DCT

1:25-cv-00719

Bayer Pharma AG v. Macleods Pharma Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00719, D. Del., 06/16/2025
  • Venue Allegations: Venue is alleged to be proper for Macleods USA as it is a Delaware corporation. Venue for its Indian parent, Macleods Pharmaceuticals Ltd., is based on it being subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ generic 2.5 mg rivaroxaban tablets, sold for use in combination with aspirin, infringe a patent covering a method for reducing the risk of major cardiovascular events.
  • Technical Context: The technology relates to antithrombotic combination therapies, where a specific low dose of the Factor Xa inhibitor rivaroxaban is combined with low-dose aspirin to treat patients with chronic coronary or peripheral artery disease.
  • Key Procedural History: The parties previously litigated the same patent in a Hatch-Waxman action that was part of a multi-district litigation (MDL). That case was settled and dismissed in January 2024. The complaint notes that the MDL is currently stayed pending a Federal Circuit appeal of a Patent Trial and Appeal Board (PTAB) decision concerning an inter partes review of the asserted patent. This new lawsuit follows the FDA's final approval and Defendants' subsequent commercial launch of the accused generic product.

Case Timeline

Date Event
2018-02-02 U.S. Patent No. 10,828,310 Priority Date
2020-11-10 U.S. Patent No. 10,828,310 Issue Date
2023-05-02 Macleods sends Notice Letter for ANDA filing
2023-06-16 Plaintiffs file prior Hatch-Waxman suit against Macleods
2024-01-25 Prior Hatch-Waxman suit settled and dismissed
2025-05-14 FDA grants final approval for Macleods' ANDA Product
2025-06-09 Original complaint filed in current action
2025-06-16 Redacted public version of complaint filed

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 (’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) faced by patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD). It notes that prior antithrombotic therapies were either insufficiently effective or caused unacceptably high rates of major bleeding, leaving a need for new approaches to improve patient outcomes ('310 Patent, col. 2:1-30).
  • The Patented Solution: The invention is based on the discovery from the large-scale COMPASS clinical trial that a specific combination therapy—a 2.5 mg dose of rivaroxaban taken twice daily with a 75-100 mg dose of aspirin taken once daily—successfully reduces the risk of myocardial infarction, stroke, or cardiovascular death in this patient population without causing an unacceptably high risk of fatal or critical-organ bleeding ('310 Patent, col. 3:25-43, 3:49-56).
  • Technical Importance: This specific dosing regimen provided a new therapeutic standard of care, demonstrating superior efficacy over aspirin alone, which was a common treatment for these patients ('310 Patent, col. 15:10-23).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶ 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 aspirin is administered in an amount of 75-100 mg daily.
  • The complaint reserves the right to assert infringement of other claims of the ’310 Patent (Compl. ¶ 53).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Macleods' 2.5 mg rivaroxaban tablets, which are the subject of Abbreviated New Drug Application (ANDA) No. 213114 ("Macleods' ANDA Product") (Compl. ¶ 2).

Functionality and Market Context

  • The accused product is a generic version of Plaintiffs' XARELTO® 2.5 mg tablet (Compl. ¶ 41). The complaint alleges that the FDA-approved labeling for Macleods' ANDA Product directs its use in a manner that practices the patented method. Specifically, the label allegedly instructs the administration of the 2.5 mg rivaroxaban product twice daily, in combination with 75-100 mg of aspirin daily, for the purpose of reducing the risk of major cardiovascular events in patients with CAD or PAD (Compl. ¶ 51). The complaint alleges that since receiving final FDA approval, Macleods has begun importing and selling this product in the United States (Compl. ¶ 50).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’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 Macleods' ANDA Product allegedly directs a method for reducing the risk of major cardiovascular events (including myocardial infarction and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). ¶51 col. 3:57-63
comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with... disease, The approved labeling for Macleods' ANDA Product allegedly directs administration of rivaroxaban and aspirin in amounts that are clinically proven effective for reducing the specified risks. ¶51 col. 3:49-56
wherein rivaroxaban is administered in an amount of 2.5 mg twice daily The approved labeling for Macleods' ANDA Product allegedly directs that the product (a 2.5 mg rivaroxaban tablet) is administered twice daily. ¶51 col. 4:9-10
and aspirin is administered in an amount of 75-100 mg daily. The approved labeling for Macleods' ANDA Product allegedly directs that aspirin is co-administered in an amount of 75-100 mg daily. ¶51 col. 4:10-11
  • Identified Points of Contention:
    • Scope Questions: A central dispute may arise over the meaning of the phrase "clinically proven effective." The question will be whether this limitation requires a specific type of proof or knowledge on the part of the infringer, or if it is met simply by administering the claimed dosages for the claimed purpose, given the clinical evidence described in the patent itself.
    • Technical Questions: The primary factual question for inducement will be whether the instructions on the approved label for Macleods' ANDA Product, in fact, direct or encourage physicians and patients to perform all steps of the claimed method. The complaint's theory relies entirely on the content of the product's label to establish infringement (Compl. ¶ 51).

V. Key Claim Terms for Construction

  • The Term: "clinically proven effective"
  • Context and Importance: This term appears in the central clause of claim 1 and sets a performance-based requirement for the claimed method. Its definition is critical, as it is not a standard structural or process step. Practitioners may focus on this term because it could be a basis for a non-infringement argument or an indefiniteness challenge under 35 U.S.C. § 112. The dispute will likely involve whether a generic drug's label, which is based on the innovator's clinical data, automatically satisfies this "proof" requirement for infringement purposes.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification extensively discusses the results of the Phase III COMPASS trial as the basis for the invention ('310 Patent, col. 3:25-34). A party could argue that the term simply refers to the objective reality established by this trial, meaning any administration of the specified drug combination for the stated purpose is inherently "clinically proven effective" as disclosed in the patent.
    • Evidence for a Narrower Interpretation: The specification’s repeated and specific linkage of efficacy to the COMPASS trial data could be used to argue for a narrower scope ('310 Patent, col. 15:10-23). A party might contend that the term requires that the administered amounts be proven effective in the manner detailed in the patent's disclosure, potentially creating a higher bar for plaintiffs to meet.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement claim is based on the allegation that Defendants' approved product labeling instructs medical professionals and patients to perform the infringing method (Compl. ¶ 51, 54). The contributory infringement claim is based on the allegation that the accused product is especially made for an infringing use and is not suitable for a substantial noninfringing use (Compl. ¶ 52).
  • Willful Infringement: The complaint alleges that Defendants' infringement is willful, citing Defendants' pre-suit knowledge of the ’310 Patent from their involvement in a prior, settled Hatch-Waxman litigation concerning the same patent (Compl. ¶ 55).

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

  • A core issue will be one of claim construction and infringement: Can the phrase "clinically proven effective" be construed in a way that is met by the act of a generic manufacturer selling a product with a label that mimics the innovator's label, which is itself based on the clinical trials disclosed in the patent?
  • A key question of damages and intent will be: How will Defendants' clear, pre-suit knowledge of the patent, established through the prior settled litigation, influence the analysis of willful infringement and any potential for enhanced damages?
  • A significant procedural question will be: Given that a related multi-district litigation involving the ’310 Patent is stayed pending a Federal Circuit appeal of a PTAB validity decision, will this court also stay the current case, or will it proceed in parallel?