impurity profile, meets all positive and negative limitations of the asserted claims.
  • A key legal question will be one of "definitional scope": The case may turn on the construction of "about" and "no added chromium." The court's interpretation will determine whether minor variations in concentration or the presence of trace impurities are sufficient for the accused products to avoid a finding of literal infringement.
  • A procedural question involves the "interrelationship of the defendants": The complaint alleges that the four defendant entities operate as a "vertically integrated" group (Compl. ¶18). A question for the court will be to determine the precise role and liability of each entity in the alleged infringement, which will depend on evidence of their concerted actions in preparing and filing the ANDA.