Mitsubishi Tanabe Pharma Corp v. Lupin Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Mitsubishi Tanabe Pharma Corporation (Japan)
  • Defendant: Lupin Limited (India) and Lupin Pharmaceuticals, Inc. (U.S.)
  • Plaintiff’s Counsel: Gibbons P.C.
• Case Identification: 2:25-cv-16680, D.N.J., 10/16/2025
• Venue Allegations: Plaintiff alleges venue is proper because Defendant Lupin Pharmaceuticals maintains a regular and established place of business in New Jersey, and both Defendants have previously consented to venue in the district through conduct in prior litigation.
• Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s RADICAVA ORS® product constitutes an act of infringement of two patents related to methods of administering oral edaravone.
• Technical Context: The technology concerns methods for the oral administration of edaravone, an approved treatment for Amyotrophic Lateral Sclerosis (ALS), a progressive neurodegenerative disease.
• Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants’ submission of ANDA No. 219415 and a corresponding notification letter to Plaintiff. The patents-in-suit are listed in the U.S. Food and Drug Administration's (FDA) "Orange Book" for RADICAVA ORS®, which was granted seven years of Orphan Drug Exclusivity (ODE) by the FDA, expiring on May 12, 2029.

Case Timeline

Date	Event
2020-11-12	Earliest Priority Date for ’025 and ’946 Patents
2022-05-12	FDA approves Plaintiff's RADICAVA ORS® (NDA No. 215446)
2022-09-01	Lupin submits FOIA request for RADICAVA ORS® Summary Basis of Approval
2024-03-28	FDA grants Orphan Drug Exclusivity for RADICAVA ORS®
2025-01-14	U.S. Patent No. 12,194,025 issues
2025-05-27	U.S. Patent No. 12,310,946 issues
2025-09-29	Lupin sends Notice Letter regarding ANDA No. 219415
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”

The Invention Explained

• Problem Addressed: The patent's background section notes that edaravone, a therapeutic agent for oxidative stress diseases like ALS, has previously been available only as an injectable agent (’025 Patent, col. 6:53-61). A significant challenge for developing an oral version is the potential for food consumption to negatively affect the drug's pharmacokinetics, or how it is absorbed and processed by the body (’025 Patent, col. 16:35-40).
• The Patented Solution: The invention provides a specific method for administering oral edaravone to mitigate the "food effect." The method claims specific time intervals between a patient's meal and the drug administration, with different intervals required depending on whether the meal was high-fat, standard, or light, thereby ensuring consistent drug absorption (’025 Patent, Abstract; col. 6:1-21).
• Technical Importance: This method allows for a viable and convenient oral formulation of an ALS therapy, reducing the patient and caregiver burden associated with intravenous administration while maintaining predictable therapeutic efficacy (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 include:
  • A method of treating amyotrophic lateral sclerosis.
  • Orally or intragastrically administering a liquid pharmaceutical composition comprising edaravone.
  • Administering with a "first time interval" from the consumption of a meal, where the interval is defined by meal type:
    • 8 hours or longer after a high-fat meal.
    • 4 hours or longer after a low-fat (standard) meal.
    • 2 hours or longer after a caloric supplement (light meal).
• The complaint does not explicitly reserve the right to assert dependent claims, but makes a general allegation against "one or more claims" (Compl. ¶45).

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

The Invention Explained

• Problem Addressed: The ’946 Patent addresses the same technical problem as the ’025 Patent: managing the food effect to ensure consistent bioavailability of orally administered edaravone for the treatment of ALS (’946 Patent, col. 7:42-62).
• The Patented Solution: The invention combines the meal-timing limitations of the ’025 Patent with a specific dosing schedule. It claims a method of treating ALS by administering the oral edaravone composition "intermittently," wherein a cycle of an administration period and an interruption period is repeated (’946 Patent, col. 44:54-65). This intermittent dosing schedule is a known therapeutic regimen for edaravone.
• Technical Importance: This claimed method provides a complete therapeutic regimen, defining not only the timing of administration relative to meals but also the cyclical dosing schedule for long-term treatment of ALS with an oral formulation.

Key Claims at a Glance

• The complaint asserts at least Independent Claim 1 (Compl. ¶55).
• The essential elements of Independent Claim 1 include:
  • A method of treating amyotrophic lateral sclerosis.
  • Orally or intragastrically administering a liquid pharmaceutical composition comprising edaravone intermittently, such that a cycle of an administration period and an interruption period is repeated at least twice.
  • Administering with a "first time interval" from the consumption of a meal, with the same time intervals based on meal type as specified in the ’025 Patent.
• The complaint alleges infringement of "one or more claims" of the patent (Compl. ¶55).

III. The Accused Instrumentality

Product Identification

Defendants’ proposed edaravone oral suspension, for which approval is sought from the FDA under ANDA No. 219415 (Compl. ¶¶2, 16).

Functionality and Market Context

The accused product is a proposed generic copy of Plaintiff’s RADICAVA ORS® oral suspension, intended for the treatment of ALS (Compl. ¶¶38, 40). The complaint alleges it is formulated at the same dose concentration of 105 mg/5 mL (Compl. ¶38). As a generic equivalent, it is intended to provide the same therapeutic benefit as the branded product—slowing the progression of ALS—but via a competing product (Compl. ¶¶8, 40). Plaintiff’s RADICAVA ORS® is described as one of only a few remaining approved drug formulations for ALS, offering a "clinically superior option" over intravenous administration (Compl. ¶¶5, 9).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim-by-claim analysis or the construction of a claim chart. The infringement allegations are pleaded generally, consistent with practice in ANDA litigation, where the act of infringement is the filing of the ANDA itself under 35 U.S.C. § 271(e)(2) (Compl. ¶¶46, 56).

The complaint’s central theory is that if Defendants were to commercially manufacture and sell their proposed generic product, its use as directed by its proposed product labeling would directly infringe the asserted method claims of the ’025 and ’946 patents (Compl. ¶¶48, 58). The complaint alleges that Defendants’ proposed product "performs substantially the same function in substantially the same way to obtain the same result as the products claimed" in the patents-in-suit (Compl. ¶¶45, 55). Infringement is asserted both literally and under the doctrine of equivalents (Compl. ¶¶45, 55).

Identified Points of Contention

• Label-Induced Infringement: The primary question for the court will be whether the proposed labeling for Defendants’ ANDA product will instruct or encourage physicians and patients to administer the drug in a manner that satisfies all limitations of the asserted method claims, including the specific meal-timing intervals and, for the ’946 patent, the intermittent dosing schedule.
• Claim Scope: A potential dispute may arise over whether Defendants can "carve out" the patented methods of use from their proposed label to avoid infringement, and whether such a carve-out would be permissible by the FDA.

V. Key Claim Terms for Construction

The complaint does not identify any specific claim terms as subjects of a likely dispute. However, based on the asserted claims, the following terms may be central to the case.

• The Term: "a first time interval from a consumption of a meal" (asserted claims of both patents)

  • Context and Importance: This phrase is the core of the patented method. Its construction will determine whether the instructions on a generic drug label meet the claim limitations. Practitioners may focus on this term because the patent defines specific meal types ("high-fat meal," "low-fat meal," "caloric supplement") with corresponding caloric and fat content values, which could be used to argue for a narrow interpretation of what constitutes a "meal" for the purposes of the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself uses the general term "meal," which could be argued to carry its plain and ordinary meaning.
    • Evidence for a Narrower Interpretation: The specification provides detailed definitions for each meal type, for example defining a "high-fat meal" as having "800 to 1000 kilocalories" with "50% of calories from lipid" (’025 Patent, col. 18:11-13). A party could argue that the claims must be read in light of these specific definitions.

• The Term: "intermittently" (’946 Patent, Claim 1)

  • Context and Importance: This term is a key limitation in the asserted claim of the ’946 Patent. The infringement analysis for this patent will depend on whether the dosing schedule on Defendants' proposed label constitutes "intermittent" administration as claimed.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term could be given its plain meaning of occurring at irregular intervals or periodically rather than continuously.
    • Evidence for a Narrower Interpretation: The specification describes a specific intermittent regimen: "an initial administration period of 14 days, followed by an interruption period of 14 days, and then further repeating an administration period of 10 days in 14 days and an interruption period of 14 days" (’946 Patent, col. 23:9-15). A defendant might argue that "intermittently" is limited to this or a structurally similar regimen.

VI. Other Allegations

Indirect Infringement

The complaint alleges that if Defendants’ product is approved and launched, they will induce infringement by others (Compl. ¶¶51, 61). In the context of an ANDA case concerning method-of-use patents, this allegation is based on the theory that the proposed product label will instruct end-users to perform the patented methods.

Willful Infringement

While the complaint does not use the word "willful," it alleges that Defendants had "actual and constructive notice" of the patents prior to filing their ANDA, citing the patents' listing in the Orange Book (Compl. ¶¶49, 59). It also requests a declaration that the case is "exceptional" for the purpose of awarding attorneys' fees under 35 U.S.C. § 285 (Compl., Prayer for Relief ¶E). These allegations form the basis for a potential future claim of willful infringement based on pre-suit knowledge.

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

• A core issue will be one of label-driven infringement: Will the contents of Defendants' proposed product label, which must be legally equivalent to the branded drug's label, be found to instruct or encourage end-users to perform the specific meal-timing and intermittent dosing steps required by the asserted method claims?
• A key question for both infringement and validity will be claim scope: Can the method claims, which recite specific time intervals tied to calorically-defined meal types, be interpreted narrowly based on the patent's detailed examples, or will they be given a broader construction based on their plain language? The answer will determine both the ease of proving infringement and the claims' vulnerability to potential invalidity challenges.