DCT
2:25-cv-14671
American Regent Inc v. Hikma Pharma USA Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: Hikma Pharmaceuticals USA Inc. (Delaware)
- Plaintiff’s Counsel: GIBBONS P.C.; STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
- Case Identification: 2:25-cv-14671, D.N.J., 08/15/2025
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Hikma Pharmaceuticals USA Inc. maintains its principal place of business in Berkeley Heights, New Jersey, and submitted its Abbreviated New Drug Application (ANDA) from that location.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an ANDA to market a generic version of Plaintiff's Multrys® injectable drug product constitutes an act of infringement of five patents related to trace element compositions for parenteral nutrition.
- Technical Context: The technology concerns stable formulations of essential trace elements (zinc, copper, selenium, manganese) required for patients, particularly neonatal and pediatric patients, who cannot receive nutrition orally.
- Key Procedural History: This is a Hatch-Waxman action initiated in response to Defendant's notification letter dated August 4, 2025, which stated that Defendant had filed an ANDA containing a Paragraph IV Certification. This certification asserts that the patents-in-suit are either invalid or will not be infringed by Defendant's proposed generic product. The patents-in-suit are listed in the U.S. Food and Drug Administration's "Orange Book" as covering Plaintiff's Multrys® drug product.
Case Timeline
| Date | Event |
|---|---|
| 2020-07-02 | Plaintiff's Multrys® approved by the FDA |
| 2020-07-02 | Earliest Priority Date for all Patents-in-Suit |
| 2023-10-17 | U.S. Patent No. 11,786,548 Issues |
| 2024-05-07 | U.S. Patent No. 11,975,022 Issues |
| 2024-06-04 | U.S. Patent No. 11,998,565 Issues |
| 2024-11-26 | U.S. Patent No. 12,150,956 Issues |
| 2024-11-26 | U.S. Patent No. 12,150,957 Issues |
| 2025-08-04 | Defendant sends Paragraph IV Notice Letter to Plaintiff |
| 2025-08-15 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,786,548 - "Trace element compositions, methods of making and use"
The Invention Explained
- Problem Addressed: The patent describes that when essential trace elements are added to parenteral nutrition (PN) solutions for intravenous feeding, the resulting admixture has a short period of stability, often only 24 to 48 hours. This short stability window necessitates frequent, time-consuming, and costly admixing procedures, leading to potential drug supply shortages and waste if a patient's treatment is delayed. (Compl. Ex. 1, ’548 Patent, col. 1:56-2:30).
- The Patented Solution: The invention is a stable, injectable trace element composition that can be added to PN solutions, resulting in an admixture that is stable for a longer period. This extended stability allows for the preparation of PN solutions in larger batches and reduces the frequency of admixing, which in turn lowers costs and improves quality of life for patients and caregivers. (’548 Patent, col. 2:49-67). The patent provides specific formulations of zinc, copper, selenium, and manganese suitable for adult, pediatric, or neonatal patients. (’548 Patent, col. 4:26-36).
- Technical Importance: The invention provides a solution to the logistical and financial burdens associated with the short shelf-life of parenteral nutrition admixtures, a critical therapy for patients unable to absorb nutrients enterally. (’548 Patent, col. 2:31-48).
Key Claims at a Glance
- The complaint does not identify specific asserted claims, but Claim 29 is representative of the subject matter directed to the accused neonatal product formulation.
- Essential elements of independent claim 29 include:
- An injectable composition comprising water, and active ingredients
- the active ingredients consisting of about 6 µg of selenium, about 1,000 µg of zinc, about 60 µg of copper, and about 3 µg of manganese per 1 mL of the injectable composition.
- The complaint reserves the right to assert infringement of one or more claims of the patent. (Compl. ¶42).
U.S. Patent No. 11,975,022 - "Trace element compositions, methods of making and use"
The Invention Explained
- Problem Addressed: As a divisional of the application leading to the ’548 Patent, the ’022 patent addresses the same technical problem of short stability periods for parenteral nutrition solutions after the addition of trace elements. (Compl. Ex. 2, ’022 Patent, col. 1:58-2:32).
- The Patented Solution: The ’022 patent claims methods of providing trace elements using stable injectable compositions, claiming the invention by the weight of the specific salt forms of the trace elements rather than their elemental weights. This provides an alternative way to define and protect the stable formulation. (’022 Patent, col. 2:51-3:2). Example 12 links the specific salt weights to the elemental weights present in the commercial Multrys® product. (’022 Patent, col. 69:41-53).
- Technical Importance: Similar to the ’548 patent, this invention provides a practical solution to the stability problem in parenteral nutrition therapy.
Key Claims at a Glance
- The complaint does not identify specific asserted claims, but Claim 1 is a representative method claim directed to the accused neonatal product formulation.
- Essential elements of independent claim 1 include:
- A method of providing trace elements to a pediatric or neonatal patient in need thereof
- the method comprising administering to the patient the injectable trace element composition
- comprising water, about 2,470 mcg of zinc sulfate or zinc sulfate heptahydrate, about 150 mcg of cupric sulfate or cupric sulfate pentahydrate, about 8.22 mcg of manganese sulfate or manganese sulfate monohydrate, and about 9.8 mcg of selenious acid per 1 mL of the injectable composition.
- The complaint reserves the right to assert infringement of one or more claims of the patent. (Compl. ¶49).
Multi-Patent Capsule: U.S. Patent No. 11,998,565
- Patent Identification: U.S. Patent No. 11,998,565, "Trace element compositions, methods of making and use," issued June 4, 2024.
- Technology Synopsis: This patent, which shares its specification with the ’548 and ’022 patents, is directed to stable injectable compositions of trace elements. The invention addresses the problem of short stability periods after trace elements are admixed with parenteral nutrition solutions. (Compl. ¶54; Compl. Ex. 3, ’565 Patent, col. 1:58-2:32).
- Asserted Claims: The complaint does not specify claims, but independent claim 19 is directed to the neonatal formulation. (Compl. Ex. 3, ’565 Patent, col. 74:1-6).
- Accused Features: The complaint alleges that Hikma's ANDA product, containing specific amounts of zinc, copper, selenium, and manganese, will infringe the patent. (Compl. ¶¶ 37, 56-57).
Multi-Patent Capsule: U.S. Patent No. 12,150,956
- Patent Identification: U.S. Patent No. 12,150,956, "Trace element compositions, methods of making and use," issued November 26, 2024.
- Technology Synopsis: This patent, also in the same family, is directed to methods of supplementing trace elements using stable injectable compositions. The technology solves the problem of limited stability for parenteral nutrition admixtures. (Compl. ¶61; Compl. Ex. 4, ’956 Patent, col. 1:58-2:32).
- Asserted Claims: The complaint does not specify claims, but independent claim 1 is directed to a method of using the neonatal formulation defined by its salt forms and weights. (Compl. Ex. 4, ’956 Patent, col. 72:50-59).
- Accused Features: The complaint alleges that the administration of Hikma's ANDA product, containing specific amounts of trace element salts, will infringe the patent's method claims. (Compl. ¶¶ 37, 63-64).
Multi-Patent Capsule: U.S. Patent No. 12,150,957
- Patent Identification: U.S. Patent No. 12,150,957, "Trace element compositions, methods of making and use," issued November 26, 2024.
- Technology Synopsis: This patent, also in the same family, is directed to methods of supplementing trace elements using stable injectable compositions. It addresses the technical challenge of short stability times for parenteral nutrition solutions containing trace elements. (Compl. ¶68; Compl. Ex. 5, ’957 Patent, col. 1:58-2:32).
- Asserted Claims: The complaint does not specify claims, but independent claim 23 is directed to a method of using the neonatal formulation defined by its elemental weights. (Compl. Ex. 5, ’957 Patent, col. 74:20-27).
- Accused Features: The complaint alleges that the administration of Hikma's ANDA product, containing specific elemental amounts of zinc, copper, selenium, and manganese, will infringe the patent's method claims. (Compl. ¶¶ 37, 70-71).
III. The Accused Instrumentality
No probative visual evidence provided in complaint.
Product Identification
- The accused instrumentality is Defendant Hikma’s generic drug product described in ANDA No. 219369 ("the ANDA Product") (Compl. ¶1).
Functionality and Market Context
- The ANDA Product is an injectable solution intended as a source of the trace elements zinc, copper, manganese, and selenium for parenteral nutrition in neonatal and pediatric patients (Compl. ¶¶ 1, 16). The complaint alleges, based on Hikma's notice letter, that the product is a "Trace Elements Injection 4* USP" containing Zinc at 1,000 mcg/mL, Copper at 60 mcg/mL, Manganese at 3 mcg/mL, and Selenium at 6 mcg/mL in single-dose vials (Compl. ¶37). The product is a generic version of Plaintiff's Multrys®, which the complaint describes as the "first and only FDA-approved multi-trace element injection for neonatal and pediatric patients weighing less than 10 kg" (Compl. ¶15).
IV. Analysis of Infringement Allegations
U.S. Patent No. 11,786,548 Infringement Allegations
| Claim Element (from Independent Claim 29) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable composition comprising water, and active ingredients, the active ingredients consisting of... | The ANDA Product is an injectable composition comprising water and the specified active ingredients. | ¶¶36-38 | col. 69:39-53 |
| about 6 µg of selenium... per 1 mL | The ANDA Product is alleged to contain Selenium at a concentration of 6 mcg/mL. | ¶37 | col. 69:50-51 |
| about 1,000 µg of zinc... per 1 mL | The ANDA Product is alleged to contain Zinc at a concentration of 1,000 mcg/mL. | ¶37 | col. 69:46-47 |
| about 60 µg of copper... per 1 mL | The ANDA Product is alleged to contain Copper at a concentration of 60 mcg/mL. | ¶37 | col. 69:48-49 |
| and about 3 µg of manganese per 1 mL of the injectable composition. | The ANDA Product is alleged to contain Manganese at a concentration of 3 mcg/mL. | ¶37 | col. 69:49-50 |
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 pediatric or neonatal patient in need thereof, the method comprising administering to the patient the injectable trace element composition comprising... | The ANDA Product is indicated for neonatal and pediatric patients and will be administered by medical practitioners, which will constitute infringement of the claimed method. | ¶¶16, 49 | col. 69:39-44 |
| water, about 2,470 mcg of zinc sulfate or zinc sulfate heptahydrate... per 1 mL | The complaint alleges the ANDA product contains the same or equivalent ingredients as Multrys®, which contains zinc sulfate equivalent to 1,000 mcg of zinc. | ¶¶36, 38 | col. 69:46-47 |
| about 150 mcg of cupric sulfate or cupric sulfate pentahydrate... per 1 mL | The ANDA product is alleged to contain the equivalent of 150 mcg of cupric sulfate. | ¶¶36, 38 | col. 69:48-49 |
| about 8.22 mcg of manganese sulfate or manganese sulfate monohydrate... per 1 mL | The ANDA product is alleged to contain the equivalent of 8.22 mcg of manganese sulfate. | ¶¶36, 38 | col. 69:49-50 |
| and about 9.8 mcg of selenious acid per 1 mL of the injectable composition. | The ANDA product is alleged to contain the equivalent of 9.8 mcg of selenious acid. | ¶¶36, 38 | col. 69:50-51 |
Identified Points of Contention
- Scope Questions: A central question for infringement will be the interpretation of the term "about," which modifies each concentration value in the asserted claims. The analysis will depend on whether the precise concentrations in Hikma's ANDA Product, which are alleged to be identical to the claimed amounts, fall within the scope of the claims as construed by the court.
- Technical Questions: The complaint alleges a direct compositional overlap between the ANDA product and the formulations described and claimed in the patents-in-suit (Compl. ¶¶ 37-39). A key evidentiary question will be whether the chemical and therapeutic properties of the ANDA Product are in fact equivalent to those of the patented invention, as alleged, or if there are any technical distinctions that might support a non-infringement position.
V. Key Claim Terms for Construction
- The Term: "about"
- Context and Importance: This term appears in the independent claims of multiple patents-in-suit, modifying the specific weights or concentrations of each trace element (e.g., '548 Patent, cl. 29; '022 Patent, cl. 1). The definition of "about" is critical because it determines the permissible range of deviation from the recited numerical values. Practitioners may focus on this term as it represents the primary, if not only, potential avenue for a literal non-infringement defense based on the product's composition.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification does not provide an explicit definition for "about," suggesting it should be given its ordinary meaning of "approximately." The patent repeatedly uses "about" when describing concentration ranges in the summary and detailed description, which may suggest that the inventors did not intend to be limited to the exact numerical values recited. (’548 Patent, col. 2:64-67, col. 4:11-20).
- Evidence for a Narrower Interpretation: The patents provide examples with highly precise numerical values, such as "8.22 mcg of manganese sulfate" and "9.8 mcg of selenious acid" (’022 Patent, cl. 1). A party could argue that such precision implies the term "about" should be construed narrowly to cover only minor variations attributable to standard manufacturing tolerances, rather than a broader range of functional equivalents.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that upon approval, Hikma's product will be administered to patients according to instructions in the proposed package insert, and that Hikma will actively encourage this conduct with knowledge and specific intent to infringe (Compl. ¶¶ 42, 49). Contributory infringement is also alleged on the basis that the ANDA Product is especially made or adapted for infringing use and is not suitable for substantial non-infringing use (Compl. ¶¶ 43, 50).
- Willful Infringement: The complaint does not use the term "willful," but it alleges that Hikma has had knowledge of the patents-in-suit since at least the date it submitted its 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, which can be associated with findings of egregious infringement conduct (Compl. ¶¶ 46, 53, 60, 67, 74).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of compositional identity: The case will likely require a factual determination of whether the precise formulation of Hikma's ANDA product, including the specific salt forms and elemental concentrations, is the same as or equivalent to the formulations claimed in the patents-in-suit, as the complaint alleges.
- A key legal question will be one of claim scope: The infringement analysis will likely hinge on the court’s construction of the term "about." The interpretation of this term will define the boundaries of the claimed invention and determine whether any potential variation in Hikma's product formulation is sufficient to avoid infringement.