DCT

1:23-cv-00551

Bayer Pharma AG v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00551, D. Del., 05/19/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware as Defendant Teva Pharmaceuticals USA, Inc. is a Delaware corporation and subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of the 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 cardiovascular risk.
  • Technical Context: The lawsuit concerns antithrombotic therapies, specifically combination treatments designed to prevent major adverse cardiovascular events like heart attacks and strokes in high-risk patients with coronary or peripheral artery disease.
  • Key Procedural History: The complaint states this action arises from an amendment to Teva’s ANDA. It notes that in a prior, consolidated action concerning the same patent, Teva USA stipulated to infringement and did not contest that its proposed product labeling would infringe claims 1-4. The patent-in-suit also successfully underwent a supplemental examination in 2021, which confirmed its patentability over the art considered in that proceeding.

Case Timeline

Date Event
2018-02-02 ’310 Patent Priority Date
2020-11-10 ’310 Patent Issue Date
2021-02-10 ’310 Patent Supplemental Examination Certificate Issued
2021-06-15 Teva sends First Notice Letter regarding ANDA No. 212247
2021-07-07 Plaintiffs file initial infringement suit against Teva
2023-04-04 Teva sends Second Notice Letter regarding an amendment to its ANDA
2023-05-19 Complaint Filing Date

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

  • Patent Identification: 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) or peripheral artery disease (PAD) face a high risk of major adverse cardiovascular events, and that prior to the invention, existing antithrombotic therapies were either not demonstrably superior to standard antiplatelet therapy or carried unacceptably high risks 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 of low-dose rivaroxaban (a Factor Xa inhibitor) and low-dose aspirin provides a clinically effective way to reduce the risk of myocardial infarction, stroke, or cardiovascular death in this patient population (’310 Patent, Abstract; col. 3:46-54). The patent discloses the specific dosage regimen of 2.5 mg of rivaroxaban twice daily combined with 75-100 mg of aspirin once daily as the core of the inventive method (’310 Patent, col. 3:61-67).
  • Technical Importance: This specific combination therapy provided a new, clinically-validated treatment that demonstrated a positive net clinical benefit in a large-scale clinical trial (the COMPASS trial), offering a new therapeutic option for a high-risk patient population (’310 Patent, col. 3:25-44).

Key Claims at a Glance

  • The complaint asserts infringement of at least 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 to the patient rivaroxaban and aspirin,
    • in amounts that are "clinically proven effective" for that purpose,
    • 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 Teva previously did not contest that its proposed product would infringe claims 1-4 (Compl. ¶40).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Teva’s proposed generic 2.5 mg rivaroxaban tablets, which are the subject of ANDA No. 212247 submitted to the FDA (Compl. ¶9).

Functionality and Market Context

  • The infringement allegation is not based on the tablet itself, but on the method of use that will be induced by the product's proposed labeling (Compl. ¶36). The complaint alleges that this labeling will direct physicians to prescribe, and patients to take, Teva's 2.5 mg rivaroxaban tablet twice daily in combination with aspirin (75-100 mg daily) to reduce the risk of major cardiovascular events in patients with CAD or PAD (Compl. ¶36). This is a Hatch-Waxman action where the filing of the ANDA itself is the statutory act of infringement, preceding any commercial launch (Compl. ¶1, 44).

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 Teva's ANDA Product allegedly directs a method for reducing the risk of major cardiovascular events, including myocardial infarction and stroke. ¶36 col. 17:56-58
...in a human patient with coronary artery disease and/or peripheral artery disease, The proposed labeling allegedly directs this method of use in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). ¶36 col. 17:59-61
...comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective... The proposed labeling allegedly directs the administration of Teva's product and aspirin in amounts that are clinically proven effective for reducing the specified risks. ¶36 col. 17:62-18:4
...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 allegedly directs its administration twice daily. ¶9, 36 col. 18:4-5
...and aspirin is administered in an amount of 75-100 mg daily. The proposed labeling allegedly directs co-administration with aspirin in a daily amount of 75-100 mg. ¶36 col. 18:5-6
  • Identified Points of Contention:
    • Scope Questions: The complaint presents the infringement case as a direct mapping of Teva's proposed label onto the claim language. Citing Teva's alleged prior stipulation of infringement (Compl. ¶36), the complaint suggests little room for dispute on claim scope. A question for the court may be whether the amendment to the ANDA, which triggered this lawsuit, introduces any new basis to contest infringement that was not covered by the prior stipulation.
    • Technical Questions: While the complaint alleges Teva's label will direct the infringing method, a core technical question is how the "clinically proven effective" limitation is met. The analysis will depend on whether the instructions and indications for use in Teva's proposed label are sufficient to induce a medical professional to perform a method that meets this efficacy-based standard as defined by the patent.

V. Key Claim Terms for Construction

  • The Term: "clinically proven effective"
  • Context and Importance: This term appears in the independent claim and links the administration of the drugs to a required outcome or standard of proof. Practitioners may focus on this term because its construction could determine whether the claim is definite and how high the bar is for proving infringement. The definition will be critical for assessing whether Teva's product label, by describing the product's FDA-approved indication, necessarily induces infringement of a method that is "clinically proven effective."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party could argue for the term's plain and ordinary meaning, suggesting that any scientifically valid clinical evidence demonstrating effectiveness would suffice, not necessarily limited to the evidence within the patent itself.
    • Evidence for a Narrower Interpretation: The specification provides a potentially explicit definition tied to the results of the COMPASS clinical trial. It states, "In one embodiment, a treatment... is efficacious when in a study of at least 9,000 patients... the primary endpoint of cardiovascular death, stroke, or myocardial infarction occurs in 4.1% of patients or less..." (’310 Patent, col. 11:60-12:2). A party could argue this language defines the specific standard of proof required by the claims.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement, stating that Teva's proposed labeling will intentionally instruct and encourage physicians and patients to use the generic product in a manner that directly infringes the ’310 patent (Compl. ¶42). It also alleges contributory infringement, asserting that the product, with its label, is especially made for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶43).
  • Willful Infringement: Willfulness is alleged based on Teva's knowledge of the ’310 patent since at least June 15, 2021, the date of its first notice letter (Compl. ¶31, 41). The complaint asserts that Teva's continued pursuit of its ANDA, despite this knowledge and the prior litigation, constitutes willful and deliberate infringement (Compl. ¶41).

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

Given the context of an ANDA filing for a method-of-use patent, and the procedural history alleged in the complaint, the dispute will likely center on the following questions for the court:

  • A primary issue will be one of induced infringement: Does the language of Teva's proposed product label, as submitted in its amended ANDA, actively instruct and encourage medical professionals to prescribe, and patients to use, the generic product in a manner that satisfies every limitation of the asserted claims, including the functional requirement that the administered amounts be "clinically proven effective"?
  • A second key question, though one that would be addressed primarily through a validity challenge rather than in response to the complaint, is the patent's validity: Is the claimed method nonobvious over prior art antithrombotic therapies? While the complaint's allegations focus on infringement, the reference to Teva's prior stipulation on infringement (Compl. ¶36) suggests that the ultimate dispute in this litigation is more likely to be about the patent's validity than about whether the proposed generic product would infringe if the patent is valid.