Mitsubishi Tanabe Pharma Corp v. Cipla USA Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Mitsubishi Tanabe Pharma Corporation (Japan)
  • Defendant: Cipla USA, Inc. (New Jersey) and Cipla Limited (India)
  • Plaintiff’s Counsel: GIBBONS P.C.
• Case Identification: 2:25-cv-16677, D.N.J., 10/16/2025
• Venue Allegations: Plaintiff alleges venue is proper because Defendant Cipla USA, Inc. is incorporated and has an established place of business in New Jersey, Defendant Cipla Limited is a foreign corporation, and both entities 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 for a generic version of RADICAVA ORS® infringes patents related to oral formulations of the drug edaravone and methods of its administration.
• Technical Context: The technology concerns oral suspension formulations of the drug edaravone, used to slow the progression of Amyotrophic Lateral Sclerosis (ALS), a fatal neurodegenerative disease for which few treatments exist.
• Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff’s receipt of a "Notice Letter" from Defendants, which included a Paragraph IV certification challenging the patents-in-suit. Plaintiff's branded product, RADICAVA ORS®, received FDA approval on May 12, 2022, and was later granted seven years of Orphan Drug Exclusivity, expiring on May 12, 2029.

Case Timeline

Date	Event
2020-11-12	Earliest Priority Date for ’025 and ’946 Patents
2022-05-12	FDA Approval of RADICAVA ORS® (NDA No. 215446)
2024-03-28	FDA Grants Orphan Drug Exclusivity for RADICAVA ORS®
2025-01-14	Issue Date of U.S. Patent No. 12,194,025
2025-05-27	Issue Date of U.S. Patent No. 12,310,946
2025-06-09	Date of Defendants' Notice Letter
2025-10-16	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 January 14, 2025

The Invention Explained

• Problem Addressed: The patent addresses the challenge of developing an effective oral formulation for edaravone, a drug previously available only as an intravenous injection for treating ALS (Compl. ¶8-9; ’025 Patent, col. 1:58-61). Clinical studies revealed that the drug's absorption and bioavailability (pharmacokinetics) are significantly and negatively affected by food consumption, with different types of meals (e.g., high-fat vs. standard) having different impacts (’025 Patent, col. 16:34-40).
• The Patented Solution: The invention is a method for administering oral edaravone that mitigates the negative food effect by specifying precise time intervals between meal consumption and drug administration, tailored to the type of meal consumed (’025 Patent, Abstract). For example, the method requires waiting 8 hours or longer after a high-fat meal, 4 hours or longer after a standard meal, or 2 hours or longer after a light meal before taking the drug, thereby preserving the drug's intended pharmacokinetic profile (’025 Patent, col. 2:5-10). Figure 1 of the patent graphically illustrates the pharmacokinetic differences that necessitate these specific time intervals (’025 Patent, col. 2:31-37).
• Technical Importance: This method provides a viable pathway for oral administration of edaravone, which substantially reduces the burden on ALS patients by eliminating the need for intravenous infusions at a healthcare facility (Compl. ¶9).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 (Compl. ¶44).
• Claim 1 of the ’025 Patent requires:
  • A method of treating amyotrophic lateral sclerosis.
  • Orally or intragastrically administering a liquid pharmaceutical composition comprising edaravone.
  • The administration occurs after a "first time interval" following the consumption of a meal.
  • The required interval is defined by the meal type: at least 8 hours for a "high-fat meal," at least 4 hours for a "low-fat meal," or at least 2 hours for a "caloric supplement."
• The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 12,310,946, "Pharmaceutical composition for oral administration of edaravone and method of administering same", Issued May 27, 2025

The Invention Explained

• Problem Addressed: The ’946 Patent shares its specification with the ’025 Patent and addresses the same problem of food effect on the pharmacokinetics of oral edaravone (’946 Patent, col. 16:34-40).
• The Patented Solution: The solution is also a method of time-controlled administration of edaravone relative to meals. However, the claims of the ’946 Patent further specify that the administration must occur as part of an intermittent dosing regimen, a common therapeutic approach for chronic conditions like ALS (’946 Patent, col. 22:48-52).
• Technical Importance: This invention provides a specific, structured intermittent dosing method for oral edaravone that accounts for food effects, aiming to provide a clinically effective and patient-friendly alternative to IV treatment (Compl. ¶9).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 (Compl. ¶54).
• Claim 1 of the ’946 Patent requires:
  • A method of treating amyotrophic lateral sclerosis.
  • Orally or intragastrically administering a liquid pharmaceutical composition comprising edaravone.
  • The administration occurs intermittently, such that a cycle of an "administration period" and an "interruption period" is repeated at least twice.
  • The administration occurs after a "first time interval" following the consumption of a meal, with the interval defined by meal type (e.g., at least 8 hours for a "high-fat meal").
• The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendants' proposed generic edaravone oral suspension, for which approval is sought from the FDA via Abbreviated New Drug Application (ANDA) No. 218428 (Compl. ¶2, 18).

Functionality and Market Context

• The product is described as a liquid suspension of edaravone at a dose concentration of 105 mg/5 ml (Compl. ¶37). As an ANDA product, it identifies Plaintiff’s RADICAVA ORS® as the reference listed drug (“RLD”), meaning it is intended to be a generic equivalent used for the same therapeutic purpose—the treatment of ALS (Compl. ¶38-39).
• The complaint alleges that Defendants intend to commercially manufacture and sell this product in the United States upon receiving FDA approval (Compl. ¶24). The filing of the ANDA itself constitutes a statutory act of infringement under 35 U.S.C. § 271(e)(2) if the proposed product or its use would infringe the patents-in-suit (Compl. ¶45, 55).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that the use of Defendants’ proposed generic product, in accordance with the instructions that will be provided on its label, will infringe the asserted method claims (Compl. ¶44, 54). The core of the infringement allegation is based on the statutory framework of ANDA litigation, where the filing of the ANDA to market a drug for a patented use is the infringing act.

’025 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of treating amyotrophic lateral sclerosis...	Defendants' ANDA seeks approval to market their proposed product for the treatment of ALS, the same indication as the reference listed drug.	¶2, ¶38	col. 21:51-53
...orally or intragastrically administering... a liquid pharmaceutical composition comprising edaravone...	Defendants' proposed product is a liquid oral suspension containing edaravone.	¶37, ¶39	col. 13:22-24
...with a first time interval... for the consumption of a high-fat meal... is 8 hours before the administration..., [etc.]	The proposed product label for Defendants' generic drug will, on information and belief, instruct patients and physicians to administer the drug using the claimed time intervals relative to meals to ensure bioequivalence with the RLD.	¶38, ¶44	col. 20:56-65

’946 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of treating amyotrophic lateral sclerosis...	Defendants' ANDA seeks approval to market their proposed product for the treatment of ALS.	¶2, ¶38	col. 21:51-53
...is administrated... intermittently such that a cycle comprising an administration period and an interruption period is repeated at least twice...	On information and belief, the proposed product label will instruct for an intermittent dosing regimen consistent with the standard of care for ALS and the label of the RLD.	¶38, ¶54	col. 22:48-61
...with a first time interval from a consumption of a meal...	On information and belief, the proposed product label will instruct patients to time administration relative to meals in a manner that meets the claim limitations.	¶38, ¶54	col. 17:1-4

Identified Points of Contention

• Scope Questions: A primary dispute may concern whether the definitions of "high-fat meal," "low-fat meal," and "caloric supplement" are limited to the specific caloric values and compositions described in the patent specification or if they can be interpreted more broadly. The resolution of this issue will be critical for determining whether the instructions on Defendants' proposed label fall within the scope of the claims.
• Technical Questions: A key question in ANDA litigation is whether the defendant's proposed label will necessarily lead to infringement. The analysis will focus on the precise language of the proposed label (once available) to determine if it instructs, encourages, or requires administration in accordance with all limitations of the patented methods. The complaint does not provide sufficient detail for analysis of the proposed label's specific instructions.

V. Key Claim Terms for Construction

• The Term: "high-fat meal," "low-fat meal," and "caloric supplement"

• Context and Importance: These terms are central to the claimed invention, as the specific time intervals required for administration are directly tied to these meal classifications. The infringement determination will depend on whether the meal types described or referenced in the accused product's label correspond to the claimed terms.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: A party could argue for the plain and ordinary meaning of these terms as understood by a person of ordinary skill in the art (e.g., a clinical pharmacologist), suggesting the patent's specific examples are illustrative, not limiting.
  • Evidence for a Narrower Interpretation: The specification provides explicit, quantitative definitions. A "high-fat meal" is defined as having "total calories per meal of 800 to 1000 kilocalories" with "calorie intake from lipid of 50%" (’025 Patent, col. 17:31-34). A "low-fat meal" (described as a "standard meal") is defined as "400 to 500 kilocalories" with "calorie intake from lipid of 25%" (’025 Patent, col. 19:15-18). A party will likely argue that the patentee acted as its own lexicographer, limiting the claims to these precise definitions.

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

• Context and Importance: This term defines the required dosing schedule in the ’946 patent. Infringement of claim 1 of the ’946 Patent hinges on whether the accused method involves not just specific meal timing but also this particular long-term dosing pattern.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: A party might contend that "intermittently" simply means any non-continuous administration schedule.
  • Evidence for a Narrower Interpretation: The specification describes a specific intermittent administration method for ALS involving repeating cycles of an "administration period" (e.g., 14 days of treatment) and an "interruption period" (e.g., 14 days of non-treatment) (’946 Patent, col. 22:53-61). A party will likely argue this detailed description limits the scope of "intermittently" to such structured, repeating cycles.

VI. Other Allegations

• Indirect Infringement: The complaint includes allegations that would support a claim for induced infringement under 35 U.S.C. § 271(b). It alleges that Defendants had knowledge of the patents and that their submission of the ANDA with a proposed label seeks approval to instruct and encourage medical professionals and patients to perform the patented methods (Compl. ¶48, 50, 58, 60).
• Willful Infringement: The complaint does not contain an explicit allegation of willful infringement or seek enhanced damages under 35 U.S.C. § 284. It does allege that Defendants had "actual and constructive notice" of the patents prior to filing the ANDA, which establishes the knowledge element for inducement (Compl. ¶48, 58).

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

• A core issue will be one of definitional scope: will the terms "high-fat meal" and "low-fat meal" be narrowly construed to the precise caloric and compositional ranges detailed in the patent specification, or will they be afforded a broader meaning? The answer will likely determine whether the instructions on a generic drug label can be found to infringe.
• A second key issue will be one of instructional infringement: assuming a claim construction is established, does the specific language of the Defendants' proposed product label (when it becomes available in discovery) actively instruct or encourage users to follow the patented method, or does it provide sufficient latitude for a non-infringing administration of the drug? The case may turn on whether the FDA requires the specific patented instructions for a finding of bioequivalence.