Colibri Heart Valve LLC v. Medtronic CoreValve LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Colibri Heart Valve LLC (Delaware)
  • Defendant: Medtronic CoreValve LLC (Delaware)
  • Plaintiff’s Counsel: Skiermont Derby LLP; Bartlit Beck LLP
• Case Identification: 8:20-cv-00847, C.D. Cal., 06/12/2020
• Venue Allegations: Venue is alleged to be proper as Defendant resides in the Central District of California, where it conducts business including the manufacture and sale of the accused products.
• Core Dispute: Plaintiff alleges that Defendant’s transcatheter aortic valve replacement (TAVR) systems infringe two patents related to the structure of prosthetic heart valves and methods for their percutaneous delivery.
• Technical Context: The lawsuit concerns TAVR technology, a minimally invasive procedure to replace a diseased heart valve, which serves as a critical alternative to open-heart surgery, particularly for high-risk patients.
• Key Procedural History: The complaint alleges that the parties met in May and July of 2014 to discuss Colibri's technology and patent portfolio. It further alleges that Colibri provided Medtronic with a presentation in July 2018 identifying both patents-in-suit. Notably, public records indicate that subsequent to the filing of this complaint, all asserted claims of the '739 patent (Claims 1-5) were cancelled as a result of an Inter Partes Review (IPR) proceeding, with a certificate issued on July 1, 2022. This post-filing development may significantly impact the viability of the infringement claims related to the '739 patent.

Case Timeline

Date	Event
2002-01-04	Earliest Priority Date for '739 and '294 Patents
2014-05-06	Colibri presents its technology to Medtronic personnel
2014-07-02	Colibri and Medtronic hold conference call discussing patent portfolio
2014-12-02	U.S. Patent 8,900,294 issues
2015-06-22	Alleged commercial marketing launch of Medtronic CoreValve Evolut R System
2015-09-08	U.S. Patent 9,125,739 issues
2017-03-20	Alleged commercial marketing launch of Medtronic CoreValve Evolut PRO System
2018-07-21	Colibri sends PowerPoint to Medtronic identifying both patents-in-suit
2019-09-19	Alleged commercial marketing launch of Medtronic CoreValve Evolut PRO+ System
2020-06-12	Complaint Filed
2022-07-01	IPR Certificate issues cancelling claims 1-5 of U.S. Patent 9,125,739

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

U.S. Patent No. 9,125,739 - Percutaneous Replacement Heart Valve and a Delivery and Implantation System, Issued September 8, 2015

The Invention Explained

• Problem Addressed: The patent background describes the drawbacks of existing heart valve replacement options. These include the need for invasive open-heart surgery, the propensity of mechanical valves to cause blood clots, and the limited durability and complex construction of prior-art tissue valves, which often require extensive suturing that can compromise function ('294 Patent, col. 1:24-col. 4:4).
• The Patented Solution: The invention is an assembly for treating a native heart valve, comprising a prosthetic valve and a delivery system. The prosthetic valve consists of a collapsible and expandable stent containing a valve made from "fixed pericardial tissue." The patent highlights two structural features: the stent flares at both ends in a "trumpet-like configuration," and the valve resides entirely within the stent's inner channel without any "reinforcing members" ('739 Patent, Abstract; col. 6:23-35).
• Technical Importance: The design aims to create a durable, less thrombogenic tissue valve that more closely mimics the anatomy of a native valve and can be delivered via a less invasive percutaneous procedure ('294 Patent, col. 3:42-53).

Key Claims at a Glance

• Independent Claim 1 is asserted (Compl. ¶49).
• Essential elements of Claim 1 include:
  • An assembly to treat a native heart valve, for use with a guidewire.
  • A prosthetic heart valve including a stent member that is collapsible, expandable, and configured for trans-luminal percutaneous delivery.
  • The stent member includes a tubular structure that flares at both ends in a "trumpet-like configuration."
  • A valve means, made of fixed pericardial tissue with two to four leaflets, resides entirely within the stent's inner channel.
  • No reinforcing members reside within the inner channel of the stent member.
  • A delivery system with a pusher member and a moveable sheath for deploying the valve.
• The complaint also asserts dependent claims 2, 3, and 5 (Compl. ¶49).

U.S. Patent No. 8,900,294 - Method of Controlled Release of a Percutaneous Replacement Heart Valve, Issued December 2, 2014

The Invention Explained

• Problem Addressed: Beyond the structural limitations of prior art valves, their delivery and deployment presented challenges. Once partially or fully deployed, repositioning or retrieving a valve was difficult or impossible, increasing the risk of misplacement and associated complications ('294 Patent, col. 12:1-12).
• The Patented Solution: The patent claims a method for the "controlled release" of a percutaneous heart valve. The key steps involve advancing the device, partially deploying it, and then "restraining" it to allow for position verification. Crucially, the method includes the ability to "recover" the partially deployed valve back into the delivery sheath to address any positioning problems before final release ('294 Patent, col. 8:1-15). This feature of recapturability is central to the invention.
• Technical Importance: This method provides surgeons with greater control during the implantation procedure, allowing for adjustments and retrieval, which can improve patient safety and the likelihood of a successful outcome ('294 Patent, col. 8:7-10).

Key Claims at a Glance

• Independent Claim 1 is asserted (Compl. ¶60).
• Essential elements of Claim 1 include the steps of:
  • Obtaining a replacement heart valve device and a delivery system.
  • Loading the valve device into the delivery system's sheath.
  • Advancing the system over a guidewire to the native heart valve location.
  • Partially deploying a distal portion of the valve device from the sheath.
  • Restraining the partially deployed device for "controlled release" with the potential for recovery.
  • Recovering the exposed distal portion of the device back into the sheath to address a positioning problem.
• The complaint also asserts dependent claims 2, 3, and 4 (Compl. ¶60).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Medtronic's CoreValve, CoreValve Evolut R, CoreValve Evolut PRO, and CoreValve Evolut PRO+ systems (the "CoreValve Products") (Compl. ¶¶5, 27).

Functionality and Market Context

The CoreValve Products are TAVR systems used to replace diseased aortic valves (Compl. ¶¶24, 26). Each system comprises a transcatheter aortic valve (a bioprosthesis) and a delivery catheter system (Compl. ¶24). The complaint alleges the valve component includes three leaflets made from porcine pericardium sutured onto a collapsible, multi-level stent (Compl. ¶27). The complaint provides an image of the Medtronic CoreValve transcatheter aortic valve, showing its mesh-like stent structure (Compl. p. 10). The delivery system is alleged to include a pusher member and a moveable sheath to deploy the valve (Compl. ¶28), and the complaint includes a diagram of the delivery catheter system showing these components (Compl. p. 11, Figure 4). The complaint further alleges that the Evolut R, PRO, and PRO+ systems include a delivery catheter that "recaptures the transcatheter aortic valve" (Compl. ¶¶34, 39). The complaint highlights that these products are part of Medtronic's Cardiac and Vascular Group, which accounts for $11.4 billion in revenue (Compl. ¶23).

IV. Analysis of Infringement Allegations

The complaint references Exhibits A and B containing detailed infringement allegations for the '739 and '294 patents, respectively, but these exhibits were not provided (Compl. ¶¶49, 60). The infringement analysis is therefore based on the narrative allegations in the body of the complaint.

'739 Patent Infringement Allegations

The complaint alleges that each of the CoreValve Products directly infringes at least claim 1 of the '739 patent (Compl. ¶¶49-50). The narrative theory asserts that the CoreValve Products meet the "assembly" limitation by comprising a prosthetic valve and a delivery catheter system (Compl. ¶26). The complaint alleges the product's stent has "flared ends in a trumpet-like configuration" (Compl. ¶27). An image of the accused valve is provided to support this characterization (Compl. p. 10, "The Medtronic CoreValve transcatheter aortic valve"). The complaint further alleges the valve leaflets are made from "porcine pericardium" (meeting the "fixed pericardial tissue" limitation) and are sutured onto the stent (Compl. ¶27), and that the associated delivery system uses a "pusher member and a moveable sheath" (Compl. ¶28).

'294 Patent Infringement Allegations

The complaint alleges infringement of method claims 1-4 of the '294 patent, primarily through indirect infringement theories (Compl. ¶¶60-62). The core allegation is that Medtronic's instructions, manuals, and videos for the CoreValve Products (specifically the Evolut R, PRO, and PRO+ systems) direct surgeons to perform the patented method (Compl. ¶¶30, 34, 39). The complaint alleges that these instructions teach users to load the valve, advance it, partially deploy it, and—critically—"recapture" the valve after partial deployment (Compl. ¶¶34, 39). This "recapture" functionality is alleged to meet the "recovering the distal portion" limitation of the claim (Compl. ¶60).

V. Key Claim Terms for Construction

Term ('739 Patent): "trumpet-like configuration"

Context and Importance

This descriptive term defines the shape of the stent, a central feature of the asserted independent claim. The infringement dispute for the '739 patent may hinge on whether the accused Medtronic stents, which flare at the ends, can be characterized as "trumpet-like." Practitioners may focus on this term because its inherent subjectivity makes it a likely candidate for a claim construction dispute and a potential indefiniteness challenge.

Intrinsic Evidence for Interpretation

• Evidence for a Broader Interpretation: The specification describes the structure in functional terms, stating it "flares markedly at both ends" ('739 Patent, col. 8:60-62). A party could argue that any stent that flares significantly at both ends meets this description, regardless of the precise curvature.
• Evidence for a Narrower Interpretation: The figures in the patent (e.g., '739 Patent, FIG. 5) depict a specific flared geometry. A party could argue that the term "trumpet-like" must be limited to the shape actually shown in the patent's own drawings, thereby narrowing the claim's scope.

Term ('294 Patent): "recovering the distal portion of the replacement heart valve device within the moveable sheath"

Context and Importance

This is the final and arguably most critical step of the asserted method claim. It defines the "recapturability" feature. Infringement requires that the accused method, as taught by Medtronic, includes this specific recovery action. The dispute may turn on whether Medtronic's "recapture" function is legally and technically the same as the patent's "recovering" step.

Intrinsic Evidence for Interpretation

• Evidence for a Broader Interpretation: The claim language itself is relatively straightforward, describing the physical action of pulling the exposed part of the valve back into the sheath ('294 Patent, col. 9:11-13). A party could argue that any system that allows the operator to reverse deployment and resheath the valve meets this limitation.
• Evidence for a Narrower Interpretation: The claim explicitly states the purpose of the recovery step is "to address a problem with the position of the replacement heart valve device" ('294 Patent, col. 9:13-15). A party could argue that this purpose limits the scope, and that a "recapture" performed for mere repositioning, rather than to fix a "problem," would not infringe.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement for both patents. For the '294 method patent, inducement is the central theory, based on allegations that Medtronic's instructional manuals and videos direct surgeons to perform the claimed steps (Compl. ¶¶62-63). For the '739 apparatus patent, inducement is based on Medtronic providing the systems and instructing on their use (Compl. ¶51). Contributory infringement is alleged on the basis that the CoreValve Products are a material part of the inventions, are especially adapted for infringing use, and are not staple articles of commerce (Compl. ¶¶55, 65).

Willful Infringement

The complaint alleges willful infringement of both patents. The basis for this allegation is Medtronic’s alleged pre-suit knowledge, stemming from meetings in 2014 where Colibri's patent portfolio was discussed and a July 2018 presentation that explicitly identified the '739 and '294 patents (Compl. ¶¶16, 48, 56, 59, 66).

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

1. The Impact of IPR: A threshold question for the '739 patent is the legal effect of the post-filing IPR decision that cancelled all asserted claims. This raises fundamental issues regarding whether Colibri can maintain its action for past damages on claims now deemed unpatentable, potentially rendering that portion of the case moot.
2. Definitional Scope: For both patents, the case will likely turn on claim construction. A core issue will be one of definitional scope: can the subjective term "trumpet-like configuration" ('739 patent) be construed to read on the shape of the Medtronic stents, and can it survive a potential challenge for indefiniteness?
3. Functional Equivalence: A central evidentiary question will be one of functional equivalence for the '294 patent: does the "recapture" function taught in Medtronic's user manuals perform the same steps, for the same purpose, as the "recovering" step recited in claim 1, which is explicitly for addressing "a problem with positioning"?