DCT

1:23-cv-16257

Miracor Medical SA v. Abbott Laboratories

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-16257, N.D. Ill., 11/27/2023
  • Venue Allegations: Venue is alleged to be proper in the Northern District of Illinois because Defendants have regular and established places of business within the district and have allegedly committed acts of infringement there.
  • Core Dispute: Plaintiff alleges that Defendant’s HeartMate 3 Left Ventricular Assist System (LVAS) products infringe six patents related to devices for assisting heart performance.
  • Technical Context: The technology at issue involves implantable blood pumps, specifically Left Ventricular Assist Devices (LVADs), which are used to treat patients with advanced heart failure by assisting the heart in circulating blood.
  • Key Procedural History: The complaint alleges that Plaintiff’s CEO notified Abbott representatives of its relevant LVAS-related patent portfolio in December 2022 and January 2023, prior to the filing of this lawsuit. It is alleged that Abbott did not pursue a license.

Case Timeline

Date Event
2007-02-27 Earliest Priority Date for all asserted patents
2022-06-07 U.S. Patent No. 11,351,356 Issued
2022-06-07 U.S. Patent No. 11,351,357 Issued
2022-07-05 U.S. Patent No. 11,376,415 Issued
2022-12-XX Plaintiff allegedly informs Defendant of relevant IP
2023-01-XX Plaintiff allegedly conducts further communications with Defendant
2023-02-07 U.S. Patent No. 11,572,879 Issued
2023-06-13 U.S. Patent No. 11,674,517 Issued
2023-09-12 U.S. Patent No. 11,754,077 Issued
2023-11-27 Complaint Filed

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

U.S. Patent No. 11,351,356

  • Patent Identification: U.S. Patent No. 11,351,356, Device to Assist the Performance of a Heart, issued June 7, 2022. (Compl. ¶20).
  • The Invention Explained:
    • Problem Addressed: The patent describes a need for a heart assist device that can provide continuous support for a failing heart without requiring a bulky external pump and in a way that minimizes mechanical stress on sensitive fluids like blood. (’356 Patent, col. 1:26-35, col. 2:23-30).
    • The Patented Solution: The patent discloses a method using a heart assist device, implemented as an intravasal rotary pump on the distal end of a catheter. The key innovation is a "magneto coupling" that magnetically links an external, blood-contacting rotor with an internal drive wheel. This design physically separates the blood path from the drive mechanism, which can be operated hydraulically or pneumatically via lumina in the catheter, thereby eliminating the need for an external pump and reducing potential blood damage. (’356 Patent, Abstract; col. 2:35-56). Figure 2 illustrates this concept, showing a rotor (18) and a drive wheel (21) coupled by separate bar magnets (16, 19).
    • Technical Importance: This approach enabled the miniaturization of a blood pump for catheter-based delivery, with a drive system designed to be less traumatic to blood cells compared to direct mechanical-contact pumps. (’356 Patent, col. 2:27-30).
  • Key Claims at a Glance:
    • The complaint asserts at least exemplary independent claim 1. (Compl. ¶32).
    • The essential elements of independent claim 1, a method claim, include:
      • Delivering a heart assist pump device so a suction end of an inflow tube is inserted into a heart ventricle while a magnetically driven rotor is positioned outside the ventricle.
      • The rotor is rotatable within a housing to act on blood and is rigidly coupled to a "first magnetic device."
      • Positioning a "second magnetic device" to drive the rotor's rotation via a "magneto coupling" with the first magnetic device.
      • Flowing blood through a "radially" positioned outflow port in a "substantially perpendicular" direction from the inflow path.
      • Orienting the rotor via the magneto coupling so it remains "entirely spaced apart" from the housing by flowing blood.
      • Connecting an "external control unit" to regulate the operation of the second magnetic device.
    • The complaint states infringement of "one or more claims," reserving the right to assert others. (Compl. ¶31).

U.S. Patent No. 11,351,357

  • Patent Identification: U.S. Patent No. 11,351,357, Device to Assist the Performance of a Heart, issued June 7, 2022. (Compl. ¶21).
  • The Invention Explained:
    • Problem Addressed: The patent addresses the same technical problem as the ’356 Patent: the need for a miniaturized, implantable, and blood-compatible heart pump system. (’357 Patent, col. 1:26-35).
    • The Patented Solution: This patent claims the system itself, rather than the method of use. The claimed system comprises a heart assist pump device with the core features described in the ’356 Patent: an inflow tube, a magnetically driven rotor coupled to a first magnetic device, a separate magnetic drive system with a second magnetic device, and a radially-oriented blood outflow port. The system is regulated by an external control unit. (’357 Patent, Abstract; col. 5:26-68). The physical configuration is that of a catheter-based pump with a magnetically coupled drive mechanism.
    • Technical Importance: The claimed system provides a complete, self-contained apparatus for assisting heart performance, featuring a design that prioritizes miniaturization and hemocompatibility through magnetic coupling. (’357 Patent, col. 2:23-30).
  • Key Claims at a Glance:
    • The complaint asserts at least exemplary independent claim 1. (Compl. ¶52).
    • The essential elements of independent claim 1, a system claim, include:
      • A heart assist pump device with an inflow tube.
      • A magnetically driven rotor coupled to a first magnetic device, where both are "entirely spaced apart" from the housing by a gap.
      • A magnetic drive system with a second magnetic device that creates a "magneto coupling" with the first.
      • A blood outflow port "positioned radially adjacent" the rotor.
      • An external control unit to regulate the second magnetic device.
    • The complaint reserves the right to assert additional claims. (Compl. ¶51).

Multi-Patent Capsule: U.S. Patent No. 11,376,415

  • Patent Identification: U.S. Patent No. 11,376,415, Device to Assist the Performance of a Heart, issued July 5, 2022. (Compl. ¶22).
  • Technology Synopsis: This patent claims a system for assisting blood circulation, focusing on the structural arrangement of a catheter-based pump. The claims recite a magnetically driven rotor that is spaced apart from the suction end of an inflow tube, a second magnetic device to drive the rotor via magneto coupling, and a blood outflow port positioned to direct blood "substantially perpendicular" from the inflow path. (’415 Patent, Claim 1).
  • Asserted Claims: At least exemplary claim 1. (Compl. ¶73).
  • Accused Features: The complaint alleges that Abbott's HeartMate 3 products are systems that infringe the ’415 Patent. (Compl. ¶72).

Multi-Patent Capsule: U.S. Patent No. 11,572,879

  • Patent Identification: U.S. Patent No. 11,572,879, Device to Assist the Performance of a Heart, issued February 7, 2023. (Compl. ¶23).
  • Technology Synopsis: This patent claims a heart-assist system where a magnetically driven rotor and its coupled "first magnetic device" are entirely spaced from the surrounding housing by a blood-filled gap. The system includes a "second magnetic device" for the drive and specifies an outflow port that is perpendicular to the central inflow axis, with an external control unit for regulation. (’879 Patent, Claim 1).
  • Asserted Claims: At least exemplary claim 1. (Compl. ¶94).
  • Accused Features: The HeartMate 3 products are accused of embodying the infringing system. (Compl. ¶93).

Multi-Patent Capsule: U.S. Patent No. 11,674,517

  • Patent Identification: U.S. Patent No. 11,674,517, Device to Assist the Performance of a Heart, issued June 13, 2023. (Compl. ¶24).
  • Technology Synopsis: This patent claims a heart-assist system with an inflow tube for a left ventricle, walls defining a blood chamber, and a magnetically driven rotor. A key claimed feature is a magnetic drive system spaced from the rotor by a wall, with an external controller regulating the drive based on a "defined cardiac output." (’517 Patent, Claim 21).
  • Asserted Claims: At least exemplary claim 1. (Compl. ¶115).
  • Accused Features: The HeartMate 3 products are accused of infringing the ’517 Patent. (Compl. ¶114).

Multi-Patent Capsule: U.S. Patent No. 11,754,077

  • Patent Identification: U.S. Patent No. 11,754,077, Device to Assist the Performance of a Heart, issued September 12, 2023. (Compl. ¶25).
  • Technology Synopsis: This patent claims a system featuring a magnetically driven rotor assembly that is entirely spaced from a stationary housing by a blood-filled gap. It recites a second magnetic device for the drive, a radial outflow port, and an external control unit that regulates operation based on a "cardiac output" value. (’077 Patent, Claim 1).
  • Asserted Claims: At least exemplary claim 1. (Compl. ¶136).
  • Accused Features: The HeartMate 3 products are accused of infringing the ’077 Patent. (Compl. ¶135).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are Abbott’s HeartMate 3 Left Ventricular Assist System (LVAS) products and any other similar Abbott products. (Compl. ¶¶ 15, 31).
  • Functionality and Market Context: The HeartMate 3 is described as a device for assisting the performance of the heart. (Compl. ¶15). The complaint alleges that Abbott encourages doctors and medical institutions to purchase and use these products to assist heart performance through various materials, including product manuals, videos, and training resources. (Compl. ¶¶ 35-37). The complaint references Exhibit 8, described as containing PDF printouts of web pages for the HeartMate 3, as providing direction on the product's use. (Compl. ¶37). The complaint does not contain technical schematics of the accused product but alleges that its implantation, assembly, and use infringe the patents-in-suit. (Compl. ¶¶ 31, 51).

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits for each asserted patent that were not provided with the pleading (Compl. ¶¶ 32, 52, 73, 94, 115, 136). The following is a prose summary of the infringement allegations.

  • '356 Patent Infringement Allegations
    The complaint alleges that Abbott directly infringes the method of claim 1 of the ’356 Patent during the "development, testing, and/or demonstration" of its HeartMate 3 products. (Compl. ¶32). The infringement theory is that Abbott performs the claimed steps of "implantation and assembly" of the device. (Compl. ¶31). The complaint further alleges that Abbott induces infringement by third parties, such as doctors, by providing instructions, manuals, and training that direct them to perform the claimed method when implanting and using the HeartMate 3 system. (Compl. ¶¶ 33, 35).

  • '357 Patent Infringement Allegations
    The complaint alleges that Abbott directly infringes the system of claim 1 of the ’357 Patent by "making, using, selling, offering for sale and/or importing" the HeartMate 3 products in the United States. (Compl. ¶51). The infringement theory is that the physical HeartMate 3 device is an embodiment of the claimed system, containing the recited inflow tube, magnetically driven rotor, magnetic drive system, and external control unit. (Compl. ¶¶ 51-52). The complaint also alleges that Abbott induces infringement by encouraging doctors and medical institutions to use the infringing products. (Compl. ¶53).

  • Identified Points of Contention:

    • Scope Questions: The patents repeatedly claim a structure with a "first magnetic device" rigidly coupled to the rotor and a "second magnetic device" that drives it. A central question will be whether the accused HeartMate 3, which is publicly known to use "Full MagLev" technology, has a structure that can be mapped to this two-part magnetic system.
    • Technical Questions: The asserted claims describe a specific blood outflow geometry that is "radially adjacent" to the rotor and "substantially perpendicular" to the inflow path (’356 Patent, Claim 1). The factual analysis will question whether the fluid dynamics and physical structure of the HeartMate 3 pump meet this specific geometric limitation.

V. Key Claim Terms for Construction

  • The Term: "magneto coupling" (’356 Patent, Claim 1; ’357 Patent, Claim 1)

  • Context and Importance: This term is fundamental to the claimed invention, defining how the drive force is transmitted to the blood-impelling rotor without physical contact. The construction of this term will be critical in determining whether the accused product's magnetic levitation and drive system falls within the scope of the claims.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the purpose of the coupling as achieving a "completely impervious separate on of the rotor from the drive wheel," which "eliminates axial passages between the drive wheel and the rotor." (’356 Patent, col. 2:51-56). This functional language may support a construction that covers any non-contact magnetic system that transmits rotational force across a sealed barrier.
    • Evidence for a Narrower Interpretation: The primary embodiment discloses the coupling as being formed by "bar magnets" (16, 19) located in "adjacent chambers separated from each other hydraulically by a sealing wall." (’356 Patent, col. 3:6-10; Fig. 2). Parties may argue that the term should be limited to this disclosed structure of two distinct, physically separate magnetic components interacting across a wall.

  • The Term: "second magnetic device... positioned to magnetically drive rotation" (’356 Patent, Claim 1; ’357 Patent, Claim 1)

  • Context and Importance: This term defines the "driver" part of the magnetic system. Practitioners may focus on this term because the accused product's drive system (a stator with electromagnetic coils) may differ significantly from the patent's embodiment of a fluid-driven paddle wheel (21) connected to a bar magnet (19). (’356 Patent, col. 4:57-61).

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claims themselves do not specify the form of the "second magnetic device," leaving open the possibility that it could cover any magnetic field generator positioned to cause rotation, including an electromagnetic one.
    • Evidence for a Narrower Interpretation: The detailed description explains that the drive wheel is "formed... as a paddle wheel and is acted upon with fluid via a lumen." (’356 Patent, col. 4:57-59). An argument could be made that the "second magnetic device" is implicitly limited by this disclosed embodiment to a component that is itself rotated by mechanical or fluidic means, rather than being a stationary electromagnetic component.

VI. Other Allegations

  • Indirect Infringement: For all asserted patents, the complaint pleads both induced and contributory infringement. Inducement is based on allegations that Abbott provides user manuals, marketing materials, and training that instruct and encourage doctors to assemble and use the HeartMate 3 products in an infringing manner. (Compl. ¶¶ 35, 55, 76). Contributory infringement is based on allegations that Abbott sells components of the HeartMate 3 system that are a material part of the invention and not suitable for substantial non-infringing use. (Compl. ¶¶ 40, 60, 81).
  • Willful Infringement: The complaint alleges willful infringement for all patents. The basis for willfulness includes alleged pre-suit knowledge of the patents, stemming from communications between Miracor's CEO and Abbott representatives in December 2022 and January 2023. (Compl. ¶¶ 26-28, 43, 63). It is also alleged that Abbott was aware of the patents shortly after their issuance and made no attempt to design around the claims. (Compl. ¶¶ 44-46).

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

  • A core issue will be one of claim construction: can the term "magneto coupling," disclosed in the context of two interacting permanent bar magnets, be construed broadly enough to read on the integrated electromagnetic levitation and drive system of the accused HeartMate 3 product?
  • A related evidentiary question will be one of structural correspondence: does the accused product’s single rotor and surrounding electromagnetic stator contain distinct components that function as the claimed "first magnetic device" (coupled to the rotor) and "second magnetic device" (the driver), or is there a fundamental mismatch in the architecture of the drive systems?
  • A third question concerns method infringement: for the method claims asserted in the ’356 Patent, a key issue will be whether the Plaintiff can prove that a single entity—either Abbott during testing or a surgeon during implantation—performs every step of the claimed method, including the final step of "connecting an external control unit."