DCT

1:25-cv-01282

Bayer Healthcare Pharma Inc v. Saba Ilac Sanayi Ve Ticaret A S

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01282, D. Del., 10/20/2025
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign corporation subject to personal jurisdiction in the district. The complaint further alleges Defendant has purposely availed itself of doing business in Delaware, maintains systematic contacts, and has previously consented to personal jurisdiction in the district in separate litigation.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for a generic version of Plaintiff's drug KERENDIA® constitutes an act of patent infringement.
  • Technical Context: The patent-in-suit relates to a method for preparing and purifying finerenone, the active pharmaceutical ingredient in KERENDIA®, which is a non-steroidal antagonist of the mineralocorticoid receptor used to treat cardiovascular and kidney diseases.
  • Key Procedural History: The asserted patent is a reissue of U.S. Patent No. 10,336,749. The lawsuit was triggered by Defendant’s Paragraph IV certification notice, which asserted that the patent-in-suit is invalid, unenforceable, and/or will not be infringed by its proposed generic product. The complaint notes that claims 1-13 of the original patent do not form a part of the reissued patent-in-suit.

Case Timeline

Date Event
2015-08-21 ’826 Patent Priority Date
2019-07-02 Original U.S. Patent No. 10,336,749 Issue Date
2021-07-09 FDA Approval of KERENDIA® New Drug Application
2024-02-06 U.S. Reissue Patent No. RE49,826 Issue Date
2025-09-07 Defendant Sent Paragraph IV Notice Letter
2025-09-12 Plaintiff Received Paragraph IV Notice Letter
2025-10-20 Complaint Filing Date

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 the prior art "research scale synthesis" of the finerenone compound as being unsuitable for large-scale industrial manufacturing. The identified problems include low overall yield, the need for many laborious and costly chromatographic purifications, and process steps that are difficult to implement at an industrial scale due to safety and technology challenges (RE’826 Patent, col. 1:48-58).
  • The Patented Solution: The patent discloses a "novel and improved process" designed for industrially practicable synthesis. This process purports to produce the finerenone compound with a high overall yield, low production costs, and high purity in a reproducible manner, avoiding the extensive chromatographic purification required by prior methods (’826 Patent, col. 1:16-23, col. 1:59-63). The patent also describes and claims a specific, stable crystalline form of the final compound, designated polymorph I (’826 Patent, col. 13:54-65).
  • Technical Importance: The development of an efficient, scalable, and reproducible synthesis process is critical for the commercial viability of a pharmaceutical product, ensuring consistent quality and enabling cost-effective mass production (’826 Patent, col. 1:59-65).

Key Claims at a Glance

  • The complaint does not identify specific claims asserted against the Defendant. It alleges infringement of "one or more claims" of the RE’826 Patent (Compl. ¶40).
  • The complaint’s summary of Defendant’s Paragraph IV Notice Letter indicates that the dispute centers on claims 14-30 (Compl. ¶31). Independent claims in this range include claim 14 (directed to the compound in a specific crystalline form, polymorph I) and claim 27 (directed to the same compound prepared by a specific process).
  • The complaint reserves the right to assert infringement of any of the patent's claims.

III. The Accused Instrumentality

Product Identification

Defendant SABA's proposed generic version of KERENDIA® (finerenone) tablets, in 10 mg and 20 mg dosages, as described in ANDA No. 220708 ("SABA's ANDA Product") (Compl. ¶1, ¶10, ¶29).

Functionality and Market Context

  • KERENDIA® (finerenone) is a non-steroidal mineralocorticoid receptor antagonist (nsMRA). It is indicated to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and other heart-related events in certain adult patients with chronic kidney disease associated with type 2 diabetes or with heart failure (Compl. ¶20).
  • The active ingredient is described in prescribing information as a "white to yellow crystalline powder" (Compl. ¶21). The complaint alleges that Defendant seeks FDA approval to market its ANDA Product for the same indications as KERENDIA® before the expiration of the RE’826 Patent (Compl. ¶1, ¶27).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim-by-claim analysis or the creation of a claim chart. The infringement theory is statutory, arising under the Hatch-Waxman Act, which defines the submission of an ANDA seeking approval to market a generic drug before the expiration of a relevant patent as an act of infringement (Compl. ¶38). The complaint alleges that SABA’s ANDA Product will, upon approval, contain the active ingredient claimed in the ’826 Patent (Compl. ¶39).

No probative visual evidence provided in complaint.

Identified Points of Contention

The complaint’s summary of Defendant's Paragraph IV Notice Letter suggests several potential areas of dispute (Compl. ¶31):

  • Scope Questions: A central dispute for claims 14-26 may be whether the crystalline form of finerenone in Defendant’s ANDA Product falls within the scope of "polymorph I" as claimed in the patent. The patent defines this polymorph by specific x-ray diffraction and IR spectrum data (’826 Patent, col. 13:40-43, col. 13:62-65).
  • Technical Questions: For product-by-process claims such as claim 27, a potential issue is whether infringement can be established based on the final product's characteristics alone, or if Plaintiff must also prove Defendant uses the claimed manufacturing process.
  • Invalidity Questions: Defendant has allegedly asserted that claims 14-30 are invalid as inherently anticipated or obvious. A further basis for invalidity is an alleged violation of 35 U.S.C. § 251, which governs reissue patents and may raise questions about whether the reissued claims improperly recaptured surrendered subject matter or broadened the scope of the original patent.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific claim terms. However, based on the technology and the likely focus on claims directed to the final product form, practitioners may focus on the following term:

  • The Term: "crystalline form of polymorph I" (from independent claim 14)
  • Context and Importance: The definition of this term is critical because infringement of the patent's compound claims appears to depend on the specific solid-state structure of the finerenone in Defendant's product. Whether Defendant's generic version contains this exact polymorph will be a dispositive issue.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party seeking a broader construction might argue that the term covers any crystalline finerenone that is bioequivalent and shares the primary structural characteristics of polymorph I, even if minor, non-critical variations in analytical data exist between batches or measurement techniques.
    • Evidence for a Narrower Interpretation: The specification provides highly specific analytical data to define polymorph I, including a list of "peak maxima of the 2 theta angle" from an x-ray diffractogram and band maxima from an IR spectrum (’826 Patent, col. 13:40-43, col. 13:62-65). A party seeking a narrower construction may argue that these enumerated peaks and bands are definitional, and a product must exhibit these exact characteristics to be considered "polymorph I."

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement to infringe, stating that Defendant knows and intends that healthcare professionals and patients will use its generic product in accordance with the product labeling, thereby infringing the patent (Compl. ¶49). It also alleges contributory infringement, asserting that the product lacks substantial non-infringing uses (Compl. ¶42).
  • Willful Infringement: The complaint alleges that Defendant has acted with "full knowledge of the RE'826 Patent," citing the patent's listing in the FDA's Orange Book and Defendant’s own Paragraph IV certification as evidence of this knowledge (Compl. ¶22, ¶28, ¶42).

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

  1. A core issue will be one of polymorphic identity: Does the finerenone in Defendant's proposed generic product exist in the specific "crystalline form of polymorph I" as characterized by the analytical data in the ’826 Patent specification, or does it utilize a different, non-infringing crystalline or amorphous form?
  2. A key legal question will concern reissue validity: Did the reissue process that resulted in the asserted claims 14-30 comply with the requirements of 35 U.S.C. § 251, or did it improperly recapture subject matter that was surrendered during the prosecution of the original patent?
  3. An evidentiary question will be one of infringement under § 271(e)(2): Given that infringement is based on the filing of an ANDA rather than an existing commercial product, what evidence can be adduced from the ANDA itself to prove that the product Defendant intends to market will meet the limitations of the asserted claims?