DCT

1:25-cv-00631

Bayer Pharma AG v. Aurobindo Pharma Ltd

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00631, D. Del., 05/21/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Aurobindo Pharma USA, Inc. is a Delaware corporation, and Defendant Aurobindo Pharma Limited is a foreign entity subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants' commercialization of a generic 2.5 mg rivaroxaban tablet infringes a patent covering a method of using that drug in combination with aspirin to reduce the risk of major cardiovascular events.
  • Technical Context: The lawsuit concerns antithrombotic therapy, specifically the use of a Factor Xa inhibitor (rivaroxaban) in combination with an antiplatelet agent (aspirin) for secondary prevention in patients with chronic atherosclerotic vascular disease.
  • Key Procedural History: The complaint notes that the parties were previously involved in Hatch-Waxman litigation concerning the same patent, which was part of a Multi-District Litigation (MDL) and subsequently settled in May 2024. The complaint also references a pending appeal of an inter partes review (IPR) involving the patent-in-suit and a third party, Mylan Pharmaceuticals.

Case Timeline

Date Event
2018-02-02 ’310 Patent Priority Date
2020-11-10 ’310 Patent Issue Date
2023-10-16 Aurobindo sends Notice Letter regarding ANDA filing
2023-12-01 Plaintiffs file initial Hatch-Waxman suit against Aurobindo
2024-05-10 Court enters stipulation of dismissal for prior settled litigation
2025-04-10 FDA grants final approval for Aurobindo's ANDA Product
2025-04-12 Aurobindo publicly announces planned commercial launch
2025-05-21 Complaint Filing Date

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

U.S. Patent No. 10,828,310 - "Reducing the Risk of Cardiovascular Events", issued November 10, 2020 (’310 Patent)

The Invention Explained

  • Problem Addressed: The patent's background section describes the high risk of major adverse cardiovascular events (e.g., heart attack, stroke) for patients with coronary artery disease (CAD) and peripheral artery disease (PAD) (’310 Patent, col. 2:1-4). It notes that prior antithrombotic treatments, including various anticoagulant and antiplatelet regimens, had not been shown to be superior to standard antiplatelet therapy or were associated with unacceptably high rates of major bleeding (’310 Patent, col. 2:4-29).
  • The Patented Solution: The invention is a specific combination therapy method using the Factor Xa inhibitor rivaroxaban and aspirin to treat this patient population (’310 Patent, Abstract). The patent discloses that a low dose of rivaroxaban (2.5 mg twice daily) administered with a low dose of aspirin (75-100 mg daily) was found to be effective in reducing cardiovascular events, based on the results of the phase III COMPASS clinical trial (’310 Patent, col. 3:26-44, 47-54).
  • Technical Importance: This specific low-dose combination therapy provided a new treatment protocol that balanced the goals of reducing ischemic events against the inherent risk of bleeding, a critical trade-off in long-term antithrombotic therapy for patients with stable cardiovascular disease (’310 Patent, col. 2:30-44).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and reserves the right to assert additional claims (Compl. ¶51).
  • Independent Claim 1 requires:
    • 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 aspirin is administered in an amount of 75-100 mg daily

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Aurobindo's 2.5 mg rivaroxaban tablets ("Aurobindo's ANDA Product"), which is a generic version of Plaintiffs' XARELTO® product (Compl. ¶2, Compl. ¶39).

Functionality and Market Context

The product is an oral anticoagulant (a Factor Xa inhibitor) (Compl. ¶30). The infringement allegations are not directed at the tablet's composition but at the method of its use as directed by its FDA-approved labeling (Compl. ¶49). The complaint alleges that Aurobindo is commercially manufacturing, using, offering to sell, selling, and/or importing this generic product into the United States following FDA approval of its Abbreviated New Drug Application (ANDA) No. 208544 (Compl. ¶2-Compl. ¶3, Compl. ¶48).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that Aurobindo induces and contributes to the infringement of the ’310 Patent through the sale and marketing of its ANDA Product with its accompanying label, which allegedly instructs users to perform the patented method (Compl. ¶49, Compl. ¶51-Compl. ¶52).

’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 The approved labeling for Aurobindo's ANDA Product allegedly directs a method of reducing the risk of major cardiovascular events, including cardiovascular death, myocardial infarction, and stroke. ¶49 col. 24:57-58
in a human patient with coronary artery disease and/or peripheral artery disease The directed method is allegedly for use in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). ¶49 col. 24:59-61
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 Aurobindo's rivaroxaban product and aspirin in amounts that are clinically proven effective for reducing the specified risks. ¶49 col. 24:61-64
wherein rivaroxaban is administered in an amount of 2.5 mg twice daily The labeling allegedly directs that Aurobindo's ANDA Product (a 2.5 mg tablet) is administered twice daily. ¶49 col. 24:64-66
and aspirin is administered in an amount of 75-100 mg daily. The labeling allegedly directs that aspirin is co-administered in an amount of 75-100 mg daily. ¶49 col. 24:66-67
  • Identified Points of Contention:
    • Scope Questions: The primary dispute will likely center on whether Aurobindo's actions meet the legal standard for inducing infringement. This raises the question of whether the language in Aurobindo's FDA-approved label actively encourages, recommends, or promotes the combined administration of its 2.5 mg rivaroxaban tablet with aspirin in a manner that directly corresponds to all limitations of the asserted claims.
    • Technical Questions: In an ANDA case where the generic label is intended to mirror the brand-name label, the factual overlap is often significant. A potential point of contention could be whether there are any "carve-outs" or differences in Aurobindo's label that would provide a basis to argue it does not instruct the specific patented method. The complaint does not provide the accused label for analysis.

V. Key Claim Terms for Construction

  • The Term: "clinically proven effective"
  • Context and Importance: This term sets the evidentiary standard for the efficacy of the claimed drug combination. Practitioners may focus on this term because its definition is central to both infringement (i.e., whether the accused product's label directs a use that is "clinically proven effective") and validity (i.e., whether the patent provides an objective standard for what this phrase means).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party could argue the term should be given its plain and ordinary meaning to one of skill in the art, encompassing any regimen that has met the regulatory threshold for approval for the claimed indication, as would be reflected on an FDA-approved label (’310 Patent, col. 10:25-29).
    • Evidence for a Narrower Interpretation: The specification repeatedly and extensively details the specific statistical results of the COMPASS trial, including specific hazard ratios and p-values (’310 Patent, col. 5:4-14; ’310 Patent, Table 2). A party could argue that "clinically proven effective" should be narrowly construed to require the specific quantitative outcomes demonstrated in that trial, potentially limiting the claim's scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced infringement and contributory infringement (Compl. ¶51). The inducement allegation is based on the assertion that Aurobindo's approved labeling and marketing actively instruct physicians and patients to use the product in an infringing manner (Compl. ¶52). The contributory infringement allegation is based on the assertion that Aurobindo's product is especially made for an infringing use, is a material part of the invention, and is not a staple article suitable for substantial noninfringing use (Compl. ¶50).
  • Willful Infringement: Willfulness is alleged based on Aurobindo's pre-suit knowledge of the ’310 Patent, purportedly gained from its involvement in prior Hatch-Waxman litigation concerning the same patent that was settled between the parties (Compl. ¶53).

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

  • A central issue will be one of inducement: Does the language on Aurobindo's FDA-approved label, in concert with its marketing activities, contain sufficient instruction and encouragement to establish that Aurobindo specifically intended for prescribers and patients to perform the patented method of combination therapy, thereby satisfying the legal requirements for induced infringement?
  • A key question for damages will be one of willfulness: Given the documented history of prior litigation and settlement involving the parties and the asserted patent, did Aurobindo's decision to launch its generic product constitute objective recklessness, potentially exposing it to enhanced damages?
  • A potential, though likely secondary, issue is one of claim scope: How will the court construe the term "clinically proven effective"? Will it be defined by the general FDA approval standard for the indication, or will it be limited to the specific quantitative results of the COMPASS trial disclosed in the patent, and what impact will that construction have on the infringement analysis?