DCT

3:25-cv-15825

KuDOS Pharma Ltd v. Sun Pharmaceutical Industries Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-15825, D.N.J., 09/19/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Sun Pharmaceutical Industries, Inc. is headquartered in the district and both defendants maintain a regular and established place of business there, with the filing of the Abbreviated New Drug Application (ANDA) constituting a future act of infringement in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an ANDA to the FDA seeking to market a generic version of the cancer drug ZEJULA (niraparib) constitutes an act of patent infringement.
  • Technical Context: The dispute centers on the field of targeted oncology, specifically the use of Poly (ADP-ribose) Polymerase (PARP) inhibitors to treat cancers that have a pre-existing deficiency in a DNA repair pathway known as homologous recombination.
  • Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Defendants’ notification to Plaintiffs, via a Paragraph IV certification letter, of their intent to market a generic drug prior to the expiration of the asserted patent.

Case Timeline

Date Event
2003-07-25 U.S. Patent No. 8,859,562 Priority Date
2014-10-14 U.S. Patent No. 8,859,562 Issues
2025-08-07 Defendants notify Plaintiff of ANDA filing with Paragraph IV certification
2025-09-19 Complaint for Patent Infringement Filed
2027-08-12 Expiration of related Orange Book-listed patents for ZEJULA
2029-04-24 Expiration of related Orange Book-listed patent for ZEJULA

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

U.S. Patent No. 8,859,562 - "Use of RNAi Inhibiting PARP Activity for the Manufacture of a Medicament for the Treatment of Cancer"

  • Patent Identification: U.S. Patent No. 8,859,562, "Use of RNAi Inhibiting PARP Activity for the Manufacture of a Medicament for the Treatment of Cancer," issued October 14, 2014 (’562 Patent).

The Invention Explained

  • Problem Addressed: The patent describes a need for cancer treatments that are both effective and selective in killing cancer cells, avoiding the damage to healthy cells and unpleasant side effects associated with conventional radio- and chemotherapy ('562 Patent, col. 2:1-7).
  • The Patented Solution: The invention is based on the discovery that cancer cells deficient in a specific DNA repair pathway called homologous recombination (HR) are "hypersensitive" to agents that inhibit another DNA repair enzyme, Poly(ADP-ribose) Polymerase (PARP) ('562 Patent, col. 2:8-14). By administering a PARP inhibitor to a patient whose cancer has an HR defect (such as those with BRCA1 or BRCA2 gene mutations), the cancer cells are selectively killed while normal cells, which have a functioning HR pathway, are largely unaffected ('562 Patent, col. 2:38-48). This concept is known as synthetic lethality.
  • Technical Importance: This therapeutic strategy represents a targeted approach to cancer treatment, exploiting a specific genetic vulnerability of the tumor rather than relying on general cytotoxic effects.

Key Claims at a Glance

  • The complaint asserts independent claim 1 of the ’562 Patent (Compl. ¶32).
  • The essential elements of Claim 1 are:
    • A method of treatment of cancer cells defective in homologous recombination (HR).
    • Identifying a human patient with a familial predisposition to gene-linked hereditary cancer, where the cancer has HR-defective cells.
    • Identifying a compound which inhibits PARP-1.
    • Administering a therapeutically effective amount of that compound to the patient.
  • The complaint does not explicitly reserve the right to assert other claims.

III. The Accused Instrumentality

Product Identification

  • Defendants’ Abbreviated New Drug Application (ANDA) No. 220688 product, which is a generic version of ZEJULA (niraparib) tablets in 100 mg, 200 mg, and 300 mg dosage forms (Compl. ¶¶1, 23).

Functionality and Market Context

  • The active pharmaceutical ingredient, niraparib, is identified as a poly (ADP-ribose) polymerase (PARP) inhibitor used for the treatment of certain cancers (Compl. ¶22). The infringement allegation is not based on the current sale of a product, but on the submission of the ANDA seeking FDA approval to sell it in the future (Compl. ¶31). The allegedly infringing functionality is the use of the ANDA product as will be directed by its proposed prescribing information and labeling (Compl. ¶32).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not contain a claim chart. The infringement theory is one of induced infringement, where Defendants' proposed product label will allegedly instruct medical professionals to perform the steps of the patented method. The following table summarizes this narrative theory.

U.S. Patent No. 8,859,562 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treatment of cancer cells defective in homologous recombination (HR) The proposed label for Defendants' ANDA product allegedly directs its use for treating cancers that are known to be associated with HR defects (Compl. ¶¶22, 32). ¶32 col. 38:25-26
identifying a human patient with a familial predisposition to gene-linked hereditary cancer, wherein said cancer comprises cancer cells defective in homologous recombination The proposed label will allegedly instruct physicians to select and treat patients with specific cancer types that are linked to hereditary HR defects, thereby directing the performance of this identification step (Compl. ¶32). ¶32 col. 38:27-31
identifying a compound which inhibits PARP-1 The ANDA product is niraparib, a PARP inhibitor. The proposed label allegedly directs physicians to identify and use this specific compound for treatment (Compl. ¶¶22, 32). ¶32 col. 38:32-33
and administering to said human patient a therapeutically effective amount of said compound. The proposed label allegedly provides dosage and administration instructions for the ANDA product, which is offered in 100 mg, 200 mg, and 300 mg tablets (Compl. ¶¶23, 32). ¶¶23, 32 col. 38:34-36
  • Identified Points of Contention:
    • Scope Questions: The infringement analysis may focus on whether the instructions in the proposed label meet the specific limitation of "identifying a human patient with a familial predisposition to gene-linked hereditary cancer." The dispute could turn on whether the label merely indicates use for a cancer type (which may be associated with such a predisposition) or if it actively directs the user to make this specific patient identification as a prerequisite for treatment.
    • Technical Questions: A potential issue is whether niraparib, described broadly as a "PARP inhibitor" (Compl. ¶22), is proven to inhibit "PARP-1" as specifically required by the claim. The defense could raise the question of whether the drug's mechanism of action aligns precisely with the claimed target.

V. Key Claim Terms for Construction

  • The Term: "identifying a human patient with a familial predisposition to gene-linked hereditary cancer"
  • Context and Importance: This term is central to the induced infringement analysis. The definition of "identifying" will determine what level of diagnostic activity the proposed label must instruct. Practitioners may focus on this term because it appears to be a diagnostic or mental step, and the extent to which a generic drug label can be said to "induce" such a step is a frequent point of contention in pharmaceutical patent litigation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discusses the invention in the general context of treating cells "defective in HR," with gene-linked hereditary cancers involving BRCA1 and BRCA2 mutations given as preferred examples ('562 Patent, col. 3:6-22). This could support an interpretation where recognizing that a patient has a cancer type strongly associated with a hereditary defect is sufficient to meet the "identifying" step.
    • Evidence for a Narrower Interpretation: The claim language is highly specific, requiring identification of a "familial predisposition" and a "gene-linked" cancer. A defendant may argue this requires more than a simple diagnosis of a cancer type and points towards a specific recognition of the patient's hereditary status, potentially through genetic testing or family history analysis. The patent's focus on specific genetic mutations (e.g., BRCA2) could be cited to support this narrower view ('562 Patent, col. 3:21-22).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement, stating that Defendants "plan and intend to, and will, actively induce infringement" through the instructions on the proposed product labeling (Compl. ¶¶32, 34). It further alleges contributory infringement, asserting that the ANDA product and its labeling "are not suitable for substantial non-infringing use" (Compl. ¶35).
  • Willful Infringement: While the complaint does not use the word "willful," it alleges that Defendants were aware of the ’562 patent "at least as of the time of submitting Sun's Paragraph IV certification" and acted "without a reasonable basis for believing" they would not be liable for infringement, which provides a factual basis for a future willfulness claim (Compl. ¶¶33, 37).

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

  • A core issue will be one of induced infringement: does the specific language of Defendants' proposed product label instruct medical professionals to perform all the steps of Claim 1, particularly the diagnostic step of "identifying a human patient with a familial predisposition to gene-linked hereditary cancer," or does it merely describe a condition of use that overlaps with the claim?
  • A key question of claim construction will be determinative: how narrowly will the court define the "identifying" limitation? Whether this step requires a formal genetic diagnosis or is met by a physician's recognition of a patient's cancer type will be critical to the outcome.