DCT

1:24-cv-00624

Pfizer Inc v. MSN Laboratories Private Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Pfizer Inc. et al. v. MSN Laboratories Private Ltd. et al., 1:24-cv-00624, D. Del., 05/23/2024
  • Venue Allegations: Venue is alleged to be proper in Delaware because Defendant MSN Pharmaceuticals Inc. is a Delaware corporation, and Defendant MSN Laboratories is a non-U.S. resident that may be sued in any district. Personal jurisdiction is asserted based on Defendants’ alleged systematic contacts with Delaware, including placing products into the stream of commerce for distribution in the state and prior consent to jurisdiction in other Delaware cases.
  • Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's NURTEC ODT® (rimegepant sulfate) constitutes an act of infringement of a patent covering a fast-dispersing dosage form for the drug.
  • Technical Context: The technology relates to pharmaceutical formulations for CGRP receptor antagonists, a class of drugs used for the acute and preventive treatment of migraine, delivered via an orally disintegrating tablet.
  • Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 219435 and a Paragraph IV certification, which stated that the patent-in-suit would not be infringed by the proposed generic product. The complaint was filed within the 45-day statutory window, which triggers an automatic 30-month stay of FDA approval for the ANDA.

Case Timeline

Date Event
2018-03-25 '724 Patent Priority Date
2021-08-10 '724 Patent Issue Date
2024-04-18 Date of MSN’s Paragraph IV Notice Letter to Pfizer
2024-05-23 Complaint Filing Date

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

U.S. Patent No. 11,083,724 - "Rimegepant for CGRP Related Disorders"

  • Patent Identification: U.S. Patent No. 11,083,724, “Rimegepant for CGRP Related Disorders,” issued August 10, 2021.

The Invention Explained

  • Problem Addressed: The patent background describes a significant unmet medical need for migraine treatments that provide enhanced patient benefits compared to existing therapies like triptans, which have limitations such as incomplete efficacy and contraindications for patients with cardiovascular disease (’724 Patent, col. 2:30-54).
  • The Patented Solution: The invention is a pharmaceutical composition containing the CGRP receptor antagonist rimegepant (or its salt) in a specific dosage form described as an "oral solid molded fast-dispersing dosage form" ('724 Patent, Abstract; col. 10:7-17). This formulation is designed to disintegrate or disperse rapidly in the mouth (e.g., within 1 to 60 seconds), which can be advantageous for migraine sufferers who may experience nausea or aversion to swallowing pills ('724 Patent, col. 10:1-6; col. 2:56-61).
  • Technical Importance: This technology provided a novel delivery mechanism for a new class of migraine medication (CGRP antagonists), offering an alternative to traditional tablets and potentially improving patient compliance and therapeutic onset.

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the ’724 patent, with Claim 1 being the only claim explicitly quoted (Compl. ¶32, ¶35, ¶47).
  • Independent Claim 1 requires:
    • A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a CGRP receptor antagonist, or a pharmaceutically acceptable salt thereof,
    • wherein the pharmaceutical composition is in a form of an oral solid molded fast-dispersing dosage form.
  • The complaint reserves the right to assert other claims (Compl. ¶32).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "MSN's ANDA Product," identified as a generic version of Pfizer's NURTEC ODT®, which is a "rimegepant sulfate orally disintegrating tablet" (Compl. ¶1, ¶11).

Functionality and Market Context

  • The complaint alleges that MSN's ANDA Product is a "generic copy" of NURTEC ODT® and that the ANDA purports to contain data on the bioequivalence of MSN's product to Pfizer's product (Compl. ¶13, ¶14). The product is intended for the same indications as NURTEC ODT®, namely the acute and preventive treatment of migraine in adults (Compl. ¶9). The filing of the ANDA itself represents a bid to enter the market for rimegepant sulfate tablets before the expiration of the patent-in-suit (Compl. ¶1). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'724 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a CGRP receptor antagonist, or a pharmaceutically acceptable salt thereof, Upon information and belief, MSN’s ANDA Product will contain a pharmaceutical composition comprising a therapeutically effective amount of rimegepant sulfate, a salt of the CGRP receptor antagonist rimegepant. ¶36, ¶48 col. 8:41-49
wherein the pharmaceutical composition is in a form of an oral solid molded fast-dispersing dosage form. Upon information and belief, the pharmaceutical composition of MSN's ANDA Product will be in a form of an oral solid molded fast-dispersing dosage form. ¶36, ¶48 col. 10:1-6
  • Identified Points of Contention:
    • Scope Questions: The primary dispute will likely concern the scope of the term "oral solid molded fast-dispersing dosage form". The question for the court will be whether this term is limited to the specific lyophilization (freeze-drying) process described in the patent's specification for creating a "molded" form, or if it can be construed more broadly to encompass other manufacturing methods that result in a pre-formed, rapidly-dissolving tablet ('724 Patent, col. 10:12-26).
    • Technical Questions: A key evidentiary question will be what manufacturing process is actually used for MSN's ANDA Product. The complaint alleges infringement "upon information and belief," but the case will depend on discovery to reveal whether MSN's process involves creating a "molded" tablet that falls within the construed scope of the claim, as opposed to a more conventional process like tablet compression.

V. Key Claim Terms for Construction

  • The Term: "oral solid molded fast-dispersing dosage form"
  • Context and Importance: This term is the central limitation distinguishing the claimed invention from a conventional pill. The definition of "molded" will be critical to the infringement analysis, as it dictates the type of manufacturing processes covered by the claim. Practitioners may focus on this term because if it is construed narrowly to cover only a specific freeze-drying process, MSN might be able to design around the patent by using an alternative manufacturing technique for its orally disintegrating tablet.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue that "molded" should be given its plain and ordinary meaning, covering any process where a solid dosage form is shaped in a mold, without being limited to the specific examples in the specification. Claim 1 itself does not specify the manufacturing method.
    • Evidence for a Narrower Interpretation: The specification describes a specific method for creating the dosage form: "The network is obtained by subliming solvent from a composition in the solid state, the composition comprising the active ingredient and a solution of the carrier in the solvent... The composition can be contained in a mold during the freeze-drying process" ('724 Patent, col. 10:12-26). A party could argue this disclosure limits the term "molded" to a product created via such a lyophilization process. The patent also incorporates by reference U.S. Patent No. 9,192,580, which describes this type of dosage form in more detail ('724 Patent, col. 10:63-65).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval of the ANDA, Defendants will induce and contribute to infringement by commercially manufacturing and selling the product with its proposed labeling (Compl. ¶34, ¶46). The contributory infringement allegation is based on the assertion that MSN's product is "especially made or adapted for use in infringing" and "is not suitable for any substantial non-infringing use" (Compl. ¶39, ¶51).
  • Willful Infringement: The complaint alleges that Defendants acted with "full knowledge of the '724 patent" and without a reasonable basis for their non-infringement position, as evidenced by their Paragraph IV certification (Compl. ¶37, ¶49). This is presented as the basis for a finding of willful infringement should the product be commercialized.

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

  • A core issue will be one of claim construction: How will the court define the phrase "oral solid molded fast-dispersing dosage form"? Will the term be limited to the lyophilized, freeze-dried products detailed in the patent’s specification, or will it be given a broader construction that could encompass other types of orally disintegrating tablets?
  • A key evidentiary question will be one of technical fact: What is the precise manufacturing process used to create MSN’s proposed generic tablet? The outcome of the infringement analysis will depend entirely on whether the facts of that process, once revealed in discovery, fall within the court's construction of the "molded" limitation in Claim 1.