DCT

1:25-cv-14977

Alkermes Inc v. Apotex Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-14977, D.N.J., 08/27/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Apotex Inc. is a foreign corporation subject to personal jurisdiction in the district, and Defendant Apotex Corp. allegedly has a regular and established place of business in New Jersey and has engaged in business activities within the state related to the subject of the suit.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the drug LYBALVI® constitutes an act of infringement of three U.S. patents covering formulations of the drug.
  • Technical Context: The technology involves immediate-release bilayer pharmaceutical tablets designed to combine olanzapine, an effective antipsychotic, with samidorphan, an agent that mitigates olanzapine-induced weight gain, in a single, chemically stable dosage form.
  • Key Procedural History: This is a Hatch-Waxman action initiated under 35 U.S.C. § 271(e)(2) following Defendants' submission of ANDA No. 220455 with a Paragraph IV certification, asserting that the patents-in-suit will not be infringed. The complaint was filed within the 45-day statutory window following receipt of Defendants' notice letter, triggering a potential 30-month stay of FDA approval for the generic product.

Case Timeline

Date Event
2020-11-12 Earliest Priority Date for ’466, ’111, and ’474 Patents
2021-05-28 FDA approves Alkermes's New Drug Application for LYBALVI®
2023-07-25 U.S. Patent No. 11,707,466 issues
2024-04-09 U.S. Patent No. 11,951,111 issues
2025-07-14 Apotex sends Notice Letter regarding ANDA filing
2025-07-15 Alkermes receives Apotex's Notice Letter
2025-08-19 U.S. Patent No. 12,390,474 issues
2025-08-20 The ’474 Patent is listed in the FDA Orange Book (approx.)
2025-08-27 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). (Compl. ¶31).

The Invention Explained

  • Problem Addressed: The patent’s background section states that while atypical antipsychotic drugs like olanzapine are effective for treating psychotic disorders, they often cause significant weight gain, which can lead to patient noncompliance and other serious health conditions like diabetes (Compl. ¶41; ’466 Patent, col. 1:36-54). Furthermore, olanzapine is chemically incompatible with samidorphan, a compound that can mitigate weight gain, leading to degradation of olanzapine when the two are combined in a single formulation (’466 Patent, col. 2:55-58).
  • The Patented Solution: The invention is a multi-layer tablet that physically separates olanzapine and samidorphan into distinct layers (’466 Patent, col. 2:65-col. 3:4). This bilayer structure prevents the chemical interaction and degradation of the active ingredients while allowing them to be delivered in a single, immediate-release oral dosage form, ensuring both are released quickly once administered (’466 Patent, col. 2:59-64).
  • Technical Importance: This formulation provides a single-tablet therapy that delivers the efficacy of olanzapine while simultaneously addressing its most significant side effect, thereby improving the potential for patient adherence and better long-term health outcomes. (Compl. ¶42).

Key Claims at a Glance

  • The complaint alleges infringement of one or more unspecified claims (Compl. ¶57). Independent claim 1 is a representative composition claim.
  • Claim 1 requires:
    • A pharmaceutically acceptable coated immediate release bilayer tablet.
    • For orally delivering a fixed dose of olanzapine and 10 mg of samidorphan.
    • A first tablet layer comprising 10 mg of samidorphan (or its salt equivalent) and specific weight percentages of microcrystalline cellulose, lactose, and magnesium stearate.
    • A second tablet layer comprising a specified dose of olanzapine (5, 10, 15, or 20 mg) and specific weight percentages of microcrystalline cellulose, lactose, and magnesium stearate.
    • A film coating over both layers.
      (’466 Patent, col. 33:8-30).

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). (Compl. ¶34).

The Invention Explained

  • Problem Addressed: The patent addresses the same technical challenges as the ’466 Patent: the significant weight gain associated with olanzapine therapy and the chemical incompatibility between olanzapine and the weight-mitigating agent samidorphan. (’111 Patent, col. 1:35-53, col. 2:55-58).
  • The Patented Solution: The invention is a method of treating schizophrenia or bipolar I disorder by administering a multi-layer tablet that physically separates olanzapine and samidorphan (’111 Patent, col. 2:46-60). The claims specify not only the tablet's composition but also its functional dissolution characteristics, requiring a rapid release of both active ingredients under specific testing conditions (’111 Patent, col. 32:61-col. 33:3).
  • Technical Importance: This patent claims the therapeutic use of the specific bilayer tablet formulation, linking the structural solution of chemical incompatibility to a method of treating patients with specific psychiatric disorders. (Compl. ¶41-42).

Key Claims at a Glance

  • The complaint alleges infringement of one or more unspecified claims (Compl. ¶77). Independent claim 1 is a representative method of treatment claim.
  • Claim 1 requires:
    • A method of treating schizophrenia or bipolar I disorder by orally administering a specific bilayer tablet once daily.
    • The tablet delivers a fixed dose of olanzapine and 10 mg of samidorphan.
    • The tablet has a first layer with samidorphan and a second layer with olanzapine, each with specified excipients and weight percentages.
    • The tablet has a film coating.
    • The tablet exhibits a specific dissolution profile: releasing at least 97% of both drugs after 30 minutes under defined USP test conditions.
      (’111 Patent, col. 32:38-col. 33:3).

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). (Compl. ¶37).
  • Technology Synopsis: The patent addresses the chemical incompatibility between olanzapine and samidorphan by formulating them into a physically separated, immediate-release, multi-layer tablet (’474 Patent, col. 3:1-10). This structural solution is designed to create a stable, single-dose combination drug that can mitigate the weight-gain side effects of olanzapine while ensuring rapid dissolution of both active ingredients upon administration (’474 Patent, col. 2:48-54).
  • Asserted Claims: The complaint asserts infringement of one or more claims of the ’474 Patent (Compl. ¶97). The patent contains independent claims 1, 11, 14, and 15.
  • Accused Features: The infringement allegation is based on Defendants’ filing of ANDA No. 220455 for a generic version of LYBALVI®, which the complaint asserts is a bioequivalent bilayer tablet containing olanzapine and samidorphan. (Compl. ¶¶49, 97).

III. The Accused Instrumentality

Product Identification

  • Defendants' proposed generic version of LYBALVI®, as described in Abbreviated New Drug Application (ANDA) No. 220455 ("Apotex's ANDA Product"). (Compl. ¶10).

Functionality and Market Context

  • The complaint alleges that Apotex represented to the FDA that its ANDA Product has the "same active ingredient, dosage form, and strengths as LYBALVI® and is bioequivalent to LYBALVI®" (Compl. ¶49). LYBALVI® is an oral tablet combining the antipsychotic olanzapine with samidorphan, an agent intended to counteract the metabolic side effects, such as weight gain, commonly associated with olanzapine (Compl. ¶44). The product is approved for treating schizophrenia and bipolar I disorder and is marketed in four strengths of olanzapine/samidorphan: 5mg/10mg, 10mg/10mg, 15mg/10mg, and 20mg/10mg (Compl. ¶¶41, 45).
  • Defendants are seeking FDA approval to commercially manufacture and sell Apotex’s ANDA Product in the United States prior to the expiration of the patents-in-suit (Compl. ¶14).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart. The following tables summarize the infringement theory for representative independent claims based on the complaint's allegation that the accused product is the "same" as and "bioequivalent" to LYBALVI®.

U.S. Patent No. 11,707,466 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutically acceptable coated immediate release bilayer tablet... Apotex's ANDA Product is allegedly a bilayer tablet with the same dosage form as LYBALVI®. ¶49 col. 3:35-38
...for orally delivering a fixed dose of olanzapine and 10 mg of samidorphan... Apotex's ANDA Product allegedly contains the same active ingredients in the same strengths as LYBALVI®, including formulations with 10 mg of samidorphan. ¶49 col. 3:38-40
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 first layer of Apotex's ANDA Product allegedly contains samidorphan and excipients that result in a product bioequivalent to LYBALVI®. ¶49 col. 3:41-49
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 second layer of Apotex's ANDA Product allegedly contains olanzapine and excipients that result in a product bioequivalent to LYBALVI®. ¶49 col. 3:50-59
and a film coating over the first and second tablet layer. Apotex's ANDA Product is allegedly a coated tablet with the same dosage form as LYBALVI®. ¶49 col. 3:60-61

U.S. Patent No. 11,951,111 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 pharmaceutically acceptable coated immediate release bilayer tablet... Defendants are seeking FDA approval for their ANDA Product with a label that will instruct physicians and patients to administer the tablet for treating these conditions. ¶¶11, 49, 80 col. 32:38-43
...wherein the bilayer tablet comprises: a first tablet layer...a second tablet layer...and a film coating... The administered tablet is Apotex's ANDA Product, which is allegedly a coated bilayer tablet containing the same active ingredients and dosage form as LYBALVI®. ¶49 col. 32:44-60
wherein the tablet releases at least 97% of olanzapine and at least 97% of the samidorphan after 30 minutes... Apotex's ANDA Product is alleged to be bioequivalent to LYBALVI®, which suggests that it meets the claimed dissolution profile. ¶49 col. 32:61-col. 33:3
  • Identified Points of Contention:
    • Scope Questions: The asserted claims recite specific numerical ranges for the weight percentages of excipients (e.g., "about 35-43 wt% microcrystalline cellulose") and functional performance (e.g., "at least 97% of olanzapine... after 30 minutes"). A central question for the court will be whether the specific formulation detailed in Defendants' confidential ANDA falls within the literal scope of these numerical limitations, or alternatively, whether any differences are insubstantial enough to support infringement under the doctrine of equivalents.
    • Technical Questions: The patents solve a chemical incompatibility problem via a specific structural and compositional solution. The complaint does not provide sufficient detail for analysis of Defendants' specific formulation. A key technical question will be what evidence exists that the formulation in the ANDA, while achieving bioequivalence, does so using the same or an equivalent combination of excipients, ratios, and physical structure as required by the claims, versus an alternative, non-infringing formulation strategy.

V. Key Claim Terms for Construction

  • The Term: "bilayer tablet"

    • Context and Importance: This term is foundational to the claimed structure that allegedly solves the chemical incompatibility problem. Its construction will determine whether Defendants' product must have two distinct layers formed from separate blends and then compressed, or if other integrated structures that functionally separate the active ingredients could fall within the claim's scope. Practitioners may focus on this term because the specific method of achieving the "bilayer" structure could be a point of non-infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The Summary of the Invention refers more generally to "multi-layer tablets" and "bi-layer tablets" as an example, which may support an interpretation that is not limited to a single manufacturing method (’466 Patent, col. 2:65-67).
      • Evidence for a Narrower Interpretation: The detailed description and examples consistently describe a process of creating two separate blends—one for samidorphan and one for olanzapine—and then compressing them together to form the tablet (’466 Patent, col. 7:15-35). This may support an argument that "bilayer tablet" implies a structure formed by such a process.

  • The Term: "about"

    • Context and Importance: This term modifies all numerical weight percentage ranges in the composition claims (e.g., "about 35-43 wt%"). The definition of "about" will be critical in determining literal infringement, as Defendants' formulation could be designed to fall just outside the explicit numerical ranges.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides an explicit definition, stating the term "is meant to encompass variations of ±10%, including ±5%, ±1%, and ±0.1% from the specified value, as such variations are appropriate to perform the disclosed methods." (’466 Patent, col. 9:44-48).
      • Evidence for a Narrower Interpretation: Defendants may argue that in the precise art of pharmaceutical formulation, the extensive tables providing specific compositions with exact percentages (e.g., Table 5, Formulation A) suggest that the ranges should be interpreted narrowly and that the boilerplate definition of "about" should be given less weight than the specific examples (’466 Patent, col. 19-22).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Defendants will actively induce infringement by marketing their ANDA Product with instructions for physicians and patients to administer it for the treatment of schizophrenia and bipolar disorder, which would constitute direct infringement of the asserted method claims (Compl. ¶¶68, 81). The complaint also alleges contributory infringement, stating that the accused product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶¶62, 82).
  • Willful Infringement: The complaint does not use the word "willful" in its infringement counts. However, it alleges Defendants have knowledge of the patents, citing their receipt of the Paragraph IV Notice Letter as evidence (Compl. ¶¶63, 83). The prayer for relief requests a declaration that this is an "exceptional case" and seeks an award of attorneys' fees under 35 U.S.C. § 285, which is typically predicated on findings of willful infringement or other litigation misconduct (Compl. p. 21, ¶G).

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

  • A core issue will be one of numerical scope: will the precise weight percentages of the excipients in Defendants' confidential ANDA formulation fall within the literal or equivalent scope of the ranges defined in the asserted claims, particularly in light of the patents' explicit definition of the term "about"?
  • A key evidentiary question will be one of formulation identity: does the evidence within the ANDA show that Defendants achieve bioequivalence by copying the specific formulation taught and claimed in the patents, or have they designed an alternative formulation that achieves the same result through a materially different and potentially non-infringing combination of components and structure?
  • A central legal question for the method claims will be infringement by labeling: will the proposed label for Defendants' ANDA Product instruct users to perform all the steps of the claimed methods of treatment, thereby supporting the allegations of induced infringement upon commercial launch?