DCT

1:24-cv-01187

Allergan Holdings UnLtd Co v. MSN Laboratories Pvt Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-01187, D. Del., 10/23/2024
  • Venue Allegations: Venue is alleged to be proper for MSN Pharmaceuticals Inc. as it is a Delaware corporation. Venue is alleged to be proper for MSN Laboratories Private Limited because it is a foreign entity subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the IBS-D drug Viberzi® constitutes an act of infringement of a patent covering specific formulations and methods of use for the active ingredient, eluxadoline.
  • Technical Context: The technology concerns pharmaceutical formulations for opioid receptor modulators used to treat gastrointestinal disorders, such as irritable bowel syndrome with diarrhea (IBS-D).
  • Key Procedural History: The complaint notes that the parties are involved in prior litigation in the same district regarding the same ANDA (No. 213576), referencing Civil Action No. 19-1727-RGA. This suggests an ongoing dispute, with the current lawsuit concerning a newly issued patent.

Case Timeline

Date Event
2013-03-14 '187 Patent Priority Date
2019-08-12 MSN Submitted ANDA No. 213576 (on or before this date)
2024-09-24 U.S. Patent No. 12,097,187 Issued
2024-10-23 Complaint Filed

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

U.S. Patent No. 12,097,187 - “Opioid Receptor Modulator Dosage Formulations”

The patent-in-suit is U.S. Patent No. 12,097,187, issued September 24, 2024 (’187 Patent).

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of formulating an opioid receptor modulator that is effective for treating gastrointestinal disorders like IBS-D while also deterring potential abuse (’187 Patent, col. 2:4-14). The background notes that while oral administration is effective for GI treatment, parenteral (e.g., injected) administration of the same compound can produce undesirable CNS-related effects, creating a risk of misuse (’187 Patent, col. 3:10-23). The patent aims to create a formulation that limits the feasibility of extracting the active ingredient for such non-oral abuse (’187 Patent, col. 3:41-58).
  • The Patented Solution: The patent discloses a specific solid oral dosage formulation containing the active ingredient (eluxadoline) combined with a particular set of inert excipients, including silicified microcrystalline cellulose, mannitol, crospovidone, and others (’187 Patent, col. 4:60-68). This composition is designed to have unique physico-chemical characteristics that improve stability and make it difficult to extract the active ingredient using common household solvents, thereby deterring abuse (’187 Patent, col. 3:59-68). The detailed manufacturing process, which involves specific blending and compression steps, is illustrated in the patent’s figures (’187 Patent, Fig. 1).
  • Technical Importance: This technology represents an approach to balance therapeutic efficacy for a GI condition with public health concerns over the abuse of opioid-related compounds, consistent with FDA guidance encouraging abuse-deterrent formulations (’187 Patent, col. 3:23-39).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the '187 patent without specifying them (Compl. ¶19). Independent claim 1 is a method of use claim.
  • Independent Claim 1:
    • A method of reducing the frequency of abdominal pain and diarrhea in an adult human patient with IBS-D.
    • Comprising orally administering 75 mg of a specific eluxadoline stereoisomer, 5-({[(2S)-2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[(1S)-1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid.
    • The administration is performed "twice daily with food."
  • The complaint does not explicitly reserve the right to assert dependent claims, but its general allegation covers all claims.

III. The Accused Instrumentality

Product Identification

Defendant MSN’s generic oral tablet products containing 75 mg and 100 mg of eluxadoline as the active ingredient, for which it seeks FDA approval via ANDA No. 213576 (Compl. ¶7, ¶18).

Functionality and Market Context

  • The accused products are intended to be generic versions of Plaintiffs' Viberzi® brand eluxadoline tablets (Compl. ¶7). Viberzi® is approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults (Compl. ¶15).
  • The complaint alleges that MSN’s submission of its ANDA seeks approval for the commercial manufacture, use, and sale of these generic tablets throughout the United States (Compl. ¶18).

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or detailed infringement contentions. It makes a general allegation that the use of MSN's ANDA products, according to the proposed package insert, will infringe the patent (Compl. ¶22). The following chart summarizes this theory for the sole independent claim.

'187 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of reducing the frequency of abdominal pain and diarrhea in an adult human patient suffering from irritable bowel syndrome with diarrhea, The ANDA product is alleged to be a generic version of Viberzi®, which is approved for the treatment of IBS-D in adults. ¶7, ¶15 col. 2:47-54
comprising orally administering to the adult human patient in need thereof 75 mg of 5-({[(2S)-2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[(1S)-1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid The ANDA seeks approval for oral tablets containing 75 mg and 100 mg of eluxadoline, the active ingredient specified in the claim. ¶18 col. 10:45-60; col. 8:1-17
twice daily with food. It is alleged that the proposed package insert and prescribing information for the ANDA product will instruct doctors and patients to administer the drug in a manner that meets this limitation. ¶22, ¶24 col. 14:60-65

Identified Points of Contention

  • Scope Questions: A potential dispute may arise over the meaning of "with food," and what specific instructions in the defendant's proposed label would be sufficient to meet this limitation.
  • Technical Questions: The central evidentiary question for infringement will be whether the instructions on MSN’s proposed product label direct or encourage administration in a way that satisfies all elements of the claimed method, including the dosage, frequency, and "with food" requirements. The complaint does not provide the proposed label for analysis.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a deep analysis, but based on the patent, certain terms in claim 1 are likely to be important.

  • The Term: "reducing the frequency of abdominal pain and diarrhea"
  • Context and Importance: This term defines the therapeutic outcome of the method. Its construction is critical because the patent’s dependent claims and specification quantify this reduction using specific metrics, such as "daily worst abdominal pain (WAP) score" and "Bristol Stool Scale (BSS)" (’187 Patent, cl. 2-6; col. 14:30-46). The dispute may center on whether infringement requires achieving a specific, measurable level of reduction as detailed in the specification, or if any general reduction suffices.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The language of independent claim 1 itself does not include a specific quantitative threshold, which could support an argument for a broader meaning covering any reduction in symptoms.
    • Evidence for a Narrower Interpretation: The specification provides concrete definitions for therapeutic efficacy, such as a "decrease of daily WAP scores from the patient's baseline WAP... of about ≥30%" and achieving a BSS score of "between 2 and 5" (’187 Patent, col. 14:30-46). A defendant may argue these specific definitions limit the scope of the general term in claim 1.

VI. Other Allegations

Indirect Infringement

The complaint alleges that once MSN's product is approved, its commercial activities and the instructions on its proposed package insert will induce infringement by doctors, pharmacists, and patients (Compl. ¶22, ¶24). It further alleges that the product is "especially made to infringe and/or are especially adapted for use in the direct infringement" of the patent, suggesting contributory infringement (Compl. ¶24).

Willful Infringement

The complaint does not use the word "willful" but does allege that MSN's actions "render this an exceptional case under 35 U.S.C. § 285," seeking an award of attorneys' fees (Compl. ¶25; Prayer for Relief ¶d). This allegation is based on the totality of MSN's alleged infringing conduct.

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

As this is an ANDA action based on a newly issued patent, the dispute will likely focus on the patent's validity, an issue not detailed in the complaint. Based strictly on the provided documents, the case raises the following questions:

  1. A core evidentiary question will be one of induced infringement: Will the final, FDA-approved label for MSN's generic product contain instructions or recommendations that directly encourage patients and physicians to perform every step of the patented method, specifically the "75 mg... twice daily with food" regimen for treating IBS-D?

  2. A central claim construction question will be the scope of efficacy: Must the "reducing" of symptoms required by claim 1 meet the quantitative benchmarks for improvement (e.g., ≥30% WAP score reduction) detailed in the patent's specification, or does any level of symptom reduction suffice?

  3. An underlying legal question will be one of patentability: Given that the active ingredient and its use for IBS-D were previously known, is the specific method of administration claimed—75 mg, twice daily, with food—sufficiently novel and non-obvious to warrant patent protection?