DCT

2:25-cv-16648

Janssen Pharmaceutica NV v. Natco Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-16648, D.N.J., 10/05/2026
  • Venue Allegations: Venue is asserted on the basis that the defendant, Natco, is a foreign corporation and may be sued in any judicial district in which it is subject to the court's personal jurisdiction. Plaintiffs also allege that Natco has previously consented to venue in the District of New Jersey in other patent litigation.
  • Core Dispute: Plaintiffs allege that Defendant's Abbreviated New Drug Application (ANDA) to market a generic version of the cancer drug BALVERSA® (erdafitinib) constitutes an act of infringement of three U.S. patents directed to methods of treating cancer.
  • Technical Context: The technology relates to personalized cancer therapy, specifically using Fibroblast Growth Factor Receptor (FGFR) inhibitors to treat patients who have been identified as having specific FGFR genetic alterations.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Natco’s ANDA No. 218578. Natco filed a Paragraph IV certification against U.S. Patent No. 12,037,644, asserting non-infringement and/or invalidity. However, the complaint notes Natco has not filed such a certification for U.S. Patent Nos. 10,478,494 and 12,678,498, though Plaintiffs have asserted them in this action, citing precedent that a Paragraph IV certification is not a prerequisite for suit. A separate litigation, Natco I, is pending between the parties concerning different patents covering the same drug product.

Case Timeline

Date Event
2014-09-26 Priority Date for U.S. Patent No. 12,037,644
2015-04-03 Priority Date for U.S. Patent Nos. 10,478,494 and 12,678,498
2019-11-19 U.S. Patent No. 10478494 Issued
2023-06-12 First Natco Notice Letter Sent to Plaintiffs
2024-07-16 U.S. Patent No. 12,037,644 Issued
2024-10-22 Certificate of Correction for '644 Patent Issued
2025-09-03 Second Natco Notice Letter Sent to Plaintiffs
2025-10-15 Original Complaint Filed
2026-07-14 U.S. Patent No. 12678498 Issued
2026-08-12 Date '498 Patent Listed in Orange Book
2026-09-11 Natco Notified of Allegations in First Amended Complaint
2026-10-05 First Amended Complaint Filed

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

U.S. Patent No. 12,037,644 - "Use of FGFR Mutant Gene Panels in Identifying Cancer Patients That Will Be Responsive to Treatment With an FGFR Inhibitor"

(Issued July 16, 2024. Compl. ¶21; ’644 Patent, front page).

The Invention Explained

  • Problem Addressed: The patent’s background section states that for cancer patients who fail first-line therapy, there is often no accepted standard of care. Although Fibroblast Growth Factor Receptor (FGFR) alterations have been observed in some cancers, therapies specifically targeting patients with such alterations were not approved at the time of the invention. (Compl. ¶21; ’644 Patent, col. 1:32-44).
  • The Patented Solution: The patent discloses methods for identifying cancer patients who are likely to respond to treatment with an FGFR inhibitor. The method involves testing a biological sample from a patient to see if it contains one or more specific genetic mutations—either FGFR fusion genes or single nucleotide polymorphisms (SNPs)—from a designated "FGFR mutant gene panel." The presence of a qualifying mutation indicates the patient will be responsive to the FGFR inhibitor therapy. (Compl. ¶21; ’644 Patent, abstract; ’644 Patent, col. 2:48-64). Figure 1 provides an illustration of exemplary FGFR fusion genes that can be detected. (’644 Patent, FIG. 1).
  • Technical Importance: The invention provides a method for personalized or precision medicine, enabling the selection of patients for a targeted cancer therapy based on the specific genetic profile of their tumor. (Compl. ¶21; ’644 Patent, col. 1:32-38).

Key Claims at a Glance

  • The complaint asserts claims 1-16, 19-21, and 23-25, which include independent claim 1. (Compl. ¶49).
  • The essential elements of independent claim 1 are:
    • A method of treating bladder cancer in a patient, comprising:
    • determining that a fibroblast growth factor receptor (FGFR) single nucleotide polymorphism FGFR3 Y373C is present in a biological sample from the patient, and
    • administering a FGFR inhibitor to the patient,
    • wherein the FGFR inhibitor comprises a compound having Structural Formula I (erdafitinib) or a pharmaceutically acceptable salt thereof. (’644 Patent, col. 119:3-12).
  • The complaint reserves the right to assert other claims.

U.S. Patent No. 10,478,494 - "FGFR/PD-1 COMBINATION THERAPY FOR THE TREATMENT OF CANCER"

(Issued November 19, 2019. Compl. ¶25; ’494 Patent, front page).

The Invention Explained

  • Problem Addressed: The patent seeks to provide improved cancer treatments, particularly for patients with FGFR-mutated cancers who may have limited options after failing other therapies. (’494 Patent, col. 1:30-41).
  • The Patented Solution: The invention is a combination therapy method. It involves administering an antibody that blocks the PD-1/PD-L1 immune checkpoint pathway together with an FGFR inhibitor. This dual-action approach is intended for patients whose tumors have been identified as having one or more FGFR variants. (’494 Patent, abstract).
  • Technical Importance: This method combines two distinct therapeutic approaches—immunotherapy and targeted small-molecule therapy—to potentially achieve a more potent anti-cancer effect than either agent used alone. (’494 Patent, abstract; ’494 Patent, col. 2:42-53).

Key Claims at a Glance

  • The complaint asserts claims 1, 3-4, 6-7, 12, and 14-15, which include independent claim 1. (Compl. ¶62).
  • The essential elements of independent claim 1 are:
    • A method of treating cancer in a patient, comprising:
    • evaluating a biological sample from the patient for the presence of one or more FGFR variants; and
    • if one or more FGFR variants are present, administering a pharmaceutically effective amount of an antibody that blocks the PD-1/PD-L1 interaction and a pharmaceutically effective amount of an FGFR inhibitor, where the inhibitor is the compound of formula (I) (erdafitinib). (’494 Patent, col. 75:40-67).
  • The complaint reserves the right to assert other claims.

U.S. Patent No. 12,678,498 - "FGFR/PD-1 COMBINATION THERAPY FOR THE TREATMENT OF CANCER"

(Issued July 14, 2026. Compl. ¶29; ’498 Patent, front page).

The Invention Explained

  • Similar to the ’494 Patent, this patent covers a combination therapy for cancer. The method involves administering an antibody that blocks the PD-1/PD-L1 immune checkpoint pathway in combination with an FGFR inhibitor to patients whose tumors are found to have one or more FGFR variants. (’498 Patent, abstract).

Key Claims at a Glance

  • Asserted Claims: Claims 1, 3-10, 18-24, and 27-36, which include independent claim 1. (Compl. ¶75).
  • Accused Features: The complaint alleges that Natco's filing of an ANDA for its erdafitinib product constitutes an act of infringement, as it is alleged that the generic drug will be used in a manner that practices the claimed combination therapy method. (Compl. ¶75; Compl. ¶78).

III. The Accused Instrumentality

Product Identification

  • Natco’s ANDA No. 218578 product, which is a generic version of BALVERSA® (erdafitinib) oral tablets in 3 mg, 4 mg, and 5 mg strengths (the "ANDA Product"). (Compl. ¶34).

Functionality and Market Context

  • The complaint alleges that by filing its ANDA, Natco has represented to the FDA that its product contains the same active ingredient (erdafitinib), dosage form, and strength as BALVERSA®, and is bioequivalent to it. (Compl. ¶40). BALVERSA® is an FGFR inhibitor approved by the FDA for the treatment of locally advanced or metastatic urothelial carcinoma in patients whose tumors have susceptible FGFR3 genetic alterations and have progressed after prior systemic therapy. (Compl. ¶19). The complaint alleges that Natco's ANDA Product, upon approval, will be marketed and used for this same indication. (Compl. ¶42).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’644 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating bladder cancer in a patient... Natco’s ANDA Product will be marketed for the treatment of urothelial carcinoma, a form of bladder cancer. ¶42 col. 119:3
...determining that a fibroblast growth factor receptor (FGFR) single nucleotide polymorphism FGFR3 Y373C is present in a biological sample from the patient... The BALVERSA® label is for patients with "susceptible FGFR3 genetic alterations," which Plaintiffs allege will require physicians to perform a determining step. The complaint alleges Natco's product will be used for these indications. ¶19; ¶42 col. 5:60-6:43
...administering a FGFR inhibitor to the patient, wherein the FGFR inhibitor comprises a compound having Structural Formula I...or a pharmaceutically acceptable salt thereof... Natco’s ANDA Product contains erdafitinib, the compound corresponding to Structural Formula I, which is an FGFR inhibitor. ¶34; ¶40 col. 59:1-7
  • Identified Points of Contention:
    • Scope Question: A key question for the court will be whether Natco’s proposed label for its generic product will induce infringement of claim 1. Specifically, the claim requires "determining" the presence of the specific FGFR3 Y373C mutation, whereas the branded drug's approved indication is for a broader category of "susceptible FGFR3 genetic alterations" (Compl. ¶19). The analysis will focus on whether the act of prescribing for the approved indication necessarily induces the specific determination required by the claim.

’494 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating cancer in a patient comprising: evaluating a biological sample from the patient for a presence of one or more FGFR variants... The approved indication for BALVERSA®, which Plaintiffs allege Natco's product will adopt, is for patients with "susceptible FGFR3 genetic alterations," implying that an evaluation step is performed. ¶19; ¶42 col. 11:42-49
...if one or more FGFR variants are present...administering to the patient a pharmaceutically effective amount of an antibody that blocks the interaction between PD-1 and PD-L1 and a pharmaceutically effective amount of an FGFR inhibitor...wherein the FGFR inhibitor is the compound of formula (I)... The complaint alleges that upon approval, Natco's ANDA Product (erdafitinib, or Formula I) will be administered to patients in a manner that infringes, which for this claim would involve co-administration with a PD-1/PD-L1 antibody. ¶62; ¶65 col. 5:6-23
  • Identified Points of Contention:
    • Legal & Evidentiary Question: The central dispute will likely be inducement. The claim requires administering two separate therapeutic agents: an FGFR inhibitor (Natco's product) and a PD-1/PD-L1 antibody. The infringement case raises the question of how Natco, by seeking to market a single-drug product, can be held liable for inducing infringement of a combination therapy claim. The analysis will depend on whether Natco's proposed product label instructs, encourages, or promotes co-administration with a PD-1/PD-L1 antibody.

V. Key Claim Terms for Construction

  • The Term: "determining" (’644 Patent, claim 1)

  • Context and Importance: The construction of "determining" is critical because it defines the action required to meet the diagnostic element of the claim. Practitioners may focus on this term because its interpretation could create or foreclose a divided infringement defense, depending on whether the actions of a single party (e.g., the prescribing physician) must meet the limitation, or if the actions of multiple parties (e.g., a lab and a physician) can be combined.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification uses the term "evaluating" in its summary, which could suggest that "determining" does not require a specific, highly technical action but rather a more general assessment of a patient's mutational status. (’644 Patent, col. 2:50-51).
    • Evidence for a Narrower Interpretation: The detailed description discloses specific, sophisticated laboratory techniques like qRT-PCR and Sanger sequencing to detect FGFR mutations. A defendant may argue that "determining" should be limited to such specific technical steps. (’644 Patent, col. 39:46-54).

  • The Term: "administering... an antibody... and a... FGFR inhibitor" (’494 Patent, claim 1)

  • Context and Importance: This term's construction is central to whether infringement can be found, as Natco's ANDA is for a single product (the FGFR inhibitor). The dispute will hinge on whether "administering... and..." requires the drugs to be co-formulated or given simultaneously, or if it can cover sequential administration as part of an overall treatment plan.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent abstract describes a "combination therapy" and methods of "treatment... comprising administering" the two agents, without specifying a required timing or formulation, which may support an interpretation covering a course of treatment where drugs are given sequentially. (’494 Patent, abstract; ’494 Patent, col. 2:42-46).
    • Evidence for a Narrower Interpretation: The patent does discuss co-administration and contemporaneous administration, which could be cited to argue for a narrower construction requiring the agents to be given at or near the same time. (’494 Patent, col. 6:20-27).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Natco will induce infringement of all asserted patents by distributing its ANDA Product with proposed labeling that will cause medical professionals to perform the steps of the claimed methods. (Compl. ¶53; Compl. ¶66; Compl. ¶79). Plaintiffs allege Natco has knowledge of the patents based on its Paragraph IV certification regarding the ’644 Patent (which would require a review of Orange Book-listed patents) and from being notified of the patents in this lawsuit. (Compl. ¶56; Compl. ¶69; Compl. ¶82).
  • Willful Infringement: Willfulness is alleged for all three patents. For the ’644 and ’494 patents, the allegations are based on alleged pre-suit knowledge derived from Natco’s submission of a Paragraph IV certification. (Compl. ¶56; Compl. ¶69). For the ’498 patent, the allegation is based on alleged post-suit knowledge from the patent’s Orange Book listing and its inclusion in this amended complaint. (Compl. ¶82).

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

  • A core issue will be one of inducement for a combination therapy: can Natco's ANDA for a single-drug product (erdafitinib) be found to induce infringement of the '494 and '498 patents, which claim a method requiring the administration of both erdafitinib and a separate PD-1/PD-L1 antibody? The analysis will likely focus on whether Natco's proposed label contains language that encourages or recommends such combination use.
  • A second key question will be one of diagnostic scope: for the '644 patent, does the claim element requiring "determining that a... FGFR3 Y373C is present" require a test for that specific mutation, or is it met by following a label that directs use in patients with the broader category of "susceptible FGFR3 genetic alterations"? This question will be central to the infringement analysis for the asserted method-of-treatment claims tied to a specific biomarker.