DCT

3:24-cv-08850

Intra Cellular Therapies Inc v. DR Reddy's Laboratories Inc

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-08850, D.N.J., 08/29/2024
  • Venue Allegations: Venue is alleged to be proper as to Dr. Reddy’s Laboratories Inc. because it is a New Jersey corporation with its principal place of business in the state. Venue is alleged as to Dr. Reddy’s Laboratories Ltd. based on its being subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the drug CAPLYTA® (lumateperone) constitutes an act of infringement of two U.S. patents covering methods of use and pharmaceutical compositions.
  • 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 like schizophrenia and bipolar depression.
  • Key Procedural History: This lawsuit is an action under the Hatch-Waxman Act, triggered by Defendant’s (DRL’s) “Second Notice Letter” indicating it filed an ANDA with a Paragraph IV certification against the patents-in-suit. This action follows a prior, pending lawsuit (3:24-cv-04314) between the same parties concerning DRL's "First Notice Letter" and a different set of patents related to the same drug product.

Case Timeline

Date Event
2018-03-16 U.S. Patent No. 11,980,617 Priority Date
2018-08-31 U.S. Patent No. 12,070,459 Priority Date
2024-02-16 DRL's First Notice Letter Sent
2024-03-28 Plaintiff Filed First Lawsuit Against DRL
2024-05-14 U.S. Patent No. 11,980,617 Issued
2024-07-08 DRL's Second Notice Letter Sent
2024-08-27 U.S. Patent No. 12,070,459 Issued
2024-08-29 Complaint Filed

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

U.S. Patent No. 11,980,617 - "Methods of Treating Acute Depression and/or Acute Anxiety"

The Invention Explained

  • Problem Addressed: The patent’s background section identifies a need for new, fast-acting antidepressant treatments, noting that conventional therapies like SSRIs can take weeks to become effective, while faster-acting drugs like ketamine have significant adverse side effects, including abuse potential and dissociative symptoms. (U.S. Patent No. 11,980,617, col. 3:7-45).
  • The Patented Solution: The invention is a method of using lumateperone (a substituted heterocycle fused gamma-carboline) for the acute treatment of depression and/or anxiety. The patent specification suggests this compound provides a rapid-acting effect through a distinct mechanism involving the enhancement of NMDA and AMPA receptor currents and activation of the mTOR signaling pathway, which differs from both traditional antidepressants and ketamine. (’617 Patent, Abstract; col. 4:46-67).
  • Technical Importance: The technology purports to offer an orally-available, rapid-acting treatment for acute depressive states without the significant side effects and abuse liability associated with ketamine, addressing a critical unmet need in psychiatric care. (’617 Patent, col. 4:50-67).

Key Claims at a Glance

  • The complaint identifies independent claim 1 as an example (Compl. ¶40).
  • The essential elements of claim 1 are:
    • A method of treating acute depression and/or acute anxiety,
    • comprising administering to a patient in need thereof,
    • a therapeutically effective amount of a Compound of Formula I (lumateperone),
    • in free, or pharmaceutically acceptable salt form.

U.S. Patent No. 12,070,459 - "Pharmaceutical Capsule Compositions Comprising Lumateperone Mono-Tosylate"

The Invention Explained

  • Problem Addressed: The patent implicitly addresses the technical challenge of creating a stable, effective, and predictable oral dosage form for lumateperone that achieves specific therapeutic goals. (’459 Patent, col. 1:22-29).
  • The Patented Solution: The invention is a specific pharmaceutical capsule containing lumateperone as a mono-tosylate salt in a solid crystal form. The claims define the capsule by the amount and concentration of the active ingredient, the presence of certain types of excipients, and, critically, by the specific pharmacokinetic (PK) profile (e.g., Cmax, Tmax, AUC) it achieves upon oral administration under fasting conditions. (’459 Patent, Abstract; col. 13:1-14).
  • Technical Importance: This specific formulation provides a reliable oral delivery system with a defined pharmacokinetic profile, which is crucial for ensuring consistent therapeutic effects and obtaining regulatory approval for a commercial drug product. (’459 Patent, col. 13:1-14).

Key Claims at a Glance

  • The complaint identifies independent claim 1 as an example (Compl. ¶65).
  • The essential elements of claim 1 are:
    • A pharmaceutical capsule for oral administration,
    • comprising lumateperone in a mono-tosylate salt form,
    • wherein the salt is in a solid crystal form,
    • wherein the capsule comprises about 60 mg of the salt,
    • wherein the capsule comprises a blend of 10-30% by weight of the salt with specific categories of diluents/carriers,
    • and wherein administration of a single capsule under fasting conditions provides a specific PK profile (defined by ranges for Cmax, Tmax, and/or AUC).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is identified as "DRL’s ANDA Product," a generic version of CAPLYTA® (lumateperone) capsules in 10.5 mg, 21 mg, and 42 mg strengths. (Compl. ¶¶1, 27).

Functionality and Market Context

  • DRL's product is a generic drug for which DRL is seeking FDA approval to manufacture, use, and sell in the U.S. market (Compl. ¶1). The complaint alleges that the product contains lumateperone and that DRL's ANDA includes bioavailability and/or bioequivalence studies intended to show it is a generic version of Plaintiff's CAPLYTA® product (Compl. ¶¶27, 38, 63). CAPLYTA® is approved for treating schizophrenia and depressive episodes associated with bipolar disorder (Compl. ¶26).

IV. Analysis of Infringement Allegations

’617 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating acute depression and/or acute anxiety, The complaint alleges that the proposed labeling for DRL's ANDA Product will direct its use for treating acute depression and/or acute anxiety. ¶41 col. 45:7
comprising administering to a patient in need thereof, a therapeutically effective amount of a Compound of Formula I: ... in free, or pharmaceutically acceptable salt form. DRL's ANDA Product contains lumateperone, which is the Compound of Formula I, and its proposed label will direct administration of a therapeutically effective dose. The complaint provides a visual of the Formula I structure. ¶38, ¶40, ¶41 col. 7:1-19
  • Identified Points of Contention:
    • Scope Questions: A central issue will be whether DRL's proposed product label, which would be expected to mirror the approved indications for CAPLYTA®, instructs or encourages the specific method of treating "acute depression and/or acute anxiety" as required by the claim. The construction of "acute" will be critical.
    • Technical Questions: The infringement allegation is predicated on the content of DRL's proposed labeling, which is not yet public. The key factual question will be what that label actually directs physicians and patients to do.

’459 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical capsule for oral administration, comprising lumateperone...in mono-tosylate salt form, wherein the lumateperone mono-tosylate is in solid crystal form... DRL's ANDA Product is alleged to be a pharmaceutical capsule containing lumateperone mono-tosylate in solid crystal form. The complaint provides a visual of the lumateperone structure. ¶65, ¶66 col. 10:10-14
wherein the capsule comprises the lumateperone mono-tosylate in an amount of about 60 mg...and wherein the capsule comprises a blend of 10 to 30% by weight... The complaint alleges that DRL's ANDA Product is formulated in a blend with specific diluents or carriers in the amounts recited in claim 1. This appears to target DRL's 42 mg lumateperone strength, which is equivalent to approximately 60 mg of the tosylate salt. ¶66 col. 19:8-16
and wherein administration of an oral dose of a single capsule under fasting conditions provides a maximal plasma concentration...of 15-55 ng/mL, and/or a time to maximal plasma concentration...of 0.7 to 1.5 hours, and/or an area under the plasma concentration...of 51 to 135 hours-ng/mL. The complaint alleges on information and belief that administration of DRL's ANDA Product will result in a pharmacokinetic profile falling within the specific ranges recited in the claim. ¶66 col. 13:1-14
  • Identified Points of Contention:
    • Scope Questions: A likely point of dispute will be the meaning of "about 60 mg" and whether any of DRL's proposed dosage strengths (10.5, 21, or 42 mg of lumateperone) fall within the scope of this limitation. Another question may be the interpretation of "and/or" connecting the three pharmacokinetic parameters, which raises the question of whether an accused product must meet one, two, or all three of the recited PK ranges.
    • Technical Questions: A key factual dispute will be whether DRL’s ANDA Product, upon administration, actually exhibits the specific pharmacokinetic profile required by the claim's functional limitations. This determination will depend on the bioequivalence data submitted to the FDA as part of the ANDA.

V. Key Claim Terms for Construction

The Term: "acute depression and/or acute anxiety" (’617 Patent, Claim 1)

  • Context and Importance: This term defines the entire scope of the patented method. The infringement case for the ’617 patent hinges on whether DRL's proposed label for its generic product, likely indicated for general depressive episodes, will be found to induce the treatment of these specifically "acute" conditions. Practitioners may focus on this term because its breadth will determine whether standard antidepressant labeling can be read to infringe a method claim directed to acute use.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a broad definition: ""acute depression" refers to the initial period of what may be a brief or a chronic episode of depression (e.g., lasting 2 days to 2 weeks, or 2 weeks to 2 months, or 2 months to 2 years, or more)." (’617 Patent, col. 35:36-40). This language could support an argument that the term covers the beginning of any treatment for depression, including the indications on DRL's likely label.
    • Evidence for a Narrower Interpretation: The same section of the specification also defines more specific conditions like "short-duration depressive episode" (4 to 13 days) and "recurrent brief depression." (’617 Patent, col. 35:1-11). A defendant could argue that "acute depression" should be construed more narrowly to refer to these specific, time-limited episodes to avoid rendering the more specific definitions superfluous.

The Term: The pharmacokinetic limitations (e.g., "maximal plasma concentration of lumateperone of 15-55 ng/mL") (’459 Patent, Claim 1)

  • Context and Importance: These functional limitations are central to defining the patented capsule formulation. Infringement depends not just on the physical composition but on the capsule's in-vivo performance. Practitioners may focus on how these ranges are to be measured and whether the use of "and/or" requires an accused product to meet all three PK limitations (Cmax, Tmax, AUC) or only one.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of "and/or" throughout the claim suggests a disjunctive reading, meaning a product could infringe by meeting the specified range for Cmax, Tmax, or AUC. This would broaden the scope of infringement. (’459 Patent, col. 19:25-33).
    • Evidence for a Narrower Interpretation: A defendant might argue that the patent’s examples, which show test data for all three parameters, suggest that a capsule embodying the invention would be expected to meet all three criteria simultaneously. The specification's pharmacokinetic data table could be used to argue that the invention is characterized by the complete profile, not just one isolated parameter. (’459 Patent, col. 16:35-45).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for both patents. Inducement is based on the allegation that DRL's proposed product labeling will instruct physicians and patients to use the generic product in an infringing manner (Compl. ¶¶47, 72). Contributory infringement is based on the allegation that DRL's product is not a staple commodity and is especially made or adapted for an infringing use (Compl. ¶¶48, 73).
  • Willful Infringement: The complaint alleges that DRL acted with full knowledge of the patents-in-suit, citing the notice letters DRL sent to the plaintiff (Compl. ¶¶51, 76). These allegations of pre-suit knowledge form the basis for a claim of willful infringement and a request for enhanced damages and attorneys' fees under 35 U.S.C. § 285 (Compl. ¶(e), p. 17).

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

  • A core issue will be one of claim scope and induced infringement: For the '617 patent, can the term "acute depression," which the patent defines broadly, be construed to read on the instructions in DRL’s proposed product label for its generic version of CAPLYTA®? The outcome will depend on the court's interpretation of the claim term in light of the patent's own definitions and the specific language of DRL's label.
  • A key evidentiary question will be one of functional performance: For the '459 patent, does DRL's generic drug product, particularly its 42 mg dosage strength, actually exhibit the specific multi-part pharmacokinetic profile (Cmax, Tmax, and AUC) required by claim 1 when administered? This will turn on a factual analysis of DRL's bioequivalence data submitted to the FDA.
  • A central procedural question inherent to this Hatch-Waxman case is how the court will evaluate infringement based on a product and label that are not yet on the market. The analysis will be a hypothetical one, focused on whether the product, if approved and marketed as proposed in the ANDA, would infringe the patents-in-suit.