DCT

1:23-cv-00022

Chiesi USA Inc v. Eugia Pharma Specialities Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00022, D.N.J., 01/04/2023
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Eugia US has a regular and established place of business in the district, and because the foreign-domiciled defendants are alien corporations subject to suit in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) for a generic version of the antiplatelet drug Kengreal® constitutes an act of infringement of seven U.S. patents covering formulations of the drug and its methods of use.
  • Technical Context: The technology relates to cangrelor, an intravenously administered P2Y12 platelet inhibitor used to reduce the risk of thrombotic events in patients undergoing percutaneous coronary intervention (PCI).
  • Key Procedural History: The litigation was triggered by Defendants’ submission of ANDA No. 217986 to the U.S. Food and Drug Administration (FDA) and their subsequent Notice Letter to Plaintiff, dated November 21, 2022, which included a "paragraph IV certification" asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by the proposed generic product.

Case Timeline

Date Event
2013-03-09 Priority Date for ’052, ’448, and ’265 Patents
2014-03-25 U.S. Patent No. 8,680,052 Issued
2015-01-14 Priority Date for ’687, ’921, ’575, and ’780 Patents
2015-06-22 FDA Approves Kengreal® (cangrelor) via NDA No. 204958
2016-03-29 U.S. Patent No. 9,295,687 Issued
2016-08-30 U.S. Patent No. 9,427,448 Issued
2016-09-13 U.S. Patent No. 9,439,921 Issued
2017-07-11 U.S. Patent No. 9,700,575 Issued
2018-03-27 U.S. Patent No. 9,925,265 Issued
2018-08-07 U.S. Patent No. 10,039,780 Issued
2022-11-21 Defendants Send Paragraph IV Notice Letter to Plaintiff
2023-01-04 Complaint Filed

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

U.S. Patent No. 8,680,052 - Methods of Treating, Reducing the Incidence of, and/or Preventing Ischemic Events (Issued Mar. 25, 2014)

The Invention Explained

  • Problem Addressed: The patent describes a need for antiplatelet agents for patients undergoing PCI that are potent, fast-acting, and reversible, in order to reduce thrombotic complications without creating an excessive risk of bleeding associated with irreversible oral agents like clopidogrel ('052 Patent, col. 1:40-48, col. 2:1-12).
  • The Patented Solution: The invention provides a specific method for administering cangrelor intravenously, comprising a weight-based bolus dose prior to PCI, followed immediately by a continuous infusion for a defined duration relative to the procedure ('052 Patent, Abstract; col. 3:11-23). This protocol is designed to achieve rapid and titratable platelet inhibition during the high-risk periprocedural period and allows for transitioning patients to oral antiplatelet therapy afterward ('052 Patent, col. 3:55-67).
  • Technical Importance: This intravenous dosing regimen provides immediate and potent antiplatelet effects that can be quickly reversed upon discontinuation, offering a level of control that was not achievable with prior oral antiplatelet agents having delayed onset and prolonged effects (Compl. ¶35).

Key Claims at a Glance

  • The complaint asserts one or more claims of the patent (Compl. ¶68). Independent claim 1 is representative.
  • Claim 1 requires:
    • A method of reducing the incidence of an ischemic event in a patient undergoing PCI.
    • Administering intravenously to the patient a 30 µg/kg bolus of cangrelor before the start of the PCI.
    • Administering intravenously a continuous infusion of cangrelor at an infusion rate of 4 µg/kg/min after the bolus.
    • Continuing the infusion for at least two hours or the duration of the PCI, whichever is longer.

U.S. Patent No. 10,039,780 - Pharmaceutical Formulations Comprising High Purity Cangrelor and Methods for Preparing and Using the Same (Issued Aug. 7, 2018)

The Invention Explained

  • Problem Addressed: The patent's background section notes that impurities generated during the synthesis and compounding of cangrelor can degrade the product, affecting its stability, shelf-life, and the ability to control dosage during administration ('780 Patent, col. 2:3-29).
  • The Patented Solution: The invention is a pharmaceutical formulation containing "high purity cangrelor," which is defined as having a combined total of five specific hydrolysis and oxidation degradants that does not exceed 1.5% by weight ('780 Patent, col. 2:47-58). The patent also discloses methods for preparing these formulations, such as controlling the pH of the solution during the compounding process, to achieve low and consistent levels of these impurities ('780 Patent, Abstract).
  • Technical Importance: This invention provides for a stable, lyophilized formulation of cangrelor with a defined purity profile, which is critical for ensuring product quality, shelf-life, and predictable therapeutic effects for an intravenously administered drug used in acute care settings (Compl. ¶35).

Key Claims at a Glance

  • The complaint asserts one or more claims of the patent (Compl. ¶158). Independent claim 1 is representative.
  • Claim 1 requires:
    • A method for treating, or reducing the risk of, stent thrombosis or myocardial infarction.
    • Administering to a subject an effective amount of a pharmaceutical formulation comprising "high purity cangrelor" or a salt thereof.
    • The formulation also includes one or more pharmaceutically acceptable excipients.
    • "High purity cangrelor" is defined as having a combined total of selected hydrolysis and oxidation degradants not exceeding about 1.5% by weight.

Multi-Patent Capsule: U.S. Patent No. 9,427,448

  • Patent Identification: U.S. Patent No. 9,427,448, "Methods of Treating, Reducing the Incidence of, and/or Preventing Ischemic Events," issued August 30, 2016 (Compl. ¶49).
  • Technology Synopsis: This patent, related to the '052 Patent, covers methods of using cangrelor to treat or prevent ischemic events in patients undergoing percutaneous coronary intervention (PCI), focusing on specific dosing regimens (Compl. ¶49).
  • Asserted Claims: The complaint asserts one or more claims of the patent (Compl. ¶98).
  • Accused Features: The proposed use of the Defendants' ANDA Product for the same indications as Kengreal®, as will allegedly be instructed by its labeling (Compl. ¶¶ 44-45).

Multi-Patent Capsule: U.S. Patent No. 9,439,921

  • Patent Identification: U.S. Patent No. 9,439,921, "Pharmaceutical Formulations Comprising High Purity Cangrelor and Methods for Preparing and Using the Same," issued September 13, 2016 (Compl. ¶50).
  • Technology Synopsis: This patent, part of the same family as the '780 Patent, is directed to stable pharmaceutical formulations containing high-purity cangrelor with low levels of specified impurities and methods of their use (Compl. ¶50).
  • Asserted Claims: The complaint asserts one or more claims of the patent (Compl. ¶113).
  • Accused Features: The formulation of Defendants' ANDA Product, which Plaintiff alleges on information and belief will infringe the patent claims (Compl. ¶¶ 106, 113).

Multi-Patent Capsule: U.S. Patent No. 9,700,575

  • Patent Identification: U.S. Patent No. 9,700,575, "Pharmaceutical Formulations Comprising High Purity Cangrelor and Methods for Preparing and Using the Same," issued July 11, 2017 (Compl. ¶51).
  • Technology Synopsis: As a member of the '780 Patent family, this patent is also directed to stable pharmaceutical formulations of high-purity cangrelor, defined by specific limits on degradation products (Compl. ¶51).
  • Asserted Claims: The complaint asserts one or more claims of the patent (Compl. ¶128).
  • Accused Features: The composition of Defendants' ANDA Product (Compl. ¶¶ 121, 128).

Multi-Patent Capsule: U.S. Patent No. 9,925,265

  • Patent Identification: U.S. Patent No. 9,925,265, "Methods of Treating or Preventing Stent Thrombosis," issued March 27, 2018 (Compl. ¶52).
  • Technology Synopsis: This patent, related to the '052 Patent, is directed to specific methods of using cangrelor to treat or prevent stent thrombosis in patients, including those undergoing PCI (Compl. ¶52).
  • Asserted Claims: The complaint asserts one or more claims of the patent (Compl. ¶143).
  • Accused Features: The intended and instructed use of the Defendants' ANDA Product to prevent stent thrombosis, as will allegedly be described in its label (Compl. ¶¶ 44-45).

Multi-Patent Capsule: U.S. Patent No. 9,295,687

  • Patent Identification: U.S. Patent No. 9,295,687, "Pharmaceutical Formulations Comprising High Purity Cangrelor and Methods for Preparing and Using the Same," issued March 29, 2016 (Compl. ¶48).
  • Technology Synopsis: As an early member of the '780 Patent family, this patent is also directed to stable pharmaceutical formulations of high-purity cangrelor (Compl. ¶48).
  • Asserted Claims: The complaint asserts one or more claims of the patent (Compl. ¶83).
  • Accused Features: The composition of Defendants' ANDA Product (Compl. ¶¶ 76, 83).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants’ proposed generic cangrelor for injection, 50 mg/10 mL vial, for which ANDA No. 217986 was submitted to the FDA (the "ANDA Product") (Compl. ¶¶ 2, 61).

Functionality and Market Context

  • The ANDA Product is a lyophilized powder for reconstitution intended for intravenous administration as a P2Y12 platelet inhibitor (Compl. ¶¶ 35, 61). The complaint alleges that the prescribing information for the ANDA Product will have the same indications and usage as the reference listed drug, Kengreal®, and will recommend the same dosage and administration, specifically as an adjunct to PCI for reducing the risk of certain ischemic events (Compl. ¶¶ 35, 44, 45). The complaint alleges the ANDA Product will be used to inhibit platelet aggregation in patients (Compl. ¶46). By filing an ANDA, Defendants seek to market this product as a generic equivalent before the expiration of the patents-in-suit (Compl. ¶2).
    No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,680,052 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of reducing the incidence of an ischemic event in a patient undergoing percutaneous coronary intervention (PCI), comprising: The ANDA Product's proposed labeling will allegedly instruct physicians to use the product for the same Indications and Usage as Kengreal®, which includes reducing the risk of periprocedural ischemic events during PCI. ¶¶35, 44 col. 1:21-25
administering intravenously to the patient a 30 µg/kg bolus of cangrelor before the start of the PCI; The ANDA Product's proposed labeling will allegedly recommend a dosage of 30 mcg/kg administered through intravenous bolus prior to PCI. ¶¶37, 45 col. 4:9-13
and administering intravenously a continuous infusion of cangrelor at an infusion rate of 4 µg/kg/min after administration of the bolus; The ANDA Product's proposed labeling will allegedly recommend an immediate follow-on infusion of 4 mcg/kg/min. ¶¶37, 45 col. 4:13-16
wherein the continuous infusion is continued for at least two hours or the duration of the PCI, whichever is longer. The ANDA Product's proposed labeling will allegedly recommend the infusion continue for at least 2 hours or the duration of the procedure, whichever is longer. ¶¶37, 45 col. 4:16-19
  • Identified Points of Contention:
    • Scope Questions: The primary dispute for method-of-use patents like the '052 Patent, where the accused generic product's label is expected to mirror the brand-name label, often shifts from infringement to validity. A key question for the court may be whether the claimed method was novel and non-obvious over the prior art at the time of invention.
    • Technical Questions: Infringement will turn on the specific instructions in the final approved label for the ANDA Product. The question will be whether those instructions will inevitably lead physicians to perform each and every step of the claimed method.

U.S. Patent No. 10,039,780 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating, or reducing the risk of stent thrombosis or myocardial infarction, the method comprising administering to a subject in need thereof an effective amount of a pharmaceutical formulation comprising: The ANDA Product is indicated as an adjunct to PCI for reducing the risk of periprocedural myocardial infarction and stent thrombosis. ¶¶35, 44 col. 12:15-20
high purity cangrelor, or a salt thereof, as an active ingredient... wherein the high purity cangrelor or salt thereof has a combined total of selected hydrolysis and oxidation degradants of cangrelor not exceeding about 1.5% by weight of the high purity cangrelor The complaint does not provide sufficient detail for analysis of this element, alleging only on information and belief that the ANDA Product is cangrelor for injection, 50 mg/10 mL. ¶¶61, 151, 158 col. 2:47-58
and one or more pharmaceutically acceptable excipients... The ANDA product is a lyophilized powder for reconstitution, which typically includes excipients. ¶35 col. 4:35-43
  • Identified Points of Contention:
    • Scope Questions: The construction of "about 1.5% by weight" may become a point of contention, specifically regarding the range implied by the word "about" and the analytical methods required to measure it.
    • Technical Questions: A central evidentiary question will be the actual chemical composition of the Defendants' ANDA Product. The complaint offers no factual allegations regarding its impurity profile. The case will likely require discovery into Defendants’ manufacturing processes and quality control data to determine if the ANDA Product contains "high purity cangrelor" as defined by the specific quantitative limitations in the claim.

V. Key Claim Terms for Construction

  • The Term: "high purity cangrelor" ('780 Patent, Claim 1)

  • Context and Importance: This term is the central limitation of the asserted formulation patents. Infringement hinges entirely on whether the Defendants' ANDA Product meets this definition. The patent itself provides a specific, quantitative definition, making this less a matter of interpretation and more a matter of technical evidence. Practitioners may focus on this term because the entire infringement case for the formulation patents depends on whether the accused product falls within this precise numerical boundary for impurities.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent repeatedly uses the phrase "not exceeding about 1.5%," which could suggest some flexibility around the 1.5% threshold ('780 Patent, col. 2:50-53).
    • Evidence for a Narrower Interpretation: The patent explicitly defines the term by reference to a "combined total of selected hydrolysis and oxidation degradants," which are specifically identified as Impurities A, B, C, D, and E ('780 Patent, col. 2:47-58). This explicit definition limits the term to these five specific impurities and their combined weight percentage.

  • The Term: "ischemic event" ('052 Patent, Claim 1)

  • Context and Importance: The scope of this term defines the medical conditions covered by the patented method. Its construction will determine whether the indications for which the ANDA product will be labeled and used fall within the patent's protection. Practitioners may focus on this term to either broaden the scope of infringement or argue that the specific uses are not covered.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification states that an ischemic event "may include stent thrombosis, myocardial infarction, ischemia-driven revascularization (IDR), and mortality" ('052 Patent, col. 1:33-37), suggesting a non-exhaustive list.
    • Evidence for a Narrower Interpretation: The detailed examples and clinical trial data described in the patent may focus on a more limited set of adjudicated ischemic events, which a defendant could argue implicitly limits the claim scope to those specific types of events demonstrated in the patent.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce infringement by actively encouraging and instructing physicians and other healthcare providers to use the ANDA Product in accordance with its proposed labeling, which allegedly details an infringing method of administration (Compl. ¶¶ 70, 85, 100, 115, 130, 145, 160).
  • Willful Infringement: The complaint does not contain a separate count for willful infringement, but it requests a finding of willfulness and enhanced damages in the prayer for relief for each asserted patent (e.g., Compl. Prayer for Relief ¶G, ¶N). The basis for this allegation appears to be Defendants' knowledge of the patents, evidenced by their filing of a Paragraph IV certification, which is an explicit statement that the patents are invalid or not infringed (Compl. ¶42).

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

  • A core issue will be one of evidentiary proof: What is the precise chemical composition and impurity profile of the Defendants' ANDA Product? The infringement analysis for the formulation patents ('780, '687, '921, '575) will depend entirely on whether discovery reveals that the product meets the specific quantitative impurity limitations required by the term "high purity cangrelor."
  • A second issue will be one of infringement by labeling: For the method-of-use patents ('052, '448, '265), the key question is whether the final, FDA-approved label for the ANDA Product will instruct medical professionals to perform a method that meets all limitations of the asserted claims. If the generic label carves out the patented use or differs materially, infringement may be avoided; if it mirrors the brand label, the dispute will likely shift to the validity of the patents themselves.