DCT

1:23-cv-02943

Janssen PHARMACEUTICALS, INC. v. Sandoz INC.

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-02943, D.N.J., 05/30/2023
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Sandoz maintains a regular and established place of business in the district, where it allegedly participated in the preparation and submission of the Abbreviated New Drug Application (ANDA) at issue. The complaint also notes that Sandoz has previously conceded to venue in the district in other patent cases.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an ANDA to market a generic version of the antidepressant Spravato® (esketamine nasal spray) constitutes an act of infringement of four U.S. patents covering methods for treating depression and related pharmaceutical compositions.
  • Technical Context: The technology relates to the use of esketamine, an enantiomer of ketamine, for the rapid treatment of major depressive disorder, a field of significant clinical interest due to the limitations of traditional antidepressants.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs’ receipt of a Paragraph IV certification notice letter from Sandoz, dated April 17, 2023, which stated Sandoz's belief that the asserted patents are invalid, unenforceable, or will not be infringed by its proposed generic product. The asserted patents are listed in the U.S. Food and Drug Administration's "Orange Book" as covering Plaintiffs' Spravato® brand esketamine nasal spray.

Case Timeline

Date Event
2014-09-15 Priority Date for '844, '134, '500, and '260 Patents
2020-12-22 U.S. Patent No. 10,869,844 Issues
2021-11-16 U.S. Patent No. 11,173,134 Issues
2022-04-26 U.S. Patent No. 11,311,500 Issues
2022-09-20 U.S. Patent No. 11,446,260 Issues
2023-04-17 Sandoz sends Paragraph IV Notice Letter to Plaintiffs
2023-05-30 Complaint Filed

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

U.S. Patent No. 10,869,844 - "Methods for the Treatment of Depression"

  • Patent Identification: U.S. Patent No. 10,869,844, "Methods for the Treatment of Depression," issued December 22, 2020. (Compl. ¶18).

The Invention Explained

  • Problem Addressed: The patent’s background section describes the significant limitations of existing antidepressant therapies, noting that 40-50% of patients fail to achieve timely remission and approximately 30% become treatment-resistant. It also highlights the association between depression and suicidal ideation, for which effective, rapid treatments are needed. (’844 Patent, col. 1:49-55, col. 2:36-43).
  • The Patented Solution: The invention provides methods for treating depression, particularly treatment-resistant depression, by administering esketamine via a specific intranasal dosing regimen. The specification extensively discusses a personalized medicine approach, linking different dosing strategies to a patient's genetic makeup, specifically the Val66Met polymorphism in the BDNF gene, which is associated with depression. (’844 Patent, Abstract; col. 5:20-35).
  • Technical Importance: The described methods seek to optimize a rapid-acting antidepressant therapy by tailoring dosage based on a genetic biomarker, which may represent an advance in personalizing psychiatric treatment. (’844 Patent, col. 6:7-13).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 2-11, 13-16, and 19-30. (Compl. ¶30).
  • The essential elements of independent claim 1 are:
    • A method of treating major depressive disorder in a human patient;
    • comprising intranasally administering (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone (esketamine);
    • in an induction dosage to the patient in an amount in the range of from about 56 mg to about 84 mg;
    • wherein the induction phase comprises a treatment period of about four weeks;
    • and the induction dosage is administered at a frequency of twice per week during the induction phase.
  • The complaint explicitly reserves the right to assert numerous dependent claims. (Compl. ¶30).

U.S. Patent No. 11,173,134 - "Methods for the Treatment of Depression"

  • Patent Identification: U.S. Patent No. 11,173,134, "Methods for the Treatment of Depression," issued November 16, 2021. (Compl. ¶19).

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problem as the ’844 Patent: the need for more effective treatments for patients with depression, including those who are resistant to conventional therapies and those with suicidal ideations. (’134 Patent, col. 1:49-55, col. 2:36-43).
  • The Patented Solution: The invention is directed to methods for treating depression with intranasal esketamine during a "maintenance phase" that follows an initial "induction phase." Like the ’844 Patent, the specification connects these dosing regimens to the patient's BDNF Val66Met genotype to personalize and sustain the antidepressant response. (’134 Patent, Abstract; col. 5:60-67).
  • Technical Importance: This technology aims to provide a long-term treatment protocol to maintain the antidepressant effect of esketamine after an initial, more intensive treatment period, potentially tailored to patient genetics. (’134 Patent, col. 6:7-13).

Key Claims at a Glance

  • The complaint asserts claims 1-30. (Compl. ¶45).
  • The essential elements of independent claim 1 are:
    • A method of treating major depressive disorder in a human patient during a maintenance phase;
    • wherein the patient has optionally been treated with esketamine in an induction phase of about four weeks;
    • comprising intranasally administering an aqueous formulation of esketamine in a maintenance dosage to provide a therapeutically effective amount of about 56 mg or about 84 mg;
    • wherein the maintenance dosage is administered at a frequency of once per week or once every two weeks during the maintenance phase.
  • The complaint asserts a broad range of claims, including dependent claims. (Compl. ¶45).

Multi-Patent Capsule: U.S. Patent No. 11,311,500

  • Patent Identification: U.S. Patent No. 11,311,500, "Methods for the Treatment of Depression," issued April 26, 2022. (Compl. ¶20).
  • Technology Synopsis: This patent, related to the ’844 and ’134 patents, discloses methods for treating depression with intranasally administered esketamine. The claims are directed at specific dosing regimens, including an induction phase and a subsequent maintenance phase, with the specification describing how these regimens can be optimized based on a patient's BDNF Val66Met genotype. (’500 Patent, Abstract).
  • Asserted Claims: Claims 1-22 are asserted. (Compl. ¶61).
  • Accused Features: The complaint alleges that Sandoz’s proposed generic product will be used according to a product label that instructs physicians and patients to perform the patented methods of treatment. (Compl. ¶¶62, 71).

Multi-Patent Capsule: U.S. Patent No. 11,446,260

  • Patent Identification: U.S. Patent No. 11,446,260, "Pharmaceutical Composition of S-Ketamine Hydrochloride," issued September 20, 2022. (Compl. ¶21).
  • Technology Synopsis: This patent claims specific aqueous formulations of S-ketamine hydrochloride for nasal administration. A key feature of the invention is that the formulation does not contain a conventional antimicrobial preservative, as the S-ketamine hydrochloride itself is alleged to provide sufficient antimicrobial properties. (’260 Patent, Abstract).
  • Asserted Claims: A wide range of claims are asserted: 1-3, 6-19, 22, 25-26, 31-43, 46-58, 61, 64-65, and 70-75. (Compl. ¶77).
  • Accused Features: The complaint alleges that the formulation of Sandoz's proposed generic esketamine nasal spray product will itself infringe the composition claims of this patent. (Compl. ¶¶78, 84).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is Sandoz Inc.’s proposed generic version of Spravato® (esketamine) nasal spray, for which Sandoz has filed Abbreviated New Drug Application No. 215418 with the U.S. Food and Drug Administration. (Compl. ¶¶2, 24).
  • Functionality and Market Context: The product is a nasal spray designed to deliver esketamine for the treatment of depression. (Compl. ¶31). The complaint alleges that Sandoz is statutorily required to copy the FDA-approved labeling for Spravato®, with limited exceptions. (Compl. ¶39). This labeling is alleged to instruct physicians and patients on methods of administration that fall within the scope of the method patents-in-suit. (Compl. ¶39). The product is intended to be a lower-cost, generic competitor to Plaintiffs' branded Spravato® product. (Compl. ¶2). No probative visual evidence provided in complaint.
  • The complaint does not provide sufficient detail for analysis of the specific formulation of Sandoz's proposed product beyond the allegation that it is a generic version of Spravato®. (Compl. ¶27).

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed, element-by-element infringement analysis or a claim chart. The infringement theory for the method patents (’844, ’134, and ’500) is based on inducement of infringement. It alleges that Sandoz's proposed product label, by mirroring the Spravato® label, will instruct healthcare providers and patients to administer the drug according to the patented dosing schedules, dosages, and administration routes. (Compl. ¶¶39, 55, 71). For the composition patent (’260), the theory is that Sandoz's product formulation itself will meet the limitations of the asserted claims. (Compl. ¶84). The complaint alleges infringement under 35 U.S.C. § 271(e)(2)(A) based on the filing of the ANDA seeking approval to market the generic product before the expiration of the patents-in-suit. (Compl. ¶¶37, 53, 69, 85).

  • Identified Points of Contention:
    • Technical Questions: A primary factual dispute will concern the contents of Sandoz's confidential ANDA. For the method patents, does the proposed label exactly track the claimed dosing regimens? For the ’260 composition patent, does the proposed formulation contain the same components and exhibit the same properties (e.g., absence of a separate antimicrobial preservative) as claimed?
    • Scope Questions: A potential legal dispute for the method patents may arise from the specification's extensive discussion of genotyping. The question may be whether the scope of claims that do not explicitly require a genotyping step (such as Claim 1 of the ’844 Patent) should nonetheless be interpreted in light of the specification’s focus on personalized dosing for specific genetic profiles.

V. Key Claim Terms for Construction

  • The Term: "about" (e.g., "about 56 mg," "about four weeks")

  • Context and Importance: This term appears in the dosage and treatment duration limitations of the method claims in the ’844 and ’134 Patents. Practitioners may focus on this term because its scope is critical to determining literal infringement. Whether the instructions on Sandoz's proposed label fall within the range of "about" the claimed numerical values will be a central issue.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification's general description of dosing regimens may support a flexible interpretation consistent with clinical realities, where exact adherence to a number is not always required. (’844 Patent, col. 5:45-54).
    • Evidence for a Narrower Interpretation: The detailed description of clinical trial results within the specification might be cited to argue that "about" refers to a narrow range of deviation from the precise values used in those studies. (’844 Patent, col. 17:21-35).

  • The Term: "maintenance phase" (’134 Patent, Claim 1)

  • Context and Importance: This term defines the temporal scope of the primary asserted claim of the ’134 Patent, distinguishing it from the "induction phase" covered by claims in patents like the ’844 Patent. The definition of when the maintenance phase begins and ends will be determinative of infringement for this patent.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent may define the maintenance phase generally as a period of treatment following an induction phase, comprising a treatment period of "at least 6 weeks." (’134 Patent, col. 6:60-61). This language suggests an open-ended duration.
    • Evidence for a Narrower Interpretation: The claim preamble's reference to an "induction phase of about four weeks" could be used to argue that the "maintenance phase" can only begin after a specific, preceding treatment period has been completed, potentially limiting the timeframe in which infringement can occur. (’134 Patent, col. 35:38-42).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, Sandoz will induce infringement by "active steps to encourage the use" of its product in an infringing manner, specifically through its product labeling, which is required to copy the approved Spravato® label. (Compl. ¶¶39, 55, 71, 87). Contributory infringement is also alleged, stating the product is not a staple article of commerce and is specifically designed for use in a manner that infringes. (Compl. ¶¶40, 56, 72, 88).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges that Sandoz has "actual knowledge" of each patent-in-suit, citing the April 17, 2023 notice letter. (Compl. ¶¶35, 51, 67, 83). It further alleges the case is "exceptional" and seeks an award of attorneys' fees under 35 U.S.C. § 285. (Compl. ¶¶43, 59, 75, 91).

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

  • A core issue will be one of evidentiary alignment: once Sandoz’s ANDA and proposed label are produced in discovery, will the prescribed methods of use map precisely onto the numerical and temporal limitations of the asserted method claims, and will the proposed drug formulation match the specific composition recited in the ’260 Patent claims?
  • A key legal question may be one of claim scope versus disclosure: for the method patents, will the court construe the claims broadly based on their plain language, or will their scope be influenced by the specification’s detailed discussion of personalizing treatment based on a patient’s BDNF genotype, a step not explicitly required by the asserted independent claims?
  • A central question of induced infringement: can Plaintiffs demonstrate that Sandoz’s proposed label would actively encourage or instruct physicians and patients to perform the specific steps of the claimed methods, thereby establishing the requisite intent for inducement?