DCT
2:25-cv-00723
American Regent Inc v. Xiromed LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: Xiromed, LLC (New Jersey) and Xiromed Pharma España, S.L. (Spain)
- Plaintiff’s Counsel: GIBBONS P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
- Case Identification: 2:25-cv-00723, D.N.J., 01/24/2025
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Xiromed, LLC is organized under New Jersey law, maintains a regular and established place of business in the district, and committed the alleged acts of infringement, including the submission of its Abbreviated New Drug Application (ANDA), in the district.
- Core Dispute: Plaintiff alleges that Defendants’ filing of an ANDA with the U.S. Food and Drug Administration to market a generic version of Plaintiff’s Tralement® drug product infringes five patents related to trace element compositions for parenteral nutrition.
- Technical Context: The technology involves stable, injectable formulations of essential trace elements (zinc, copper, manganese, selenium) used for parenteral nutrition in patients who cannot receive nourishment orally or enterally.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following a notice letter dated December 10, 2024, in which Defendants notified Plaintiff of their ANDA submission containing a Paragraph IV Certification, asserting that the patents-in-suit are invalid or will not be infringed by the proposed generic 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 |
| 2024-12-10 | Defendants’ Paragraph IV Certification Notice Letter |
| 2025-01-24 | Complaint Filing Date |
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 parenteral nutrition (PN) formulations admixed with trace elements typically have a short stability period of 24 to 48 hours at room temperature, which necessitates frequent, time-consuming, and costly admixing procedures under aseptic conditions (’548 Patent, col. 2:5-18). This practice increases waste if a patient's nutrition is put on hold and requires patients or caregivers to make frequent trips to healthcare facilities for newly admixed solutions (’548 Patent, col. 2:18-30).
- The Patented Solution: The invention provides a stable, injectable trace element composition that, when added to a parenteral nutrition solution, allows the final admixture to remain stable for a longer period than previously possible (’548 Patent, col. 2:46-53). The solution comprises specific concentrations of zinc, copper, selenium, and manganese while controlling for or excluding other elements like chromium, aluminum, and iron, thereby extending the usable life of the admixed PN formulation (’548 Patent, col. 45:60-col. 46:7).
- Technical Importance: The claimed stable composition reduces the frequency of admixing, which may lower costs, reduce waste, and improve the quality of life for both patients on long-term PN and their caregivers (’548 Patent, col. 2:31-39).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" (’548 Patent, Compl. ¶57), and while not specifying claims, independent claim 1 is representative of the asserted composition.
- 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 of the injectable composition,
- wherein the injectable composition contains 0 µg per 1 mL to about 10 µg per 1 mL of iron,
- does not contain any vitamins,
- contains no added chromium and no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL of the injectable composition.
- The complaint's use of "one or more claims" suggests a reservation of the right to assert dependent claims.
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 of conventional parenteral nutrition formulations once trace elements have been added, leading to logistical burdens, increased costs, and potential for drug supply shortages due to waste (’022 Patent, col. 2:5-24).
- The Patented Solution: The invention is a stable injectable composition containing specific amounts of zinc, copper, selenium, and manganese (’022 Patent, Abstract). This patent's claims define the composition with specific upper limits for impurities like chromium, aluminum, and iron, rather than focusing on whether an element was "added," providing an alternative way to claim a stable formulation with a controlled chemical profile (’022 Patent, col. 45:65-col. 46:3).
- Technical Importance: This patented solution offers the same benefits of improved stability, reduced waste, and enhanced patient convenience as described for the ’548 Patent (’022 Patent, col. 2:31-39).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" (’022 Patent, Compl. ¶64). Independent claim 1 is representative.
- Essential elements of independent claim 1 include:
- An injectable 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 of the injectable composition,
- wherein the injectable composition contains impurities of chromium, aluminum, and iron, wherein the impurities are chromium in an amount not to exceed 1 µg, aluminum in an amount not to exceed 6 µg, and 0 µg to about 10 µg of the iron per 1 mL of the injectable composition.
- The complaint's language implies the right to assert dependent claims may be reserved.
U.S. Patent No. 11,998,565 - "Trace element compositions, methods of making and use"
- Technology Synopsis: The patent addresses the technical problem of short stability in parenteral nutrition formulations containing trace elements (’565 Patent, col. 1:49-col. 2:30). It provides a stable injectable composition with specific amounts of four trace elements as a solution (’565 Patent, Abstract).
- Asserted Claims: The complaint is non-specific; independent claim 1 is a representative composition claim.
- Accused Features: The accused features are the specific concentrations of zinc, copper, manganese, and selenium in the Defendants' proposed generic drug product (Compl. ¶¶ 51-53, 71).
U.S. Patent No. 12,150,956 - "Trace element compositions, methods of making and use"
- Technology Synopsis: The patent is directed to solving the problem of limited stability in existing parenteral nutrition admixtures by disclosing a stable injectable composition of trace elements (’956 Patent, col. 1:49-col. 2:30). The solution involves a specific formulation of zinc, copper, selenium, and manganese (’956 Patent, Abstract).
- Asserted Claims: The complaint is non-specific; independent claim 1 is a representative composition claim.
- Accused Features: The accused features are the specific concentrations of zinc, copper, manganese, and selenium in the Defendants' proposed generic drug product (Compl. ¶¶ 51-53, 78).
U.S. Patent No. 12,150,957 - "Trace element compositions, methods of making and use"
- Technology Synopsis: The patent addresses the problem of short stability in parenteral nutrition with added trace elements by providing a stable injectable composition of zinc, copper, selenium, and manganese (’957 Patent, col. 1:49-col. 2:30).
- Asserted Claims: The complaint is non-specific; independent claim 1 is a representative composition claim.
- Accused Features: The accused features are the specific concentrations of zinc, copper, manganese, and selenium in the Defendants' proposed generic drug product (Compl. ¶¶ 51-53, 85).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is the generic drug product described in Xiromed’s ANDA No. 219728 ("the ANDA Product") (Compl. ¶1).
Functionality and Market Context
- The ANDA Product is identified as "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" (Compl. ¶52). It is a generic version of Plaintiff’s Tralement® product and is alleged to contain the same or equivalent ingredients in the same or equivalent amounts (Compl. ¶51, ¶53). The product is intended to be administered to patients by medical practitioners as a source of trace elements for parenteral nutrition (Compl. ¶31, ¶57).
- The complaint alleges the ANDA product, if approved, will compete with Tralement®, which is described as the first and only FDA-approved multi-trace element injection for patients weighing at least 10 kg (Compl. ¶30).
IV. Analysis of Infringement Allegations
'548 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| 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 ANDA Product is alleged to be a trace elements injection containing 60 mcg Se/mL, 3 mg Zn/mL (3,000 µg/mL), 0.3 mg Cu/mL (300 µg/mL), and 55 mcg Mn/mL. | ¶52 | col. 10:1-5 |
| wherein the injectable composition... contains no added chromium and no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL... | The complaint alleges infringement but does not provide specific details regarding the chromium or aluminum content of the ANDA product. | ¶56 | col. 13:46-52 |
'022 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable 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... | The ANDA Product is alleged to be a trace elements injection containing 60 mcg Se/mL, 3 mg Zn/mL (3,000 µg/mL), 0.3 mg Cu/mL (300 µg/mL), and 55 mcg Mn/mL. | ¶52 | col. 10:1-5 |
| wherein the injectable composition contains impurities of chromium, aluminum, and iron, wherein the impurities are chromium in an amount not to exceed 1 µg, aluminum in an amount not to exceed 6 µg, and 0 µg to about 10 µg of the iron per 1 mL... | The complaint does not provide sufficient detail for analysis of the impurity profile of the ANDA product. | ¶63 | col. 13:46-65 |
No probative visual evidence provided in complaint.
Identified Points of Contention
- Scope Questions: A potential issue for construction may be the term "about" as it modifies the concentration of each active ingredient. Does the term provide a broad range of equivalence, or does the precise nature of pharmaceutical formulation require a narrower interpretation?
- Technical Questions: A central factual dispute will likely concern the impurity profile of the ANDA Product. For the ’548 Patent, what evidence will show whether chromium is "added" during Defendants' manufacturing process, or if its presence is an unavoidable trace impurity from raw materials? For the ’022 Patent and others, what is the actual measured amount of chromium, aluminum, and iron in the ANDA Product, and does it fall within the claimed ranges for impurities?
V. Key Claim Terms for Construction
Term: "about"
Context and Importance: This term governs the scope of the claimed concentrations for all four active trace elements (e.g., "about 3,000 µg of zinc"). The infringement analysis hinges on whether the concentrations in the manufactured ANDA Product, including any process variations, fall within the range defined by "about." Practitioners may focus on this term because even though the ANDA formulation appears to match the claimed values exactly, establishing the permissible boundaries of the claim is critical to proving or disproving infringement for any manufactured batch.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides broad ranges for the elements, such as "from about 800 µg to about 4,000 µg of zinc" (’548 Patent, col. 3:41-43), which may support the view that "about" is intended to have its ordinary, flexible meaning of "approximately."
- Evidence for a Narrower Interpretation: The patent claims and specification also recite highly specific concentrations (e.g., 3,000 µg of zinc, 55 µg of manganese) and present these precise values in formulation tables (’548 Patent, Table 1). A party could argue that in the context of pharmaceutical manufacturing, where precision is paramount, "about" should be construed narrowly to mean very close to the stated value.
Term: "no added chromium" (from ’548 Patent)
Context and Importance: This negative limitation is a key distinguishing feature of claim 1 of the ’548 Patent. The infringement determination will depend on whether any chromium detected in the ANDA Product is considered "added." This term's construction is critical because later patents in the same family, such as the ’022 Patent, explicitly permit chromium as an impurity up to a certain threshold, creating a potential contrast in scope.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (favoring non-infringement): A defendant may argue that "added" implies an intentional act of inclusion as a formulated ingredient. The specification distinguishes between the four primary trace elements and potential "elemental impurities" that may be present, such as chromium (’548 Patent, col. 12:28-34, Table 2). This could support an argument that the mere presence of trace chromium as a contaminant from raw materials does not meet the "added" limitation.
- Evidence for a Narrower Interpretation (favoring infringement): A plaintiff may argue that "no added chromium" should be construed to mean that the final composition is essentially free of chromium that is not naturally present in the human body, regardless of its origin in the manufacturing process. The background discusses reducing the daily doses of trace elements like chromium, suggesting an inventive goal of eliminating it from the final formulation (’548 Patent, col. 2:41-45).
VI. Other Allegations
Indirect Infringement
The complaint alleges both induced and contributory infringement. Inducement is based on the allegation that Defendants' proposed package insert will instruct and encourage medical practitioners to administer the ANDA Product in an infringing manner (Compl. ¶57, ¶64). Contributory infringement is based on allegations that Defendants know the ANDA Product is especially made for infringing uses and is not suitable for substantial non-infringing use (Compl. ¶58, ¶65).
Willful Infringement
The complaint does not use the term "willful infringement," but it alleges that Defendants have had knowledge of the patents-in-suit since at least the date they submitted the ANDA with a Paragraph IV certification (Compl. ¶60, ¶67). The complaint also asserts that the case is "exceptional" and requests an award of attorneys' fees under 35 U.S.C. § 285, which is often associated with findings of willful infringement or other litigation misconduct (Compl. ¶61, ¶68).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of compositional fact: what is the precise chemical profile of the Defendants' ANDA product as manufactured? Discovery regarding the final concentrations of the four active trace elements and, more critically, the presence, quantity, and source of any chromium, aluminum, and iron will be central to the infringement analysis for all five patents.
- A key legal question will be one of definitional interpretation: can the limitation "no added chromium" from the ’548 patent be interpreted to read on a product that may contain trace levels of chromium as an unavoidable impurity from its raw materials, and how does that scope compare to the explicit impurity threshold of "not to exceed 1 µg" of chromium recited in the ’022 patent?