Pharmacosmos AS v. Teva Pharma Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Pharmacosmos A/S; Pharmacosmos Holding A/S; and Pharmacosmos Therapeutics Inc. (Denmark; Delaware)
  • Defendant: Teva Pharmaceuticals, Inc.; and Teva Pharmaceuticals USA, Inc. (Delaware)
  • Plaintiff’s Counsel: FBT Gibbons LLP; Arnold & Porter Kaye Scholer LLP
• Case Identification: Pharmacosmos A/S v. Teva Pharmaceuticals, Inc., 2:25-cv-03218, D.N.J., 02/02/2026
• Venue Allegations: Venue is alleged to be proper as Defendants reside in New Jersey, maintain a regular and established place of business in the district, and have agreed not to contest venue for the purposes of this action.
• Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's COSELA® (trilaciclib) product constitutes an act of infringement of three U.S. patents covering methods of cancer treatment and morphic forms of the drug.
• Technical Context: The technology relates to combination cancer therapies, specifically methods of using a CDK4/6 inhibitor to mitigate chemotherapy-induced myelosuppression and preserve a patient's immune response.
• Key Procedural History: This action was brought under the Hatch-Waxman Act following Defendant's Paragraph IV certification notice to Plaintiff regarding U.S. Patent Nos. 11,529,352 and 12,168,666, which are listed in the FDA's Orange Book for COSELA®. U.S. Patent No. 12,527,798 issued after the initial complaint was filed and was added via this amended complaint; Defendant has not yet submitted a certification for this patent.

Case Timeline

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

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

• Patent Identification: U.S. Patent No. 11,529,352, “Preservation of Immune Response During Chemotherapy Regimens,” issued December 20, 2022 (Compl. ¶42).

The Invention Explained

• Problem Addressed: The patent's background describes that while combining chemotherapy with immune checkpoint inhibitors can be an effective cancer treatment, chemotherapy itself can damage immune system cells, thereby "diminishing the efficacy of the chemotherapy/checkpoint inhibitor combination" (’352 Patent, col. 1:11-18).
• The Patented Solution: The invention is a therapeutic method involving the specifically timed administration of a selective, fast-acting, short half-life cyclin-dependent kinase 4/6 (CDK4/6) inhibitor prior to each dose of chemotherapy. This timing transiently arrests the cell cycle of immune cells, protecting them from the chemotherapy's toxicity. This protection is intended to preserve the host's innate immune system, allowing it to better attack cancer cells, particularly when a checkpoint inhibitor is also used as part of the regimen (’352 Patent, Abstract; col. 2:30-56; FIG. 3).
• Technical Importance: This approach seeks to improve the efficacy and durability of immunotherapy-chemotherapy combinations by mitigating the known immunosuppressive side effects of the chemotherapy component (’352 Patent, col. 2:8-15).

Key Claims at a Glance

• The complaint asserts independent claim 1 (Compl. ¶67).
• The essential elements of independent claim 1 include:
  • A method of treating a human having cancer comprising administering a therapeutic regimen with an induction phase and a maintenance phase.
  • The induction phase comprises administering: (i) an effective amount of a selective CDK4/6 inhibitor (trilaciclib), (ii) an effective amount of a chemotherapeutic agent, and (iii) an effective amount of an immune checkpoint inhibitor.
  • The CDK4/6 inhibitor is administered only 24 hours or less prior to the administration of the chemotherapeutic agent.
  • The chemotherapeutic agent is cytotoxic to immune effector cells.
  • The maintenance phase comprises administering at least one dose of the immune checkpoint inhibitor and is administered after the induction phase ends.
• The complaint reserves the right to assert other claims, stating the accused use "will infringe one or more claims of the ’352 patent" (Compl. ¶66).

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

• Patent Identification: U.S. Patent No. 12,168,666, “Morphic Forms of Trilaciclib And Methods of Manufacture Thereof,” issued December 17, 2024 (Compl. ¶43).

The Invention Explained

• Problem Addressed: The patent states that the drug trilaciclib is "not very soluble in water" and becomes less soluble as pH increases toward the neutral pH of blood. This poses a challenge for creating a concentrated intravenous (IV) solution for rapid administration, as a large volume of fluid would otherwise be required (’666 Patent, col. 1:55-63).
• The Patented Solution: The patent discloses advantageous crystalline or "morphic" forms of trilaciclib, specifically a dihydrochloride salt referred to as "Pattern 1." This crystalline form is described as highly purified and stable, with properties that make it suitable for large-scale manufacturing and formulation into a concentrated IV solution (’666 Patent, Abstract; col. 2:11-44). The patent provides the X-ray powder diffraction (XRPD) data that defines this crystalline structure (’666 Patent, FIG. 1).
• Technical Importance: Developing a stable and soluble solid-state form of a drug is a critical step in pharmaceutical development, enabling consistent manufacturing and safe, effective administration to patients.

Key Claims at a Glance

• The complaint does not identify specific claims of the ’666 Patent that are asserted against the Defendant. It alleges that the manufacture, use, or sale of Teva's ANDA product will infringe "one or more claims of the ’666 patent" (Compl. ¶86). The patent includes claims directed to compositions of matter (e.g., specific crystalline forms of trilaciclib) and methods of manufacture.

U.S. Patent No. 12,527,798 - "Preservation of Immune Response During Chemotherapy Regimens"

• Patent Identification: U.S. Patent No. 12,527,798, “Preservation of Immune Response During Chemotherapy Regimens,” issued January 20, 2026 (Compl. ¶44).
• Technology Synopsis: This patent, like the ’352 patent, is directed to a method of preserving the immune system during cancer treatment. It discloses a therapeutic regimen where a selective CDK4/6 inhibitor is administered with specific timing relative to a chemotherapeutic agent and a PD-L1 immune checkpoint inhibitor to protect immune cells from damage and enhance the overall anti-tumor response (’798 Patent, Abstract; col. 2:30-56).
• Asserted Claims: The complaint asserts independent claim 15 (Compl. ¶101).
• Accused Features: The complaint alleges that the use of Defendant's ANDA Product, in accordance with its proposed labeling, will constitute infringement of claim 15. This infringement would occur by practicing the claimed method of treating small cell lung cancer with a specific, timed regimen of trilaciclib, a chemotherapeutic agent (e.g., carboplatin and etoposide), and a PD-L1 inhibitor (Compl. ¶100, 102).

III. The Accused Instrumentality

Product Identification

• Defendant's Abbreviated New Drug Application (ANDA) No. 219413 Product, which is a proposed generic version of Plaintiff's COSELA® (trilaciclib) for injection, intravenous drug product, at a 300 mg/vial strength (Compl. ¶1, 33).

Functionality and Market Context

• The accused product contains the active ingredient trilaciclib, a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients (Compl. ¶36, 48). The complaint includes a visual of the chemical structure of trilaciclib as recited in the asserted patents (Compl. ¶67, 101).
• Plaintiff alleges that the labeling for Defendant's ANDA Product ("Teva's ANDA Product Labeling") will be "substantially identical" to the prescribing information for COSELA® (Compl. ¶64, 98). The COSELA® label instructs administration as a "30-minute intravenous infusion completed no more than 4 hours prior to the start of chemotherapy" (Compl. ¶37). The complaint alleges that Defendant's filing of its ANDA seeks approval to market this generic version prior to the expiration of the patents-in-suit (Compl. ¶1).

IV. Analysis of Infringement Allegations

U.S. Patent No. 11,529,352 Infringement Allegations

Identified Points of Contention

• Scope Questions: The infringement theory for the method claims ('352 and '798 patents) is one of inducement, which depends on the content of the Defendant's proposed product label. A central question will be whether the language of the final, FDA-approved label for Teva's ANDA Product will direct or encourage physicians to perform each and every step of the claimed methods, thereby establishing the requisite intent for inducement.
• Technical Questions: For the '666 patent, which claims specific morphic forms of trilaciclib, the infringement analysis will be a direct factual inquiry. The key question for the court will be whether the crystalline form of the trilaciclib active pharmaceutical ingredient in Defendant's ANDA product is identical to a form claimed in the patent. This will likely require expert analysis of competing characterization data (e.g., XRPD).

V. Key Claim Terms for Construction

• The Term: "induction phase" and "maintenance phase" (from '352 Patent, Claim 1)
• Context and Importance: The asserted method claim is structurally defined by these two distinct phases, each with specific required components and occurring in sequence. The definitions of these terms and the boundary between them will be critical for determining whether an accused treatment regimen meets the claim limitations.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The claim language itself provides definitions for the phases based on the agents administered within them (e.g., the induction phase includes the CDK4/6 inhibitor, chemo agent, and checkpoint inhibitor, while the maintenance phase includes the checkpoint inhibitor alone). A party could argue the terms should be given their plain meaning as defined by these components.
  • Evidence for a Narrower Interpretation: The patent specification describes specific clinical trial designs, such as Study 1 (G1T28-05), which involve a set number of induction cycles (e.g., "a maximum of 4 cycles") before a maintenance phase begins (’352 Patent, FIG. 41; col. 49:5-20). A party may argue that these exemplary embodiments suggest the terms should be construed to require a more structured, multi-cycle definition as practiced in the supporting clinical trials.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement for the '352 and '798 method patents. Inducement is based on the allegation that Defendant's product labeling will instruct physicians to perform the patented methods, and that Defendant has knowledge of the patents and specific intent to cause infringement (Compl. ¶72, 74, 106, 108). Contributory infringement is based on the allegation that the product is especially made for an infringing use and is not a staple article of commerce with substantial non-infringing uses (Compl. ¶75, 109).
• Willful Infringement: Willfulness is alleged for all three patents based on Defendant’s knowledge. For the '352 and '666 patents, pre-suit knowledge is alleged based on Defendant’s sending of a Paragraph IV Notice Letter (Compl. ¶33, 78, 89). For the '798 patent, knowledge is alleged based on the patent's issuance and listing in the Orange Book, followed by Plaintiff's filing of this amended complaint (Compl. ¶56, 112). The complaint asserts Defendant acted without a reasonable basis for believing it would not be liable for infringement (Compl. ¶78, 89, 112).

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

• A primary issue will be one of induced infringement: Will the final, FDA-approved label for Defendant's generic product contain instructions that direct, encourage, or recommend that physicians administer the product in a manner that practices all the steps of the asserted method claims, thereby establishing the specific intent required for inducement?
• A key factual question for the '666 patent will be one of compositional identity: Does the specific crystalline form of the trilaciclib active pharmaceutical ingredient in Defendant's ANDA product meet the limitations of the '666 patent's claims, which are directed to particular morphic forms of the compound?
• A central legal question will be one of claim construction: How will the court define the boundaries of the "induction phase" and "maintenance phase"? The outcome may depend on whether the terms are construed broadly based on their components or more narrowly based on the specific multi-cycle clinical trial protocols described in the specification.