DCT

1:23-cv-00795

Allergan Holdings Unltd Co v. Sun Pharmaceutical Industries Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00795, D. Del., 07/21/2023
  • Venue Allegations: Venue is alleged to be proper because Defendant is a foreign corporation subject to personal jurisdiction in the District of Delaware.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiffs’ Viberzi® (eluxadoline) tablets constitutes an act of patent infringement.
  • Technical Context: The technology relates to specific oral dosage formulations for opioid receptor modulators used to treat gastrointestinal disorders like irritable bowel syndrome with diarrhea (IBS-D).
  • Key Procedural History: The complaint notes that Defendant Sun has been involved in prior litigation with Plaintiffs in the same court regarding the same ANDA (No. 213447), referencing Civil Action Nos. 19-1727-RGA and 20-1479-RGA. This history may be relevant to questions of personal jurisdiction and potentially to willfulness.

Case Timeline

Date Event
2013-03-14 '527 Patent Earliest Priority Date
2019-07-31 Defendant Submitted ANDA No. 213447 (on or before this date)
2022-11-01 '527 Patent Issued
2023-07-21 Complaint Filed

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

  • Patent Identification: U.S. Patent No. 11,484,527, Opioid Receptor Modulator Dosage Formulations, issued November 1, 2022. (Compl. ¶11).

The Invention Explained

  • Problem Addressed: The patent describes the need for effective pharmacological treatments for irritable bowel syndrome with diarrhea (IBS-D), a common gastrointestinal disorder for which existing treatments are limited. (col. 2:9-26). It also addresses the abuse potential associated with opioid receptor agonists, noting that parenteral administration (e.g., injection) can lead to CNS-related effects, creating a risk for abuse and diversion. (col. 3:9-21; col. 3:46-59).
  • The Patented Solution: The patent discloses solid oral dosage formulations of the active ingredient eluxadoline combined with specific inert excipients, such as silicified microcrystalline cellulose and crospovidone. (’527 Patent, Abstract; col. 4:4-20). This specific composition is designed to provide effective treatment for IBS-D when taken orally while possessing physico-chemical features that may deter or limit abuse, such as by making it difficult to extract the active ingredient for injection or snorting. (’527 Patent, col. 3:60-col. 4:3).
  • Technical Importance: The formulation aims to deliver the therapeutic benefits of a mixed opioid receptor agonist/antagonist for IBS-D while mitigating the abuse and diversion risks commonly associated with opioid-based medications. (col. 2:45-47; col. 3:46-59).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the '527 patent. (Compl. ¶16). Claim 1 is the sole independent claim.
  • 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 100 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,
    • twice daily with food.
  • The complaint does not explicitly reserve the right to assert dependent claims, but the general allegation of infringing "one or more claims" preserves this option.

III. The Accused Instrumentality

  • Product Identification: Defendant Sun's proposed generic oral tablet products containing 75 mg and 100 mg of eluxadoline as the active ingredient, as described in ANDA No. 213447. (Compl. ¶15).
  • Functionality and Market Context:
    • The complaint alleges that Sun's ANDA filing seeks FDA approval to manufacture and sell a generic version of Plaintiffs' Viberzi® brand eluxadoline tablets. (Compl. ¶6).
    • Viberzi® is approved for the treatment of IBS-D in adults. (Compl. ¶12). The infringement allegation is predicated on the basis that Sun's generic product, if approved, will be used according to its proposed package insert and prescribing information for the same indication, thereby practicing the patented method. (Compl. ¶19).

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or detailed element-by-element allegations. The infringement theory is based on 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA for the purpose of obtaining approval to market a drug claimed in a patent as an act of infringement. The core allegation is that the intended use of Sun's proposed generic product, as will be described in its labeling, will meet all the elements of the asserted claims. (Compl. ¶19).

No probative visual evidence provided in complaint.

'527 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 intended use of Sun's ANDA product, as directed by its proposed labeling, is for treating IBS-D in adults, the approved indication for the reference listed drug, Viberzi®. ¶6, ¶12, ¶19 col. 33:34-37
comprising orally administering to the adult human patient in need thereof Sun's ANDA seeks approval for "generic oral tablet products." ¶15 col. 33:37-38
100 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 Sun's ANDA seeks approval for products containing, inter alia, 100 mg of eluxadoline, the active ingredient specified in the claim. ¶15 col. 33:38-40
twice daily with food. The complaint alleges that the proposed package insert for Sun's product will instruct users to perform the claimed steps, which includes the specified dosing regimen. ¶19 col. 33:40-41
  • Identified Points of Contention:
    • Scope Questions: A central question will be whether the instructions for use in the proposed labeling for Sun's ANDA product direct or encourage administration in a manner that meets every limitation of Claim 1, particularly the "twice daily with food" requirement.
    • Technical Questions: Since this is an ANDA case, the primary dispute is typically legal and based on the ANDA filing itself, rather than a technical mismatch in product operation. A key question for the court will be to compare the language of the asserted claims against the contents of Sun's ANDA and its proposed label to determine if the intended use constitutes infringement.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a deep analysis of claim construction disputes. However, based on the claim language, certain terms may become focal points.

  • The Term: "with food"
  • Context and Importance: This limitation defines a specific condition under which the drug is to be administered. Practitioners may focus on this term because infringement of the method claim requires that the accused infringer (or those it induces) practices all steps, including this one. The outcome could depend on whether Sun’s proposed label mandates, suggests, or is silent on administration "with food."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification does not appear to define or elaborate on the term "with food," which might suggest the parties should rely on its plain and ordinary meaning to one of skill in the art.
    • Evidence for a Narrower Interpretation: The patent does not appear to provide a specific definition or embodiment that would narrow the term. A party seeking a narrower construction might need to rely on extrinsic evidence or arguments based on the prosecution history, which is not provided in the complaint.

VI. Other Allegations

  • Indirect Infringement: Plaintiffs allege that if Sun commercially sells its ANDA product, it will induce infringement by "doctors, pharmacists, healthcare providers and patients" who will use the product according to the proposed package insert. (Compl. ¶19). Contributory infringement is also alleged, based on the assertion that Sun knows its product is "especially made for an infringing use" and is not a staple article of commerce suitable for substantial non-infringing use. (Compl. ¶21).
  • Willful Infringement: The complaint does not use the term "willful" but does allege that "Sun's actions render this an exceptional case under 35 U.S.C. § 285" (Compl. ¶22), which is the basis for seeking attorneys' fees, often tied to findings of willful infringement or other litigation misconduct. The allegation of knowledge is based on Sun's ANDA filing referencing the branded product and its associated patents. (Compl. ¶12, ¶21).

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

  1. A Label-Driven Infringement Question: Will the specific language of the proposed package insert for Sun's generic product be found to instruct or encourage users to administer the 100 mg tablet "twice daily with food," thereby meeting all limitations required to find inducement of infringement of Claim 1?
  2. An Evidentiary Question of Intent: What evidence, including the history of prior litigation between the parties over the same ANDA, will be presented to support Plaintiffs' claims of induced infringement and their assertion that this is an "exceptional case" warranting an award of attorneys' fees?