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) and Medtronic plc (Ireland)
  • Plaintiff’s Counsel: Goodwin Procter LLP
• Case Identification: 8:19-cv-02351, C.D. Cal., 12/05/2019
• Venue Allegations: Venue is alleged to be proper in the Central District of California because Defendant Medtronic resides in the district and because substantial events, including the manufacture and sale of the accused products, occurred there.
• Core Dispute: Plaintiff alleges that Defendant’s transcatheter aortic valve replacement (TAVR) systems infringe patents related to prosthetic heart valve assemblies, delivery systems, and methods of controlled deployment.
• Technical Context: The technology at issue is in the field of minimally invasive cardiovascular medicine, specifically concerning the structure and implantation of artificial heart valves designed to replace diseased native valves without open-heart surgery.
• Key Procedural History: The complaint alleges that Plaintiff and Defendant met in May and July 2014 under a non-disclosure agreement, during which Plaintiff presented its heart valve technology and discussed its patent portfolio, including applications that would later issue as the patents-in-suit. Subsequent to the filing of this complaint, an Inter Partes Review (IPR) certificate was issued for the ’739 patent, indicating that all claims of the patent, including the asserted Claim 1, have been cancelled.

Case Timeline

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

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

The Invention Explained

• Problem Addressed: The patent seeks to address shortcomings of prior artificial tissue valves, which required extensive suturing that could compromise anatomical accuracy and durability, and which often lacked long-term structural integrity (’739 Patent, col. 3:41-54).
• The Patented Solution: The invention is an assembly for percutaneous heart valve replacement, comprising a prosthetic heart valve and a delivery system. The valve itself consists of a collapsible stent with ends that flare in a "trumpet-like configuration" and a valve means made from pericardial tissue that resides entirely within the stent’s channel without any additional "reinforcing members" (’739 Patent, col. 7:3-7). The delivery system is designed for controlled, minimally invasive implantation (’739 Patent, Abstract; col. 7:8-20).
• Technical Importance: The technology aims to enable a less invasive, more durable, and more anatomically faithful approach to replacing diseased heart valves compared to prior art methods that relied on more complex constructions or open-heart surgery (’739 Patent, col. 3:11-19).

Key Claims at a Glance

• The complaint asserts independent Claim 1 (Compl. ¶20, ¶50).
• Essential elements of Claim 1 include:
  • A prosthetic heart valve that includes a stent member and a valve means.
  • The stent member is collapsible, expandable, and includes a "tubular structure away from a central portion that flares at both ends in a trumpet-like configuration."
  • The valve means includes two to four leaflets of "fixed pericardial tissue," "resides entirely within the inner channel of the stent member," and has "no reinforcing members" within that inner channel.
  • A delivery system with a "pusher member and a moveable sheath" to hold the valve in a collapsed state for delivery.
• The complaint reserves the right to assert additional claims (Compl. ¶50).

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: The patent addresses the clinical challenge of accurately positioning a percutaneously delivered heart valve, where misplacement can lead to severe complications, and the lack of a reliable method to reposition the device once deployment has begun (’294 Patent, col. 2:29-51).
• The Patented Solution: The patent claims a method for implanting a heart valve that gives a surgeon the ability to recapture and reposition the device. The key steps involve advancing the delivery system, partially deploying the valve, restraining it to assess its position, and, if necessary, recovering the exposed portion of the valve back into the delivery sheath to correct a positioning problem before final release (’294 Patent, Abstract; col. 9:1-15).
• Technical Importance: This method of controlled release and potential recovery ("recapturability") provides a significant safety and precision advantage, allowing surgeons to correct for suboptimal placement during the procedure, thereby reducing procedural risk (’294 Patent, col. 9:6-10).

Key Claims at a Glance

• The complaint asserts independent Claim 1 (Compl. ¶23, ¶60).
• Essential elements of Claim 1 include:
  • "obtaining" a specified replacement heart valve and delivery system.
  • "loading" the valve device into the delivery system's sheath.
  • "advancing" the system transluminally to the native heart valve location.
  • "partially deploying" a distal portion of the valve device.
  • "restraining" the partially deployed device to allow for controlled release and potential recovery.
  • "recovering" the exposed distal portion of the valve back into the sheath to address a positioning problem.
• The complaint reserves the right to assert additional claims (Compl. ¶60).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Medtronic’s transcatheter aortic valve replacement systems, specifically the CoreValve, CoreValve Evolut R, CoreValve Evolut PRO, and CoreValve Evolut PRO+ Systems (collectively, "CoreValve Products") (Compl. ¶5, ¶8).

Functionality and Market Context

The CoreValve Products are TAVR systems, each comprising a transcatheter aortic valve (a bioprosthesis) and a delivery catheter system (Compl. ¶25). The valve component is described as having three leaflets made from porcine pericardium sutured onto a collapsible, multi-level stent with "flared ends in a trumpet-like configuration" (Compl. ¶28, ¶34, ¶39, ¶44). An image of the Medtronic CoreValve transcatheter aortic valve shows its mesh-like stent structure (Compl. p. 10). The delivery catheter systems for the Evolut R, PRO, and PRO+ models are alleged to utilize a handle that "deploys, and recaptures the transcatheter aortic valve" (Compl. ¶35, ¶40). The complaint presents the products as successive generations in Medtronic's TAVR product line and notes Medtronic's position as a major medical device company (Compl. ¶24, ¶26, ¶32, ¶37, ¶42).

IV. Analysis of Infringement Allegations

’739 Patent Infringement Allegations

Identified Points of Contention

• Procedural Question: The primary issue for the ’739 patent is the post-filing cancellation of all its claims (1-5) by the U.S. Patent and Trademark Office, as reflected in the IPR Certificate. This development raises the question of whether any viable infringement claim based on this patent remains.
• Scope Questions: Assuming the claims were valid, a central dispute would concern the negative limitation "no reinforcing members." The court would have to determine if the sutures used to attach the leaflets to the stent in the accused products constitute "reinforcing members." A further question would be whether the accused stents possess a "trumpet-like configuration" within the meaning of the claim.

’294 Patent Infringement Allegations

Identified Points of Contention

• Technical Question: A key issue will be whether the "recapture" function of the accused Evolut systems performs the specific sequence of "restraining" and "recovering" steps as recited in Claim 1. The infringement analysis will depend on a detailed examination of the accused systems' actual mechanics of operation, not just their marketed capabilities.
• Factual Question: Infringement of the method claim requires that all steps be performed. The court will need to consider what evidence exists that surgeons using the accused systems perform the entire claimed method, including the final "recovering" step, which may only occur when a positioning problem arises.

V. Key Claim Terms for Construction

For the ’739 Patent:

• The Term: "no reinforcing members"
• Context and Importance: This negative limitation is critical. If the sutures used in the accused devices are construed as "reinforcing members," there can be no infringement. Practitioners may focus on this term because its ambiguity creates a clear non-infringement argument.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (favors non-infringement): The patent does not define the term, leaving it open to its plain and ordinary meaning. A defendant could argue that anything that adds strength or reinforcement, including the extensive suturing required to attach a leaflet to a metal stent, qualifies as a "reinforcing member."
  • Evidence for a Narrower Interpretation (favors infringement): A plaintiff could argue that in the context of the patent, the term refers to distinct, separate structural components added for reinforcement, not the sutures that are inherent to attaching the tissue to the stent.

For the ’294 Patent:

• The Term: "recovering the distal portion of the replacement heart valve device within the moveable sheath"
• Context and Importance: This step defines the final action in the patented "recapture" method. The infringement analysis will turn on whether the accused devices perform this specific action.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification frames the step functionally, as being performed "in order to address a problem with the position of the replacement heart valve device" (’294 Patent, col. 9:13-15). This may support an interpretation that covers any mechanical action that achieves this result.
  • Evidence for a Narrower Interpretation: The claim language is specific, requiring recovery of the "distal portion ... that was exposed." A defendant could argue this implies a specific re-sheathing action and that their device's mechanism for recapture operates differently, thus falling outside the literal scope of the claim.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement for both patents. The inducement theory is based on Medtronic allegedly providing instructions and guidance to surgeons to use the CoreValve Products in their "normal and customary way," which allegedly infringes the patents (Compl. ¶53, ¶63). The contributory infringement theory alleges the CoreValve systems are a material part of the inventions, are especially adapted for infringing use, and are not staple articles of commerce suitable for substantial noninfringing use (Compl. ¶55, ¶65).
• Willful Infringement: Willfulness is alleged for both patents. The claim is primarily based on alleged pre-suit knowledge stemming from meetings in May and July 2014, where Colibri allegedly disclosed its technology and pending patent applications to Medtronic (Compl. ¶17, ¶49, ¶59).

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

1. A dispositive procedural issue will be the effect of the Inter Partes Review Certificate that cancelled all asserted claims of the ’739 patent. The central question for this portion of the case is whether any basis for an infringement claim under the ’739 patent remains.
2. For the ’294 patent, a key evidentiary question will be one of functional operation: does the "recapture" mechanism in Medtronic’s later-generation TAVR systems perform every step of the method recited in Claim 1? The case will likely require a detailed technical comparison between the patented method and the specific sequence of actions performed by the accused systems when repositioned.
3. A central legal and factual question for willfulness will be the significance of the 2014 meetings between the parties. The court will have to determine whether the information Medtronic allegedly received was specific enough to establish knowledge of the patents and an objectively high risk of infringement once they issued.