DCT

1:23-cv-01457

AstraZeneca Ab v. ScieGen Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-01457, D. Del., 12/21/2023
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant consented to personal jurisdiction and venue in the District of Delaware for the purposes of this action. The complaint further alleges jurisdiction is appropriate based on Defendant's filing of an Abbreviated New Drug Application (ANDA) with the intent to market its generic product in Delaware upon approval.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an ANDA for a generic version of the drug BRILINTA® (ticagrelor) constitutes an act of infringement of a patent covering a method of using ticagrelor for the long-term prevention of atherothrombotic events.
  • Technical Context: The technology concerns a specific method of using ticagrelor, an antiplatelet agent, to reduce the long-term risk of blood clots, heart attacks, and strokes in a high-risk patient population.
  • Key Procedural History: This is a Hatch-Waxman action filed under 35 U.S.C. § 271(e)(2). The lawsuit was triggered by a November 8, 2023 Notice Letter from Defendant to Plaintiff, which included a Paragraph IV certification asserting that Plaintiff's patent is invalid, unenforceable, and/or will not be infringed by Defendant's proposed generic product.

Case Timeline

Date Event
2015-01-27 U.S. Patent No. 10,300,065 Priority Date
2019-05-28 U.S. Patent No. 10,300,065 Issue Date
2023-11-08 Defendant sends Paragraph IV Notice Letter to Plaintiff
2023-12-09 Defendant consents to jurisdiction and venue in Delaware
2023-12-21 Complaint Filing Date

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

U.S. Patent No. 10,300,065 - "Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction"

The Invention Explained

  • Problem Addressed: The patent's background section describes that while antiplatelet therapy is a cornerstone for preventing ischemic events after an acute coronary syndrome, practice guidelines generally recommend such treatment for only up to one year after a myocardial infarction (MI). This leaves a gap in established treatments for long-term secondary prevention for patients who remain at heightened risk. (Compl. Exhibit A, ’065 Patent, col. 3:1-19).
  • The Patented Solution: The invention provides a method for long-term treatment of patients with a prior MI by administering a 60 mg dose of ticagrelor twice daily in combination with low-dose aspirin. This method is based on the results of the PEGASUS-TIMI 54 clinical trial, which demonstrated that this specific lower-dose regimen, when used for long-term therapy, effectively reduces the risk of cardiovascular death, MI, or stroke compared to aspirin alone. (Compl. Exhibit A, ’065 Patent, Abstract; col. 4:14-30).
  • Technical Importance: The invention established a clinical protocol for a lower-intensity, long-term dual antiplatelet therapy, addressing the need for an improved balance between efficacy and bleeding risk in the chronic phase of treatment for post-MI patients. (Compl. Exhibit A, ’065 Patent, col. 3:56-61).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1. (Compl. ¶36).
  • The essential elements of independent claim 1 are:
    • A method for reducing the rate of a composite endpoint of cardiovascular death, myocardial infarction, or stroke in a patient in recognized need thereof.
    • The method comprises administering to the patient twice daily a pharmaceutical composition comprising 60 mg ticagrelor.
    • The patient has a history of myocardial infarction.
    • The patient is also administered a daily maintenance dose of aspirin of 75 mg to 150 mg.
    • The rate of the composite endpoint is reduced relative to a dosing regimen where the patient receives only the daily maintenance dose of aspirin.

III. The Accused Instrumentality

Product Identification

Defendant's proposed 90 mg and 60 mg generic versions of ticagrelor tablets, which are the subject of Abbreviated New Drug Application (“ANDA”) No. 218962 filed with the FDA. (Compl. ¶1).

Functionality and Market Context

The complaint alleges that Defendant's product is a generic version of AstraZeneca's BRILINTA® drug product. (Compl. ¶1). As a generic, the product is intended to be bioequivalent to BRILINTA® and prescribed for the same therapeutic uses. The complaint alleges that upon approval, Defendant will manufacture, market, and sell its generic ticagrelor products throughout the United States, including in Delaware. (Compl. ¶8, ¶23).

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart. The infringement theory, typical in Hatch-Waxman cases concerning method-of-use patents, is that Defendant's submission of its ANDA for a product with a proposed label that encourages performance of the patented method is an act of infringement under 35 U.S.C. § 271(e)(2). The following chart summarizes this alleged infringement.

No probative visual evidence provided in complaint.

’065 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for reducing the rate of a composite endpoint...comprising administering to the patient twice daily a pharmaceutical composition comprising 60 mg ticagrelor... Defendant seeks FDA approval to market a 60 mg generic ticagrelor tablet, and its proposed product label will allegedly instruct or encourage physicians and patients to use it in a manner that performs the claimed method. ¶1, ¶31, ¶36 col. 88:58-62
wherein the patient has a history of myocardial infarction The proposed product label for Defendant's generic ticagrelor is expected to include indications for use in patients with a history of myocardial infarction, mirroring the approved uses for BRILINTA®. ¶28 col. 88:63-64
wherein the patient is also administered a daily maintenance dose of aspirin of 75 mg to 150 mg The standard of care and the BRILINTA® label, which Defendant's proposed label will likely follow, call for co-administration of ticagrelor with a daily maintenance dose of aspirin. ¶28; Compl. Exhibit A, ’065 Patent, col. 3:36-42 col. 88:65-67
wherein the rate of the composite endpoint in the patient is reduced relative to a dosing regimen where the patient receives the daily maintenance dose of aspirin...only Defendant's ANDA relies on AstraZeneca’s clinical data demonstrating the efficacy of BRILINTA®. By seeking approval for a bioequivalent product, Defendant's product is intended to achieve the same claimed therapeutic outcome. ¶1, ¶31 col. 88:68 - col. 89:4

Identified Points of Contention

  • Scope Questions: The primary infringement dispute may center on whether Defendant's proposed product label induces infringement of every limitation of claim 1. A key question for the court will be whether the label encourages physicians to prescribe the 60 mg dose specifically for the long-term, post-MI patient population claimed in the patent, or if Defendant might "carve out" the patented use from its proposed label. The complaint does not provide the proposed label for analysis. (Compl. ¶32).
  • Technical Questions: In Hatch-Waxman litigation, the dispute often focuses more on patent validity than infringement. A central question, based on Defendant's Paragraph IV certification, will be whether the claimed method is invalid as obvious over prior art related to ticagrelor or other antiplatelet therapies. (Compl. ¶32).

V. Key Claim Terms for Construction

The complaint does not identify any specific claim terms for construction. Based on the patent and the nature of the dispute, the following terms may become central to the case.

"history of myocardial infarction"

  • Context and Importance: The definition of this term is critical for defining the scope of the eligible patient population. Practitioners may focus on this term because its construction could determine whether the claim is limited to the specific long-term, stable patient population studied in the patent's key clinical trial or if it covers a broader set of patients.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language of the claim itself does not specify any time limitation (e.g., more than one year post-MI), referring only to a "history." (Compl. Exhibit A, ’065 Patent, col. 88:63-64).
    • Evidence for a Narrower Interpretation: The specification extensively details the PEGASUS-TIMI 54 trial, which enrolled "stable patients with a history of myocardial infarction" that occurred "1 to 3 years prior." (Compl. Exhibit A, ’065 Patent, col. 3:36-42, col. 19:9-11). A party could argue that the claims should be limited to this context, which represents the core of the disclosed invention.

"reducing the rate of a composite endpoint...relative to a dosing regimen where the patient receives the daily maintenance dose of aspirin...only"

  • Context and Importance: This is a "wherein" clause describing the result of the method. Its construction is important because it determines what must be proven to show infringement. The dispute may turn on whether this clause is an affirmative limitation on the method or simply states the intended purpose and inherent result of performing the claimed administration steps.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (Infringement by Administration): The claim is structured as "A method for reducing the rate...comprising administering..." (Compl. Exhibit A, ’065 Patent, col. 88:58-62). This suggests the infringing act is the administration of the drug as specified, with the reduction in risk being the inherent outcome of that administration.
    • Evidence for a Narrower Interpretation (Requires Proof of Result): The patent specification is filled with clinical data from the PEGASUS trial that was generated specifically to prove this efficacy outcome. (Compl. Exhibit A, ’065 Patent, Fig. 2-Panel A, Table 8). A party might argue that this data's prominence indicates the "reducing the rate" clause is a material limitation of the claim.

VI. Other Allegations

Indirect Infringement

While not explicitly pled as a separate count, the core of the infringement allegation against an ANDA filer for a method-of-use patent is induced infringement under 35 U.S.C. § 271(b). The complaint alleges that upon approval, Defendant's marketing and sale of its generic product will cause infringement. (Compl. ¶36). This infringement would be performed by physicians who prescribe the drug and patients who take it, allegedly in response to the instructions and indications on Defendant's product label.

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

  • A central issue will be one of induced infringement: does Defendant's proposed product label, which was not included in the complaint, provide instructions that would lead physicians to prescribe its 60 mg generic ticagrelor tablets for the specific long-term, post-myocardial infarction treatment method covered by all limitations of the asserted claims?
  • As this is a Hatch-Waxman case initiated by a Paragraph IV certification, a primary question for the court will be patent validity. Will the claimed method of administering a 60 mg twice-daily dose of ticagrelor for long-term secondary prevention be found non-obvious in light of prior art knowledge regarding ticagrelor's 90 mg dose and other antiplatelet therapies?
  • A key legal question will be one of claim scope: can the term "history of myocardial infarction" be construed broadly according to its plain meaning, or will the court limit its scope to the specific long-term (1-3 years post-event) patient population that was the focus of the PEGASUS clinical trial described in the patent's specification?