Abiomed Inc v. Maquet Cardiovascular LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Abiomed Inc. (Delaware)
  • Defendant: Maquet Cardiovascular LLC (Delaware)
  • Plaintiff’s Counsel: White & Case LLP
• Case Identification: 1:16-cv-10914, D. Mass., 10/12/2017
• Venue Allegations: Plaintiff Abiomed alleges venue is proper in the District of Massachusetts because a substantial part of the relevant events occurred in the district, Maquet transacts business there, and Maquet accused Abiomed, a Massachusetts-based business, of infringement.
• Core Dispute: Plaintiff seeks a declaratory judgment that its Impella® line of intravascular heart pumps does not infringe six patents owned by Defendant related to guidable intravascular blood pumps.
• Technical Context: The technology at issue involves miniaturized, catheter-based blood pumps designed for percutaneous insertion to provide ventricular support for patients with failing hearts.
• Key Procedural History: This action for declaratory judgment was precipitated by a series of communications, initiated by a December 15, 2015 letter from Maquet, in which Maquet accused Abiomed of infringing the patents-in-suit and demanded that Abiomed take a license. The complaint alleges these actions created a substantial controversy warranting declaratory relief.

Case Timeline

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

U.S. Patent No. 7,022,100 - "Guidable Intravascular Blood Pump and Related Methods"

• Issued: April 4, 2006

The Invention Explained

• Problem Addressed: The patent describes prior art intravascular blood pumps as being difficult to guide into the correct position within a patient's circulatory system, noting that the natural tendency of a catheter to stay straight may cause inadvertent and dangerous placement, such as in the carotid ostia (’100 Patent, col. 2:5-22). Supplemental guide catheters, while effective, consume valuable space within blood vessels ’100 Patent, col. 2:30-44
• The Patented Solution: The invention proposes an improved intravascular blood pump equipped with integrated features for selectively guiding the device to a predetermined location, thereby eliminating the need for a separate, large-diameter guide catheter ’100 Patent, col. 2:48-55 A principal embodiment is an "over-the-wire" design where a central lumen passes through the pump system, allowing it to slide along a pre-positioned guide wire to the target location ’100 Patent, col. 2:56-65 ’100 Patent, FIG. 1
• Technical Importance: This integrated approach was intended to improve the safety, precision, and efficiency of placing intravascular heart pumps for ventricular assist procedures ’100 Patent, col. 2:48-55

Key Claims at a Glance

• The complaint alleges non-infringement of at least claim 16, which depends from independent claim 9 Compl. ¶27
• Independent Claim 9:
  • An intravascular blood pump system comprising an intravascular blood pump with a coupled cannula, the pump including a rotor, a shroud for the rotor, and a drive cable for driving the rotor.
  • A guide mechanism adapted to guide the pump and cannula to a predetermined location.
  • A drive cable sheath with a central lumen for receiving the drive cable.
  • A purge fluid delivery system coupled to the drive cable sheath to deliver purge fluid to the rotor.
• The complaint states that Abiomed has not infringed any claim of the patent Compl. ¶28

U.S. Patent No. 8,888,728 - "Guidable Intravascular Blood Pump and Related Methods"

• Issued: November 18, 2014

The Invention Explained

• Problem Addressed: Similar to the ’100 Patent, the ’728 Patent addresses the significant drawback that prior art intravascular blood pumps are difficult to guide into the appropriate position within a patient's circulatory system ’728 Patent, col. 2:9-13
• The Patented Solution: The patent describes an intravascular blood pump system with an integrated "over-the-wire" guide mechanism, comprising a central lumen through at least a portion of the system, which allows the device to be advanced over a guide element (like a guide wire) to a predetermined location ’728 Patent, col. 2:59- col. 3:4 The specification also discloses "side-rigger" and "guide catheter" type mechanisms ’728 Patent, col. 3:5-42
• Technical Importance: The technology seeks to provide a more reliable and less cumbersome method for accurately placing ventricular assist devices within the heart and vasculature ’728 Patent, col. 2:51-58

Key Claims at a Glance

• The complaint alleges non-infringement of at least independent claims 1 and 10 Compl. ¶32
• Independent Claim 1:
  • An intravascular blood pump system comprising an intravascular blood pump (with a rotor having a tapering hub and at least one blade, and a shroud) and a cannula extending from the shroud.
  • A first lumen for delivering purge fluid to the pump.
  • A guide mechanism configured as a second lumen adapted to guide a distal portion of the system, wherein an axis of the guide mechanism extends through a region delimited by the outer cannula surface, and which is configured to allow a guide wire to slideably advance therealong.
• Independent Claim 10:
  • An intravascular blood pump system with a pump coupled to a catheter and a cannula.
  • First and second sets of apertures for fluid communication.
  • A guide mechanism configured as an elongate lumen sized substantially smaller than the cannula's inner diameter.
  • A blood pressure detection mechanism with a fluid column.
  • A guide wire arranged to be advanced along the lumen.
• The complaint states that Abiomed has not infringed any claim of the patent Compl. ¶33

U.S. Patent No. 9,327,068 - "Guidable Intravascular Blood Pump and Related Methods"

• Issued: May 3, 2016
• Technology Synopsis: This patent, from the same family, describes an intravascular blood pump system with integrated guiding features. It focuses on embodiments using an "over-the-wire" mechanism where a central lumen through the pump system allows it to be advanced over a pre-placed guide wire to a desired location in the patient's circulatory system (’068 Patent, col. 2:52-65).
• Asserted Claims: Independent claims 1, 10, and 20 Compl. ¶37
• Accused Features: The complaint alleges that Maquet has accused Abiomed's Impella 2.5®, Impella 5.0®, Impella CP®, and Impella RP® products of infringement Compl. ¶37

U.S. Patent No. 9,545,468 - "Guidable Intravascular Blood Pump and Related Methods"

• Issued: January 17, 2017
• Technology Synopsis: This patent also relates to guidable intravascular blood pumps. The described solution includes equipping the pump with guiding features, such as an "over-the-wire" configuration with a central lumen, to allow for selective positioning at a predetermined location within the circulatory system without needing a separate, large guide catheter ’468 Patent, col. 2:50-61
• Asserted Claims: Independent claims 1 and 22 Compl. ¶42
• Accused Features: The complaint alleges that Maquet has accused Abiomed's Impella 2.5®, Impella 5.0®, and Impella CP® products of infringement Compl. ¶42

U.S. Patent No. 9,561,314 - "Guidable Intravascular Blood Pump and Related Methods"

• Issued: February 7, 2017
• Technology Synopsis: This patent continues the theme of an intravascular blood pump system with an integrated guide mechanism. The described invention involves concepts such as an "over-the-wire" system with a central lumen for a guide wire or a "side-rigger" type guide mechanism to facilitate precise placement within a patient's heart or vasculature ’314 Patent, col. 3:1-12
• Asserted Claims: Independent claims 1, 20, and 27 Compl. ¶47
• Accused Features: The complaint alleges that Maquet has accused Abiomed's Impella 2.5®, Impella 5.0®, and Impella CP® products of infringement Compl. ¶47

U.S. Patent No. 9,597,437 - "Guidable Intravascular Blood Pump and Related Methods"

• Issued: March 21, 2017
• Technology Synopsis: This patent describes an intravascular blood pump with guiding features to enable selective positioning. The specification discloses various guiding approaches, including an "over-the-wire" configuration, a "side-rigger" or "rapid exchange" type mechanism, and a "guide catheter" type mechanism ’437 Patent, col. 2:60 - col. 3:43
• Asserted Claims: Independent claims 1 and 28 Compl. ¶52
• Accused Features: The complaint alleges that Maquet has accused Abiomed's Impella 2.5®, Impella 5.0®, and Impella CP® products of infringement Compl. ¶52

III. The Accused Instrumentality

Product Identification

• The accused instrumentalities are Abiomed's Impella® products, specifically the Impella 2.5®, Impella 5.0®, Impella CP®, and Impella RP® intravascular heart pumps Compl. ¶4

Functionality and Market Context

• The complaint describes the accused products as catheter-based intracardiac heart pumps used in hospitals for left and right ventricular support Compl. ¶8 Abiomed is presented as a "pioneer and global leader" in this technology, and the Impella 2.5® is identified as the "world's smallest heart pump" Compl. ¶¶7-8 The complaint does not provide specific technical details about the structure or operation of the Impella pumps' guidance or fluid systems, focusing instead on their market position and life-saving purpose Compl. ¶¶7-8 Compl. ¶17

IV. Analysis of Infringement Allegations

The complaint is for a declaratory judgment of non-infringement and therefore does not contain claim charts illustrating infringement. It references infringement charts provided by Maquet in a pre-suit letter, but those charts were not filed with the complaint Compl. ¶17 The complaint's narrative theory is a general denial that the manufacture, use, or sale of the Impella products constitutes an act of infringement of any claim of the patents-in-suit, either literally or under the doctrine of equivalents Compl. ¶¶28-29 Compl. ¶¶33-34

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The Term: "guide mechanism"

• Patent Citation: ’100 Patent, Claim 9; ’728 Patent, Claim 1
• Context and Importance: This term is central to the inventive concept of all patents-in-suit, which is the integration of guiding features into the pump system itself. The scope of this term will be critical to determining whether the method used to place the accused Impella pumps falls within the claims. Practitioners may focus on whether this term is limited to the specific "over-the-wire," "side-rigger," and "guide catheter" embodiments disclosed or if it can be construed more broadly.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: Claim 9 of the ’100 patent recites the term broadly as a "guide mechanism adapted to guide said intravascular blood pump and cannula," without limiting its structure. The summary of the invention also refers generally to "integrated features for selectively guiding" the pump ’100 Patent, col. 2:50-51
  • Evidence for a Narrower Interpretation: The detailed description focuses on three specific types of guide mechanisms: an "over-the-wire" type, a "side-rigger" or "rapid exchange" type, and a "guide catheter" type ’100 Patent, col. 2:56 - col. 3:42 A defendant may argue that the term should be construed in light of these disclosed embodiments.

The Term: "purge fluid delivery system is coupled to said drive cable sheath"

• Patent Citation: ’100 Patent, Claim 9
• Context and Importance: The functional and structural relationship between the purge fluid system and the drive cable sheath is a specific limitation in claim 9. The infringement analysis may turn on whether the accused products have a system that is "coupled" in the manner required by the claim.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The term "coupled" is a general connector word, and a plaintiff may argue it should be given its plain and ordinary meaning, covering any form of functional or physical connection.
  • Evidence for a Narrower Interpretation: The specification shows a specific embodiment where the purge fluid system includes inlet and outlet conduits that connect to a housing, which in turn is secured to the drive cable sheath to provide fluid communication with side lumens and a central lumen within the sheath ’100 Patent, FIG. 5 ’100 Patent, col. 11:24-40 A defendant could argue this detailed disclosure limits the scope of "coupled."

VI. Other Allegations

Indirect Infringement

• The complaint states that Maquet has alleged Abiomed "directly and indirectly" infringes the patents-in-suit Compl. ¶4 Compl. ¶¶21-23 Abiomed denies that it has "contributed to infringement of nor induced others to infringe" the patents Compl. ¶30 Compl. ¶35 The complaint does not provide the specific factual basis for Maquet's indirect infringement allegations.

Willful Infringement

• Willful infringement is not alleged, as this is an action for declaratory judgment of non-infringement. However, the complaint notes that Maquet sent letters asserting infringement of specific patents and stated that the letters constituted "actual notice under 35 U.S.C. §287(a)" Compl. ¶¶21-23 This allegation of pre-suit knowledge, beginning with the December 15, 2015 letter, could form the basis for a subsequent willfulness claim by Maquet Compl. ¶17

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

• A core issue will be one of definitional scope: how will the term "guide mechanism" be construed? The case may turn on whether this term is limited to the specific "over-the-wire" or "side-rigger" structures disclosed in the patents, or if it can be read more broadly to encompass the technology used to place Abiomed's Impella® pumps.
• A central evidentiary question will be one of technical correspondence: can Abiomed demonstrate, on a claim-by-claim and element-by-element basis, that its Impella® products lack at least one limitation of each asserted claim? The dispute will likely focus on a detailed technical comparison of the accused products' structures for guidance, fluid purging, and pressure sensing against the specific limitations recited in the patent claims.