DCT
1:14-cv-12405
Cardiaq Valve Tech Inc v. Neovasc Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: CardiAQ Valve Technologies, Inc. (Delaware)
- Defendant: Neovasc Inc. (Canada); Neovasc Tiara Inc. (Canada)
- Plaintiff’s Counsel: Knobbe, Martens, Olson & Bear, LLP
- Case Identification: 1:14-cv-12405, D. Mass., 01/15/2015
- Venue Allegations: Venue is asserted based on Defendants' systematic and continuous business contacts within Massachusetts, including relationships with Massachusetts-based customers, and actions giving rise to the claims occurring within the district.
- Core Dispute: Plaintiff alleges that its personnel are the true inventors of Defendants' U.S. Patent No. 8,579,964 and that Defendants misappropriated Plaintiff's trade secrets, disclosed under a non-disclosure agreement, to develop their Tiara™ transcatheter mitral valve.
- Technical Context: The technology involves transcatheter mitral valve implantation (TMVI) systems, which are designed to provide a less-invasive alternative to open-heart surgery for patients suffering from mitral regurgitation.
- Key Procedural History: The complaint alleges that Plaintiff disclosed its proprietary TMVI technology to Defendant Neovasc Inc. under a non-disclosure agreement beginning in June 2009 for the purpose of engaging Neovasc as a contract manufacturer. The complaint further alleges that Neovasc used this confidential information to secretly develop its own competing product and file for patents, omitting Plaintiff's personnel as inventors. Subsequent to the filing of this complaint, the USPTO issued a Certificate of Correction for the '964 patent on January 3, 2017, adding CardiAQ's Dr. Arshad Quadri and Mr. Jeremy Brent Ratz as named inventors.
Case Timeline
| Date | Event |
|---|---|
| 2009-06-04 | Non-Disclosure Agreement executed between CardiAQ and Neovasc |
| 2009-07-02 | CardiAQ issues Purchase Order for assembly services to Neovasc |
| 2010-05-05 | Earliest Priority Date of '964 Patent; Neovasc files first related patent application |
| 2012-01-XX | CardiAQ learns of Neovasc's published patent application |
| 2013-03-XX | Neovasc Tiara Inc. is created as a subsidiary |
| 2013-11-12 | U.S. Patent No. 8,579,964 issues |
| 2014-02-03 | Neovasc announces first human implant of the Tiara™ valve |
| 2015-01-15 | Plaintiff files Second Amended Complaint |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,579,964 - "Transcatheter Mitral Valve Prosthesis"
- Patent Identification: U.S. Patent No. 8,579,964, "Transcatheter Mitral Valve Prosthesis," issued November 12, 2013.
The Invention Explained
- Problem Addressed: The patent addresses dysfunction of the heart's mitral valve, which can lead to mitral regurgitation (the backward leakage of blood). While traditional open-heart surgery can repair or replace the valve, such procedures are highly invasive. The patent notes the need for improved, less-invasive transcatheter-based solutions ('964 Patent, col. 1:12-51).
- The Patented Solution: The patent describes a prosthetic mitral valve that can be delivered to the heart via a catheter in a collapsed state and then expanded on-site. The core of the invention is a multi-part anchor designed to secure the prosthesis within the complex and asymmetric anatomy of the native mitral valve. This anchor includes an "atrial skirt" that sits on the atrial side, an "annular region" that engages the valve annulus, and a "ventricular skirt" with specific "trigonal anchoring tabs" that lock onto key anatomical structures (the fibrous trigones) to prevent migration ('964 Patent, Abstract; col. 3:1-4:68).
- Technical Importance: This design provides a method for anchoring a replacement valve by conforming to specific, non-uniform anatomical landmarks, which may offer greater stability and a more secure seal compared to prostheses relying on purely radial force for fixation.
Key Claims at a Glance
- The complaint asserts that CardiAQ personnel invented the subject matter of independent claim 1 and dependent claims 2-28 (Compl. ¶36).
- Independent Claim 1 recites a method of anchoring a prosthetic valve, with the key steps including:
- Providing a prosthetic valve comprising an anchor with an atrial skirt, an annular region, and a ventricular skirt.
- The ventricular skirt includes a "first trigonal anchoring tab" on its anterior portion.
- Expanding the atrial skirt to lie over the superior surface of the native mitral valve.
- Expanding the annular region to engage the native mitral valve annulus.
- Anchoring the "first trigonal anchoring tab" against a "first fibrous trigone" on one side of the native valve's anterior leaflet.
- Expanding the ventricular skirt to displace the native mitral valve leaflets.
III. The Accused Instrumentality
Product Identification
- The Neovasc Tiara™ Transcatheter Mitral Valve and the associated intellectual property, including the '964 Patent itself (Compl. ¶33, 43).
Functionality and Market Context
- The complaint alleges that the Tiara valve is a TMVI system designed and developed using CardiAQ's confidential technology and trade secrets (Compl. ¶34). The functionality of the Tiara valve is alleged to embody the inventions described in the '964 Patent, which CardiAQ claims its personnel conceived (Compl. ¶13, 34). The complaint notes that Neovasc created a dedicated subsidiary, Neovasc Tiara Inc., for the purpose of developing and owning the intellectual property related to this technology, and announced the "Successful First Human Implant" of the device in a February 3, 2014 press release (Compl. ¶33, 34).
IV. Analysis of Inventorship Allegations
The complaint does not allege patent infringement, but rather incorrect inventorship of the '964 Patent. The core allegations map CardiAQ's claimed inventions to the features recited in the '964 Patent's claims.
No probative visual evidence provided in complaint.
'964 Patent Inventorship Allegations
| Claim Element (from Independent Claim 1) | Alleged CardiAQ Invention (Compl. ¶13) | Complaint Citation | Patent Citation |
|---|---|---|---|
| an anchor having an atrial skirt, an annular region, a ventricular skirt | A mitral valve prosthetic comprising a frame with an atrial portion, an annular region, and a ventricular portion that displaces the native mitral valve leaflets radially outward. | ¶13.b | col. 7:40-44 |
| wherein the ventricular skirt comprises a first trigonal anchoring tab disposed on an anterior portion of the ventricular skirt | A ventricular anchor that anchors against a first fibrous trigone on a first side of an anterior leaflet of the native mitral valve. | ¶13.b | col. 8:16-22 |
| expanding the atrial skirt radially outward so as to lie over a superior surface of the patient's native mitral valve | An atrial portion that anchors against a portion of the atrium. The complaint also alleges invention of a feature where expanding the atrial portion comprises sealing it against the superior surface of the native mitral valve. | ¶13.b, 13.e | col. 7:45-49 |
| radially expanding the annular region of the anchor to conform with and to engage the native mitral valve annulus | An annular region that engages the native mitral valve annulus. | ¶13.b | col. 7:50-53 |
| anchoring the first trigonal anchoring tab against a first fibrous trigone on a first side of an anterior leaflet of the native mitral valve | A ventricular anchor that anchors against a first fibrous trigone on a first side of an anterior leaflet of the native mitral valve, which Neovasc recites as "a first trigonal anchoring tab." | ¶13.b | col. 8:16-22 |
Identified Points of Contention:
- Evidentiary Question: The central dispute is factual and will depend on the evidence of conception and communication. A key question for the court will be what tangible evidence (e.g., emails, engineering drawings, lab notebooks, meeting minutes) CardiAQ can produce to demonstrate that its personnel, Dr. Quadri and Mr. Ratz, conceived of the specific structural elements recited in the '964 Patent's claims and communicated those conceptions to Neovasc.
- Inventive Contribution: The analysis will likely focus on the legal standard for inventorship. The court will need to determine whether the alleged contributions by CardiAQ personnel were significant enough to make them inventors of the claimed subject matter, and conversely, what, if any, inventive contributions were made by the named Neovasc inventors.
V. Key Claim Terms for Construction
While claim construction is typically central to infringement, its role in an inventorship dispute is to define the metes and bounds of what was allegedly invented.
The Term: "trigonal anchoring tab"
Context and Importance: This term describes a highly specific feature designed to engage a particular anatomical landmark (the fibrous trigone). Proving who conceived of this specific anchoring strategy and structure is critical to the inventorship claim. Practitioners may focus on this term because it represents a specific, non-obvious solution to the anchoring problem, making its origin a key point of dispute.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the tabs as part of a system for "anchoring against the fibrous trigones on either side of the anterior leaflet of the native mitral valve" (col. 4:55-59), which could suggest the term covers any tab-like structure performing this function.
- Evidence for a Narrower Interpretation: The figures provide specific depictions of the "trigonal tab" (e.g., '964 Patent, Fig. 10, element 824). Its meaning could be narrowed to the particular shape, size, and location shown in the preferred embodiments.
The Term: "asymmetrically expanding the annular region"
Context and Importance: This concept, detailed in dependent claims but referenced in the complaint (Compl. ¶13.g), reflects a design tailored to the D-shaped, non-uniform nature of the mitral valve annulus. Establishing who conceived of this asymmetrical design is fundamental to proving invention of the overall device architecture.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent describes the anchor portion as potentially "asymmetrical along its longitudinal axis" to "facilitate close accommodation of the asymmetrical contours" of the native valve (col. 3:10-15). This supports a broad, functional definition.
- Evidence for a Narrower Interpretation: Dependent claim 12 specifies an anterior portion that is "substantially flat" and a posterior portion that is "cylindrically shaped" ('964 Patent, col. 29:5-9). An argument could be made that the term requires this specific geometric configuration.
VI. Other Key Allegations
- Breach of Contract: The complaint alleges that Neovasc breached the non-disclosure agreement by using CardiAQ's confidential information for a purpose other than the proposed business relationship—namely, to develop its own competing product and file for patents (Compl. ¶43, 48).
- Misappropriation of Trade Secrets: The complaint alleges that Defendants misappropriated CardiAQ's trade secrets by using and disclosing CardiAQ's proprietary TMVI technology for their own benefit without authorization (Compl. ¶66).
- Fraud: The complaint alleges that Neovasc intentionally concealed its plan to compete with CardiAQ, thereby fraudulently inducing CardiAQ to continue sharing highly valuable and confidential technical information (Compl. ¶53-55).
VII. Analyst’s Conclusion: Key Questions for the Case
- An Evidentiary Question of Conception: A primary issue will be one of evidence: What documentation, such as dated drawings, emails, or witness testimony, will be required to establish that CardiAQ personnel conceived of the specific, claimed features like the "trigonal anchoring tab" and the asymmetric anchor design, and that these concepts were communicated to Neovasc prior to Neovasc's own conception?
- The Nexus of Derivation: The case will likely turn on proving a direct link between the information CardiAQ disclosed and the invention claimed by Neovasc. A key question is whether the evidence demonstrates that the named inventors derived the claimed invention from CardiAQ's disclosures, rather than arriving at the solution through their own independent development efforts.
- The Scope of the Remedy: A central question for the remedy phase will be the extent of each party's contribution. To justify the requested relief of assigning the patent entirely to CardiAQ, the evidence would need to show not only that CardiAQ's personnel were inventors, but that the named Neovasc inventors either made no inventive contribution or derived all of their contributions from CardiAQ.