DCT

2:24-cv-07807

American Regent Inc v. Somerset Therap LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: American Regent, Inc. v. Somerset Therapeutics, LLC et al., 2:24-cv-07807, D.N.J., 07/16/2024
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant submitted its Abbreviated New Drug Application (ANDA) from its New Jersey place of business and maintains a regular and established place of business in the state.
  • Core Dispute: Plaintiff alleges that Defendant's submission of an ANDA to the FDA seeking to market a generic version of Plaintiff's Selenious Acid injectable products constitutes an act of infringement of a patent covering trace element compositions.
  • Technical Context: The technology concerns stable, injectable trace element compositions, such as selenious acid, which are used as nutritional supplements in intravenous (parenteral) feeding for patients who cannot eat normally.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 218780 with a Paragraph IV certification, asserting non-infringement or invalidity of the patent-in-suit. Plaintiff received a notice letter from Defendant regarding the ANDA filing on June 10, 2024. The patent-in-suit is listed in the FDA's "Orange Book" as covering Plaintiff's approved Selenious Acid products. The complaint also references a related litigation between the parties in the same district.

Case Timeline

Date Event
2019-04-30 FDA approves Plaintiff's New Drug Application for Selenious Acid
2020-07-02 ’565 Patent Priority Date
2024-06-04 ’565 Patent issues
2024-06-10 Defendant sends Paragraph IV Notice Letter to Plaintiff
2024-07-16 Complaint filed
2041-07-01 ’565 Patent expiration date listed in Orange Book

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

U.S. Patent No. 11,998,565 - Trace element compositions, methods of making and use

  • Patent Identification: U.S. Patent No. 11,998,565, Trace element compositions, methods of making and use, issued June 4, 2024 (’565 Patent).

The Invention Explained

  • Problem Addressed: The patent describes a problem with conventional parenteral nutrition (PN), where admixing required trace elements leads to compositions with short stability (typically 24-48 hours) ('565 Patent, col. 1:57-61). This instability necessitates frequent, time-consuming, and costly preparation of PN solutions under sterile conditions, increases waste, and creates logistical burdens for healthcare providers and caregivers ('565 Patent, col. 2:5-24).
  • The Patented Solution: The invention provides stable injectable compositions of trace elements that, when added to parenteral nutrition, result in a final product that remains stable for a significantly longer period ('565 Patent, Abstract). This extended stability is intended to reduce the frequency of admixing, lower costs, and allow for the preparation of PN solutions in larger, more convenient batches ('565 Patent, col. 2:32-44). The patent specifically claims compositions containing certain concentrations of selenium, with strict limits on other elements like chromium and aluminum ('565 Patent, Claim 1).
  • Technical Importance: By creating trace element formulations that enhance the stability of final parenteral nutrition admixtures, the invention aims to improve the quality of life for patients and caregivers and reduce waste and labor costs in clinical settings ('565 Patent, col. 2:35-44).

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims, with the notice letter having addressed claims 1–2, 4–11, 13–17, 19–20, 22–26, and 28–29 (Compl. ¶33, ¶40). Independent claim 1 is representative of the asserted technology.
  • 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 reserves the right to assert other claims, which would include dependent claims (Compl. ¶40).

III. The Accused Instrumentality

Product Identification

  • Defendant’s Abbreviated New Drug Application (ANDA) Product, identified as "Selenious Acid Injection, USP, (600 mcg Selenium/10 mL (60 mcg Selenium/mL)) in a 10 mL pharmacy bulk package" (Compl. ¶35).

Functionality and Market Context

  • The accused product is a generic version of Plaintiff’s approved Selenious Acid drug, intended for use as a trace element supplement in parenteral nutrition (Compl. ¶1, ¶34). The complaint alleges that the ANDA Product contains the "same or equivalent ingredients in the same or equivalent amounts" as Plaintiff’s reference listed drug and will exhibit the "same or equivalent chemical and therapeutic properties" (Compl. ¶36, ¶37). It is positioned to compete directly with Plaintiff’s product upon receiving FDA approval (Compl. ¶19).
  • 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 product is an "Injection, USP," which is a sterile preparation intended for parenteral use and typically comprises water as a vehicle (Compl. ¶35). ¶35 col. 15:26-29
...6 µg or 60 µg of selenium... per 1 mL of the injectable composition. The accused product is described as containing "60 mcg Selenium/mL" (Compl. ¶35), which falls within the claimed range. ¶35 col. 4:21-25
...no chromium or chromium in an amount not to exceed 1 µg... The complaint alleges on information and belief that the ANDA product contains the same or equivalent ingredients as the reference product (Compl. ¶36). However, the complaint provides no specific data regarding the concentration of chromium in the accused product. ¶36 col. 16:55-58
...no aluminum or aluminum in an amount not to exceed 6 µg... The complaint does not provide sufficient detail for analysis of this element. ¶36 col. 17:10-14
...no iron or iron in an amount up to 10 µg... The complaint does not provide sufficient detail for analysis of this element. ¶36 col. 71:59-62
...and fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL... The complaint does not provide sufficient detail for analysis of this element. ¶36 col. 71:62-65

Identified Points of Contention

  • Scope Questions: The case may raise questions about the interpretation of the negative limitations in Claim 1, such as "no chromium." A dispute could arise over whether this term requires an absolute absence of the element or is defined by the subsequent phrase "or chromium in an amount not to exceed 1 µg."
  • Technical Questions: A central technical question will be evidentiary: what are the precise, measured concentrations of chromium, aluminum, iron, and fluoride in the Defendant’s ANDA product? The infringement analysis for the negative and range-based limitations of Claim 1 will depend entirely on factual evidence obtained through discovery and testing, as the complaint relies on the general premise of bioequivalence rather than specific analytical data (Compl. ¶36).

V. Key Claim Terms for Construction

  • The Term: "no chromium"
  • Context and Importance: This is a negative limitation that is central to defining the patented composition. The patent repeatedly highlights low or non-existent levels of certain elements as a key feature of the invention ('565 Patent, col. 16:55-68). The construction of this term will be critical for determining whether the presence of any detectable amount of chromium in the accused product avoids infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (i.e., absolute zero): A party could argue that the plain and ordinary meaning of "no" requires a complete absence of chromium.
    • Evidence for a Narrower Interpretation (i.e., a defined threshold): A party may argue that the claim itself provides the definition, where "no chromium" is clarified by the subsequent clause "or chromium in an amount not to exceed 1 µg." This interpretation is supported by the specification, which states that "the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all," but also that any chromium impurity should not exceed a certain amount, suggesting the patentee contemplated trace levels ('565 Patent, col. 16:58-61).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Defendant’s proposed product labeling will instruct and encourage medical practitioners to administer the ANDA Product in a manner that directly infringes the ’565 patent (Compl. ¶40). The complaint further alleges contributory infringement on the basis that the ANDA Product is especially made for an infringing use and is not suitable for substantial non-infringing use (Compl. ¶41).
  • Willful Infringement: The complaint does not contain an explicit count for willful infringement. However, it alleges that Defendant has had knowledge of the ’565 patent "since at least the date Somerset submitted the ANDA with a Paragraph IV Certification" (Compl. ¶43). It also seeks a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶44).

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

  • A core issue will be one of evidentiary proof: Can Plaintiff demonstrate through testing that Defendant’s ANDA product actually meets the precise quantitative limitations recited in the asserted claims, particularly the low-level or zero-level thresholds for impurities like chromium, aluminum, and iron? The complaint's reliance on the ANDA's bioequivalence premise may not be sufficient to establish infringement of these specific claim elements.
  • A key legal question will be one of claim construction: How will the court interpret the negative limitation "no chromium"? The outcome of the case could hinge on whether this term is construed to mean an absolute absence of the element or is defined as an amount below the 1 µg/mL threshold explicitly provided in the same claim phrase.