DCT

1:23-cv-00794

Allergan Holdings Unltd Co v. MSN Laboratories Pvt Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00794, D. Del., 07/21/2023
  • Venue Allegations: Venue is alleged to be proper for MSN Pharmaceuticals Inc. as a Delaware corporation and for MSN Laboratories Private Limited as a foreign entity subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Viberzi® (eluxadoline) tablets constitutes an act of infringement of a patent directed to methods of using the drug.
  • Technical Context: The technology concerns oral pharmaceutical formulations of eluxadoline, an opioid receptor modulator used for treating irritable bowel syndrome with diarrhea (IBS-D).
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendants' submission of ANDA No. 213576 to the U.S. Food and Drug Administration (FDA). The asserted patent is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") for Viberzi®. The complaint notes prior litigation between the parties in the same district concerning the same ANDA.

Case Timeline

Date Event
2013-03-14 ’527 Patent Priority Date
2019-08-12 Defendant's ANDA No. 213576 Submission Date
2022-11-01 ’527 Patent Issue Date
2023-07-21 Complaint Filing Date

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

U.S. Patent No. 11,484,527 - Opioid Receptor Modulator Dosage Formulations

The Invention Explained

  • Problem Addressed: The patent describes the challenge of formulating an active pharmaceutical ingredient, 5-({[2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid (eluxadoline), for effective oral delivery ('527 Patent, col. 2:32-58). A further problem addressed is the potential for abuse of opioid receptor agonists. The patent notes the need for formulations that can deter abuse via non-oral routes, such as injection or snorting, referencing FDA guidance on assessing abuse potential ('527 Patent, col. 3:21-57).
  • The Patented Solution: The patent discloses specific solid oral dosage formulations of eluxadoline that claim to provide effective treatment for conditions like IBS-D while possessing physicochemical features that may limit or deter abuse ('527 Patent, col. 4:58-67). While the specification details abuse-deterrent compositions, the claims are directed to specific methods of using the drug for treatment. The claimed solution is a method of administering a specific dose of the drug on a particular schedule to achieve a therapeutic effect ('527 Patent, col. 34:34-40).
  • Technical Importance: The claimed invention provides a specific therapeutic regimen for treating IBS-D, a common and disruptive gastrointestinal disorder ('527 Patent, col. 2:9-21).

Key Claims at a Glance

  • The complaint asserts infringement of at least Claim 1, the sole independent claim of the '527 patent (Compl. ¶¶ 19, 22).
  • The essential elements of independent Claim 1 are:
    • 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 patient
    • 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 reserves the right to assert infringement of other claims, which would include dependent claims 2-6 (Compl. ¶ 22).

III. The Accused Instrumentality

Product Identification

Defendants' generic oral tablet products containing 75 mg and 100 mg of eluxadoline, for which approval is sought under ANDA No. 213576 (Compl. ¶18).

Functionality and Market Context

The accused products are generic versions of Plaintiffs' Viberzi® brand tablets and are intended for the same therapeutic use: the treatment of IBS-D in adults (Compl. ¶¶ 7, 15). The act of infringement alleged in the complaint is the submission of the ANDA itself, which seeks FDA approval to market a product for use in a manner that allegedly infringes the '527 patent's method claims (Compl. ¶19). The complaint alleges that the proposed package insert for the generic product will instruct medical professionals and patients to use the product in an infringing manner (Compl. ¶22).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart. The following table summarizes the infringement theory for Claim 1 based on the complaint's narrative allegations.

’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... Defendants' ANDA seeks approval to market a generic version of Viberzi®, a drug indicated for treating IBS-D. The proposed product label is alleged to instruct this use. ¶7, ¶15, ¶22 col. 2:45-52
...comprising orally administering to the adult human patient in need thereof 100 mg of...[eluxadoline]... Defendants' ANDA specifically seeks approval for a 100 mg oral tablet formulation of eluxadoline. ¶18 col. 34:36-40
...twice daily with food. The complaint alleges that the proposed package insert and prescribing information for Defendants' product will instruct its use in a way that meets all claim elements, which would include administration twice daily with food. ¶22 col. 34:34-40
  • Identified Points of Contention:
    • Evidentiary Question: A central issue will be the precise language of the proposed product label submitted with ANDA No. 213576. The court will need to determine if the label's instructions direct, recommend, or encourage administration of the 100 mg dose "twice daily with food," which is necessary to support a finding of induced infringement of Claim 1.
    • Scope Questions: The case may raise the question of whether a label that is permissive, rather than mandatory, regarding administration "with food" (e.g., "may be taken with or without food") is sufficient to induce infringement of a claim that explicitly requires this step.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of most claim terms. However, based on the structure of the asserted method claim, the following term may be critical.

  • The Term: "with food"
  • Context and Importance: This limitation is a specific, affirmative step required by Claim 1. Whether Defendants' product label instructs administration "with food" will be a dispositive issue for infringement. Practitioners may focus on this term because if the accused label does not require this step, Plaintiffs' inducement theory may fail.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party arguing for a broad interpretation would likely assert that the term should be given its plain and ordinary meaning, such as co-administration with any amount of food during a meal, without specific requirements as to caloric content or timing. The patent specification does not appear to provide an explicit definition.
    • Evidence for a Narrower Interpretation: The '527 patent itself does not appear to define or limit the term "with food." A party arguing for a narrower construction might rely on the prosecution history (not provided) or extrinsic evidence to argue that the term implies a specific clinical context (e.g., administration with a high-fat meal) that is not present in the accused product's instructions.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement (Compl. ¶¶ 20, 23). The inducement allegation is based on the assertion that Defendants' proposed product labeling will instruct doctors and patients to perform the patented method (Compl. ¶22). The contributory infringement allegation is based on the assertion that the product is not a staple article of commerce suitable for substantial non-infringing use and is especially adapted for use in an infringing manner (Compl. ¶24).
  • Willful Infringement: The complaint does not use the term "willful," but it does allege that Defendants have knowledge of the infringing nature of their activities (Compl. ¶24). It further requests that the case be found "exceptional" under 35 U.S.C. § 285, which is the statutory basis for an award of attorneys' fees (Compl. ¶25).

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

  • A core evidentiary question will be one of instruction versus permission: Does the specific language in the proposed label for Defendants' generic product actively instruct or encourage administration in accordance with every step of the patented method, particularly the "with food" limitation, or does it merely permit such use, potentially weakening the claim for induced infringement?
  • A key legal question will be one of claim scope: How will the court construe the term "with food"? The definition of this seemingly simple phrase could prove critical if the Defendants' proposed label provides ambiguous or non-specific instructions regarding food intake.
  • A likely defense will center on invalidity: While not yet raised, Defendants will almost certainly challenge the validity of Claim 1, likely arguing that the specific method of administering a known drug was obvious to a person of ordinary skill in the art based on prior knowledge of eluxadoline's properties and standard clinical practices for treating IBS-D.