DCT

1:25-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: 1:25-cv-16901, D.N.J., 10/24/2025
  • Venue Allegations: Venue is alleged to be proper as to Defendant Dr. Reddy’s Laboratories, Ltd., a foreign corporation, based on its personal jurisdiction in the district. Venue is alleged to be proper as to Defendant Dr. Reddy’s Laboratories, Inc. because it is incorporated in New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the drug KERENDIA® (finerenone) constitutes an act of infringement of a patent covering a specific crystalline form and method of preparation for the active pharmaceutical ingredient.
  • Technical Context: The technology concerns pharmaceutical chemistry, specifically an improved, industrially-scalable process for manufacturing finerenone and isolating it in a defined crystalline polymorphic form for use in oral tablets.
  • Key Procedural History: The patent-in-suit, RE49,826, is a reissue of U.S. Patent No. 10,336,749. The complaint notes that the asserted patent is the subject of multiple other infringement proceedings filed by Bayer against other 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 Approves Bayer’s New Drug Application for KERENDIA® (finerenone)
2024-02-06 U.S. Reissue Patent No. RE49,826 Issued
2025-09-12 Defendant sends Paragraph IV Notice Letter to Plaintiff
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"

  • Issued: February 6, 2024.

The Invention Explained

  • Problem Addressed: The patent’s background section states that prior "research scale" methods for synthesizing the finerenone compound were unsuitable for large-scale industrial production. These prior methods allegedly suffered from low overall yield, required many laborious chromatographic purifications, and involved safety and technological difficulties that made them impractical for manufacturing the drug in commercial quantities (RE’826 Patent, col. 5:45-59).
  • The Patented Solution: The patent describes a "novel and improved process" that is more efficient and scalable (RE’826 Patent, col. 5:12-16). This process allows for the reproducible production of the finerenone compound in high yield and purity, meeting regulatory requirements for clinical trials and commercial supply (RE’826 Patent, col. 5:60-65). A key aspect of the invention is the ability to isolate the final compound in a specific, stable crystalline form, identified as "polymorph I," which ensures reproducible bioavailability when formulated into a tablet (RE’826 Patent, col. 13:56-62).
  • Technical Importance: The development of a robust, scalable manufacturing process and the identification of a stable crystalline form are critical steps in moving a drug from laboratory discovery to a commercially viable pharmaceutical product.

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" (Compl. ¶53), and notes that Defendant's Paragraph IV letter addressed claims 14-30 (Compl. ¶43). Independent claim 14 is representative of the asserted product claims.
  • Independent Claim 14 requires:
    • 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.
  • The complaint does not explicitly reserve the right to assert dependent claims, but the general allegation of infringing "one or more claims" leaves this possibility open.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the generic finerenone drug product for which Dr. Reddy's Laboratories ("DRL") seeks FDA approval under Abbreviated New Drug Application (ANDA) No. 220694 ("DRL's ANDA Product") (Compl. ¶1).

Functionality and Market Context

DRL's ANDA Product is a proposed generic version of Bayer's KERENDIA®, which is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) (Compl. ¶32, ¶39). It is indicated for use in adult patients to treat chronic kidney disease associated with type 2 diabetes and certain types of heart failure (Compl. ¶32). The complaint alleges DRL seeks approval to market 10 mg and 20 mg tablets of its generic finerenone product in the United States (Compl. ¶41).

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or provide specific details mapping elements of the asserted patent claims to features of DRL's ANDA Product. The central allegation is that DRL's submission of its ANDA with a Paragraph IV certification—stating that the RE’826 Patent is invalid or will not be infringed—constitutes a statutory act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶51). The complaint further alleges that upon FDA approval, DRL's commercial manufacture, use, or sale of its generic finerenone product will directly infringe one or more claims of the ’826 Patent (Compl. ¶53).

Identified Points of Contention

  • Scope Questions: The dispute will likely focus on whether DRL's proposed generic product meets the specific limitations of the asserted claims. For claim 14, this raises the question of whether DRL's active pharmaceutical ingredient exists in the claimed "crystalline form of polymorph I," as defined by the X-ray diffractogram peaks recited in the claim.
  • Technical Questions: A central evidentiary question will be whether the analytical data for DRL's ANDA Product, which is currently confidential within the ANDA filing, shows the same polymorphic form claimed in the ’826 Patent. The comparison of X-ray diffraction patterns and other analytical data between DRL's product and the patented polymorph will be a key technical issue.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

  • The Term: "crystalline form of polymorph I" (from Claim 14)
  • Context and Importance: The definition of this term is dispositive for infringement of the product claims. Polymorphism refers to the ability of a solid material to exist in multiple crystalline forms, which can have different physical properties, including solubility and stability. Infringement of claim 14 hinges entirely on whether DRL's product is, in fact, "polymorph I." Practitioners may focus on this term because generic manufacturers sometimes attempt to design around such patents by developing a different, non-infringing polymorphic form of the same active ingredient.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The complaint does not present evidence for a broader interpretation. A party seeking one might argue that minor, instrument-related variations in analytical data should not preclude a finding that a product is "polymorph I."
    • Evidence for a Narrower Interpretation: The patent provides a highly specific definition of polymorph I, characterizing it not only by XRPD peaks (RE’826 Patent, col. 14:40-44) but also by its IR spectrum (RE’826 Patent, col. 14:63-65), Raman spectrum (RE’826 Patent, col. 15:15-19), and a distinct melting point of 252° C. (RE’826 Patent, col. 15:12-14). This detailed, multi-faceted definition may support a narrow construction requiring a match across these analytical measures.

VI. Other Allegations

Indirect Infringement

The complaint alleges that upon approval of its ANDA, DRL will induce infringement by encouraging healthcare professionals and patients to use its product in an infringing manner, consistent with the product's labeling (Compl. ¶62). It also alleges contributory infringement will occur upon commercialization (Compl. ¶54).

Willful Infringement

The complaint alleges that DRL has acted with full knowledge of the ’826 Patent, citing the Paragraph IV Notice Letter as evidence of pre-suit knowledge (Compl. ¶40, ¶55). It further alleges DRL lacks a reasonable basis for believing its product would not infringe (Compl. ¶55).

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

  • A core issue will be one of technical identity: Does the active pharmaceutical ingredient in DRL's proposed generic product exist in the specific "crystalline form of polymorph I" as defined by the analytical data recited in claim 14 of the RE’826 Patent, or has DRL developed a distinct, non-infringing polymorph?
  • A second central issue will be patent validity: DRL’s Paragraph IV letter asserts that claims 14-30 are invalid as inherently anticipated (Compl. ¶43). The case will therefore likely involve a determination of whether the specific, purified crystalline form claimed by Bayer was disclosed or necessarily present in the prior art, even if not explicitly identified at the time.