DCT

1:23-cv-00410

Bayer Pharma AG v. DR Reddy's Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00410, D. Del., 04/13/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Dr. Reddy's Inc. is subject to personal jurisdiction in the district and has previously consented to venue. Defendant Dr. Reddy's Ltd. is alleged to be a foreign entity subject to personal jurisdiction.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' 2.5 mg XARELTO® product constitutes an act of infringement of a patent covering a method of using rivaroxaban in combination with aspirin to reduce the risk of certain cardiovascular events.
  • Technical Context: The technology at issue is a combination drug therapy, specifically a Factor Xa inhibitor (rivaroxaban) and an antiplatelet agent (aspirin), intended for long-term use in patients with stable coronary or peripheral artery disease to prevent major adverse cardiovascular events.
  • Key Procedural History: The complaint notes that this is the second lawsuit between the parties concerning the same patent and ANDA product. In prior consolidated litigation, Defendants allegedly stipulated to infringement of the patent-in-suit. This new action was initiated after Plaintiffs received a "Second Notice Letter" from Defendants regarding an updated patent certification for their ANDA.

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 regarding '310 Patent
2021-05-24 Plaintiffs file initial suit against Dr. Reddy's on '310 Patent
2023-03-15 Dr. Reddy's sends Second Notice Letter regarding '310 Patent
2023-04-13 Current 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 the significant risk of major adverse cardiovascular events (e.g., heart attack, stroke) faced by patients with coronary artery disease (CAD) and peripheral artery disease (PAD). It notes that prior antithrombotic therapies were often not demonstrably superior to standard antiplatelet therapy (aspirin) or were associated with unacceptably high rates of major bleeding (’310 Patent, col. 2:1-29).
  • The Patented Solution: The invention is a specific combination therapy method based on findings from the large-scale COMPASS clinical trial (’310 Patent, col. 3:26-34). It involves 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). This specific regimen was found to be more effective at reducing the risk of cardiovascular death, stroke, and myocardial infarction than aspirin alone, without creating an unacceptably high risk of fatal or critical organ bleeding (’310 Patent, col. 3:51-59).
  • Technical Importance: The patented method provided a novel, clinically validated treatment that demonstrated a statistically significant improvement in efficacy over the existing standard of care for a large patient population with stable atherosclerotic vascular disease (’310 Patent, col. 17:41-51).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶37).
  • 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 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.

III. The Accused Instrumentality

Product Identification

  • Defendants' Abbreviated New Drug Application (ANDA) No. 208534 for 2.5 mg rivaroxaban tablets, which is a proposed generic version of Plaintiffs' XARELTO® product (Compl. ¶1, ¶9).

Functionality and Market Context

  • The accused instrumentality is the future marketing and sale of Defendants' generic rivaroxaban product. The infringement allegation is based on the proposed labeling for this ANDA product. The complaint alleges that this label will direct medical professionals and patients to use the generic drug in a manner that directly practices the method of the ’310 patent—specifically, by instructing the administration of 2.5 mg rivaroxaban twice daily in combination with daily aspirin to reduce the risk of major cardiovascular events in patients with chronic CAD or PAD (Compl. ¶34).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’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 proposed labeling for the ANDA Product allegedly directs a method of reducing the risk of major cardiovascular events, including myocardial infarction and stroke. ¶34 col. 4:1-5
in a human patient with coronary artery disease and/or peripheral artery disease, The proposed labeling allegedly directs this method for use in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). ¶34 col. 4:2-4
comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective... The proposed labeling allegedly directs the co-administration of Defendants' rivaroxaban product and aspirin in amounts that Plaintiffs assert are clinically proven effective. ¶34 col. 4:5-9
wherein rivaroxaban is administered in an amount of 2.5 mg twice daily The proposed labeling allegedly directs that Defendants' 2.5 mg rivaroxaban product be administered twice daily. ¶34 col. 4:9-10
and aspirin is administered in an amount of 75-100 mg daily. The proposed labeling allegedly directs that aspirin be administered daily in an amount of 75-100 mg. ¶34 col. 4:10-11

Identified Points of Contention

  • Prior Stipulation: The complaint's primary assertion is that infringement is not in dispute, citing Defendants' alleged stipulation to infringement in a prior, consolidated action involving the same patent and ANDA product (Compl. ¶34). This raises the legal question of what preclusive effect, if any, that stipulation has in this new case.
  • Inducement: As this is an ANDA case asserting a method claim, the core legal question is whether the proposed product label encourages, recommends, or promotes infringement by instructing users to perform the claimed method. The complaint alleges the label "directs a method" and "directs the administration" of the drug combination in a manner that meets all claim limitations (Compl. ¶34), which, if proven, would support a finding of induced infringement.

V. Key Claim Terms for Construction

The Term: "clinically proven effective"

  • Context and Importance: This term appears in claim 1 and defines the standard that the claimed drug combination must meet. Its construction is critical because it links the scope of the patent claim to a functional outcome, rather than just a chemical structure or dosage. Practitioners may focus on this term because it determines what level of evidence is required to prove both infringement and validity. The dispute could center on whether this term is defined exclusively by the clinical trial data disclosed in the patent itself or if it can be satisfied by other evidence.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Language in the specification suggests that the invention itself is the discovery of the clinical effectiveness. For example, the Summary section states, "The invention concerns the discovery that combination therapy of rivaroxaban and aspirin... shows efficacy in reducing the risk of myocardial infarction, stroke, and/or cardiovascular death" (’310 Patent, col. 3:51-55). This could support an argument that any administration meeting the dosage and patient criteria satisfies the "clinically proven effective" limitation by virtue of the patent's own teachings.
    • Evidence for a Narrower Interpretation: The specification provides highly specific quantitative results from the COMPASS clinical trial, such as specific hazard ratios (e.g., "the hazard ratio... is 0.70-0.80 ... preferably 0.76") (’310 Patent, col. 5:4-7). This language could be used to argue for a narrower construction where "clinically proven effective" requires a showing of a specific, statistically significant level of efficacy that mirrors the results reported in the patent.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b). The factual basis is the allegation that Defendants' proposed product labeling will instruct physicians and patients to use the generic drug in a way that practices every step of the patented method (Compl. ¶34, ¶40). The complaint further alleges that the product's labeling is "not suitable for substantial noninfringing use" (Compl. ¶41).

Willful Infringement

  • Willfulness is alleged based on Defendants' knowledge of the ’310 Patent since at least the date of their "First Notice Letter" on April 14, 2021, and their continued pursuit of FDA approval for their ANDA product thereafter (Compl. ¶39). The prior litigation between the parties is also cited as evidence of knowledge (Compl. ¶32).

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

  • A central issue appears to be one of patent validity, not infringement. The complaint alleges that Defendants previously stipulated to infringement, shifting the likely focus of the dispute to whether the ’310 patent is valid over the prior art. In a typical ANDA case, this would involve arguments of obviousness based on previous knowledge of the two component drugs and combination therapies.
  • The case will also present a key procedural question regarding the legal effect of the prior infringement stipulation. The court will need to determine if Defendants are precluded from re-litigating infringement in this new action, which was filed in response to an "updated paragraph IV certification," or if the prior stipulation is merely strong evidence for Plaintiffs.
  • Finally, a primary question may be one of remedy and deterrence. Given the allegations of continued intent to infringe despite a prior lawsuit and stipulation, the case may turn on whether Plaintiffs can prove willful infringement, potentially leading to enhanced damages and an award of attorneys' fees, and on the specific terms of any injunction against the launch of the generic product.