DCT
2:25-cv-16648
Janssen Pharmaceutica NV v. Natco Pharma Ltd
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Janssen Pharmaceutica NV (Belgium), Janssen Biotech, Inc. (Pennsylvania), and Astex Therapeutics Ltd. (England and Wales)
- Defendant: Natco Pharma Ltd. (India)
- Plaintiff’s Counsel: Robinson Miller LLC
- Case Identification: 2:25-cv-16648, D.N.J., 10/15/2025
- Venue Allegations: Venue is alleged to be proper because Defendant is a foreign corporation subject to personal jurisdiction in the district and has previously consented to venue in the jurisdiction in similar patent actions.
- Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiffs’ BALVERSA® (erdafitinib) tablets constitutes an act of infringement of two U.S. patents.
- Technical Context: The technology pertains to personalized cancer therapy, specifically methods for treating cancer using Fibroblast Growth Factor Receptor (FGFR) inhibitors based on patient-specific genetic markers or in combination with other therapies.
- Key Procedural History: A separate patent infringement action between the same parties concerning the same ANDA but different patents is currently pending in the same district (Janssen Pharms. NV, et al. v. Natco Pharma Ltd., No. 2:23-cv-03959). Defendant has filed a Paragraph IV Certification for U.S. Patent No. 12,037,644, asserting that the patent is invalid and/or will not be infringed. The complaint notes that Defendant has not filed a similar certification for U.S. Patent No. 10,478,494.
Case Timeline
| Date | Event |
|---|---|
| 2014-09-26 | U.S. Patent No. 12,037,644 Priority Date |
| 2015-04-03 | U.S. Patent No. 10,478,494 Priority Date |
| 2019-11-19 | U.S. Patent No. 10,478,494 Issue Date |
| 2023-06-12 | Date of "First Natco Notice Letter" regarding other patents |
| 2024-07-16 | U.S. Patent No. 12,037,644 Issue Date |
| 2024-10-22 | U.S. Patent No. 12,037,644 Certificate of Correction Issued |
| 2025-09-03 | Date of "Second Natco Notice Letter" including Paragraph IV Certification for the '644 Patent |
| 2025-10-15 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
No probative visual evidence provided in complaint.
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
The Invention Explained
- Problem Addressed: The patent addresses the challenge of identifying which cancer patients are likely to benefit from treatment with a Fibroblast Growth Factor Receptor (FGFR) inhibitor, particularly for patients who have failed first-line therapy and for whom no standard of care exists ('644 Patent, col. 1:29-41).
- The Patented Solution: The invention provides methods for identifying a responsive cancer patient by evaluating a biological sample from the patient for the presence of one or more specific genetic mutations ("FGFR mutants") from a defined "FGFR mutant gene panel" ('644 Patent, Abstract). The presence of such a mutant indicates that the patient is a candidate for treatment with an FGFR inhibitor ('644 Patent, col. 2:10-22).
- Technical Importance: This method facilitates a personalized medicine approach, allowing for the selection of targeted therapies based on a patient's specific tumor genetics rather than a generalized treatment protocol ('644 Patent, col. 1:29-33).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-16, 19-21, and 23-25 (Compl. ¶44). Independent claim 1 is representative:
- A method of treating bladder cancer in a patient, the method 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].
U.S. Patent No. 10,478,494 - "FGFR/PD-1 Combination Therapy for the Treatment of Cancer," issued November 19, 2019
The Invention Explained
- Problem Addressed: The patent background notes the lack of approved therapies for cancer patients with FGFR alterations and the general difficulty in treating patients who have failed front-line therapies ('494 Patent, col. 1:27-38).
- The Patented Solution: The invention describes a conditional, sequential combination therapy for cancer. The method involves first administering an antibody that blocks the PD-1/PD-L1 immune checkpoint pathway. If this immunotherapy proves ineffective, the patient is then tested for the presence of specific FGFR gene fusions. If such fusions are present, an FGFR inhibitor is then administered ('494 Patent, Abstract; col. 2:40-62).
- Technical Importance: This invention provides a structured treatment algorithm that combines two distinct therapeutic modalities—immunotherapy and targeted kinase inhibition—to create a potential second-line treatment option for patients who do not respond to initial immunotherapy ('494 Patent, col. 5:22-36).
Key Claims at a Glance
- The complaint asserts infringement of claims 1, 3-4, 6-7, 12, and 14-15 (Compl. ¶58). Independent claim 1 is representative:
- A method of treating cancer in a patient comprising:
- administering to the patient a pharmaceutically effective amount of an antibody that blocks the interaction between PD-1 and PD-L1;
- monitoring the efficacy of the antibody; and
- if the antibody is not efficacious,
- evaluating a biological sample from the patient for a presence of one or more FGFR variants comprising a specific FGFR fusion gene, and
- administering a pharmaceutically effective amount of an FGFR inhibitor (the compound of formula I [erdafitinib]) if the variants are present.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Natco’s erdafitinib oral tablet (3 mg, 4 mg, and 5 mg), for which Natco seeks FDA approval via ANDA No. 218578 (Compl. ¶30).
Functionality and Market Context
- The complaint alleges that Natco's ANDA product is a generic copy of Plaintiffs’ branded drug BALVERSA® (Compl. ¶30). It is alleged to contain the same active ingredient (erdafitinib, an FGFR inhibitor), and to have the same dosage form, strength, and method of administration as BALVERSA® (Compl. ¶36). The complaint alleges that upon approval, Natco will market its product for the same indication as BALVERSA®: the treatment of locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3 genetic alterations (Compl. ¶¶19, 38).
IV. Analysis of Infringement Allegations
The complaint does not provide claim charts. The analysis below is based on the infringement theories articulated in the complaint's narrative sections.
U.S. Patent No. 12,037,644 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating bladder cancer in a patient, the method comprising: | Natco's ANDA seeks approval for its product to be marketed for the treatment of urothelial carcinoma, a type of bladder cancer. | ¶¶19, 38 | col. 26:1-2 |
| determining that a fibroblast growth factor receptor (FGFR) single nucleotide polymorphism FGFR3 Y373C is present in a biological sample from the patient, and | The proposed labeling for Natco's product will allegedly instruct medical professionals to administer the drug to patients with susceptible FGFR3 genetic alterations, which Plaintiffs allege will induce the performance of this prerequisite diagnostic step. | ¶¶47, 48 | col. 5:1-4 |
| administering a FGFR inhibitor to the patient, wherein the FGFR inhibitor comprises a compound having Structural Formula I | Natco’s ANDA product contains erdafitinib, the compound of Structural Formula I, and its proposed labeling will allegedly instruct physicians to administer it to patients. | ¶¶30, 36, 38 | col. 25:50-67 |
Identified Points of Contention:
- Scope Questions: A primary question may be whether the proposed label for Natco’s product will specifically instruct or require physicians to test for the FGFR3 Y373C polymorphism, as recited in the claim, or if it will refer more generally to "susceptible FGFR3 alterations." The correspondence between the label's instructions and the claim's specific diagnostic step will be central.
- Legal Questions: This is a method claim that involves a diagnostic step ("determining") and a treatment step ("administering"). This raises the possibility of a divided infringement defense, where the analysis will question whether Natco can be held liable for inducing acts that may be performed by separate entities (e.g., a diagnostic lab and a prescribing physician).
U.S. Patent No. 10,478,494 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating cancer...comprising: administering...an antibody that blocks the interaction between PD-1 and PD-L1; monitoring the efficacy...; and if the antibody is not efficacious, evaluating a biological sample...for a presence of one or more FGFR variants... | Plaintiffs allege that Natco's proposed product labeling will induce medical professionals to perform this entire sequence of steps, positioning Natco's erdafitinib as a treatment option following failed immunotherapy in patients with specific FGFR variants. | ¶¶61, 62 | col. 9:28-38 |
| and administering...an FGFR inhibitor if the one or more FGFR variants are present...wherein the FGFR inhibitor is the compound of formula (I) | Natco’s ANDA product is erdafitinib (the compound of formula I), and the complaint alleges its proposed label will instruct its administration within the specific context of the full claimed method. | ¶¶30, 36, 61 | col. 9:33-38 |
Identified Points of Contention:
- Technical Questions: The infringement allegation hinges on the contents of Natco's proposed label. A key factual question will be whether the label instructs the specific, multi-step, conditional treatment regimen claimed in the patent: use of erdafitinib after failure of a PD-1/PD-L1 antibody therapy and subsequent genetic testing.
- Legal Questions: As with the ’644 Patent, this claim raises divided infringement questions, as the full method involves administering an antibody (not sold by Natco), monitoring, testing, and then administering Natco's product. Plaintiffs' inducement theory will require showing Natco's intent to cause all steps of the claimed method to be performed.
V. Key Claim Terms for Construction
For the '644 Patent:
- The Term: "determining that a...polymorphism...is present"
- Context and Importance: This term defines the diagnostic predicate of the method claim. Its construction is critical because it links the patient's genetic status to the administration of the drug. Practitioners may focus on this term to analyze whether the actions of a diagnostic lab can be attributed to the entity administering the drug for purposes of infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discloses that the "evaluating" or "determining" step can be accomplished through various known techniques, such as qRT-PCR or sequencing, suggesting the term is not limited to a specific methodology ('644 Patent, col. 20:3-10).
- Evidence for a Narrower Interpretation: The claim structure links "determining" and "administering" with the word "and," which may support an argument that the steps must be performed by, or attributable to, a single actor or a joint enterprise, potentially narrowing the scope of infringing conduct.
For the '494 Patent:
- The Term: "if the antibody is not efficacious"
- Context and Importance: This conditional phrase serves as the trigger for the second half of the claimed method (testing for FGFR variants and administering the FGFR inhibitor). Its definition is central to infringement, as it establishes the circumstances under which the accused product would be used in an infringing manner.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests efficacy can be monitored by standard clinical methods, such as "evaluating the patient's symptoms," "evaluating the severity," or "measuring tumor size," which could support interpreting "not efficacious" according to a physician's clinical judgment ('494 Patent, col. 8:60-64).
- Evidence for a Narrower Interpretation: The patent does not provide a precise quantitative threshold for what constitutes a lack of efficacy. A defendant may argue that the term is subjective and fails to provide an objective standard, potentially raising an indefiniteness challenge under 35 U.S.C. § 112.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement for both patents, based on the assertion that Natco’s proposed product labeling will instruct medical professionals to perform the steps of the claimed methods (Compl. ¶¶47-48, 61-62). The complaint also alleges contributory infringement of the '644 patent, asserting that Natco's product and its labeling are "especially made or adapted for use in infringing" and are "not suitable for substantial non-infringing use" (Compl. ¶51).
- Willful Infringement: Willfulness is alleged for both patents. For the '644 Patent, the complaint bases this allegation on Natco's knowledge of the patent from at least the date it submitted its Paragraph IV Certification (Compl. ¶52). For the '494 Patent, knowledge is alleged from at least the same date (Compl. ¶66). The complaint further alleges that Natco acted "without a reasonable basis for believing that it would not be liable" (Compl. ¶¶53, 67).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of evidentiary proof regarding the proposed label: Will Plaintiffs be able to demonstrate that the specific instructions in Natco's proposed ANDA label map directly onto the specific and conditional steps recited in the asserted claims of the '644 and '494 patents?
- The case will likely present a central legal question of divided infringement: For both method patents, can Plaintiffs establish that Natco is liable for inducing infringement when the claimed steps (e.g., genetic testing, administering an antibody, monitoring efficacy, administering Natco's drug) are necessarily performed by multiple, independent actors such as diagnostic labs, physicians, and patients?
- A further issue will be one of claim scope and definiteness, particularly for the '494 patent: Can the conditional limitation "if the antibody is not efficacious" be construed to set an objective, ascertainable standard for infringement, or does its reliance on clinical judgment render the claim's scope indefinite?