DCT
2:25-cv-02642
American Regent Inc v. Amneal Pharma Of New York LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: Amneal Pharmaceuticals of New York, LLC (Delaware); Amneal EU, Limited (Ireland)
- Plaintiff’s Counsel: GIBBONS P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
- Case Identification: 2:25-cv-02642, D.N.J., 04/11/2025
- Venue Allegations: Venue is alleged in the District of New Jersey based on Defendant Amneal Pharmaceuticals of New York, LLC having a regular and established place of business in the district, and Defendant Amneal EU, Limited being a foreign entity subject to suit in any judicial district.
- Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's Tralement® product constitutes an act of infringement of five U.S. patents directed to trace element compositions for parenteral nutrition.
- Technical Context: The technology involves stable, injectable formulations of essential trace elements (zinc, copper, selenium, manganese) used to support patients who cannot receive nutrition orally or enterally.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following a Notice Letter dated March 3, 2025, in which Defendants notified Plaintiff of their ANDA filing containing a Paragraph IV Certification, asserting that the patents-in-suit are invalid or will not be infringed by their proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2020-07-02 | Earliest Patent Priority Date for all Patents-in-Suit |
| 2020-07-02 | FDA approves Plaintiff's New Drug Application for Tralement® |
| 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 |
| 2025-03-03 | Defendants send Paragraph IV Notice Letter to Plaintiff |
| 2025-04-11 | Complaint for Patent Infringement filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,786,548 - Trace element compositions, methods of making and use
- Issued: October 17, 2023
The Invention Explained
- Problem Addressed: Parenteral nutrition solutions containing trace elements often have a short stability period of 24 to 48 hours after being admixed, leading to waste, increased costs, and frequent trips to healthcare facilities for patients. The patent background notes this requires disposal of unused nutrition and can lead to drug supply shortages (’548 Patent, col. 2:5-24).
- The Patented Solution: The invention is a stable, injectable trace element composition that, when added to parenteral nutrition, remains stable for a longer period. This allows the nutrition to be prepared in larger batches, reducing waste and improving convenience for patients and caregivers ('548 Patent, Abstract; col. 2:31-39). The patent provides specific formulations of zinc, copper, selenium, and manganese designed to achieve this stability ('548 Patent, col. 3:1-12).
- Technical Importance: The solution provides a longer in-use shelf-life for admixed parenteral nutrition, which can reduce healthcare costs and improve the quality of life for patients dependent on intravenous feeding ('548 Patent, col. 2:31-44).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims; independent claim 1 is representative of the core composition claims ('548 Patent, col. 71:53-62).
- The essential elements of independent claim 1 are an injectable composition comprising:
- water
- about 60 µg of selenium per 1 mL
- about 3,000 µg of zinc per 1 mL
- about 300 µg of copper per 1 mL
- about 55 µg of manganese per 1 mL
- contains 0 µg per 1 mL to about 10 µg per 1 mL of iron
- contains no added chromium
- contains no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL
- The complaint does not specify dependent claims but reserves the right to assert them.
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 '022 Patent addresses the same technical problem as the '548 Patent: the limited stability of admixed parenteral nutrition formulations, which results in waste, expense, and inconvenience for patients requiring intravenous nutritional support (’022 Patent, col. 2:5-24).
- The Patented Solution: The invention provides a method of using a stable trace element composition to provide nutrition to a patient. By administering a composition with specific concentrations of zinc, copper, selenium, and manganese, the method allows for longer stability periods, reducing the frequency of admixing and improving patient care ('022 Patent, Abstract; col. 4:56-68).
- Technical Importance: This patented method enables the practical benefits of the stable composition, such as reduced healthcare costs and improved quality of life for patients dependent on parenteral nutrition, by defining its administration ('022 Patent, col. 2:31-44).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims; independent claim 1 is representative of the core method claims ('022 Patent, col. 73:1-12).
- The essential elements of independent claim 1 are a method of providing trace elements to a patient, comprising administering an injectable trace element composition to the patient, the composition comprising:
- water
- about 60 µg of selenium per 1 mL
- about 3,000 µg of zinc per 1 mL
- about 300 µg of copper per 1 mL
- about 55 µg of manganese per 1 mL
- contains 0 µg per 1 mL to about 10 µg per 1 mL of iron
- contains no added chromium
- contains no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL
- The complaint does not specify dependent claims but reserves the right to assert them.
U.S. Patent No. 11,998,565 - Trace element compositions, methods of making and use
- Issued: June 4, 2024 (Compl. ¶35)
- Technology Synopsis: The patent describes stable injectable trace element compositions for parenteral nutrition, addressing the problem of short stability periods in existing formulations. The patented solution provides specific concentrations of zinc, copper, selenium, and manganese to achieve longer stability, reducing waste and improving patient convenience (’565 Patent, Abstract; col. 2:5-39).
- Asserted Claims: The complaint alleges infringement of one or more claims; independent claim 1 is representative ('565 Patent, col. 71:35-43).
- Accused Features: The accused feature is Defendants' ANDA Product, a proposed generic version of Tralement®, which is alleged to have the same or equivalent ingredients as the patented compositions (Compl. ¶¶47-49, 67-68).
U.S. Patent No. 12,150,956 - Trace element compositions, methods of making and use
- Issued: November 26, 2024 (Compl. ¶38)
- Technology Synopsis: The patent is directed to stable injectable trace element compositions for parenteral nutrition. It addresses the technical challenge of limited stability in admixed nutritional solutions by disclosing specific formulations of trace elements that remain stable for longer periods, thereby reducing healthcare costs and patient burden (’956 Patent, Abstract; col. 2:5-39).
- Asserted Claims: The complaint alleges infringement of one or more claims; independent claim 1 is representative ('956 Patent, col. 71:35-43).
- Accused Features: The infringement allegations are directed at Defendants' ANDA Product, which is alleged to contain the same or equivalent formulation as that claimed in the patent (Compl. ¶¶47-49, 74-75).
U.S. Patent No. 12,150,957 - Trace element compositions, methods of making and use
- Issued: November 26, 2024 (Compl. ¶41)
- Technology Synopsis: The patent discloses stable injectable trace element compositions for use in parenteral nutrition, solving the problem of short in-use stability of existing formulations. The invention provides specific concentrations of zinc, copper, selenium, and manganese that extend the viability of the admixed nutrition, offering clinical and economic benefits (’957 Patent, Abstract; col. 2:5-39).
- Asserted Claims: The complaint alleges infringement of one or more claims; independent claim 1 is representative ('957 Patent, col. 71:35-43).
- Accused Features: The allegations target Defendants' proposed generic version of Tralement®, which the complaint asserts will embody the patented trace element formulation (Compl. ¶¶47-49, 81-82).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendants' Abbreviated New Drug Application No. 219027 product ("the ANDA Product") (Compl. ¶1).
Functionality and Market Context
- The ANDA Product is a generic version of Plaintiff's Tralement® (trace elements injection 4*, USP) (Compl. ¶47). According to the Notice Letter cited in the complaint, the product is a "Trace Elements Injection 4* USP, (3 mg Zn/mL, 0.3 mg Cu/mL, 55 mcg Mn/mL and 60 mcg Se/mL) single-dose vials (1 mL Fill)" (Compl. ¶48). The complaint alleges the ANDA Product contains the same or equivalent ingredients in the same or equivalent amounts as Tralement® and will feature the same or equivalent chemical and therapeutic properties (Compl. ¶¶47, 49, 50). The product seeks FDA approval to enter the market as a generic competitor to Tralement® prior to the expiration of the Patents-in-Suit (Compl. ¶1).
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, | The ANDA Product is an injectable solution containing water for injection. | ¶48 | col. 10:65-67 |
| about 60 µg of selenium per 1 mL of the injectable composition, | The ANDA Product is formulated to contain 60 mcg Se/mL. | ¶48 | col. 11:1-2 |
| about 3,000 µg of zinc per 1 mL of the injectable composition, | The ANDA Product is formulated to contain 3 mg Zn/mL (3,000 µg/mL). | ¶48 | col. 10:1-4 |
| about 300 µg of copper per 1 mL of the injectable composition, | The ANDA Product is formulated to contain 0.3 mg Cu/mL (300 µg/mL). | ¶48 | col. 9:5-11 |
| about 55 µg of manganese per 1 mL of the injectable composition, | The ANDA Product is formulated to contain 55 mcg Mn/mL. | ¶48 | col. 9:12-20 |
| contains no added chromium | The ANDA Product is a generic version of Tralement®, which is formulated without added chromium. | ¶47 | col. 13:46-53 |
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 in need thereof, the method comprising administering an injectable trace element composition to the patient, | The proposed package insert for the ANDA Product will instruct patients and medical practitioners to administer the composition. | ¶60 | col. 4:56-68 |
| the composition comprising...about 3,000 µg of zinc...about 300 µg of copper...about 60 µg of selenium...and about 55 µg of manganese per 1 mL... | The ANDA Product is alleged to contain 3 mg Zn/mL, 0.3 mg Cu/mL, 60 mcg Se/mL, and 55 mcg Mn/mL. | ¶48 | col. 10:1-4 |
| contains no added chromium | The ANDA Product is formulated as a generic equivalent of Tralement®, which contains no added chromium. | ¶47 | col. 13:46-53 |
Identified Points of Contention
- Scope Questions: The asserted claims recite concentrations using the term "about" (e.g., "about 60 µg of selenium"). The ANDA product is alleged to contain exact concentrations (e.g., "60 mcg Se/mL") (Compl. ¶48). A potential dispute may arise over whether the exact concentrations in the ANDA product fall within the scope of the term "about" as used in the patent claims.
- Technical Questions: In this ANDA litigation, the complaint alleges the accused product is a bioequivalent generic, containing the "same or equivalent ingredients in the same or equivalent amounts" as the branded drug (Compl. ¶47, ¶49). Therefore, the primary questions are less about technical operation and more about whether the specific formulation of the ANDA product, as disclosed to the FDA, meets every limitation of the asserted patent claims as those claims are properly construed by the court.
No probative visual evidence provided in complaint.
V. Key Claim Terms for Construction
Term: "about"
- Context and Importance: This term modifies every recited concentration in the representative independent claims of the lead patents. The scope of "about" will be critical to determining literal infringement. If construed narrowly to mean only the recited value, Defendants might argue non-infringement based on manufacturing tolerances or slight formulation differences. If construed more broadly to encompass a range of values, Plaintiff's infringement case may be strengthened.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification explicitly states, "For the purposes of this specification and appended claims, unless otherwise indicated, all numbers expressing quantities of ingredients...are to be understood as being modified in all instances by the term 'about.'" ('548 Patent, col. 5:35-41). This language suggests the patentees intended the term to have a broadening effect on all numerical limitations.
- Evidence for a Narrower Interpretation: The patents provide specific target values in exemplary embodiments, such as in Table 1, which lists precise quantities (e.g., "60 µg Se/mL") ('548 Patent, col. 11-12). A party could argue that these precise examples limit the scope of "about" to a narrow range around the stated values, consistent with standard scientific rounding or measurement precision.
Term: "contains no added chromium"
- Context and Importance: This negative limitation is present in the representative independent claims. Its construction is central to infringement, as the dispute may turn on whether trace amounts of chromium present as unavoidable impurities in the ANDA Product fall within the claim's prohibition. Practitioners may focus on this term because it creates a potential non-infringement argument if any amount of chromium is detected, regardless of its source.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (for Defendant): A party could argue that "no added chromium" is an absolute prohibition and that the presence of any detectable chromium, even as an impurity, means the product does not meet the limitation.
- Evidence for a Narrower Interpretation (for Plaintiff): The specification discusses chromium as a potential impurity and sets a limit for it ("Not more than 1.0 µg/mL") separate from the active ingredients, suggesting a distinction between an impurity and an "added" component ('548 Patent, col. 13:46-53, Table 2). This may support an interpretation that "no added chromium" means chromium is not included as an intentional, functional ingredient in the formulation, thereby distinguishing it from unavoidable trace contaminants.
VI. Other Allegations
Indirect Infringement
- The complaint alleges induced infringement, stating that Defendants' proposed package insert and instructions will encourage and direct medical practitioners and patients to administer the ANDA Product in a manner that directly infringes the asserted method claims (Compl. ¶¶53, 60). Contributory infringement is also alleged on the basis that the ANDA Product is especially made or adapted for infringing uses and is not suitable for substantial non-infringing use (Compl. ¶¶54, 61).
Willful Infringement
- Willfulness is alleged based on Defendants' knowledge of the Patents-in-Suit, which the complaint asserts existed at least from the date they submitted the ANDA with the Paragraph IV Certification (Compl. ¶¶56, 63). The complaint also asserts that the case is "exceptional" and seeks an award of attorneys' fees (Compl. ¶¶57, 64).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: how will the court construe the term "about" preceding the numerical concentrations in the asserted claims? The outcome of this construction will likely determine whether the exact formulation of the ANDA Product literally infringes the patents.
- A second key issue will be the interpretation of a negative limitation: does the claim term "contains no added chromium" prohibit the presence of any detectable chromium, or does it only exclude chromium that is intentionally included as a functional ingredient? This question will be central to infringement analysis, particularly if the accused product contains trace amounts of chromium as an impurity.
- The case will also present a fundamental question of patent validity: Defendants' Paragraph IV certification asserts that the patents are invalid (Compl. ¶46). Consequently, a central question for the court, to be developed through discovery and expert testimony, will be whether the asserted claims are patentable over the prior art.