DCT

2:24-cv-07812

American Regent Inc v. Zydus Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-07812, D.N.J., 07/16/2024
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant is incorporated in, maintains its principal place of business in, and has committed acts of infringement in New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for generic versions of Plaintiff's Selenious Acid injectable products constitutes an act of patent infringement.
  • Technical Context: The technology relates to stable, injectable trace element compositions used in parenteral nutrition to provide essential minerals like selenium to patients who are unable to receive nourishment orally.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Defendant’s Paragraph IV certification filed with its ANDA, asserting that its proposed generic product would not infringe Plaintiff's patent or that the patent is invalid. Plaintiff was notified of the ANDA filing via a notice letter dated June 10, 2024. The patent-in-suit is listed in the FDA's "Orange Book" in connection with Plaintiff's approved Selenious Acid products.

Case Timeline

Date Event
2019-04-30 Plaintiff's New Drug Application for Selenious Acid products approved by FDA
2020-07-02 ’565 Patent Priority Date
2024-06-04 ’565 Patent Issue Date
2024-06-10 Defendant sends Paragraph IV Notice Letter to Plaintiff
2024-07-16 Complaint Filing Date
2041-07-01 ’565 Patent Expiration Date

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

  • 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 describes challenges with parenteral nutrition (PN), where nutrients are delivered intravenously. Specifically, when trace elements are added to PN solutions, the resulting mixture often has a short stability period of 24-48 hours, leading to waste, increased costs, and logistical burdens for patients and providers. Additionally, existing multi-element formulations may not allow for easy customization of dosages to meet specific patient needs (’565 Patent, col. 1:11-2:44).
  • The Patented Solution: The invention provides stable, injectable compositions containing specific concentrations of trace elements, such as selenium. These compositions are designed to remain stable for longer periods when added to PN solutions, which facilitates preparation in larger batches, reduces waste, and improves patient quality of life. The patent claims specific formulations, including some that purposefully exclude or limit certain elements like chromium to enhance safety and customizability (’565 Patent, Abstract; col. 2:46-59).
  • Technical Importance: By providing longer-stability formulations, the invention addresses a practical need for more efficient, cost-effective, and safer administration of essential trace elements in parenteral nutrition therapy (’565 Patent, col. 2:31-38).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the ’565 Patent without specifying them (Compl. ¶33). Independent claim 1 is representative of the asserted composition technology.
  • Independent Claim 1 recites:
    • 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 foreclose the possibility of asserting other independent or dependent claims.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant's proposed generic Selenious Acid products, which are the subject of Abbreviated New Drug Application (ANDA) No. 219322 (Compl. ¶1).

Functionality and Market Context

  • The complaint identifies the accused products as "selenious acid solutions, intravenous" in three concentrations: 12 mcg/2 mL (equivalent to 6 mcg/mL), 60 mcg/mL, and 600 mcg/10 mL (Compl. ¶28). These products are alleged to be generic versions of Plaintiff's FDA-approved Selenious Acid products and are intended for use as a supplement in parenteral nutrition (Compl. ¶27). The complaint alleges that the accused ANDA Products contain the "same or equivalent ingredients in the same or equivalent amounts" and will have the "same or equivalent chemical and therapeutic properties" as Plaintiff's branded products (Compl. ¶¶27, 30). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

  • ’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 Products are described as intravenous "solutions," which are water-based. ¶28 col. 2:62-3:3
...6 µg or 60 µg of selenium... The accused ANDA Products are alleged to be offered in concentrations of 12 mcg/2 mL (i.e., 6 µg/mL) and 60 mcg/mL of selenious acid. ¶28 col. 4:26-35
...no chromium or chromium in an amount not to exceed 1 µg... The complaint alleges that the ANDA Products will infringe, which implies their formulation meets this limitation, asserting they are "same or equivalent" to Plaintiff's products. ¶¶27, 32 col. 13:59-61; Table 2
...no aluminum or aluminum in an amount not to exceed 6 µg... The complaint's general infringement allegation implies this limitation is met. ¶¶27, 32 col. 18:24-25; Table 2
...no iron or iron in an amount up to 10 µg... The complaint's general infringement allegation implies this limitation is met. ¶¶27, 32 col. 13, Table 2
...and fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition. The complaint's general infringement allegation implies this limitation is met. ¶¶27, 32 col. 45:41-44
  • Identified Points of Contention:
    • Technical Questions: A central question will be whether the precise formulation of the Zydus ANDA product, as specified in its confidential ANDA submission, meets every limitation of the asserted claims. The complaint does not provide specific details on the impurity profile (e.g., chromium, aluminum, iron, fluoride content) of the accused product, making this a key area for discovery and potential dispute.
    • Scope Questions: The case will likely involve determining whether the accused products, alleged to be "same or equivalent" to Plaintiff's products, fall within the scope of claims that contain specific negative limitations (e.g., "no chromium"). The level of detection and what constitutes "no" or an amount "not to exceed" a certain level may become a central issue.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a deep analysis of claim construction disputes. However, based on the technology and claim language, certain terms are likely to be critical.

  • The Term: "no chromium" / "not to exceed 1 µg" (and similar negative limitations)
  • Context and Importance: These negative limitations are central to defining the scope of the invention. Infringement requires proving the absence or near-absence of these specified elements in the accused product. Practitioners may focus on this term because the interpretation of "no" (e.g., absolutely zero vs. below a certain detection threshold) and the precision of the numerical cap will be dispositive for infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides impurity limits in Table 2, listing "Chromium (Cr): Not more than 1.0 µg/mL" ('565 Patent, col. 13). Plaintiff may argue this demonstrates that the claim term "not to exceed 1 µg" is intended to permit trace amounts up to that specified level, rather than requiring absolute absence.
    • Evidence for a Narrower Interpretation: The specification also states, "In many cases, the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all" ('565 Patent, col. 13:59-61). Defendant may argue this language supports a stricter interpretation, requiring that "no chromium" means an amount below the limit of detection for standard analytical methods.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). It posits that Zydus, with knowledge and specific intent, will encourage and aid infringement by medical practitioners through the instructions in its proposed product package insert (Compl. ¶33).
  • Willful Infringement: Willfulness is alleged based on Zydus having knowledge of the ’565 Patent at least as of the date it submitted its ANDA with a Paragraph IV certification (Compl. ¶36). The complaint also asserts that the case is "exceptional" under 35 U.S.C. § 285, seeking an award of attorneys' fees (Compl. ¶37).

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

  • A central issue will be one of evidentiary proof: once the confidential details of the ANDA are produced, does the accused generic formulation literally meet every positive and negative limitation of the asserted claims? The dispute will hinge on a direct comparison between the claim language and the chemical composition of the accused product.
  • The case may also turn on a key question of claim construction: how should the court define the negative limitations, such as "no chromium or chromium in an amount not to exceed 1 µg"? The outcome of the infringement analysis will likely depend on whether this language requires absolute absence of the element or permits the presence of trace impurities below the specified cap.