DCT

2:25-cv-16679

Mitsubishi Tanabe Pharma Corp v. Apotex Inc

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-16679, D.N.J., 10/16/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Apotex Corp. maintains a regular and established place of business in the state and employs a sales force there. Further, the complaint alleges that both defendants have previously consented to jurisdiction and venue in this district through conduct in prior litigation. As a foreign corporation, Apotex Inc. may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's RADICAVA ORS® product constitutes an act of infringement of three patents related to oral formulations and administration methods for the active ingredient edaravone.
  • Technical Context: The technology concerns oral suspension formulations of edaravone, an approved treatment for Amyotrophic Lateral Sclerosis (ALS), a fatal neurodegenerative disease, offering a less burdensome administration route than the prior intravenous formulation.
  • Key Procedural History: This is a patent infringement action filed under the Hatch-Waxman Act, triggered by Defendants’ submission of ANDA No. 219256. The complaint notes that Plaintiff's branded product, RADICAVA ORS®, was granted Orphan Drug Exclusivity by the FDA, expiring on May 12, 2029.

Case Timeline

Date Event
2018-11-02 Earliest Priority Date for ’409 Patent
2020-11-12 Earliest Priority Date for ’025 and ’946 Patents
2022-05-12 FDA Approval of RADICAVA ORS® (NDA No. 215446)
2025-01-14 ’025 Patent Issued
2025-04-29 ’409 Patent Issued
2025-05-27 ’946 Patent Issued
2025-10-16 Complaint Filed

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 January 14, 2025

The Invention Explained

  • Problem Addressed: The patent describes that while edaravone is considered a Biopharmaceutics Classification System (BCS) Class 1 drug—having high solubility and high permeability—its absorption is nevertheless negatively affected by the consumption of food prior to administration (’025 Patent, col. 16:35-40). This food effect creates a technical challenge for ensuring consistent and effective dosing.
  • The Patented Solution: The invention claims a method of administering an oral edaravone composition by specifying minimum time intervals between consumption of a meal and administration of the drug, with the required interval varying based on the meal's caloric and fat content (’025 Patent, Abstract). For example, the patent teaches waiting at least eight hours after a "high-fat meal" but only two hours after a "light meal" to avoid the negative impact on the drug's pharmacokinetics (’025 Patent, col. 2:5-10).
  • Technical Importance: This dosing regimen allows for predictable bioavailability of an oral ALS treatment, which improves patient quality of life compared to intravenous administration while ensuring the intended therapeutic effect is achieved (Compl. ¶¶ 8-9).

Key Claims at a Glance

  • The complaint asserts at least Independent Claim 1 (Compl. ¶44).
  • Independent Claim 1 is a method claim for treating amyotrophic lateral sclerosis, comprising the essential elements of:
    • Orally or intragastrically administering a liquid pharmaceutical composition comprising edaravone.
    • Administering the composition after a specific time interval following a meal.
    • The interval is defined as 8 hours or longer for a high-fat meal (800-1000 calories, 50% fat), 4 hours or longer for a low-fat meal (400-500 calories, 25% fat), or 2 hours or longer for a caloric supplement (250 calories).

U.S. Patent No. 12,285,409 - "Edaravone Suspension for Oral Administration," Issued April 29, 2025

The Invention Explained

  • Problem Addressed: The patent is directed to creating a stable, effective, and patient-friendly oral formulation of edaravone. The background notes that for ALS patients, who often develop difficulty swallowing (dysphagia), a liquid formulation is preferable to solid dosage forms like tablets (’409 Patent, col. 3:15-20). The technical challenge is to create a liquid suspension where the active ingredient does not settle unevenly, remains chemically stable, and is easily administered.
  • The Patented Solution: The invention is a specific pharmaceutical composition: an aqueous suspension containing edaravone particles and a dispersant (’409 Patent, Abstract). The claims detail specific physical characteristics of the formulation, including edaravone particle size ranges, the concentration of edaravone, and the required pharmacokinetic profile (Cmax and AUC) that the formulation must achieve upon administration (’409 Patent, Claim 1).
  • Technical Importance: This formulation provides a uniform and stable liquid dosage form of edaravone, which is critical for accurate dosing and is better suited for ALS patients than solid oral drugs or intravenous infusions (Compl. ¶¶ 8-9).

Key Claims at a Glance

  • The complaint asserts at least Independent Claim 1 (Compl. ¶54).
  • Independent Claim 1 is a composition claim for an edaravone suspension for human oral administration, comprising the essential elements of:
    • Water, edaravone particles, and a dispersant.
    • Edaravone particles having a D50 particle size of 10-100 µm and a D90 particle size of 50-300 µm.
    • A blending amount of edaravone particles from 0.2% to 36% (w/v).
    • When administered in a 90-120 mg dose, the suspension exhibits a mean Cmax of 500-2500 ng/mL and a mean AUC of 1000-2500 h*ng/mL.

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 patent addresses the technical problem that edaravone's oral bioavailability is negatively affected by food consumption, despite its classification as a BCS Class 1 drug (’946 Patent, col. 16:35-40; col. 44:15-21). The claimed solution is a method of administering oral edaravone with specific minimum time intervals between a meal and drug administration, where the interval length is dictated by the type of meal consumed (’946 Patent, Abstract).
  • Asserted Claims: The complaint asserts at least Independent Claim 1 (Compl. ¶64).
  • Accused Features: The accused feature is Defendants' proposed generic edaravone suspension, which, when used as directed by its anticipated product labeling, is alleged to meet the limitations of the claimed method of administration (Compl. ¶¶ 64-65).

III. The Accused Instrumentality

Product Identification

  • Defendants' proposed edaravone oral suspension, for which they seek FDA approval via ANDA No. 219256 (Compl. ¶2).

Functionality and Market Context

  • The accused product is a proposed generic copy of MTPC’s RADICAVA ORS®, formulated as an oral suspension containing edaravone at a dose concentration of 105 mg/5 ml (Compl. ¶38). As a generic, it relies on MTPC's clinical data to establish safety and efficacy for the treatment of ALS (Compl. ¶37). The complaint asserts that RADICAVA ORS® is one of only three remaining approved APIs for ALS and provides a "clinically superior option" over the prior intravenous formulation, reducing patient burden (Compl. ¶¶ 5, 9). The accused product seeks to compete in this market (Compl. ¶40).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’025 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating amyotrophic lateral sclerosis, comprising: orally or intragastrically administering... a liquid pharmaceutical composition comprising edaravone... Defendants' ANDA product is a liquid pharmaceutical composition containing edaravone for the treatment of ALS. ¶38, ¶40 col. 44:11-14
... with a first time interval from a consumption of a meal... wherein the first time interval... is 8 hours or longer after the consumption of a high-fat meal... 4 hours or longer after the consumption of a low-fat meal... or 2 hours or longer after the consumption of a caloric supplement... The complaint alleges that Defendants will induce infringement by instructing physicians and patients, via the product's label, to administer the drug according to these specific time intervals relative to meals. ¶46-47 col. 44:15-26

’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' ANDA product is an edaravone suspension for oral administration. The complaint alleges it contains the claimed components. ¶38, ¶54 col. 30:15-21
... wherein the edaravone particles in the suspension 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 on information and belief that the proposed product infringes, which implies that the physical characteristics of its formulation, such as particle size, meet the claim limitations literally or equivalently. ¶54 col. 30:22-25
... a blending amount of the edaravone particles is in a range of 0.2% (w/v) to 36% (w/v)... Defendants' product concentration of 105 mg/5 ml is equivalent to 2.1% (w/v), which falls within the claimed range. ¶38 col. 30:26-27
... when edaravone in the edaravone suspension is in a range of 90 to 120 mg, edaravone in a plasma 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... As an ANDA product, Defendants' product must be bioequivalent to RADICAVA ORS®, and is therefore alleged to produce the same pharmacokinetic profile claimed by the patent. ¶37, ¶54 col. 30:28-34
  • Identified Points of Contention:
    • Scope Questions: For the method claims in the ’025 and ’946 Patents, a question may arise as to whether the definitions of "high-fat meal," "low-fat meal," and "caloric supplement" are sufficiently definite and how they apply to real-world dietary habits, though the claims provide explicit caloric and fat percentage definitions.
    • Technical Questions: For the composition claims in the ’409 Patent, the central dispute will likely concern the physical properties of the accused product. A key question for the court will be whether Defendants’ formulation literally meets the claimed particle size ranges and utilizes a "dispersant" as defined in the patent, or whether Plaintiff will need to prove infringement under the doctrine of equivalents.

V. Key Claim Terms for Construction

  • The Term: "high-fat meal" / "low-fat meal" (or "standard meal")

    • Context and Importance: These terms are the lynchpin of the method claims in the ’025 and ’946 Patents. The infringement of these patents by end-users, and thus Defendants' inducement of that infringement, depends on whether the product label instructs administration according to timing that is conditioned on these specific meal types. Practitioners may focus on these terms to determine if there is any ambiguity that could be exploited in a non-infringement or invalidity argument.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification discusses meal types in general terms, noting that "consumptions of meals prior to administration affect the pharmacokinetics of edaravone" (’025 Patent, col. 16:35-37), which could suggest the invention applies broadly to food-drug interactions.
      • Evidence for a Narrower Interpretation: The claims themselves provide explicit, quantitative definitions (e.g., "a high-fat meal in a range of 800 to 1000 calories with 50% fat") (’946 Patent, Claim 1). This language provides strong evidence that the terms should be construed narrowly and precisely according to these numeric boundaries.

  • The Term: "dispersant"

    • Context and Importance: This term is a central element of the composition claim in the ’409 Patent. The infringement analysis will turn on whether the excipient used by Defendants in their formulation falls within the definition of a "dispersant." Defendants may argue their chosen agent has a different primary function or different properties to avoid infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent defines "dispersant" functionally, for example, as an agent that "allows the edaravone particles to be well dispersed in water without causing the edaravone particles to form secondary agglomerates" (’409 Patent, col. 7:6-10). This functional language may support a construction covering any agent that performs this role.
      • Evidence for a Narrower Interpretation: The specification provides a specific list of exemplary dispersants, including "polyvinyl alcohol, sucrose fatty acid ester, polysorbate, methylcellulose, and hypromellose" (’409 Patent, col. 7:39-42). This list of specific examples could be used to argue for a narrower construction limited to these or structurally similar compounds.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Defendants' commercial activities will induce and/or contribute to infringement of the asserted patents (Compl. ¶¶ 47, 57, 67). The basis for inducement of the method claims (’025 and ’946 Patents) is the allegation that Defendants' product label will instruct patients and physicians to administer the drug using the patented meal-timing methods (Compl. ¶¶ 50, 60, 70).
  • Willful Infringement: The complaint alleges that Defendants had "actual and constructive notice" of the patents-in-suit prior to filing their ANDA (Compl. ¶¶ 48, 58, 68). While the word "willful" is not used, the prayer for relief requests a declaration of an "exceptional case" and an award of attorneys' fees pursuant to 35 U.S.C. § 285, which is predicated on such knowledge and conduct (Compl., Prayer for Relief ¶E).

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

  • A core issue will be one of compositional identity: What are the precise physical and chemical characteristics of the Defendants' proposed generic formulation? An evidentiary analysis will be required to determine if its edaravone particle sizes and chosen excipients literally fall within the scope of the claims of the ’409 patent, or if the infringement case will depend on the more complex doctrine of equivalents.
  • A central legal question will be one of induced infringement: Does the act of seeking FDA approval for a generic drug, whose label must mirror the brand-name drug's label, constitute an affirmative act of inducement to infringe the patented methods of administration recited in the ’025 and ’946 patents?
  • A key question for the defense, though not yet articulated in a responsive pleading, will likely be one of patent validity: Can the claimed administration methods, which are based on observed pharmacokinetic food effects, withstand a challenge that they would have been obvious to a person of ordinary skill in the art conducting routine drug development studies?