DCT

1:25-cv-15324

Alkermes Inc v. MSN Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-15324, D.N.J., 09/05/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendants having regular and established places of business in the district, deriving substantial revenue from the state, and preparing and filing the Abbreviated New Drug Application (ANDA) from Piscataway, New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA to the U.S. Food and Drug Administration seeking approval to market a generic version of Plaintiff’s LYBALVI® product constitutes an act of infringement of four U.S. patents.
  • Technical Context: The technology concerns pharmaceutical formulations and methods for treating psychiatric disorders by combining the atypical antipsychotic olanzapine with the opioid antagonist samidorphan, which is intended to mitigate olanzapine-induced weight gain.
  • Key Procedural History: This is a Hatch-Waxman action initiated in response to a Notice Letter from Defendant MSN, which included a Paragraph IV certification stating its belief that certain patents listed in the FDA’s Orange Book for LYBALVI® are invalid, unenforceable, or will not be infringed by its proposed generic product.

Case Timeline

Date Event
2010-08-23 ’960 Patent Priority Date
2014-07-15 U.S. Patent No. 8,778,960 Issues
2020-11-12 ’466, ’111, and ’474 Patents Priority Date
2021-05-28 FDA approves Plaintiff'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
2025-07-30 Defendant sends Notice Letter regarding its ANDA submission
2025-08-19 U.S. Patent No. 12,390,474 Issues
2025-08-20 ’474 Patent listed in the FDA Orange Book
2025-09-05 Complaint for Patent Infringement filed

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

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

The Invention Explained

  • Problem Addressed: The patent describes that olanzapine, an effective antipsychotic, and samidorphan, an agent used to mitigate olanzapine-induced weight gain, are chemically incompatible and that olanzapine is susceptible to degradation in the presence of samidorphan ('466 Patent, col. 2:54-61). This incompatibility poses a significant challenge to creating a stable combination drug product.
  • The Patented Solution: The invention is a multi-layer tablet, specifically a bilayer tablet, that physically separates the olanzapine and samidorphan into distinct layers ('466 Patent, col. 2:62-col. 3:2). This structure prevents the chemical interaction and subsequent degradation of the active ingredients, while still allowing for their simultaneous, immediate release upon ingestion, thereby ensuring the stability and efficacy of the combination therapy from a single dosage form ('466 Patent, col. 3:2-6).
  • Technical Importance: This formulation provides a stable, single-tablet combination therapy, which can enhance patient convenience and compliance for a treatment that addresses both a primary psychiatric condition and a significant medication-induced side effect ('466 Patent, col. 2:65-col. 3:2).

Key Claims at a Glance

  • The complaint asserts one or more claims of the ’466 Patent (Compl. ¶68). Independent claim 1 is representative of the asserted composition claims.
  • Essential Elements of Claim 1:
    • 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 samidorphan (or a salt thereof), about 35-43 wt % microcrystalline cellulose, about 37-43 wt % lactose, and about 1.5 to 2.0 wt % magnesium stearate.
    • A second tablet layer comprising a dose of olanzapine (5, 10, 15, or 20 mg), about 38-42 wt % microcrystalline cellulose, about 46-49 wt % lactose, and about 1.0 wt % magnesium stearate.
    • A film coating over the first and second tablet layers.
  • The complaint does not explicitly reserve the right to assert dependent claims.

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

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problem as the ’466 Patent: the chemical incompatibility of olanzapine and samidorphan, which complicates the development of a stable combination oral dosage form (’111 Patent, col. 2:54-61).
  • The Patented Solution: The invention claims a method of treating schizophrenia or bipolar I disorder by orally administering the specific bilayer tablet formulation that physically separates the two active ingredients (’111 Patent, Claim 1). The patent ties the therapeutic method directly to the use of the stable, immediate-release, bilayer tablet structure.
  • Technical Importance: The patent provides method-of-use protection for the specific bilayer tablet formulation, linking the novel structure of the drug product to its intended therapeutic application and creating an additional layer of intellectual property protection.

Key Claims at a Glance

  • The complaint asserts one or more claims of the ’111 Patent (Compl. ¶88). Independent claim 1 is a method of treatment claim.
  • Essential Elements of Claim 1:
    • A method of treating schizophrenia or bipolar I disorder in a patient.
    • The method comprises orally administering a specific pharmaceutically acceptable coated immediate release bilayer tablet.
    • The administered tablet contains a first layer with 10 mg samidorphan and specific excipients/percentages and a second layer with a dose of olanzapine and specific excipients/percentages, mirroring the structure claimed in the ’466 Patent.
    • The tablet has a specified dissolution profile, releasing at least 97% of both active ingredients after 30 minutes in a specific test condition.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 8,778,960 - "Methods for Treating Antipsychotic-Induced Weight Gain"

  • Technology Synopsis: The patent addresses the problem of significant weight gain associated with atypical antipsychotic drugs like olanzapine, which is a common reason for patient non-compliance (’960 Patent, col. 1:40-67). The patented solution is a method of reducing this pharmacologically induced weight gain by administering an effective amount of an opioid receptor modulator, identified as samidorphan (referred to as "Compound 1" in the specification), to a patient in need thereof (’960 Patent, col. 2:40-48, Claim 1). Figure 1 of the patent graphically depicts experimental results showing that co-administration of olanzapine with Compound 1 significantly mitigates weight gain in rats compared to olanzapine alone (’960 Patent, Fig. 1).
  • Asserted Claims: The complaint asserts one or more claims of the patent (Compl. ¶108). Claim 1 is the sole independent claim.
  • Accused Features: The accused feature is the intended use of MSN’s ANDA Product, which contains both olanzapine and samidorphan. The complaint alleges that the product's proposed package insert will instruct healthcare providers and patients to use the product, thereby directly infringing the claimed method of reducing antipsychotic-induced weight gain (Compl. ¶¶113, 115, 116).

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

  • Technology Synopsis: Like the related ’466 and ’111 patents, this patent addresses the chemical incompatibility between olanzapine and samidorphan by claiming a multilayer tablet structure (’474 Patent, col. 2:54-61). The claims are directed to a tablet composition with specific diluents and disintegrants in each layer, along with specified dissolution profiles, designed to ensure stability and immediate release of both active ingredients (’474 Patent, Claims 1, 14, 15).
  • Asserted Claims: The complaint asserts one or more claims of the patent (Compl. ¶139). The independent claims are 1, 6, 11, 14, and 15.
  • Accused Features: The accused feature is the physical composition and formulation of MSN’s ANDA Product itself. The complaint alleges that by being a bioequivalent generic, the product will necessarily embody the claimed bilayer structure and excipient composition (Compl. ¶60, ¶139).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "MSN's ANDA Product," a proposed generic version of LYBALVI® for which MSN Pharmaceuticals, Inc. has filed Abbreviated New Drug Application (ANDA) No. 220726 with the FDA (Compl. ¶11, ¶58).

Functionality and Market Context

  • The ANDA Product is an oral tablet combining two active pharmaceutical ingredients: olanzapine, an antipsychotic, and samidorphan, an opioid receptor antagonist (Compl. ¶55, ¶60). The product is intended for the treatment of schizophrenia and bipolar disorder, with the samidorphan component functioning to counteract metabolic side effects, such as weight gain, associated with olanzapine (Compl. ¶52, ¶55). The complaint alleges that MSN has represented to the FDA that its product has the same active ingredients, dosage form, and strengths as LYBALVI® and is bioequivalent to it (Compl. ¶60).

IV. Analysis of Infringement Allegations

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 for orally delivering a fixed dose of olanzapine and 10 mg of samidorphan... MSN’s ANDA Product is alleged to be a generic version of the LYBALVI® bilayer tablet, containing the same dosage form and strengths of olanzapine and samidorphan. ¶60 col. 3:35-37
a first tablet layer comprising: 10 mg samidorphan or a pharmaceutically acceptable salt...about 35-43 wt % microcrystalline cellulose...about 37-43 wt % lactose... As a bioequivalent generic, MSN's ANDA Product is alleged to contain a first layer with 10 mg of samidorphan and the same excipients in substantially the same weight percentages as required by the claim. ¶60 col. 3:37-51
a second tablet layer comprising: a dose of olanzapine selected from the group consisting of 5 mg, 10 mg, 15 mg and 20 mg...about 38-42 wt % microcrystalline cellulose... As a bioequivalent generic, MSN's ANDA Product is alleged to contain a second, separate layer with a dose of olanzapine and the same excipients in substantially the same weight percentages as required by the claim. ¶60 col. 3:52-col. 4:2
a film coating over the first and second tablet layer... The ANDA product is alleged to be a coated tablet that is bioequivalent to LYBALVI®, which is a film-coated tablet. ¶60 col. 4:3-4

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 in a patient in need thereof, the method comprising orally administering to the patient, once daily, a...bilayer tablet... The complaint alleges MSN intends to market its ANDA Product with a package insert that will instruct healthcare providers and patients to administer the tablet for its approved indications, which include schizophrenia and bipolar I disorder. ¶91, ¶98, ¶99 col. 15:10-24
wherein the bilayer tablet comprises: a first tablet layer comprising: 10 mg samidorphan...a second tablet layer comprising: a dose of olanzapine... The ANDA Product itself is alleged to be the specific bilayer tablet recited in the claim, containing separate layers of olanzapine and samidorphan with the claimed excipients and proportions, as it is represented to be a bioequivalent generic copy of LYBALVI®. ¶60, ¶88 col. 31:48-col. 32:6
wherein the tablet releases at least 97% of olanzapine and at least 97% of the samidorphan after 30 minutes when the tablet is tested in 500 mL USP acetate buffer at pH 1.0... As MSN's product is alleged to be bioequivalent to LYBALVI®, its dissolution profile is expected to meet the release rate limitations defined in the claim. ¶60 col. 32:7-14

Identified Points of Contention

  • Scope Questions: The infringement allegations rely heavily on the representation that MSN's ANDA Product is bioequivalent to LYBALVI® (Compl. ¶60). A central question will be one of formulation identity: does the specific formulation detailed in MSN's ANDA—including the precise excipients, their weight percentages, and the tablet structure—fall within the literal scope of the asserted claims, particularly the numerical ranges defined by terms such as "about 35-43 wt %"?
  • Technical Questions: For the method claims of the ’111 Patent, a key question will be one of inducement: what evidence does the complaint provide that the proposed label for MSN's ANDA Product will instruct or encourage administration in a manner that satisfies all limitations of the claimed method, including the specific dissolution profile?

V. Key Claim Terms for Construction

The Term: "bilayer tablet" (’466 Patent, Claim 1)

  • Context and Importance: This term defines the core physical structure of the claimed invention, which is central to solving the problem of chemical incompatibility. The scope of this term is critical because if the accused product uses a different structure (e.g., a tablet-in-tablet, a three-layer tablet, or a granulated mixture), it may fall outside the claims' literal scope. Practitioners may focus on whether this term is limited to a structure of exactly two layers in direct contact.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification introduces the invention in the context of "multi-layer tablets" generally, suggesting the concept is not strictly limited to two layers, and refers to the bilayer as a preferred embodiment (’466 Patent, col. 3:2-6).
    • Evidence for a Narrower Interpretation: The independent claims consistently and exclusively recite a "bilayer tablet" comprising a "first tablet layer" and a "second tablet layer," and the detailed embodiments focus entirely on this two-layer structure, which may support a construction limited to exactly two layers (’466 Patent, col. 3:35-37; Claim 1).

The Term: "about" (as used in numerical ranges, e.g., "about 35-43 wt %") (’466 Patent, Claim 1)

  • Context and Importance: The claims recite specific weight percentage ranges for the excipients. The definition of "about" will determine the degree of flexibility in these ranges and will be critical to the infringement analysis, as the accused product may have slightly different percentages.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of "about" itself implies that the inventors did not intend for the numerical ranges to be exact and absolute. The specification describes the invention in functional terms, suggesting that variations that achieve the same result should be included.
    • Evidence for a Narrower Interpretation: The patent provides numerous examples with highly specific formulation tables detailing excipient percentages to two decimal places (e.g., ’466 Patent, Tables 4-7). A party might argue that this level of precision informs a narrow interpretation of "about," limiting it to minor variations that do not affect the stated values.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges both induced and contributory infringement for all four patents-in-suit. The allegations of inducement are based on the assertion that Defendants' marketing and the proposed package insert for the ANDA Product will encourage and instruct healthcare providers and patients to use the product in an infringing manner (Compl. ¶79, ¶99, ¶115). Contributory infringement is alleged on the basis that the ANDA product is especially made or adapted for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶81, ¶101, ¶120).

Willful Infringement

  • The complaint does not contain a separate count for willful infringement, but it lays the factual groundwork for such a claim. It alleges that Defendants had pre-suit knowledge of the ’960, ’111, and ’466 Patents via the Paragraph IV Notice Letter and of the ’474 Patent via its public listing in the FDA’s Orange Book (Compl. ¶74, ¶94, ¶111, ¶147). The prayer for relief seeks a declaration that this is an exceptional case and an award of attorneys' fees, which is consistent with an allegation of willful infringement (Compl. p. 29, ¶G).

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

  • A primary issue will be one of structural and compositional equivalence: will discovery reveal that MSN's proposed generic product employs the specific bilayer structure and falls within the claimed weight percentage ranges for its excipients, or will minor formulation differences provide a basis for a non-infringement argument?
  • A key evidentiary question will concern induced infringement: will the final, FDA-approved label for MSN's product contain explicit instructions for treating schizophrenia or bipolar I disorder in a manner that directly maps onto the elements of the asserted method claims, thereby establishing the requisite intent for inducement?
  • As is typical in ANDA litigation, a central focus of the defense will likely be patent validity. The case may turn on whether Defendants can establish by clear and convincing evidence that combining these two known compounds in a bilayer tablet—a common formulation technique for incompatible drugs—was obvious to a person of ordinary skill in the art at the time of the invention.