DCT

1:25-cv-14685

Alkermes Inc v. Teva Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-14685, D.N.J., 08/20/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Teva Pharmaceuticals, Inc. maintains a regular and established place of business in the district, and the foreign corporate defendants are subject to personal jurisdiction there.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the drug LYBALVI® constitutes an act of patent infringement.
  • Technical Context: The technology concerns pharmaceutical formulations for immediate-release, multi-layer tablets designed to combine two chemically incompatible active ingredients: olanzapine (an antipsychotic) and samidorphan (an agent to mitigate olanzapine's side effect of weight gain).
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a "Notice Letter" from Teva, dated July 3, 2025, informing them of Teva's filing of ANDA No. 220379. The complaint alleges this filing is a statutory act of infringement seeking approval to market a generic product prior to the expiration of the patents-in-suit.

Case Timeline

Date Event
2020-11-12 Earliest Priority Date for all Patents-in-Suit
2021-05-28 FDA approves Alkermes' 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
2025-07-03 Teva sends Notice Letter regarding ANDA No. 220379
2025-08-19 U.S. Patent No. 12,390,474 Issues
2025-08-20 ’474 Patent listed in FDA Orange Book (on or about this date)
2025-08-20 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. 11707466, entitled “Immediate Release Multilayer Tablet,” issued on July 25, 2023 (Compl. ¶38).

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of creating a single oral dosage form containing both the atypical antipsychotic olanzapine and the opioid antagonist samidorphan (’466 Patent, col. 1:15-18). While olanzapine is an effective treatment for disorders like schizophrenia, it is associated with significant weight gain, a side effect that samidorphan can mitigate (’466 Patent, col. 1:36-45, col. 2:27-32). The core technical problem is that olanzapine and samidorphan are chemically incompatible and degrade when formulated together, making a stable, combined tablet difficult to manufacture (’466 Patent, col. 2:55-58).
  • The Patented Solution: The patent discloses a multi-layer, specifically a bilayer, tablet that physically separates the olanzapine and samidorphan into distinct layers (’466 Patent, col. 2:58-63). This structure prevents their chemical interaction, ensuring the stability of both active ingredients, while still allowing for a substantially immediate release profile for both drugs upon administration (’466 Patent, col. 2:50-54). The invention details specific formulations, including types and weight percentages of excipients, that achieve both the required stability and the desired rapid dissolution characteristics (’466 Patent, col. 3:3-20).
  • Technical Importance: This formulation enables the co-administration of two chemically incompatible drugs in a single, stable, once-daily tablet, which may improve patient adherence and therapeutic outcomes by simultaneously treating a primary disorder and mitigating a major side effect (’466 Patent, col. 2:65-col. 3:2).

Key Claims at a Glance

The complaint asserts infringement of one or more claims without specifying them (Compl. ¶63). Independent claim 1 is representative of the patented composition.

  • Independent Claim 1:
    • A pharmaceutically acceptable coated immediate release bilayer tablet for delivering fixed doses of olanzapine and 10 mg of samidorphan.
    • A first layer containing 10 mg of samidorphan (or a salt thereof) and specific weight percentages of microcrystalline cellulose (35-43 wt %), lactose (37-43 wt %), and magnesium stearate (1.5-2.0 wt %).
    • A second layer containing a dose of olanzapine (5, 10, 15, or 20 mg) and specific weight percentages of microcrystalline cellulose (38-42 wt %), lactose (46-49 wt %), and magnesium stearate (1.0 wt %).
    • A film coating over both layers.

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

  • Patent Identification: U.S. Patent No. 11951111, entitled “Immediate Release Multilayer Tablet,” issued on April 9, 2024 (Compl. ¶41).

The Invention Explained

  • Problem Addressed: The ’111 Patent addresses the same technical problem as the ’466 Patent: the chemical incompatibility of olanzapine and samidorphan, which complicates the development of a stable, single-tablet combination therapy designed to treat psychotic disorders while mitigating weight-gain side effects (’111 Patent, col. 1:15-col. 2:40).
  • The Patented Solution: The solution is also a multi-layer tablet that physically separates the two active ingredients to prevent degradation while enabling immediate release (’111 Patent, col. 2:45-54). The ’111 Patent claims a method of using such a tablet, with specific compositional and functional (dissolution rate) characteristics, to treat schizophrenia or bipolar I disorder (’111 Patent, col. 32:36-67).
  • Technical Importance: As with the ’466 Patent, this invention provides a method for using a stable combination therapy that may enhance patient compliance by simplifying the treatment regimen for serious mental illnesses (’111 Patent, col. 2:65-col. 3:2).

Key Claims at a Glance

The complaint asserts infringement of one or more claims without specification (Compl. ¶83). Independent claim 1 is a representative method of treatment claim.

  • Independent Claim 1:
    • A method of treating schizophrenia or bipolar I disorder.
    • The method comprises orally administering, once daily, a specific pharmaceutically acceptable coated immediate release bilayer tablet.
    • The tablet delivers a fixed dose of olanzapine and 10 mg of samidorphan from two distinct layers with specified compositions, similar to those described in the ’466 Patent.
    • The tablet is further defined by a functional limitation: it must release at least 97% of both olanzapine and samidorphan after 30 minutes when tested under specific conditions (500 mL USP acetate buffer at pH 1.0).

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

  • Patent Identification: U.S. Patent No. 12390474, entitled “Immediate Release Multilayer Tablet,” issued on August 19, 2025 (Compl. ¶44).

Technology Synopsis

The ’474 Patent covers the same core technology as the other patents-in-suit: a stable, immediate-release bilayer tablet formulation that physically separates the chemically incompatible active ingredients olanzapine and samidorphan (’474 Patent, Abstract; col. 1:50-col. 2:5). The invention enables a single-tablet combination therapy for treating psychotic disorders while addressing the common side effect of weight gain (’474 Patent, col. 1:50-55).

Asserted Claims

The complaint does not specify claims, but independent claims 1 and 11 are the broadest composition claims in the patent.

Accused Features

The complaint alleges that Teva's proposed generic LYBALVI® product, as described in its ANDA, will infringe the ’474 Patent by containing the same active ingredients in a bilayer tablet dosage form intended for the same therapeutic use (Compl. ¶¶11, 56, 103, 106).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Teva’s proposed generic LYBALVI® product, which is the subject of Abbreviated New Drug Application No. 220379 ("the Teva ANDA Product") (Compl. ¶11).

Functionality and Market Context

  • The complaint alleges that by filing its ANDA, Teva has represented to the FDA that its proposed generic product has the same active ingredients (olanzapine and samidorphan), dosage form, and strengths as the branded LYBALVI® product and is bioequivalent to it (Compl. ¶56). LYBALVI® is a combination product used to treat schizophrenia and bipolar I disorder, where the samidorphan component is included to counteract weight gain associated with olanzapine (Compl. ¶¶48, 51). Teva's filing of an ANDA with a Paragraph IV certification is a statutory act of infringement, indicating Teva's intent to market its generic product before the expiration of the patents-in-suit (Compl. ¶¶16, 57).

IV. Analysis of Infringement Allegations

The complaint does not contain an exhibit with claim charts. The following tables summarize the infringement theory based on the complaint's narrative allegations, which primarily rely on the assertion that Teva's ANDA product is a generic equivalent of the LYBALVI® product covered by the patents.

11,707,466 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... The Teva ANDA Product is alleged to have the same dosage form as LYBALVI®, which is a bilayer tablet containing olanzapine and samidorphan. ¶56 col. 2:45-48
a first tablet layer comprising: 10 mg samidorphan or a pharmaceutically acceptable salt of samidorphan in an amount to deliver 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 Teva ANDA Product is alleged to have the same active ingredients and strengths as LYBALVI® and to be its bioequivalent, which suggests it contains a first layer with samidorphan and excipients that meet the claimed compositional requirements. ¶56 col. 3:35-51
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... about 46-49 wt % lactose... and about 1.0 wt % magnesium stearate... The Teva ANDA Product is alleged to have the same active ingredients and strengths as LYBALVI® and to be its bioequivalent, which suggests it contains a second layer with olanzapine and excipients that meet the claimed compositional requirements. ¶56 col. 3:45-51
a film coating over the first and second tablet layer As a proposed generic equivalent intended for commercial sale, the Teva ANDA Product is expected to have a standard pharmaceutical film coating. The allegation that it has the same dosage form as LYBALVI® supports the presence of this element. ¶56 col. 4:1-3

11,951,111 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 in a patient in need thereof, the method comprising orally administering to the patient, once daily, a pharmaceutically acceptable coated immediate release bilayer tablet... Teva is seeking FDA approval to market its ANDA product for the same indications as LYBALVI®, which includes schizophrenia and bipolar I disorder. The product's proposed label will allegedly instruct physicians and patients to administer the tablet for these conditions. ¶¶51, 56, 86 col. 15:9-14
wherein the bilayer tablet comprises: a first tablet layer comprising... a second tablet layer comprising... The Teva ANDA Product is alleged to be a bioequivalent bilayer tablet with the same active ingredients and dosage form as the product described in the patents, thereby meeting the compositional limitations of the tablet used in the claimed method. ¶56 col. 32:44-60
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... The complaint alleges that the Teva ANDA Product is bioequivalent to LYBALVI®, which suggests that it will exhibit the same or a very similar dissolution profile and meet the functional requirements of the claim. ¶56 col. 32:61-67

No probative visual evidence provided in complaint.

Identified Points of Contention

  • Scope Questions: A primary issue may be whether the specific formulation detailed in Teva's confidential ANDA falls within the scope of the patent claims. This includes whether the exact weight percentages of excipients in the Teva ANDA Product meet the ranges modified by the term "about," and whether any different excipients used are functional equivalents.
  • Technical Questions: A key factual question will be whether Teva’s product meets the functional dissolution requirements recited in claims like Claim 1 of the ’111 Patent. While the complaint relies on Teva’s representation of bioequivalence, infringement will ultimately depend on evidence from testing the Teva ANDA Product under the specific conditions defined in the patent claims.

V. Key Claim Terms for Construction

  • The Term: "about"

    • Context and Importance: This term appears before every numerical weight percentage range in the composition claims (e.g., "about 35-43 wt %"). The construction of "about" is critical because it will define the permissible deviation from the stated ranges. Teva's infringement liability may depend entirely on whether its specific formulation, if not identical to the claimed ranges, is close enough to be considered "about" the claimed values.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides an explicit definition, stating that "the term 'about' 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. 9:45-49). Plaintiffs may argue this express definition should control.
      • Evidence for a Narrower Interpretation: A defendant may argue that in the context of pharmaceutical formulations, where small variations can impact stability and dissolution, the term should be construed more narrowly. They might point to the specific formulation tables in the patent (e.g., Table 4, ’466 Patent, col. 19-20) as evidence of the precision required to achieve the invention, suggesting "about" should not extend to cover formulations that are meaningfully different.

  • The Term: "immediate release"

    • Context and Importance: The patents are for an "immediate release" tablet. The meaning of this term is central to the invention, as the goal was to achieve rapid dissolution despite the bilayer structure needed for stability. The term's scope will be tied to the functional dissolution rate limitations that appear in several claims (e.g., claim 2 of the '466 Patent and claim 1 of the '111 Patent).
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the goal as achieving a "substantially immediate release profile" (’466 Patent, col. 2:51-52), suggesting the term may not be limited to a single, rigid definition but rather describes the general character of the drug's release.
      • Evidence for a Narrower Interpretation: The patents repeatedly define the release characteristics with specific numerical limits and testing conditions (e.g., "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") (’111 Patent, col. 32:61-67). A defendant may argue that these detailed functional limitations serve to define what "immediate release" means in the context of this specific invention.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b) (Compl. ¶¶65, 85, 106). The factual basis for this allegation is that Teva, by submitting its ANDA, intends for healthcare providers to prescribe and patients to take the generic product for its approved indications (schizophrenia and bipolar I disorder), and that the product's label will actively encourage and instruct this infringing use (Compl. ¶¶66, 86, 107).
  • Willful Infringement: The complaint does not include a separate count for willful infringement. However, it alleges that Defendants had knowledge of the ’466 and ’111 Patents, as evidenced by their Notice Letter, and knew or should have known of the ’474 Patent due to its listing in the FDA's Orange Book (Compl. ¶¶69, 89, 110, 116). The prayer for relief requests a declaration that the case is "exceptional" and an award of attorneys' fees, which is relief often associated with findings of willful infringement or other litigation misconduct (Compl. p. 22, ¶G).

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

  • A core issue will be one of specification matching: does the precise formulation detailed in Teva's confidential ANDA—including the identity and weight percentage of each excipient—literally fall within the numerical ranges defined by the patents' composition claims? The construction of the term "about" will be central to resolving this question.
  • A key evidentiary question will be one of functional performance: irrespective of bioequivalence, does Teva's product in fact meet the specific dissolution rate limitations recited in the asserted method claims when tested under the precise conditions specified in the patents? This will require factual evidence from laboratory testing of the accused product.
  • A third question concerns induced infringement: assuming the Teva product is found to meet the claims' compositional elements, will Teva's proposed product label be sufficient evidence of an intent to induce physicians and patients to perform the patented method of treatment?