DCT

2:25-cv-03326

IN RE RADICAVA ORS

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-03326, D.N.J., 01/05/2026
  • Venue Allegations: Plaintiff alleges venue is proper for the two foreign Defendant entities as they may be sued in any judicial district. Venue is alleged as proper for the U.S. Defendant entity based on its purported regular and established place of business in New Jersey.
  • Core Dispute: Plaintiff alleges that Defendants' proposed generic edaravone product, for which they seek FDA approval via a New Drug Application, infringes eight patents covering Plaintiff's oral suspension formulation for its branded drug, RADICAVA ORS®.
  • Technical Context: The technology concerns oral formulations of the drug edaravone, used to treat the fatal neurodegenerative disease Amyotrophic Lateral Sclerosis (ALS), offering a less burdensome alternative to intravenous administration.
  • Key Procedural History: This action arises under the Hatch-Waxman Act following Defendants' submission of a 505(b)(2) New Drug Application (NDA No. 219846) for a generic edaravone product, AUKONTALS. The complaint was precipitated by Defendants' notification to Plaintiff of a Paragraph IV certification alleging non-infringement of the asserted patents, which are listed in the FDA's Orange Book for RADICAVA ORS®. Plaintiff's product also possesses FDA-granted Orphan Drug Exclusivity.

Case Timeline

Date Event
2018-11-02 Earliest Priority Date for ’341, ’416, ’450, ’352, ’660, and ’409 Patents
2020-11-12 Earliest Priority Date for ’025 and ’946 Patents
2021-04-27 U.S. Patent No. 10,987,341 Issues
2022-02-08 U.S. Patent No. 11,241,416 Issues
2022-05-12 FDA approves Plaintiff's RADICAVA ORS® (NDA No. 215446)
2022-10-25 U.S. Patent No. 11,478,450 Issues
2023-11-28 U.S. Patent No. 11,826,352 Issues
2024-03-28 FDA grants Orphan Drug Exclusivity for RADICAVA ORS®
2024-04-16 U.S. Patent No. 11,957,660 Issues
2025-01-14 U.S. Patent No. 12,194,025 Issues
2025-03-13 Defendants send "Non-Infringement Analysis Report" to Plaintiff
2025-03-16 Plaintiff receives Defendants' "Access Offer Letter"
2025-04-22 Plaintiff receives access to redacted portions of Defendants' NDA
2025-04-29 U.S. Patent No. 12,285,409 Issues
2025-05-27 U.S. Patent No. 12,310,946 Issues
2026-01-05 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 10,987,341 - *"Edaravone Suspension for Oral Administration"*

  • Patent Identification: U.S. Patent No. 10,987,341, "Edaravone Suspension for Oral Administration," issued April 27, 2021.

The Invention Explained

  • Problem Addressed: The patent's background describes Amyotrophic Lateral Sclerosis (ALS) as an intractable neurodegenerative disease for which edaravone is a therapeutic agent ('341 Patent, col. 1:33-46). Historically, edaravone was only available as an injection, creating a significant burden for ALS patients and their caregivers (Compl. ¶8). Developing an oral formulation with bioavailability equivalent to the injection presents a technical challenge ('341 Patent, col. 24:12-21).
  • The Patented Solution: The invention is an oral suspension containing edaravone particles, a dispersant, and water ('341 Patent, Abstract; col. 2:62-64). The formulation is designed to create a stable, uniform suspension that can be quickly redispersed even after storage, ensuring consistent dosing and achieving a therapeutic effect and blood concentration profile comparable to the intravenous version ('341 Patent, col. 7:1-10, col. 8:21-30).
  • Technical Importance: This technology provided a means for patients with ALS, who often have difficulty swallowing, to receive edaravone treatment orally, reducing the need for clinical visits and the burden associated with intravenous infusions (Compl. ¶¶ 8-9).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶52).
  • Independent Claim 1 requires:
    • An edaravone suspension for human oral administration
    • Comprising water, edaravone particles dispersed in the water, and a dispersant
    • The dispersant maintains the edaravone particles in a solid state in the water
    • The blending amount of edaravone particles is in a range of 0.5% (w/v) to 36% (w/v)
    • The dispersant is selected from a specific group including polyvinyl alcohol, methylcellulose, hypromellose, sucrose fatty acid ester, and polysorbate
  • The complaint does not explicitly reserve the right to assert dependent claims but makes general allegations of infringement of "one or more claims" (Compl. ¶52).

U.S. Patent No. 11,241,416 - *"Edaravone Suspension for Oral Administration"*

  • Patent Identification: U.S. Patent No. 11,241,416, "Edaravone Suspension for Oral Administration," issued February 8, 2022.

The Invention Explained

  • Problem Addressed: The '416 Patent, a continuation of the '341 Patent, addresses the same technical problem: the need for an effective and less burdensome oral formulation of edaravone for ALS patients as an alternative to intravenous injection (’416 Patent, col. 1:40-43; Compl. ¶8).
  • The Patented Solution: The solution is an oral suspension of edaravone particles in water with a dispersant (’416 Patent, Abstract). The claims of this patent further define the invention by incorporating specific functional properties of the dispersant (e.g., transmission scattering light intensity) and the pharmacokinetic profile (e.g., Cmax and AUC) that the suspension achieves upon oral administration, ensuring bioequivalence with the established intravenous therapy (’416 Patent, col. 2:1-2, col. 2:16-25).
  • Technical Importance: As with the parent patent, this invention provides a more patient-friendly administration route for a critical ALS therapy (Compl. ¶¶ 8-9).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶62).
  • Independent Claim 1 requires:
    • An edaravone suspension for human oral administration comprising water, edaravone particles, and a dispersant
    • The dispersant has a "transmission scattering light intensity of 1% or more"
    • The blending amount of the dispersant is 0.001% to 1.0% (w/v)
    • The blending amount of edaravone is 0.5% to 36% (w/v)
    • When a 90 to 120 mg dose is administered, it exhibits a mean Cmax of 500 to 2500 ng/mL and a mean AUC₀₋∞ of 1000 to 2500 h*ng/mL
  • The complaint does not explicitly reserve the right to assert dependent claims but alleges infringement of "one or more claims" (Compl. ¶62).

U.S. Patent No. 11,478,450 - *"Edaravone Suspension for Oral Administration"*

  • Patent Identification: U.S. Patent No. 11,478,450, "Edaravone Suspension for Oral Administration," issued October 25, 2022.
  • Technology Synopsis: The ’450 Patent relates to methods of treating ALS by orally administering a specific edaravone oral formulation to a patient in need thereof, addressing the burden of intravenous administration (’450 Patent, col. 1:35-42). The claimed method achieves a specific pharmacokinetic profile equivalent to an intravenous injection (’450 Patent, col. 2:27-38).
  • Asserted Claims: Independent Claim 1 (Compl. ¶72).
  • Accused Features: Defendants' submission of NDA No. 219846 for its proposed edaravone product is alleged to constitute infringement (Compl. ¶71).

U.S. Patent No. 11,826,352 - *"Edaravone Suspension for Oral Administration"*

  • Patent Identification: U.S. Patent No. 11,826,352, "Edaravone Suspension for Oral Administration," issued November 28, 2023.
  • Technology Synopsis: The ’352 Patent claims an edaravone suspension characterized by the inclusion of a thickening agent and specific viscosity and IDDSI level properties ('352 Patent, Claim 1). This is intended to provide a formulation that is easier for patients with dysphagia (difficulty swallowing), a common symptom in ALS, to ingest without risk of aspiration ('352 Patent, col. 6:15-23).
  • Asserted Claims: Independent Claim 1 (Compl. ¶82).
  • Accused Features: Defendants' submission of NDA No. 219846 for its proposed edaravone product is alleged to constitute infringement (Compl. ¶81).

U.S. Patent No. 11,957,660 - *"Edaravone Suspension for Oral Administration"*

  • Patent Identification: U.S. Patent No. 11,957,660, "Edaravone Suspension for Oral Administration," issued April 16, 2024.
  • Technology Synopsis: The ’660 Patent claims an edaravone suspension that lacks preservatives but does not exhibit bacterial growth for at least 28 days ('660 Patent, Claim 1). This formulation addresses the technical challenge of creating a stable, multi-use aqueous suspension without relying on common preservatives, which can be beneficial for patient safety ('660 Patent, col. 7:16-20).
  • Asserted Claims: Independent Claim 1 (Compl. ¶92).
  • Accused Features: Defendants' submission of NDA No. 219846 for its proposed edaravone product is alleged to constitute infringement (Compl. ¶91).

U.S. Patent No. 12,194,025 - *"Pharmaceutical composition for oral administration of edaravone and method of administering same"*

  • Patent Identification: U.S. Patent No. 12,194,025, "Pharmaceutical composition for oral administration of edaravone and method of administering same," issued January 14, 2025.
  • Technology Synopsis: The ’025 Patent is directed to a method of treating an oxidative stress disease by administering an edaravone composition with a specific time interval relative to food consumption (’025 Patent, Abstract). The invention addresses the problem that food intake can affect the drug's pharmacokinetics, and it provides specific fasting windows after different types of meals (high-fat, standard, light) to ensure proper drug absorption (’025 Patent, col. 2:1-12).
  • Asserted Claims: Independent Claim 1 (Compl. ¶102).
  • Accused Features: Defendants' submission of NDA No. 219846 and its proposed label instructions are alleged to infringe the claimed method (Compl. ¶¶ 101, 103).

U.S. Patent No. 12,285,409 - *"Edaravone Suspension for Oral Administration"*

  • Patent Identification: U.S. Patent No. 12,285,409, "Edaravone Suspension for Oral Administration," issued April 29, 2025.
  • Technology Synopsis: The ’409 Patent claims an edaravone suspension defined by specific particle size ranges for the edaravone (D50 and D90) and a resulting pharmacokinetic profile ('409 Patent, Claim 1). Controlling particle size is a key technique for managing the dissolution rate and bioavailability of a poorly soluble drug in a suspension formulation ('409 Patent, col. 9:48-54).
  • Asserted Claims: Independent Claim 1 (Compl. ¶112).
  • Accused Features: Defendants' submission of NDA No. 219846 for its proposed edaravone product is alleged to constitute infringement (Compl. ¶111).

U.S. Patent No. 12,310,946 - *"Pharmaceutical composition for oral administration of edaravone and method of administering same"*

  • Patent Identification: U.S. Patent No. 12,310,946, "Pharmaceutical composition for oral administration of edaravone and method of administering same," issued May 27, 2025.
  • Technology Synopsis: The ’946 Patent, related to the ’025 Patent, claims a method of treating ALS by administering a liquid edaravone composition intermittently, with specific time intervals relative to meal consumption to ensure proper absorption (’946 Patent, Claim 1). It addresses the same food-effect problem within the context of the intermittent dosing schedule often used for ALS treatment (’946 Patent, col. 11:1-14).
  • Asserted Claims: Independent Claim 1 (Compl. ¶122).
  • Accused Features: Defendants' submission of NDA No. 219846 and its proposed label instructions are alleged to infringe the claimed method (Compl. ¶¶ 121, 123).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendants' proposed edaravone product, to be marketed under the brand name AUKONTALS, for the treatment of ALS (Compl. ¶18). The complaint alleges this product is the subject of NDA No. 219846, which was submitted to the FDA for approval under the 505(b)(2) pathway (Compl. ¶¶ 18, 41).

Functionality and Market Context

The proposed AUKONTALS product is a generic version of Plaintiff's RADICAVA ORS® and contains the same active pharmaceutical ingredient, edaravone (Compl. ¶18). The complaint alleges that the proposed product is formulated as "90 milligrams (3 x 30 milligram tablets) of edaravone" (Compl. ¶42). By filing an NDA that relies on Plaintiff’s clinical data for RADICAVA ORS®, Defendants seek to enter the market for orally administered ALS treatments upon approval (Compl. ¶41).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim chart analysis. The infringement allegations are pleaded on "information and belief" and assert that Defendants' proposed product infringes "literally and/or under the doctrine of equivalents" (Compl. ¶¶ 52, 62, 72, 82, 92, 102, 112, 122). The complaint's narrative theory is that the proposed AUKONTALS product, by containing edaravone for the treatment of ALS and relying on Plaintiff's NDA data, will necessarily practice the inventions claimed in the patents-in-suit. The complaint posits that any differences between the accused product and the patent claims "are insubstantial" and that the product "performs substantially the same function in substantially the same way to obtain the same result" as the claimed inventions (e.g., Compl. ¶52).

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Scope Questions: A primary point of contention may arise from the alleged form of the accused product. The complaint alleges Defendants seek approval for "tablets" (Compl. ¶42), while the core composition patents (’341, ’416, ’450, ’352, ’660, ’409) claim an "edaravone suspension," a liquid form. This raises the fundamental question of whether claims directed to a pre-formulated liquid suspension can, as a matter of law, read on a solid tablet, either literally or under the doctrine of equivalents.
    • Technical Questions: The complaint provides no technical detail on how Defendants' alleged tablets meet the specific limitations of the suspension claims. For instance, it raises the evidentiary question of what component in a tablet would function as a "dispersant dispersing the edaravone particles in water" as required by claim 1 of the '341 Patent. The infringement analysis will depend on evidence from the confidential NDA regarding the tablet's excipients and its behavior upon ingestion.

V. Key Claim Terms for Construction

  • The Term: "edaravone suspension" (from claim 1 of the ’341 Patent)

    • Context and Importance: This term is foundational, as it defines the dosage form of the claimed invention. Its construction will be critical because the complaint alleges the accused product is a tablet, not a pre-formulated suspension (Compl. ¶42). The outcome of the literal infringement analysis may depend entirely on whether "suspension" is limited to a liquid dosage form or can encompass a solid that forms a suspension in vivo.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claims do not explicitly state that the suspension must exist ex vivo or prior to administration. A party could argue that if a tablet, upon contact with stomach fluid, creates a mixture of solid edaravone particles in a liquid that meets the other claim limitations, it forms the claimed "suspension" at the point of therapeutic activity.
      • Evidence for a Narrower Interpretation: The patents' titles, abstracts, detailed descriptions, and numerous examples consistently describe the invention as a liquid formulation prepared for oral administration ('341 Patent, Abstract; Title; col. 4:50-54; Examples 1-31). This consistent usage suggests the term refers to the pharmaceutical product itself, as manufactured and sold, which is a liquid.

  • The Term: "dispersant" (from claim 1 of the ’341 Patent)

    • Context and Importance: This term defines a key functional excipient in the claimed formulation. For a tablet to infringe, one or more of its components must be identifiable as a "dispersant" performing the claimed function. Practitioners may focus on this term to dispute whether excipients in a tablet, such as binders or disintegrants, meet the patent's more specific description of a dispersant.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The plain meaning of "dispersant" is an agent that promotes the separation of fine particles in a medium. A party may argue that any excipient in the tablet that helps edaravone particles spread out in stomach fluid meets this broad definition.
      • Evidence for a Narrower Interpretation: The specification provides specific examples of dispersants (e.g., polyvinyl alcohol, methylcellulose) and describes testing their functional properties, such as their effect on transmission scattering light intensity and contact angle, in the context of creating a stable liquid formulation ('341 Patent, col. 4:1-col. 5:8). This may support a construction requiring the "dispersant" to be an agent selected for these specific properties related to stabilizing a pre-made suspension.

VI. Other Allegations

  • Indirect Infringement: The complaint includes allegations that Defendants will induce and contribute to infringement upon FDA approval and commercialization of AUKONTALS (Compl. ¶¶ 55, 58). These allegations are prospective and are not supported by specific factual assertions regarding instructions or user manuals, as the product is not yet on the market.
  • Willful Infringement: The complaint does not include a formal count for willful infringement. However, it alleges that Defendants had "actual and constructive notice" of the patents prior to submitting their NDA, citing the patents' listing in the Orange Book (Compl. ¶¶ 56, 66, 76, 86, 96, 106, 116, 126). This allegation establishes pre-suit knowledge, a prerequisite for any future claim of willfulness.

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of definitional scope: can the term "edaravone suspension," which the patents consistently describe as a pre-formulated liquid, be construed to read on the accused solid "tablets"? The case may turn on whether the claims cover a dosage form as manufactured or a state created in vivo after ingestion.
  • A key evidentiary question will be one of functional correspondence: assuming the definitional scope can be overcome, what evidence from Defendants' confidential NDA will Plaintiff present to demonstrate that the excipients within a solid tablet perform the specific functions of a "dispersant" and/or "thickening agent" as described and claimed in the patents-in-suit for a liquid medium?
  • A third central question will concern the doctrine of equivalents: if literal infringement fails due to the suspension-versus-tablet distinction, can Plaintiff prove that a tablet performs substantially the same function, in substantially the same way, to achieve the same result as the claimed liquid suspension, or is the difference in dosage form a fundamental divergence in the "way" the invention works?