DCT

2:25-cv-01521

Genentech Inc v. Zydus Lifesciences Global FZE

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-01521, D.N.J., 02/27/2025
  • Venue Allegations: Venue is alleged to be proper for the foreign defendants as they are subject to personal jurisdiction in the district and for the U.S. defendant as it is incorporated and maintains a regular and established place of business in New Jersey.
  • Core Dispute: Plaintiffs allege that Defendants' Abbreviated New Drug Application (ANDA) to market a generic version of the drug EVRYSDI® (risdiplam) constitutes an act of infringement of a patent covering a specific crystalline form of the active ingredient.
  • Technical Context: The technology concerns pharmaceutical solid-state chemistry, specifically a thermodynamically stable crystalline polymorph of risdiplam, an oral therapy for spinal muscular atrophy (SMA).
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of an ANDA with a Paragraph IV certification, asserting that the patent-in-suit is not infringed or is invalid. The complaint was filed within the 45-day statutory period following receipt of Defendants' notice letter, triggering an automatic 30-month stay on FDA approval of the generic product.

Case Timeline

Date Event
2018-10-19 Priority Date for U.S. Patent No. 12,122,789
2024-10-22 Issue Date for U.S. Patent No. 12,122,789
2025-01-14 Date of Zydus's Paragraph IV Notice Letter
2025-02-27 Complaint Filing Date

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

U.S. Patent No. 12,122,789 - "Forms of Pyrido[1,2-a]pyrimidin-4-one Derivatives, Its Formulation and Its Process of Making," issued October 22, 2024

The Invention Explained

  • Problem Addressed: The patent addresses the need for specific, stable physical forms of the active pharmaceutical ingredient risdiplam. Different crystalline forms (polymorphs) of a drug can have varying physical properties that affect manufacturing, stability, and bioavailability, and the patent notes that its inventive form offers advantages in "ease of manufacturing (formulation), and dosage form stability" as well as "improved chemical stability" and "processability" compared to other forms (’789 Patent, col. 2:60-67).
  • The Patented Solution: The patent discloses and claims specific crystalline forms of the compound of formula (I), known as risdiplam, which is depicted in the complaint (Compl. ¶48). The primary invention is "crystalline polymorphic Form A," which is identified as the "thermodynamic stable polymorph" and is characterized by a unique X-ray powder diffraction (XRPD) pattern, among other properties (’789 Patent, col. 2:51-52; col. 3:4-39). The patent also claims pharmaceutical compositions and kits that include this specific crystalline form.
  • Technical Importance: Identifying and securing a single, stable crystalline form of an active pharmaceutical ingredient is critical for developing a safe, effective, and commercially viable drug product with consistent quality and a reliable shelf life (’789 Patent, col. 2:58-63).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claims 1, 9, and 11 (Compl. ¶53).
  • Independent Claim 1: A solid form of the compound of formula (I) that is "crystalline Form A," defined by an X-ray powder diffraction (XRPD) pattern that comprises at least two characteristic peaks selected from a specified list of seven 2-theta angles.
  • Independent Claim 9: A pharmaceutical composition that comprises the solid form of claim 1 and a pharmaceutically acceptable excipient.
  • Independent Claim 11: A kit that comprises the pharmaceutical composition of claim 9 and water to be used as a solvent to constitute the composition into an oral aqueous solution.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the "Zydus ANDA Product," a generic version of Plaintiffs' EVRYSDI® (risdiplam) for oral solution, for which Defendants seek FDA approval via ANDA No. 219902 (Compl. ¶1, ¶36).

Functionality and Market Context

  • The Zydus ANDA Product is a powder intended for constitution into an oral solution for the treatment of spinal muscular atrophy (SMA) (Compl. ¶30, ¶36). As a generic drug, it is intended to be bioequivalent to the branded EVRYSDI® product (Compl. ¶39). The complaint alleges that the proposed generic product, if approved, will be sold nationwide and will displace sales of EVRYSDI® (Compl. ¶13, ¶24). The complaint includes a dosage table from the EVRYSDI® label, which the Zydus product label is expected to copy, detailing administration based on patient age and weight (Compl. ¶34).

IV. Analysis of Infringement Allegations

’789 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A solid form of a compound of formula (I) The Zydus ANDA Product contains risdiplam, the compound of formula (I), as its active ingredient. The complaint alleges that claim 1 encompasses solid forms of risdiplam. ¶32, ¶36, ¶53 col. 1:15-40
Wherein the solid form is crystalline Form A having an x-ray powder diffraction (XRPD) pattern comprising at least two XRPD peaks selected from the group consisting of 8.3 (±0.2) degrees two-theta, 11.4 (±0.2) degrees two-theta, 15.1 (±0.2) degrees two-theta, 15.9 (±0.2) degrees two-theta, 17.0 (±0.2) degrees two-theta. 24.0 (±0.2) degrees two-theta, and 25.6 (±0.2) degrees two-theta angle of diffraction. The complaint alleges that Zydus's filing of its ANDA infringes claim 1. It further alleges that in its Paragraph IV notice letter, "Zydus has not contested infringement of claims 1, 9, and 11." ¶53 col. 53:18-24
  • Identified Points of Contention:
    • Scope Questions: The central infringement allegation rests on the specific crystalline form of risdiplam. A primary question for the court is whether the product defined in the Zydus ANDA will, in fact, be "crystalline Form A" as claimed. The complaint's assertion that Zydus has not contested infringement of the asserted claims may shift the primary focus of the case from infringement to the patent's validity (Compl. ¶53).
    • Technical Questions: Should infringement be contested, the dispute would turn on analytical characterization. A key technical question would be whether XRPD analysis of the Zydus ANDA Product demonstrates a pattern with at least two peaks from the claimed list, measured within the ±0.2 degrees two-theta tolerance specified in the claim.

V. Key Claim Terms for Construction

  • The Term: "crystalline Form A"
  • Context and Importance: This term defines the specific polymorph at the heart of the asserted claims. Its construction will determine the precise physical and analytical characteristics required to prove infringement. Practitioners may focus on this term because polymorphism is central to many pharmaceutical patents, and the scope of a polymorph claim is often a critical issue.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Claim 1 itself defines the form by requiring only "at least two" peaks from a list of seven, which may support an interpretation that does not require the presence of all, or even the most intense, characteristic peaks (’789 Patent, cl. 1).
    • Evidence for a Narrower Interpretation: The specification describes Form A as the "thermodynamic stable polymorph" and provides a full XRPD pattern in FIG. 1 and a longer list of peaks in Table 2 (’789 Patent, col. 2:51-52; FIG. 1; Table 2). A party may argue that to be "crystalline Form A," a sample must exhibit characteristics more representative of the full pattern described in the specification, not just any two peaks from the recited list.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Zydus will induce infringement of at least claim 11 (the kit claim) (Compl. ¶56). This allegation is based on the assertion that the Zydus ANDA Product's label will, as required by FDA regulations, essentially copy the EVRYSDI® label and therefore instruct or encourage physicians and patients to combine the powdered drug with water to form an oral solution, thereby performing the steps of the claimed kit method (Compl. ¶54).
  • Willful Infringement: The complaint alleges that Zydus was aware of the ’789 Patent at the time it submitted its ANDA and that its assertion of invalidity lacks a good faith basis (Compl. ¶60). This allegation of pre-suit knowledge and litigation misconduct forms the basis for a claim of willful infringement, which could lead to enhanced damages if Plaintiffs prevail.

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

  • A central issue will be one of patent validity: Given the allegation that infringement is not contested, the case will likely focus on whether the claims to "crystalline Form A" are novel, non-obvious, and adequately described and enabled by the patent's specification, as Zydus will need to prove the patent is invalid to succeed.
  • A key question of induced infringement will be whether the instructions on Zydus's proposed product label will be found to actively encourage the constitution of the powder with water, thereby meeting the legal standard for inducing infringement of the kit claim (claim 11).
  • A final question will concern willfulness and exceptional case status: Does the factual and legal basis provided in Zydus's Paragraph IV notice letter support a finding that its invalidity positions were objectively baseless, potentially justifying an award of enhanced damages or attorneys' fees?