DCT

8:19-cv-00345

Edwards Lifesciences Corp v. Abbott Cardiovascular Systems Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 8:19-cv-00345, C.D. Cal., 02/22/2019
  • Venue Allegations: Venue is asserted based on Defendant's alleged commission of infringing acts within the district and its maintenance of several established places of business, including one in Temecula, California.
  • Core Dispute: Plaintiff alleges that Defendant’s MitraClip line of mitral valve repair devices infringes three patents related to catheter-delivered clips and methods for treating atrioventricular regurgitation.
  • Technical Context: The technology concerns minimally invasive medical devices used to repair leaking heart valves (mitral regurgitation) by clipping the valve leaflets together without requiring open-heart surgery.
  • Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of all three asserted patents (or their pending applications) because Defendant cited them in Information Disclosure Statements (IDS) filed with the U.S. Patent and Trademark Office during the prosecution of its own, separate patents. This alleged prior knowledge may be used to support claims of indirect and willful infringement.

Case Timeline

Date Event
2000-08-11 Priority Date for ’767, ’669, and ’313 Patents
2004-04-13 U.S. Patent No. 6,719,767 ('767 Patent) Issues
2004-09-22 Defendant allegedly cites '767 Patent in an IDS
2006-03-14 U.S. Patent No. 7,011,669 ('669 Patent) Issues
2011-11-22 U.S. Patent No. 8,062,313 ('313 Patent) Issues
2018-07-25 Defendant allegedly cites '669 Patent and '313 application in an IDS
2019-02-22 Complaint Filed

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

U.S. Patent No. 6,719,767 - "Device and a Method for Treatment of Atrioventricular Regurgitation," Issued Apr. 13, 2004

The Invention Explained

  • Problem Addressed: The patent describes atrioventricular regurgitation (a leaky heart valve) as a serious condition typically treated by open-heart surgery, a procedure that is particularly hazardous for elderly patients or those with poor ventricular function (ʼ767 Patent, col. 1:24-44, col. 2:6-14).
  • The Patented Solution: The invention is a device and method for treating regurgitation in a beating heart, avoiding open-heart surgery. It proposes a "suturing means," such as a clip, delivered through a catheter via blood vessels to the heart valve leaflets (ʼ767 Patent, Abstract). This clip is designed to be transitional between an open state, to capture the free edges of two leaflets, and a closed state, to bind them together, thereby improving the valve's ability to close (ʼ767 Patent, col. 2:22-31, 38-43).
  • Technical Importance: The technology provided a conceptual basis for a percutaneous, catheter-based alternative to the Alfieri "edge-to-edge" surgical stitch, aiming to make valve repair accessible to patients who were poor candidates for conventional surgery (ʼ767 Patent, col. 1:62-col. 2:14).

Key Claims at a Glance

  • The complaint asserts independent Claim 14 (Compl. ¶18).
  • The essential elements of Claim 14 are:
    • A device for treatment of atrioventricular regurgitation comprising a suturing means introducible via blood vessels to two leaflets of an atrioventricular valve.
    • The suturing means is designed for binding the two leaflets together to improve valve closing.
    • The suturing means is transitional between an open state and a substantially closed state.
    • The suturing means comprises a clip.
    • The device further comprises a catheter for introducing the clip, where the catheter has a retractable outermost sheet that covers the clip.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 7,011,669 - "Device and a Method for Treatment of Atrioventricular Regurgitation," Issued Mar. 14, 2006

The Invention Explained

  • Problem Addressed: As a continuation of the '767 Patent, the '669 Patent addresses the same problem: the high risks associated with conventional open-heart surgery for treating mitral regurgitation (ʼ669 Patent, col. 2:9-14).
  • The Patented Solution: This patent claims a method for using a catheter-delivered clip to stabilize a heart valve leaflet. The claimed method involves providing a delivery catheter and a clip made from a "temperature-activated memory material," advancing the clip to the leaflet, transforming it from a "delivery state" to an "open state" to receive the leaflet's edge, positioning the leaflet, and then transforming the clip to a "closed state" to secure it (ʼ669 Patent, Claim 1).
  • Technical Importance: By claiming the specific procedural steps for implanting the device, the patent sought to protect the surgical technique itself, not just the physical apparatus (ʼ669 Patent, col. 3:29-42).

Key Claims at a Glance

  • The complaint asserts independent Claim 1 (Compl. ¶27).
  • The essential elements of Claim 1 are:
    • A method of stabilizing a first heart valve leaflet, comprising:
    • Providing a delivery catheter and a clip formed from a temperature-activated memory material.
    • Securing the clip in a delivery state to the catheter.
    • Advancing the clip to a position adjacent to the leaflet.
    • Transforming the clip from the delivery state to an open state to receive the leaflet's edge.
    • Positioning the leaflet's edge within the clip opening.
    • Transforming the clip from the open state to a closed state to secure the leaflet.
  • The complaint alleges infringement of "one or more claims," suggesting other claims may be asserted later (Compl. ¶28).

U.S. Patent No. 8,062,313 - "Device and a Method for Treatment of Atrioventricular Regurgitation," Issued Nov. 22, 2011

  • Patent Identification: U.S. Patent No. 8,062,313, "Device and a Method for Treatment of Atrioventricular Regurgitation," Issued Nov. 22, 2011 (Compl. ¶13).
  • Technology Synopsis: This patent, which is a continuation of the '669 patent, claims an apparatus for securing heart valve leaflets. The claims focus on the structural details of a clip having multiple pairs of arms that form "V" shapes in an open state to receive leaflet tissue and a delivery catheter system specifically configured to hold and deploy this clip (ʼ313 Patent, Claim 1; Abstract).
  • Asserted Claims: The complaint asserts at least Claim 1 (Compl. ¶36).
  • Accused Features: The MitraClip implant and its associated clip delivery system are accused of infringing the '313 Patent's apparatus claims (Compl. ¶¶35, 38).

III. The Accused Instrumentality

  • Product Identification: The "Accused Products" are identified as the MitraClip, MitraClip NT, MitraClip NTR, and MitraClip XTR devices (Compl. ¶6).
  • Functionality and Market Context: The complaint alleges that the Accused Products are mitral valve repair devices that include an implantable clip and a catheter-based clip delivery system (Compl. ¶20). These systems are allegedly used by clinicians to perform transcatheter repair of the mitral valve by grasping and fastening the valve leaflets together, as instructed in Defendant's "Instructions for Use" documents (Compl. ¶¶26, 28). The complaint alleges these products are manufactured, sold, and imported by Defendant for use in the United States (Compl. ¶6).

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits (Exhibits 4, 6, and 7) that are not attached to the filed complaint document. As such, the infringement theories are summarized below in prose based on the complaint’s narrative allegations. No probative visual evidence provided in complaint.

  • '767 Patent Infringement Allegations: The complaint alleges that the Accused Products directly infringe at least Claim 14, either literally or under the doctrine of equivalents (Compl. ¶18). The theory appears to be that the MitraClip system, consisting of an implantable clip and a delivery catheter with a sheath, meets all elements of the claimed device. The MitraClip implant allegedly constitutes the claimed "clip" and "suturing means," while its delivery system is the claimed "catheter" with a "retractable outermost sheet" (Compl. ¶¶18, 20).

  • '669 Patent Infringement Allegations: The complaint alleges that Defendant indirectly infringes at least method Claim 1 by inducement and contribution (Compl. ¶¶26, 27). The core allegation is that Defendant instructs clinicians, through materials like its "Instructions for Use," to perform a method of implanting the MitraClip that directly infringes the steps of Claim 1 (Compl. ¶¶28, 30). This allegedly includes using a catheter to advance a clip made of a memory material and transforming it through open and closed states to capture valve leaflets, thereby practicing the patented method (Compl. ¶¶28, 29).

  • Identified Points of Contention:

    • Scope Questions: A potential dispute for the '767 Patent concerns the scope of "suturing means." The court may need to determine if this term is limited to the specific embodiments shown in the patent or if it functionally encompasses any catheter-delivered clip for leaflet approximation, including the accused MitraClip.
    • Technical Questions: For the '669 Patent, a key factual question is whether the material composition of the accused MitraClip meets the "temperature-activated memory material" limitation of Claim 1. The infringement analysis will depend on evidence regarding the MitraClip's material properties and mechanism of action (i.e., whether its transformation is temperature-based, mechanically driven, or both).

V. Key Claim Terms for Construction

  • Term 1 ('767 Patent, Claim 14): "suturing means"

    • Context and Importance: This term defines the central component of the claimed device. Its construction is critical because if defined narrowly, it might not read on the specific mechanical design of the accused MitraClip. Practitioners may focus on this term to determine if it is a broad functional description or is limited by the patent's specific examples.
    • Intrinsic Evidence for a Broader Interpretation: The claim states the "suturing means comprises a clip," which may suggest a clip is one embodiment, not a limitation on the broader "means" (ʼ767 Patent, col. 8:43-44).
    • Intrinsic Evidence for a Narrower Interpretation: The specification heavily details a particular clip with two pairs of arms connected by crossbars (Fig. 2), which a party could argue implicitly limits the scope of "suturing means" to that structure and its equivalents (ʼ767 Patent, col. 4:51-65).

  • Term 2 ('669 Patent, Claim 1): "clip formed from a temperature-activated memory material"

    • Context and Importance: This limitation defines a specific material property of the clip used in the claimed method. The infringement determination for the '669 Patent may hinge on whether the accused MitraClip is proven to be made from a material with this characteristic.
    • Intrinsic Evidence for a Broader Interpretation: The specification identifies Nitinol, a well-known temperature-activated memory metal, as a preferred material, not necessarily the only one ("Preferably, the suturing means consists of a memory material such as Nitinol") (ʼ669 Patent, col. 3:23-24). This could support an interpretation covering any material that functions as a temperature-activated memory material.
    • Intrinsic Evidence for a Narrower Interpretation: A party could argue that the term requires the clip's change of state (e.g., from open to closed) to be primarily driven by temperature change, as opposed to a clip made of a memory metal that is actuated by purely mechanical forces from the delivery system.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement of the '669 Patent, citing Defendant's "Instructions for Use" as evidence of its intent for clinicians to perform the patented method (Compl. ¶¶28, 31). It also alleges contributory infringement, stating the Accused Products are a material part of the invention, not a staple commodity, and are especially adapted for infringing use (Compl. ¶27). For the '767 and '313 patents, the complaint alleges infringement under 35 U.S.C. § 271(f) by supplying components from the U.S. for assembly abroad (Compl. ¶¶21-22, 39-40).
  • Willful Infringement: While the complaint does not use the word "willful," it lays a foundation for such a claim by alleging pre-suit actual knowledge. The complaint alleges Defendant knew of the '767 Patent as early as 2004 and the '669 and '313 patents (or their applications) as early as 2018, based on Defendant's citation of these patents in its own filings before the USPTO (Compl. ¶¶23, 32, 41). The prayer for relief seeks a finding that the case is "exceptional" under 35 U.S.C. § 285, which can be based on a finding of willful infringement (Compl. ¶47).

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

  1. A central issue will be one of claim construction: Can the term "suturing means" in the '767 patent be construed broadly enough to cover the accused MitraClip device, or is it limited to the specific structures disclosed in the patent? Further, does the MitraClip's composition and actuation mechanism satisfy the "temperature-activated memory material" limitation in the '669 patent's method claim?

  2. A key evidentiary question will be one of indirect infringement: For the '669 patent, can Plaintiff prove that Defendant's "Instructions for Use" and other materials specifically intended for clinicians to perform every step of the asserted method claim, thereby inducing direct infringement by those clinicians?

  3. A significant dispute will concern knowledge and intent: Will the evidence of Defendant's pre-suit knowledge of the patents, based on its own IDS citations during patent prosecution, be sufficient to establish the specific intent required for induced infringement and to support a finding of willfulness that could lead to enhanced damages?