DCT

3:24-cv-10236

Intra-Cellular THERAPIES, INC. v. DR. Reddy's Laboratories INC.

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-10236, D.N.J., 11/01/2024
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Dr. Reddy's Laboratories Inc. being a corporation organized in and having a principal place of business in New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff’s CAPLYTA® (lumateperone) product constitutes an act of infringement of three U.S. patents related to methods of use, pharmaceutical compositions, and specific capsule formulations.
  • Technical Context: The technology at issue involves pharmaceutical treatments for neuropsychiatric conditions, specifically focusing on the compound lumateperone for treating bipolar disorder and related depressive episodes.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendant’s notification to Plaintiff of its ANDA filing seeking to market a generic drug prior to patent expiry. The complaint notes that this lawsuit is part of a broader, ongoing litigation between the parties involving multiple other patents covering the same CAPLYTA® product and the same generic ANDA, indicating a multi-front legal strategy to protect the branded drug franchise.

Case Timeline

Date Event
2018-08-31 U.S. Patent No. 12,128,043 Priority Date
2019-07-07 U.S. Patent No. 12,090,155 Priority Date
2019-12-11 U.S. Patent No. 12,122,792 Priority Date
2024-02-16 Defendant sends First Notice Letter of ANDA filing to Plaintiff
2024-03-28 Plaintiff files first related lawsuit against Defendant
2024-07-08 Defendant sends Second Notice Letter to Plaintiff
2024-08-29 Plaintiff files second related lawsuit against Defendant
2024-09-17 U.S. Patent No. 12,090,155 Issues
2024-10-22 U.S. Patent No. 12,122,792 Issues
2024-10-29 U.S. Patent No. 12,128,043 Issues
2024-11-01 Complaint Filing Date

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

U.S. Patent No. 12,090,155 - "Methods"

  • Issued: September 17, 2024

The Invention Explained

  • Problem Addressed: The patent’s background section identifies a need for safer and more effective treatments for Bipolar II Disorder, noting that it is frequently misdiagnosed and that existing antipsychotic agents are often associated with significant side effects, including sedation, metabolic issues, and an increased risk of suicidal thoughts (U.S. Patent No. 12,090,155, col. 3:13-30).
  • The Patented Solution: The invention provides a method for treating major depressive episodes associated with Bipolar II Disorder by administering the compound lumateperone, typically as a tosylate salt (U.S. Patent No. 12,090,155, Abstract). The patent asserts that lumateperone is surprisingly effective for this indication and exhibits a favorable safety profile, specifically that it does not increase movement disorders (akathisia), suicidal ideation, or metabolic side effects, nor does it trigger manic episodes (U.S. Patent No. 12,090,155, col. 3:34-46).
  • Technical Importance: This patented method provides a therapeutic approach for Bipolar II Disorder with a distinct pharmacological profile and potentially fewer adverse effects compared to previously available treatments (’155 Patent, col. 3:18-30).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 22 (’155 Patent, col. 14:50-58, col. 16:15-23; Compl. ¶40-41).
  • Essential elements of independent claim 1 include:
    • A method for treating a major depressive episode associated with Bipolar II Disorder
    • Comprising administering a therapeutically effective amount of lumateperone in mono-tosylate salt form
    • The method comprises once daily administration
    • The administration is of a tablet or capsule comprising about 60 mg of lumateperone mono-tosylate
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 12,122,792 - "Pharmaceutical Compositions Comprising 4-((6bR,10aS)-3-methyl...yl)phenyl)butan-1-one for Treating Conditions of the Central Nervous System and Cardiac Disorders"

  • Issued: October 22, 2024

The Invention Explained

  • Problem Addressed: The patent’s background section describes the general need for new compounds to treat central nervous system disorders by modulating serotonin receptors, serotonin transporters (SERT), and dopamine receptors (U.S. Patent No. 12,122,792, col. 1:44-54).
  • The Patented Solution: The patent discloses and claims pharmaceutical compositions containing a specific compound identified as Formula I, which the patent explains is a synthetic by-product of lumateperone (’792 Patent, Abstract; col. 3:1-9). The invention is based on the unexpected discovery that this particular by-product possesses its own potent and unique receptor binding profile, making it a distinct therapeutic agent (’792 Patent, col. 25:1-3, col. 26:1-3). The asserted claims cover compositions that include both this by-product (Formula I) and lumateperone (identified in the patent as Formula II) within a specific weight ratio.
  • Technical Importance: This invention identifies a previously known manufacturing impurity as a novel, pharmacologically active compound, creating patentability for compositions that contain this specific impurity in relation to the main active pharmaceutical ingredient.

Key Claims at a Glance

  • The complaint asserts independent claim 29 (’792 Patent, col. 29:1-col. 30:2; Compl. ¶68, ¶70).
  • Essential elements of independent claim 29 include:
    • A pharmaceutical composition comprising:
      • (i) a compound of Formula I in free base or pharmaceutically acceptable salt form
      • (ii) a compound of Formula II in toluenesulfonic acid addition salt form
    • wherein the composition comprises the two compounds in a weight ratio in the range of from 1:200 to 1:2000
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 12,128,043 - "Pharmaceutical Capsules Comprising Lumateperone Mono-Tosylate"

  • Issued: October 29, 2024
  • Technology Synopsis: The patent addresses the need for a specific oral capsule formulation of lumateperone mono-tosylate in a solid crystal form (U.S. Patent No. 12,128,043, Abstract). The invention claims a capsule with a specific blend of lumateperone mono-tosylate (10 to 30% by weight), particular excipients, and a multi-part dissolution profile, which together are designed to ensure stable and effective oral delivery of the drug (’043 Patent, col. 19:10-col. 20:20).
  • Asserted Claims: The complaint asserts at least independent claim 1 (Compl. ¶94).
  • Accused Features: The complaint alleges that Defendant’s ANDA Product is a pharmaceutical capsule comprising lumateperone mono-tosylate in solid crystal form, blended with specific diluents, and having a dissolution profile that meets the parameters recited in the claim (Compl. ¶95).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "DRL's ANDA Product," a generic version of CAPLYTA® (lumateperone) capsules intended for commercial sale in the United States in 10.5 mg, 21 mg, and 42 mg dosage strengths (Compl. ¶1, ¶28).

Functionality and Market Context

  • The DRL ANDA Product is a pharmaceutical drug containing lumateperone, which is approved for the treatment of schizophrenia and depressive episodes associated with bipolar disorder (Compl. ¶27-28). The complaint alleges, upon information and belief, that Defendant's proposed product label will direct its use for these conditions (Compl. ¶42-43). The product is alleged to be a capsule formulation containing lumateperone mono-tosylate that embodies the specific compositions and physical properties claimed in the patents-in-suit (Compl. ¶69-70, ¶95). The filing of the ANDA itself signifies a commercial intent to enter the market currently occupied by Plaintiff's branded CAPLYTA® product (Compl. ¶1).

IV. Analysis of Infringement Allegations

'155 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for the treatment of a major depressive episode associated with Bipolar II Disorder, comprising administering to a patient in need thereof, Use of DRL's ANDA Product as directed by its proposed label would involve treating this specific condition. ¶42 col. 3:34-36
a therapeutically effective amount of lumateperone in mono-tosylate salt form, DRL’s ANDA Product contains lumateperone in mono-tosylate salt form. ¶42 col. 5:37-44
wherein the method comprises once daily administration of a tablet or capsule comprising about 60 mg of lumateperone mono-tosylate in combination or association with a pharmaceutically acceptable diluent or carrier. DRL's ANDA Product is a capsule, and its proposed label would direct once-daily administration of a dose containing a therapeutically effective amount equivalent to about 60 mg of lumateperone mono-tosylate. ¶42 col. 7:5-10

'792 Infringement Allegations

Claim Element (from Independent Claim 29) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition comprising: 1) a compound of Formula I... in free base or pharmaceutically acceptable salt form; and DRL's ANDA Product is alleged to be a pharmaceutical composition that contains the compound of Formula I, which is depicted as a chemical structure in the complaint. ¶68, ¶70 col. 3:12-42
(ii) a compound of Formula II... in toluenesulfonic acid addition salt form; DRL's ANDA Product contains lumateperone (depicted as Formula II in the complaint) in a toluenesulfonic acid addition salt form. ¶65, ¶68, ¶70 col. 2:20-29
wherein the pharmaceutical composition comprises the compound of Formula I and the compound of Formula II in a weight ratio in the range of from 1:200 to 1:2000. DRL's ANDA Product is alleged to contain the compounds of Formula I and Formula II within the claimed weight ratio. ¶70 col. 16:5-9

Identified Points of Contention

  • Scope Questions: For the ’792 Patent, a central question is whether an alleged manufacturing by-product or impurity (Formula I) present in the accused generic drug renders the product a "pharmaceutical composition comprising" that by-product within the meaning of the claim. This raises the question of whether trace or unintended components fall within the claim's scope, especially given the specific weight ratio limitation. The complaint provides a chemical structure for Formula I (Compl. ¶68), which will be the basis for identifying the alleged impurity.
  • Technical Questions: The infringement theory for the ’792 Patent will depend on factual evidence. A key technical question is whether DRL's ANDA Product actually contains the compound of Formula I and, if so, whether its quantity relative to lumateperone falls within the claimed 1:200 to 1:2000 weight ratio (Compl. ¶70). For the ’155 Patent, the dispute may center on the specific language in DRL's proposed product label and whether it meets the legal standard for inducing infringement of the claimed method.

V. Key Claim Terms for Construction

The Term: "A pharmaceutical composition comprising" (’792 Patent, Claim 29)

  • Context and Importance: The construction of this term is critical because the infringement allegation for the ’792 Patent hinges on the presence of an alleged manufacturing impurity (Formula I) in Defendant's product. Practitioners may focus on whether "comprising" should be read to include unintended, trace-level by-products, or if the context implies an intentional combination of active components.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain meaning of "comprising" is open-ended and inclusive, suggesting that any composition containing the recited elements, regardless of their origin or purpose, would be covered. The patent specification describes Formula I as a compound with a distinct pharmacological profile, not merely an inert substance, which may support the view that its presence is a material element of the composition (’792 Patent, col. 3:1-9, col. 25:1-3).
    • Evidence for a Narrower Interpretation: The patent's title and abstract frame the invention around "Pharmaceutical Compositions... for Treating Conditions," which could support an argument that the term "comprising" should be construed in a therapeutic context, implying a combination of components present in amounts relevant to the composition's function, rather than incidental impurities.

The Term: "a single pharmaceutical capsule dissolves... to the extent of at least 85% after 15 minutes, and/or to the extent of at least 92% after 30 minutes, and/or to the extent of at least 94% after 45 minutes" (’043 Patent, Claim 1)

  • Context and Importance: This multi-part dissolution profile is a key limitation defining the formulation claimed in the ’043 Patent. The use of "and/or" between the three time-point conditions creates ambiguity. Practitioners may focus on this term because the infringement analysis will depend on whether an accused product must meet one, some, or all of these dissolution criteria.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of "and/or" could be interpreted disjunctively, meaning a capsule that meets any one of the three dissolution conditions (e.g., dissolving to at least 85% after 15 minutes) would infringe the claim. This interpretation would broaden the claim's scope. The complaint alleges the accused product dissolves "according to one or more of the parameters recited in claim 1" (Compl. ¶95), suggesting Plaintiff may advance this broader reading.
    • Evidence for a Narrower Interpretation: A defendant may argue that the series of escalating dissolution percentages over time implies a required performance profile, and that the "and/or" phrasing should be interpreted to mean the capsule must meet the relevant benchmark at each tested time point up to 45 minutes. The patent's detailed examples showing dissolution data may provide context for how this profile should be understood (’043 Patent, col. 14, Table; col. 16, Table).

VI. Other Allegations

Indirect Infringement

  • The complaint alleges active inducement of infringement for all patents, asserting that Defendant’s proposed product labeling will instruct and encourage physicians and patients to use the ANDA product in a manner that directly infringes the claimed methods and compositions (Compl. ¶49, ¶76, ¶101). It also pleads contributory infringement, alleging the product is especially made for an infringing use and is not a staple article of commerce (Compl. ¶50, ¶77, ¶102).

Willful Infringement

  • The complaint alleges that Defendant acted with "full knowledge" of the patents-in-suit and without a reasonable basis for believing it would not be liable for infringement (Compl. ¶53, ¶80, ¶105). This allegation is predicated on Defendant’s Paragraph IV certification to the FDA, which asserts the patents are invalid, unenforceable, or not infringed.

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

  • A core issue will be one of compositional identity: does the defendant's generic product contain the specific dimeric by-product (Formula I of the ’792 Patent) at a quantity that falls within the claimed weight ratio of 1:200 to 1:2000? This is a dispositive evidentiary question that will likely require sophisticated analytical chemistry to resolve.
  • A second central question will be one of induced infringement: for the ’155 method-of-use patent, does the precise language of the defendant’s proposed product label meet the legal threshold for actively encouraging or recommending that medical professionals use the generic drug to treat the specific condition of "a major depressive episode associated with Bipolar II Disorder"?
  • A third key question will involve claim scope and technical performance: for the ’043 formulation patent, can the multi-part dissolution profile, connected by "and/or," be met by satisfying only one of the time-point criteria, or must the accused product demonstrate a performance curve that meets all specified dissolution percentages? The resolution of this construction issue will define the technical evidence required to prove infringement.