DCT

2:25-cv-02224

American Regent Inc v. Hikma Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-02224, D.N.J., 04/01/2025
  • Venue Allegations: Venue is alleged in the District of New Jersey based on Defendant’s principal place of business in Berkeley Heights, New Jersey, and the commission of alleged acts of infringement in the district, including the submission of the Abbreviated New Drug Application (ANDA).
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA to the U.S. Food and Drug Administration (FDA) seeking to market generic versions of Plaintiff's Tralement® drug product constitutes an act of infringement of five U.S. patents related to injectable trace element compositions.
  • Technical Context: The technology concerns stable, injectable formulations of essential trace elements (zinc, copper, manganese, and selenium) used in parenteral nutrition for patients who cannot receive nutrition orally or enterally.
  • Key Procedural History: This is a Hatch-Waxman action initiated in response to Defendant’s Paragraph IV certification asserting that the patents-in-suit are invalid or will not be infringed by its proposed generic product. Plaintiff states that the asserted patents are listed in the FDA's "Orange Book" in connection with its Tralement® product.

Case Timeline

Date Event
2020-07-02 Earliest Priority Date for all Patents-in-Suit
2020-07-02 Plaintiff's Tralement® NDA approved by FDA
2023-10-17 U.S. Patent No. 11,786,548 Issued
2024-05-07 U.S. Patent No. 11,975,022 Issued
2024-06-04 U.S. Patent No. 11,998,565 Issued
2024-11-26 U.S. Patent No. 12,150,956 Issued
2024-11-26 U.S. Patent No. 12,150,957 Issued
2025-02-14 Defendant notifies Plaintiff via letter of its ANDA submission
2025-04-01 Complaint Filed

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

No probative visual evidence provided in complaint.

U.S. Patent No. 11,786,548 - Trace element compositions, methods of making and use

  • Patent Identification: U.S. Patent No. 11,786,548, "Trace element compositions, methods of making and use," issued October 17, 2023.

The Invention Explained

  • Problem Addressed: The patent describes that when trace elements are added to parenteral nutrition (PN) solutions, the resulting admixture has a short stability period, often just 24 to 48 hours. This necessitates frequent, costly, and time-consuming preparation of PN bags, increasing waste and the risk of supply shortages. (Compl. Ex. 1, ’548 Patent, col. 1:56-col. 2:34).
  • The Patented Solution: The invention is a stable, injectable trace element composition that can be added to parenteral nutrition, allowing the final admixture to remain stable for a longer period. This reduces the frequency of admixing, which in turn lowers costs and improves the quality of life for patients and caregivers. (’548 Patent, col. 2:46-54). The composition provides specific amounts of zinc, copper, selenium, and manganese while carefully controlling for or excluding other elements like chromium and aluminum. (’548 Patent, col. 11:5-col. 12:4).
  • Technical Importance: The invention provides a solution to the logistical and stability challenges of supplementing PN with trace elements, aiming to make the therapy safer, more convenient, and more cost-effective. (’548 Patent, col. 2:35-45).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the ’548 Patent. Independent claim 1 is representative:
  • An injectable composition comprising:
    • water,
    • about 60 µg of selenium per 1 mL,
    • 3,000 µg of zinc per 1 mL,
    • about 300 µg of copper per 1 mL,
    • and about 55 µg of manganese per 1 mL.
  • The composition is further defined by negative limitations:
    • containing 0 µg to about 10 µg of iron per 1 mL,
    • containing no vitamins,
    • containing no added chromium,
    • and containing no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL.

U.S. Patent No. 11,975,022 - Trace element compositions, methods of making and use

  • Patent Identification: U.S. Patent No. 11,975,022, "Trace element compositions, methods of making and use," issued May 7, 2024.

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problem as the ’548 Patent: the short stability period of parenteral nutrition after the addition of trace elements, which creates clinical and economic burdens. (Compl. Ex. 2, ’022 Patent, col. 1:56-col. 2:34).
  • The Patented Solution: The invention is a method of providing trace elements to a patient by administering the stable injectable composition described in the patent family. This method allows for the maintenance of plasma trace elements in patients requiring parenteral nutrition. (’022 Patent, col. 3:14-21, Abstract).
  • Technical Importance: The patented method provides a clinically relevant application for the stable composition, directly addressing the therapeutic need to supplement trace elements in patients on parenteral nutrition. (’022 Patent, col. 2:35-45).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the ’022 Patent. Independent claim 1 is representative:
  • A method of providing trace elements to a patient in need thereof, comprising:
    • administering an injectable trace element composition to the patient,
    • wherein the composition comprises water, about 60 µg of selenium, about 3,000 µg of zinc, about 300 µg of copper, and about 55 µg of manganese per 1 mL,
    • and wherein the composition contains no iron or iron up to 10 µg/mL, no vitamins, no added chromium, and no aluminum or aluminum up to 6 µg/mL.

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. (Compl. ¶24).
  • Technology Synopsis: This patent, part of the same family, is directed to stable injectable compositions containing specific amounts of trace elements (zinc, copper, selenium, manganese) intended for parenteral nutrition. The invention aims to solve the problem of short-term stability of parenteral nutrition admixtures. (Compl. ¶¶54-56).
  • Asserted Claims: The complaint alleges infringement of one or more claims of the ’565 Patent. (Compl. ¶55).
  • Accused Features: The accused features are the formulation and proposed use of Defendant's ANDA Products, which are alleged to contain the same active ingredients in the same amounts as Plaintiff's Tralement® product. (Compl. ¶¶36-39, 56).

U.S. Patent No. 12,150,956 - Trace element compositions, methods of making and use

  • Patent Identification: U.S. Patent No. 12,150,956, "Trace element compositions, methods of making and use," issued November 26, 2024. (Compl. ¶27).
  • Technology Synopsis: This patent, part of the same family, is directed to stable injectable compositions containing specific amounts of trace elements (zinc, copper, selenium, manganese) intended for parenteral nutrition. The invention aims to solve the problem of short-term stability of parenteral nutrition admixtures. (Compl. ¶¶61-63).
  • Asserted Claims: The complaint alleges infringement of one or more claims of the ’956 Patent. (Compl. ¶62).
  • Accused Features: The accused features are the formulation and proposed use of Defendant's ANDA Products, which are alleged to contain the same active ingredients in the same amounts as Plaintiff's Tralement® product. (Compl. ¶¶36-39, 63).

U.S. Patent No. 12,150,957 - Trace element compositions, methods of making and use

  • Patent Identification: U.S. Patent No. 12,150,957, "Trace element compositions, methods of making and use," issued November 26, 2024. (Compl. ¶30).
  • Technology Synopsis: This patent, part of the same family, is directed to stable injectable compositions containing specific amounts of trace elements (zinc, copper, selenium, manganese) intended for parenteral nutrition. The invention aims to solve the problem of short-term stability of parenteral nutrition admixtures. (Compl. ¶¶68-70).
  • Asserted Claims: The complaint alleges infringement of one or more claims of the ’957 Patent. (Compl. ¶69).
  • Accused Features: The accused features are the formulation and proposed use of Defendant's ANDA Products, which are alleged to contain the same active ingredients in the same amounts as Plaintiff's Tralement® product. (Compl. ¶¶36-39, 70).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are Defendant's proposed generic drug products described in ANDA No. 219369 ("the ANDA Products"). (Compl. ¶1).
  • Functionality and Market Context: The ANDA Products are identified as "Trace Elements Injection 4* USP" containing 3 mg Zn/mL, 0.3 mg Cu/mL, 55 mcg Mn/mL, and 60 mcg Se/mL. (Compl. ¶37). These products are intended for use as a source of zinc, copper, manganese, and selenium for parenteral nutrition in adult and pediatric patients. (Compl. ¶16). The complaint alleges that the ANDA Products are generic versions of Plaintiff’s Tralement® product and contain the "same or equivalent ingredients in the same or equivalent amounts." (Compl. ¶36, 38).

IV. Analysis of Infringement Allegations

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

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An injectable composition comprising water... Defendant’s ANDA Products are injectable compositions comprising water. ¶37 col. 11:21
...about 60 µg of selenium... The ANDA Products allegedly contain 60 mcg Se/mL. ¶37 col. 10:1-10
...3,000 µg of zinc... The ANDA Products allegedly contain 3 mg Zn/mL, which is equivalent to 3,000 µg/mL. ¶37 col. 10:1-10
...about 300 µg of copper... The ANDA Products allegedly contain 0.3 mg Cu/mL, which is equivalent to 300 µg/mL. ¶37 col. 10:1-10
...and about 55 µg of manganese per 1 mL... The ANDA Products allegedly contain 55 mcg Mn/mL. ¶37 col. 10:1-10
...wherein the injectable composition contains...no added chromium... The complaint alleges the ANDA Products have the same or equivalent properties as Tralement®, which is formulated without added chromium. ¶39 col. 14:49-53
  • Identified Points of Contention:
    • Scope Questions: A central question may be the interpretation of the negative limitation "no added chromium." The parties may dispute whether this term prohibits only the intentional inclusion of chromium as a formulated ingredient or if it also covers trace amounts of chromium that may be introduced as impurities during the manufacturing process. The patent's specification listing chromium as a potential elemental impurity with an acceptable limit could be a focal point of this dispute. (Compl. Ex. 1, ’548 Patent, col. 13-14, Table 2).
    • Technical Questions: The infringement analysis will likely depend on factual evidence from Defendant’s ANDA regarding the precise amounts of all claimed components and, crucially, the levels of potential impurities like iron and aluminum in the final drug product, including any elements that might leach from the proposed container closure system.

U.S. Patent No. 11,975,022 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of providing trace elements to a patient...comprising administering an injectable trace element composition to the patient... Defendant's submission of the ANDA seeks approval to market a product that will be administered to patients according to its proposed label, thereby inducing infringement of the method. ¶49, 50 col. 3:14-21
...the injectable trace element composition comprising water, about 60 µg of selenium, about 3,000 µg of zinc, about 300 µg of copper, and about 55 µg of manganese per 1 mL... As described in the infringement analysis of the ’548 Patent, the formulation of the ANDA product is alleged to meet these compositional elements. ¶37, 38 col. 10:1-10
  • Identified Points of Contention:
    • Scope Questions: Infringement of this method claim hinges on the intended use of the ANDA product. A key question for the court will be whether the instructions for use in Defendant’s proposed product label direct or encourage medical professionals to perform the claimed administrative steps.
    • Technical Questions: As with the ’548 Patent, a key factual question will be whether Defendant's ANDA product meets all the positive and negative limitations of the composition being administered in the claimed method.

V. Key Claim Terms for Construction

  • The Term: "no added chromium"
  • Context and Importance: This negative limitation is critical because infringement requires the absence of "added" chromium. Practitioners may focus on this term because its definition will determine whether trace amounts of chromium present as impurities from the manufacturing process or raw materials fall within the scope of the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language of the claim could suggest that any chromium not naturally present in the other listed ingredients is "added," regardless of intent.
    • Evidence for a Narrower Interpretation: The patent specification, when discussing the problem to be solved, focuses on adjusting recommended daily doses of trace elements, suggesting that "added" refers to chromium included as an intentional, formulated ingredient for therapeutic effect. (Compl. Ex. 1, ’548 Patent, col. 1:45-51). Further, Table 2 in the specification lists an acceptable limit for chromium as an elemental impurity (not more than 1.0 µg/mL), which may support an interpretation that the claims are not intended to cover unavoidable manufacturing impurities. (’548 Patent, col. 13-14).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced and contributory infringement for all asserted patents. The basis for inducement is the allegation that Defendant's proposed package insert for its ANDA Products will instruct and encourage patients and medical practitioners to administer the product in an infringing manner. (Compl. ¶¶42, 49). Contributory infringement is alleged on the basis that Defendant knows its ANDA Products are especially made for an infringing use and are not suitable for a substantial non-infringing use. (Compl. ¶¶43, 50).
  • Willful Infringement: While not explicitly using the term "willful," the complaint alleges that Defendant has had knowledge of each patent "since at least the date Hikma submitted the ANDA with a Paragraph IV Certification." (Compl. ¶¶45, 52, 59, 66, 73). Plaintiff also pleads that the case is "exceptional" and seeks an award of attorneys' fees under 35 U.S.C. § 285. (Compl. ¶¶46, 53, 60, 67, 74).

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

  • A core issue will be one of claim scope and interpretation: how will the court construe the negative limitation "no added chromium" in light of intrinsic evidence, such as the patent's specification, which simultaneously appears to contemplate the presence of chromium as a potential impurity within specified limits?
  • A key evidentiary question will be one of factual compliance: what will discovery reveal about Defendant’s manufacturing process and final drug product formulation, specifically concerning the presence and quantity of impurities such as iron, aluminum, and chromium, which are central to the asserted claims' negative limitations?
  • A central issue for the method claims will be induced infringement: does the specific language in the proposed label for Defendant’s generic product actively instruct or encourage end-users to perform the steps of the patented methods, thereby creating liability for inducement?