DCT

1:25-cv-01086

Alkermes Inc v. Apotex Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01086, D. Del., 08/28/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Apotex Corp. is a Delaware corporation and Defendant Apotex Inc., a foreign corporation, is subject to personal jurisdiction in the district based on past litigation conduct and planned business activities.
  • Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the drug LYBALVI® constitutes an act of infringement of three patents related to immediate-release multilayer tablet formulations.
  • Technical Context: The technology concerns pharmaceutical formulations designed to combine two chemically incompatible active ingredients—olanzapine (an antipsychotic) and samidorphan (an agent to mitigate olanzapine-induced weight gain)—into a single, stable, immediate-release tablet.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a notice letter from Apotex, dated July 14, 2025, which included a Paragraph IV certification against two of the patents-in-suit. The complaint alleges Apotex has previously litigated patent disputes in the District of Delaware and consented to personal jurisdiction in those cases.

Case Timeline

Date Event
2020-11-12 Priority Date for '466, '111, and '474 Patents
2021-05-28 FDA approval for Plaintiff's LYBALVI® product
2023-07-25 U.S. Patent No. 11,707,466 Issued
2024-04-09 U.S. Patent No. 11,951,111 Issued
2025-07-14 Defendant sent Notice Letter regarding ANDA filing
2025-08-19 U.S. Patent No. 12,390,474 Issued
2025-08-20 '474 Patent listed in FDA Orange Book (approx.)
2025-08-28 Complaint Filed

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

U.S. Patent No. 11,707,466 - "Immediate Release Multilayer Tablet"

  • Patent Identification: U.S. Patent No. 11,707,466, "Immediate Release Multilayer Tablet," issued July 25, 2023 (’466 Patent, cover; Compl. ¶31).

The Invention Explained

  • Problem Addressed: The patent’s background section states that while atypical antipsychotic drugs like olanzapine are effective, they frequently cause significant weight gain, which can lead to patient non-compliance and other serious health risks (’466 Patent, col. 1:36-52). A further technical challenge is that olanzapine and samidorphan—an agent that can mitigate weight gain—are chemically incompatible and degrade when formulated together, making a stable, single-pill combination difficult to achieve (’466 Patent, col. 2:55-58).
  • The Patented Solution: The invention is a multilayer tablet, specifically a bilayer tablet, that physically separates the olanzapine and samidorphan into distinct layers (’466 Patent, Abstract; col. 3:1-9). This physical separation prevents the chemical interaction and subsequent degradation of the active ingredients, while specific excipients and formulation parameters ensure that both drugs are released immediately upon administration (’466 Patent, Abstract).
  • Technical Importance: The bilayer tablet design enables the creation of a stable, once-daily oral combination therapy for two chemically incompatible drugs, which can improve patient convenience and adherence while addressing a critical side effect of an important class of medication (’466 Patent, col. 2:48-54).

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the ’466 Patent (Compl. ¶57). Independent claim 1 is representative of the patented composition.
  • Essential Elements of Independent Claim 1:
    • A pharmaceutically acceptable coated immediate release bilayer tablet for delivering a fixed dose of olanzapine and 10 mg of samidorphan.
    • A first tablet layer comprising specific amounts of samidorphan, microcrystalline cellulose, lactose, and magnesium stearate.
    • A second, distinct tablet layer comprising a dose of olanzapine and specific amounts of microcrystalline cellulose, lactose, and magnesium stearate.
    • A film coating over both layers.
  • The complaint does not specify assertion of dependent claims, but the general allegation reserves the right to do so.

U.S. Patent No. 11,951,111 - "Immediate Release Multilayer Tablet"

  • Patent Identification: U.S. Patent No. 11,951,111, "Immediate Release Multilayer Tablet," issued April 9, 2024 (’111 Patent, cover; Compl. ¶34).

The Invention Explained

  • Problem Addressed: The patent addresses the same problems as the ’466 Patent: the clinical need to mitigate weight gain associated with olanzapine therapy and the technical hurdle of chemical incompatibility between olanzapine and the mitigating agent, samidorphan (’111 Patent, col. 1:15-55, col. 2:55-58).
  • The Patented Solution: The invention is a method of treating schizophrenia or bipolar I disorder by administering the specific bilayer tablet composition described in the patent family. The claims are directed to the use of a tablet that physically separates the two active pharmaceutical ingredients to ensure stability, formulated to achieve a specific, rapid dissolution profile for both drugs (’111 Patent, Abstract; col. 15:46-51).
  • Technical Importance: This patent claims the therapeutic application of the formulation technology, protecting the use of the stable combination tablet to achieve a desired clinical outcome in patients with specific psychiatric disorders (’111 Patent, col. 15:9-14).

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the ’111 Patent (Compl. ¶77). Independent claim 1 is representative of the claimed method.
  • Essential Elements of Independent Claim 1:
    • A method of treating schizophrenia or bipolar I disorder.
    • The method comprises orally administering, once daily, a specific coated immediate release bilayer tablet.
    • The tablet contains a first layer with samidorphan and a second layer with olanzapine, each with specified excipients and weight percentages.
    • The tablet exhibits a specific dissolution profile, releasing at least 97% of both drugs within 30 minutes under defined testing conditions.
  • The complaint implicitly reserves the right to assert dependent claims.

U.S. Patent No. 12,390,474 - "Immediate Release Multilayer Tablet"

  • Patent Identification: U.S. Patent No. 12,390,474, "Immediate Release Multilayer Tablet," issued August 19, 2025 (’474 Patent, cover; Compl. ¶37).
  • Technology Synopsis: This patent, part of the same family, also addresses the chemical incompatibility between olanzapine and samidorphan by using a multilayer tablet structure (’474 Patent, col. 2:55-58). The invention provides a stable, single-unit oral dosage form that allows for immediate release of both active pharmaceutical ingredients, overcoming the degradation that would occur in a simple mixture (’474 Patent, Abstract).
  • Asserted Claims: The complaint asserts "one or more claims" (Compl. ¶97). Independent claims include 1, 11, 14, and 15.
  • Accused Features: The complaint accuses Apotex's proposed generic version of LYBALVI® of infringing. The allegations suggest the accused product is a multilayer tablet containing olanzapine and samidorphan for treating schizophrenia and bipolar I disorder, thereby embodying the patented technology (Compl. ¶¶10, 49, 101).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Apotex's ANDA Product," a proposed generic version of LYBALVI® that is the subject of Abbreviated New Drug Application No. 220455 filed with the U.S. Food and Drug Administration (Compl. ¶¶10, 47).

Functionality and Market Context

  • The complaint alleges that Apotex has represented to the FDA that its ANDA Product has the same active ingredients (olanzapine and samidorphan), dosage form, and strengths as Plaintiff's LYBALVI® product and is bioequivalent to it (Compl. ¶49). LYBALVI® is an approved combination drug product for the treatment of schizophrenia and bipolar I disorder (Compl. ¶44). The function of the combination is to provide the therapeutic effects of the antipsychotic olanzapine while using samidorphan to counteract metabolic side effects, particularly weight gain (Compl. ¶44). Apotex allegedly intends to market and sell its generic product in the United States upon receiving final FDA approval, directly competing with and displacing sales of LYBALVI® (Compl. ¶¶11, 19).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not include a claim chart or detail a specific, limitation-by-limitation infringement theory. The infringement allegations are premised on the fact that Apotex's ANDA filing seeks approval for a generic drug that is necessarily a copy of LYBALVI® in its composition and function. The summary below is based on this theory.

’466 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutically acceptable coated immediate release bilayer tablet for orally delivering a fixed dose of olanzapine and 10 mg of samidorphan Apotex's ANDA Product is alleged to be a generic, bioequivalent version of LYBALVI®, which is a coated, immediate release, bilayer tablet formulation. ¶¶10, 49 col. 3:1-4
a first tablet layer comprising: 10 mg samidorphan... about 35-43 wt% microcrystalline cellulose... about 37-43 wt % lactose... and about 1.5 to about 2 wt% magnesium stearate The ANDA Product is alleged to contain a layer with samidorphan and to use the same or equivalent excipients in similar weight percentages to achieve bioequivalence with LYBALVI®. ¶49 col. 3:36-45
a second tablet layer comprising: a dose of olanzapine... about 38-42 wt % microcrystalline cellulose... about 46-49 wt % lactose... and about 1.0 wt % magnesium stearate The ANDA Product is alleged to contain a separate layer with olanzapine and to use the same or equivalent excipients in similar weight percentages to achieve bioequivalence with LYBALVI®. ¶49 col. 3:45-58
and a film coating over the first and second tablet layer The ANDA Product is alleged to be a coated tablet, consistent with the formulation of the LYBALVI® product. ¶49 col. 4:20-21

’111 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating schizophrenia or bipolar I disorder... comprising orally administering... a... bilayer tablet The proposed labeling for Apotex's ANDA Product will allegedly instruct physicians and patients to administer the product for the claimed indications, thereby inducing infringement of the method claim. ¶¶15, 80-81 col. 15:9-14
[compositional elements of the bilayer tablet...] Apotex's ANDA product is alleged to be a bilayer tablet with the same composition and structure as LYBALVI®, thereby meeting these limitations when administered. ¶49 col. 3:1-58
wherein the tablet releases at least 97% of olanzapine and at least 97% of the samidorphan after 30 minutes... As a bioequivalent product, Apotex's ANDA Product is alleged to have a dissolution profile that meets this functional release limitation. ¶49 col. 12:44-54
  • Identified Points of Contention:
    • Scope Questions: A central dispute may concern the scope of the quantitative limitations in the claims, particularly the weight percentage ranges for excipients modified by the term "about" (e.g., "about 35-43 wt%"). This raises the question of whether a formulation that is bioequivalent but uses excipient percentages outside the literal claimed ranges can be considered infringing. The construction of "bilayer tablet" may also be contested if Apotex's product uses an alternative structure for separating the active ingredients.
    • Technical Questions: Since the complaint does not contain the specific formulation of the ANDA product, a key technical question for discovery will be how Apotex's product achieves bioequivalence. The dispute may focus on whether Apotex uses the same claimed combination of excipients and physical structure or has developed a non-infringing "design-around" formulation that achieves the same clinical result through a different technical means.

V. Key Claim Terms for Construction

  • The Term: "bilayer tablet"

  • Context and Importance: This structural term is fundamental to the claims of the patents-in-suit. Its construction will determine whether infringement can be avoided by using an alternative tablet structure (e.g., a tablet-in-tablet or other multilayer arrangement) that still physically separates the two active ingredients. Practitioners may focus on this term because Apotex's non-infringement position could depend on arguing its product is not, structurally, a "bilayer tablet."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification states, "The disclosure contemplates multi-layer tablets as well as a bilayer tablet," which suggests "bilayer" could be viewed as one example of a broader inventive concept of physical separation by layering (’466 Patent, col. 3:1-4).
    • Evidence for a Narrower Interpretation: The independent claims specifically recite a "bilayer tablet," not the broader "multilayer" term (’466 Patent, col. 33:8). The detailed description of the manufacturing process focuses on compressing two distinct blend layers together, which may support a narrower definition requiring two parallel strata (’466 Patent, col. 7:35-40).

  • The Term: "about [X-Y] wt%" (e.g., "about 35-43 wt% microcrystalline cellulose")

  • Context and Importance: The scope of the numerical ranges for excipients is critical in ANDA litigation. A defendant may seek to avoid infringement by formulating its generic product with weight percentages that are numerically outside the claimed range. The definition of "about" will determine whether such a formulation is nonetheless infringing.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent describes certain formulations as "exemplary preferred," which may suggest that variations are contemplated (’466 Patent, col. 4:50). A broader reading might encompass any percentage that achieves the same function (e.g., stability and immediate release) in a substantially similar way.
    • Evidence for a Narrower Interpretation: The claims recite very specific numerical ranges (’466 Patent, Claim 1). The patent's examples provide tables with highly precise weight percentages (e.g., 38.46% and 42.23%), which could be used to argue that the inventors considered these specific ranges to be important for the invention's performance and that "about" should be limited to minor experimental variance (’466 Patent, col. 19-20, Table 4).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce infringement of the method claims upon FDA approval by marketing the ANDA product with labeling that instructs physicians and patients to administer it for the treatment of schizophrenia and bipolar I disorder (Compl. ¶¶61, 81, 102). It further alleges contributory infringement, stating that the ANDA product is especially made for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶¶62, 82, 103).
  • Willful Infringement: The complaint alleges that Defendants had pre-suit knowledge of the patents. For the ’466 and ’111 Patents, knowledge is predicated on the Paragraph IV notice letter sent by Defendants (Compl. ¶¶63, 83). For the later-issued ’474 Patent, knowledge is alleged based on its public listing in the FDA's Orange Book (Compl. ¶104). The willfulness allegation is based on Defendants' intent to proceed with commercialization despite this alleged knowledge.

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

  • A core issue will be one of definitional scope: can the term "bilayer tablet" and the quantitative "about [X-Y] wt%" ranges for excipients be construed narrowly to the specific embodiments disclosed, or will they be interpreted more broadly to cover other structures or formulations that achieve the same functional result of a stable, bioequivalent, immediate-release combination product?
  • A central evidentiary question will be one of technical identity: does Apotex's ANDA product, which is designed to be a clinical copy, achieve bioequivalence by also being a technical copy that falls within the literal scope of the claims, or has Apotex engineered a non-infringing design-around that utilizes a different structure or formulation?