DCT

2:24-cv-11308

Genentech Inc v. Natco Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-11308, D.N.J., 12/19/2024
  • Venue Allegations: Venue is alleged to be proper because the defendant, Natco, is a foreign corporation subject to personal jurisdiction in the United States and may be sued in any judicial district.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the spinal muscular atrophy treatment 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 polymorphism, specifically a thermodynamically stable crystalline form of the active pharmaceutical ingredient risdiplam, which is critical for drug product manufacturing, stability, and performance.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendant’s submission of an ANDA with a Paragraph IV certification, asserting that the patent-in-suit is invalid, unenforceable, or will not be infringed. Plaintiffs received a notice letter from Defendant regarding the ANDA filing on November 20, 2024.

Case Timeline

Date Event
2018-10-19 ’789 Patent Priority Date
2024-10-22 ’789 Patent Issue Date
2024-11-20 Natco sends Notice Letter of ANDA Filing
2024-12-19 Complaint Filing Date

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

  • Patent Identification: 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 challenge that different physical forms (polymorphs) of a drug compound can have varied properties. Finding a form with advantageous characteristics is crucial for pharmaceutical development, as it can affect manufacturing ease, formulation, and the stability of the final product (’789 Patent, col. 2:58-63).
  • The Patented Solution: The invention is a specific crystalline polymorph of the compound risdiplam, designated "Form A." This form is described as the thermodynamically stable polymorph and is structurally defined by a unique pattern of peaks in an X-ray powder diffraction (XRPD) analysis (’789 Patent, col. 2:49-53). The patent asserts that Form A offers improved chemical stability and better processability (e.g., faster filtration) compared to other forms of the compound (’789 Patent, col. 2:64-col. 3:2).
  • Technical Importance: Identifying a single, stable crystalline form of an active pharmaceutical ingredient is a critical step in drug development, as it helps ensure product consistency, predictable dissolution rates in the body, and long-term shelf life (’789 Patent, col. 2:58-63).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 9 and 11 (Compl. ¶37).
  • Independent Claim 1:
    • A solid form of a compound of formula (I) (risdiplam);
    • Wherein the solid form is crystalline Form A having an x-ray powder diffraction (XRPD) pattern comprising at least two XRPD peaks selected from a specified group of seven peaks, including those at 8.3, 11.4, 15.1, 15.9, 17.0, 24.0, and 25.6 (±0.2) degrees two-theta (’789 Patent, col. 53:5-24).
  • Dependent Claim 9: A pharmaceutical composition comprising the solid form of claim 1 and a pharmaceutically acceptable excipient (Compl. ¶33).
  • Dependent Claim 11: A kit comprising the pharmaceutical composition of claim 9 and water as a solvent to constitute an oral aqueous solution (Compl. ¶34).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Natco’s proposed generic risdiplam product for oral solution, as described in its Abbreviated New Drug Application (ANDA) No. 219848 (the "Natco ANDA Product") (Compl. ¶¶ 1, 20).

Functionality and Market Context

  • The Natco ANDA Product is intended to be a generic version of Plaintiffs’ EVRYSDI® drug, which is indicated for the treatment of spinal muscular atrophy (SMA) (Compl. ¶¶ 1, 14). As a generic, it is required to be bioequivalent to the brand-name drug (Compl. ¶21).
  • The complaint alleges that Natco’s product will be administered orally once daily, with the dosage determined by patient age and body weight, and that its label will essentially copy the EVRYSDI® label (Compl. ¶¶ 18, 38). The complaint includes a dosage table from the EVRYSDI® label as an example of the instructions Natco's product will allegedly carry (Compl. ¶18).

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 Natco ANDA Product is a generic version of EVRYSDI® and contains the active ingredient risdiplam, which is the compound of formula (I). ¶¶ 16, 20 col. 53:5-11
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 Natco's filing of its ANDA seeking approval to market its generic risdiplam product constitutes infringement of claim 1. The complaint further notes that Natco's notice letter did not contest infringement of this claim. ¶37 col. 53:12-24
  • Identified Points of Contention:
    • Scope Questions: In pharmaceutical patent litigation involving polymorphs, a central dispute often revolves around whether the generic product uses the exact crystalline form claimed in the patent. The case may raise the question of whether Natco's product uses a different, non-infringing polymorph or an amorphous form of risdiplam that is nonetheless bioequivalent to EVRYSDI®.
    • Technical Questions: The complaint does not provide direct evidence, such as an XRPD analysis of Natco's product, to prove its crystalline structure. Therefore, a primary technical question for discovery and trial will be to determine the actual polymorphic form of the risdiplam active pharmaceutical ingredient (API) contained in the Natco ANDA Product.

V. Key Claim Terms for Construction

  • The Term: "crystalline Form A"
  • Context and Importance: The definition of this term is dispositive for the infringement analysis of claim 1 and the claims that depend on it. The dispute will likely center on whether the risdiplam in Natco's product falls within the scope of this term. Practitioners may focus on this term because the patent claims a specific polymorph, and generic manufacturers often attempt to design around such patents by using a different, non-infringing form.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language defines "crystalline Form A" by requiring an XRPD pattern with "at least two" peaks selected from a list of seven (’789 Patent, col. 53:15-24). A party could argue this creates a relatively broad definition that does not require the presence of all, or even most, of the characteristic peaks.
    • Evidence for a Narrower Interpretation: The specification provides a complete representative XRPD pattern for Form A in Figure 1 and describes it as "the thermodynamic stable polymorph" (’789 Patent, Fig. 1; col. 2:52-53). A party could argue that to be "crystalline Form A," an accused product must exhibit an XRPD pattern substantially identical to that shown in Figure 1 and embody the properties of the thermodynamically stable form, rather than merely possessing any two peaks from the recited list.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Natco will induce and contribute to the infringement of at least claim 11 (the kit claim). The inducement theory is based on the allegation that the Natco ANDA Product's label will instruct physicians and patients to mix the supplied powder with water, thereby directing them to perform the claimed method of constituting the oral solution (Compl. ¶38). The contributory infringement allegation is based on the assertion that the product is not a staple article of commerce and has no substantial non-infringing uses (Compl. ¶39).
  • Willful Infringement: The complaint alleges that Natco was aware of the ’789 Patent when it submitted its ANDA and that its invalidity contentions lack a good faith basis, which may support a claim for willful infringement (Compl. ¶44).

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

  • A central issue will be one of polymorphic identity: Does the risdiplam API in Natco’s proposed generic product in fact have the specific crystalline structure of "Form A" as claimed in the ’789 Patent? This is a factual question that will likely be resolved through competing expert analyses of physical evidence obtained during discovery.
  • A key legal question will be one of claim scope: If Natco's API exhibits some, but not all, of the characteristics of Form A described in the patent, the court will have to determine the boundaries of the term "crystalline Form A." Specifically, is the presence of any "at least two" XRPD peaks from the claimed list sufficient to prove infringement, or does the claim require a more holistic match to the patent's exemplary figures and description of the thermodynamically stable polymorph?