DCT

1:25-cv-00191

American Regent Inc v. Meitheal Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00191, D. Del., 02/14/2025
  • Venue Allegations: Venue is alleged to be proper based on Defendant Meitheal being organized under the laws of Delaware and Defendant Kindos being a foreign company that 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 Selenious Acid injectable products constitutes an act of infringement of patents covering trace element compositions.
  • Technical Context: The technology concerns stable, injectable pharmaceutical compositions of trace elements, such as selenium, designed for addition to parenteral nutrition for patients who cannot receive nourishment orally.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 219472 with a Paragraph IV certification, challenging the asserted patents. Plaintiff's patents are listed in the FDA's "Orange Book" for its approved Selenious Acid products, and Defendants provided Plaintiff with a notice letter regarding the ANDA filing on December 30, 2024.

Case Timeline

Date Event
2019-04-30 Plaintiff's New Drug Application for Selenious Acid approved by FDA
2020-07-02 Earliest Priority Date for ’565 and ’957 Patents
2024-06-04 U.S. Patent No. 11,998,565 issues
2024-11-26 U.S. Patent No. 12,150,957 issues
2024-12-30 Defendants send Notice Letter to Plaintiff regarding ANDA filing
2025-02-14 Complaint filed

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

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

  • Patent Identification: U.S. Patent No. 11,998,565, "Trace element compositions, methods of making and use," issued June 4, 2024.

The Invention Explained

  • Problem Addressed: The patent's background section describes the short stability of parenteral nutrition (PN) solutions once trace elements are added, typically lasting only 24 to 48 hours. This necessitates frequent, costly, and time-consuming admixing, creating logistical burdens for patients and healthcare providers. Additionally, existing multi-element formulations may not be easily customizable for specific patient needs. (’565 Patent, col. 1:46 - col. 2:48).
  • The Patented Solution: The invention provides a stable injectable composition containing specific concentrations of trace elements like selenium. This composition, when added to a parenteral nutrition solution, allows the combined mixture to remain stable for a longer period, reducing waste and the frequency of admixing. The patent focuses on compositions with specific impurity profiles, such as very low or no chromium, aluminum, and iron. (’565 Patent, Abstract; col. 3:5-21).
  • Technical Importance: By creating a more stable formulation, the invention enables the preparation of parenteral nutrition in larger batches, which can improve patient quality of life and reduce healthcare costs associated with long-term intravenous feeding. (’565 Patent, col. 2:31-48).

Key Claims at a Glance

  • The complaint does not identify specific claims but alleges infringement of one or more claims. Independent claim 1 is representative of the patented composition.
  • Independent Claim 1:
    • An injectable composition comprising water,
    • 6 µg or 60 µg of selenium,
    • no chromium or chromium in an amount not to exceed 1 µg,
    • no aluminum or aluminum in an amount not to exceed 6 µg,
    • no iron or iron in an amount up to 10 µg, and
    • fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition.

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

  • Patent Identification: U.S. Patent No. 12,150,957, "Trace element compositions, methods of making and use," issued November 26, 2024.

The Invention Explained

  • Problem Addressed: The '957 Patent addresses the same technical problems as the ’565 Patent: the short stability of parenteral nutrition after the addition of trace elements and the difficulty in customizing dosages with existing formulations. (’957 Patent, col. 1:12 - col. 2:49).
  • The Patented Solution: The invention claims a method of providing a stable injectable composition to a patient. The composition itself is defined by specific amounts of selenium and very low or non-existent levels of certain impurities like chromium and aluminum, addressing the stability and customization problems identified in the background. (’957 Patent, Abstract; col. 3:5-21).
  • Technical Importance: This patent protects the method of using the stable trace element compositions, complementing the composition claims of related patents by covering the therapeutic application of the technology. (’957 Patent, col. 2:31-49).

Key Claims at a Glance

  • The complaint does not identify specific claims but alleges infringement of one or more claims. Independent claim 1 is representative of the patented method.
  • Independent Claim 1:
    • A method of providing an injectable composition to a patient in need thereof, the method comprising administering at least the injectable composition to the patient,
    • the injectable composition comprising water,
    • 6 µg, 40 µg or 60 µg of selenium,
    • no chromium or chromium in an amount not to exceed 1 µg,
    • no aluminum or aluminum in an amount not to exceed 6 µg,
    • no iron or iron in an amount not to exceed 10 µg, and
    • fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the generic drug product described in Abbreviated New Drug Application No. 219472 ("the ANDA Product") (Compl. ¶1).

Functionality and Market Context

  • The complaint identifies the ANDA Product as "Selenious Acid Injection, USP, (600 mcg Selenium/10 mL (60 mcg/mL))" (Compl. ¶32). It is alleged to be a generic version of Plaintiff's Selenious Acid product, containing the "same or equivalent ingredients in the same or equivalent amounts" and intended for the "same or equivalent" use (Compl. ¶¶31, 33).
  • The complaint alleges that Defendants seek approval to commercially manufacture, use, and sell this product in the United States prior to the expiration of the Asserted Patents (Compl. ¶1). The ANDA filing itself is presented as evidence of Defendants' intent to enter the market upon FDA approval (Compl. ¶13).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or identify specific asserted claims. The infringement allegations are framed under 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA seeking approval to market a generic drug before patent expiration as a statutory act of infringement. The core allegation is that the ANDA Product, if approved and marketed as described in the ANDA, will infringe the Asserted Patents (Compl. ¶¶36, 43).

The complaint alleges that upon approval, Defendants' manufacture, use, and sale of the ANDA Product would constitute direct infringement (Compl. ¶¶38, 45). It further alleges that the product's proposed package insert will instruct medical professionals and patients on an infringing use, thereby inducing infringement by third parties (Compl. ¶¶37, 44).

Identified Points of Contention

  • The primary dispute will concern whether the chemical composition of the ANDA Product, as specified in Defendants' confidential FDA filing, falls within the scope of the asserted claims.
    • Scope Questions: A central question will be whether Defendants' ANDA product meets the negative limitations of the claims, such as "no chromium or chromium in an amount not to exceed 1 µg" and "no aluminum or aluminum in an amount not to exceed 6 µg." The interpretation of "no" versus the specified upper limit for these impurities will be a likely point of contention.
    • Technical Questions: A key factual question will be what the ANDA specifies regarding the concentration of selenium and the levels of impurities like chromium, aluminum, iron, and fluoride. The infringement analysis will depend entirely on the technical specifications for the ANDA Product submitted to the FDA.

V. Key Claim Terms for Construction

  • The Term: "no chromium or chromium in an amount not to exceed 1 µg" (from claim 1 of the ’565 and ’957 Patents).
  • Context and Importance: This is a negative limitation defining an impurity profile, which appears central to the patentability of the claimed invention. Practitioners may focus on this term because the infringement analysis will depend on whether the ANDA product's specified level of chromium falls within this range. The construction of "no" in the context of the alternative upper limit ("or...not to exceed 1 µg") may be disputed.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language of the disjunctive "or" suggests two distinct possibilities: either a complete absence of chromium or an amount at or below the 1 µg threshold. This could support an argument that any product with 1 µg/mL of chromium or less infringes this limitation.
    • Evidence for a Narrower Interpretation: Defendants may argue that the term "no chromium" implies a level below the limit of detection for standard analytical equipment. The specification's discussion of reducing contaminants and providing safer formulations could be used to argue that the invention is directed to compositions that are substantially free of certain elements, potentially supporting a narrower construction focused on achieving undetectable or near-zero levels. (’565 Patent, col. 2:40-48).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement, asserting that Defendants' proposed package insert for the ANDA Product will instruct and encourage patients and medical practitioners to administer the product in a manner that directly infringes the claims (Compl. ¶¶37, 44). Contributory infringement is also alleged, based on the assertion that the ANDA Product is especially made or adapted for infringing uses and is not suitable for substantial non-infringing use (Compl. ¶¶38, 45).
  • Willful Infringement: The complaint alleges that Defendants have had knowledge of the Asserted Patents since at least the date they submitted the ANDA with a Paragraph IV Certification (Compl. ¶40). Plaintiff also pleads that the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285, which is often associated with findings of willful infringement or other litigation misconduct (Compl. ¶¶41, 47).

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

  • A core issue will be one of definitional scope: How will the court construe the negative and quantitative limitations in the claims, particularly the phrase "no [element] or [element] in an amount not to exceed [X] µg"? The outcome of this construction will likely determine whether the specifications of the ANDA product fall within the scope of the claims.
  • The central evidentiary question will be one of chemical composition: Does the product formulation detailed in Defendants' confidential ANDA submission to the FDA meet every limitation of an asserted patent claim, including the specific concentration of selenium and the maximum allowable levels for impurities such as chromium, aluminum, and iron?