DCT

2:25-cv-16901

Bayer Healthcare Pharma Inc v. DR Reddy's Laboratories Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-16901, D.N.J., 10/24/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Dr. Reddy's Laboratories, Inc. is incorporated in New Jersey. Venue over foreign parent Dr. Reddy's Laboratories, Ltd. is alleged based on its control over the New Jersey subsidiary, its systematic contacts with the state, and its history of availing itself of the jurisdiction of the court by previously initiating and defending litigation in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the drug KERENDIA® constitutes an act of infringement of a patent covering a specific crystalline form of the active pharmaceutical ingredient, finerenone.
  • Technical Context: The dispute centers on the chemical synthesis and purification of finerenone, a non-steroidal mineralocorticoid receptor antagonist used to treat chronic kidney disease associated with type 2 diabetes and certain types of heart failure.
  • Key Procedural History: The patent-in-suit is a reissue of U.S. Patent No. 10,336,749. The lawsuit was initiated under the Hatch-Waxman Act following Defendant’s submission of a Paragraph IV certification, which asserted that the patent-in-suit is invalid and/or will not be infringed by its proposed generic product. Plaintiff notes that the patent-in-suit is also the subject of other pending litigation against different generic drug manufacturers in the District of Delaware.

Case Timeline

Date Event
2015-08-21 RE49,826 Patent Priority Date
2019-07-02 Original U.S. Patent No. 10,336,749 Issued
2021-07-09 FDA Approved Plaintiff's KERENDIA® Drug Product
2024-02-06 U.S. Reissue Patent No. RE49,826 Issued
2025-09-12 Defendant Sent Paragraph IV Notice Letter
2025-09-15 Plaintiff Received Paragraph IV Notice Letter
2025-10-24 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"

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 earlier methods suffered from low overall yield, required multiple "laborious" chromatographic purifications, and used large excesses of reagents, making them inefficient and costly for commercial production (RE’826 Patent, col. 2:49-57).
  • The Patented Solution: The patent discloses an improved, industrially scalable process that produces the finerenone compound in high yield and purity without requiring chromatographic purification of intermediates (RE’826 Patent, col. 6:62-67). A key aspect of the invention is a final crystallization process that reproducibly yields a specific, stable crystalline form of the compound, designated "polymorph I," which is suitable for pharmaceutical formulation (RE’826 Patent, col. 13:55 - col. 14:23).
  • Technical Importance: The invention provides an "industrially practicable synthesis" necessary to manufacture the active pharmaceutical ingredient at a scale and level of purity required for clinical trials and commercial sale (RE’826 Patent, col. 2:58-65).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims but notes Defendant's Paragraph IV certification addresses claims 14-30 (Compl. ¶43). Independent claim 14 is a product claim directed to the specific crystalline form of the finerenone compound.
  • Independent Claim 14 Elements:
    • 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 makes general allegations of infringement of "one or more claims" (Compl. ¶53), which may preserve the right to assert other independent or dependent claims.

III. The Accused Instrumentality

Product Identification

  • Defendant’s proposed generic finerenone tablets (10 mg and 20 mg), as described in Abbreviated New Drug Application (ANDA) No. 220694 ("DRL's ANDA Product") (Compl. ¶1, ¶41).

Functionality and Market Context

  • DRL's ANDA Product is a generic version of Plaintiff's KERENDIA® drug, a non-steroidal mineralocorticoid receptor antagonist (nsMRA) (Compl. ¶1, ¶32). It is indicated to reduce the risk of kidney and cardiovascular problems in certain adult patients with chronic kidney disease associated with type 2 diabetes, as well as for certain adult patients with heart failure (Compl. ¶32).
  • The complaint alleges that Defendant seeks FDA approval to commercially manufacture, use, and sell this generic product in the United States before the expiration of the RE’826 Patent (Compl. ¶39).

IV. Analysis of Infringement Allegations

The complaint pleads infringement in a conclusory manner, as is common in initial complaints filed under the Hatch-Waxman Act. It alleges that the commercial manufacture, use, or sale of DRL's ANDA Product will infringe one or more claims of the RE’826 patent but does not provide a technical breakdown of this allegation (Compl. ¶52, ¶53). The analysis below is based on the infringement theory implied by the assertion of a product claim like claim 14 against DRL's ANDA Product.

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) DRL's ANDA Product is alleged to contain finerenone, the compound of formula (I), as its active pharmaceutical ingredient. ¶39, ¶41 col. 15:45-63
in crystalline form of polymorph I The complaint does not specify the polymorphic form of the API in DRL’s ANDA Product but alleges it will infringe, implying it is or will be polymorph I. ¶52, ¶53 col. 14:45-47
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 provides no data regarding the x-ray diffractogram of DRL’s API but alleges infringement, implying it will meet these structural limitations. ¶52, ¶53 col. 56:65 - col. 57:4
  • Identified Points of Contention:
    • Evidentiary Question: The central dispute will likely be factual: What is the precise crystalline structure of the finerenone active pharmaceutical ingredient (API) described in DRL's ANDA? This will require discovery into DRL's confidential ANDA submission and analysis of its proposed API.
    • Technical Question: Does the x-ray powder diffraction pattern of DRL's API show peaks at the specific 2-theta angles recited in claim 14? The complaint provides no evidence on this point, making it a primary question for litigation.

V. Key Claim Terms for Construction

  • The Term: "crystalline form of polymorph I"
  • Context and Importance: The definition of this term is dispositive for product claims like claim 14. Pharmaceutical compounds can often exist in multiple crystalline forms (polymorphs), each with different physical properties. The infringement analysis will turn entirely on whether the API in Defendant's product is the specific "polymorph I" claimed in the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language of claim 14 defines the polymorph by the presence of only three specific x-ray diffraction peaks ("at 8.5, 14.1, and 19.0"). A party could argue that any crystalline form exhibiting at least these three peaks falls within the claim's scope, regardless of other structural differences.
    • Evidence for a Narrower Interpretation: The patent specification provides a much more detailed characterization of "polymorph I," including an extensive list of additional x-ray diffraction peaks (RE’826 Patent, col. 42, table), specific IR and Raman spectra data (RE’826 Patent, col. 14:64 - col. 15:23), and a melting point of 252° C (RE’826 Patent, col. 15:13-14). A party may argue that the term "polymorph I" should be construed to require consistency with this full data set, thereby narrowing the claim to a more specific and rigorously defined structure.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Defendant will induce and contribute to infringement by selling its generic product with labeling that instructs healthcare professionals and patients to use the product in an infringing manner (Compl. ¶54, ¶62).
  • Willful Infringement: The complaint alleges that Defendant "has acted with full knowledge of the RE'826 Patent," citing the Paragraph IV Notice Letter sent to Bayer as evidence of this knowledge (Compl. ¶40, ¶55). This allegation is based on post-suit knowledge derived from the pre-suit notification process mandated by the Hatch-Waxman Act.

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

  • A core issue will be one of technical evidence: What is the precise polymorphic form of the finerenone API in Defendant's ANDA? The case will likely depend on expert analysis of confidential manufacturing data and physical samples to determine if the proposed generic product meets the structural limitations of the asserted patent claims.
  • A key legal question will be one of definitional scope: How will the court construe the term "crystalline form of polymorph I"? Will its meaning be limited to the explicit list of three X-ray diffraction peaks in claim 14, or will it be narrowed by the extensive characterization data provided elsewhere in the patent specification? The outcome of this claim construction will be critical to the infringement analysis.