DCT

1:26-cv-07358

Alkermes Inc v. Apotex Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-07358, D.N.J., 06/18/2026
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Apotex Corp. has a regular and established place of business in the state, has consented to venue in a related action, and engages in substantial business there. Venue is alleged as proper for Apotex Inc. as a foreign corporation subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendant's filing of an Abbreviated New Drug Application (ANDA) to market a generic version of LYBALVI® (olanzapine/samidorphan) constitutes an act of infringement of eleven patents covering methods of treating antipsychotic-induced weight gain and related technologies.
  • Technical Context: The technology involves a combination pharmaceutical product designed to provide the therapeutic benefits of an atypical antipsychotic (olanzapine) while mitigating the common and significant side effect of weight gain by using an opioid receptor antagonist (samidorphan).
  • Key Procedural History: The complaint notes that this action is related to a pending consolidated action in the same court (Alkermes, Inc. v. Teva Pharmaceuticals, Inc., et al., No. 25-cv-14685), which also involves Defendants and their ANDA for a generic LYBALVI® product, but concerns a different set of patents. This current suit arises from a subsequent Paragraph IV certification letter received by Plaintiffs.

Case Timeline

Date Event
2009-12-04 Earliest Priority Date for '848 Patent
2010-08-23 Earliest Priority Date for '960, '977, '235, '054, '785, '541, '425, '166, '805, '035 Patents
2014-07-15 U.S. Patent No. 8,778,960 Issued
2015-09-01 U.S. Patent No. 9,119,848 Issued
2015-09-08 U.S. Patent No. 9,126,977 Issued
2016-12-13 U.S. Patent No. 9,517,235 Issued
2019-05-28 U.S. Patent No. 10,300,054 Issued
2020-07-21 U.S. Patent No. 10,716,785 Issued
2021-05-28 FDA Approval of LYBALVI® (NDA No. 213378)
2021-11-30 U.S. Patent No. 11,185,541 Issued
2022-02-08 U.S. Patent No. 11,241,425 Issued
2022-06-07 U.S. Patent No. 11,351,166 Issued
2023-10-24 U.S. Patent No. 11,793,805 Issued
2025-01-14 U.S. Patent No. 12,194,035 Issued
2025-07-15 Alkermes receives first notice letter regarding ANDA No. 220455
2025-08-14 Apotex produces ANDA No. 220455 to Plaintiffs in Related Action
2026-05-25 Alkermes receives subsequent Paragraph IV notice letter for Patents-in-Suit
2026-06-18 Complaint Filed

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

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

  • Patent Identification: U.S. Patent No. 8,778,960, "Methods for Treating Antipsychotic-Induced Weight Gain," issued July 15, 2014 Compl. ¶32

The Invention Explained

  • Problem Addressed: Atypical antipsychotic drugs such as olanzapine are highly effective for treating psychotic disorders but frequently cause significant weight gain, which can lead to patient non-compliance, obesity, and related health problems like diabetes Compl. ¶66 '960 Patent, col. 1:45-54
  • The Patented Solution: The invention is a method to reduce this drug-induced weight gain by co-administering an opioid modulator, specifically a compound of Formula I (samidorphan), with the atypical antipsychotic '960 Patent, abstract '960 Patent, col. 2:6-11 This co-administration is intended to suppress food intake and lower circulating ghrelin levels that are elevated by the antipsychotic drug '960 Patent, col. 2:12-19
  • Technical Importance: This approach allows patients to receive the benefits of atypical antipsychotic therapy while mitigating one of its most significant and medically dangerous side effects, potentially improving both treatment adherence and long-term health outcomes Compl. ¶67

Key Claims at a Glance

  • The complaint does not identify specific asserted claims but makes general allegations of infringement of one or more claims Compl. ¶82
  • Independent claim 1 is the sole independent claim in the '960 patent. Its essential elements are:
    • A method of reducing antipsychotic induced weight gain
    • comprising administering to a patient in need of treatment an effective amount of a compound of formula [samidorphan] or a pharmaceutically acceptable salt thereof;
    • wherein said antipsychotic is olanzapine.

U.S. Patent No. 9,119,848 - "Morphinan Derivatives for the Treatment of Drug Overdose"

  • Patent Identification: U.S. Patent No. 9,119,848, "Morphinan Derivatives for the Treatment of Drug Overdose," issued September 1, 2015 Compl. ¶35

The Invention Explained

  • Problem Addressed: The standard treatment for opioid overdose, naloxone, has a short duration of action. This creates a risk of "renarcotisation" where the overdose effects return after the naloxone wears off, often requiring prolonged hospitalization and repeated dosing to ensure patient safety '848 Patent, col. 2:1-16
  • The Patented Solution: The invention provides for the use of specific carboxamide substituted morphinans, such as samidorphan (Compound 1), which exhibit a longer duration of action (e.g., 24-48 hours) compared to naloxone for treating drug overdose '848 Patent, col. 2:18-29
  • Technical Importance: A longer-acting opioid antagonist could simplify overdose treatment, reduce the need for extended hospitalization for monitoring, and lower the risk of patient harm from renarcotisation after discharge '848 Patent, col. 2:12-16

Key Claims at a Glance

  • The complaint does not identify specific asserted claims but makes general allegations of infringement Compl. ¶104
  • Independent claim 1 is the sole independent claim in the '848 patent. Its essential elements are:
    • A method of treating opioid toxicity or overdose in a subject in need thereof
    • comprising administrating L-malate salt of Compound-1 [samidorphan]
    • wherein said opioid toxicity or overdose is resulting from an opioid drug
    • administered to a non-dependent patient.

Multi-Patent Capsule

  • Patent Identification: U.S. Patent No. 9,126,977, "Methods for Treating Antipsychotic-Induced Weight Gain," issued September 8, 2015 Compl. ¶38

    • Technology Synopsis: The patent describes methods for reducing weight gain associated with atypical antipsychotics like olanzapine by administering an opioid modulator (samidorphan) '977 Patent, abstract It also discloses compositions containing both an atypical antipsychotic and the opioid modulator '977 Patent, claim 10
    • Asserted Claims: The complaint does not specify claims Compl. ¶¶123-144
    • Accused Features: Apotex's proposed generic product, which is a co-formulation of olanzapine and samidorphan, is alleged to infringe (Compl. ¶¶69; Compl. 75).

  • Patent Identification: U.S. Patent No. 9,517,235, "Methods for Treating Antipsychotic-Induced Weight Gain," issued December 13, 2016 Compl. ¶41

    • Technology Synopsis: The patent claims methods of reducing diseases or disorders associated with the adverse metabolic profile of olanzapine, such as obesity and diabetes, by administering samidorphan '235 Patent, claim 1 '235 Patent, abstract It also claims methods of lowering circulating ghrelin levels by administering samidorphan '235 Patent, claim 7
    • Asserted Claims: The complaint does not specify claims Compl. ¶¶145-166
    • Accused Features: Apotex's proposed generic product containing olanzapine and samidorphan is alleged to practice the claimed methods (Compl. ¶¶69; Compl. 75).

  • Patent Identification: U.S. Patent No. 10,300,054, "Methods for Treating Antipsychotic-Induced Weight Gain," issued May 28, 2019 Compl. ¶44

    • Technology Synopsis: The patent claims compositions comprising olanzapine and samidorphan, and methods of treating disorders like schizophrenia or bipolar disorder by administering such a composition '054 Patent, claim 1 '054 Patent, claim 8
    • Asserted Claims: The complaint does not specify claims Compl. ¶¶167-188
    • Accused Features: Apotex's proposed generic product is a composition of olanzapine and samidorphan alleged to be used for the claimed methods (Compl. ¶¶69; Compl. 75).

  • Patent Identification: U.S. Patent No. 10,716,785, "Methods for Treating Antipsychotic-Induced Weight Gain," issued July 21, 2020 Compl. ¶47

    • Technology Synopsis: The patent claims methods of reducing antipsychotic-induced weight gain by administering a composition containing an atypical antipsychotic and samidorphan '785 Patent, claim 1 The claims specify particular patient populations, such as those who have already experienced weight gain from the antipsychotic '785 Patent, claim 2
    • Asserted Claims: The complaint does not specify claims Compl. ¶¶189-210
    • Accused Features: The administration of Apotex's proposed generic product is alleged to practice the claimed methods (Compl. ¶¶69; Compl. 75).

  • Patent Identification: U.S. Patent No. 11,185,541, "Methods for Treating Antipsychotic-Induced Weight Gain," issued November 30, 2021 Compl. ¶50

    • Technology Synopsis: The patent claims methods of treating schizophrenia by orally administering a daily pharmaceutical composition containing olanzapine and 10 mg of samidorphan '541 Patent, claim 1
    • Asserted Claims: The complaint does not specify claims Compl. ¶¶211-232
    • Accused Features: Apotex's proposed generic product is alleged to be a composition that will be administered according to the claimed method (Compl. ¶¶69; Compl. 75).

  • Patent Identification: U.S. Patent No. 11,241,425, "Composition for Treating Mental Illness," issued February 8, 2022 Compl. ¶53

    • Technology Synopsis: The patent claims methods of reducing weight gain associated with olanzapine administration by orally administering a composition containing olanzapine and 10 mg of samidorphan '425 Patent, claim 1 '425 Patent, claim 9
    • Asserted Claims: The complaint does not specify claims Compl. ¶¶233-254
    • Accused Features: Apotex's proposed generic product containing olanzapine and samidorphan is alleged to be the composition used in the claimed methods (Compl. ¶¶69; Compl. 75).

  • Patent Identification: U.S. Patent No. 11,351,166, "Methods for Treating Antipsychotic-Induced Weight Gain," issued June 7, 2022 Compl. ¶56

    • Technology Synopsis: The patent claims a method for treating a human patient suffering from bipolar disorder or schizophrenia by co-administering olanzapine and samidorphan to mitigate weight gain '166 Patent, claim 1
    • Asserted Claims: The complaint does not specify claims Compl. ¶¶255-276
    • Accused Features: Apotex's proposed generic product is a co-formulation of olanzapine and samidorphan alleged to be used for the claimed methods (Compl. ¶¶69; Compl. 75).

  • Patent Identification: U.S. Patent No. 11,793,805, "Methods for Treating Antipsychotic-Induced Weight Gain," issued October 24, 2023 Compl. ¶59

    • Technology Synopsis: The patent claims a method for treating schizophrenia where significant weight gain induced by olanzapine is mitigated by the co-administration of samidorphan '805 Patent, claim 8
    • Asserted Claims: The complaint does not specify claims Compl. ¶¶277-298
    • Accused Features: Apotex's proposed generic product, a co-formulation of olanzapine and samidorphan, is alleged to be used to practice the claimed method (Compl. ¶¶69; Compl. 75).

  • Patent Identification: U.S. Patent No. 12,194,035, "Methods for Treating Antipsychotic-Induced Weight Gain," issued January 14, 2025 Compl. ¶62

    • Technology Synopsis: The patent claims methods for treating bipolar disorder, or manic/mixed episodes associated with it, by administering a composition of olanzapine and 10 mg of samidorphan '035 Patent, claim 1 '035 Patent, claim 15
    • Asserted Claims: The complaint does not specify claims Compl. ¶¶299-320
    • Accused Features: Apotex's proposed generic product is alleged to be the composition that will be administered according to the claimed methods (Compl. ¶¶69; Compl. 75).

III. The Accused Instrumentality

Product Identification

Apotex's proposed generic LYBALVI® (olanzapine/samidorphan) tablets, which are the subject of Abbreviated New Drug Application ("ANDA") No. 220455 Compl. ¶10 Compl. ¶72

Functionality and Market Context

The complaint alleges that Apotex's ANDA Product is a combination drug product containing olanzapine, an atypical antipsychotic, and samidorphan, an opioid receptor antagonist Compl. ¶69 It is alleged to have the same active ingredients, dosage form, and strengths as Plaintiffs' branded LYBALVI® product and to be bioequivalent to it Compl. ¶75 The function of the samidorphan component is to counteract metabolic side effects, such as weight gain, caused by the olanzapine component Compl. ¶69 The complaint alleges that Apotex intends to market and sell its ANDA Product in the United States, including in New Jersey, and that it will displace sales of the branded LYBALVI® product Compl. ¶11 Compl. ¶20

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide element-by-element infringement allegations. The infringement theory is based on the statutory infringement provision of the Hatch-Waxman Act, where the filing of an ANDA for a generic version of a branded drug is an act of infringement if the generic product will be used in a manner that practices a patented method Compl. ¶82 Compl. ¶85 The allegations rest on the premise that Apotex's ANDA Product is bioequivalent to LYBALVI® and its FDA-approved label will instruct users to perform the patented methods Compl. ¶75 Compl. ¶85

'960 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of reducing antipsychotic induced weight gain The complaint alleges that the proposed product label for Apotex's ANDA Product will be substantively identical to that of LYBALVI® and will teach the use of the product, which contains the opioid antagonist samidorphan to mitigate weight gain from olanzapine. ¶85 col. 2:6-11
comprising administering to a patient in need of treatment an effective amount of a compound of formula [samidorphan] or a pharmaceutically acceptable salt thereof Apotex's ANDA Product is alleged to contain samidorphan and be bioequivalent to LYBALVI®, and its label will instruct administration to patients. ¶75 col. 2:6-11
wherein said antipsychotic is olanzapine. Apotex's ANDA Product is a combination product containing olanzapine. ¶69; ¶75 col. 2:55-58
  • Identified Points of Contention:
    • Scope Questions: The complaint's infringement theory for the '960 patent appears to be a standard application of the Hatch-Waxman Act for a method-of-use patent. The central dispute will likely focus on the validity of the patent and the precise scope of the claims, rather than on a technical mismatch in operation, given the alleged bioequivalence of the generic product Compl. ¶75
    • Technical Questions: A key question for the '848 patent, which claims a method for treating opioid overdose, is how Plaintiffs will establish infringement by a product indicated for treating mental illness Compl. ¶69 Compl. ¶104 The complaint does not allege that the proposed generic product is intended for, or that its label will instruct, use for treating opioid overdose. This suggests a potential fundamental mismatch between the claimed method and the accused product's intended use, raising the question of whether any infringement can occur.

V. Key Claim Terms for Construction

  • The Term: "reducing antipsychotic induced weight gain" (from '960 Patent, claim 1)
  • Context and Importance: The entire purpose of the invention is to achieve this "reduction." Practitioners may focus on this term because its definition is critical to determining infringement. The dispute may center on whether any statistically significant reduction is sufficient, or if a specific, clinically meaningful threshold of weight gain mitigation must be met, as suggested by data in the patent specification.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification defines "reducing" as "any indicia of success in the prevention or reduction of weight gain" '960 Patent, col. 8:49-52, which may support an argument that any measurable effect constitutes reduction.
    • Evidence for a Narrower Interpretation: The specification provides specific quantitative examples, such as mitigating a "percentage increase in weight ... by at least 2%, 5%, 10%," and discusses maintaining a "healthful weight range" (BMI between 19 and 25) '960 Patent, col. 8:55-65 '960 Patent, col. 9:5-14 Figure 1 of the patent shows a graph where "Compound 1" (samidorphan) attenuates olanzapine-induced weight gain to a level similar to vehicle control, which a defendant may argue sets a high bar for what the patent teaches as effective "reduction."

VI. Other Allegations

  • Indirect Infringement: The complaint alleges Defendants will actively induce infringement under 35 U.S.C. § 271(b) Compl. ¶85 Compl. ¶95 The basis for this allegation is that Defendants will prepare a prescribing label for their ANDA Product that is "substantively identical to that of LYBALVI®," which will teach, encourage, and instruct healthcare providers and patients to use the product in an infringing manner Compl. ¶85 The complaint also alleges contributory infringement under 35 U.S.C. § 271(c), stating the ANDA Product is especially adapted for an infringing use and has no substantial non-infringing use Compl. ¶86 Compl. ¶89
  • Willful Infringement: The complaint alleges Defendants "are aware, have knowledge of, or are wilfully blind to the fact" that their actions will infringe Compl. ¶87 Compl. ¶88 This allegation of knowledge is based on Defendants' submission of the Paragraph IV certification notice letter and their involvement in the "ongoing Related Action" concerning the same ANDA product Compl. ¶90

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

  1. Scope of Method Claims: A central issue will be the applicability of patents with claims directed to specific methods of treatment to a product whose primary indication may differ. For instance, can claims from the '848 patent, directed to treating opioid overdose, be infringed by the intended and labeled use of a product for treating mental illness? This raises a core question of whether infringement can be found absent direct evidence of an accused infringing use.
  2. Claim Construction of "Reducing Weight Gain": The case will likely involve a significant dispute over the construction of the term "reducing antipsychotic induced weight gain." The key question for the court will be whether this term requires a specific, clinically significant level of weight mitigation, as suggested by experimental data in the patents, or if any statistically measurable reduction suffices, as broader language in the specification might suggest.
  3. Hatch-Waxman Infringement and Labeling: As this is an ANDA litigation, a key evidentiary question will be the comparison of the proposed label for Apotex's generic product with the asserted patent claims. The analysis will turn on whether the instructions and indications for use on the proposed label direct medical professionals and patients to perform the steps of the patented methods, thereby constituting induced infringement.
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