DCT

1:26-cv-00037

Cardiovalve Ltd v. Edwards Lifesciences Corp

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-00037, D. Del., 01/14/2026
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because both Defendant entities are incorporated in the state of Delaware.
  • Core Dispute: Plaintiffs allege that Defendant’s PASCAL Precision Transcatheter Valve Repair System infringes a patent related to a method for repairing a native heart valve using a clip-based implant.
  • Technical Context: The technology relates to minimally invasive transcatheter systems for repairing heart valve regurgitation, a significant condition in cardiovascular medicine where blood leaks backward through a valve.
  • Key Procedural History: The complaint details a significant pre-suit history between the parties. Defendant preemptively challenged the patent-in-suit via an inter partes review (IPR) proceeding before the U.S. Patent and Trademark Office. The Patent Trial and Appeal Board (PTAB) upheld the validity of the challenged claims, a decision that was subsequently affirmed by the U.S. Court of Appeals for the Federal Circuit. These proceedings may have estoppel implications for Defendant's invalidity defenses in the present litigation.

Case Timeline

Date Event
2011-08-05 U.S. Patent No. 10,702,385 Priority Date
2020-07-07 U.S. Patent No. 10,702,385 Issue Date
2021-06-04 Defendant files IPR petition against the ’385 Patent
2022-09-15 Defendant receives FDA approval for PASCAL System
2022-12-06 PTAB issues Final Written Decision upholding ’385 Patent claims
2025-06-09 Federal Circuit affirms PTAB decision
2025-11-20 USPTO issues Inter Partes Review Certificate for ’385 Patent
2026-01-14 Complaint Filing Date

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

U.S. Patent No. 10,702,385 - *"Implant for Heart Valve"*

Issued on July 7, 2020 (the “’385 Patent”)

The Invention Explained

  • Problem Addressed: The patent’s background section describes regurgitation of a heart valve caused by ischemic heart disease, where dilatation of the valve annulus prevents the valve leaflets from fully closing, leading to reduced cardiac output and weakening of the ventricle (Compl. ¶28; ’385 Patent, col. 1:40-52).
  • The Patented Solution: The invention is a method and apparatus for minimally invasive heart valve repair. A prosthetic support with at least two clips is delivered via a catheter to the native valve. The clips are used to grasp the native leaflets and couple them together, forming a “double-orifice” arrangement that restores the valve’s function as a check valve without requiring a full valve replacement (’385 Patent, col. 2:25-31). The clips can be opened and closed independently of each other to facilitate this procedure (’385 Patent, Abstract).
  • Technical Importance: This approach provides a transcatheter-based, minimally invasive method for repairing a heart valve, potentially avoiding the need for open-heart surgery (’385 Patent, col. 1:53-58).

Key Claims at a Glance

  • The complaint asserts independent method claim 11 (Compl. ¶52).
  • Claim 11 requires a multi-step method, the essential elements of which include:
    • Transluminally advancing an implant with a first clip and a second clip to the heart.
    • The clips being fixedly coupled to each other.
    • Advancing the implant out of a delivery tube.
    • Forming a double-orifice arrangement by using a clip controller to independently open the first and second clips, grip the respective first and second leaflets, and independently close the clips.
    • Decoupling the clip controller and withdrawing the delivery apparatus.
  • The complaint does not explicitly assert any dependent claims but reserves the right to do so (Compl. p. 12, n. 2).

III. The Accused Instrumentality

Product Identification

  • The Edwards PASCAL Precision Transcatheter Valve Repair System, which includes the PASCAL and PASCAL Ace implants (collectively, "PASCAL") (Compl. ¶1).

Functionality and Market Context

  • The PASCAL system is described as a transcatheter device for heart valve repair (Compl. ¶1). The complaint alleges it is delivered via a catheter to a patient's native heart valve to repair regurgitation (Compl. ¶¶60-61, 67-68). The system allegedly uses an implant with clips to grasp the native valve leaflets, coupling them to create a "double-orifice configuration" (Compl. ¶¶94-96, 101-104). The complaint references an instructional video for healthcare professionals on Defendant's website, which illustrates the system's "navigation and implant deployment" (Compl. ¶60). Figure 3 in the complaint depicts the PASCAL implant positioned around heart leaflets, with one clip closed and the other open (Compl. ¶96). The complaint alleges the PASCAL system received FDA approval in September 2022 and has been marketed and sold in the U.S. since shortly thereafter (Compl. ¶6, 31).

IV. Analysis of Infringement Allegations

’385 Patent Infringement Allegations

Claim Element (from Independent Claim 11) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for use at a native valve of a heart of a subject, the valve including a first leaflet and a second leaflet, the method comprising: The PASCAL system is intended for use by healthcare professionals at a patient's native heart valve, which has leaflets. ¶¶59-64 col. 27:14-17
[1] transluminally advancing, to the heart, an implant coupled to a delivery apparatus, The PASCAL implant is delivered to the heart via a femoral vein access using a delivery apparatus. Figure 1 of the complaint shows the implant being advanced within a blue delivery tube. ¶¶66-68 col. 27:18-20
[2] the implant including [2a] a first clip, [2b] a second clip...[2e] the first clip and the second clip fixedly coupled to each other, The PASCAL implant is alleged to have first and second clips, formed by sets of clip arms, that are fixedly coupled at the base of the implant. ¶¶70-73 col. 27:21-28
[2c] a support portion flexibly coupled to the first and second clips, The implant allegedly includes a larger support portion from which the clips extend, with the clips being able to move with respect to the support portion. ¶¶74-75 col. 27:29-30
[6] forming the first leaflet and the second leaflet into a double-orifice arrangement by using the implant to couple a middle scallop of the first leaflet to a middle scallop of the second leaflet by, using the clip controller: The PASCAL implant is allegedly used to couple the native leaflets to form a double-orifice arrangement, as shown in the complaint's Figure 5. ¶¶93-95, 101-106 col. 27:54-59
[6a] opening the first clip by deflecting the first-clip arm; [6b] independently of opening the first clip, opening the second clip by deflecting the second-clip arm; The PASCAL implant is allegedly positioned by independently opening and closing each clip. The complaint's Figure 3 is cited to show one clip closed while the other is open. Defendant's Instructions for Use are cited for the ability to grasp leaflets "simultaneously ... or each leaflet individually." ¶¶94, 96-99 col. 27:60-64
[6c] gripping the first leaflet with the first clip... [6d] independently of gripping the first leaflet, gripping the second leaflet with the second clip... Each clip is allegedly used to grip a leaflet independently. ¶¶97-99 col. 27:65-col. 28:5
[7] decoupling the clip controller from the implant; and [8] withdrawing the delivery apparatus from the subject. Once the implant is in place, the clip controller is decoupled and the entire delivery apparatus is withdrawn from the patient, as shown in the complaint's Figure 4. ¶¶107-114 col. 28:6-8

Identified Points of Contention

  • Scope Questions: A potential point of contention may arise from the mapping of claim terms to the accused device's components. The complaint states that it uses terminology from the PASCAL Instructions for Use and the ’385 Patent "interchangeably" but reserves the right to alter its identifications (Compl. p. 12, n. 2). This raises the question of whether Defendant will dispute that its "clasps" and "paddles" (Compl. ¶99) meet the definitions of the claimed "first clip" and "second clip."
  • Technical Questions: The claim requires performing certain steps "independently," such as opening the second clip "independently of opening the first clip." The complaint alleges this is satisfied by the ability to actuate the clips individually (Compl. ¶99). The dispute may turn on the factual and technical degree of independence in the PASCAL system's operation and whether it meets the standard required by the claim as construed by the court.

V. Key Claim Terms for Construction

  • The Term: "independently of opening the first clip, opening the second clip" and "independently of gripping the first leaflet, gripping the second leaflet"

    • Context and Importance: These limitations are central to the claimed method of operation. The infringement analysis for the PASCAL system, which the complaint alleges features "independent grasping" (Compl. ¶136), will hinge on the construction of "independently." Practitioners may focus on this term because it defines a key functional capability of the claimed invention.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The plain language of Claim 11 does not specify a particular mechanical or electrical mechanism for achieving independence, which may support a construction covering any method where the clips are not required to be operated simultaneously or in a fixed sequence.
      • Evidence for a Narrower Interpretation: The patent’s abstract states that "The first and second clips are opened and closed independently of each other" (’385 Patent, Abstract). The specification may describe specific embodiments or control mechanisms that could be used to argue for a more limited construction tied to the disclosed structures that enable independent action.

  • The Term: "support portion"

    • Context and Importance: The relationship between the "clips" and the "support portion" is a key structural aspect of the claimed implant. The complaint identifies a "larger element that extends proximally from the base of the clips" as the support portion in the PASCAL device (Compl. ¶74). The definition of this term will be critical to determining if the accused device contains this claimed structure.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim describes the support portion functionally as being "flexibly coupled" to the clips and having an "opening" (Compl. ¶52). This functional language may support a broader definition that is not limited to a specific shape or material.
      • Evidence for a Narrower Interpretation: Figures in the patent, such as Figure 1A, depict the support portion (60) as a specific annular, lattice-like structure. Defendant may argue that the term should be limited to the structures disclosed in the patent's embodiments.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement based on Defendant's affirmative acts of encouraging direct infringement by third-party healthcare providers (Compl. ¶¶116-117). The alleged acts include providing product documentation, Instructions for Use, marketing videos, and demonstrations that instruct users on how to operate the PASCAL system in a manner that allegedly practices the claimed method (Compl. ¶¶118-121). Contributory infringement is also alleged, based on the PASCAL system having no substantial non-infringing uses (Compl. ¶¶130, 141).
  • Willful Infringement: Willfulness is alleged based on Defendant’s knowledge of the ’385 Patent since at least June 4, 2021, the date it filed its IPR petition (Compl. ¶122). The complaint further alleges that Defendant knew or should have known it had "no viable defense to infringement" after the PTAB and the Federal Circuit affirmed the patentability of the claims, yet it continued to market and sell the PASCAL system (Compl. ¶¶125, 129).

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

  • A core issue will be one of claim construction: whether the components of the accused PASCAL system, as described in its own technical and marketing documents (e.g., "clasps," "paddles," "spacer"), map onto the specific structural and functional limitations of Claim 11, such as "first clip," "second clip," and "support portion."
  • A central question will be the interpretation and application of the term "independently" as it relates to the operation of the PASCAL system's clips. The case may depend on evidence showing the precise manner and degree to which the clips can be manipulated separately during a medical procedure.
  • Given the detailed pre-suit litigation history, a key evidentiary question will concern willfulness. The analysis will likely focus on Defendant’s state of mind and litigation conduct, particularly its decision to continue selling the accused product after its unsuccessful IPR challenge was affirmed on appeal by the Federal Circuit.