DCT

1:25-cv-01299

Bayer Healthcare Pharma Inc v. DR Reddys Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01299, D. Del., 10/23/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant Dr. Reddy's Laboratories, Ltd. is a foreign corporation subject to personal jurisdiction in the district, and Defendant Dr. Reddy's Laboratories, Inc. is qualified to do business, has customers, and maintains licenses in Delaware. The complaint also asserts that both entities have previously availed themselves of the district's jurisdiction by initiating or defending other lawsuits.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of the drug KERENDIA® (finerenone) constitutes an act of infringement of a patent covering a specific crystalline form of the finerenone compound.
  • Technical Context: The patent-in-suit relates to pharmaceutical chemistry, specifically the preparation and purification of a crystalline polymorph of an active pharmaceutical ingredient used as a non-steroidal mineralocorticoid receptor antagonist for treating chronic kidney disease and heart failure.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of an ANDA with a Paragraph IV certification, asserting that U.S. Reissue Patent No. RE49,826 is invalid, unenforceable, or will not be infringed. The asserted patent is a reissue of U.S. Patent No. 10,336,749, and the complaint notes that claims 1-13 of the original patent are not part of the reissued patent, a fact that may be relevant to claim scope interpretation.

Case Timeline

Date Event
2015-08-21 ’826 Patent Priority Date
2019-07-02 Original U.S. Patent No. 10,336,749 Issued
2021-07-09 FDA Approves Plaintiff's KERENDIA® (finerenone)
2024-02-06 U.S. Reissue Patent No. RE49,826 Issued
2025-09-12 Defendant Sends Paragraph IV Notice Letter
2025-09-15 Plaintiff Receives Paragraph IV Notice Letter
2025-10-23 Complaint Filed

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

U.S. Reissue 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”

  • Patent Identification: U.S. Reissue 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 manufacturing. These prior methods were allegedly inefficient, requiring high dilution, large excesses of reagents, and multiple laborious chromatographic purification steps, resulting in a low overall yield (’826 Patent, col. 2:1-10).
  • The Patented Solution: The patent discloses an improved, "industrially practicable synthesis" designed to produce the finerenone compound in a reproducible manner with high overall yield, low production costs, and high purity, notably without requiring chromatographic purification of intermediates (’826 Patent, col. 2:60-67). The process culminates in the isolation of the compound in a specific, stable crystalline form, designated "polymorph I" (’826 Patent, col. 13:57-65).
  • Technical Importance: The development of a robust and scalable manufacturing process that yields a consistent, high-purity crystalline form of an active pharmaceutical ingredient is critical for ensuring drug safety, efficacy, and commercial viability (’826 Patent, col. 2:60-67).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the ’826 Patent without specifying particular claims (Compl. ¶51). Defendant's Paragraph IV letter allegedly challenged claims 14-30 (Compl. ¶41). Independent claim 14 is representative of the asserted subject matter.
  • Independent Claim 14:
    • A compound of the formula (I) 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.

III. The Accused Instrumentality

Product Identification

  • Defendant’s proposed generic finerenone drug product, described in Abbreviated New Drug Application No. 220694 (Compl. ¶1). The ANDA seeks approval to market 10 mg and 20 mg generic finerenone tablets (Compl. ¶39).

Functionality and Market Context

  • The accused product is a pharmaceutical composition intended to be a generic equivalent of Plaintiff's KERENDIA® product (Compl. ¶1). KERENDIA® (finerenone) is indicated for reducing the risk of kidney and cardiovascular problems in adult patients with chronic kidney disease associated with type 2 diabetes, and for certain patients with heart failure (Compl. ¶30). The filing of the ANDA signifies Defendant's intent to market this generic version in the United States upon receiving FDA approval (Compl. ¶37).

IV. Analysis of Infringement Allegations

The complaint pleads infringement based on "information and belief" and does not include a detailed claim chart. The infringement theory is that the active pharmaceutical ingredient in Defendant's ANDA product will meet the limitations of the asserted claims, including the specific crystalline form requirements.

No probative visual evidence provided in complaint.

RE49,826 Infringement Allegations

Claim Element (from Independent Claim 14) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound of the formula (I) Defendant’s ANDA Product contains finerenone, the compound corresponding to formula (I). ¶¶1, 39 col. 14:48-65
in crystalline form of polymorph I The finerenone active ingredient in Defendant’s ANDA Product is allegedly in the specific crystalline form identified as polymorph I. ¶¶49, 51 col. 13:57-65
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 crystalline finerenone in Defendant’s ANDA Product will, upon analysis, allegedly produce an X-ray powder diffraction (XRPD) pattern with peaks at the recited 2-theta angles. ¶¶49, 51 col. 56:65-67
  • Identified Points of Contention:
    • Factual Question: The central dispute will likely be factual: does the active pharmaceutical ingredient in Defendant's ANDA product actually exist as "crystalline form of polymorph I" as claimed? The resolution of this question will depend on competing analytical chemistry data (e.g., XRPD, spectroscopy) characterizing the physical form of Defendant's finerenone.
    • Scope Question: A potential dispute may arise over the definition of "polymorph I." Claim 14 defines the polymorph by referencing three specific XRPD peaks, while the patent specification describes polymorph I using a larger set of seven XRPD peaks, along with specific IR and Raman spectral data (’826 Patent, col. 14:40-44). This raises the question of whether an accused product must exhibit only the three peaks recited in the claim or a fuller set of characteristics described in the specification to meet the claim limitation.

V. Key Claim Terms for Construction

  • The Term: "crystalline form of polymorph I"

  • Context and Importance: This term is the central limitation of claim 14. The infringement analysis will depend entirely on whether Defendant’s generic product contains this specific solid-state form of finerenone. Practitioners may focus on this term because its precise scope—whether it is defined solely by the explicit language of the claim or is implicitly limited by the more detailed descriptions in the specification—will be dispositive.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party could argue that the claim itself provides the complete definition. Claim 14 explicitly requires only three specific XRPD peaks ("peak maxima...at 8.5, 14.1, and 19.0") to identify the polymorph, suggesting that the presence of these three peaks is sufficient for infringement, regardless of other physical characteristics (’826 Patent, col. 56:65-67).
    • Evidence for a Narrower Interpretation: A party could argue that the specification provides a more complete and limiting definition of "polymorph I." The patent states that polymorph I is "characterized in that the x-ray diffractogram of the compound exhibits peak maxima...at 8.5, 14.1, 17.2, 19.0, 20.5, 25.6, 26.5" and has a defined melting point of 252° C (’826 Patent, col. 13:62-64; col. 14:40-44). This language could be used to argue that a compound must meet this more extensive set of criteria to be considered "polymorph I."

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Defendant will actively induce and contribute to infringement by marketing and selling its ANDA product (Compl. ¶52). The basis for inducement is the allegation that Defendant knows and intends for healthcare professionals and patients to use the product in an infringing manner, consistent with its labeling (Compl. ¶60).
  • Willful Infringement: Plaintiff alleges that Defendant has acted with "full knowledge of the RE'826 Patent and without a reasonable basis for believing" its generic product would not infringe (Compl. ¶53). This allegation is predicated on Defendant's Paragraph IV certification, which establishes pre-suit knowledge of the patent.

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

  • A core issue will be one of physical characterization: Does the finerenone active ingredient in Defendant's proposed generic product, when subjected to analytical testing, exhibit the properties of the "crystalline form of polymorph I" required by the asserted claims? This is a central evidentiary question that will likely be resolved through a battle of experts and their interpretation of laboratory data.
  • The case may also turn on a question of definitional scope: For purposes of infringement, is "polymorph I" sufficiently defined by the three X-ray diffraction peaks recited in independent claim 14, or must an accused product also exhibit the more extensive set of structural and physical characteristics described for polymorph I in the patent's specification? The court’s construction of this key term will be critical to the outcome.