DCT

1:25-cv-00349

Bayer Pharma AG v. Lupin Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00349, D. Del., 03/20/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Lupin Pharmaceuticals, Inc. is a Delaware corporation, and Defendant Lupin Limited is subject to personal jurisdiction in the district as an alien defendant.
  • Core Dispute: Plaintiffs allege that Defendants' marketing and sale of a generic 2.5 mg rivaroxaban product infringes a patent covering a method of reducing the risk of cardiovascular events by co-administering specific doses of rivaroxaban and aspirin.
  • Technical Context: The technology relates to combination antithrombotic therapy, specifically using a factor Xa inhibitor (rivaroxaban) with an antiplatelet agent (aspirin) for patients with coronary or peripheral artery disease.
  • Key Procedural History: The complaint notes extensive prior litigation between the parties over the same patent, including a "Consolidated Infringement Action" (C.A. No. 21-314-RGA) in the same district. In that prior action, Defendants allegedly stipulated that the use of their generic product in accordance with its labeling would infringe claims 1-4 of the patent-in-suit. The complaint also notes that the prior consolidated action is currently stayed pending the final resolution of an appeal from an inter partes review (IPR) proceeding involving the patent-in-suit (IPR2022-00517). This new lawsuit follows the FDA's final approval and Defendants' commercial launch of the generic product.

Case Timeline

Date Event
2018-02-02 ’310 Patent Priority Date
2020-11-10 U.S. Patent No. 10,828,310 Issued
2021-01-15 Lupin's First Notice Letter (Paragraph IV) for ANDA No. 208555
2021-03-01 Initial infringement lawsuit filed by Bayer/Janssen against Lupin
2021-10-27 Infringement actions consolidated (the "Consolidated Infringement Action")
2023-12-21 Lupin's Second Notice Letter
2024-02-02 Second infringement lawsuit filed by Bayer/Janssen against Lupin
2024-04-01 Lupin stipulates to infringement of claims 1-4 in consolidated action
2025-03-03 FDA grants final approval for Lupin's ANDA Product
2025-03-07 Lupin launches its generic Rivaroxaban product in the U.S.
2025-03-20 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

The Invention Explained

  • Problem Addressed: The patent describes a need for improved therapies for patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD), who remain at high risk for major adverse cardiovascular events like heart attack and stroke. (’310 Patent, col. 2:1-5). Existing antithrombotic treatments were described as either insufficiently effective or presenting unacceptably high risks of major bleeding. (’310 Patent, col. 2:5-29).
  • The Patented Solution: The patent discloses that a specific combination therapy—administering a low dose of the factor Xa inhibitor rivaroxaban (2.5 mg twice daily) together with a low dose of aspirin (75-100 mg daily)—can effectively reduce the risk of cardiovascular events. (’310 Patent, Abstract; col. 4:51-65). The specification details the results of the large-scale COMPASS clinical trial, which provides the clinical data underpinning the invention's claims of efficacy and safety. (’310 Patent, col. 13:37-18:53).
  • Technical Importance: This specific dual-pathway approach (anticoagulant plus antiplatelet) at these particular low doses was presented as providing a superior balance of efficacy and safety compared to prior treatment regimens for this patient population. (’310 Patent, col. 17:41-52).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1. (Compl. ¶47).
  • 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 the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral arterial disease,
    • 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 notes a prior stipulation by Lupin to infringing dependent claims 2-4 as well. (Compl. ¶41).

III. The Accused Instrumentality

Product Identification

"Lupin's ANDA Product," which is a generic version of the 2.5 mg rivaroxaban tablets marketed by Plaintiffs as XARELTO®. (Compl. ¶¶ 1-2).

Functionality and Market Context

The accused instrumentality is the use of Lupin's 2.5 mg rivaroxaban tablets according to their FDA-approved labeling. (Compl. ¶45). The complaint alleges this labeling recommends, instructs, and encourages healthcare professionals to prescribe, and patients to use, the generic product in a manner that directly infringes the patented method. (Compl. ¶45). Specifically, the label allegedly directs administration of the 2.5 mg rivaroxaban tablet twice daily in combination with 75-100 mg of aspirin to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease. (Compl. ¶¶ 29, 45). The complaint alleges Lupin launched this product in the U.S. on or about March 7, 2025, following final FDA approval. (Compl. ¶3). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’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 Lupin's 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). ¶45 col. 18:56-64
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 coronary artery disease and/or peripheral arterial disease... The approved labeling for Lupin's ANDA Product allegedly directs the administration of Lupin's rivaroxaban product and aspirin in amounts that are "clinically proven effective in reducing the risk of MI, stroke or CV death in a human patient with CAD and/or PAD". ¶45 col. 4:51-55
wherein rivaroxaban is administered in an amount of 2.5 mg twice daily... Lupin's ANDA Product is a 2.5 mg tablet of rivaroxaban, and its approved labeling allegedly directs that it be administered twice daily. ¶¶2, 45 col. 18:64-65
and aspirin is administered in an amount of 75-100 mg daily. The approved labeling for Lupin's ANDA Product allegedly directs that aspirin be co-administered in an amount of 75-100 mg daily. ¶45 col. 18:65-67

Identified Points of Contention

  • Scope Questions: While the complaint alleges a direct mapping of the label's instructions to the claim elements, a potential dispute may arise over the meaning of "clinically proven effective." The question may be whether simply having an FDA-approved label for the same indication satisfies this limitation, or if it requires a specific quantum of evidence matching that disclosed in the patent's specification (e.g., the COMPASS trial data).
  • Legal Questions: A central issue will likely be the legal effect of Lupin's prior stipulation of infringement in the "Consolidated Infringement Action." (Compl. ¶41). The court will need to determine if that stipulation, made in the context of a pre-launch suit under 35 U.S.C. § 271(e)(2), has preclusive effect on the issue of infringement in this post-launch suit based on actual commercial activity.

V. Key Claim Terms for Construction

The Term

"clinically proven effective"

Context and Importance

This term appears in the second element of independent claim 1 and defines the standard of efficacy for the claimed method. The patent is heavily based on the specific outcomes of the COMPASS clinical trial. Therefore, the construction of this term is critical to determining the scope of the claim and whether Lupin's product, used as directed by its label, infringes. Practitioners may focus on this term because it links the claim language directly to the extensive clinical data presented in the patent.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The plain language of the term could be argued to encompass any method that meets the regulatory standard for clinical proof of effectiveness for the recited indication, such as obtaining FDA approval for a generic product with a label mirroring the innovator's.
  • Evidence for a Narrower Interpretation: The patent specification repeatedly ties effectiveness to the specific statistical results of the COMPASS trial, such as specific hazard ratios and p-values. (’310 Patent, col. 11:1-15; FIG. 2A, Table 2). A party could argue that "clinically proven effective" is defined by and limited to achieving the specific outcomes detailed in the patent, such as the hazard ratio of 0.76 for the primary outcome versus aspirin alone. (’310 Patent, col. 16:6-9).

VI. Other Allegations

Indirect Infringement

The complaint alleges induced infringement, stating that Lupin's approved product labeling and marketing actively instruct and encourage healthcare professionals and patients to perform the patented method. (Compl. ¶¶ 45, 49). It also alleges contributory infringement, asserting that Lupin's product is a material part of the invention, is especially made for an infringing use, and is not suitable for substantial non-infringing use. (Compl. ¶46).

Willful Infringement

Willfulness is alleged based on Lupin's pre-suit knowledge of the ’310 patent, evidenced by its involvement in years of prior litigation over the same patent, including receiving notice letters and filing Paragraph IV certifications. (Compl. ¶¶ 35, 38, 50).

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

  • A core issue will be one of issue preclusion: what is the legal effect, if any, of Defendants' stipulation in a prior, pre-launch litigation that their product's use would infringe claims 1-4 of the ’310 patent? The court's decision on this point could be dispositive of the infringement question.
  • A key question of claim construction will be the definition of "clinically proven effective." The case may turn on whether this phrase requires achieving the specific statistical outcomes disclosed in the patent's clinical trial data, or if it is met by obtaining FDA approval with labeling for the claimed therapeutic use.
  • A significant background issue that will influence the litigation strategy is the pending appeal of a PTAB decision regarding the validity of the ’310 patent. While not directly addressed in the complaint's allegations, the ultimate outcome of that appeal could render the entire infringement dispute moot.