DCT

1:25-cv-00754

Bayer Pharma AG v. Hetero Labs Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00754, D. Del., 06/18/2025
  • Venue Allegations: Venue is alleged to be proper in Delaware because Defendant Camber is a Delaware corporation, and Defendants Hetero and Ascent are subject to personal jurisdiction in the district. The complaint alleges purposeful availment through business activities and consent to jurisdiction and venue in a prior settlement agreement between the parties.
  • Core Dispute: Plaintiffs allege that Defendants’ launch of a generic version of the 2.5 mg XARELTO® (rivaroxaban) tablet product infringes a patent covering a method of using rivaroxaban in combination with aspirin to reduce the risk of certain cardiovascular events.
  • Technical Context: The technology relates to a pharmaceutical combination therapy for the secondary prevention of major adverse cardiovascular events, such as heart attack and stroke, in patients with established atherosclerotic vascular disease.
  • Key Procedural History: This action follows a prior Hatch-Waxman lawsuit between the parties concerning the same patent and ANDA product, which was consolidated into an MDL. The complaint states that the prior action was settled in November 2024, with Defendants allegedly admitting that the patent is valid and enforceable and that an unlicensed launch of their product would infringe. The complaint further alleges that while the settlement permitted a launch under certain conditions, it specified that any such launch would be unlicensed and at risk for damages, with infringement liability "deemed admitted." The complaint also notes that the prior MDL was stayed pending an appeal of a related Inter Partes Review (IPR) proceeding at the PTAB.

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 Issued
2024-04-01 Ascent sends Paragraph IV Notice Letter regarding its ANDA
2024-05-16 Plaintiffs file initial Hatch-Waxman infringement suit against Defendants
2024-11-05 Court enters stipulation dismissing prior litigation pursuant to a settlement agreement
2025-05-14 FDA grants final approval for Ascent's ANDA Product; Defendants allegedly begin importation and/or sales
2025-06-18 Complaint filed in the present action

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 addresses the significant risk of major adverse cardiovascular events (e.g., myocardial infarction, stroke, cardiovascular death) faced by patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD) (U.S. Patent No. 10,828,310, col. 1:1-4). The background section notes that while various antithrombotic therapies exist, there remains a need for new approaches to improve health outcomes in these patient populations, as prior regimens have not been satisfactorily effective or have posed unacceptably high bleeding risks (col. 1:15-29).
  • The Patented Solution: The invention is based on the discovery that a specific combination therapy—low-dose rivaroxaban (a factor Xa inhibitor) administered with low-dose aspirin—is effective at reducing the risk of cardiovascular events in patients with stable atherosclerotic vascular disease (’310 Patent, col. 3:46-55). The patent specification extensively discusses the results of the COMPASS clinical trial, which demonstrated the efficacy and safety profile of this combination therapy (’310 Patent, col. 3:26-34).
  • Technical Importance: This combination therapy provided a novel treatment paradigm that demonstrated a statistically significant reduction in major cardiovascular events compared to aspirin alone, a long-standing standard of care for this patient population (’310 Patent, col. 17:40-51).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶37, ¶55).
  • 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 the risk of [the same events in the same patient population],
    • 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 does not explicitly reserve the right to assert other claims, but the settlement agreement allegedly includes an admission regarding claims 1-8 (Compl. ¶49).

III. The Accused Instrumentality

Product Identification

  • "Ascent's ANDA Product," which is identified as 2.5 mg rivaroxaban tablets submitted for approval under Abbreviated New Drug Application (ANDA) No. 219332 (Compl. ¶2).

Functionality and Market Context

  • The accused product is a generic version of Plaintiffs' XARELTO® 2.5 mg tablet (Compl. ¶43). The complaint alleges that the FDA-approved labeling for the product directs its administration in combination with aspirin for the same indications as the patented method (Compl. ¶53). Specifically, the labeling allegedly instructs administration of the 2.5 mg rivaroxaban tablet twice daily along with 75-100 mg of aspirin daily to reduce the risk of major cardiovascular events in patients with CAD and/or PAD (Compl. ¶53). The product is positioned as a lower-cost generic alternative to the branded XARELTO® product (Compl. ¶2).

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 complaint alleges that the approved labeling for Ascent's ANDA Product directs its use for a method of reducing the risk of major cardiovascular events in patients with chronic CAD or PAD (Compl. ¶53). ¶53 col. 3:56-62
...comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk... The approved labeling allegedly directs the administration of the 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" (Compl. ¶53). ¶53 col. 4:5-9
...wherein rivaroxaban is administered in an amount of 2.5 mg twice daily... Ascent's ANDA Product is a 2.5 mg rivaroxaban tablet, and its approved labeling allegedly directs that it be administered twice daily (Compl. ¶2, ¶53). ¶2, ¶53 col. 4:9-10
...and aspirin is administered in an amount of 75-100 mg daily. The approved labeling allegedly directs that the product be administered in combination with aspirin in an amount of 75-100 mg daily (Compl. ¶53). ¶53 col. 4:10-11
  • Identified Points of Contention:
    • Contractual Preclusion: The complaint’s central allegation is that a prior settlement agreement contains an admission of infringement, leaving only damages to be litigated (Compl. ¶49, ¶51). A primary point of contention will be the legal force and scope of this alleged admission. The court will need to determine if this agreement precludes Defendants from contesting liability in the current action.
    • Conditional Launch: The complaint mentions the settlement permits a launch "under certain conditions" but that such a launch would be "at risk" (Compl. ¶50). This raises the question of whether Defendants' launch met those conditions and how the satisfaction of, or failure to meet, those conditions impacts the alleged admission of liability.
    • No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

While the complaint alleges that liability has been admitted, claim construction may still be relevant if that admission is successfully challenged.

  • The Term: "clinically proven effective"
  • Context and Importance: This term sets the standard of efficacy for the claimed method. Its interpretation is critical because it could define the evidentiary bar for infringement. Practitioners may focus on this term because if liability is not admitted, Defendants could argue that the data supporting their ANDA does not meet the specific efficacy standard established by the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language of the term suggests that any recognized form of clinical proof would suffice, such as the evidence required for an FDA approval of a generic drug's labeling for a particular indication.
    • Evidence for a Narrower Interpretation: The specification is heavily reliant on the results of the COMPASS clinical trial (’310 Patent, col. 3:26-34). A party could argue that "clinically proven effective" is implicitly defined by and limited to the specific quantitative outcomes of that trial, such as the hazard ratio of 0.76 for the primary outcome (col. 16:5-7) and other specific results detailed throughout the patent.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement based on the approved labeling for the ANDA Product. It claims the label instructs physicians and patients to use the product in combination with aspirin in the exact manner recited by the patent claims (Compl. ¶53, ¶56). Contributory infringement is also alleged, with the assertion that the product is especially made for an infringing use and has no substantial noninfringing use (Compl. ¶54).
  • Willful Infringement: Willfulness is alleged based on Defendants' knowledge of the '310 patent from prior litigation and, most significantly, from the prior settlement agreement in which they allegedly admitted that an unlicensed launch would constitute infringement (Compl. ¶57).

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

  • A central issue will be one of preclusion and contract interpretation: what is the legal effect of the prior settlement agreement? Does it, as alleged, operate as a binding admission of infringement liability for the current at-risk launch, thereby limiting the dispute primarily to the calculation of damages?
  • A key secondary question will involve the interpretation of the settlement's launch provisions: the complaint states the agreement allowed for launch "under certain conditions" while remaining "at risk" for damages (Compl. ¶50). The resolution of this case may depend on what those conditions were and whether they were met, which could dictate whether the alleged liability-admission clause is triggered.
  • If the court finds that liability is not admitted, the case will turn on a question of definitional scope: can the term "clinically proven effective" in Claim 1 be satisfied by the evidence supporting an ANDA approval, or is it implicitly limited by the patent's specification to the specific quantitative efficacy results of the patentee's own COMPASS clinical trial?