DCT
2:24-cv-02268
American Regent Inc v. Apotex Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: Apotex, Inc. (Canada) and Apotex, Corp. (Delaware)
- Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
- Case Identification: 2:24-cv-02268, D.N.J., 03/11/2024
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Apotex Corp. maintains a permanent and continuous presence in the state as a registered drug wholesaler, and Defendant Apotex Inc., a foreign corporation, is subject to personal jurisdiction in the district.
- Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application for generic versions of Plaintiff's Tralement® and Multrys® injectable drug products infringes a patent related to stable trace element compositions for parenteral nutrition.
- Technical Context: The technology involves injectable solutions containing essential trace metals (zinc, copper, selenium, manganese) used for intravenous feeding in patients who cannot receive nutrition orally.
- Key Procedural History: This is a patent infringement action filed under the Hatch-Waxman Act, triggered by Defendants' submission of Abbreviated New Drug Application (ANDA) No. 218576 to the FDA. The ANDA contained a Paragraph IV Certification asserting that U.S. Patent No. 11,786,548 is invalid or will not be infringed by the proposed generic products.
Case Timeline
| Date | Event |
|---|---|
| 2020-07-02 | Earliest Priority Date for '548 Patent |
| 2020-07-02 | FDA approves Plaintiff's Tralement® and Multrys® NDA No. 209376 |
| 2023-10-17 | U.S. Patent No. 11,786,548 issues |
| 2024-01-25 | Defendants send Paragraph IV Notice Letter to Plaintiff |
| 2024-03-11 | 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"
The Invention Explained
- Problem Addressed: The patent's background section describes stability issues with existing trace element compositions used for parenteral (intravenous) nutrition, which often must be discarded after 24-48 hours, leading to waste, cost, and potential supply shortages (ʼ548 Patent, col. 2:5-24). It also notes that recommended daily doses for elements like copper and manganese have been reduced, but existing all-in-one formulations are not easily customizable to provide these lower doses (ʼ548 Patent, col. 2:46-56).
- The Patented Solution: The invention is a stable, injectable trace element composition that can be stored for longer periods, thereby reducing waste and improving the quality of life for patients and caregivers (ʼ548 Patent, col. 2:31-44). The composition contains specific concentrations of zinc, copper, selenium, and manganese in an acidic solution (pH 1.5-3.5), which enhances stability, and is formulated to provide medically appropriate doses while excluding or strictly limiting certain other elements like chromium and aluminum (ʼ548 Patent, Abstract; col. 18, Table 5).
- Technical Importance: The invention provides a means to supply essential trace minerals for long-term intravenous nutrition in a formulation that is more stable and better aligned with modern clinical dosage recommendations than prior products (ʼ548 Patent, col. 2:31-44).
Key Claims at a Glance
- The complaint does not specify claims but alleges infringement of "one or more claims" (Compl. ¶48). Independent Claim 1 is representative and appears to map directly to one of the accused products.
- The essential elements of Independent Claim 1 are:
- 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
- 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
- The complaint reserves the right to assert other claims, including dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are Defendants' proposed generic drug products submitted to the FDA under ANDA No. 218576 ("the ANDA Products") (Compl. ¶1). The ANDA Products are generic versions of Plaintiff's Tralement® and Multrys® products (Compl. ¶42).
Functionality and Market Context
- The complaint describes the ANDA Products as single-dose, 1 mL injectable compositions intended to provide trace elements for parenteral nutrition (Compl. ¶43). The generic Tralement® is 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. ¶43). The generic Multrys® is alleged to contain 1000 mcg of zinc, 60 mcg of copper, 3 mcg of manganese, and 6 mcg of selenium per 1 mL (Compl. ¶43).
- The complaint alleges that Plaintiff's Tralement® and Multrys® are the "first and only FDA-approved" multi-trace element injections for their respective patient populations, suggesting the ANDA Products seek to enter a market established by Plaintiff's commercial embodiments of the '548 patent (Compl. ¶¶30, 32, 34).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint alleges infringement but does not provide a claim chart. The following chart summarizes the infringement theory for the generic Tralement® product based on the allegations in the complaint against representative Independent Claim 1.
- '548 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable composition comprising water... | The ANDA Products are injectable compositions | ¶43 | col. 12:22-24 |
| 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 proposed generic version of Tralement® is a 1 mL composition containing 60 mcg of selenium, 3 mg of zinc (3,000 µg), 0.3 mg of copper (300 µg), and 55 mcg of manganese | ¶43 | col. 12:13-21 |
| wherein the injectable composition... does not contain any vitamins... | The complaint does not explicitly state the ANDA products lack vitamins but alleges they are generic versions of Tralement®, which the patent describes as being free of vitamins | ¶42 | col. 29:1-2 |
| contains no added chromium... | The complaint does not specify whether the ANDA products contain chromium. The patent, which the ANDA products are alleged to infringe, claims a composition with "no added chromium" | ¶47 | col. 29:1-2 |
| and no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL of the injectable composition. | The complaint does not provide specific details on the aluminum content of the ANDA products. Infringement is alleged of a patent that claims an aluminum limit of not more than 6 µg/mL | ¶47 | col. 29:1-5 |
- Identified Points of Contention:
- Scope Questions: The complaint alleges infringement of claims containing the negative limitation "no added chromium." A primary point of contention will be the scope of this term. The dispute will question whether this limitation requires an absolute absence of any detectable chromium or if it permits the presence of trace amounts of chromium as an unavoidable impurity from raw materials or manufacturing processes, so long as it is not an intentionally "added" ingredient.
- Technical Questions: While the complaint alleges that the primary active ingredients in the generic Tralement® product match the quantities in Claim 1, the case will require evidentiary proof of the full composition of the ANDA products. A key technical question is what evidence will show the ANDA products meet the negative limitations of the claims, such as containing "no added chromium" and "no...vitamins."
V. Key Claim Terms for Construction
- The Term: "no added chromium" (from Claim 1)
- Context and Importance: This negative limitation is central to defining the scope of the invention. Its construction will likely be dispositive for infringement. The dispute will focus on whether this term forbids even trace impurities of chromium or merely forbids the inclusion of chromium as a recited, functional ingredient. Practitioners may focus on this term because the patent repeatedly emphasizes the novelty of its specific formulation, including the elements it omits.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (e.g., zero tolerance): The specification states that "in many cases, the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all," which could support an argument that the patentee intended to exclude any amount of chromium (ʼ548 Patent, col. 16:45-51).
- Evidence for a Narrower Interpretation (e.g., permitting impurities): The claim language specifies "no added chromium," not "contains no chromium." A party could argue this wording was intentionally chosen to distinguish between chromium included as an ingredient and trace amounts present as an incidental, unavoidable impurity. The patent also lists chromium as a potential impurity to be monitored, which could suggest an acknowledgment that trace amounts may be present (ʼ548 Patent, col. 28, table).
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that upon approval, Defendants' marketing and the products' proposed package inserts will actively encourage and instruct medical practitioners and patients to use the ANDA Products in an infringing manner (Compl. ¶48). It also alleges contributory infringement, asserting that the ANDA Products are especially made for an infringing use and are not suitable for substantial non-infringing use (Compl. ¶49).
- Willful Infringement: The complaint alleges that Defendants have had knowledge of the '548 patent "since at least the date Apotex submitted the ANDA with a Paragraph IV Certification" (Compl. ¶51). This alleged knowledge, combined with the act of seeking FDA approval, forms the basis for the willfulness allegation. The complaint also seeks a finding that the case is "exceptional" under 35 U.S.C. § 285 (Compl. ¶52).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this Hatch-Waxman litigation will likely depend on the court's determination of the following central questions:
- A core issue will be one of definitional scope: How will the court construe the negative limitation "no added chromium"? The case will hinge on whether this term establishes a zero-tolerance standard for any detectable chromium or if it permits the presence of trace impurities not included as a specified ingredient.
- A key evidentiary question will follow: What is the actual composition of the proposed ANDA products? Discovery will focus on whether Defendants' products contain any level of chromium, vitamins, or other elements excluded by the asserted claims, and if so, what is their source.