DCT

1:25-cv-00753

Bayer Pharma AG v. Alembic Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00753, D. Del., 06/18/2025
  • Venue Allegations: Plaintiffs allege venue is proper in Delaware because the U.S. defendant is a Delaware corporation, the foreign defendants are subject to personal jurisdiction in the district, and all defendants allegedly consented to jurisdiction and venue in a prior settlement agreement.
  • Core Dispute: Plaintiffs allege that Defendants' generic rivaroxaban product infringes a patent covering a method of reducing the risk of cardiovascular events through the combined administration of rivaroxaban and low-dose aspirin.
  • Technical Context: The technology involves a combination drug therapy designed to prevent major adverse cardiovascular events, such as heart attacks and strokes, in patients with chronic coronary or peripheral artery disease.
  • Key Procedural History: The complaint alleges that the parties entered a settlement agreement in February 2024 wherein Defendants admitted that the patent-in-suit is valid and that an unlicensed launch of their generic product would constitute infringement. The current action appears to arise from a provision in that agreement permitting an "at-risk" launch, with the complaint stating the sole issue for litigation is the amount of damages owed.

Case Timeline

Date Event
2018-02-02 Earliest Priority Date for ’310 Patent
2020-11-10 ’310 Patent Issue Date
2024-02 Alleged Settlement Agreement Between Parties
2024-03-27 Alembic's Notice Letter to Plaintiffs
2025-05-14 FDA Approval of Alembic's ANDA Product
2025-06-18 Complaint Filing Date

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

U.S. Patent No. 10,828,310 - "Reducing the Risk of Cardiovascular Events"

  • Patent Identification: U.S. Patent No. 10,828,310, "Reducing the Risk of Cardiovascular Events," issued November 10, 2020.

The Invention Explained

  • Problem Addressed: The patent's background section describes the high risk of major adverse cardiovascular events (e.g., myocardial infarction, stroke) faced by patients with coronary artery disease (CAD) and peripheral artery disease (PAD). It notes that prior antithrombotic therapies were either not demonstrably superior to standard care (aspirin alone) or presented unacceptably high risks of major bleeding. (’310 Patent, col. 2:1-29).
  • The Patented Solution: The invention is a specific combination therapy using a low dose of the Factor Xa inhibitor rivaroxaban (2.5 mg twice daily) co-administered with a low dose of aspirin (75-100 mg once daily). This particular dosage regimen is described as providing a superior reduction in cardiovascular events compared to aspirin alone, while managing the risk of bleeding events, as demonstrated in the large-scale COMPASS clinical trial. (’310 Patent, Abstract; col. 3:25-54).
  • Technical Importance: The invention provided a novel, evidence-based treatment regimen that showed a statistically significant improvement in outcomes for a large patient population with stable atherosclerotic vascular disease. (’310 Patent, col. 3:25-34).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1. (Compl. ¶37, ¶53).
  • The essential elements of independent claim 1 are:
    • A method of reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral artery disease,
    • comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective in reducing said risk,
    • wherein rivaroxaban is administered in an amount of 2.5 mg twice daily,
    • and wherein aspirin is administered in an amount of 75-100 mg daily.
  • The complaint notes that under a prior settlement, the Defendants have allegedly admitted that claims 1-8 are valid and enforceable. (Compl. ¶44).

III. The Accused Instrumentality

Product Identification

  • Alembic's 2.5 mg rivaroxaban tablets, approved under Abbreviated New Drug Application (ANDA) No. 210301 ("Alembic's ANDA Product"). (Compl. ¶2).

Functionality and Market Context

  • The accused product is a generic version of Plaintiffs' XARELTO® 2.5 mg tablet. (Compl. ¶2). The complaint alleges that the FDA-approved labeling for Alembic's ANDA Product directs its use in a manner that practices the patented method. Specifically, the label is alleged to instruct the administration of the 2.5 mg rivaroxaban tablet twice daily in combination with aspirin (75-100 mg daily) for reducing the risk of major cardiovascular events in patients with coronary or peripheral artery disease. (Compl. ¶51).
    No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that infringement is "deemed admitted" pursuant to a prior settlement agreement, and bases its infringement theory on the instructions provided in the accused product's labeling. (Compl. ¶45, ¶51).

’310 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral artery disease... The approved labeling for Alembic's ANDA Product allegedly "directs a method of reducing the risk of major cardiovascular events (cardiovascular (CV) death, myocardial infarction (MI), and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD)." ¶51 col. 19:56-61
...comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk... The labeling allegedly directs the administration of Alembic's rivaroxaban product and aspirin "in amounts that are clinically proven effective in reducing the risk of MI, stroke or CV death." ¶51 col. 19:61-64
...wherein rivaroxaban is administered in an amount of 2.5 mg twice daily... The labeling allegedly directs that "Alembic's ANDA Product is administered twice daily." The product is a 2.5 mg rivaroxaban tablet. ¶51, ¶2 col. 19:64-65
...and aspirin is administered in an amount of 75-100 mg daily. The labeling allegedly directs that "aspirin is administered in an amount of 75-100 mg daily." ¶51 col. 19:65-67
  • Identified Points of Contention:
    • Legal Question: The primary dispute, as framed by the complaint, is not whether infringement occurs, but rather the legal and financial consequences of that infringement. The central question for the court will be to determine the amount of damages owed by Alembic for its "at-risk" launch, based on the terms of the alleged February 2024 settlement agreement. (Compl. ¶45).
    • Factual Question: A key factual question will be the quantification of damages. This may involve evidence of Alembic's sales, market impact, and potentially Plaintiffs' lost profits or a reasonable royalty, all interpreted through the lens of the settlement agreement.

V. Key Claim Terms for Construction

Given the allegation that infringement liability is "deemed admitted," claim construction may not be central to the liability phase of the case. However, the interpretation of certain terms could still influence the scope and calculation of damages.

  • The Term: "clinically proven effective"
  • Context and Importance: This term, which appears in claim 1, sets the standard of efficacy for the claimed method. Practitioners may focus on this term because its interpretation could be relevant to arguments about the value of the patented invention and, consequently, the appropriate measure of damages for its infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification extensively discusses the results of the COMPASS trial, describing a "significant reduction" in the primary outcome. Language such as the "24% (p<0.001)" reduction in the composite of cardiovascular death, stroke, and myocardial infarction could support a broader view that any statistically significant positive result meets the "clinically proven" standard. (’310 Patent, col. 16:10-16).
    • Evidence for a Narrower Interpretation: The patent also provides highly specific data from the clinical trial, such as a "hazard ratio for the primary outcome was 0.76 (95% confidence interval [CI], 0.66 to 0.86; P<0.001)." (’310 Patent, col. 16:1-8). This could support a narrower interpretation, tethering the definition of "clinically proven effective" to achieving a specific quantum of benefit similar to that documented in the patent.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b), based on the theory that Defendants' marketing and sale of the ANDA Product with its approved labeling instructs and encourages physicians to prescribe, and patients to use, the product in an infringing manner. (Compl. ¶51, ¶54). The complaint also alleges contributory infringement under § 271(c), stating the product is a material part of the invention and is not suitable for substantial noninfringing use. (Compl. ¶52).
  • Willful Infringement: Willfulness is alleged based on Defendants' knowledge of the ’310 patent. This knowledge is purportedly evidenced by Defendants having sent a notice letter regarding the patent and having entered into a settlement agreement where they allegedly admitted the patent's validity and the infringing nature of their product launch. (Compl. ¶45, ¶55).

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

As framed by the complaint, this case appears to be a dispute over damages and contract interpretation rather than a traditional patent liability contest. The key questions for the court are likely to be:

  1. A primary issue will be one of contractual interpretation: what are the enforceable terms of the alleged February 2024 settlement agreement regarding the calculation of damages for an "at-risk" launch where infringement liability is "deemed admitted"?
  2. A central evidentiary question will be the quantification of damages: based on the settlement's terms and patent law principles, what is the appropriate monetary relief (e.g., lost profits or a reasonable royalty) to compensate for the admitted infringement?
  3. A further legal question will be one of enhanced damages: does Alembic's conduct, in making an "at-risk" launch contemplated by a settlement agreement, nevertheless constitute willful infringement under 35 U.S.C. § 284, thereby exposing it to a potential award of enhanced damages?