DCT

2:24-cv-07811

American Regent Inc v. Xiromed LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: American Regent Inc v. Xiromed LLC, 2:24-cv-07811, D.N.J., 07/16/2024
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant Xiromed, LLC is organized under the laws of New Jersey, maintains a regular and established place of business in the district, and committed acts of infringement there.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's Selenious Acid injection product constitutes an act of infringement of a patent covering trace element compositions for parenteral nutrition.
  • Technical Context: The technology relates to stable, injectable pharmaceutical formulations of trace elements, such as selenium, which are administered intravenously to patients who cannot absorb nutrients through the digestive tract.
  • Key Procedural History: This lawsuit was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a Paragraph IV Notice Letter, dated June 11, 2024, from Defendants. The notice informed Plaintiff of Defendants' ANDA filing, which seeks FDA approval to market a generic drug prior to the expiration of Plaintiff's U.S. Patent No. 11,998,565, which is listed in the FDA's Orange Book.

Case Timeline

Date Event
2019-04-30 Plaintiff's NDA for Selenious Acid products approved by FDA
2020-07-02 ’565 Patent Priority Date
2024-06-04 ’565 Patent issues
2024-06-11 Defendants send Paragraph IV Notice Letter to Plaintiff
2024-07-16 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

The Invention Explained

  • Problem Addressed: The patent's background section describes challenges with existing methods of providing trace elements in parenteral nutrition (PN). Admixing these elements into PN solutions is often time-consuming, and the resulting admixture has a short stability period of only 24-48 hours, leading to waste and increased costs. This short stability also necessitates frequent preparations, burdening both patients and healthcare providers (’565 Patent, col. 1:10-2:44).
  • The Patented Solution: The invention provides stable, injectable trace element compositions that, when added to parenteral nutrition, result in an admixture that is stable for a longer period (e.g., up to 14 days under refrigeration). This extended stability is intended to reduce waste, lower costs, and improve convenience by allowing for less frequent admixing (’565 Patent, col. 2:46-59; col. 4:1-5). The patent discloses specific formulations, such as a selenious acid injection, with carefully controlled levels of ingredients and impurities (’565 Patent, Abstract; col. 23:1-9).
  • Technical Importance: By creating a more stable formulation for parenteral nutrition, the invention sought to improve the efficiency and reduce the logistical burdens associated with administering essential nutrients to critically ill patients (’565 Patent, col. 2:32-36).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the ’565 patent without specifying them (Compl. ¶44). The primary independent claims of the patent are 1, 6, 15, and 26.
  • 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.
  • The complaint does not explicitly reserve the right to assert dependent claims, but the general allegation for "one or more claims" leaves this possibility open.

III. The Accused Instrumentality

Product Identification

Defendants' Abbreviated New Drug Application (ANDA) Product, identified as "Selenious Acid 600 mcg Selenium/10 mL in an intravenous solution" (Compl. ¶¶1, 39).

Functionality and Market Context

  • The accused ANDA Product is a generic version of Plaintiff's commercial Selenious Acid product, which is used as a source of selenium for parenteral nutrition (Compl. ¶¶38, 39).
  • The complaint alleges the ANDA Product contains the "same or equivalent ingredients in the same or equivalent amounts" as Plaintiff's approved drug and will feature the "same or equivalent chemical and therapeutic properties" (Compl. ¶¶40, 41). The product is intended to be administered by patients or medical practitioners according to a proposed package insert (Compl. ¶44).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not include a claim chart. The following table summarizes the infringement allegations for representative independent claim 1 based on the facts provided in the complaint.

’565 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An injectable composition comprising water, The accused ANDA Product is described as an "intravenous solution," which is water-based. ¶39 col. 5:29-31
6 µg or 60 µg of selenium, The accused ANDA Product is identified as "Selenious Acid 600 mcg Selenium/10 mL," which is equivalent to 60 µg of selenium per mL, meeting a limitation of the claim. ¶39 col. 15:20-24
no chromium or chromium in an amount not to exceed 1 µg, The complaint alleges the ANDA product contains the "same or equivalent ingredients" as the reference drug, but does not provide specific details on the chromium content. ¶40 col. 13:58-61
no aluminum or aluminum in an amount not to exceed 6 µg, The complaint does not provide specific details on the aluminum content of the accused product. ¶40 col. 17:5-10
no iron or iron in an amount up to 10 µg, and The complaint does not provide specific details on the iron content of the accused product. ¶40 col. 13:58-61
fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition. The complaint does not provide specific details on the fluoride content of the accused product. ¶40 col. 23:1-4

Identified Points of Contention

  • Technical Questions: A key evidentiary issue will be whether Defendants' ANDA Product meets the negative and positive limitations of the asserted claims. The complaint does not provide the full formulation of the ANDA Product, so discovery will be required to determine if it contains, for example, fluoride within the claimed range or if its levels of chromium, aluminum, and iron are low enough to meet the "no or" limitations. The allegation of equivalence (Compl. ¶40) is a legal conclusion that will require factual support from the confidential ANDA filing.

V. Key Claim Terms for Construction

  • The Term: "no chromium" (and similar negative limitations like "no aluminum," "no iron")
  • Context and Importance: These negative limitations are central to defining the scope of the invention. The infringement analysis will likely depend on whether Defendants' ANDA product, which may contain unavoidable trace impurities, can be considered to have "no" chromium. Practitioners may focus on this term because its construction could be dispositive; a strict "absolute zero" interpretation would make infringement difficult to prove, whereas a more practical interpretation could favor the patentee.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (i.e., allowing for trace impurities): The claim itself recites "no chromium or chromium in an amount not to exceed 1 µg," which suggests "no" is not absolute and is intended to cover amounts at or below a certain threshold (’565 Patent, col. 71:39-40). The specification provides detailed tables of acceptable elemental impurity limits, including for chromium (not more than 1.0 µg/mL), which further supports reading "no" as "not intentionally added and below specified limits" rather than "absolutely absent" (’565 Patent, col. 13:58-61).
    • Evidence for a Narrower Interpretation (i.e., requiring absolute absence): A defendant may argue that the word "no" should be given its plain and ordinary meaning of complete absence, and that the alternative ("or chromium in an amount not to exceed 1 µg") is a distinct option, not a definition of "no."

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce infringement by instructing medical practitioners and patients, via the product's proposed package insert, to administer the ANDA Product in an infringing manner. It also alleges contributory infringement, stating the product is especially made for an infringing use and is not suitable for substantial non-infringing use (Compl. ¶¶44, 45).
  • Willful Infringement: While the complaint does not use the word "willful," it alleges that Defendants had knowledge of the ’565 patent at least as of the date they submitted the ANDA with a Paragraph IV certification (Compl. ¶47). It further alleges the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285, which is often predicated on a finding of willful or egregious conduct (Compl. ¶48).

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

  • A central issue will be one of evidentiary proof: As is common in ANDA litigation, the complaint makes broad allegations of equivalence. The case will turn on whether discovery of Defendants' confidential ANDA reveals a product formulation that meets every limitation of an asserted claim, particularly the specific impurity limits for elements like chromium and aluminum and the presence of other elements like fluoride.
  • The dispositive legal question may be one of claim construction: How will the court interpret the negative limitation "no chromium"? The resolution of whether this term means an absolute absence or merely the absence of an intentionally added amount below a specified threshold could determine the outcome of the infringement analysis.