DCT

2:25-cv-16664

Mitsubishi Tanabe Pharma Corp v. Sandoz Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-16664, D.N.J., 10/15/2025
  • Venue Allegations: Venue is based on Defendant's regular and established place of business in New Jersey, and on allegations that Defendant prepared and submitted its Abbreviated New Drug Application (ANDA) from this district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA seeking FDA approval to market a generic version of Plaintiff’s RADICAVA ORS® product constitutes an act of infringement of eight U.S. patents related to oral formulations of edaravone.
  • Technical Context: The patents concern oral suspension formulations of the active pharmaceutical ingredient edaravone for the treatment of Amyotrophic Lateral Sclerosis (ALS), a fatal neurodegenerative disease.
  • Key Procedural History: This is a Hatch-Waxman action initiated under 35 U.S.C. § 271(e)(2) following Defendant's submission of ANDA No. 220086 with a Paragraph IV certification, asserting non-infringement, invalidity, or unenforceability of the patents-in-suit. The complaint was filed within the 45-day statutory window, triggering an automatic 30-month stay on FDA approval of the generic product. Plaintiff's branded product, RADICAVA ORS®, is noted to have Orphan Drug Exclusivity until May 12, 2029.

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 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
2025-04-29 U.S. Patent No. 12,285,409 Issues
2025-05-27 U.S. Patent No. 12,310,946 Issues
2025-08-29 Defendant Sandoz sends Paragraph IV Notice Letter regarding ANDA No. 220086
2025-10-15 Complaint Filed

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

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

The Invention Explained

  • Problem Addressed: The patent addresses the need for an effective therapeutic agent for Amyotrophic Lateral Sclerosis (ALS), an intractable neurodegenerative disease (ʼ341 Patent, col. 4:32-34). It implicitly addresses the burden associated with previous edaravone treatments, which were available only as intravenous injections, by creating an oral alternative (Compl. ¶8).
  • The Patented Solution: The invention is a suspension of edaravone particles in water, stabilized by a specific dispersant (ʼ341 Patent, Abstract). This formulation is designed to be easily taken by patients who may have difficulty swallowing (dysphagia), while achieving a therapeutic effect and bioavailability equivalent to an intravenous injection, thereby reducing the burden on patients and caregivers (ʼ341 Patent, col. 4:65-col. 5:2; col. 7:10-20). The pharmacokinetic profile of the oral suspension (PO) compared to an intravenous injection (IV) is illustrated in the patent's FIGURE.
  • Technical Importance: The development of a stable and bioavailable oral suspension for a drug previously limited to intravenous administration represents a significant improvement in patient quality of life and treatment accessibility for a fatal disease (Compl. ¶8-9).

Key Claims at a Glance

  • The complaint asserts at least Independent Claim 1 (Compl. ¶45).
  • The essential elements of Independent Claim 1 are:
    • An edaravone suspension for human oral administration, comprising:
    • water;
    • edaravone particles comprising edaravone dispersed in the water; and
    • a dispersant dispersing the edaravone particles in water such that the dispersant maintains the edaravone particles in a solid particle state in the water,
    • wherein a blending amount of the edaravone particles is in a range of 0.5% (w/v) to 36% (w/v), and
    • the dispersant is at least one dispersant selected from the group consisting of polyvinyl alcohol, methylcellulose, hypromellose, sucrose fatty acid ester and polysorbate.
  • The complaint does not explicitly reserve the right to assert dependent claims but refers generally to "one or more claims" (Compl. ¶45).

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

The Invention Explained

  • Problem Addressed: This patent, part of the same family as the ’341 Patent, addresses the same technical problem: creating an effective and patient-friendly oral formulation of edaravone for treating ALS (ʼ416 Patent, col. 4:32-34; Compl. ¶8).
  • The Patented Solution: The solution is again an oral suspension of edaravone particles. This patent's claims define the dispersant by a functional property—its ability to achieve a "transmission scattering light intensity of 1% or more" under specific test conditions—rather than solely by a list of chemical names (ʼ416 Patent, Claim 1; col. 4:4-26). This functional definition aims to capture any substance that effectively keeps the edaravone particles properly suspended, ensuring dose uniformity and stability (ʼ416 Patent, col. 3:63-col. 4:3).
  • Technical Importance: As with the ’341 patent, this technology provides an oral alternative to an IV drug, and by using a functional claim limitation, it seeks to protect the core inventive concept of a stable suspension more broadly.

Key Claims at a Glance

  • The complaint asserts at least Independent Claim 1 (Compl. ¶55).
  • The essential elements of Independent Claim 1 are:
    • An edaravone suspension for human oral administration, comprising:
    • water;
    • edaravone particles comprising edaravone and dispersed in the water; and
    • a dispersant exhibiting a transmission scattering light intensity of 1% or more,
    • wherein a blending amount of the dispersant is in a range of 0.001% (w/v) to 1.0% (w/v),
    • a blending amount of the edaravone particles is in a range of 0.5% (w/v) to 36% (w/v).
  • The complaint refers generally to "one or more claims" of the patent (Compl. ¶55).

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

  • Technology Synopsis: This patent relates to an edaravone oral suspension for treating ALS, claiming a method of administration that achieves a specific pharmacokinetic profile (e.g., Cmax and AUC) equivalent to an intravenous injection, thereby ensuring therapeutic equivalence in a more patient-friendly dosage form (’450 Patent, Abstract; col. 2:20-36). The claims focus on the method of treating ALS by administering the oral suspension.
  • Asserted Claims: Independent Claim 1 (Compl. ¶65).
  • Accused Features: The proposed Sandoz generic edaravone suspension product, which is intended to be administered for the treatment of ALS (Compl. ¶64-65).

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

  • Technology Synopsis: This patent claims an edaravone oral suspension that includes a thickening agent, such as xanthan gum or tragacanth powder, in addition to the edaravone particles and dispersant (’352 Patent, Abstract; Claim 1). The inclusion of a thickening agent is intended to improve storage stability and make the suspension easier for patients with dysphagia to swallow without risk of aspiration.
  • Asserted Claims: Independent Claim 1 (Compl. ¶75).
  • Accused Features: The proposed Sandoz generic edaravone suspension product (Compl. ¶74-75).

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

  • Technology Synopsis: This patent claims an edaravone suspension that is formulated to be free of preservatives yet resists bacterial growth, a surprising technical effect (’660 Patent, col. 7:17-21). It also claims specific compositions that are stable and bioequivalent to the IV formulation.
  • Asserted Claims: Independent Claim 1 (Compl. ¶85).
  • Accused Features: The proposed Sandoz generic edaravone suspension product (Compl. ¶84-85).

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

  • Technology Synopsis: This patent covers a method of treating an oxidative stress disease (like ALS) by administering an edaravone composition with a specific time interval after a meal (’025 Patent, Abstract). The invention addresses the problem of food affecting the drug's absorption, specifying different waiting periods after high-fat, standard, or light meals to ensure proper bioavailability.
  • Asserted Claims: Independent Claim 1 (Compl. ¶95).
  • Accused Features: The proposed Sandoz generic edaravone suspension, the use of which will allegedly involve the claimed method of administration (Compl. ¶94-95).

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

  • Technology Synopsis: This patent claims an edaravone suspension containing specific stabilizers, such as a sulfite and a cysteine, to prevent oxidative degradation of the edaravone active ingredient (’409 Patent, Claim 13). The invention focuses on ensuring the chemical stability of the formulation during storage and use.
  • Asserted Claims: Independent Claim 1 (Compl. ¶105).
  • Accused Features: The proposed Sandoz generic edaravone suspension product (Compl. ¶104-105).

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

  • Technology Synopsis: This patent, related to the ’025 patent, also claims a method of treating ALS by administering a liquid edaravone composition based on a specific time interval after a meal to avoid food-effect issues (’946 Patent, Abstract). The claims are directed to a method of treatment involving specific dosing schedules relative to food intake.
  • Asserted Claims: Independent Claim 1 (Compl. ¶115).
  • Accused Features: The proposed Sandoz generic edaravone suspension, the use of which will allegedly involve the claimed method of administration (Compl. ¶114-115).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendant Sandoz's proposed generic edaravone oral suspension, for which Sandoz seeks FDA approval via ANDA No. 220086 (Compl. ¶16, ¶34).

Functionality and Market Context

  • The complaint alleges that Sandoz's product is a generic copy of Plaintiff's RADICAVA ORS® product, designed to have the same active ingredient, dosage form, and strength (105 mg/5 mL) (Compl. ¶35, ¶37). The product is intended for the treatment of ALS, a rare and fatal neurodegenerative disease for which there are few approved treatments (Compl. ¶3, ¶5). Sandoz's product is positioned to compete directly with RADICAVA ORS® upon receiving FDA approval (Compl. ¶16).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for analysis of infringement on an element-by-element basis. The infringement allegations are pleaded generally on "information and belief" based on Sandoz's filing of ANDA No. 220086 to market a generic copy of RADICAVA ORS® (Compl. ¶44-45, ¶54-55). The complaint asserts that because Sandoz's product is a generic copy intended to be bioequivalent to the branded product, it will necessarily meet the limitations of the asserted claims, either literally or under the doctrine of equivalents (Compl. ¶45, ¶55). No claim chart or specific mapping of accused product features to claim elements is provided.

  • Identified Points of Contention:
    • Scope Questions: The central dispute will likely concern whether Sandoz’s formulation falls within the scope of the patent claims. Sandoz's Paragraph IV certification suggests it will argue non-infringement, which may involve asserting that its formulation uses different excipients, different concentrations, or has different physical properties than those explicitly recited in the claims. For example, a key question for the '341 Patent will be whether the excipient used by Sandoz is one of the five specific types of "dispersant" listed in Claim 1.
    • Technical Questions: A primary factual question will be the precise composition and properties of Sandoz’s proposed product, details of which are contained in its confidential ANDA materials (Compl. ¶40). For the ’416 Patent, a technical question will be whether the dispersant in Sandoz's formulation exhibits a "transmission scattering light intensity of 1% or more" when measured according to the patent's prescribed method. The outcome will depend on evidence developed during discovery concerning the accused product's formulation.

V. Key Claim Terms for Construction

  • The Term: "dispersant" (’341 Patent, Claim 1)

  • Context and Importance: The definition of "dispersant" is critical because Claim 1 of the ’341 patent limits the invention to a suspension containing a dispersant selected from a specific list of five chemical classes. Sandoz’s non-infringement defense may depend on arguing that an excipient in its formulation, while performing a similar function, does not fall within the patent’s definition of "dispersant" or is not one of the recited types.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides a functional definition, stating a dispersant is any that "allows the edaravone particles to be well dispersed in water without causing the edaravone particles to form secondary agglomerates" (’341 Patent, col. 5:63-65). This language could support an argument that the term should be interpreted functionally.
    • Evidence for a Narrower Interpretation: Claim 1 itself contains the narrowing phrase "selected from the group consisting of," which is typically construed as a closed list. The specification also provides "Specific examples of a preferred dispersant" from that list, including polyvinyl alcohol as "most preferably" the dispersant (’341 Patent, col. 5:55-62), which may be used to argue that the scope is limited to these specific examples.

  • The Term: "transmission scattering light intensity of 1% or more" (’416 Patent, Claim 1)

  • Context and Importance: This is a functional limitation that defines a key component (the dispersant) by a performance characteristic rather than its chemical identity. Sandoz’s non-infringement position could be that its chosen dispersant does not meet this specific, measurable threshold. The case may turn on the results of tests conducted on the accused product according to the patent's specified methodology.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: Practitioners may argue that minor deviations in test results should not preclude infringement, especially if the accused dispersant achieves the same overall result of a stable suspension. The doctrine of equivalents may be raised if Sandoz's product performs substantially the same function in substantially the same way to achieve the same result.
    • Evidence for a Narrower Interpretation: The specification provides a highly detailed, multi-step protocol for measuring this property, including the instrument used (TURBISCAN Tower), sample bottle dimensions, measurement height, and timing (’416 Patent, col. 4:4-26). This detailed protocol provides strong evidence for a narrow construction that requires strict adherence to the specified test and its resulting numerical threshold.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Sandoz will induce and contribute to infringement upon approval and commercial launch of its generic product (Compl. ¶51, ¶61). This allegation is based on the premise that Sandoz’s product labeling will instruct physicians and patients to use the product in a manner that directly infringes the asserted composition and method claims.
  • Willful Infringement: The complaint does not use the term "willful infringement." However, it alleges that Sandoz had "actual and constructive notice" of the patents-in-suit prior to filing its ANDA (Compl. ¶49, ¶59). Furthermore, the prayer for relief requests a declaration that this is an "exceptional case" and seeks an award of attorneys' fees pursuant to 35 U.S.C. § 285, which are remedies often associated with findings of willful infringement or other litigation misconduct (Compl., Prayer for Relief ¶E).

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

  • A core issue will be one of claim scope and design-around: did the defendant, Sandoz, formulate its generic product with different excipients, concentrations, or physical properties that place it outside the literal boundaries of the asserted claims? The dispute will likely focus on whether Sandoz’s formulation is a bioequivalent copy that nonetheless avoids one or more specific limitations recited in the patent claims.
  • A key evidentiary question will be one of functional performance: for claims defined by functional properties, such as the "transmission scattering light intensity" in the ’416 patent, does Sandoz’s product actually exhibit the claimed characteristic when tested under the conditions specified in the patent? The answer will depend on expert testing and analysis of the accused product's confidential formulation.
  • A central legal question will be the construction of key claim terms, such as "dispersant". The extent to which these terms are limited to the specific examples in the specification versus a broader functional definition will be critical in determining the scope of the patents and the viability of any non-infringement defense.