DCT

2:25-cv-03218

Pharmacosmos As v. Teva Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-03218, D.N.J., 04/24/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant entities Teva Inc. and Teva USA reside in New Jersey, maintain regular and established places of business in the district, and have committed acts of infringement there. The complaint also alleges that parent company Teva Ltd. has purposely availed itself of the jurisdiction by directing its subsidiaries' activities in New Jersey and has previously consented to jurisdiction by initiating or defending other lawsuits in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s cancer therapy drug COSELA® (trilaciclib) constitutes an act of infringement of two U.S. patents.
  • Technical Context: The dispute relates to pharmaceutical methods for protecting a patient’s immune system during chemotherapy and to specific crystalline forms of the active pharmaceutical ingredient.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant Teva Inc.'s Paragraph IV Notice Letter, dated March 11, 2025, which asserted that its proposed generic product would not infringe the patents-in-suit. The complaint was filed within the 45-day statutory window, triggering an automatic stay of FDA approval for Teva's ANDA.

Case Timeline

Date Event
2016-12-05 U.S. Patent No. 11,529,352 Priority Date
2020-06-15 U.S. Patent No. 12,168,666 Priority Date
2021-02-12 FDA approves Plaintiff's COSELA® (trilaciclib) NDA
2022-12-20 U.S. Patent No. 11,529,352 Issues
2024-12-17 U.S. Patent No. 12,168,666 Issues
2025-03-11 Defendant sends Paragraph IV Notice Letter to Plaintiff
2025-03-12 Plaintiff receives Paragraph IV Notice Letter
2025-04-24 Complaint Filing Date

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

U.S. Patent No. 11,529,352 - “Preservation of Immune Response During Chemotherapy Regimens”

The Invention Explained

  • Problem Addressed: The patent’s background section describes a dilemma in cancer treatment: combining chemotherapy with immune checkpoint inhibitors can enhance the body’s anti-tumor response, but the chemotherapy itself often damages immune cells, thereby "diminishing the efficacy of the... combination" (Compl. ¶1; ’352 Patent, col. 2:11-17). The technical problem is how to shield the patient's immune system from the harmful effects of chemotherapy to maximize the benefit of immunotherapy (’352 Patent, col. 2:18-24).
  • The Patented Solution: The invention proposes a therapeutic regimen involving the "specifically-timed administration" of a selective, fast-acting, short half-life Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor just prior to administering chemotherapy (’352 Patent, col. 2:34-40). This timing is intended to temporarily arrest immune cells in a phase of the cell cycle where they are less vulnerable to damage from the chemotherapeutic agent, preserving their function and enhancing the overall anti-cancer effect of the combined therapy (’352 Patent, col. 4:3-15).
  • Technical Importance: This approach seeks to uncouple the tumor-killing effects of chemotherapy from its immunosuppressive side effects, potentially making combination therapies more effective for a broader set of patients (’352 Patent, Abstract).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims, providing Claim 1 as an example (Compl. ¶¶ 69-70).
  • Independent Claim 1 contains the following essential elements:
    • A method of treating cancer in a human.
    • The method comprises a therapeutic regimen with two distinct phases: an "induction phase" and a "maintenance phase."
    • The induction phase involves co-administering three components: (i) a specific CDK4/6 inhibitor (trilaciclib), (ii) a chemotherapeutic agent cytotoxic to immune cells, and (iii) an immune checkpoint inhibitor.
    • A key timing limitation requires that during the induction phase, the CDK4/6 inhibitor is administered "only 24 hours or less prior to" the chemotherapeutic agent.
    • The maintenance phase occurs "following the cessation of the induction phase" and comprises administering at least one dose of the immune checkpoint inhibitor.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 12,168,666 - “Morphic Forms of Trilaciclib And Methods of Manufacture Thereof”

The Invention Explained

  • Problem Addressed: The patent identifies a significant formulation challenge with the active ingredient trilaciclib. The drug is "not very soluble in water" and its solubility decreases as pH increases toward the neutral pH of human blood (’666 Patent, col. 2:50-54). This poses a substantial obstacle for creating a concentrated intravenous (IV) formulation needed for effective and rapid administration during cancer treatment (’666 Patent, col. 2:55-65).
  • The Patented Solution: The invention is an "advantageous isolated morphic form" of trilaciclib, specifically a highly crystalline dihydrochloride form designated "Pattern 1" (’666 Patent, col. 2:10-14). This specific polymorphic form exhibits superior stability and properties that enable the manufacture of a stable, concentrated IV solution, thereby solving the drug delivery problem (’666 Patent, col. 2:14-20).
  • Technical Importance: The discovery of a stable, soluble crystalline form is often a critical step in transforming a promising chemical compound into a viable and manufacturable pharmaceutical product.

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the ’666 Patent without identifying specific claims (Compl. ¶ 89).
  • Independent Claim 1 of the patent is a composition of matter claim directed to:
    • A crystalline compound of the structure for trilaciclib.
    • Wherein the compound is a dihydrochloride.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

  • Teva's ANDA Product, identified as ANDA No. 219413, a generic version of COSELA® (trilaciclib) for injection, intravenous drug product (Compl. ¶ 1, 19).

Functionality and Market Context

  • The complaint alleges that Teva's ANDA Product contains the active ingredient trilaciclib and is intended for the same therapeutic use as COSELA®: to "decrease the incidence of chemotherapy-induced myelosuppression" in certain adult cancer patients (Compl. ¶¶ 43, 54).
  • It is further alleged that Teva's ANDA Product Labeling will be "substantially identical" to the prescribing information for COSELA®, thereby instructing physicians and healthcare providers on its administration and use (Compl. ¶ 67).

IV. Analysis of Infringement Allegations

11,529,352 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a human having cancer comprising administering to the human a therapeutic regimen comprising a) an induction phase and b) a maintenance phase, The complaint alleges Teva's ANDA Product Labeling will instruct the use of the product in a therapeutic regimen for cancer that includes both an induction and maintenance phase, mirroring the COSELA® clinical study protocol. ¶71; ¶47 col. 33:1-5
a) the induction phase comprising: i) administering to the human an effective amount of a selective Cyclin Dependent Kinase 4/6 (CDK4/6) inhibitor of structure: [chemical structure] Teva's ANDA Product is a generic version of trilaciclib, the specific CDK4/6 inhibitor shown in the chemical structure diagram provided in the complaint. The visual evidence of the chemical structure is provided in the complaint. ¶70; ¶54 col. 33:8-12
ii) administering to the human an effective amount of a chemotherapeutic agent, and iii) administering to the human an effective amount of an immune checkpoint inhibitor, The COSELA® prescribing information, which Teva's label will allegedly mirror, details administration with a "platinum/etoposide-containing regimen" (chemotherapeutic agents) and an immune checkpoint inhibitor like atezolizumab. ¶45; ¶47 col. 33:13-16
wherein, during the induction phase, the CDK4/6 inhibitor is only administered 24 hours or less prior to the administration of the chemotherapeutic agent... The COSELA® prescribing information instructs that the drug should be administered as an infusion "completed no more than 4 hours prior to the start of chemotherapy." ¶44; ¶70 col. 33:17-21
b) the maintenance phase comprising: i) administering to the human at least one dose of an effective amount of the immune checkpoint inhibitor, and wherein the maintenance phase is administered following the cessation of the induction phase. The COSELA® clinical study regimen described in the prescribing information includes a maintenance phase where atezolizumab (an immune checkpoint inhibitor) is administered as a monotherapy after the induction cycles are complete. ¶45; ¶47 col. 33:24-28

12,168,666 Infringement Allegations

The complaint does not specify which claims of the ’666 Patent are asserted and provides no claim chart or element-by-element infringement allegations for this patent. The infringement theory appears to be that Defendant’s ANDA Product itself is, or contains, the specific crystalline form of trilaciclib dihydrochloride claimed in the patent (Compl. ¶¶ 89, 90). Analysis of infringement will depend on a factual comparison of Teva's product with the claimed morphic forms.

  • Identified Points of Contention:
    • Scope Questions ('352 Patent): A potential question is whether the terms "induction phase" and "maintenance phase" as used in the patent are limited to the specific multi-cycle induction and subsequent monotherapy regimen described in the specification (e.g., ’352 Patent, FIG. 41), or if they can be read more broadly.
    • Technical Questions ('666 Patent): The central question will be one of physical identity. Does the active pharmaceutical ingredient in Teva's ANDA Product exhibit the specific crystalline structure, such as the X-ray powder diffraction (XRPD) pattern, claimed in the ’666 Patent? This is an empirical question that will likely be resolved through expert analysis and discovery.

V. Key Claim Terms for Construction

  • The Term: "a therapeutic regimen comprising a) an induction phase and b) a maintenance phase" (’352 Patent, Claim 1)
  • Context and Importance: This two-part structure is a core limitation of the method claim. The definition of what constitutes an "induction phase" versus a "maintenance phase" will be critical to determining infringement, as the required components and timing differ between the two. Practitioners may focus on this term because the patent specification provides a specific clinical trial example (four cycles of triple-therapy induction followed by checkpoint inhibitor monotherapy maintenance) that could be argued to limit the scope of these terms (’352 Patent, FIG. 41; col. 2:34-40).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself does not specify the number of cycles in each phase or the precise agents beyond their class. This may support an argument that the terms cover any cancer treatment regimen that begins with a period of combined therapy (induction) and is followed by a period of less intensive or different therapy (maintenance).
    • Evidence for a Narrower Interpretation: The patent’s detailed description and figures repeatedly illustrate a specific structure: an induction phase consisting of multiple cycles of the triple-drug combination, followed by a maintenance phase consisting only of the checkpoint inhibitor (’352 Patent, col. 6:45-55; FIG. 3; FIG. 41). This could support an argument that the terms are limited to regimens that follow this specific "combination-then-monotherapy" sequence.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Teva will actively induce infringement of the ’352 Patent because its product labeling will instruct physicians to administer the generic drug according to the patented method (Compl. ¶ 75). It further alleges contributory infringement, stating that Teva's product is not a staple article of commerce and is especially made or adapted for use in an infringing manner (Compl. ¶ 78).
  • Willful Infringement: Willfulness is alleged based on Teva’s knowledge of the patents-in-suit, as evidenced by its submission of a Paragraph IV Certification, and its alleged lack of a reasonable basis for believing it would not be liable for infringement (Compl. ¶ 81, 92).

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

  • A core issue will be one of induced infringement: Will the instructions on Teva's proposed product label be found to actively encourage physicians to perform the specific two-phase therapeutic regimen required by Claim 1 of the ’352 patent, including the distinct "induction phase" and "maintenance phase" structure?
  • A key evidentiary question will be one of physical identity: Does the trilaciclib active ingredient in Teva’s proposed generic product possess the specific crystalline structure ("morphic form") defined by the claims of the ’666 patent? This will likely turn on competing expert analyses of the physical product.