DCT

1:21-cv-01001

Bayer Pharma AG v. Teva Pharma USA Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-01001, D. Del., 07/07/2021
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Teva USA is a Delaware corporation and both defendants are subject to personal jurisdiction 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® product constitutes an act of infringement of a patent covering a method for reducing the risk of cardiovascular events by co-administering rivaroxaban and aspirin.
  • Technical Context: The technology concerns combination drug therapy aimed at preventing major adverse cardiovascular events, such as heart attacks and strokes, in high-risk patients with established atherosclerotic vascular disease.
  • Key Procedural History: This is a Hatch-Waxman patent infringement action triggered by a notice letter dated June 15, 2021, in which Teva informed Plaintiffs that it had filed an ANDA containing a Paragraph IV certification against the patent-in-suit, which is listed in the U.S. Food and Drug Administration's "Orange Book" for 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 Issued
2021-06-15 Teva sends Notice Letter to Plaintiffs
2021-07-07 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 10,828,310 - "Reducing the Risk of Cardiovascular Events"

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 cardiovascular events like heart attack and stroke. (’310 Patent, col. 2:2-5). Existing antithrombotic regimens were described as either insufficiently effective or posing an unacceptably high risk of major bleeding. (’310 Patent, col. 2:5-29).
  • The Patented Solution: The invention is a method of treatment using a specific, low-dose combination therapy of rivaroxaban (a Factor Xa inhibitor) and aspirin. The patent discloses that the combination of 2.5 mg of rivaroxaban administered twice daily with 75-100 mg of aspirin administered daily was found to be effective at reducing the risk of major cardiovascular events without causing an unacceptably high risk of fatal bleeding or bleeding in critical organs. (’310 Patent, col. 3:50-56; col. 4:5-14).
  • Technical Importance: This specific combination therapy was presented as a novel and effective approach for long-term prevention in a high-risk patient population where previous combination therapies had not demonstrated a favorable benefit-risk profile. (’310 Patent, col. 2:30-44).

Key Claims at a Glance

  • The complaint asserts infringement of at least 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 such a patient;
    • 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 notes that Defendant's notice letter did not contest that use of its product in accordance with the proposed labeling would infringe claims 1-4. (Compl. ¶38).

III. The Accused Instrumentality

Product Identification

Teva's generic 2.5 mg rivaroxaban tablets, for which it submitted Abbreviated New Drug Application (ANDA) No. 212247 to the FDA. (Compl. ¶9).

Functionality and Market Context

The accused instrumentality is the generic drug product in conjunction with its proposed labeling. The complaint alleges that this labeling will direct physicians to prescribe, and patients to take, Teva's 2.5 mg rivaroxaban product twice daily in combination with aspirin (in a 75-100 mg daily dose) to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease. (Compl. ¶34). The act of infringement is Teva's filing of the ANDA seeking approval to market this product for this labeled use prior to the expiration of the ’310 Patent. (Compl. ¶1, ¶35).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

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 Teva's ANDA Product allegedly directs a method for reducing the risk of major cardiovascular events (including MI and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). ¶34 col. 3:50-56
comprising administering to the human patient rivaroxaban and aspirin Teva's ANDA Product contains rivaroxaban, and its proposed labeling allegedly directs co-administration with aspirin. ¶33, ¶34 col. 4:5-8
in amounts that are clinically proven effective in reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with... disease The complaint alleges Teva's proposed labeling directs administration of its product and aspirin in "amounts that are clinically proven effective" for the indicated patient population and therapeutic goal. ¶34 col. 4:6-9
wherein rivaroxaban is administered in an amount of 2.5 mg twice daily Teva's ANDA is for a 2.5 mg rivaroxaban tablet, and the proposed labeling will allegedly direct administration twice daily. ¶9, ¶34 col. 4:8-10
and aspirin is administered in an amount of 75-100 mg daily. The proposed labeling for Teva's product allegedly directs that aspirin be co-administered in an amount of 75-100 mg daily. ¶34 col. 4:10-11

Identified Points of Contention

  • Scope Questions: In a Hatch-Waxman case where the defendant's proposed label is expected to mirror the patented method, the primary dispute is often over patent validity rather than infringement. However, a potential infringement dispute could arise over the scope of the term "clinically proven effective." A dispute could center on what level of evidence is required to satisfy this limitation and whether the data in the patent specification is sufficient.
  • Technical Questions: A key legal and factual question for the court will be whether Teva’s act of filing the ANDA with the proposed label, which instructs users to perform the patented method, constitutes an act of induced infringement under 35 U.S.C. § 271(e)(2). The complaint's assertion that Teva's notice letter "did not contest that the use of Teva's ANDA Product in accordance with its proposed labeling would infringe claims 1-4" may be a significant piece of evidence on this point. (Compl. ¶38).

V. Key Claim Terms for Construction

The Term

"clinically proven effective"

Context and Importance

This term appears in the independent claim and defines the standard of efficacy for the claimed amounts of rivaroxaban and aspirin. Its construction is critical because it links the administration steps to a required therapeutic outcome. Practitioners may focus on this term because, if found to be indefinite, it could invalidate the claim. Alternatively, its construction could set the evidentiary bar for what constitutes proof of infringement.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The patent specification repeatedly references the Phase III COMPASS clinical trial as the basis for the invention's findings. (’310 Patent, col. 3:26-34). This may support an interpretation that "clinically proven effective" means having been shown to be effective in a large-scale, controlled, and statistically significant clinical study of the type described in the patent.
  • Evidence for a Narrower Interpretation: The patent quantifies the results of the COMPASS trial with specific hazard ratios and P-values. (’310 Patent, Table 2; col. 16:3-8). This could support a narrower interpretation requiring a specific, quantitative level of statistical proof, potentially tying the term directly to the numerical results disclosed in the patent's specification.

VI. Other Allegations

Indirect Infringement

The complaint's central theory is induced infringement. It alleges that Teva's proposed product label will actively instruct and encourage physicians and patients to administer the generic product in a manner that directly infringes the method claims of the ’310 Patent. (Compl. ¶34, ¶40). The complaint also pleads contributory infringement, alleging the product is especially adapted for an infringing use and is not suitable for a substantial non-infringing use. (Compl. ¶41).

Willful Infringement

The complaint alleges that Teva has had knowledge of the ’310 Patent since at least the time it sent its notice letter and Paragraph IV certification on June 15, 2021. (Compl. ¶31, ¶39). It further alleges that Teva "specifically intends to infringe" upon receiving FDA approval, forming the basis for a claim of willfulness based on pre-suit knowledge. (Compl. ¶39).

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

  • A central issue will be one of induced infringement: does the filing of an ANDA with a proposed product label that mirrors the patented method of treatment, and which will allegedly instruct and encourage doctors and patients to perform that method, constitute an act of infringement under 35 U.S.C. § 271(e)(2)? The complaint’s allegation that Teva did not contest this point in its pre-suit correspondence will be a key factual issue for the court to consider.
  • A second key question will address claim scope and definiteness: can the term "clinically proven effective," which sets the standard for the claimed therapeutic benefit, be construed with sufficient clarity based on the patent's disclosure of the COMPASS trial results? The court’s construction of this term will likely determine whether the claim is definite and may influence the infringement analysis.