DCT

3:24-cv-04662

AbbVie Inc v. MSN Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-04662, D.N.J., 04/08/2024
  • Venue Allegations: Venue is alleged as proper in the District of New Jersey because Defendant MSN Pharmaceuticals Inc. has its principal place of business in New Jersey, and the other foreign-domiciled defendants may be sued in any judicial district.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to market generic versions of the migraine drug UBRELVY® (ubrogepant) constitutes an act of infringement of four U.S. patents covering tablet formulations and methods of treatment.
  • Technical Context: The technology concerns pharmaceutical compositions and dosing regimens for ubrogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist used for the acute treatment of migraine.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Plaintiffs’ receipt of a Notice Letter from MSN, dated February 23, 2024, which included a Paragraph IV certification. This certification alleges that the asserted patents are invalid, unenforceable, and/or will not be infringed by MSN's proposed generic products.

Case Timeline

Date Event
2014-02-05 Earliest Priority Date for ’836 and ’709 Patents
2018-11-06 ’836 Patent Issued
2019-12-23 FDA Approval for UBRELVY® (NDA No. 211765)
2020-12-22 Earliest Priority Date for ’515 and ’542 Patents
2023-08-08 ’515 Patent Issued
2024-01-02 ’542 Patent Issued
2024-02-23 MSN Sends Notice Letter to AbbVie
2024-03-12 ’709 Patent Issued
2024-04-08 Complaint Filed

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

U.S. Patent No. 10,117,836 - "Tablet Formulation for CGRP Active Compounds"

  • Patent Identification: U.S. Patent No. 10,117,836, "Tablet Formulation for CGRP Active Compounds," issued November 6, 2018. (Compl. ¶44).

The Invention Explained

  • Problem Addressed: The patent describes certain CGRP antagonist compounds as having low aqueous solubility, making them difficult to formulate into solid oral dosage forms like tablets that can provide rapid drug release for acute conditions such as migraine. Liquid formulations, while easier to develop for bioavailability, are considered commercially unattractive for chronic or acute therapies. (’836 Patent, col. 2:1-14).
  • The Patented Solution: The invention creates a solid dispersion by using a hot-melt extrusion process to disperse the CGRP compound (API) within a water-soluble polymer matrix, along with a dispersing agent. This extrudate is then combined with a specific "disintegration system" designed to make the final tablet disintegrate rapidly (e.g., in less than five minutes) upon ingestion, thereby overcoming the API's low solubility and enabling immediate release. (’836 Patent, Abstract; col. 4:5-12).
  • Technical Importance: This formulation technology enables a class of poorly water-soluble but potent CGRP antagonists to be delivered as a stable, fast-acting oral tablet for acute migraine treatment. (’836 Patent, col. 2:15-34).

Key Claims at a Glance

The complaint asserts infringement of "one or more claims" without further specification (Compl. ¶80). Independent claim 1 is representative of the formulation technology:

  • A tablet comprising: (a) an extrudate comprising: (i) a water-soluble polymer matrix; (ii) a dispersing agent; and (iii) a compound of Formula I...
  • wherein the dispersing agent and compound of Formula I is dispersed within said polymer matrix; and
  • (b) a disintegration system,
  • wherein said tablet has a hardness of from about 12 kP to about 18 kP,
  • and wherein said tablet achieves complete disintegration in less than about 5 minutes in a standard tablet disintegration test.

U.S. Patent No. 11,717,515 - "Treatment of Migraine"

  • Patent Identification: U.S. Patent No. 11,717,515, "Treatment of Migraine," issued August 8, 2023. (Compl. ¶49).

The Invention Explained

  • Problem Addressed: The patent addresses the need for optimized and targeted dosing regimens for CGRP antagonists, particularly for specific patient populations that may be at higher risk, such as those with severe hepatic impairment. (’515 Patent, col. 1:19-27).
  • The Patented Solution: The patent claims a specific method for safely and effectively treating migraine in patients with severe hepatic impairment, defined as having a Child-Pugh Class C score. The method comprises administering a 50 mg dose of ubrogepant, with the option for a second 50 mg dose at least two hours later. This specific dosing is supported by pharmacokinetic data showing that patients with severe hepatic impairment have significantly higher systemic exposure to the drug. (’515 Patent, Abstract; col. 2:51-58; Fig. 1).
  • Technical Importance: The invention provides a precise, evidence-based dosing protocol for a vulnerable patient population, enhancing the drug's safety profile and allowing it to be used in patients who might otherwise be dosed incorrectly or for whom the treatment would be contraindicated. (’515 Patent, col. 3:35-40).

Key Claims at a Glance

The complaint asserts infringement of "one or more claims" without further specification (Compl. ¶113). Independent claim 1 is representative of the method of treatment:

  • A method for the acute treatment of migraine with or without aura in a patient with severe hepatic impairment,
  • the method comprising orally administering 50 mg of ubrogepant to the patient,
  • wherein the patient has a Child-Pugh score of Child-Pugh Class C,
  • and wherein the patient's migraine is safely and effectively treated.

Multi-Patent Capsule

  • Patent Identification: U.S. Patent No. 11,857,542, "Treatment of Migraine," issued January 2, 2024. (Compl. ¶53).
  • Technology Synopsis: This patent claims methods for treating migraine with ubrogepant in other specific patient populations. It addresses the need for safe and effective dosing regimens for patients with severe renal impairment or those concurrently taking drugs that are inhibitors or inducers of the CYP3A4 enzyme, which metabolizes ubrogepant. The solution involves specific dose adjustments, such as administering a 50 mg dose to patients with severe renal impairment. (’542 Patent, Abstract; col. 2:1-5).
  • Asserted Claims: The complaint asserts infringement of "one or more claims" without further specification. (Compl. ¶141).
  • Accused Features: The accused feature is the anticipated use of MSN's generic products according to its proposed label, which Plaintiffs allege will instruct or encourage the patented methods of use for specific patient populations. (Compl. ¶¶142-144).

Multi-Patent Capsule

  • Patent Identification: U.S. Patent No. 11,925,709, "Tablet Formulation for CGRP Active Compounds," issued March 12, 2024. (Compl. ¶57).
  • Technology Synopsis: As a continuation of the application leading to the ’836 Patent, this patent covers related technology for formulating poorly soluble CGRP antagonists. It describes a solid oral dosage form comprising a hot-melt extrudate of the active compound in a water-soluble polymer matrix (specifically PVP-VA) with a dispersing agent (specifically TPGS), combined with a disintegration system to ensure rapid release. (’709 Patent, Abstract). The invention addresses the same technical challenge of creating a stable, fast-acting oral tablet for a poorly soluble drug.
  • Asserted Claims: The complaint asserts infringement of "one or more claims" without further specification. (Compl. ¶170).
  • Accused Features: The accused instrumentality is the composition of MSN's generic ubrogepant tablets. Plaintiffs allege the tablets themselves are formulated in a way that infringes the patent's claims covering the specific combination of excipients and manufacturing process. (Compl. ¶¶168-170).

III. The Accused Instrumentality

Product Identification

  • Defendants’ ubrogepant oral tablets, 50 mg and 100 mg, for which marketing approval is sought under ANDA No. 219218 ("MSN's generic products"). (Compl. ¶¶1, 62).

Functionality and Market Context

  • The complaint alleges that MSN's generic products are intended to be generic versions of Plaintiffs' commercial product, UBRELVY® Tablets, and that MSN has represented to the FDA that its products are "pharmaceutically and therapeutically equivalent" to UBRELVY®. (Compl. ¶¶62, 78).
  • Functionally, the products are oral tablets for the acute treatment of migraine attacks in adults. (Compl. ¶39). The complaint alleges that to obtain FDA approval, MSN must show its product is bioequivalent to UBRELVY® and that its proposed labeling recommends the same approved conditions of use. (Compl. ¶¶69-70).
  • The market context is that of generic competition to a branded pharmaceutical. UBRELVY® is described as one of only two orally available CGRP receptor antagonists approved for acute migraine treatment and the only one indicated for a patient with severe hepatic impairment. (Compl. ¶42).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or detailed technical allegations regarding the composition or proposed labeling of MSN's generic products. The infringement theory is predicated on the regulatory requirements of the ANDA process, which allegedly compel MSN's products and their labeling to be the same as or equivalent to the patented UBRELVY® product and its FDA-approved label. (Compl. ¶¶69-70, 78).

’836 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A tablet comprising: (a) an extrudate comprising: (i) a water-soluble polymer matrix; (ii) a dispersing agent; and (iii) a compound of Formula I... MSN’s generic products are tablets containing ubrogepant, which the complaint alleges are equivalent to UBRELVY® and must therefore contain an equivalent formulation. ¶¶78-79 col. 3:41-47
wherein the dispersing agent and compound of Formula I is dispersed within said polymer matrix; and (b) a disintegration system, The complaint alleges that MSN's generic product will be bioequivalent, which suggests it must achieve rapid disintegration and dissolution through a comparable formulation structure. ¶¶69, 78 col. 4:1-12
wherein said tablet has a hardness of from about 12 kP to about 18 kP, The complaint does not provide specific details on the physical properties of MSN's tablets but alleges they are equivalent to UBRELVY®, which is covered by the patent. ¶78 col. 4:8-9
and wherein said tablet achieves complete disintegration in less than about 5 minutes... The complaint's theory rests on the allegation that MSN's product must be bioequivalent, which necessitates rapid disintegration to achieve the required therapeutic effect. ¶¶69, 78 col. 4:9-12
  • Identified Points of Contention:
    • Technical Questions: The central question is factual: what is the actual composition and manufacturing process of MSN's generic products? The complaint provides no direct evidence. The dispute will focus on whether MSN's formulation uses a "water-soluble polymer matrix," a "dispersing agent," and a "disintegration system" that fall within the scope of the claims, and whether the final tablet meets the claimed hardness and disintegration time limitations.
    • Scope Questions: A potential dispute may arise over whether MSN has "designed around" the patent by, for example, using different excipients that perform similar functions but are chemically distinct from those described and claimed in the patent. The scope of terms like "disintegration system" will be critical.

’515 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for the acute treatment of migraine...in a patient with severe hepatic impairment...wherein the patient has a Child-Pugh score of Child-Pugh Class C, The complaint alleges MSN will induce infringement by providing a product with a label that instructs or encourages physicians to prescribe it for patients with severe hepatic impairment. ¶¶114-116 col. 2:51-54
the method comprising orally administering 50 mg of ubrogepant to the patient, The complaint alleges MSN's proposed label will necessarily mirror the UBRELVY® label, which includes instructions for the 50 mg dose in this patient population. ¶¶70, 116 col. 2:54-55
and wherein the patient's migraine is safely and effectively treated. This element is alleged to be met when physicians and patients follow the instructions on MSN's proposed label. ¶¶114, 116 col. 32:49-50
  • Identified Points of Contention:
    • Evidentiary Questions: The key question is what MSN's proposed product label states. Does it contain instructions for use in patients with severe hepatic impairment? Infringement depends on evidence that MSN's affirmative acts encourage or instruct the performance of the patented method.
    • Legal Questions: A potential dispute may center on whether MSN has engaged in a "skinny label" strategy to omit, or "carve out," the patented method of use from its proposed labeling. If successful, this could provide a defense to induced infringement.

V. Key Claim Terms for Construction

For the ’836 Patent (Formulation):

  • The Term: "disintegration system"
  • Context and Importance: This term is central to the invention, as the combination of a stable solid dispersion with a rapid disintegration mechanism is the core technical solution. Infringement will depend on whether MSN's product contains a set of excipients that meets the definition of this system.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language defines the system functionally: one that "achieves complete disintegration in less than about 5 minutes" under specific test conditions (’836 Patent, col. 16:62-65). This may support a construction covering any combination of excipients that achieves this result.
    • Evidence for a Narrower Interpretation: The specification repeatedly describes the preferred system as comprising "powdered sodium chloride and croscarmellose sodium," often in a "1:1 wt. ratio." (’836 Patent, col. 4:13-16). A defendant may argue that the term should be limited to this specific embodiment or its close equivalents.

For the ’515 Patent (Method of Use):

  • The Term: "safely and effectively treated"
  • Context and Importance: This term appears in the final clause of the method claim. Its construction could impact the scope of infringement, as a defendant might argue it imposes an additional requirement beyond simply performing the claimed administrative step.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Plaintiffs may argue this is a statement of intended purpose or inherent result of performing the claimed method steps. The specification links the 50 mg dose to clinical data showing it provides the appropriate exposure level in patients with severe hepatic impairment, implying safety and efficacy are the natural outcome. (’515 Patent, col. 3:45-52).
    • Evidence for a Narrower Interpretation: A defendant could argue the term is indefinite for failing to inform a person of ordinary skill what specific clinical outcome constitutes "safe and effective." Alternatively, they could argue that it requires proof of a successful clinical outcome in an individual patient for infringement to occur, a high evidentiary bar.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for all four patents. The basis is the allegation that MSN’s proposed package insert and promotional activities will instruct and encourage medical professionals and patients to use MSN's generic products in a manner that directly infringes the claims (e.g., by prescribing the patented methods of use). (Compl. ¶¶82-83, 115-116, 143-144, 172-173). For the formulation patents ('836 and '709), the complaint also alleges contributory infringement, stating the products are especially adapted for an infringing use and have no substantial non-infringing use. (Compl. ¶¶86-87, 176-177).
  • Willful Infringement: The complaint does not use the term "willful infringement." However, it alleges that MSN had knowledge of the ’836, ’515, and ’542 patents as evidenced by its Paragraph IV Notice Letter. (Compl. ¶¶82, 115, 143). For the ’709 patent, which was issued after the date of the Notice Letter, the complaint alleges that the filing of the lawsuit itself provides notice. (Compl. ¶¶166, 183). These allegations may form the basis for a later claim of enhanced damages.

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

This case presents a classic Hatch-Waxman dispute that will likely turn on three central questions:

  1. A core issue for the formulation patents ('836 and '709) will be one of technical proof: does the specific, and currently undisclosed, formulation of MSN's generic product literally meet every element of the asserted composition claims, or did MSN successfully "design around" the patents with a non-infringing formulation that is merely bioequivalent?
  2. A key question for the method-of-use patents ('515 and '542) will be one of induced infringement: does MSN's proposed product label contain language that actively instructs or encourages physicians to prescribe the drug for the patented uses (e.g., in patients with severe hepatic or renal impairment), or has MSN utilized a "skinny label" to carve out these patented indications?
  3. An overarching issue for the entire case will be patent validity: can MSN prove, by clear and convincing evidence, that the asserted claims are invalid, as it certified to the FDA? The details of these invalidity contentions, once revealed, will define a major front in the litigation.