DCT

1:25-cv-01247

Bayer Healthcare Pharma Inc v. Teva Pharma Inc

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01247, D. Del., 10/09/2025
  • Venue Allegations: Venue is alleged to be proper as to the domestic Teva entities because they are incorporated in Delaware. Venue as to the foreign parent, Teva Ltd., is alleged based on its purposeful availment of the jurisdiction through its subsidiaries, its business contacts within Delaware, and its history of initiating and consenting to 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® (finerenone) constitutes an act of infringement of a patent covering an improved method for preparing the active pharmaceutical ingredient.
  • Technical Context: The technology concerns a chemical synthesis process for finerenone, a non-steroidal mineralocorticoid receptor antagonist used to treat cardiovascular and renal diseases, particularly in patients with type 2 diabetes.
  • Key Procedural History: The litigation was triggered by Defendant's submission of ANDA No. 220737 with a Paragraph IV certification, asserting that the patent-in-suit is invalid, unenforceable, or will not be infringed. The patent-in-suit, RE49,826, is a reissue of U.S. Patent No. 10,336,749.

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 Approves Bayer’s KERENDIA® New Drug Application
2024-02-06 RE’826 Reissue Patent Issued
2025-08-26 Teva Sends Paragraph IV Notice Letter to Bayer
2025-08-27 Bayer Receives Paragraph IV Notice Letter
2025-10-09 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, issued February 6, 2024 (Compl. ¶39; ’826 Patent, cover).

The Invention Explained

  • Problem Addressed: The patent’s background section states that prior "research scale" methods for synthesizing the subject compound were unsuitable for industrial production due to low overall yield, the use of very high dilutions and excessive reagents, and the need for multiple chromatographic purifications, which are costly, solvent-intensive, and difficult to scale (RE’826 Patent, col. 2:45-58).
  • The Patented Solution: The patent discloses an improved, industrially scalable process that produces the active ingredient in high yield and purity without requiring chromatographic purification of intermediates (RE’826 Patent, col. 4:62-67). The process, outlined in Scheme 2 of the patent, is described as more efficient and economically viable for multi-ton scale production, meeting regulatory requirements for clinical trials and commercial supply (RE’826 Patent, col. 2:59-67; col. 6:50-57).
  • Technical Importance: The invention provides an industrially practicable synthesis method, enabling the large-scale and cost-effective manufacture of a therapeutically significant compound (RE’826 Patent, col. 2:59-63).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" of the RE’826 Patent without specifying particular claims (Compl. ¶57). Teva’s Paragraph IV Notice Letter reportedly challenges the validity and/or infringement of claims 14-30 (Compl. ¶47). Independent claim 2, a process claim, is representative of the invention's core methodology.
  • Independent Claim 2 (Process Claim):
    • A process for preparing the compound of formula (I).
    • The process comprises separating a racemic compound of formula (XIII) into its enantiomers.
    • The racemic compound of formula (XIII) is itself prepared by reacting a compound of formula (XVIII) with an orthoester (XX).
  • The complaint reserves the right to assert other claims.

III. The Accused Instrumentality

Product Identification

  • Teva’s proposed generic finerenone tablets (10 mg and 20 mg), as described in Abbreviated New Drug Application (ANDA) No. 220737 (“Teva’s ANDA Product”) (Compl. ¶1, ¶16, ¶45).

Functionality and Market Context

  • The accused product is a generic version of KERENDIA®, a non-steroidal mineralocorticoid receptor antagonist (nsMRA) indicated for reducing the risk of kidney disease progression, cardiovascular events, and heart failure hospitalization in certain patient populations (Compl. ¶36).
  • The complaint alleges that Teva is "one of the leading generic pharmaceutical companies in the United States" and that it seeks FDA approval to manufacture, market, and sell its generic finerenone product before the expiration of the ’826 Patent (Compl. ¶8, ¶43).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or specific factual allegations mapping Teva’s manufacturing process to the elements of the asserted patent claims. The infringement theory is statutory, based on 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA seeking approval to market a drug claimed in a patent as an act of infringement (Compl. ¶55). The core allegation is that the process Teva will use to manufacture its generic product, as described in its confidential ANDA, will infringe one or more claims of the ’826 Patent upon approval (Compl. ¶56-57).

  • Identified Points of Contention:
    • Scope Questions: A central issue will be whether Teva's undisclosed manufacturing process falls within the scope of the asserted claims. As Teva’s Paragraph IV letter challenges infringement of certain claims (Compl. ¶47), the dispute may focus on whether Teva’s process includes different chemical steps, intermediates, or purification methods that distinguish it from the patented process.
    • Technical Questions: The primary technical question is evidentiary: what specific synthesis route, reaction conditions, and separation techniques are described in Teva's confidential ANDA, and do they meet every limitation of an asserted claim? The complaint provides no information on this point, which will be a focus of discovery.

V. Key Claim Terms for Construction

  • The Term: "separating a racemic compound ... into its enantiomers" (from Claim 2)

    • Context and Importance: This step is central to isolating the desired stereoisomer of the active ingredient. The definition of "separating" could be pivotal. Practitioners may focus on this term because Teva may argue that its method for chiral resolution is distinct from the methods contemplated by the patent, thereby avoiding infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language itself does not specify a particular separation technology, which may support a construction covering any process that achieves the functional result of separating the enantiomers (’826 Patent, col. 46:27-44).
      • Evidence for a Narrower Interpretation: The specification provides a detailed description of a specific preparative chiral HPLC method, including Simulated Moving Bed (SMB) technology, a particular "Chiralpak AS-V" stationary phase, and a "methanol/acetonitrile 60:40" eluent mixture (’826 Patent, col. 12:50-col. 13:9). Parties arguing for a narrower scope may contend that the claims should be limited to this disclosed embodiment.

  • The Term: "is prepared by reacting a compound of the formula (XVIII) with an orthoester (XX)" (from Claim 2)

    • Context and Importance: This limitation defines the chemical history of the racemic mixture that undergoes separation. Infringement of this process claim requires that the material being separated was synthesized via this specific reaction. The dispute could turn on whether Teva uses an alternative synthesis path to arrive at the racemic intermediate.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim recites a general reaction between two classes of compounds without specifying solvents, catalysts, temperatures, or other reaction conditions, potentially supporting a broad reading (’826 Patent, col. 46:39-44).
      • Evidence for a Narrower Interpretation: The detailed description teaches specific, preferred conditions for this reaction, including the use of dimethylacetamide (DMA) or NMP as a solvent, a particular range of sulfuric acid catalyst, and a preferred temperature of 115° C (’826 Patent, col. 12:20-34). A defendant might argue these specific disclosures limit the scope of the more general claim language.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if its ANDA is approved, Teva will induce and contribute to infringement by marketing and selling its generic product with labeling that instructs healthcare professionals and patients on its use (Compl. ¶58, ¶66).
  • Willful Infringement: Willfulness is alleged based on Teva acting with "full knowledge of the RE’826 Patent" via the Paragraph IV notice process and proceeding "without a reasonable basis" for believing its product would not infringe (Compl. ¶59).

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

  1. A primary issue will be one of evidentiary proof: What are the specific steps, reagents, and conditions of the manufacturing process described in Teva’s confidential ANDA submission? The outcome of the infringement analysis will depend entirely on a comparison of this undisclosed process to the limitations of the asserted claims.
  2. A critical legal question will be one of claim scope: Will the process claims be interpreted broadly to cover the general chemical transformations described, or will they be narrowed by the specification's detailed disclosure of preferred reaction conditions, solvents, and a specific chiral HPLC separation technology?
  3. The case will also involve a significant validity dispute: As foreshadowed by Teva's Paragraph IV certification, a central battleground will be whether the asserted claims of the ’826 Patent are valid over the prior art, with Teva expected to argue that the patented process was anticipated or would have been obvious.