DCT
2:24-cv-11503
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.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
- Case Identification: 2:24-cv-11503, D.N.J., 12/30/2024
- Venue Allegations: Venue is based on Defendant Amneal Pharmaceuticals of New York, LLC having a regular and established place of business in New Jersey and having committed acts of infringement in the district, including submitting its ANDA with the intent to market the accused product in New Jersey.
- Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the FDA to market a generic version of Plaintiff's Selenious Acid injection products constitutes an act of infringement of patents related to trace element compositions for parenteral nutrition.
- Technical Context: The technology concerns stable, injectable trace element compositions, particularly those containing selenium, used as supplements for patients who cannot receive nutrition orally.
- Key Procedural History: The action arises under the Hatch-Waxman Act, triggered by Defendants' submission of ANDA No. 219069 with a Paragraph IV certification challenging the asserted patents. Plaintiff received a notice letter from Defendants regarding this submission on November 15, 2024.
Case Timeline
| Date | Event |
|---|---|
| 2019-04-30 | FDA approves Plaintiff's New Drug Application for Selenious Acid products |
| 2020-07-02 | Earliest Priority Date for ’565 and ’957 Patents |
| 2024-06-04 | U.S. Patent No. 11,998,565 issues |
| 2024-11-15 | Defendants notify Plaintiff of ANDA submission via Notice Letter |
| 2024-11-26 | U.S. Patent No. 12,150,957 issues |
| 2024-12-30 | Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,998,565 - "Trace element compositions, methods of making and use"
The Invention Explained
- Problem Addressed: The patent describes challenges with existing trace element supplements for parenteral nutrition (PN). Specifically, when trace elements are added to PN solutions, the resulting admixture often has a short stability period (24-48 hours), which leads to waste, increased costs, and frequent, inconvenient admixing for patients and healthcare providers (Compl., Ex. A, ’565 Patent, col. 1:46-2:30).
- The Patented Solution: The invention provides stable injectable trace element compositions that, when added to PN solutions, allow the admixture to remain stable for a longer period (e.g., at least 3 to 14 days). This extended stability is intended to reduce costs, minimize waste, and improve the quality of life for patients by allowing PN solutions to be prepared in larger batches and less frequently (’565 Patent, col. 2:31-43). The patent discloses specific formulations containing elements like selenium, often with defined limits or the exclusion of other elements like chromium.
- Technical Importance: The solution addresses a practical logistical and economic burden in the administration of long-term parenteral nutrition by extending the usable life of admixed nutritional solutions.
Key Claims at a Glance
- The complaint asserts claims 1-2, 4-11, 13-17, 19-20, 22-26, and 28-29 (Compl. ¶32). Independent claim 1 is representative of the asserted composition claims.
- Independent Claim 1:
- An injectable composition comprising: water,
- 6 µg or 60 µg of selenium,
- no chromium or chromium in an amount not to exceed 1 µg,
- no aluminum or aluminum in an amount not to exceed 6 µg,
- no iron or iron in an amount up to 10 µg, and
- fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition.
U.S. Patent No. 12,150,957 - "Trace element compositions, methods of making and use"
The Invention Explained
- Problem Addressed: The ’957 Patent shares a common specification with the ’565 Patent and addresses the same technical problem of short stability periods for parenteral nutrition solutions once trace elements are added (Compl., Ex. B, ’957 Patent, col. 1:46-2:30).
- The Patented Solution: The ’957 Patent claims methods of using the stable injectable trace element compositions described in the specification. The invention provides methods for administering these specific formulations to patients to maintain their plasma trace element levels, thereby preventing deficiencies (’957 Patent, col. 5:1-13).
- Technical Importance: This patent protects the therapeutic application of the stable compositions, covering the act of administering the specific formulations to patients requiring parenteral nutritional support.
Key Claims at a Glance
- The complaint asserts one or more unspecified claims of the patent (Compl. ¶¶48-50). Independent claim 1 is representative of the asserted method of use claims.
- Independent Claim 1:
- A method of providing an injectable composition to a patient in need thereof,
- the method comprising administering at least the injectable composition to the patient,
- the injectable composition comprising water, 6 µg, 40 µg or 60 µg of selenium,
- no chromium or chromium in an amount not to exceed 1 µg,
- no aluminum or aluminum in an amount not to exceed 6 µg,
- no iron or iron in an amount not to exceed 10 µg, and
- fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition.
III. The Accused Instrumentality
Product Identification
Defendants' "ANDA Product," identified as "Selenious Acid Injection, USP, (600 mcg Selenium/10 mL (60 mcg/mL))" (Compl. ¶¶1, 37).
Functionality and Market Context
The complaint alleges the ANDA Product is a generic version of Plaintiff's Selenious Acid product, which is used as a reference listed drug (Compl. ¶36). The ANDA Product is alleged to contain the "same or equivalent ingredients in the same or equivalent amounts" as Plaintiff's product and is intended for use in the same manner (Compl. ¶36). The product is intended for administration by patients or medical practitioners as a supplement to parenteral nutrition (Compl. ¶¶42, 49).
IV. Analysis of Infringement Allegations
U.S. Patent No. 11,998,565 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 aqueous solution. | ¶37 | col. 4:11-15 |
| ...6 µg or 60 µg of selenium... | The ANDA Product is alleged to be a generic equivalent of Plaintiff's product and is identified as containing 60 mcg/mL of selenium. | ¶37 | col. 4:26-29 |
| ...no chromium or chromium in an amount not to exceed 1 µg... | The ANDA Product is alleged to have the same or equivalent ingredients as Plaintiff's product, which is covered by the claim. | ¶36 | col. 16:58-60 |
| ...no aluminum or aluminum in an amount not to exceed 6 µg... | The ANDA Product is alleged to have the same or equivalent ingredients as Plaintiff's product, which is covered by the claim. | ¶36 | col. 18:15-25 |
| ...no iron or iron in an amount up to 10 µg... | The ANDA Product is alleged to have the same or equivalent ingredients as Plaintiff's product, which is covered by the claim. | ¶36 | col. 16, Table 4 |
| ...and fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL... | The ANDA Product is alleged to have the same or equivalent ingredients as Plaintiff's product, which is covered by the claim. | ¶36 | col. 17:5-9 |
U.S. Patent No. 12,150,957 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method...comprising administering at least the injectable composition to the patient... | The proposed package insert for the ANDA Product will allegedly instruct patients and/or medical practitioners to administer the product. | ¶49 | col. 5:1-13 |
| ...the injectable composition comprising water...6 µg, 40 µg or 60 µg of selenium...[plus other negative limitations]... | The ANDA Product to be administered is identified as containing 60 mcg/mL of selenium and is alleged to be a generic equivalent of the patented composition. | ¶¶36, 37 | col. 4:11-15; 4:26-29 |
- Identified Points of Contention:
- Factual Questions: The core of the dispute will be factual: what is the precise formulation of Defendants' ANDA Product? The complaint's infringement theory relies entirely on the allegation that the ANDA Product is a "generic version" with the "same or equivalent ingredients" (Compl. ¶36). The case may turn on whether the ANDA product's formulation, once disclosed in discovery, meets every limitation of the asserted claims, including the specific selenium concentration and the negative limitations regarding chromium, aluminum, and iron.
- Scope Questions: A central issue may be the construction of the negative limitations, such as "no chromium." The question for the court will be whether this term requires absolute absence of the element or an amount below a certain level of detection or quantification. The patent specification's reference to "no detectable chromium or no chromium at all" suggests this may be a point of dispute (’565 Patent, col. 16:59-60).
No probative visual evidence provided in complaint.
V. Key Claim Terms for Construction
- The Term: "no chromium" (and similar negative limitations like "no aluminum," "no iron")
- Context and Importance: This term is critical because infringement requires that the accused product lack chromium (or contain it only up to 1 µg/mL). The definition will determine the standard of proof for infringement. Practitioners may focus on this term because absolute absence is difficult to prove, and the parties will likely dispute whether "no" means zero, below a standard detection limit, or not intentionally added as an active ingredient.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (i.e., allowing for trace amounts): The claim language "no chromium or chromium in an amount not to exceed 1 µg" could be read to define a single range of 0 to 1 µg, where "no" simply refers to the lower bound of that range rather than a separate, absolute standard.
- Evidence for a Narrower Interpretation (i.e., requiring absolute or non-detectable absence): The specification states, "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 "no chromium" means an amount below the limit of detection (’565 Patent, col. 16:58-60). The disjunctive "or" in the claim ("no chromium or chromium in an amount not to exceed...") could be interpreted to present two distinct alternatives: complete absence, or presence up to 1 µg.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that Defendants' proposed package insert for the ANDA Product will instruct and encourage patients and medical practitioners to administer the product in a manner that directly infringes the method claims (Compl. ¶¶42, 49). It also alleges contributory infringement, stating the ANDA Product is especially made for infringing use and is not suitable for substantial non-infringing use (Compl. ¶¶43, 50).
- Willful Infringement: The complaint does not use the term "willful," but it alleges that Defendants have had "knowledge of the ’565 patent since at least the date Amneal submitted the ANDA" and that this submission was a knowing act of infringement (Compl. ¶45). Plaintiff seeks a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶46, 52).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of evidentiary proof: does the chemical composition of Defendants' ANDA Product, as revealed through discovery and testing, literally meet every positive and negative limitation of the asserted claims? The complaint's theory rests on the premise of bioequivalence, but infringement will depend on the actual, undisclosed formulation.
- A central legal question will be one of claim construction: how will the court interpret the negative limitation "no chromium"? The case's outcome may depend on whether this term is construed to mean an absolute absence, an amount below a standard limit of detection, or simply the absence of chromium as an intentionally added ingredient.