DCT
2:25-cv-12169
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/New Jersey) and Amneal EU, Limited (Ireland)
- Plaintiff’s Counsel: Gibbons P.C.
- Case Identification: 2:25-cv-12169, D.N.J., 06/26/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Amneal Pharmaceuticals of New York, LLC maintains its principal place of business in Bridgewater, New Jersey, and has committed acts of infringement in the district.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff’s Multrys® product constitutes infringement of five U.S. patents related to trace element compositions for parenteral nutrition.
- Technical Context: The technology concerns stable, injectable compositions of essential trace elements (zinc, copper, manganese, selenium) used to supplement parenteral nutrition for neonatal and pediatric patients who cannot receive oral or enteral nutrition.
- Key Procedural History: The lawsuit was triggered by Defendant’s Paragraph IV Certification in its ANDA submission, a formal notice to the patent holder that the generic applicant believes the patents-in-suit are invalid or will not be infringed by the generic product.
Case Timeline
| Date | Event |
|---|---|
| 2020-07-02 | Plaintiff's Multrys® receives original FDA approval |
| 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 |
| 2025-06-09 | Defendant sends Notice Letter to Plaintiff regarding ANDA submission |
| 2025-06-26 | 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 stability issues with existing parenteral nutrition (PN) formulations when trace elements are added, noting that such admixtures often have a short shelf-life of 24 to 48 hours, requiring frequent and costly preparation under aseptic conditions (’548 Patent, col. 1:49-2:30). This short stability period also prevents the creation of customized, multi-day batches of PN for patients (’548 Patent, col. 2:25-30).
- The Patented Solution: The invention is a stable, injectable trace element composition that can be added to parenteral nutrition, allowing the admixture to remain stable for a longer period (’548 Patent, col. 2:46-54). The composition provides specific concentrations of zinc, copper, selenium, and manganese, formulated to maintain stability and meet the metabolic needs of adult, pediatric, or neonatal patients (’548 Patent, col. 4:26-37).
- Technical Importance: The invention aims to reduce the time, cost, and supply chain risks associated with frequent admixing of parenteral nutrition, while improving the quality of life for patients and caregivers by reducing trips to healthcare facilities (’548 Patent, col. 2:31-39).
Key Claims at a Glance
- The complaint does not identify specific asserted claims but alleges infringement of one or more claims (Compl. ¶53). Independent claim 1 is a composition claim directed to an adult/pediatric formulation.
- Essential elements of independent claim 1 include:
- An injectable composition comprising water, about 60 µg of selenium, 3,000 µg of zinc, about 300 µg of copper, and about 55 µg of manganese per 1 mL.
- The composition contains 0 µg to about 10 µg of iron per 1 mL.
- The composition does not contain any vitamins.
- The composition contains no added chromium.
- The composition contains 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
The Invention Explained
- Problem Addressed: Similar to the ’548 Patent, this patent addresses the short stability period of parenteral nutrition after the addition of trace elements, which complicates patient care and increases costs (’022 Patent, col. 1:49-2:30).
- The Patented Solution: This patent claims specific compositions and methods of use for trace elements intended for neonatal patients, a distinct and vulnerable patient population (’022 Patent, col. 4:33-37). The claimed solution is a stable, injectable composition with lower concentrations of zinc, copper, and manganese, and a specific concentration of selenium, tailored for neonates weighing less than 10 kg (’022 Patent, claims 15, 28).
- Technical Importance: The invention provides a specific, stable, and ready-to-use trace element formulation for neonatal patients, addressing their unique metabolic needs and reducing the need for potentially error-prone manual dose adjustments from adult formulations (’022 Patent, col. 2:49-3:2).
Key Claims at a Glance
- The complaint does not identify specific asserted claims (Compl. ¶60). Independent claim 15 is a composition claim directed to a neonatal formulation.
- Essential elements of independent claim 15 include:
- An injectable composition comprising water, about 1,000 µg of zinc, about 60 µg of copper, about 6 µg of selenium, and about 3 µg of manganese per 1 mL.
- The composition contains 0 µg to about 10 µg of iron per 1 mL.
- The composition does not contain any vitamins.
- The composition contains no added chromium.
- The composition contains no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL.
U.S. Patent No. 11,998,565 - Trace element compositions, methods of making and use
- Technology Synopsis: The patent addresses the same technical problem of stability in parenteral nutrition admixtures (’565 Patent, col. 1:49-2:30). The claimed solution is a method of supplementing trace elements by administering a specific composition containing zinc, copper, manganese, and selenium, tailored for pediatric or neonatal patients (’565 Patent, claim 18).
- Asserted Claims: The complaint does not specify claims but alleges infringement of one or more claims (Compl. ¶67). Independent claims 1 and 18 are method claims.
- Accused Features: The accused features are the formulation and intended use of the Defendant's ANDA Product, which is alleged to be a generic version of Plaintiff's Multrys® product (Compl. ¶¶47-49, 67).
U.S. Patent No. 12,150,956 - Trace element compositions, methods of making and use
- Technology Synopsis: This patent also addresses the problem of limited stability in parenteral nutrition with trace elements (’956 Patent, col. 1:49-2:30). The patent claims methods of providing trace elements to a patient by administering an injectable composition containing specific salt forms of the elements, such as zinc sulfate and cupric sulfate, in particular amounts (’956 Patent, claim 12).
- Asserted Claims: The complaint does not specify claims but alleges infringement of one or more claims (Compl. ¶74). Independent claims 1, 12, 18, 19, 25, 26, and 30 are method claims.
- Accused Features: The accused features are the specific salt forms, concentrations, and intended use of the Defendant's ANDA Product (Compl. ¶¶47-49, 74).
U.S. Patent No. 12,150,957 - Trace element compositions, methods of making and use
- Technology Synopsis: This patent addresses the same technical problem of stability in parenteral nutrition admixtures (’957 Patent, col. 1:49-2:30). The patent claims methods of supplementing trace elements in pediatric or neonatal patients by administering compositions containing specific concentrations of zinc, copper, selenium, and manganese (’957 Patent, claim 1).
- Asserted Claims: The complaint does not specify claims but alleges infringement of one or more claims (Compl. ¶81). Independent claims 1, 12, 18, 19, and 26 are method claims.
- Accused Features: The accused features are the formulation and intended use of the Defendant's ANDA Product for pediatric and neonatal populations (Compl. ¶¶47-49, 81).
III. The Accused Instrumentality
Product Identification
Defendant’s Abbreviated New Drug Application No. 219027 ("the ANDA Product") for a generic version of Plaintiff's Multrys® (trace elements injection 4*, USP) (Compl. ¶1).
Functionality and Market Context
The ANDA Product is an injectable solution intended for use as a source of the trace elements zinc, copper, manganese, and selenium for parenteral nutrition (Compl. ¶27, ¶47). The complaint alleges the ANDA Product is a "Trace Elements Injection 4* USP, (1000 mcg Zn/mL, 60 mcg Cu/mL, 3 mcg Mn/mL and 6 mcg Se/mL) single-dose vials (1 mL Fill)" (Compl. ¶48). The product is designed to be a generic equivalent to Plaintiff's Multrys®, which is indicated for neonatal and pediatric patients weighing less than 10 kg (Compl. ¶27, ¶47).
No probative visual evidence provided in complaint.
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 product is an injectable solution containing water. | ¶48 | col. 4:12-14 |
| about 60 µg of selenium, | The ANDA product contains 6 mcg Se/mL. | ¶48 | col. 4:26-29 |
| 3,000 µg of zinc, | The ANDA product contains 1000 mcg Zn/mL. | ¶48 | col. 4:26-29 |
| about 300 µg of copper, and | The ANDA product contains 60 mcg Cu/mL. | ¶48 | col. 4:26-29 |
| about 55 µg of manganese per 1 mL of the injectable composition, | The ANDA product contains 3 mcg Mn/mL. | ¶48 | col. 4:26-29 |
| wherein the injectable composition contains no added chromium | The ANDA product is alleged to meet this negative limitation. | ¶47, ¶49 | col. 11:58-60 |
- Identified Points of Contention:
- Scope Questions: The infringement analysis for the ’548 Patent raises a significant question of claim scope, particularly concerning the term "about." The concentrations of zinc (1000 µg/mL vs. claimed 3000 µg/mL), copper (60 µg/mL vs. claimed 300 µg/mL), manganese (3 µg/mL vs. claimed 55 µg/mL), and selenium (6 µg/mL vs. claimed 60 µg/mL) in the accused product are substantially different from the values recited in claim 1. This suggests that any infringement argument for this claim may rely heavily on the doctrine of equivalents rather than literal infringement.
- Technical Questions: A central evidentiary question will be whether the function of the lower-concentration accused product is substantially the same as the function of the claimed higher-concentration composition, and whether the differences between them are insubstantial.
U.S. Patent No. 11,975,022 Infringement Allegations
| Claim Element (from Independent Claim 15) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable composition comprising water, | Defendant's ANDA product is an injectable solution containing water. | ¶48 | col. 4:33-37 |
| about 1,000 µg of zinc, | The ANDA product contains 1000 mcg Zn/mL. | ¶48 | col. 4:33-37 |
| about 60 µg of copper, | The ANDA product contains 60 mcg Cu/mL. | ¶48 | col. 4:33-37 |
| about 6 µg of selenium, and | The ANDA product contains 6 mcg Se/mL. | ¶48 | col. 4:33-37 |
| about 3 µg of manganese per 1 mL of the injectable composition, | The ANDA product contains 3 mcg Mn/mL. | ¶48 | col. 4:33-37 |
| wherein the injectable composition contains no added chromium | The ANDA product is alleged to meet this negative limitation. | ¶47, ¶49 | col. 4:33-37 |
- Identified Points of Contention:
- Scope Questions: In contrast to the ’548 Patent, the concentrations of trace elements described in the ANDA Product (Compl. ¶48) appear to map directly onto the values recited in claim 15 of the ’022 Patent. This suggests a potentially strong case for literal infringement of this patent, shifting the focus to questions of validity (e.g., anticipation, obviousness) or non-infringement based on other limitations.
- Technical Questions: A key question for the defense may be whether any trace impurities from manufacturing or source materials could constitute "added chromium," thereby avoiding infringement of that negative limitation.
V. Key Claim Terms for Construction
For the ’548 Patent
- The Term: "about" (as in "about 3,000 µg of zinc")
- Context and Importance: The definition of "about" is critical because the accused product's concentrations are numerically distinct and substantially lower than those recited in claim 1 of the ’548 Patent. Practitioners may focus on this term because its scope will determine whether the infringement allegation can proceed under a theory of literal infringement or must rely on the more stringent doctrine of equivalents.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification uses the term "about" repeatedly when describing concentration ranges, suggesting an intent to claim some degree of variability around the stated numbers (’548 Patent, col. 3:63-4:4).
- Evidence for a Narrower Interpretation: The patent discloses specific neonatal formulations with markedly different concentrations (e.g., 1000 µg of zinc), which could be used to argue that "about 3,000 µg" was not intended to encompass a value as low as 1000 µg (’548 Patent, col. 4:33-37). The existence of separate claims in the patent family covering the lower concentrations found in the accused product (e.g., claim 15 of the ’022 Patent) may also support a narrower construction.
For the ’022 Patent
- The Term: "no added chromium"
- Context and Importance: This negative limitation is central to the infringement analysis, especially in the context of pharmaceutical manufacturing where trace impurities are common. Practitioners may focus on this term because its construction will determine the threshold for infringement; specifically, whether the unavoidable presence of trace amounts of chromium from raw materials or processing equipment constitutes "added" chromium.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term could be interpreted to mean only chromium that is intentionally included as a recited, active ingredient in the formulation, thereby excluding incidental impurities. The specification distinguishes between the four claimed trace elements and chromium, which it notes is not typically needed in some instances (’022 Patent, col. 2:7-9).
- Evidence for a Narrower Interpretation: The term could be construed to mean a composition that is absolutely free of chromium above a certain de minimis or detection threshold. The patent's detailed discussion of controlling other elemental impurities (e.g., aluminum, lead, arsenic) to very low levels could suggest an intent to strictly limit all non-recited elements, including chromium (’022 Patent, col. 13:45-15:44).
VI. Other Allegations
Indirect Infringement
The complaint alleges that upon FDA approval, Defendant will induce infringement by patients and medical practitioners. This allegation is based on the instructions that will be in the proposed package insert for the ANDA Product, which will allegedly direct users to administer the product in an infringing manner (Compl. ¶53, ¶60). The complaint also alleges contributory infringement, stating the ANDA Product is especially made or adapted for infringing use and is not suitable for substantial non-infringing use (Compl. ¶54, ¶61).
Willful Infringement
The complaint does not use the term "willful infringement" but alleges that Defendant has had knowledge of the patents-in-suit since at least the date it submitted its ANDA with a Paragraph IV Certification (Compl. ¶56, ¶63, ¶70, ¶77, ¶84). This allegation of pre-suit knowledge could form the basis for a future claim of willful infringement if infringement is found.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of infringement scope versus claim differentiation: The accused product's formulation appears to read directly on claims in the ’022 Patent family while being numerically distant from claims in the ’548 Patent. A key question for the court will be whether the term "about" in the ’548 patent can be construed broadly enough to cover a formulation that is explicitly claimed in a separate patent in the same family, or if the doctrine of claim differentiation limits such a broad interpretation.
- A central question will be one of validity in view of an apparent design-around failure: Given the direct mapping of the accused product to at least one asserted patent (’022 Patent), the case may turn on Defendant's ability to invalidate that patent. The key question for the court will be whether the specific combination of four trace elements at the claimed neonatal concentrations was obvious to a person of ordinary skill in the art at the time of the invention.
- A key evidentiary question will be one of technical purity and negative limitations: The dispute may focus on the meaning of "no added chromium." The central question will be whether Defendant's manufacturing process and quality control can demonstrate that its product is free of "added" chromium, or if unavoidable trace impurities sourced from raw materials or equipment are sufficient to meet this limitation.