DCT
2:24-cv-01022
American Regent Inc v. Somerset Therap LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: RK Pharma, Inc. (Delaware)
- Plaintiff’s Counsel: GIBBONS P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
- Case Identification: 2:24-cv-01022, D.N.J., 01/03/2025
- Venue Allegations: Venue is alleged based on Defendant’s affiliate, VGYAAN Pharmaceuticals LLC, submitting the Abbreviated New Drug Application (ANDA) from its Skillman, New Jersey place of business. The complaint further notes that Defendant has a regular and established place of business in New Jersey and has agreed not to contest venue for this action.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA to the U.S. Food and Drug Administration seeking approval to market generic versions of Plaintiff's Tralement® and Multrys® products constitutes an act of infringement of five U.S. patents related to injectable trace element compositions.
- Technical Context: The technology involves stable, injectable multi-trace element formulations (containing zinc, copper, manganese, and selenium) used for parenteral nutrition in patients who cannot receive oral or enteral nutrition.
- Key Procedural History: This patent infringement action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 218537 with a Paragraph IV Certification. Plaintiff was notified of the ANDA filing via a Notice Letter dated January 23, 2024. The current filing is a Second Amended Complaint in a consolidated action.
Case Timeline
| Date | Event |
|---|---|
| 2020-07-02 | Plaintiff's Tralement® and Multrys® products approved by FDA |
| 2020-07-02 | Earliest Priority Date for all Patents-in-Suit |
| 2023-10-17 | ’548 Patent Issued |
| 2024-01-23 | Defendant sends Notice Letter to Plaintiff regarding ANDA filing |
| 2024-05-07 | ’022 Patent Issued |
| 2024-06-04 | ’565 Patent Issued |
| 2024-11-26 | ’956 Patent Issued |
| 2024-11-26 | ’957 Patent Issued |
| 2025-01-03 | Second Amended 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
- Patent Identification: U.S. Patent No. 11,786,548, "Trace element compositions, methods of making and use," issued October 17, 2023 (’548 Patent).
The Invention Explained
- Problem Addressed: The patent’s background section describes the problem of instability in parenteral nutrition (PN) solutions once trace elements are added. This short stability period of 24 to 48 hours necessitates frequent, costly, and time-consuming admixing under aseptic conditions, leading to product waste, potential supply shortages, and inconvenience for patients and caregivers (’548 Patent, col. 2:5-30).
- The Patented Solution: The invention is a stable injectable trace element composition that, when added to a PN solution, allows the admixture to remain stable for a longer period of time, such as at least three days (’548 Patent, col. 3:4-8; Abstract). This extended stability allows for batch preparation, reducing waste and logistical burdens. The composition specifically comprises defined amounts of zinc, copper, selenium, and manganese, and notably contains no added chromium, addressing a need for formulations with adjusted trace element levels (’548 Patent, col. 2:41-48).
- Technical Importance: By providing a composition with extended stability, the invention enables more efficient and less wasteful preparation of parenteral nutrition, a critical therapy for patients unable to absorb nutrients through the digestive tract (’548 Patent, col. 2:31-44).
Key Claims at a Glance
- The complaint alleges infringement of one or more claims without specifying them; independent claim 1 is representative of the core invention (Compl. ¶51).
- Independent Claim 1 of the ’548 Patent requires:
- 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
- about 55 µg of manganese per 1 mL
- contains 0 µg to about 10 µg of iron per 1 mL
- does not contain any vitamins
- contains no added chromium
- contains no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL
- The complaint does not explicitly reserve the right to assert dependent claims.
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 (’022 Patent).
The Invention Explained
- Problem Addressed: As a divisional of the application leading to the ’548 Patent, this patent addresses the same technical problem of short stability periods for parenteral nutrition solutions containing trace elements (’022 Patent, col. 2:5-30).
- The Patented Solution: The patent claims methods of providing trace elements to patients by administering a stable injectable composition. The composition itself is identical to that described in the ’548 Patent, featuring specific concentrations of zinc, copper, selenium, and manganese, and lacking added chromium, thereby allowing for extended stability of the final parenteral nutrition admixture (’022 Patent, Abstract; col. 2:49-67).
- Technical Importance: The claimed method provides a more efficient and less wasteful clinical protocol for administering essential trace elements as part of parenteral nutrition therapy (’022 Patent, col. 2:31-44).
Key Claims at a Glance
- The complaint alleges infringement of one or more claims without specifying them; independent claim 1 is representative (Compl. ¶58).
- Independent Claim 1 of the ’022 Patent requires:
- 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 the same formulation elements as Claim 1 of the ’548 Patent (water, specific amounts of selenium, zinc, copper, and manganese, with limitations on iron, vitamins, chromium, and aluminum)
- The complaint does not explicitly reserve the right to assert dependent claims.
Additional Patents-in-Suit
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 (’565 Patent).
- Technology Synopsis: As part of the same patent family, the ’565 Patent addresses the problem of instability in parenteral nutrition admixtures. It claims a method of administering a stable trace element composition specifically formulated for neonatal and pediatric patients weighing less than 10 kg (’565 Patent, Abstract; Compl. ¶¶24-25).
- Asserted Claims: The complaint asserts infringement of one or more claims; independent claim 1 is representative (Compl. ¶64).
- Accused Features: The accused features are the formulation and proposed method of use for Defendant's generic version of Multrys®, which is alleged to contain 1000 mcg of zinc, 60 mcg of copper, 3 mcg of manganese, and 6 mcg of selenium (Compl. ¶46).
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 (’956 Patent).
- Technology Synopsis: A continuation in the same patent family, the ’956 Patent also addresses the problem of instability in parenteral nutrition admixtures. It claims the stable injectable composition itself, with element concentrations corresponding to the adult/pediatric formulation found in the ’548 Patent (’956 Patent, Abstract).
- Asserted Claims: The complaint asserts infringement of one or more claims; independent claim 1 is representative (Compl. ¶70).
- Accused Features: The accused features are the formulations for Defendant's generic versions of Tralement®, which are alleged to contain 3 mg of zinc, 0.3 mg of copper, 55 mcg of manganese, and 60 mcg of selenium per 1 mL (Compl. ¶46).
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 (’957 Patent).
- Technology Synopsis: A continuation in the same patent family, the ’957 Patent addresses the problem of instability in parenteral nutrition admixtures. It claims the stable injectable composition itself, with element concentrations corresponding to the neonatal/pediatric formulation found in the ’565 Patent (’957 Patent, Abstract).
- Asserted Claims: The complaint asserts infringement of one or more claims; independent claim 1 is representative (Compl. ¶76).
- Accused Features: The accused features are the formulation for Defendant's generic version of Multrys®, which is alleged to contain 1000 mcg of zinc, 60 mcg of copper, 3 mcg of manganese, and 6 mcg of selenium (Compl. ¶46).
III. The Accused Instrumentality
Product Identification
- Defendant RK Pharma’s proposed generic drug products, identified as the "ANDA Products," which are generic versions of Plaintiff's Tralement® (trace elements injection 4*, USP) and Multrys® (trace elements injection 4*, USP) products (Compl. ¶1).
Functionality and Market Context
- The complaint, citing Defendant's Notice Letter, identifies three distinct product formulations submitted for FDA approval in ANDA No. 218537 (Compl. ¶46). The first is a 1 mL single-dose generic of Tralement® containing 3 mg of zinc, 0.3 mg of copper, 55 mcg of manganese, and 60 mcg of selenium. The second is a 5 mL pharmacy bulk package of the same Tralement® formulation. The third is a generic version of Multrys® containing 1000 mcg of zinc, 60 mcg of copper, 3 mcg of manganese, and 6 mcg of selenium. These products are intended for use in parenteral nutrition and are alleged to have the same or equivalent chemical and therapeutic properties as Plaintiff’s branded drugs (Compl. ¶¶45, 48). The complaint includes a screenshot from Defendant's website describing its "Group of Companies" as being "engaged in all phases of the generic pharmaceutical business," which suggests the commercial context for the accused products (Compl. p. 4).
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... | The accused generic Tralement® product is an injectable formulation. | ¶46 | col. 15:1-17 |
| about 60 µg of selenium... | The accused generic Tralement® product allegedly contains 60 mcg of selenium. | ¶46 | col. 15:1-17 |
| 3,000 µg of zinc... | The accused generic Tralement® product allegedly contains 3 mg (3,000 µg) of zinc. | ¶46 | col. 15:1-17 |
| about 300 µg of copper... | The accused generic Tralement® product allegedly contains 0.3 mg (300 µg) of copper. | ¶46 | col. 15:1-17 |
| about 55 µg of manganese per 1 mL... | The accused generic Tralement® product allegedly contains 55 mcg of manganese. | ¶46 | col. 15:1-17 |
| contains 0 µg per 1 mL to about 10 µg per 1 mL of iron... | The complaint does not provide sufficient detail for analysis of this element. | ¶34 | col. 15:1-17 |
| contains no added chromium | The complaint does not provide sufficient detail for analysis of this element. | ¶34 | col. 15:1-17 |
| no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL... | The complaint does not provide sufficient detail for analysis of this element. | ¶34 | col. 15:1-17 |
’022 Patent 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, comprising administering an injectable trace element composition to the patient... | The complaint alleges that Defendant’s proposed package insert will instruct and encourage medical practitioners to administer the accused generic Tralement® product to patients. | ¶58 | col. 15:18-47 |
| the 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 administered product is the accused generic Tralement® formulation, which allegedly contains the specified amounts of trace elements. | ¶46, ¶58 | col. 15:18-47 |
| wherein the injectable composition... contains no added chromium... | The complaint does not provide sufficient detail for analysis of the negative limitations of the administered composition. | ¶34, ¶58 | col. 15:18-47 |
- Identified Points of Contention:
- Evidentiary Questions: The central dispute may concern the negative limitations common to the asserted claims. What evidence does the complaint provide that the accused ANDA products contain "no added chromium," have iron and aluminum levels below the claimed maximums, and contain no vitamins? The complaint states it was unable to access the ANDA to make this assessment, framing this as a key area for discovery (Compl. ¶34).
- Scope Questions: The term "about" qualifies several concentration limitations (e.g., "about 60 µg of selenium"). While the complaint alleges exact numerical correspondence, any manufacturing variance in the accused products could raise the question of whether such variations fall within the scope of "about" as used in the patents.
V. Key Claim Terms for Construction
The Term: "no added chromium"
- Context and Importance: This negative limitation appears in the independent claims of multiple patents-in-suit and is critical for distinguishing the invention from prior art formulations that included chromium. Practitioners may focus on this term because its construction will determine whether the presence of any amount of chromium, even as an unavoidable trace impurity from raw materials or manufacturing equipment, removes the accused product from the scope of the claims.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (i.e., allowing for impurities): The specification distinguishes between intentionally added components and impurities, discussing limits for chromium as a "potential elemental impurity" (’548 Patent, col. 13:46-62, Table 2). This could support an argument that "no added chromium" means chromium is not included as an active ingredient, while tolerating its presence as a monitored impurity.
- Evidence for a Narrower Interpretation (i.e., requiring absolute absence): The background highlights that "daily doses of chromium are not typically needed," suggesting a deliberate and complete exclusion is a key feature of the invention (’548 Patent, col. 2:41-48). The explicit recitation of "no added chromium" in the claim, as opposed to a limit on chromium concentration, could support an argument for strict exclusion.
The Term: "about"
- Context and Importance: This term modifies the concentration of each active trace element in the asserted claims (e.g., "about 3,000 µg of zinc"). Its scope is central to determining literal infringement. Practitioners may focus on this term because if Defendant’s manufacturing process results in concentrations that deviate slightly from the patent’s recited values, the meaning of "about" will determine whether those products infringe.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the invention in terms of ranges, such as "about 800 µg to about 4,000 µg of zinc," suggesting the inventors did not intend to be limited to the exact numbers recited in the claims (’548 Patent, col. 3:5-12).
- Evidence for a Narrower Interpretation: The patent provides tables with precise target values for the formulation (e.g., Table 1 specifies exactly "3 mg Zn/mL") and notes that the injectable composition's characteristics are based on "drug product release specifications" (’548 Patent, Table 1; col. 12:29-34). This could support an interpretation that "about" encompasses only minor variations consistent with pharmaceutical manufacturing tolerances.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement for all asserted method claims. The basis is the allegation that Defendant's proposed package insert for its ANDA Products will instruct and encourage medical practitioners to administer the products in a manner that directly infringes the claims (Compl. ¶¶51, 58, 64, 70, 76). The complaint also alleges contributory infringement, stating the ANDA Products are especially made for infringing use and are not suitable for substantial non-infringing uses (Compl. ¶¶52, 59, 65, 71, 77).
- Willful Infringement: The complaint does not contain an explicit count for willful infringement. However, it alleges that RK Pharma has had knowledge of the ’548 Patent since at least the date it submitted its ANDA, which could form the basis for enhanced damages for any post-suit infringement (Compl. ¶54). The complaint also asserts that the case is “exceptional,” seeking an award of attorneys’ fees under 35 U.S.C. § 285 (Compl. ¶¶55, 61, 67, 73, 79).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of factual proof: does the composition detailed in Defendant’s confidential ANDA submission meet the negative limitations recited in the asserted claims, particularly the requirement of "no added chromium" and the upper limits on iron and aluminum? The resolution of the infringement question may depend entirely on the contents of that undisclosed regulatory filing.
- A key question of claim construction will be the scope of the term "no added chromium." The case may turn on whether this term requires the absolute absence of chromium or if it permits the presence of unavoidable trace impurities that are not deliberately included as an active ingredient.
- A primary question for the method claims will be one of intent to induce: will the language in Defendant’s proposed package insert provide sufficient evidence of a specific intent to encourage medical professionals to administer the accused products in a way that directly infringes the patented methods?