DCT

1:24-cv-01188

Allergan Holdings UnLtd Co v. Sun Pharmaceutical Industries Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-01188, D. Del., 10/23/2024
  • Venue Allegations: Venue is asserted on the basis that the defendant is a foreign corporation and therefore may be sued in any judicial district, coupled with allegations that it is subject to personal jurisdiction in Delaware.
  • Core Dispute: Plaintiffs allege that Defendant's Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Viberzi® (eluxadoline) tablets constitutes an act of infringement of a patent covering a method of using the drug to treat Irritable Bowel Syndrome with Diarrhea (IBS-D).
  • Technical Context: The technology concerns a specific method of administering an oral pharmaceutical for treating IBS-D, a common and chronic gastrointestinal disorder affecting a significant portion of the population.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Defendant’s ANDA submission. The patent-in-suit issued after the ANDA was filed; Plaintiffs cite precedent suggesting this does not preclude infringement liability. The complaint notes that Defendant did not contest personal jurisdiction in prior, related litigation in the same district concerning the same ANDA, which may be relevant to procedural arguments.

Case Timeline

Date Event
2013-03-14 Earliest Priority Date for ’187 Patent
2019-07-31 ANDA No. 213447 Submitted (on or before this date)
2024-09-24 ’187 Patent 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,” Issued Sep. 24, 2024

The Invention Explained

  • Problem Addressed: The patent’s background section describes Irritable Bowel Syndrome with Diarrhea (IBS-D) as a common functional gastrointestinal disorder for which safe and effective pharmacological treatments are limited (col. 2:11-28).
  • The Patented Solution: The invention is a method of treatment using eluxadoline, a compound that functions as both an agonist for the mu-opioid receptor (MOR) and an antagonist for the delta-opioid receptor (DOR) (col. 2:1-5). This dual-action profile is described as advantageous for treating both the diarrhea and abdominal pain associated with IBS-D, potentially without the constipating side effects of pure MOR agonists (col. 2:45-58). The claimed method involves administering a specific dosage of the compound under specific conditions to achieve this therapeutic effect (’187 Patent, col. 22:42-49).
  • Technical Importance: The development of mixed-profile opioid receptor modulators represented an effort to create more targeted therapies for complex conditions like IBS-D by simultaneously addressing multiple symptom pathways (col. 2:40-49).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" without specifying them (Compl. ¶19). Independent claim 1 is the sole independent claim in the patent.
  • Independent Claim 1:
    • A method of reducing the frequency of abdominal pain and diarrhea
    • in an adult human patient suffering from irritable bowel syndrome with diarrhea,
    • 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 [eluxadoline]
    • twice daily
    • with food.

III. The Accused Instrumentality

Product Identification

  • Defendant’s proposed 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. 213447 (Compl. ¶15).

Functionality and Market Context

  • The accused products are generic versions of Plaintiffs' Viberzi® brand tablets, which are approved for the treatment of IBS-D in adults (Compl. ¶6, ¶12). The infringement allegation is based on the method of using these tablets. Plaintiffs allege that the proposed package insert and prescribing information for Defendant's generic product will instruct medical professionals and patients to administer the drug in a manner that directly infringes the patented method (Compl. ¶19).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not contain a claim chart. The infringement theory for a method claim in a Hatch-Waxman case typically relies on the instructions for use in the proposed drug label. The table below summarizes the likely allegations for the 75 mg product based on this theory.

’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... Defendant's ANDA seeks approval for a generic version of Viberzi®, which is indicated for the treatment of IBS-D in adults. The proposed label will allegedly instruct this use. ¶12, ¶19 col. 22:42-45
comprising orally administering to the adult human patient in need thereof... Defendant's product is an oral tablet intended for administration to patients. ¶15 col. 22:45-46
75 mg of [eluxadoline]... Defendant's ANDA explicitly seeks approval for a 75 mg dosage strength of eluxadoline. ¶15 col. 22:46-48
twice daily... The proposed label will allegedly instruct for twice-daily administration, consistent with the approved use of the branded drug. ¶19 col. 22:48-49
with food. The proposed label will allegedly instruct that the tablet be administered with food. ¶19 col. 22:49
  • Identified Points of Contention:
    • Scope Questions: A primary question concerns the 100 mg dosage strength in Defendant's ANDA (Compl. ¶15). As independent Claim 1 is explicitly limited to a "75 mg" dose, infringement by the 100 mg product would require an argument based on the doctrine of equivalents or reliance on other, unspecified claims.
    • Technical Questions: The infringement analysis for this method claim will focus heavily on the content of Defendant's proposed product label. A key evidentiary question for the court will be whether the label's instructions for use direct, encourage, or recommend each and every step of the claimed method.

V. Key Claim Terms for Construction

  • The Term: "with food"
  • Context and Importance: This term defines a condition of administration in Claim 1. Its construction is critical because infringement will depend on whether the instructions in Defendant's proposed label fall within the scope of this term. Practitioners may focus on this term because its precise meaning (e.g., during a meal, after a meal, with any amount of food) could be a point of dispute.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim itself does not define the quantity or type of food, nor the precise timing of administration relative to food intake. An argument could be made that the term should be given its plain and ordinary meaning, which could encompass a wide range of scenarios.
    • Evidence for a Narrower Interpretation: The specification provides an exemplary embodiment where the drug "is administered to the subject with one or more daily meals, more preferably with breakfast and dinner" (col. 15:39-41). A party could argue this context suggests the term implies administration with a substantial "meal," as opposed to a minor snack, potentially narrowing its scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, asserting that Defendant's proposed package insert and prescribing information will instruct doctors, pharmacists, and patients to perform the patented method (Compl. ¶19, ¶21). The complaint also alleges the products are not staple articles of commerce and are especially adapted for infringing use, forming a basis for contributory infringement (Compl. ¶21).
  • Willful Infringement: While the complaint does not use the term "willful," it requests a finding that this is an "exceptional case" under 35 U.S.C. § 285, which allows for an award of attorneys' fees (Compl. ¶22, Prayer ¶d). This allegation is based on Defendant's alleged knowledge that its activities would result in the use of an infringing product (Compl. ¶21).

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

  1. Infringement of the 100 mg Product: A key issue will be one of infringement scope: given that Claim 1 is limited to a "75 mg" dose, can Plaintiffs establish that the marketing and sale of the accused 100 mg product infringes, either under the doctrine of equivalents or through other claims not yet identified in the pleadings?

  2. Claim Validity: A central question in nearly all Hatch-Waxman litigation is patent validity. The court will likely have to determine whether the claimed method—administering a specific dosage regimen of a known compound to treat a condition for which it was known to be effective—would have been obvious to a person of ordinary skill in the art at the time of the invention.

  3. Label-Based Infringement: The case will also turn on an evidentiary question of inducement: do the specific instructions and recommendations in Defendant's final, FDA-approved label actively encourage or instruct users to perform all steps of the patented method as construed by the court?