DCT

1:17-cv-10510

Edwards Lifesciences v. Neovasc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-10510, D. Mass., 03/24/2017
  • Venue Allegations: Plaintiff alleges venue is proper based on Defendants’ systematic and continuous contacts with Massachusetts, actions giving rise to the claims, and participation in a related, prior case in the same district.
  • Core Dispute: Plaintiff seeks a court order to correct the inventorship of two patents related to transcatheter mitral valve technology, alleging its founders were omitted as co-inventors and that a prior court judgment regarding a parent patent is determinative on this issue.
  • Technical Context: The technology involves prosthetic heart valves that can be delivered via catheter to replace a malfunctioning native mitral valve, a less invasive alternative to open-heart surgery.
  • Key Procedural History: A prior lawsuit between the parties (14-CV-12405-ADB) resulted in a jury verdict finding trade secret misappropriation by Neovasc and a subsequent court order correcting the inventorship of a related parent patent, U.S. Patent No. 8,579,964, to add Plaintiff’s founders. The current complaint alleges that this prior judgment, under the doctrine of issue preclusion, mandates the correction of inventorship for the patents-in-suit due to their claimed subject matter overlapping with the parent patent. The complaint also notes that one of the patents-in-suit, the ’790 Patent, is subject to a terminal disclaimer over the parent patent, which was filed to overcome a double patenting rejection during prosecution.

Case Timeline

Date Event
2009-06-04 Business relationship between CardiAQ and Neovasc Inc. allegedly began.
2009-10-20 Neovasc engineer allegedly drew first sketch of what would become the "Tiara" TMVI device.
2010-04-XX Business relationship between CardiAQ and Neovasc Inc. allegedly ended.
2010-05-05 Earliest patent priority date (Provisional Application filing).
2013-11-12 U.S. Patent No. 8,579,964 (related parent patent) issued.
2014-06-XX CardiAQ filed first action against Neovasc (14-CV-12405-ADB).
2016-01-26 U.S. Patent No. 9,241,790 issued.
2016-02-02 U.S. Patent No. 9,248,014 issued.
2016-05-19 Jury verdict in prior action found Neovasc liable for trade secret misappropriation and determined CardiAQ's founders contributed to the conception of the '964 Patent.
2016-10-31 Court in prior action ordered inventorship of the '964 Patent be corrected.
2016-11-21 Final judgment entered in prior action.
2017-03-24 Complaint filed in present action.

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

U.S. Patent No. 9,241,790 - “Transcatheter Mitral Valve Prosthesis”

The Invention Explained

  • Problem Addressed: The patent background describes the high-risk nature of conventional open-heart surgery for replacing or repairing a dysfunctional mitral valve, which can lead to mitral regurgitation (blood leaking backward into the left atrium) (Compl. ¶15; ’790 Patent, col. 1:41-51). Less invasive, transcatheter techniques existed but could be difficult to deliver, expensive, or not suitable for all patients (’790 Patent, col. 2:60-67).
  • The Patented Solution: The invention is a prosthetic mitral valve that can be delivered via catheter in a collapsed state and then expanded at the site of the native valve (’790 Patent, Abstract). The prosthesis anchor is specifically designed with multiple sections—an "atrial skirt," an "annular region," and a "ventricular skirt"—to secure the device against the complex anatomy of the mitral valve from both the atrial and ventricular sides, thereby preventing migration (’790 Patent, col. 3:1-11). The complaint alleges this multi-zone anchoring concept, including features to engage specific anatomical structures like the fibrous trigones, was conceived by CardiAQ’s founders (Compl. ¶23, ¶34). The complaint provides a visual comparison chart to show that the elements of the asserted claims in the ’790 Patent correspond directly to elements previously adjudicated in the related '964 Patent (Compl. ¶33).
  • Technical Importance: This design aimed to provide a stable, self-anchoring replacement valve that conforms to the unique D-shaped anatomy of the mitral annulus, a significant challenge for percutaneous valve replacement technology (Compl. ¶15; ’790 Patent, col. 4:36-39).

Key Claims at a Glance

  • Independent Claims Asserted: Claim 1 (a method claim) and Claim 9 (dependent on Claim 1) are explicitly referenced in the complaint's claim comparison chart (Compl. ¶33). The complaint alleges inventorship of subject matter covered by Claims 1-7, 9, 12, 15, 18, 20, 21, and 23-27 (Compl. ¶41).
  • Essential Elements of Independent Claim 1:
    • Delivering a prosthetic cardiac mitral valve in a collapsed configuration.
    • The valve comprises an anchor having a "first anterior trigonal anchoring tab".
    • Radially expanding the anchor to engage the native mitral valve.
    • Anchoring the valve by expanding the "first anterior trigonal anchoring tab" radially outward and "engaging" it against a "first fibrous trigone" of the native mitral valve.
    • Disposing adjacent chordae tendineae between the tab and an anterior surface of the anchor.
  • The complaint alleges inventorship of numerous dependent claims as well (Compl. ¶41).

U.S. Patent No. 9,248,014 - “Transcatheter Mitral Valve Prosthesis”

The Invention Explained

  • Problem Addressed: The technical problem is identical to that described for the ’790 Patent: the need for a less invasive, reliably anchored prosthetic mitral valve (’014 Patent, col. 1:41-51).
  • The Patented Solution: This patent claims the prosthetic mitral valve apparatus itself, rather than the method of anchoring it. The claimed structure corresponds to the device used in the method of the ’790 Patent, featuring an anchor with a ventricular skirt that includes a "first trigonal anchoring tab" configured to engage a "first fibrous trigone" on the native valve (’014 Patent, col. 9:55-67). The design intends to capture the native anterior leaflet and chordae tendineae between the tab and the anchor body, providing a secure anchor point (’014 Patent, col. 10:1-8). The complaint asserts that the claims of the ’014 Patent are "substantially similar" to those of the '964 Patent and presents a side-by-side chart to illustrate this overlap (Compl. ¶37).
  • Technical Importance: As with the ’790 Patent, the technical contribution lies in a valve anchor structured to engage specific anatomical landmarks for stable, transcatheter implantation, addressing a key challenge in the field (’014 Patent, col. 4:36-39).

Key Claims at a Glance

  • Independent Claims Asserted: Claim 1 (an apparatus claim) and Claim 9 (dependent on Claim 1) are referenced in the complaint's claim comparison chart (Compl. ¶37). The complaint alleges inventorship of subject matter covered by Claims 1-9, 11, 12, 15, 16, 19-24, and 26 (Compl. ¶48).
  • Essential Elements of Independent Claim 1:
    • A prosthetic mitral valve for anchoring in a patient's heart.
    • An anchor having a collapsed configuration and an expanded configuration.
    • The anchor comprises a ventricular skirt with a "first trigonal anchoring tab" on its anterior portion.
    • The tab is configured to engage a "first fibrous trigone" such that the native anterior leaflet is disposed between the tab and an anterior surface of the anchor.
    • The tab is configured such that adjacent chordae tendineae are disposed between the tab and the anterior surface of the anchor.
  • The complaint alleges inventorship of numerous dependent claims as well (Compl. ¶48).

III. The Accused Instrumentality

This is a correction of inventorship action, not an infringement action; therefore, there is no accused instrumentality.

IV. Analysis of Infringement Allegations

This is a correction of inventorship action, not an infringement action; therefore, there are no infringement allegations to analyze.

V. Key Claim Terms for Construction

While claim construction is central to infringement, in this inventorship dispute, the consistency of key technical terms across patents is central to the Plaintiff's argument of subject matter overlap.

  • The Term: "trigonal anchoring tab"
  • Context and Importance: This term appears in the independent claims of both the '790 and '014 patents, as well as the parent '964 patent (Compl. ¶33, ¶37). It describes a specific structural element of the prosthetic valve's anchor designed to engage the heart's fibrous trigones—key anatomical landmarks. The consistent presence and function of this element across all three patents may support the Plaintiff's argument that the inventions are substantially the same and that the inventive contribution from its founders, previously established for the '964 patent, extends to the patents-in-suit.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claims themselves define the tab by its function ("configured to engage a first fibrous trigone") and location ("disposed on an anterior portion of the ventricular skirt") rather than by a specific shape or material (’014 Patent, col. 9:60-67). This functional language could be argued to cover any structure that performs the specified anchoring role at that location.
    • Evidence for a Narrower Interpretation: The specification describes the tabs in more detail, for example, as "a pair of ventricular trigonal tabs 824 on the anterior portion of the anchor" (’790 Patent, col. 16:20-22) and shows them in specific embodiments like Figure 10. A party could argue that the term should be limited to the D-shaped, multi-strut structures depicted, which are "inclined upward in the upstream direction" (’790 Patent, col. 16:26-29).

VI. Correction of Inventorship Allegations

  • Plaintiff CardiAQ brings claims for correction of inventorship under 35 U.S.C. § 256 for both the ’790 and ’014 Patents (Compl. ¶¶40-46, 47-53). The core of the allegation is that CardiAQ’s founders, Dr. Quadri and Mr. Ratz, "invented the subject matter of one or more of the claims" of each patent in collaboration with Neovasc's employees (Compl. ¶41, ¶48).
  • The complaint alleges that the contributions of Dr. Quadri and Mr. Ratz were corroborated by testimony, communications, and physical prototypes in a prior litigation (Compl. ¶44, ¶51).
  • Crucially, the complaint asserts that the court in the prior litigation "already resolved the question of Dr. Quadri and Mr. Ratz's contribution" to the invention claimed in the related '964 Patent (Compl. ¶45, ¶52). Because the '790 and '014 Patents allegedly claim "overlapping subject matter" with the '964 Patent, Plaintiff argues that the legal doctrine of "issue preclusion prohibits re-litigation of the inventorship of the claimed subject matter" (Compl. ¶45, ¶52).

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

The resolution of this case appears to hinge on legal questions stemming from the prior litigation, rather than a de novo technical analysis of inventorship.

  • A central question will be one of issue preclusion: Does the prior judgment, which added Plaintiff's founders as inventors to the '964 parent patent, legally compel the same outcome for the related '790 and '014 patents? This will likely require the court to determine if the specific inventive concepts and claimed subject matter in the patents-in-suit are substantially identical to those already adjudicated for the '964 patent.
  • A related question is one of claim scope comparison: How similar are the claims of the '790 and '014 patents to the claims of the '964 patent? The analysis will likely focus on whether the core technical features, such as the "trigonal anchoring tab", represent the same inventive contribution across all three patents, thereby satisfying the requirements for preclusion.
  • Should the court find that issue preclusion does not apply, a key factual question would re-emerge: What was the precise nature and significance of the technical contributions made by Plaintiff's founders, and do those contributions constitute co-inventorship of the specific claims asserted in the '790 and '014 patents?