DCT

1:25-cv-01283

Bayer Healthcare Pharma Inc v. ScieGen Pharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01283, D. Del., 10/20/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant intends to engage in infringing activities in the state upon FDA approval of its generic product and has separately agreed not to contest venue for this litigation.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s KERENDIA® (finerenone) drug constitutes an act of infringement of a patent claiming a specific crystalline form of the finerenone active pharmaceutical ingredient.
  • Technical Context: The technology at issue is pharmaceutical chemistry, specifically relating to the solid-state form (polymorphism) of an active pharmaceutical ingredient used in a drug for treating chronic kidney disease and heart failure.
  • Key Procedural History: The patent-in-suit is a reissue of U.S. Patent No. 10,336,749. The complaint states that Defendant provided a Paragraph IV Notice Letter asserting that the patent's claims are invalid for obviousness, establishing the central validity dispute for the litigation under the Hatch-Waxman Act.

Case Timeline

Date Event
2015-08-21 RE'826 Patent Priority Date
2019-07-02 Original U.S. Patent No. 10,336,749 Issued
2021-07-09 FDA Approval of KERENDIA® (NDA No. 215341)
2024-02-06 U.S. Reissued Patent No. RE49,826 Issued
2025-09-08 Defendant Sent Paragraph IV Notice Letter
2025-09-12 Plaintiff Received Paragraph IV Notice Letter
2025-10-20 Complaint Filed

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

U.S. Reissued Patent No. RE49,826 - "Method for the preparation of (4S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1-6-naphthyridine-3-carboxamide and the purification thereof for use as an active pharmaceutical ingredient"

  • Issued: February 6, 2024

The Invention Explained

  • Problem Addressed: The patent's background section describes prior "research scale" methods for synthesizing the finerenone compound as being unsuitable for large-scale industrial production. These prior methods allegedly suffered from low overall yield, the need for many laborious and costly chromatographic purifications, and the use of high excesses of reagents, making them economically and technically impractical for commercial manufacturing (RE’826 Patent, col. 5:46-58).
  • The Patented Solution: The patent discloses an "industrially practicable synthesis" designed to produce the finerenone compound with high yield, low cost, and high purity suitable for regulatory approval (RE’826 Patent, col. 5:59-65). A key aspect of the patented solution is a final crystallization process that reproducibly yields a single, defined crystalline form of the compound, designated "polymorph I," which has a specific melting point and is described as having "very good stability properties" (RE’826 Patent, col. 13:62-65, col. 15:26-30).
  • Technical Importance: The development of a robust, scalable process to reliably produce a specific, stable crystalline form of an active pharmaceutical ingredient is a critical step for ensuring consistent quality, bioavailability, and safety in a commercial drug product (RE’826 Patent, col. 13:56-62).

Key Claims at a Glance

  • The complaint does not identify specific claims but alleges infringement of "one or more claims" (Compl. ¶41). The primary independent claims appear to be 14, 19, 23, and 27, which define the finerenone compound as "crystalline form of polymorph I" based on different analytical properties.
  • Independent Claim 14:
    • A compound of the formula (I) [finerenone]
    • in crystalline form of polymorph I
    • wherein the x-ray diffractogram of the compound exhibits peak maxima of the 2 theta angle at 8.5, 14.1, and 19.0.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

Defendant ScieGen's proposed generic finerenone tablets (10 mg and 20 mg), which are the subject of Abbreviated New Drug Application (ANDA) No. 220745 submitted to the FDA (Compl. ¶¶1, 30).

Functionality and Market Context

The accused product is a generic pharmaceutical intended to be a therapeutic equivalent to Plaintiff's brand-name drug, KERENDIA® (Compl. ¶1). KERENDIA® (finerenone) is a non-steroidal mineralocorticoid receptor antagonist used to reduce the risk of certain kidney and cardiovascular events in adult patients with chronic kidney disease associated with type 2 diabetes, and for other heart failure indications (Compl. ¶21).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or sufficient technical detail mapping elements of the accused product to the patent claims. The infringement allegation is a statutory one under the Hatch-Waxman Act, where the act of submitting an ANDA for a generic drug containing a patented invention is an act of infringement (Compl. ¶40; 35 U.S.C. § 271(e)(2)(A)). The underlying infringement theory is that the finerenone active pharmaceutical ingredient in Defendant’s ANDA Product is, or will be, the specific "crystalline form of polymorph I" claimed in the RE’826 Patent.

No probative visual evidence provided in complaint.

Identified Points of Contention

  • Scope Questions: The dispute may turn on the interpretation of the claim language defining "polymorph I." A key question will be whether the specified analytical data points, such as the X-ray diffraction peaks recited in claim 14, must be matched exactly or if some degree of experimental variance is permitted within the claim's scope.
  • Technical Questions: A central technical question will be evidentiary: What are the actual solid-state properties of the finerenone API manufactured by the Defendant? The case will likely require discovery and expert analysis of Defendant's ANDA submission and physical samples to determine if the material meets the claimed characterization parameters (e.g., XRD, IR, Raman spectra).

V. Key Claim Terms for Construction

  • The Term: "crystalline form of polymorph I"
  • Context and Importance: This term is the central limitation of the asserted product claims. The entire infringement analysis will depend on whether the Defendant's API is properly characterized as this specific polymorph. Practitioners may focus on this term because the patent distinguishes its "reproducibly formed" polymorph I from materials produced by prior art methods.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue that the term should cover any crystalline finerenone that is substantially similar to the characterized form, allowing for minor variations in analytical measurements (e.g., peak positions in an X-ray diffractogram) that are common within the field of materials science.
    • Evidence for a Narrower Interpretation: The specification provides highly specific data to define polymorph I, stating it has a "defined melting point of 252° C." and listing numerous specific peak maxima from X-ray diffraction, IR, and Raman spectra (RE’826 Patent, col. 13:64-65; col. 14:40-43). Language such as "only one polymorph I is reproducibly formed" may be cited to argue that the claims are limited to a single, narrowly-defined crystal structure possessing these exact properties (RE’826 Patent, col. 13:62-64).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement and contributory infringement on the basis that Defendant knows and intends for healthcare professionals and patients to use its generic product according to its proposed label, thereby causing infringement (Compl. ¶50). It further alleges that the generic product is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶43).
  • Willful Infringement: The complaint alleges that Defendant "has acted with full knowledge of the RE'826 Patent," a claim premised on Defendant's Paragraph IV certification against the patent, which is listed in the FDA's Orange Book as covering KERENDIA® (Compl. ¶¶23, 43).

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

  • A core issue will be one of technical and evidentiary alignment: Does the finerenone active pharmaceutical ingredient in Defendant’s ANDA product possess the specific analytical characteristics (e.g., the X-ray diffraction peaks at 2 theta angles of 8.5, 14.1, and 19.0) required by the patent's claims for "crystalline form of polymorph I"?
  • A second central issue will be patent validity: As raised in Defendant’s Paragraph IV letter, a key legal question will be whether the claimed "crystalline form of polymorph I" was an obvious variant of the finerenone compound to a person of ordinary skill in pharmaceutical chemistry, or whether its discovery and isolation involved an inventive step.