DCT

2:25-cv-16665

Mitsubishi Tanabe Pharma Corp v. Shanghai Auzone Biological Technology Co Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:

  • Case Identification: 2:25-cv-16665, D.N.J., 10/15/2025

  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Auzone Biological Technology (USA) Ltd. has a regular and established place of business in the state, while the other two foreign-domiciled Defendants may be sued in any judicial district.

  • Core Dispute: Plaintiff alleges that Defendants’ submission of a New Drug Application to the FDA for a generic version of Plaintiff’s RADICAVA ORS® product constitutes an act of infringement against three patents related to edaravone formulations and methods of administration for treating Amyotrophic Lateral Sclerosis (ALS).

  • Technical Context: The technology concerns pharmaceutical compositions of edaravone, an active ingredient used to slow the progression of ALS, formulated as an oral suspension to improve patient convenience over previous intravenous treatments.

  • Key Procedural History: This action is a Hatch-Waxman suit triggered by Defendants’ submission of New Drug Application (NDA) No. 219846, which seeks FDA approval to market a generic edaravone product. The complaint notes that this is the second lawsuit filed by the Plaintiff against the Defendants concerning this same NDA; a prior suit, filed April 25, 2025, involves a different set of patents. The current suit follows Defendants' Paragraph IV certification notice, which asserts that their proposed generic product does not infringe the patents-in-suit.

Case Timeline

Date Event
2018-11-02 ’409 Patent Priority Date
2020-11-12 ’025 and ’946 Patents Priority Date
2022-05-12 FDA approves Plaintiff's RADICAVA ORS® (NDA No. 215446)
2024-03-28 FDA grants Orphan Drug Exclusivity for RADICAVA ORS®
2025-01-14 ’025 Patent Issued
2025-03-13 Defendants send Paragraph IV notice letter regarding the ’025 patent
2025-04-22 Plaintiff receives access to portions of Defendants' NDA
2025-04-25 Plaintiff files first suit against Defendants (Civil Action No. 25-3326)
2025-04-29 ’409 Patent Issued
2025-05-27 ’946 Patent Issued
2025-10-15 Complaint Filing Date

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

U.S. Patent No. 12,194,025 - "Pharmaceutical composition for oral administration of edaravone and method of administering same" (Issued Jan. 14, 2025)

The Invention Explained

  • Problem Addressed: The patent addresses the unexpected discovery that food consumption significantly affects the pharmacokinetics (i.e., absorption and concentration in the blood) of oral edaravone, despite it being classified as a BCS Class 1 drug, which would normally suggest minimal food effect (’025 Patent, col. 16:30-39). This variability could impact the drug's efficacy and safety.
  • The Patented Solution: The invention is a method for administering oral edaravone to maintain consistent drug absorption similar to a fasted state. It accomplishes this by defining specific minimum time intervals between the consumption of a meal and the administration of the drug, with the required interval depending on the meal type (e.g., 8 hours for a high-fat meal, 4 hours for a standard meal, 2 hours for a light meal) (’025 Patent, Abstract; col. 6:1-21).
  • Technical Importance: This method provides a clear, predictable dosing regimen that allows for the benefits of oral administration while mitigating the pharmacokinetic variability caused by food-drug interactions, a critical factor for managing a chronic condition like ALS (’025 Patent, col. 19:55-65).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶49).
  • Essential elements of Independent Claim 1 include:
    • A method of treating amyotrophic lateral sclerosis.
    • Orally or intragastrically administering a liquid pharmaceutical composition comprising edaravone.
    • Observing a "first time interval" from the consumption of a meal to the administration of the composition.
    • Wherein the interval is at least 8 hours for a "high-fat meal" (800-1000 calories, 50% fat), 4 hours for a "low-fat meal" (400-500 calories, 25% fat), or 2 hours for a "caloric supplement" (250 calories).
    • Such that the resulting decrease in Cmax (peak concentration) or AUC (total exposure) is limited relative to administration in a fasted state (’025 Patent, col. 43:56-45:11).
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 12,285,409 - "Edaravone suspension for oral administration" (Issued Apr. 29, 2025)

The Invention Explained

  • Problem Addressed: The patent background describes edaravone's use as an ALS therapeutic agent, traditionally administered intravenously, and notes the need for an oral formulation to reduce the burden on patients and caregivers (’409 Patent, col. 6:45-55). The implicit problem is developing a liquid oral formulation that is stable, palatable, easy for patients with swallowing difficulties to take, and provides sufficient bioavailability.
  • The Patented Solution: The invention is a specific aqueous suspension for oral administration containing edaravone particles of a defined size range, a dispersant (such as polyvinyl alcohol), and water (’409 Patent, Abstract; col. 6:9-12). The specification details how specific particle sizes (D50 and D90 values), dispersants, and other optional excipients (like thickeners and sweeteners) work together to create a stable, easily redispersible, and effective formulation (’409 Patent, col. 7:31-41; col. 8:19-24).
  • Technical Importance: This formulation provides a stable, ready-to-use oral liquid version of edaravone that achieves a pharmacokinetic profile comparable to an intravenous injection, making the therapy significantly more accessible and less burdensome for ALS patients (’409 Patent, col. 9:60-67).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶59).
  • Essential elements of Independent Claim 1 include:
    • An edaravone suspension for human oral administration comprising water, edaravone particles, and a dispersant.
    • The edaravone particles have a D50 particle size of 10-100 µm and a D90 particle size of 50-300 µm.
    • The blending amount of edaravone particles is 0.2% to 36% (w/v).
    • When a 90 to 120 mg dose is administered, the formulation achieves a mean Cmax of 500-2500 ng/mL and a mean AUC of 1000-2500 h*ng/mL (’409 Patent, col. 30:15-32).
  • The complaint does not explicitly reserve the right to assert dependent claims.

Multi-Patent Capsule

  • 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: This patent addresses the technical problem of food-drug interaction affecting the absorption of oral edaravone (’946 Patent, col. 16:35-39). The patented solution is a method of treating ALS by administering a liquid edaravone composition according to specific time intervals after a meal, where the interval length is defined by the type of meal consumed (high-fat, standard, or light), thereby ensuring consistent pharmacokinetic performance (’946 Patent, Abstract).
    • Asserted Claims: The complaint asserts at least independent claim 1 (Compl. ¶69).
    • Accused Features: The complaint alleges that Defendants' submission of NDA No. 219846 for their proposed edaravone product, which is indicated for the treatment of ALS, constitutes a statutory act of infringement of the claimed method (Compl. ¶¶68, 70).

III. The Accused Instrumentality

Product Identification

The accused act is the submission of New Drug Application No. 219846 to the FDA for a proposed generic edaravone product for oral suspension, to be marketed under the name AUKONTALS (Compl. ¶¶20, 48).

Functionality and Market Context

The complaint alleges that AUKONTALS is a proposed generic edaravone product for the treatment of ALS (Compl. ¶20). It contains 90 milligrams of edaravone and relies on Plaintiff's FDA-approved product, RADICAVA ORS®, as its Reference Labeled Drug (RLD) (Compl. ¶¶39-40). By filing an NDA under the 505(b)(2) pathway, Defendants seek an abbreviated approval to market their product as an alternative to RADICAVA ORS® before the expiration of the patents-in-suit (Compl. ¶¶3-4). The complaint alleges that upon approval, Defendants intend to commercially manufacture, distribute, and sell this product throughout the United States (Compl. ¶23). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges infringement under 35 U.S.C. § 271(e)(2), which defines the submission of an NDA seeking approval to market a drug claimed in a patent as an act of infringement (Compl. ¶50). The analysis is based on information and belief, as Plaintiff's access to the details of Defendants' product is limited (Compl. ¶46).

’025 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating amyotrophic lateral sclerosis... orally or intragastrically administering... a liquid pharmaceutical composition comprising edaravone... The complaint alleges Defendants seek FDA approval to market their proposed AUKONTALS product for the treatment of ALS, which constitutes infringement of this method claim. ¶¶20, 48, 52 col. 43:56-62
...with a first time interval from a consumption of a meal... wherein the first time interval... is 8 hours before the administration [for a high-fat meal], ...4 hours... [for a low-fat meal], ...or 2 hours... [for a caloric supplement]... The complaint alleges on information and belief that the proposed product infringes, which implies that its intended use, as will be described in its labeling, will involve administration according to these time intervals. ¶¶49, 52, 55 col. 44:1-67
  • Identified Points of Contention:
    • Scope Questions: A central issue for this method patent will be one of induced infringement: does the proposed product label for AUKONTALS instruct, direct, or encourage medical professionals and patients to administer the drug using the specific meal-timing schedules required by Claim 1? The analysis will depend on the precise language of the proposed label submitted in the NDA.
    • Technical Questions: A factual question may arise as to whether Defendants' NDA data demonstrates that their product, when administered according to the claimed methods, meets the pharmacokinetic outcomes specified in the claim (e.g., Cmax or AUC decrease of less than 20% or 10%, respectively).

’409 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An edaravone suspension for human oral administration, comprising: water; edaravone particles... and a dispersant... Defendants' AUKONTALS is alleged to be an oral suspension of edaravone for treating ALS, which the complaint alleges infringes one or more claims of the ’409 patent. ¶¶20, 39, 59 col. 30:15-19
...wherein the edaravone particles... have a D50 particle size in a range of 10 µm to 100 µm and a D90 particle size of in a range of 50 µm to 300 µm... The complaint alleges infringement on information and belief, but does not provide specific details on the particle size distribution within the AUKONTALS product. ¶¶59, 46 col. 30:20-23
...when edaravone... in a range of 90 to 120 mg... exhibits a mean Cmax in a range of 500 to 2500 ng/ml and a mean AUC0-∞ in a range of 1000 to 2500 h*ng/mL... The complaint alleges Defendants' product contains 90 mg of edaravone and that it will infringe. This implies the product is expected to exhibit a pharmacokinetic profile falling within the claimed ranges. ¶¶39, 59 col. 30:26-32
  • Identified Points of Contention:
    • Scope Questions: The definition of "dispersant" may be contested. The infringement analysis may question whether an excipient in the AUKONTALS formulation performs the function of a dispersant as contemplated by the patent, or if it serves a different primary purpose.
    • Technical Questions: The primary dispute will likely be factual and dependent on the confidential NDA contents: 1) Do the edaravone particles in the AUKONTALS formulation meet the specific D50 and D90 particle size limitations of Claim 1? 2) Does the bioequivalence data in the NDA show that the 90 mg dose of AUKONTALS produces a Cmax and AUC that fall within the ranges claimed in the patent?

V. Key Claim Terms for Construction

  • The Term: "high-fat meal," "low-fat meal," and "caloric supplement" (’025 Patent, Claim 1)

    • Context and Importance: These terms are central to the scope of the method claims, as they define the conditions under which the specific administration timing rules apply. Their construction will determine whether the instructions on the accused product's label recommend a course of action that falls within the claim.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Narrower Interpretation: Claim 1 itself provides express definitions: a "high-fat meal" is "in a range of 800 to 1000 calories with 50% fat," a "low-fat meal" is "in a range of 400 to 500 calories with 25% fat," and a "caloric supplement" is "250 calories" (’025 Patent, col. 44:48-67). Parties seeking to limit the claim scope will argue that these numerical ranges are strict requirements.
      • Evidence for a Broader Interpretation: The specification refers to these meal types in the context of FDA and EMA guidelines (’025 Patent, col. 18:45-51). A party might argue these terms should be understood in the broader context of how a person of ordinary skill in the art of clinical pharmacology would classify meals, potentially allowing for minor deviations from the specified calorie counts.

  • The Term: "dispersant" (’409 Patent, Claim 1)

    • Context and Importance: This term is a critical component of the claimed formulation. Whether an excipient in the accused product qualifies as a "dispersant" will be a key infringement question. Practitioners may focus on this term because generic formulators may use different excipients that could be argued to fall outside the patent's definition.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the function of the dispersant as allowing edaravone particles to be "well dispersed in water without causing the edaravone particles to form secondary agglomerates" (’409 Patent, col. 7:6-10). A party could argue that any agent performing this function meets the definition.
      • Evidence for a Narrower Interpretation: The specification provides specific examples, such as polyvinyl alcohol, sucrose fatty acid ester, and methylcellulose (’409 Patent, col. 7:41-45). A party might argue that the term should be construed as limited to these classes of compounds or others with similar chemical and physical properties described in the patent, such as those meeting specific "transmission scattering light intensity" or "contact angle" test results also described in the specification (’409 Patent, col. 7:10-14, col. 7:46-49).

VI. Other Allegations

  • Indirect Infringement: For the method claims in the ’025 and ’946 patents, the complaint alleges future acts of inducement and contributory infringement. The basis for these allegations is the eventual commercialization of the AUKONTALS product, which would involve activities such as marketing and providing a product label that will allegedly instruct or encourage physicians and patients to use the product in an infringing manner (Compl. ¶¶55, 65, 75).
  • Willful Infringement: The complaint does not use the word "willful" but alleges that Defendants had "actual and constructive notice" of the patents prior to filing their NDA (Compl. ¶¶53, 63, 73). In its prayer for relief, Plaintiff requests a declaration that this is an "exceptional case" and an award of attorneys' fees pursuant to 35 U.S.C. § 285, which suggests an intent to pursue a claim of egregious conduct (Compl., Prayer for Relief ¶E).

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

  • A central factual question will be one of technical identity: does the AUKONTALS formulation, as confidentially described in NDA No. 219846, contain "edaravone particles" with the specific size distribution and a "dispersant" that fall within the parameters of the asserted claims of the ’409 composition patent? The case will likely require expert testimony on pharmaceutical formulation and analysis of the undisclosed product specifications.
  • A core legal and factual issue will be one of induced infringement: will the proposed FDA-approved label for AUKONTALS instruct, encourage, or otherwise lead physicians and patients to administer the drug according to the specific meal-timing schedules claimed in the ’025 and ’946 method patents, thus making Defendants liable for infringement upon commercial launch?
  • A key evidentiary question will be one of bioequivalence: does the pharmacokinetic data submitted in the NDA demonstrate that the AUKONTALS product meets the Cmax and AUC parameters recited in the asserted claims, and how will this data compare to the clinical trial data disclosed in the patents-in-suit?