Bayer Pharma AG v. Aurobindo Pharma Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Bayer Pharma AG, Bayer AG (Germany), and Janssen Pharmaceuticals, Inc. (Pennsylvania)
  • Defendant: Aurobindo Pharma Limited (India) and Aurobindo Pharma USA, Inc. (Delaware)
  • Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
• Case Identification: 1:25-cv-00631, D. Del., 05/29/2025
• 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 subject to personal jurisdiction in the district.
• Core Dispute: Plaintiffs allege that Defendants’ generic rivaroxaban tablets infringe a patent covering a method of reducing the risk of cardiovascular events by administering rivaroxaban in combination with aspirin.
• Technical Context: The technology concerns a combination drug therapy method for treating patients with stable atherosclerotic vascular disease, a leading cause of mortality and morbidity.
• Key Procedural History: The complaint notes that this lawsuit follows a prior, settled Hatch-Waxman action between the same parties over the same patent, which was part of a Multi-District Litigation (MDL). The complaint also references a pending appeal of an inter partes review (IPR) proceeding involving a third party (Mylan) and the patent-in-suit, suggesting ongoing validity challenges in other forums.

Case Timeline

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 (the “’310 Patent”), issued November 10, 2020.

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 peripheral artery disease (PAD) (’310 Patent, col. 2:1-4). It notes that prior antithrombotic therapies were either not shown to be superior to standard antiplatelet therapy or caused unacceptably high rates of major bleeding (’310 Patent, col. 2:4-30).
• The Patented Solution: The invention is a method of treatment using a combination therapy of a specific low dose of rivaroxaban (2.5 mg twice daily), a factor Xa inhibitor, and a low dose of aspirin (75-100 mg daily) (’310 Patent, Abstract). This specific combination was found in the COMPASS clinical trial to effectively reduce the risk of cardiovascular events in patients with stable CAD or PAD without causing an unacceptably high risk of fatal or critical organ bleeding (’310 Patent, col. 3:47-59).
• Technical Importance: The claimed method provided a novel therapeutic regimen that demonstrated superior efficacy over the existing standard of care (aspirin alone) for a large patient population at high risk for thrombotic events (’310 Patent, col. 2:21-30).

Key Claims at a Glance

• The complaint asserts infringement of at least independent claim 1 (Compl. ¶51).
• 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
  • wherein aspirin is administered in an amount of 75-100 mg daily.
• The complaint alleges infringement of "one or more claims," reserving the right to assert other claims, including dependent claims (Compl. ¶51).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Aurobindo’s Abbreviated New Drug Application (ANDA) No. 208544 product, which consists of 2.5 mg rivaroxaban tablets (“Aurobindo’s ANDA Product”) (Compl. ¶2).

Functionality and Market Context

• Aurobindo’s product is a generic version of Plaintiffs’ branded anticoagulant drug, XARELTO® (Compl. ¶2). The infringement allegation is not based on the composition of the tablet itself, but on the method of use for which it is sold. The complaint alleges that the FDA-approved labeling for Aurobindo’s ANDA Product directs medical professionals and patients to use the 2.5 mg rivaroxaban tablets in combination with low-dose aspirin for the specific patient population covered by the ’310 Patent (Compl. ¶49).
• The complaint alleges that Aurobindo has received final FDA approval and has begun, or intends to begin, commercially manufacturing, using, selling, and importing the product, positioning it as a direct generic competitor to the 2.5 mg strength of XARELTO® (Compl. ¶3, ¶48).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’310 Patent Infringement Allegations

Identified Points of Contention

• Scope Questions: The infringement analysis will likely focus on the scope of the phrase "clinically proven effective." A central question for the court may be whether this phrase requires a specific quantum of efficacy, such as that demonstrated in the COMPASS trial data cited in the patent, or if it is satisfied by the general indication for use on the generic product’s label.
• Technical Questions: As this is a method-of-use case centered on a product label, the primary factual question is whether the instructions and indications on Aurobindo's FDA-approved label direct users to perform each and every step of the claimed method. The complaint alleges a direct correspondence between the label's instructions and the claim limitations (Compl. ¶49).

V. Key Claim Terms for Construction

• The Term: "clinically proven effective"
• Context and Importance: This term appears in the second limitation of claim 1 and sets a functional, efficacy-based requirement for the claimed method. The construction of this term is critical because it could define the evidentiary standard required to prove infringement. Practitioners may focus on this term because it is not a standard structural or dosing limitation and its meaning will dictate whether the indication on the accused product's label is sufficient to meet the claim.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The term itself, given its plain and ordinary meaning to a person of skill in the art, could be interpreted to mean any product shown to be effective through clinical trials for the stated purpose. The patent does not provide an explicit definition that narrows the term.
  • Evidence for a Narrower Interpretation: The ’310 Patent specification is overwhelmingly based on the results of a single, large-scale clinical trial (COMPASS) (’310 Patent, col. 3:26-44; col. 15:23-16:51). A party could argue that "clinically proven effective" is implicitly defined by the specific outcomes, hazard ratios, and statistical significance levels reported from that trial in the specification, effectively tethering the claim's scope to that particular data.

VI. Other Allegations

• Indirect Infringement: The core of the complaint is indirect infringement. It alleges that Aurobindo induces infringement by marketing its product with a label that instructs physicians and patients to practice the patented method (Compl. ¶52). The complaint also alleges contributory infringement, stating 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 (Compl. ¶53). The complaint supports this by citing the prior Hatch-Waxman litigation between the parties involving the same patent, which establishes that Aurobindo was aware of the patent and Plaintiffs' infringement contentions before launching its product (Compl. ¶53).

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

1. A central issue will be one of induced infringement: does the FDA-approved label for Aurobindo’s generic product contain instructions and indications that directly encourage or lead physicians to prescribe, and patients to use, the drug in a manner that practices every element of the patented method, thereby establishing the requisite specific intent for inducement?
2. The case may turn on a question of definitional scope: will the court construe the term "clinically proven effective" to require the specific, quantitative efficacy results detailed in the patent’s supporting clinical trial data, or will a more general indication of effectiveness on the accused product's label suffice to meet this limitation?
3. A key question regarding damages and potential enhancement will be one of culpability: given the history of a prior settled lawsuit over the same patent, does Aurobindo's decision to launch its generic product constitute objective recklessness sufficient to support a finding of willful infringement?