DCT

3:24-cv-10238

Intra Cellular Therapies Inc v. MSN Laboratories Private Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-10238, D.N.J., 11/01/2024
  • Venue Allegations: Venue is alleged to be proper because the defendant is a foreign corporation subject to personal jurisdiction within the District of New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s CAPLYTA® (lumateperone) drug product constitutes an act of infringement of three recently issued U.S. patents covering methods of use, specific pharmaceutical compositions containing a manufacturing by-product, and finished capsule formulations.
  • Technical Context: The technology relates to pharmaceutical treatments for central nervous system disorders, specifically methods and formulations for lumateperone, an atypical antipsychotic used to treat conditions such as bipolar depression.
  • Key Procedural History: This complaint is the latest in a series of infringement suits filed by the Plaintiff against the Defendant concerning the same ANDA. Prior suits, filed on March 28, 2024, and August 29, 2024, have been consolidated. This pattern suggests Plaintiff is asserting newly issued patents from its portfolio to protect its CAPLYTA® franchise as they are granted by the USPTO.

Case Timeline

Date Event
2018-12-14 Earliest Priority Date ('043 Patent)
2019-07-07 Earliest Priority Date ('155 Patent)
2019-12-11 Earliest Priority Date ('792 Patent)
2024-02-16 Defendant's ANDA Notice Letter Sent
2024-03-28 Plaintiff Files First Related Lawsuit
2024-08-29 Plaintiff Files Second Related Lawsuit
2024-09-17 '155 Patent Issued
2024-10-22 '792 Patent Issued
2024-10-29 '043 Patent Issued
2024-11-01 Complaint Filing Date

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

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

  • Patent Identification: U.S. Patent No. 12,090,155, "Methods," issued September 17, 2024.
  • The Invention Explained:
    • Problem Addressed: The patent's background section highlights the need for safer and more effective treatments for Bipolar II Disorder, noting it is a prevalent condition that is often misdiagnosed or improperly treated with therapies that can cause significant side effects like sedation, metabolic issues, or suicidal thoughts (’155 Patent, col. 3:14-30, col. 3:55-4:2).
    • The Patented Solution: The invention is a method of treating Bipolar II Disorder by administering lumateperone. The patent specification describes clinical trial results suggesting that lumateperone provides therapeutic benefit without triggering mania or common adverse side effects associated with other antipsychotics, such as akathisia, restlessness, or weight gain (’155 Patent, col. 5:1-28).
    • Technical Importance: The claimed method provides a therapeutic option for Bipolar II depression that may possess a more favorable safety profile compared to existing treatments, addressing a significant unmet clinical need (’155 Patent, col. 3:26-30).
  • Key Claims at a Glance:
    • The complaint asserts independent claims 1 and 22 (Compl. ¶¶37-38).
    • Claim 1 Elements:
      • A method for the treatment of a major depressive episode associated with Bipolar II Disorder,
      • comprising administering to a patient in need thereof, a therapeutically effective amount of lumateperone in mono-tosylate salt form,
      • 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.
    • Claim 22 Elements:
      • A method for the treatment of a depressive episode associated with Bipolar II Disorder,
      • comprising administering to a patient in need thereof, a therapeutically effective amount of lumateperone in mono-tosylate salt form,
      • wherein the method comprises once daily administration of a tablet or capsule comprising about 60 mg of lumateperone monotosylate in combination or association with a pharmaceutically acceptable diluent or carrier.

U.S. Patent No. 12,122,792 - "Pharmaceutical Compositions Comprising..."

  • Patent Identification: U.S. Patent No. 12,122,792, titled "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 discloses a specific compound, described as a synthetic by-product in the synthesis of lumateperone, that has its own potent biological activity at various neurotransmitter receptors (’792 Patent, col. 3:3-9). Pharmaceutical manufacturing processes often produce impurities, and managing or characterizing their effects is a key technical challenge.
    • The Patented Solution: The invention claims pharmaceutical compositions that contain a mixture of this specific by-product (identified as "Formula I") and lumateperone (identified as "Formula II"). By claiming a composition containing this specific dimer impurity, the patent protects not just the pure drug substance but also a particular impurity profile that may arise during manufacturing (’792 Patent, col. 5:3-12).
    • Technical Importance: This approach creates a potential patent barrier around drug products that contain this specific, identifiable by-product, which may be difficult for a generic manufacturer to design around without altering its own synthesis process.
  • Key Claims at a Glance:
    • The complaint asserts independent claims 1 and 29 (Compl. ¶¶64-65).
    • Claim 1 Elements:
      • A pharmaceutical composition comprising a pharmaceutically acceptable diluent or carrier in admixture with:
      • (i) a compound of Formula I (the dimer by-product) in free base or pharmaceutically acceptable salt form; and
      • (ii) a compound of Formula II (lumateperone) in free base or pharmaceutically acceptable salt form.
    • Claim 29 Elements:
      • A pharmaceutical composition comprising:
        1. a compound of Formula I in free base or pharmaceutically acceptable salt form; and
      • (ii) a compound of Formula II in toluenesulfonic acid addition salt form;
      • 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.

Multi-Patent Capsule

  • Patent Identification: U.S. Patent No. 12,128,043, "Pharmaceutical Capsules Comprising Lumateperone Mono-Tosylate," issued October 29, 2024 (Compl. ¶84).
  • Technology Synopsis: The patent is directed to specific oral capsule formulations of lumateperone mono-tosylate. The claims recite a capsule comprising lumateperone mono-tosylate in solid crystal form, blended with certain types of excipients in specific weight percentages, which achieves a defined dissolution profile (i.e., how quickly the drug dissolves in a test medium) (’043 Patent, Abstract; ’043 Patent, col. 3:58-4:50). This specificity is intended to ensure consistent bioavailability and therapeutic effect.
  • Asserted Claims: The complaint asserts independent claim 1 (Compl. ¶91).
  • Accused Features: Defendant's generic capsule is alleged to be a pharmaceutical capsule containing lumateperone mono-tosylate in solid crystal form, combined with specific diluents or carriers in the claimed amounts, and to meet the dissolution parameters recited in claim 1 (Compl. ¶92).

III. The Accused Instrumentality

  • Product Identification: Defendant MSN's generic lumateperone capsules in 10.5 mg, 21 mg, and 42 mg strengths, for which it submitted ANDA No. 219248 to the FDA seeking approval for commercialization (Compl. ¶¶1-2).
  • Functionality and Market Context: The accused product is a generic version of Plaintiff’s branded drug, CAPLYTA®, which is approved for the treatment of schizophrenia and bipolar depression (Compl. ¶¶25-26). The filing of an ANDA with a Paragraph IV certification, which challenges the patents listed for the branded drug, is the statutorily defined act of infringement that triggers this type of litigation (Compl. ¶27). The complaint alleges that upon approval, Defendant intends to manufacture and sell this product in the U.S. market (Compl. ¶8).

IV. Analysis of Infringement Allegations

12,090,155 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... Defendant's proposed product labeling would direct physicians and patients to use the product for this claimed therapeutic method. ¶39 col. 3:35-37
...comprising administering to a patient in need thereof, a therapeutically effective amount of lumateperone in mono-tosylate salt form... Defendant's ANDA Product contains lumateperone, and its proposed use is for a therapeutic effect. ¶35, ¶39 col. 5:36-43
...wherein the method comprises once daily administration of a tablet or capsule comprising about 60 mg of lumateperone mono-tosylate... Defendant's proposed label would direct once-daily administration of a capsule containing a therapeutically effective amount, including a 42 mg strength that is equivalent to about 60 mg of the mono-tosylate salt. ¶39, ¶26 col. 5:56-62

12,122,792 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... Defendant's ANDA product is alleged, upon information and belief, to be a composition that contains the specific dimer by-product identified as Formula I. The complaint provides the chemical structure for this claimed dimer compound (Compl. p. 15). ¶67 col. 7:45-67
...and (ii) a compound of Formula II in toluenesulfonic acid addition salt form... Defendant's ANDA product contains lumateperone (Formula II) in the specified toluenesulfonic acid (tosylate) salt form. The complaint displays the chemical structure for lumateperone (Compl. p. 15). ¶67, ¶62 col. 8:1-20
...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. Defendant's ANDA product is alleged, upon information and belief, to contain the two compounds within the claimed weight ratio range. ¶67 col. 9:45-50
  • Identified Points of Contention:
    • Scope Questions: For the ’155 Patent, a potential point of contention may be whether the language in Defendant’s final approved product label will be specific enough to induce infringement of a method for treating "Bipolar II Disorder" explicitly, or if it will use broader language that Plaintiff may argue still encourages the claimed use.
    • Technical Questions: For the ’792 Patent, the central dispute will be factual. The complaint alleges "upon information and belief" that the accused product contains the specific "Formula I" dimer. This raises the critical evidentiary question of whether this specific compound is present in Defendant's product at all, and if so, whether it falls within the claimed weight ratio. This will likely be a primary focus of discovery and expert chemical analysis. A similar factual question exists for the ’043 Patent regarding whether the accused product's excipient blend and dissolution profile meet the claim limitations. The complaint provides the structure of the claimed lumateperone compound from the '043 patent's claim 1 (Compl. p. 19).

V. Key Claim Terms for Construction

  • The Term: "a compound of Formula I" (’792 Patent, Claim 1)

  • Context and Importance: This term defines the specific chemical structure of the dimer by-product. The infringement allegation for the entire ’792 Patent hinges on the presence of this exact compound in the accused product. Practitioners may focus on this term because if discovery reveals that Defendant's product contains a different isomer, a related but distinct by-product, or no dimer at all, the infringement claim for this patent would fail.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term itself is precise, leaving little room for a "broader" interpretation of the chemical structure. However, a plaintiff may argue that the term should be understood to cover common, pharmaceutically acceptable variations if not explicitly disclaimed.
    • Evidence for a Narrower Interpretation: The patent provides a specific chemical drawing for Formula I, defining its exact stereochemistry and atomic connectivity (’792 Patent, col. 7:45-67). A defendant will likely argue that the claim is limited to this exact structure and does not read on any other related impurities that may be present.

  • The Term: "about 60 mg of lumateperone mono-tosylate" (’155 Patent, Claim 1)

  • Context and Importance: Defendant's ANDA is for capsules containing 10.5 mg, 21 mg, and 42 mg of lumateperone free base (Compl. ¶26). The 42 mg free base dose is equivalent to approximately 60 mg of the mono-tosylate salt. The dispute will center on whether the 42 mg free base product meets the "about 60 mg" limitation for the salt form.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification explicitly links the clinically tested 42 mg daily dose to the 60 mg tosylate salt amount, stating "lumateperone...one 42 mg daily (administered orally as 60 mg of the tosylate salt) met the primary endpoint" (’155 Patent, col. 5:58-62). Plaintiff may argue this passage defines the 42 mg free base dose as being equivalent to the claimed amount.
    • Evidence for a Narrower Interpretation: A defendant may argue that in the context of pharmaceutical dosing, "about" implies a very narrow range of acceptable deviation (e.g., standard manufacturing tolerances) and that a product labeled as "42 mg" of the active moiety cannot be considered to comprise "about 60 mg" of a different salt form for infringement purposes.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement for all three patents. For the ’155 method patent, this is based on the allegation that Defendant’s proposed product labeling will instruct medical professionals and patients to perform the claimed method of treating Bipolar II Disorder (Compl. ¶46). For the composition patents, inducement is alleged based on the intended sale and marketing of the infringing product (Compl. ¶¶73, 98). Contributory infringement is also alleged, based on the product being especially made for an infringing use and not being a staple article of commerce (Compl. ¶¶47, 74, 99).
  • Willful Infringement: Willfulness is alleged based on Defendant’s "full knowledge" of the patents-in-suit and its decision to proceed with its ANDA "without a reasonable basis for believing that it would not be liable for infringement" (Compl. ¶¶50, 77, 102). This allegation is supported by Defendant’s statutory obligation to review listed patents and provide a Paragraph IV certification, as well as the context of the ongoing consolidated litigation between the parties.

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

  • A central issue will be one of compositional identity: does Defendant's ANDA product, as formulated, contain the specific dimer by-product ("Formula I") claimed in the ’792 patent, and does it possess the precise blend of crystalline form, excipients, and dissolution characteristics required by the claims of the ’043 patent? The outcome of these infringement questions will likely depend entirely on the results of chemical and physical analysis of Defendant's product.
  • A key legal question will be one of induced infringement: for the ’155 method-of-use patent, will the final, FDA-approved label for Defendant's generic product include language that explicitly or implicitly encourages its administration for the treatment of depressive episodes associated with Bipolar II Disorder, thereby satisfying the legal standard for inducing infringement?
  • A broader strategic question relates to patent portfolio enforcement: given that this suit asserts three recently-issued patents in the context of a larger, ongoing dispute, the case will test the effectiveness of a brand manufacturer's strategy of sequentially asserting later-granted patents covering specific methods, impurity profiles, and formulations to extend protection for a drug product beyond the life of its foundational patents.