DCT
1:17-cv-12311
Maquet Cardiovascular LLC v. Abiomed Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Maquet Cardiovascular LLC (Delaware)
- Defendant: Abiomed, Inc. (Delaware), Abiomed R&D, Inc. (Delaware), and Abiomed Europe GmbH (Germany)
- Plaintiff’s Counsel: Alston & Bird LLP
- Case Identification: 1:17-cv-12311, D. Mass., 04/02/2019
- Venue Allegations: Venue is alleged to be proper based on Defendants' commission of infringing acts within the district, the principal places of business for Abiomed, Inc. and Abiomed R&D being in the district, and Defendants' purposeful direction of sales and marketing activities toward residents of the district. The complaint also notes that Abiomed, Inc. previously filed a related declaratory judgment action in the same district.
- Core Dispute: Plaintiff alleges that Defendant’s Impella line of intravascular blood pumps infringes two patents related to guidable intravascular blood pump systems and methods.
- Technical Context: The technology concerns miniaturized intravascular blood pumps used to provide temporary circulatory support for patients with compromised heart function, such as during high-risk cardiac procedures.
- Key Procedural History: The complaint alleges that Plaintiff provided Defendant with notice of the patent applications that led to the patents-in-suit prior to their issuance. It also states that during the prosecution of the application for the '238 Patent, the patent examiner considered documents and arguments from inter partes review (IPR) proceedings that Defendant had initiated concerning related patents, which may be relevant to future validity disputes.
Case Timeline
| Date | Event |
|---|---|
| 1999-09-03 | Priority Date for ’238 and ’783 Patents |
| 2008-01-01 | Alleged Infringement Begins (approx.) |
| 2016-08-24 | Plaintiff allegedly notifies Defendant of application leading to ’238 Patent |
| 2017-10-17 | U.S. Patent No. 9,789,238 Issues |
| 2019-01-31 | Plaintiff allegedly notifies Defendant of application leading to ’783 Patent |
| 2019-03-26 | U.S. Patent No. 10,238,783 Issues |
| 2019-04-02 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,789,238 - Guidable Intravascular Blood Pump and Related Methods
Issued October 17, 2017
The Invention Explained
- Problem Addressed: Prior art intravascular blood pumps were difficult to guide into the correct position within a patient's circulatory system. The natural tendency of the associated catheter to remain straight could lead to dangerous misplacement, while using a separate, large-diameter guide catheter to aid placement consumes valuable space within blood vessels and increases the required puncture size (’783 Patent, col. 1:21-62).
- The Patented Solution: The invention is an intravascular blood pump system with integrated guiding features, which allows a physician to selectively guide the pump to a desired location without needing a separate, oversized guide catheter (’783 Patent, col. 2:63-col. 3:4). This is achieved by incorporating a lumen within the pump system itself, through which a standard guide wire can pass to steer the device through the patient's vasculature (’783 Patent, col. 3:5-16).
- Technical Importance: This integrated approach was designed to allow for more precise, efficient, and safer placement of the blood pump during critical cardiac procedures by eliminating the drawbacks associated with prior art placement techniques (’783 Patent, col. 3:1-4).
Key Claims at a Glance
- The complaint asserts independent Claim 1 and dependent Claims 13 and 19 (Compl. ¶20, ¶25).
- Essential elements of independent method Claim 1 include:
- Providing an intravascular blood pump system comprising a pump, catheter, cannula, and an elongate lumen for a guide wire.
- Passing the guide wire through the patient's artery to position its distal end in the left ventricle.
- Placing the guide wire through the cannula and the elongate lumen.
- Advancing the cannula into the patient over the guide wire to position it across the aortic valve.
- Passing purge fluid through a purge lumen toward the pump.
- Measuring pressure adjacent the pump.
- Spinning the rotor to pump blood from the left ventricle into the aorta to provide left-heart support.
- The complaint reserves the right to assert additional claims (Compl. ¶20, ¶25).
U.S. Patent No. 10,238,783 - Guidable Intravascular Blood Pump and Related Methods
Issued March 26, 2019
The Invention Explained
- Problem Addressed: As described for the related ’238 Patent, prior art intravascular pumps were difficult to guide accurately, and existing solutions involving separate guide catheters were cumbersome and invasive (’783 Patent, col. 1:21-62).
- The Patented Solution: The invention is an intravascular blood pump system that integrates a guide mechanism directly into the pump and cannula assembly (’783 Patent, Abstract). As illustrated in figures such as FIG. 8 and FIG. 9, this guide mechanism is a lumen incorporated into or alongside the cannula wall, allowing a guide wire to pass through it to steer the device, thereby eliminating the need for a separate, bulky guide catheter (’783 Patent, col. 13:35-49).
- Technical Importance: This integrated design aims to simplify the procedure for placing the pump, reduce the risk of misplacement, and minimize the invasiveness of the procedure by reducing the size of the required vascular access point (’783 Patent, col. 3:1-4).
Key Claims at a Glance
- The complaint asserts independent Claims 1, 8, 17, and 24 (Compl. ¶30).
- Essential elements of independent system Claim 1 include:
- An intravascular blood pump comprising a rotor with a tapering hub and a shroud.
- A cannula extending from the shroud with a substantially circular cross-section.
- A guide mechanism comprising a lumen adapted to guide the pump system.
- A specific geometric relationship wherein an axis of the guide mechanism extends through a region delimited by the outer cannula surface.
- The guide mechanism is configured to allow a guide wire to slideably advance along it.
- The complaint reserves the right to assert additional claims (Compl. ¶30).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are the Impella Recover LP 2.5 device (“Impella 2.5”), the Impella 5.0, and the Impella CP products (Compl. ¶13).
Functionality and Market Context
- The complaint alleges these products are intravascular blood pumps used to supplement or fully support a patient's blood circulation (Compl. ¶12). The infringement allegations describe the products as systems for providing left-heart support that are guided to a predetermined location within the circulatory system by a guide wire (Compl. ¶25, ¶34). They are alleged to comprise the core components of a rotor, cannula, and an integrated guide mechanism (Compl. ¶34).
- The complaint alleges the products have been manufactured, marketed, and sold in the United States since at least 2008 (Compl. ¶13).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
U.S. Patent No. 9,789,238 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for providing left-heart support using an intravascular blood pump system... | The complaint alleges that Defendants' customers and end users directly infringe by practicing a method of using the Impella products for left-heart support. | ¶25 | col. 9:1-col. 10:65 |
| the method comprising: passing the guide wire through the patient's femoral artery such that a distal end of the guide wire is positioned in the left ventricle of the patient's heart; | It is alleged that the standard medical procedure for using the Impella products includes this step. | ¶25 | col. 9:32-35 |
| placing the guide wire through both the cannula and the elongate lumen such that the guide wire extends proximally away from the intravascular blood pump... | It is alleged that use of the Impella products involves threading them over a pre-positioned guide wire via a guide lumen. | ¶25 | col. 10:50-57 |
| advancing the cannula into the patient using the guide wire and positioning the cannula across an aortic valve... such that a distal end of the cannula and the at least one second port are positioned in the left ventricle and a proximal end of the cannula and the at least one first port are positioned in the aorta... | It is alleged that the documented use of the Impella products for left-heart support requires this specific trans-valvular placement. | ¶25 | col. 9:36-41 |
| and the elongate lumen lies wholly within the left ventricle during left-heart support; | It is alleged that when the Impella products are properly positioned for use, the structural component corresponding to the claimed elongate lumen is located entirely within the left ventricle. | ¶25 | col. 13:55-59 |
| spinning the rotor so as to pump blood from the patient's heart into the at least one second port through the cannula lumen and out the at least one first port to provide left-heart support. | It is alleged that the fundamental operation of the Impella products involves a rotor pumping blood from the left ventricle into the aorta. | ¶25 | col. 10:4-10 |
U.S. Patent No. 10,238,783 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an intravascular blood pump system, comprising: an intravascular blood pump comprising: a rotor having a rotor hub tapering in a distal direction... and a shroud within which the rotor is rotatably disposed; | The complaint alleges the Impella products are pump systems that include a rotor with a tapering hub disposed within a shroud. | ¶34 | col. 11:8-12 |
| a cannula extending from the shroud and comprising an outer cannula surface, the outer cannula surface having a substantially circular cross-section along a portion of its length; | The complaint alleges the Impella products include a cannula with a circular cross-section extending from the pump's shroud. | ¶34 | col. 10:25-30 |
| a guide mechanism comprising a lumen having a proximal end and a distal end, the guide mechanism adapted to guide a distal portion of said intravascular blood pump system to a predetermined location... | The complaint alleges the Impella products include an integrated guide mechanism with a lumen for a guide wire. | ¶34 | col. 13:14-24 |
| wherein an axis coaxial with and extending through a portion of said guide mechanism extends through a region delimited by the outer cannula surface... | The complaint alleges the Impella products possess the claimed geometric relationship where the axis of the guide mechanism is located within the outer boundary of the cannula. | ¶34 | col. 13:45-49 |
Identified Points of Contention
- Scope Questions: For the ’238 Patent method claim, a key question may be whether the standard, documented use of the accused products requires practicing every step of the claim, particularly the specific positional limitation that "the elongate lumen lies wholly within the left ventricle during left-heart support." For the ’783 Patent system claim, a central question will be how broadly the court construes the geometric limitation "a region delimited by the outer cannula surface." The dispute may focus on whether this requires the guide mechanism to be integrated into the cannula wall itself, as shown in patent figures, or if it can be met by other structures.
- Technical Questions: The complaint makes conclusory allegations by reciting claim language. A primary question for the court will be what specific evidence demonstrates that the physical structure of the Impella products meets the detailed limitations of the asserted claims. For instance, what is the precise location and orientation of the accused product's guide wire lumen relative to its cannula surface to prove it meets the "axis... extends through a region delimited by" limitation of Claim 1 of the ’783 Patent?
V. Key Claim Terms for Construction
- The Term: "a region delimited by the outer cannula surface" (from Claim 1 of the ’783 Patent).
- Context and Importance: This term defines the spatial relationship between the guide mechanism and the cannula, which is the core of the claimed invention. The infringement analysis for the ’783 Patent will likely depend on whether the physical structure of the accused Impella products falls within the court's construction of this phrase.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Parties arguing for a broader scope may contend that the plain meaning of "delimited by" means any space contained within the outer boundary or circumference of the cannula. This reading would not require the guide mechanism to be physically part of the cannula wall.
- Evidence for a Narrower Interpretation: Parties arguing for a narrower scope may point to the patent's figures, such as Figure 8 and Figure 9, which depict the guide mechanism's lumen (126) as being either integrated into the cannula wall (14) or formed on its interior surface (’783 Patent, Fig. 8, 9). They may argue that the specification consistently describes a physically integrated or immediately adjacent structure, suggesting the "region" is limited to the immediate vicinity of the cannula wall itself (’783 Patent, col. 13:41-49).
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement of both patents based on Defendant’s employees instructing physicians on the use of the Impella products and providing documentation that allegedly instructs on infringing use (Compl. ¶21, ¶36). Contributory infringement is alleged on the basis that the accused pumps are a material part of the inventions and are not staple articles of commerce suitable for substantial noninfringing use (Compl. ¶24, ¶38). The complaint also includes an allegation of infringement under 35 U.S.C. § 271(f) for the ’783 Patent, asserting that Defendant supplies components from the U.S. for assembly into infringing products in Germany (Compl. ¶31).
- Willful Infringement: Willfulness is alleged for both patents based on pre-suit knowledge. For the ’238 Patent, the complaint alleges knowledge as of an August 24, 2016 letter identifying the pending application (Compl. ¶17). For the ’783 Patent, knowledge is alleged as of a January 31, 2019 letter identifying the published application (Compl. ¶29).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: how will the court construe the key structural limitations that define the integration of the guide mechanism with the pump system? Specifically, can the phrase "a region delimited by the outer cannula surface" in the ’783 Patent be read to cover the specific design of the accused Impella products, or is it limited to the precise embodiments shown in the patent's figures?
- A key evidentiary question will be one of factual correspondence: given the complaint's direct mapping of claim language onto the accused products, what specific technical evidence will Plaintiff provide to demonstrate that the accused devices meet each element of the system claims and that their real-world medical use invariably performs each step of the method claims? The outcome may depend on whether there is a functional and structural match or a fundamental mismatch between the patented invention and the accused technology.