DCT

2:24-cv-07802

American Regent Inc v. Gland Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-07802, D.N.J., 07/16/2024
  • Venue Allegations: Venue is alleged to be proper because the Defendant is a foreign company not residing in any U.S. judicial district. Personal jurisdiction is asserted based on the Defendant's alleged continuous business activities in New Jersey, plans to sell the accused product in the state, and prior litigation conduct within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's Selenious Acid injection product constitutes an act of patent infringement.
  • Technical Context: The technology relates to stable, injectable trace element compositions, specifically selenious acid, used as a supplement in parenteral nutrition for patients who cannot receive nutrition orally.
  • Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following a notice letter dated June 10, 2024, in which Defendant notified Plaintiff of its ANDA filing containing a Paragraph IV certification against the asserted patent. 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 (NDA) for Selenious Acid approved by FDA
2020-07-02 Earliest Priority Date for U.S. Patent No. 11,998,565
2024-06-04 U.S. Patent No. 11,998,565 issues
2024-06-10 Defendant sends Paragraph IV Notice Letter to Plaintiff
2024-07-16 Complaint filed
2041-07-01 U.S. Patent No. 11,998,565 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 that when trace elements are added to parenteral nutrition (PN) solutions, the resulting admixture often has a short stability period of only 24 to 48 hours, leading to waste, increased costs, and logistical burdens for patients and healthcare providers (’565 Patent, col. 2:5-24). Furthermore, existing multi-element formulations make it difficult to customize doses to meet specific patient needs (’565 Patent, col. 2:46-56).
  • The Patented Solution: The invention provides stable, injectable trace element compositions that, when added to PN, allow the admixture to remain stable for a longer period, such as up to 14 days under refrigeration (’565 Patent, col. 4:1-5, 39:35-41). This extended stability is intended to reduce waste and allow for the preparation of PN solutions in larger, more efficient batches (’565 Patent, col. 2:31-45). The patent discloses specific formulations, including some that omit chromium, which was a component of older formulations.
  • Technical Importance: The invention aims to solve a practical clinical problem by creating more stable and flexible parenteral nutrition options, potentially improving patient care and reducing healthcare costs.

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim, including independent claims 1, 15, and 26, among others (Compl. ¶¶22, 28).
  • Independent Claim 1: An injectable composition with the following elements:
    • 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
    • fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition
  • The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶29).

III. The Accused Instrumentality

Product Identification

  • Defendant's generic Selenious Acid product, as described in Abbreviated New Drug Application (ANDA) No. 219629 ("the ANDA Product") (Compl. ¶1).

Functionality and Market Context

  • The ANDA Product is a generic version of Plaintiff's FDA-approved Selenious Acid products and is intended to be a therapeutic equivalent (Compl. ¶23).
  • The complaint alleges the ANDA product is a "selenious acid (trace elements injection selenious acid, USP) in 10 mL pharmacy bulk package vial" (Compl. ¶24). It is further alleged to contain "selenious acid in the same or equivalent amounts as ARI's Selenious Acid products ((1) eq. 600 mcg Selenium/10 mL (eq. 60 mcg Selenium/mL))" (Compl. ¶25).
  • The ANDA filing represents a commercial effort to enter the U.S. market with a generic competitor to Plaintiff's branded product prior to the expiration of the ’565 Patent (Compl. ¶1).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

U.S. Patent No. 11,998,565 Infringement Allegations

The complaint does not provide a detailed claim chart but alleges that the ANDA Product will infringe because it will contain the same or equivalent ingredients as the reference listed drug. The analysis below is based on the allegations in the complaint.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An injectable composition comprising water... The ANDA Product is an injectable solution containing selenious acid (Compl. ¶24). ¶24 col. 45:36
...6 µg or 60 µg of selenium... The ANDA Product is alleged to contain selenious acid equivalent to 60 mcg Selenium/mL (Compl. ¶25). ¶25 col. 45:36-41
...no chromium or chromium in an amount not to exceed 1 µg... The complaint does not provide sufficient detail for analysis of this element, but alleges the product will have the same or equivalent chemical properties as Plaintiff's product (Compl. ¶¶23, 26). ¶¶23, 26 col. 45:62-65
...no aluminum or aluminum in an amount not to exceed 6 µg... The complaint does not provide sufficient detail for analysis of this element. col. 45:62-65
...no iron or iron in an amount up to 10 µg... The complaint does not provide sufficient detail for analysis of this element. col. 45:62-65
...and fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition. The complaint does not provide sufficient detail for analysis of this element. col. 45:65-71
  • Identified Points of Contention:
    • Scope Questions: A central dispute may concern the negative limitations of the claim. The case will likely turn on whether the formulation specified in Defendant's ANDA will necessarily result in a product that contains "no chromium," "no aluminum," and "no iron" (or amounts below the specified thresholds) as required by the claim. The interpretation of "no" (e.g., absolute absence vs. below a limit of detection) could become a focal point.
    • Technical Questions: A key evidentiary question is what the full specification of the ANDA Product reveals about its impurity profile. Infringement will depend on whether the concentrations of chromium, aluminum, iron, and fluoride in the proposed generic product, as manufactured according to the ANDA, fall within the claimed ranges.

V. Key Claim Terms for Construction

  • The Term: "no chromium or chromium in an amount not to exceed 1 µg"
  • Context and Importance: This negative limitation appears to be a key point of distinction over prior art formulations that contained chromium. Practitioners may focus on this term because the infringement analysis will depend heavily on whether trace amounts of chromium, potentially present as manufacturing impurities in the ANDA product, fall within the scope of "no chromium."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (Plaintiff-favored): The specification states that in many cases, "the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all" (’565 Patent, col. 16:59-61). This language may support an argument that the patentee intended to exclude any product with a measurable amount of chromium, up to the 1 µg cap.
    • Evidence for a Narrower Interpretation (Defendant-favored): The claim itself provides an alternative ("or chromium in an amount not to exceed 1 µg"), which may suggest that "no chromium" is not an absolute requirement but rather the lower bound of a permissible range (from zero up to 1 µg). A defendant could argue that this structure accommodates unavoidable trace impurities inherent in the manufacturing process.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant will induce infringement by encouraging and instructing patients and medical practitioners, via the proposed product's package insert, to administer the ANDA Product in an infringing manner (Compl. ¶29). It also alleges contributory infringement, asserting the product is not suitable for substantial non-infringing use (Compl. ¶30).
  • Willful Infringement: The complaint does not contain a separate count for willfulness but alleges Defendant has had knowledge of the ’565 Patent since at least the date of its ANDA submission (Compl. ¶32). It further asserts that the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285, which lays the groundwork for a potential willfulness claim (Compl. ¶33).

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

This case appears to center on the precise chemical composition of the defendant's proposed generic product as defined in its ANDA. The primary questions for the court will likely be:

  1. A central evidentiary question will be one of compositional identity: Does the defendant's ANDA specify a formulation that will, upon manufacture, necessarily meet every positive and negative limitation of the asserted claims? The dispute will hinge on the precise levels of selenium, chromium, aluminum, iron, and fluoride in the proposed generic product.
  2. A key legal issue will be one of claim scope: How will the court construe the negative limitation "no chromium or chromium in an amount not to exceed 1 µg"? The resolution of whether this term requires an absolute absence of chromium or merely an amount below a certain threshold will be critical to determining infringement.