DCT

1:25-cv-01043

Bayer Pharma AG v. DR Reddy's Laboratories Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01043, D. Del., 08/19/2025
  • Venue Allegations: Venue is alleged to be proper based on the defendants being subject to personal jurisdiction in the district. For the U.S. entity, the complaint also alleges prior consent to venue in this district in related litigation.
  • Core Dispute: Plaintiffs allege that Defendant’s generic rivaroxaban tablets infringe a patent covering a method of using a specific low-dose combination of rivaroxaban and aspirin to reduce the risk of major cardiovascular events.
  • Technical Context: The technology relates to pharmaceutical combination therapy for secondary prevention of cardiovascular events like heart attack and stroke in high-risk patients with established coronary or peripheral artery disease.
  • Key Procedural History: The complaint notes significant prior litigation between the parties over the patent-in-suit. In a prior "Consolidated Infringement Action," Dr. Reddy's allegedly stipulated that its product would infringe claims 1-4 of the patent. The complaint also references that this prior action is stayed pending the appeal of an inter partes review (IPR) proceeding involving the patent-in-suit, suggesting that the primary dispute between the parties centers on patent validity rather than infringement.

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
2021-04-14 Dr. Reddy's sends First Notice Letter of ANDA filing
2021-05-24 Plaintiffs file initial infringement suit against Dr. Reddy's
2023-03-15 Dr. Reddy's sends Second Notice Letter
2023-04-13 Plaintiffs file second infringement suit against Dr. Reddy's
2025-05-14 FDA grants final approval for Dr. Reddy's ANDA Product
2025-08-19 Complaint Filing Date

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, death) faced by patients with coronary artery disease (CAD) or peripheral artery disease (PAD). It notes that prior antithrombotic therapies beyond aspirin alone had not been shown to be superior or were associated with unacceptably high rates of major bleeding (’310 Patent, col. 2:1-29).
  • The Patented Solution: The invention is a method of treatment based on the discovery that a specific combination therapy—a low dose of the factor Xa inhibitor rivaroxaban (2.5 mg twice daily) administered with a low dose of aspirin (75-100 mg daily)—is effective at reducing the risk of these cardiovascular events (’310 Patent, col. 3:44-55). This discovery is expressly tied to the results of the phase III COMPASS clinical trial mentioned in the specification (’310 Patent, col. 3:28-34).
  • Technical Importance: The claimed method purports to provide a more effective therapy for this high-risk patient population than the prior standard of care without resulting in an "unacceptably high risk of fatal bleeding or bleeding in critical organs" (’310 Patent, col. 3:51-55).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 and notes a prior stipulation by Defendant to infringement of claims 1-4 (Compl. ¶¶ 1, 38).
  • Independent Claim 1:
    • 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...,
    • 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.

III. The Accused Instrumentality

Product Identification

  • "Dr. Reddy's ANDA Product," which is a 2.5 mg rivaroxaban tablet intended as a generic version of Plaintiffs’ XARELTO® product (Compl. ¶¶ 1-2).

Functionality and Market Context

  • The accused instrumentality is the generic drug product in conjunction with its FDA-approved labeling. The complaint alleges that the product's "Medication Guide" instructs and encourages healthcare professionals and patients to use the 2.5 mg rivaroxaban tablets in the patented method—specifically, for reducing the risk of major cardiovascular events in patients with CAD or PAD, administered twice daily in combination with daily aspirin (75-100 mg) (Compl. ¶44). The product has received final FDA approval and is allegedly being imported and sold in the United States (Compl. ¶¶ 3, 42-43).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

  • Claim Chart Summary: The infringement theory is based on inducement, where Defendant’s product labeling is alleged to instruct users to perform the patented method.

’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 The approved Medication Guide for the ANDA Product "directs a method of reducing the risk of major cardiovascular events (cardiovascular (CV) death, myocardial infarction (MI), and stroke)." ¶44 col. 3:56-4:11
in a human patient with coronary artery disease and/or peripheral artery disease The Medication Guide directs this method for use in "patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD)." ¶44 col. 3:46-51
comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk of [such events]... The Medication Guide "directs the administration of Dr. Reddy's ANDA Product and aspirin in amounts that are clinically proven effective in reducing the risk of MI, stroke or CV death..." ¶44 col. 4:56-65
wherein rivaroxaban is administered in an amount of 2.5 mg twice daily The product is a 2.5 mg tablet of rivaroxaban, and its Medication Guide directs that it be "administered twice daily." ¶¶2, 44 col. 4:7-11
and aspirin is administered in an amount of 75-100 mg daily. The Medication Guide directs that aspirin be "administered once daily in an amount of 75-100 mg daily." ¶44 col. 4:7-11
  • Identified Points of Contention:
    • Scope Questions: While the complaint references a prior stipulation to infringement by Dr. Reddy's (Compl. ¶38), a potential point of contention in claim construction could revolve around the phrase "clinically proven effective." The question may arise as to whether this phrase is defined by the patent’s own disclosure of the COMPASS trial data or if it sets an external, objective standard of efficacy that could be subject to debate.
    • Technical Questions: The central technical question for infringement is whether the instructions in Defendant's product labeling directly correspond to each step of the claimed method. Based on the allegations, the language in the Medication Guide appears to closely track the claim limitations, which may explain the prior stipulation of infringement (Compl. ¶¶ 38, 44).

V. Key Claim Terms for Construction

  • The Term: "clinically proven effective"
  • Context and Importance: This term is central as it defines the required outcome of the administration steps. Its construction could determine whether the claim is limited to the specific results disclosed in the patent or if it can be interpreted more broadly or narrowly. Practitioners may focus on this term because it links the method steps to a functional outcome, which can be a focal point for both infringement and validity (e.g., indefiniteness) arguments.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification repeatedly describes the invention as a method proven by the results of the COMPASS trial, suggesting that "clinically proven effective" means achieving the results shown in that trial and disclosed in the patent (’310 Patent, col. 3:28-43; col. 16:1-21). This could support an interpretation where the patent itself provides the definition for the term.
    • Evidence for a Narrower Interpretation: The claims do not explicitly mention the COMPASS trial. An argument could be made that "clinically proven effective" requires meeting a contemporary, objective standard of clinical proof that is independent of the patent's disclosure. Language in the summary referring to "amounts that are clinically proven effective" could be argued to set a performance standard rather than simply referencing the patent's own data (’310 Patent, col. 4:1-11).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement under 35 U.S.C. § 271(b), stating that Defendant's approved labeling "recommends, instructs, and/or encourages" healthcare professionals and patients to perform the patented method (Compl. ¶¶ 44, 48). The complaint also alleges contributory infringement under § 271(c), asserting that the product, with its label, is especially adapted for infringement and is not a staple article suitable for substantial noninfringing use (Compl. ¶45).
  • Willful Infringement: Willfulness is alleged based on Defendant's knowledge of the ’310 patent, evidenced by its involvement in prior, related litigation concerning infringement of the same patent (Compl. ¶49).

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

  • A central issue will be one of patent validity: Given the complaint’s reference to Defendant's prior stipulation of infringement and an ongoing appeal of an IPR proceeding, the primary battleground will likely be whether the asserted claims of the ’310 patent are valid over the prior art, rather than whether Defendant’s product infringes them.
  • A key question for damages will be willfulness: With an extensive history of litigation between the parties over the ’310 patent, the court will need to determine whether Defendant’s decision to launch its generic product after receiving FDA approval constituted willful infringement, which could expose it to enhanced damages.
  • A latent issue remains one of claim scope: Should the validity of the patent survive, the precise meaning of "clinically proven effective" could become a focal point. The question is whether this term is self-defining based on the data disclosed within the patent or if it imposes an external efficacy standard that must be met, a determination that would impact the ultimate scope of the patent's enforceability.