DCT

1:22-cv-01228

Bayer Pharma AG v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00063, N.D.W. Va., 08/05/2022
  • Venue Allegations: Venue is alleged to be proper as to Mylan Pharmaceuticals Inc. because it is a West Virginia corporation. Venue is alleged as to Mylan Inc. based on its purported subjection to personal jurisdiction, previous consent to venue in the district, and alleged substantial preparation of the Abbreviated New Drug Application (ANDA) within the district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an ANDA to market 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 low-dose aspirin.
  • Technical Context: The technology involves a combination drug therapy using an anticoagulant (rivaroxaban) and an antiplatelet agent (aspirin) to reduce the risk of major adverse cardiovascular events in patients with coronary or peripheral artery disease.
  • Key Procedural History: The complaint references prior litigation between the parties over the same patent, initiated on July 22, 2021, which was subsequently transferred to the District of Delaware for consolidated Multi-District Litigation (MDL) proceedings. This lawsuit follows Defendants' "Second Notice Letter," dated June 21, 2022, concerning their ANDA submission and Paragraph IV certification asserting the patent is invalid and/or not infringed.

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 Issue Date
2021-06-01 Mylan sends First Notice Letter of ANDA filing to Plaintiffs
2021-07-22 Plaintiffs file initial infringement suit against Mylan
2022-06-21 Mylan sends Second Notice Letter to Plaintiffs
2022-08-05 Complaint Filing Date

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 that patients with Coronary Artery Disease (CAD) and/or Peripheral Artery Disease (PAD) face a high risk of major adverse cardiovascular events. It notes that prior to the invention, anticoagulant therapies had not been satisfactorily shown to be superior to standard antiplatelet therapy and often carried an unacceptably high risk of major bleeding events ('310' Patent, col. 2:2-29).
  • The Patented Solution: The invention is a method of treatment based on the discovery that a combination therapy of a specific low dose of rivaroxaban (2.5 mg twice daily) and a low dose of aspirin (75-100 mg daily) is effective at reducing the risk of myocardial infarction, stroke, or cardiovascular death in patients with stable atherosclerotic vascular disease. This combination therapy was found to provide this benefit without an unacceptably high risk of fatal bleeding or bleeding in critical organs ('310 Patent, col. 4:51-59). The patent specification is based on the results of the phase III COMPASS clinical trial ('310 Patent, col. 5:17-21).
  • Technical Importance: The claimed method provided a novel therapeutic regimen that successfully balanced the antithrombotic efficacy needed to prevent cardiovascular events with the risk of bleeding, a central challenge in managing patients with stable CAD and PAD ('310 Patent, col. 17:41-52).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 ('310 Patent, col. 18:56-65; Compl. ¶38).
  • Independent Claim 1 requires:
    • 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,
    • 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 alleges infringement of "at least claim 1," which preserves the right to assert other claims, including dependent claims, later in the litigation (Compl. ¶38).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Mylan’s Abbreviated New Drug Application (ANDA) No. 212220, submitted to the FDA to obtain approval for a generic version of Plaintiffs' 2.5 mg rivaroxaban tablets ("Mylan's ANDA Product") (Compl. ¶9). The filing of the ANDA is the statutory act of infringement under 35 U.S.C. § 271(e)(2) for a method patent.

Functionality and Market Context

The complaint alleges that the proposed labeling for Mylan's ANDA Product will instruct physicians and patients on a method of use that directly corresponds to the patented method. Specifically, the label will allegedly direct the administration of Mylan's 2.5 mg rivaroxaban product twice daily in combination with aspirin (75-100 mg daily) to reduce the risk of major cardiovascular events in patients with chronic CAD and/or PAD (Compl. ¶35). This creates the basis for a claim of induced infringement upon approval and marketing of the generic product.

Visual Evidence

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,828,310 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 proposed labeling for Mylan's ANDA Product allegedly "directs a method of reducing the risk of major cardiovascular events (cardiovascular (CV) death, myocardial infarction (MI), and stroke) in patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD)." ¶35 col. 4:1-10
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... The complaint alleges Mylan's ANDA Product contains rivaroxaban and that its proposed labeling directs co-administration with aspirin in amounts that are "clinically proven effective in reducing the risk of MI, stroke or CV death." ¶31, ¶35 col. 4:1-10
wherein rivaroxaban is administered in an amount of 2.5 mg twice daily Mylan's ANDA is for a 2.5 mg rivaroxaban tablet, and the proposed labeling allegedly directs that the product "will be administered twice daily." ¶9, ¶35 col. 18:61-64
and aspirin is administered in an amount of 75-100 mg daily. The proposed labeling for Mylan's ANDA Product allegedly directs that "aspirin is administered in an amount of 75-100 mg daily." ¶35 col. 18:64-65

Identified Points of Contention

  • Validity vs. Infringement: The complaint states that in its notice letters, Mylan did not contest infringement on any basis other than the alleged invalidity of the '310 patent's claims (Compl. ¶39). This suggests the primary battleground will be patent validity (likely obviousness) rather than non-infringement.
  • Scope Questions: A central evidentiary question for induced infringement will be whether Mylan's proposed product label, once produced in discovery, actually contains instructions that encourage, recommend, or promote the co-administration of its rivaroxaban product with aspirin for the claimed indication and at the claimed dosages, thereby satisfying the legal standard for inducement.

V. Key Claim Terms for Construction

The Term

"clinically proven effective"

Context and Importance

This term appears in the third element of claim 1 and links the administration of the drugs to a required outcome. Practitioners may focus on this term because its definition could be case-dispositive for both validity and infringement. Defendants may argue that prior art had already "clinically proven" the effectiveness of similar combinations, rendering the claim obvious. Conversely, Plaintiffs may argue this term imparts a specific, non-obvious level of efficacy that was only demonstrated by the COMPASS trial data disclosed in the patent.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The claim language itself does not tie the term to a specific clinical trial. Plaintiffs could argue that "clinically proven effective" should be given its plain and ordinary meaning: demonstrated to be effective through any well-controlled clinical trial, not just the specific COMPASS trial detailed in the specification.
  • Evidence for a Narrower Interpretation: Defendants could argue that the patent specification defines this term by implication through its extensive reliance on the COMPASS trial results. They may point to the detailed efficacy data, such as the specific hazard ratio of 0.76 (95% CI, 0.66 to 0.86; P<0.001), as the standard for what the patent considers "clinically proven effective," thereby limiting the claim's scope to that demonstrated outcome ('310 Patent, col. 16:5-7; Fig. 2A).

VI. Other Allegations

Indirect Infringement

The complaint alleges that Mylan will actively induce infringement by creating a product label that instructs physicians and patients to perform the patented method (Compl. ¶35, ¶41). It further alleges contributory infringement, stating that Mylan's product with its proposed labeling is especially made for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶42).

Willful Infringement

The complaint does not use the term "willful," but it alleges Mylan has had knowledge of the '310 patent since at least June 1, 2021, via its first notice letter, and that it "specifically intends to infringe" (Compl. ¶40). Plaintiffs also seek a declaration that this is an "exceptional case" and request attorneys' fees pursuant to 35 U.S.C. § 285, which is often associated with findings of willful infringement or other litigation misconduct (Compl. Prayer for Relief (e)).

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

  • A central issue will be one of patent validity: Was the claimed method of combining 2.5 mg of rivaroxaban twice daily with 75-100 mg of aspirin daily for this patient population obvious to a person of ordinary skill in the art at the time of the invention, or do the specific dosages and resulting efficacy/safety profile represent a non-obvious discovery?
  • The case will also depend on claim construction: How will the court define the term "clinically proven effective"? Will the term be limited to the specific statistical outcomes of the COMPASS trial as disclosed in the patent, or will it be afforded a broader meaning, and how will that construction impact the analyses of both infringement and validity?
  • Finally, a key evidentiary question for induced infringement will be whether the final, FDA-approved label for Mylan's generic product will contain sufficient instructions and indications to meet the legal standard for encouraging or directing infringement of the patented method.