DCT

1:24-cv-00248

American Regent Inc v. Somerset Therap LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00248, D. Del., 02/23/2024
  • Venue Allegations: Venue is alleged to be proper as all three defendant LLCs are organized under the laws of the State of Delaware.
  • Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's Tralement® product constitutes an act of infringement of a patent covering stable trace element formulations.
  • Technical Context: The technology concerns injectable pharmaceutical compositions that provide essential trace elements (zinc, copper, manganese, selenium) for patients requiring parenteral (intravenous) nutrition.
  • Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 218824 to the FDA. The ANDA contained a Paragraph IV Certification asserting that U.S. Patent No. 11,786,548 is invalid or will not be infringed. Plaintiff was notified of the ANDA filing via a letter dated January 8, 2024. The patent-in-suit is listed in the FDA's "Orange Book" as covering the Tralement® drug product.

Case Timeline

Date Event
2020-07-02 '548 Patent Priority Date
2020-07-02 Plaintiff's Tralement® NDA Approved
2023-10-17 '548 Patent Issue Date
2024-01-08 Defendants' ANDA Notice Letter Sent
2024-02-23 Complaint Filing Date
2041-07-01 '548 Patent Expiration Date

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

  • Patent Identification: 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 admixing trace elements into parenteral nutrition solutions creates formulations with a short stability period, often just 24 to 48 hours. This necessitates frequent, time-consuming, and costly preparation of doses under aseptic conditions, and increases the risk of waste if a patient's treatment is paused ('548 Patent, col. 2:3-24).
  • The Patented Solution: The invention provides a stable, injectable trace element composition with specific quantities of zinc, copper, selenium, and manganese. This formulation is designed to be stable for a longer period of time when added to parenteral nutrition, which reduces the frequency of admixing, lowers costs, and improves the quality of life for patients and caregivers ('548 Patent, Abstract; col. 2:46-54).
  • Technical Importance: By creating a more stable formulation, the invention allows for trace element doses to be prepared in larger batches and less frequently, streamlining a critical aspect of care for patients who cannot receive nutrition orally ('548 Patent, col. 2:31-44).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims of the '548 patent, and notes that Defendants' notice letter did not provide non-infringement positions for claims 1-26, 34-37, 40-41, 44-46, 48, 51-52, and 55-56 (Compl. ¶42). Independent claim 1 is representative:
  • 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.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' generic trace element injection product described in ANDA No. 218824 ("the ANDA Product") (Compl. ¶1).

Functionality and Market Context

  • The ANDA Product is an injectable drug intended as a generic version of Plaintiff's Tralement® product, designed to provide trace elements for patients on parenteral nutrition (Compl. ¶¶1, 43). The complaint alleges that the Defendants' notice letter disclosed the composition of the ANDA Product as comprising "3 mg of zinc, 0.3 mg of copper, 55 mcg of manganese, and 60 mcg of selenium in single-dose vials with 1 ml of fill" (Compl. ¶44). The complaint further alleges the ANDA Product contains the "same or equivalent ingredients in the same or equivalent amounts" as Tralement® (Compl. ¶43).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'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 described as a "trace element injection 4 USP... single-dose vials (1 mL fill) product" intended for parenteral nutrition. ¶40 col. 4:1-4
about 60 µg of selenium The ANDA Product is alleged to be comprised of "60 mcg of selenium." ¶44 col. 4:26-29
3,000 µg of zinc The ANDA Product is alleged to be comprised of "3 mg of zinc" (equivalent to 3,000 µg). ¶44 col. 4:26-29
about 300 µg of copper The ANDA Product is alleged to be comprised of "0.3 mg of copper" (equivalent to 300 µg). ¶44 col. 4:26-29
about 55 µg of manganese per 1 mL The ANDA Product is alleged to be comprised of "55 mcg of manganese." ¶44 col. 4:26-29
contains 0 µg per 1 mL to about 10 µg per 1 mL of iron The complaint alleges the ANDA Product is a generic version of Tralement®, which is a commercial embodiment of the patent. ¶¶35, 43 col. 45:58-59
does not contain any vitamins The complaint alleges the ANDA Product is a generic version of Tralement®, which is a commercial embodiment of the patent. ¶¶35, 43 col. 45:59-60
contains no added chromium The complaint alleges the ANDA Product is a generic version of Tralement®, which is a commercial embodiment of the patent. ¶¶35, 43 col. 45:60-61
  • Identified Points of Contention:
    • Evidentiary Questions: The complaint's allegations regarding the positive limitations (zinc, copper, etc.) appear to map directly onto the claim language based on the disclosed ANDA Product composition. A primary point of contention will be proving the negative limitations. The complaint does not provide direct evidence that the ANDA Product contains little to no iron, no vitamins, and "no added chromium," instead relying on the allegation that it is a generic equivalent to Tralement®, which is an embodiment of the patent (Compl. ¶¶35, 43). The factual accuracy of these negative limitations in the ANDA Product will be a central issue.
    • Scope Questions: The term "about" preceding several claimed quantities provides some flexibility. While the alleged composition of the ANDA product appears to match the recited values exactly, any variation discovered in the actual product could raise questions about the scope of "about" in the context of a pharmaceutical formulation.

V. Key Claim Terms for Construction

  • The Term: "no added chromium"
  • Context and Importance: This negative limitation is critical because infringement requires proof that the accused product lacks an element that has been "added." This is distinct from a composition that is completely free of chromium, as trace amounts could be present as impurities from raw materials or manufacturing. Practitioners may focus on this term because the dispute will likely concern the source and characterization of any chromium detected in the ANDA Product.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (i.e., that "no added" permits incidental impurities): The patent specification distinguishes between active ingredients and potential impurities. Table 2 lists a specification for chromium as an elemental impurity with a limit of "Not more than 1.0 µg/mL," which suggests the patent contemplates the presence of incidental chromium while claiming a formulation with "no added chromium" ('548 Patent, col. 14:1-1). This supports an interpretation where the claim prohibits intentional inclusion of chromium as a functional ingredient, but does not forbid trace impurities.
    • Evidence for a Narrower Interpretation (i.e., that any presence of chromium violates the limitation): A defendant could argue that the term is ambiguous or that any detectable level of chromium, regardless of source, falls outside the scope of "no added chromium." However, the plain language of the claim, which specifies "added," and the specification's separate treatment of chromium as a potential impurity present strong evidence against this narrower view.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Defendants intend for the ANDA Product to be administered according to a proposed package insert, which will instruct medical practitioners and patients to perform the infringing acts (Compl. ¶49). It also alleges contributory infringement on the basis that the ANDA Product is especially made for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶50).
  • Willful Infringement: The complaint alleges that Defendants have had knowledge of the '548 patent since at least the date they submitted the ANDA, and that this submission constituted a known act of infringement (Compl. ¶52). This forms the basis for an allegation of willfulness and a request for a finding that the case is "exceptional" under 35 U.S.C. § 285 (Compl. ¶53).

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

  • A central issue will be one of evidentiary proof: can Plaintiff demonstrate, through discovery of the ANDA, that Defendants' product meets the negative limitations of Claim 1? The litigation will likely focus on the precise formulation details concerning iron, vitamins, aluminum, and especially chromium in the ANDA Product.
  • A key legal and factual question will be one of characterization: if trace amounts of chromium are found in the ANDA product, were they "added" as contemplated by the claim, or are they unavoidable process impurities? The patent's own distinction between active ingredients and elemental impurities will be critical in resolving this core infringement question.
  • The ultimate outcome may depend on validity challenges, which Defendants raised in their Paragraph IV certification (Compl. ¶41). While the complaint focuses on infringement, the strength and nature of Defendants' invalidity arguments, once revealed, will be a determinative factor in the litigation.