DCT
1:17-cv-01141
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 district (Santa Ana, CA) and a substantial portion of the events giving rise to the claims, including the manufacture and sale of the accused products, occurred there.
- Core Dispute: Plaintiff alleges that Defendant’s CoreValve line of transcatheter aortic valve replacement (TAVR) products and associated delivery systems infringe patents related to the structure of replacement heart valves and methods for their controlled, percutaneous deployment.
- Technical Context: The technology involves transcatheter aortic valve replacement (TAVR), a minimally invasive procedure that provides an alternative to open-heart surgery for patients with severe heart valve disease.
- Key Procedural History: The complaint alleges that Plaintiff disclosed its patented technology and patent portfolio to Defendant in meetings and communications beginning in May 2014, prior to the issuance of the patents-in-suit. Subsequent to the filing of this complaint, all asserted claims (1-5) of U.S. Patent No. 9,125,739 were cancelled in an Inter Partes Review (IPR) proceeding, with a certificate issued on July 1, 2022.
Case Timeline
| Date | Event |
|---|---|
| 2002-01-04 | Earliest Priority Date for '739 and '294 Patents |
| 2014-01-01 | Medtronic began commercial marketing of CoreValve System (approx.) |
| 2014-05-06 | Colibri presents TAVI system and patent portfolio to Medtronic |
| 2014-12-02 | U.S. Patent No. 8,900,294 Issued |
| 2015-06-22 | Medtronic began marketing CoreValve Evolut R System (approx.) |
| 2015-09-08 | U.S. Patent No. 9,125,739 Issued |
| 2017-03-20 | Medtronic began marketing CoreValve Evolut PRO System (approx.) |
| 2018-07-21 | Colibri sends Medtronic presentation identifying both patents-in-suit |
| 2019-09-19 | Medtronic began marketing CoreValve Evolut PRO+ System (approx.) |
| 2020-06-12 | First Amended Complaint Filed |
| 2022-07-01 | U.S. Patent Office issues certificate cancelling all claims of '739 Patent |
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 describes the clinical need for replacing diseased heart valves and notes the drawbacks of prior art solutions. These include the thrombogenicity and need for anticoagulants with mechanical valves, and the poor durability and complex, imprecise manufacturing of existing tissue valves, which often required extensive suturing. ('739 Patent, col. 3:20-4:53).
- The Patented Solution: The invention is an assembly comprising a prosthetic heart valve and a delivery system. The core of the valve is a stent member with flared ends creating a "trumpet-like configuration" and a valve made from pericardial tissue leaflets that reside entirely within the stent's inner channel, notably without any "reinforcing members." ('739 Patent, Abstract; col. 6:23-40). This design aims to create a durable, percutaneously deliverable valve that better mimics natural valve anatomy and function. ('739 Patent, col. 4:46-53).
- Technical Importance: The invention sought to improve upon earlier TAVR devices by providing a valve structure that was both anatomically accurate and manufacturable, avoiding the failure points associated with extensive suturing or clamping of tissue leaflets. ('739 Patent, col. 4:35-53).
Key Claims at a Glance
- Independent Claim 1 is asserted.
- The essential elements of Claim 1, an assembly, include:
- A prosthetic heart valve comprising:
- A stent member that is collapsible, expandable, and configured for percutaneous delivery.
- The stent member includes a tubular structure that "flares at both ends in a trumpet-like configuration."
- A valve means with two to four leaflets made of "fixed pericardial tissue," residing entirely within the stent's inner channel.
- A negative limitation: "no reinforcing members reside within the inner channel of the stent member."
- A delivery system comprising a pusher member and a moveable sheath, where the valve is collapsed onto the pusher and restrained by the sheath for delivery.
- A prosthetic heart valve comprising:
- 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: The patent identifies the risks associated with implanting prosthetic heart valves, particularly the difficulty of ensuring correct positioning with delivery systems that deploy the valve in a single, irreversible action. ('294 Patent, col. 9:6-10).
- The Patented Solution: The patent claims a method of deploying a replacement heart valve that allows for "controlled release." The key steps involve partially deploying the valve from its sheath, assessing its position, and—critically—restraining the device with the "potential that the replacement heart valve device can be recovered if there is a problem with positioning." ('294 Patent, col. 9:6-10). The final step is the actual recovery of the partially deployed valve back into the sheath to address such a positioning problem. ('294 Patent, col. 9:11-15).
- Technical Importance: This method provides a significant safety advantage by allowing a surgeon to deploy, evaluate, and recapture/reposition the valve, thereby reducing the risk of misplacement, which is a major complication of TAVR procedures. ('294 Patent, col. 9:6-10).
Key Claims at a Glance
- Independent Claim 1 is asserted.
- The essential steps of method Claim 1 include:
- "obtaining" a specific heart valve and delivery system.
- "loading" the valve device into the moveable sheath.
- "advancing" the system transluminally to the native heart valve location.
- "partially deploying" a distal portion of the valve device.
- "restraining" the device for controlled release, with the potential for recovery.
- "recovering" the exposed distal portion back into the sheath to address a positioning problem.
- The complaint also asserts dependent claims 2-4 (Compl. ¶60).
III. The Accused Instrumentality
Product Identification
- The Medtronic CoreValve, CoreValve Evolut R, CoreValve Evolut PRO, and CoreValve Evolut PRO+ Systems (the "CoreValve Products") (Compl. ¶¶5, 27).
Functionality and Market Context
- The accused products are TAVR systems, each comprising a transcatheter aortic valve (a bioprosthesis) and a delivery catheter system (Compl. ¶24). The valve component is alleged to feature three leaflets made from porcine pericardium, which are sutured onto a collapsible, multi-level, radiopaque stent (Compl. ¶27). The complaint specifically alleges the stent has "flared ends in a trumpet-like configuration" (Compl. ¶27). The complaint provides an image of the accused valve. This image shows the accused Medtronic CoreValve transcatheter aortic valve and its shape (Compl. p. 10, ¶27).
- The delivery system includes a pusher member and a moveable sheath or capsule to hold the valve in a crimped position for delivery (Compl. ¶28). For the CoreValve Evolut R, PRO, and PRO+ models, the complaint alleges the delivery system "enables the valve to be recaptured after partial deployment" (Compl. p. 13:4).
- The complaint positions Medtronic as part of the "world's largest medical device company" and notes its TAVR products are a significant part of its Cardiac and Vascular Group's revenue (Compl. ¶23).
IV. Analysis of Infringement Allegations
'739 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a stent member... collapsible, expandable and configured for trans-luminal percutaneous delivery, wherein the stent member includes a tubular structure away from a central portion that flares at both ends in a trumpet-like configuration | The CoreValve Products include a "collapsible and expandable, multi-level, radiopaque stent with flared ends in a trumpet-like configuration." | ¶27 | col. 6:27-31 |
| a valve means including two to four individual leaflets made of fixed pericardial tissue, wherein the valve means resides entirely within the inner channel of the stent member | The CoreValve Products' valve includes "three valve leaflets, manufactured from porcine pericardium" that are "sutured onto" the stent. | ¶27 | col. 7:1-3 |
| and wherein no reinforcing members reside within the inner channel of the stent member | The complaint does not provide specific allegations for this element. | N/A | col. 7:4-5 |
| a delivery system including a pusher member and a moveable sheath | The CoreValve Products include a "delivery catheter system" that "comprises a pusher member and a moveable sheath." | ¶28 | col. 7:6-7 |
| wherein the prosthetic heart valve is collapsed onto the pusher member... and is restrained... by the moveable sheath | The delivery catheter system's capsule "covers and maintains the transcatheter aortic valve in a crimped position." | ¶28 | col. 7:9-13 |
Identified Points of Contention
- Scope Questions: A central dispute would have concerned the negative limitation "no reinforcing members reside within the inner channel." The defense would likely question whether the sutures used to affix the leaflets or portions of the stent frame itself constitute "reinforcing members," an issue on which the complaint is silent.
- Technical Questions: The meaning of "trumpet-like configuration" would be a focus of claim construction. The question is whether the alleged flaring of the CoreValve products (Compl. p. 10, ¶27) matches the scope of this term as defined by the patent specification.
'294 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| obtaining a replacement heart valve device and a delivery and implantation system | Medtronic makes, sells, and provides the accused CoreValve Products, which are comprised of a valve and delivery system. | ¶¶26-28 | col. 8:4-5 |
| after the obtaining step, loading the replacement heart valve device into the lumen of the moveable sheath | The complaint describes and depicts compression loading systems for the CoreValve products that compress the valve into the catheter. For example, Figure 3 shows the "Medtronic CoreValve compression loading system" (Compl. p. 11, ¶29). | ¶¶29, 35, 40, 45 | col. 8:18-23 |
| after the loading step, advancing the delivery and implantation system transluminally | Medtronic provides instructions and the system is designed for transluminal advancement to the heart. | ¶30 | col. 8:24-28 |
| after the advancing step, partially deploying a distal portion of the replacement heart valve device | The delivery system catheter for the Evolut R and later models is alleged to have an integrated handle that "loads, deploys, and recaptures" the valve. | ¶34 | col. 9:1-5 |
| after the partially deploying step, restraining the replacement heart valve device... with a potential that the replacement heart valve device can be recovered | The delivery system for the Evolut R, PRO, and PRO+ models is alleged to include a "moveable sheath with a lumen that enables the valve to be recaptured after partial deployment." | ¶34 | col. 9:6-10 |
| after the restraining step, recovering the distal portion of the replacement heart valve device within the moveable sheath | The delivery catheter for the Evolut R and later models "recaptures the transcatheter aortic valve." | ¶34 | col. 9:11-15 |
Identified Points of Contention
- Scope Questions: A key issue may be whether all accused products meet all method steps. The complaint's allegations regarding the "recapture" capability are strongest for the Evolut R, PRO, and PRO+ systems, raising the question of whether the original CoreValve system infringes the "restraining" and "recovering" steps of the claim.
- Technical Questions: Infringement of a method claim requires evidence that the accused products are actually used by surgeons in a way that performs every claimed step in the specified order. The defense may challenge whether the "recovering" step is a routine or required part of the standard procedure for using the CoreValve products.
V. Key Claim Terms for Construction
Term from '739 Patent: "trumpet-like configuration"
- Context and Importance: This non-standard term is a key structural limitation of the claimed stent. Its construction will determine whether the shape of Medtronic's CoreValve stents, which the complaint alleges have "flared ends" (Compl. ¶27), falls within the claim's scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The detailed description does not provide a precise geometric definition, which may support an interpretation covering a range of flared-end designs.
- Evidence for a Narrower Interpretation: The specification states the tubular structure "flares markedly at both ends in a trumpet-like configuration" ('739 Patent, col. 8:61-63). A defendant might argue that "markedly" requires a degree of flaring that is significant and visually consistent with the patent's figures, rather than any minimal flare.
Term from '739 Patent: "no reinforcing members"
- Context and Importance: Practitioners may focus on this term because negative limitations are often critical to distinguishing inventions from the prior art and accused products. The absence of specific allegations in the complaint on this point suggests it is a likely area of dispute.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (i.e., fewer things are "reinforcing members"): The patent contrasts its invention with prior art where tissue was "clamped in a sandwich-fashion between two stent components" ('739 Patent, col. 4:8-12). This could support an interpretation where "reinforcing members" refers to separate, distinct structural components for clamping, and not to integral elements like sutures.
- Evidence for a Narrower Interpretation (i.e., more things are "reinforcing members"): A defendant could argue that any element adding structural support to the leaflets, including the sutures affixing them to the stent or the stent struts themselves, constitutes a "reinforcing member," thereby designing around the claim.
Term from '294 Patent: "recovering the distal portion of the replacement heart valve device within the moveable sheath"
- Context and Importance: This term is the crux of the invention's safety feature. The dispute will center on what actions by a surgeon using the accused device constitute "recovering."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A plaintiff might argue that any retraction of the valve back into the sheath to adjust its position meets the limitation, as it fulfills the purpose of addressing a "problem with positioning."
- Evidence for a Narrower Interpretation: The claim language is specific, requiring recovery of the "distal portion...within the moveable sheath that was exposed." A defendant could argue this requires full or substantial resheathing of the previously deployed portion, not just a minor adjustment or partial retraction.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement for both patents. It claims Medtronic provides "guidance and instruction to third parties" such as surgeons, including instructional manuals and videos, that cause them to use the CoreValve products in an infringing manner (Compl. ¶¶30, 53, 63).
- Willful Infringement: The complaint alleges willful infringement for both patents. The basis for willfulness is alleged pre-suit knowledge of Colibri's technology and patent rights, stemming from meetings and presentations that occurred as early as May 2014 and a specific presentation identifying the patents-in-suit by number in July 2018 (Compl. ¶¶16, 48, 56, 59, 66).
VII. Analyst’s Conclusion: Key Questions for the Case
- Impact of Post-Filing Invalidation: The primary issue governing the '739 Patent is the subsequent cancellation of all its asserted claims by the U.S. Patent Office. While the complaint was filed when the patent was presumptively valid, this IPR outcome is dispositive and effectively terminates the infringement controversy for that patent.
- Functional Equivalence of Method Steps: For the remaining '294 method patent, a key evidentiary question will be one of functional performance: does the standard use of Medtronic's CoreValve systems, particularly the earlier models, require surgeons to perform the specific "restraining" and "recovering" steps as recited in Claim 1? The case will likely depend on evidence of how the devices are actually used in clinical practice versus the precise sequence mandated by the claim.
- Definitional Scope: Assuming the '739 patent were still at issue, a central question would be one of definitional scope: could the negative limitation "no reinforcing members" be construed to read on a valve where leaflets are affixed with sutures, and is the accused stent's shape properly described as a "trumpet-like configuration"? These claim construction disputes would have been foundational to the infringement analysis.