DCT

1:23-cv-01219

Bayer Pharma AG v. Taro Pharmaceutical Industries Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-01219, D. Del., 10/26/2023
  • Venue Allegations: Venue is alleged to be proper for Taro Pharmaceutical Industries Ltd., an Israeli corporation, because it is subject to personal jurisdiction in Delaware. Venue is alleged to be proper for its U.S. subsidiary, Taro Pharmaceuticals U.S.A., Inc., because it is subject to personal jurisdiction and has previously consented to venue in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of the anticoagulant XARELTO® infringes a patent related to a combination therapy for reducing cardiovascular event risk.
  • Technical Context: The technology involves a specific low-dose combination of the Factor Xa inhibitor rivaroxaban and aspirin, a treatment regimen intended to reduce the risk of major cardiovascular events in patients with coronary or peripheral artery disease.
  • Key Procedural History: This action follows a prior lawsuit filed by Plaintiffs against Defendants in 2021 based on an initial ANDA submission for the same product. That case was consolidated into a multi-defendant action where Defendant Taro stipulated to infringement of the patent-in-suit. The current complaint was triggered by Defendant’s September 2023 notice letter regarding an amendment to its ANDA, which Plaintiffs allege constitutes a new act of 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 Issue Date
2021-06-11 Defendant sends First Notice Letter with P-IV Certification
2021-07-07 Plaintiffs file initial infringement suit against Defendant
2023-09-11 Defendant sends Second Notice Letter regarding ANDA amendment
2023-10-26 Current 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 the high risk of major adverse cardiovascular events (e.g., heart attack, stroke) faced by patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD). It notes that prior antithrombotic therapies were often unable to sufficiently reduce this risk without causing unacceptably high rates of major bleeding (’310 Patent, col. 1:49 - col. 2:29).
  • The Patented Solution: The invention is a specific combination therapy using 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 particular regimen, based on the results of the COMPASS clinical trial, was found to be effective in reducing major cardiovascular events while maintaining a manageable bleeding risk profile, a balance that previous therapies had not achieved (’310 Patent, Abstract; col. 3:26-55).
  • Technical Importance: The claimed method provided a novel therapeutic strategy that demonstrated superior efficacy over the standard of care (aspirin alone) for a large population of high-risk cardiovascular patients (’310 Patent, col. 15:10-21).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶39).
  • 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 rivaroxaban and aspirin;
    • in amounts that are clinically proven effective to achieve said risk reduction;
    • 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

  • The accused instrumentality is "Taro’s ANDA Product," a generic 2.5 mg rivaroxaban tablet for which Taro seeks FDA approval via Abbreviated New Drug Application (ANDA) No. 208557 (Compl. ¶10). The act of infringement alleged is the submission of this ANDA under 35 U.S.C. § 271(e)(2) (Compl. ¶43).

Functionality and Market Context

  • The complaint alleges that the proposed labeling for Taro’s ANDA Product will direct physicians and patients to use the generic drug in a manner that practices the patented method. Specifically, the label allegedly directs the administration of Taro's 2.5 mg rivaroxaban product twice daily, in combination with aspirin (75-100 mg daily), for the purpose of reducing the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease (Compl. ¶36). The filing seeks to launch a generic version of Plaintiffs' XARELTO® product (Compl. ¶1).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'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 Defendant’s ANDA Product directs a method of reducing the risk of major cardiovascular events, including cardiovascular death, myocardial infarction, and stroke. ¶36 col. 3:56-61
...in a human patient with coronary artery disease and/or peripheral artery disease... The proposed labeling directs use in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). ¶36 col. 4:1-4
...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... The proposed label directs the administration of Defendant's rivaroxaban product and aspirin in amounts that are alleged to be clinically proven effective for the indicated patient population and risk-reduction purpose. ¶36 col. 4:5-11
...wherein rivaroxaban is administered in an amount of 2.5 mg twice daily... Defendant's ANDA Product is a 2.5 mg rivaroxaban tablet, and the proposed label directs its administration twice daily. ¶36 col. 4:9-11
...and aspirin is administered in an amount of 75-100 mg daily. The proposed label further directs administration of the rivaroxaban product in combination with aspirin administered in an amount of 75-100 mg daily. ¶36 col. 4:10-11
  • Identified Points of Contention:
    • Scope Questions: The complaint alleges that Defendant previously stipulated to infringement of the '310 patent in a consolidated action (Compl. ¶36). A central question for the court may be the legal effect of this prior stipulation on the current proceeding, which arises from an amended ANDA. The complaint does not specify how the ANDA was amended, beyond referencing "additional use codes," raising the question of whether the amendment creates a basis to distinguish the newly accused product from the one subject to the prior stipulation (Compl. ¶35).
    • Technical Questions: The infringement analysis will turn on whether the method described in the proposed label for the generic product falls within the scope of the patent's claims. A key point of inquiry may be how the term "clinically proven effective" is defined and whether the data supporting the ANDA meets that standard as set forth in the patent.

V. Key Claim Terms for Construction

  • The Term: "clinically proven effective"

  • Context and Importance: This term appears in the preamble and body of claim 1 and is critical for defining the required therapeutic outcome of the claimed method. Practitioners may focus on this term because it is not a purely objective parameter and its construction will determine what level of evidence is required to prove infringement. The dispute may center on whether any clinical evidence suffices or whether the proof must mirror the specific results of the COMPASS trial detailed in the patent.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The plain language of the term itself does not explicitly limit the source or nature of the clinical proof, which could support an argument that any competent and reliable clinical trial data demonstrating efficacy would satisfy the limitation.
    • Evidence for a Narrower Interpretation: The specification is based entirely on the results of the COMPASS clinical trial, repeatedly referencing its specific outcomes, hazard ratios, and statistical significance as the "discovery" underlying the invention (’310 Patent, col. 3:26-30; col. 15:10-21; Table 2). This could support an argument that "clinically proven effective" is implicitly defined by and limited to the specific efficacy and safety profile demonstrated in that trial.

  • The Term: "a human patient with coronary artery disease and/or peripheral artery disease"

  • Context and Importance: This term defines the patient population to whom the method applies. Its scope is central to the infringement analysis, as infringement by inducement will require showing that the proposed label for Defendant's product directs use in this same patient population.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term itself is a generally understood medical classification, which could support a construction encompassing all patients who would be medically diagnosed with CAD or PAD.
    • Evidence for a Narrower Interpretation: The patent's detailed description provides the specific inclusion and exclusion criteria for patients enrolled in the COMPASS trial (’310 Patent, col. 13:56 - col. 14:4). A party could argue that these detailed criteria serve to define and narrow the scope of the patient population covered by the claims.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant will actively induce infringement upon approval of its ANDA. This allegation is based on the proposed product labeling, which allegedly instructs physicians to prescribe and patients to use the generic product in a manner that directly practices the patented method (Compl. ¶¶ 36, 41). The complaint also alleges contributory infringement, stating that Defendant's product, with its proposed labeling, is especially made for an infringing use and is not suitable for substantial non-infringing use (Compl. ¶42).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges that Defendant has had knowledge of the '310 patent since at least June 11, 2021, the date of its first notice letter, and has continued to pursue approval for its allegedly infringing product notwithstanding this knowledge (Compl. ¶40). Plaintiffs request a declaration that this is an "exceptional case" and seek an award of attorneys' fees pursuant to 35 U.S.C. § 285 (Compl. p. 12, ¶(e)).

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

  • A key procedural question will be one of preclusion and scope: what is the legal effect of the Defendant's stipulation to infringement in the prior consolidated litigation? The court will likely need to determine if that stipulation applies to the newly amended ANDA and to what extent it narrows the factual and legal issues in dispute in the current case.
  • A core issue will be one of claim interpretation: can the term "clinically proven effective," which is rooted in the specific clinical trial data disclosed in the patent, be met by the evidence supporting Defendant's ANDA? The outcome may depend on whether the court construes this term as requiring replication of the patent's specific statistical results or as meeting a more general standard of efficacy.
  • While not yet raised in a responsive pleading, a central question in this type of ANDA litigation is typically patent validity. The case may ultimately turn on whether Defendant can prove by clear and convincing evidence that the specific dosage combination of rivaroxaban and aspirin was obvious or otherwise unpatentable at the time of the invention.