DCT

1:23-cv-01372

Bayer Pharma AG v. Aurobindo Pharma Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-01372, D. Del., 12/01/2023
  • Venue Allegations: Venue is alleged to be proper for Aurobindo Pharma USA, Inc. as a Delaware corporation. For Aurobindo Pharma Limited (India), venue is asserted based on its subjection to personal jurisdiction in the district, including through the activities of its U.S. subsidiary and its history of litigating in the district.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of the 2.5 mg XARELTO® (rivaroxaban) product constitutes an act of infringement of a patent covering a method of using rivaroxaban in combination with aspirin to reduce cardiovascular risk.
  • Technical Context: The lawsuit concerns a combination drug therapy in the field of anticoagulants, specifically targeting the prevention of major adverse cardiovascular events like heart attack and stroke in patients with coronary or peripheral artery disease.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Aurobindo's submission of a Paragraph IV certification in its ANDA, asserting that its generic product would not infringe the patent-in-suit or that the patent is invalid. The complaint notes the patent is listed in the FDA's "Orange Book" in connection with the 2.5 mg strength of XARELTO®.

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 Issues
2023-10-16 Aurobindo sends Notice Letter regarding ANDA submission
2023-12-01 Complaint Filed

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 are at high risk for major adverse cardiovascular events (’310 Patent, col. 2:1-4). Previous antithrombotic treatments, such as aspirin alone or vitamin K antagonists, were described as either insufficiently effective or posing an unacceptably high risk of major bleeding ('310 Patent, col. 2:15-29).
  • The Patented Solution: The invention is a specific combination therapy using a low dose of rivaroxaban (a Factor Xa inhibitor) with a low dose of aspirin. This combination is asserted to achieve a superior reduction in the risk of cardiovascular events compared to aspirin alone, without creating an unacceptably high risk of fatal bleeding or bleeding in critical organs ('310 Patent, Abstract; col. 3:51-59). The patent presents extensive clinical trial data (the COMPASS trial) to support this balance of efficacy and safety ('310 Patent, col. 15:23-col. 16:51).
  • Technical Importance: The claimed method provided a dual-pathway antithrombotic approach that, according to the patent's clinical data, offered a new, more effective option for long-term prevention of cardiovascular events in a large patient population with stable atherosclerotic disease ('310 Patent, col. 17:41-52).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶40).
  • 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 to achieve said risk reduction;
    • 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 does not explicitly reserve the right to assert dependent claims, but the prayer for relief is broad enough to potentially cover them (Compl. p. 12).

III. The Accused Instrumentality

Product Identification

  • Aurobindo's ANDA No. 208544 product, which is a generic version of the 2.5 mg rivaroxaban tablet, marketed by Plaintiffs as XARELTO® (Compl. ¶¶ 9, 34).

Functionality and Market Context

  • The accused instrumentality is the filing of an ANDA seeking FDA approval to market a generic 2.5 mg rivaroxaban tablet (Compl. ¶1). The infringement allegation is based on the assertion that Aurobindo's proposed product labeling will instruct physicians and patients to use the generic rivaroxaban in combination with aspirin for the same indications as the branded product (Compl. ¶37). This intended use, if carried out, would allegedly practice the method claimed in the '310 patent. The complaint alleges that upon approval, Aurobindo will manufacture, market, and sell this product in the United States (Compl. ¶12).

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, On information and belief, Aurobindo's proposed product labeling will direct a method for reducing the risk of major cardiovascular events (including myocardial infarction and stroke) in patients with chronic coronary artery disease or peripheral artery disease. ¶37 col. 4:1-4
comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk... The proposed labeling allegedly directs the administration of Aurobindo's rivaroxaban product and aspirin in amounts that are clinically proven effective to reduce the specified risks. ¶37 col. 4:5-8
wherein rivaroxaban is administered in an amount of 2.5 mg twice daily Aurobindo's ANDA is for a 2.5 mg tablet of rivaroxaban, and its proposed labeling will allegedly direct administration twice daily. ¶¶34, 37 col. 4:8-10
and aspirin is administered in an amount of 75-100 mg daily. The proposed labeling for Aurobindo's product will allegedly direct co-administration with aspirin in a daily amount of 75-100 mg. ¶37 col. 4:10-11
  • Identified Points of Contention:
    • Scope Questions: A potential dispute may arise over the meaning of "clinically proven effective." The question for the court could be whether this phrase is defined by the specific results of the COMPASS trial detailed in the patent, or if it sets a broader, objective standard of efficacy that could be challenged by other clinical evidence.
    • Technical Questions: In an ANDA case, infringement analysis centers on whether the proposed generic label will inevitably lead to the practice of the patented method. While the complaint alleges a direct correspondence, a key question will be whether the proposed label for Aurobindo’s product mandates the combination therapy in a manner that directly reads on every limitation of the asserted claims, or if non-infringing uses are possible or recommended.

V. Key Claim Terms for Construction

  • The Term: "clinically proven effective"
  • Context and Importance: This term appears in the main "comprising" clause of claim 1 and sets the standard for the claimed combination's efficacy. Its construction is critical because it links the administered dosages to a required functional outcome. Practitioners may focus on this term because its definition will determine what evidence is needed to prove both infringement and validity.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent's general background discussion of the need for new therapies could be used to argue for a broad, objective standard of clinical proof, independent of any single trial ('310 Patent, col. 2:27-29).
    • Evidence for a Narrower Interpretation: The patent specification is overwhelmingly based on the results of the "phase III COMPASS trial" ('310 Patent, col. 3:26-28). Plaintiffs may argue that "clinically proven effective" is implicitly defined by the extensive data, hazard ratios, and outcomes from this specific trial, which are detailed throughout the patent and form the basis of the invention ('310 Patent, col. 11:1-15; col. 17:41-52).

VI. Other Allegations

  • Indirect Infringement: The core of the complaint is a claim for induced infringement. Plaintiffs allege that Aurobindo, by filing its ANDA, intends for its generic product to be used in an infringing manner and that its proposed product labeling will instruct and encourage physicians and patients to perform the patented method of administration (Compl. ¶¶ 37, 42). The complaint also alleges the product with its proposed label "is not suitable for substantial noninfringing use," which suggests a basis for contributory infringement (Compl. ¶43).
  • Willful Infringement: The complaint does not contain a separate count for willful infringement. However, it alleges facts that could support such a claim, stating that Aurobindo has "knowledge of the claims of the '310 patent" and "specifically intends to infringe" (Compl. ¶41). This alleged knowledge is based on the patent's listing in the FDA Orange Book and the notice letter sent by Aurobindo (Compl. ¶¶ 32, 34).

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

  • A central issue will be one of claim construction: Can the phrase "clinically proven effective," as used in Claim 1, be defined solely by the clinical trial data presented within the '310 patent's specification, or does it establish a broader, objective standard of efficacy that might be subject to challenge through external evidence?
  • A key question of induced infringement will be whether Aurobindo's proposed product label, which is expected to mirror the brand-name label, constitutes sufficient evidence of specific intent to encourage or promote the performance of the patented method, particularly in a manner that satisfies all claim limitations.
  • While not detailed in the complaint, a dispositive issue for the litigation will likely be one of validity: Was the specific dosage regimen of 2.5 mg rivaroxaban twice daily combined with 75-100 mg aspirin daily non-obvious to a person of ordinary skill in the art at the time of the invention, given the prior art relating to each compound individually and in other combinations?