Genentech Inc v. Sun Pharmaceutical Industries Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:

  • Plaintiff: Genentech, Inc. (Delaware) and Hoffmann-La Roche Inc. (New Jersey)
  • Defendant: Natco Pharma Limited (India), Sun Pharmaceutical Industries Ltd. (India), and Sun Pharmaceutical Industries, Inc. (Delaware)
  • Plaintiff’s Counsel: Robinson Miller LLC; Groombridge, Wu, Baughman & Stone LLP

• Case Identification: 2:24-cv-10567, D.N.J., 02/12/2026

• Venue Allegations: Venue is alleged to be proper as to Defendant Natco Pharma Limited because it is a foreign corporation subject to personal jurisdiction in the district. Venue is alleged to be proper as to the Sun Defendants based on their consent to venue in the District of New Jersey.

• Core Dispute: Plaintiffs allege that Defendants' 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 specific crystalline forms and formulations of the drug.

• Technical Context: The technology relates to pharmaceutical chemistry, specifically the solid-state form of risdiplam, a small molecule drug that acts as a splicing modifier to treat the neurodegenerative disease spinal muscular atrophy (SMA).

• Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a notice letter dated November 20, 2024, in which Defendants advised of their ANDA filing containing a Paragraph IV certification alleging that the patent-in-suit is invalid, unenforceable, and/or will not be infringed.

Case Timeline

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”

The patent-in-suit is U.S. Patent No. 12,122,789 (the “’789 Patent”), issued October 22, 2024.

The Invention Explained

• Problem Addressed: The patent does not explicitly state a problem in its background section but focuses on the characterization of various solid forms of the risdiplam compound Compl. ¶39 In pharmaceutical development, identifying a stable solid form of an active pharmaceutical ingredient is a critical challenge to ensure consistent manufacturing, shelf-life, and bioavailability.

• The Patented Solution: The invention describes the discovery and characterization of specific crystalline forms (polymorphs) of risdiplam, with a focus on a form designated "crystalline Form A" (’789 Patent, col. 2:50-51). The patent defines this form by its unique X-ray powder diffraction (XRPD) pattern and identifies it as the thermodynamically stable polymorph, suggesting it is resistant to converting into other crystalline forms over time (’789 Patent, col. 2:50-51; ’789 Patent, Claim 1).

• Technical Importance: The identification of a thermodynamically stable crystalline form is significant for creating a reliable and consistent drug product, as it mitigates risks associated with physical instability that could alter the drug's performance and safety profile.

Key Claims at a Glance

• The complaint asserts independent claim 1 and dependent claims 9 and 11 Compl. ¶44

• 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 the group consisting of 8.3 (±0.2), 11.4 (±0.2), 15.1 (±0.2), 15.9 (±0.2), 17.0 (±0.2), 24.0 (±0.2), and 25.6 (±0.2) degrees two-theta.

• The complaint also asserts dependent claim 9, which covers a pharmaceutical composition comprising the solid form of claim 1, and claim 11, which covers a kit that includes the pharmaceutical composition of claim 9 and water for constitution into an oral solution Compl. ¶¶40-41 The complaint notes infringement of "one or more claims... including, but not limited to, claims 1, 9, and 11" Compl. ¶47

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendants' proposed generic risdiplam product for oral solution, for which approval is sought from the FDA under ANDA No. 219848 (the "Natco ANDA Product") Compl. ¶¶1, 25

Functionality and Market Context

• The Natco ANDA Product contains risdiplam as its active pharmaceutical ingredient and is intended as a generic substitute for Plaintiffs' EVRYSDI® product for the treatment of spinal muscular atrophy (SMA) Compl. ¶¶1, 19

• The complaint alleges the Natco ANDA Product is presented as a powder for constitution into an oral solution, similar to EVRYSDI® Compl. ¶22; Compl. ¶25

• Defendants' ANDA is alleged to contain data demonstrating the bioequivalence of the Natco ANDA Product and EVRYSDI® Compl. ¶28

• The complaint contains a table from the EVRYSDI® label showing the recommended dosing regimen determined by patient age and body weight Compl. p. 7, Table 1 The complaint alleges that the label for the Natco ANDA Product will essentially copy this information, as required by FDA regulations Compl. ¶45

IV. Analysis of Infringement Allegations

The complaint alleges that the filing of the ANDA itself is a technical act of infringement of the ’789 Patent Compl. ¶¶34, 44 The pleading does not contain a detailed claim chart but asserts that the Natco ANDA Product will infringe claims 1, 9, and 11, and that Defendants did not contest infringement in their Paragraph IV notice letter Compl. ¶44

’789 Patent Infringement Allegations

Identified Points of Contention

• Technical Questions: The central infringement question is factual and evidentiary. The complaint does not provide any characterization data (e.g., XRPD data) for the Natco ANDA Product. The analysis will depend on evidence, not yet presented in the pleadings, that characterizes the solid form of risdiplam used by Defendants. This raises the question: what analytical data will establish whether the Defendants' risdiplam product is, in fact, the claimed crystalline Form A?

• Scope Questions: The term "comprising at least two XRPD peaks" is open-ended. A potential point of contention may arise if the accused product has an XRPD pattern that includes two of the recited peaks but differs in other respects from the pattern disclosed for Form A in the patent. This raises the question of whether a partial match of characteristic peaks is sufficient to fall within the claim scope, or if the overall pattern must be considered to identify the substance as "crystalline Form A."

V. Key Claim Terms for Construction

• The Term: "crystalline Form A"

• Context and Importance: This term defines the specific polymorph that is the subject of claim 1. The determination of infringement will depend entirely on whether the Natco ANDA Product contains this specific form. Practitioners may focus on this term because polymorph litigation often turns on subtle differences in crystal structure that can be exploited to argue for or against infringement.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The claim defines "crystalline Form A" functionally by its XRPD pattern, stating it must comprise "at least two" peaks from a specified list ('789 Patent, claim 1). This language may support an interpretation where any crystalline form of risdiplam meeting this two-peak minimum falls within the scope of "Form A," regardless of other properties.
  • Evidence for a Narrower Interpretation: The specification describes "Crystalline polymorphic Form A" as "the thermodynamic stable polymorph" (’789 Patent, col. 2:50-51). Parties may argue that this description limits the scope of "crystalline Form A" to only the single most thermodynamically stable form of risdiplam, and that a product containing a different, albeit potentially similar, polymorph would not infringe.

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement to infringe at least claim 11, the kit claim Compl. ¶45 The basis for this allegation is that the label for the Natco ANDA Product, by copying the EVRYSDI® label, will necessarily instruct physicians and patients to constitute the drug powder with water to form an oral solution, thereby completing the claimed kit and performing the patented method of use Compl. ¶45

• Willful Infringement: The complaint does not contain an explicit count for willful infringement. However, it alleges that Defendants were aware of the ’789 Patent when they submitted the ANDA and that their statement regarding invalidity is "devoid of a good faith basis in either the facts or the law" Compl. ¶51 These allegations may form the basis for a later claim of willfulness or a request for enhanced damages.

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

• A central evidentiary question will be one of technical identity: what analytical evidence will be presented to prove or disprove that the solid form of risdiplam in Defendants' generic product is the specific "crystalline Form A" defined by the XRPD pattern in claim 1 of the '789 Patent?

• A key legal question for indirect infringement will be one of instruction and intent: does the label for the accused generic product, by instructing pharmacists or patients on how to constitute the powder into an oral solution, induce infringement of the '789 patent's kit claim?

• Given that the complaint alleges infringement is not contested, the case may ultimately turn on a question of validity: will Defendants be able to demonstrate by clear and convincing evidence that the asserted claims are invalid (e.g., as anticipated or obvious in light of prior art), overcoming the patent's statutory presumption of validity?