DCT

1:24-cv-00327

American Regent Inc v. Apotex Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00327, D. Del., 03/13/2024
  • Venue Allegations: Venue is alleged to be proper for Apotex Corp. as a Delaware corporation and for Apotex, Inc. as a foreign corporation subject to personal jurisdiction in the district, based in part on prior litigation conduct.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiff's Tralement® and Multrys® products constitutes an act of infringement of a patent for trace element compositions for parenteral nutrition.
  • Technical Context: The technology concerns stable, injectable formulations of essential trace elements (zinc, copper, manganese, selenium) used for intravenous feeding of patients who cannot receive nutrition orally.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following a notice letter dated January 25, 2024, in which Apotex provided a Paragraph IV Certification asserting that its proposed generic products would not infringe, or that the patent-in-suit is invalid.

Case Timeline

Date Event
2020-07-02 Earliest Priority Date ('548 Patent)
2020-07-02 FDA Approval for Plaintiff's Tralement® and Multrys®
2023-10-17 Issue Date for U.S. Patent No. 11,786,548
2024-01-25 Apotex sends Paragraph IV Notice Letter to Plaintiff
2024-03-13 Complaint Filing Date
2041-07-01 Patent Expiration Date listed in Orange Book

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 that parenteral nutrition admixed with trace elements typically has a short stability period of 24 to 48 hours at room temperature, which can lead to waste, increased costs, and frequent, time-consuming preparations under aseptic conditions ('548 Patent, col. 2:3-17).
  • The Patented Solution: The invention provides specific injectable compositions of trace elements (zinc, copper, selenium, and manganese) that, when added to parenteral nutrition, result in a mixture that is stable for a longer period of time ('548 Patent, Abstract; col. 2:31-35). This extended stability is intended to reduce the frequency of admixing, avoid waste, and improve the quality of life for patients and caregivers by reducing trips to healthcare facilities ('548 Patent, col. 2:35-44).
  • Technical Importance: The development of trace element formulations that enable longer stability for admixed parenteral nutrition addresses a practical need in clinical settings for efficiency, cost reduction, and patient convenience ('548 Patent, col. 2:31-44).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the ’548 Patent without specifying them (Compl. ¶46). Independent claim 1 is representative:
  • Claim 1 Elements:
    • 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 does not explicitly reserve the right to assert dependent claims, but the broad allegation of infringing "one or more claims" leaves this possibility open (Compl. ¶46).

III. The Accused Instrumentality

Product Identification

  • Defendants’ proposed generic drug products ("the ANDA Products") submitted under ANDA No. 218576, which are generic versions of Plaintiff's Tralement® and Multrys® products (Compl. ¶1, 40).

Functionality and Market Context

  • The complaint identifies two accused products based on Apotex's Notice Letter: (1) 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; and (2) a single-dose, 1 mL generic version of Multrys® containing different concentrations of the same elements (Compl. ¶41).
  • These products are described as containing the same or equivalent active ingredients in the same or equivalent amounts as the reference listed drugs and are intended to provide trace elements for parenteral nutrition (Compl. ¶29, 40, 42). The submission of the ANDA with a Paragraph IV certification is the statutory act of infringement that triggers this lawsuit (Compl. ¶1, 45).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 11,786,548 Infringement Allegations

The following chart analyzes the infringement allegations for the accused generic Tralement® product against representative independent claim 1.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An injectable composition comprising water... The accused product is a single-dose, 1 mL generic version of an injectable drug. ¶41 col. 12:21
...about 60 µg of selenium... The accused generic Tralement® product contains 60 mcg of selenium. ¶41 col. 12:19-20
...3,000 µg of zinc... The accused generic Tralement® product contains 3 mg (3,000 µg) of zinc. ¶41 col. 12:13-14
...about 300 µg of copper... The accused generic Tralement® product contains 0.3 mg (300 µg) of copper. ¶41 col. 12:15-16
...and about 55 µg of manganese per 1 mL... The accused generic Tralement® product contains 55 mcg of manganese. ¶41 col. 12:17-18
...contains 0 µg per 1 mL to about 10 µg per 1 mL of iron... The complaint does not provide specific allegations regarding the iron content of the ANDA Products. N/A col. 45:59-61
...does not contain any vitamins... The complaint does not provide specific allegations regarding the vitamin content of the ANDA Products. N/A col. 45:61-62
...contains no added chromium... The complaint does not provide specific allegations regarding the presence of added chromium in the ANDA Products. N/A col. 45:62
...and no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL... The complaint does not provide specific allegations regarding the aluminum content of the ANDA Products. N/A col. 45:62-64

Identified Points of Contention:

  • Scope Questions: The complaint alleges that the accused generic Tralement® product contains quantities of zinc, copper, manganese, and selenium that exactly match the values recited in claim 1. A potential point of dispute may center on the meaning of "about," although the alleged exact match could diminish the relevance of this term if proven.
  • Technical Questions: A central evidentiary question will be whether the ANDA products meet the negative limitations of the claims. The complaint does not allege facts to support the absence of vitamins, the absence of "added" chromium, or the claimed low levels of iron and aluminum. Apotex’s defense may focus on proving that its products contain these substances in amounts outside the claimed limitations, thereby avoiding infringement.

V. Key Claim Terms for Construction

The Term: "about"

  • Context and Importance: This term qualifies the concentration of selenium, copper, and manganese in claim 1. The definition of "about" is critical because it determines the permissible range of deviation from the recited numerical values. If Apotex's products have concentrations that differ even slightly from the patent's figures, the scope of this term will be dispositive for literal infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification frequently uses "about" to describe concentration ranges, such as "about 800 µg to about 4,000 µg of zinc," suggesting an intent for numerical flexibility rather than strict precision ('548 Patent, col. 2:65-66).
    • Evidence for a Narrower Interpretation: The patent provides tables with highly specific, non-approximated values for certain embodiments (e.g., Table 1 lists "3 mg Zn/mL" and "60 µg Se/mL" exactly) ('548 Patent, col. 12:13-20). A party could argue that the use of such precise values in the specification suggests "about" should be construed narrowly to encompass only minor variations, such as those attributable to standard measurement error.

The Term: "no added chromium"

  • Context and Importance: This negative limitation is crucial because prior art multi-trace element products often contained chromium. Practitioners may focus on this term because Apotex could argue for non-infringement if its product contains any level of chromium, for instance as an unavoidable impurity from the manufacturing process or raw materials.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (Plaintiff's view): The patent distinguishes the invention from prior art that intentionally included chromium. The specification also separately discusses elemental impurities and sets maximum limits for them, including chromium, which could support an interpretation that "no added" refers to chromium not being included as a deliberate, active ingredient, while allowing for the presence of trace impurities ('548 Patent, col. 13, Table 2; col. 14:46-54).
    • Evidence for a Narrower Interpretation (Defendant's view): A defendant could argue that "no added chromium" means the final composition must be essentially free of chromium, regardless of its source. The patent's emphasis on creating a chromium-free formulation could be used to argue that any process resulting in the presence of chromium, even from leaching, constitutes an "addition" that places the product outside the claim scope ('548 Patent, col. 14:52-54).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Apotex intends for its ANDA Products to be administered by medical practitioners according to its proposed package insert, and that such administration will infringe the ’548 Patent (Compl. ¶46). Contributory infringement is also alleged on the basis that the ANDA Products are especially made for an infringing use and are not suitable for substantial non-infringing use (Compl. ¶47).
  • Willful Infringement: The complaint alleges that Apotex has had knowledge of the ’548 Patent since at least the date it submitted its ANDA with the Paragraph IV Certification (Compl. ¶49). This alleged knowledge forms the basis for the willfulness and exceptional case allegations (Compl. ¶50).

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

  • A key evidentiary question will be one of compositional proof: Can American Regent demonstrate through chemical analysis that Apotex's proposed generic products meet the negative limitations of the asserted claims, specifically the absence of "added" chromium, the absence of vitamins, and the claimed low concentrations of iron and aluminum? The complaint is currently silent on these elements.
  • A central legal question will be one of definitional scope: Should the term "no added chromium" be construed to mean a complete absence of chromium, or does it permit the presence of unavoidable trace impurities that are not intentionally included as an ingredient? The answer will determine whether the potential presence of manufacturing-related impurities in Apotex's products is a viable non-infringement defense.