DCT
1:20-cv-00361
Speyside Medical LLC v. Medtronic CoreValve LLC
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Speyside Medical, LLC (Delaware)
- Defendant: Medtronic Corevalve, LLC (Delaware) and Medtronic, Inc. (Minnesota)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:20-cv-00361, D. Del., 06/12/2020
- Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware based on Defendant Medtronic Corevalve, LLC being organized in Delaware and both defendants having registered agents, systematic contacts, and sales of the accused products within the district. The complaint also notes that Defendants have agreed not to contest venue in the court for this action.
- Core Dispute: Plaintiff alleges that Defendant’s Evolut and CoreValve transcatheter aortic valve replacement (TAVR) systems infringe five patents related to prosthetic heart valves, their delivery systems, and methods of implantation.
- Technical Context: The technology relates to transcatheter aortic valve replacement, a minimally invasive alternative to open-heart surgery for patients with diseased aortic valves, which represents a significant and competitive medical device market.
- Key Procedural History: The complaint alleges that Defendant Medtronic was aware of the technology underlying the patents-in-suit through meetings with the original patent assignee, Direct Flow Medical Inc., beginning as early as 2006. The original complaint in this action was filed on March 13, 2020.
Case Timeline
| Date | Event |
|---|---|
| 2005-05-05 | Earliest Priority Date for ’118, ’941, and ’040 Patents |
| 2006-01-01 | Earliest alleged meeting between Medtronic and original patent owner |
| 2010-05-19 | Earliest Priority Date for ’708 Patent |
| 2012-05-01 | Earliest Priority Date for ’897 Patent |
| 2013-02-19 | ’118 Patent Issued |
| 2016-09-20 | ’897 Patent Issued |
| 2016-12-06 | ’941 Patent Issued |
| 2017-03-28 | ’708 Patent Issued |
| 2019-10-22 | ’040 Patent Issued |
| 2020-03-13 | Original Complaint Filed |
| 2020-06-12 | Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,377,118 - "Unstented Heart Valve With Formed In Place Support Structure"
- Patent Identification: U.S. Patent No. 8,377,118, "Unstented Heart Valve With Formed In Place Support Structure," issued February 19, 2013. (Compl. ¶16).
The Invention Explained
- Problem Addressed: The patent’s background section describes the significant risks, mortality, and long recovery associated with traditional open-heart surgery for valve replacement. (’118 Patent, col. 2:33-40). It also notes limitations of existing stent-based transcatheter valves, which have a fixed, rigid structure that can be difficult to deploy accurately and without complication. (’118 Patent, col. 3:45-56).
- The Patented Solution: The invention is a prosthetic heart valve system that lacks a pre-formed rigid stent. Instead, it features a flexible, expandable "carrier element" or cuff that is delivered via catheter in a collapsed state. Once positioned at the native valve, the cuff can be inflated to create a support structure in situ. (’118 Patent, col. 3:52-56). This allows the valve to be deployed, evaluated, collapsed back into a "moveable configuration," and repositioned for optimal placement before being secured. (’118 Patent, col. 5:40-49).
- Technical Importance: This "form-in-place" and repositionable design sought to provide a less invasive alternative to open-heart surgery while improving upon first-generation TAVR devices by offering greater procedural control and precision. (Compl. ¶23).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims, including at least independent method claim 1. (Compl. ¶37).
- The essential elements of Claim 1 include:
- Delivering an implantable expandable carrier element and replacement valve endovascularly while the heart is beating.
- Expanding the carrier element from a collapsed to a first expanded configuration to seal against the native anatomy.
- Evaluating the position of the carrier element.
- At least partially collapsing the carrier element from the first expanded configuration to a moveable configuration.
- Repositioning the carrier element in the moveable configuration.
- Expanding the carrier element from the moveable configuration to a second expanded configuration to secure it.
U.S. Patent No. 9,445,897 - "Prosthetic Implant Delivery Device With Introducer Catheter"
- Patent Identification: U.S. Patent No. 9,445,897, "Prosthetic Implant Delivery Device With Introducer Catheter," issued September 20, 2016. (Compl. ¶17).
The Invention Explained
- Problem Addressed: The patent’s background section notes that transcatheter valve procedures can lead to vascular complications, and one method for reducing such risks is to decrease the diameter of the delivery device. (’897 Patent, col. 2:22-29).
- The Patented Solution: The patent describes an integrated delivery system where the delivery catheter (carrying the valve) is preassembled within an introducer catheter. The key inventive concept is a specific dimensional relationship: the outer diameter of the delivery catheter's distal end is greater than the inner diameter of the introducer catheter's distal end. (’897 Patent, col. 3:40-44). This configuration allows the tip of the delivery catheter itself to function as a dilator for the blood vessel, enabling the use of a smaller, less traumatic introducer sheath. (’897 Patent, Abstract).
- Technical Importance: This design aimed to reduce the "crossing profile" of the entire system, thereby minimizing the risk of vascular injury during insertion and advancement, a critical consideration in TAVR procedures. (Compl. ¶23).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims, including at least independent method claim 1. (Compl. ¶47).
- The essential elements of Claim 1 include:
- Advancing together a preassembled delivery catheter and introducer catheter into a patient's vascular system.
- The delivery catheter comprises a prosthetic valve and a distal tip that can be inserted directly into the access vessel.
- The distal tip dilates the access vessel for the introducer catheter.
- During advancement, an outer diameter of the delivery catheter's distal end is greater than an inner diameter of the introducer catheter's distal end.
- The prosthetic valve is at least partially disposed within the delivery catheter's distal end during advancement.
- Deploying the prosthetic valve.
U.S. Patent No. 9,510,941 - "Method Of Treating A Patient Using A Retrievable Transcatheter Prosthetic Heart Valve"
- Patent Identification: U.S. Patent No. 9,510,941, "Method Of Treating A Patient Using A Retrievable Transcatheter Prosthetic Heart Valve," issued December 6, 2016. (Compl. ¶18).
- Technology Synopsis: This patent claims a method for replacing a native heart valve where the expandable carrier element is deployed in a specific sequence. The method requires expanding a distal end of the carrier element prior to expanding a proximal end, which allows the replacement valve to function and prevent blood backflow during the deployment process before the device is fully secured. (’941 Patent, Abstract; col. 81:35-44).
- Asserted Claims: At least independent method claim 17. (Compl. ¶57).
- Accused Features: The complaint accuses the method of using Medtronic's TAVR devices, alleging that they are deployed by expanding the distal end of the valve's frame before the proximal end. (Compl. ¶60).
U.S. Patent No. 9,603,708 - "Low Crossing Profile Delivery Catheter For Cardiovascular Prosthetic Implant"
- Patent Identification: U.S. Patent No. 9,603,708, "Low Crossing Profile Delivery Catheter For Cardiovascular Prosthetic Implant," issued March 28, 2017. (Compl. ¶19).
- Technology Synopsis: This patent is directed to a delivery catheter apparatus with a low-profile distal end having an outer diameter of 18 French or less. The catheter carries a cardiovascular prosthetic implant that includes a support structure and a natural tissue valve whose leaflets have a thickness of at least about 0.011 inches. (’708 Patent, Abstract). The invention combines a low-profile delivery system with a specific, durable valve leaflet construction.
- Asserted Claims: At least independent apparatus claim 21. (Compl. ¶66).
- Accused Features: The complaint accuses Medtronic’s Evolut Pro+ system, which it alleges has a "14 Fr Equivalent" profile and includes a bioprosthesis with natural tissue leaflets. (Compl. ¶73).
U.S. Patent No. 10,449,040 - "Method of Treating a Patient Using a Retrievable Transcatheter Prosthetic Heart Valve"
- Patent Identification: U.S. Patent No. 10,449,040, "Method of Treating a Patient Using a Retrievable Transcatheter Prosthetic Heart Valve," issued October 22, 2019. (Compl. ¶20).
- Technology Synopsis: This patent claims a method of treating a patient that includes deploying a prosthetic valve, testing its performance, and then at least partially reversing the deployment to reposition the valve before re-deploying it. A key element of the claimed method is that the prosthetic valve itself "does not include an interlocking locking mechanism," which is what enables the repositioning and redeployment steps. (’040 Patent, Abstract; col. 82:19-23).
- Asserted Claims: At least independent method claim 7. (Compl. ¶80).
- Accused Features: The complaint accuses Medtronic's TAVR systems, which are marketed as "recapturable" and "repositionable," of being used to practice the claimed method. (Compl. ¶¶25, 83).
III. The Accused Instrumentality
Product Identification
- Medtronic's Evolut™ and CoreValve™ transcatheter aortic valve replacement ("TAVR") lines of devices, including the Evolut Pro+ System, the Evolut Pro System, and the Evolut R System. (Compl. ¶¶7, 24).
Functionality and Market Context
- The Accused Products are systems for replacing a diseased aortic heart valve through a minimally invasive transcatheter procedure, an alternative to open-heart surgery. (Compl. ¶¶21, 23).
- The complaint alleges the systems include a bioprosthetic valve made with a self-expanding nitinol frame and porcine pericardial tissue leaflets. (Compl. ¶25).
- A key functionality highlighted in the complaint is that the devices are "recapturable and repositionable," allowing a surgeon to partially deploy, evaluate, and then recapture the valve to adjust its position before final deployment. (Compl. ¶25; ¶40, p. 16).
- The Evolut Pro+ system is specifically identified as having a low-profile delivery system with an "InLine Sheath" that provides a "14 Fr Equivalent" outer diameter. (Compl. ¶50, p. 23; ¶73, p. 40).
IV. Analysis of Infringement Allegations
'8,377,118 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| delivering an implantable expandable carrier element and an implantable replacement valve having leaflets endovascularly to a vicinity of the native aortic heart valve while the heart is beating, | Using an imaging and delivery system, a physician threads the compressed bioprosthetic heart valve through a catheter and positions it within the diseased valve. | ¶40 | col. 7:45-53 |
| expanding the carrier element from a collapsed delivery configuration to a first expanded configuration; | The physician begins deploying the valve, which expands from a compressed state within the catheter to a partially or fully expanded state within the native valve. | ¶40 | col. 7:49-53 |
| evaluating the position of the carrier element; | The Instructions for Use allegedly instruct surgeons to "evaluate the bioprosthesis position" before completing deployment. A video still illustrates the expansion of the prosthetic valve within the native aortic valve (Compl. ¶40, p. 15). | ¶40 | col. 7:54-56 |
| at least partially collapsing the carrier element from the first expanded configuration to a moveable configuration... | The Accused Products are allegedly "recapturable during deployment," and the Instructions for Use direct the physician to "initiate bioprosthesis recapture" by rotating a deployment knob. This collapses the valve into a state allowing for movement. | ¶40 | col. 7:54-61 |
| repositioning the carrier element in the moveable configuration in the vicinity of the native aortic heart valve; | The Accused Products' Instructions for Use state that a "partially recaptured bioprosthesis can be repositioned or fully recaptured." | ¶40 | col. 7:62-65 |
| expanding the carrier element from the moveable configuration to a second expanded configuration to secure the carrier element... | After repositioning, the surgeon redeploys the bioprosthesis to secure it in the final position. | ¶40 | col. 7:65-col. 8:5 |
- Identified Points of Contention:
- Scope Questions: The dispute may focus on the scope of "moveable configuration." The defense could argue that the "partial recapture" of the accused device, which may involve partially re-sheathing an expanded frame, is technically distinct from "at least partially collapsing the carrier element" as contemplated by the patent.
- Technical Questions: A factual question may be whether the multi-step process outlined in claim 1—expand, evaluate, collapse, reposition, re-expand—is a required sequence for every use of the Accused Products or merely an optional capability. The complaint relies on marketing materials and instructions, and the defense may argue that actual clinical practice does not always map directly onto this claimed method.
'9,445,897 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| advancing together a delivery catheter and an introducer catheter that is preassembled over the delivery catheter into a patient's vascular system, | The Accused Products allegedly include a "Delivery Catheter System with InLine Sheath," which is a preassembled system advanced into the patient's vasculature. A product diagram shows the preassembled Evolut PRO+ Delivery Catheter System with its integrated InLine Sheath (Compl. ¶50, p. 23). | ¶50 | col. 3:9-14 |
| the delivery catheter comprising a prosthetic valve and a distal tip that can be inserted directly into the access vessel such that the distal tip dilates the access vessel for the introducer catheter, | The Instructions for Use allegedly direct the user to "Insert the catheter tip and capsule through the access site." The complaint alleges the tip and capsule dilate the vessel. | ¶50 | col. 3:15-20 |
| wherein during advancement, an outer diameter of a distal end of the delivery catheter being greater than an inner diameter of a distal end of the introducer catheter, | Product specifications for the Evolut PRO+ system allegedly show a capsule outer diameter of 18 Fr (6.0 mm), while the integrated sheath is a "14 Fr equivalent," creating the claimed dimensional relationship. | ¶50 | col. 3:40-44 |
| the prosthetic valve being at least partially disposed within the distal end of the delivery catheter during advancement of the introducer catheter; and | The Accused Products' delivery system features a "capsule that covers and maintains the bioprosthesis in a crimped position" at the distal end of the catheter during advancement. | ¶50 | col. 3:21-25 |
| deploying the prosthetic valve. | Upon positioning, the physician deploys the valve from the capsule into the native valve. | ¶50 | col. 1:44-46 |
- Identified Points of Contention:
- Scope Questions: The central legal question may be the construction of the functional limitation "the distal tip dilates the access vessel." The defense might argue that this requires the tip to be the primary or sole dilating element, whereas in their system, the entire distal end of the device contributes to passage through the vessel.
- Technical Questions: The infringement allegation hinges on a precise dimensional relationship between the delivery catheter's capsule and the "14 Fr equivalent" introducer sheath. A factual dispute could arise over the exact points of measurement and whether the "greater than" limitation is met under all conditions of use.
V. Key Claim Terms for Construction
For the ’118 Patent
- The Term: "moveable configuration"
- Context and Importance: This term is critical for the repositioning feature of the claimed method. The outcome of the case may depend on whether the accused devices' "partial recapture" state, where the valve may be partially resheathed but not fully collapsed, meets the definition of a "moveable configuration." Practitioners may focus on this term because it distinguishes the invention from a simple one-time deployment.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests a broad functional meaning, describing that after partial or full deployment, "the implant 100 can be... retracted into the deployment catheter 300 if it is retracted." (’118 Patent, col. 50:1-8). This language could support an interpretation where any state permitting retraction or movement qualifies.
- Evidence for a Narrower Interpretation: Claim 1 recites collapsing the element "from the first expanded configuration to a moveable configuration." This sequence could imply a distinct, collapsed state rather than just a partially resheathed one. The abstract describes a "reduced cross-sectional configuration," which could be argued to require more than just partial resheathing of a fully expanded frame. (’118 Patent, Abstract).
For the ’897 Patent
- The Term: "distal tip dilates the access vessel for the introducer catheter"
- Context and Importance: This functional language defines the inventive concept of using the delivery device itself to prepare the vessel for the introducer. Infringement depends on whether the accused device performs this specific function. Medtronic could argue its "InLine Sheath" is simply a low-profile integrated system and that any dilation is incidental, not a claimed function.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent’s summary states that an objective is to "reduce ratio of the diameter of the delivery device" to avoid "vascular complications." (’897 Patent, col. 2:22-29). This context may support interpreting "dilates" broadly to encompass any action by the tip that facilitates the entry of the integrated sheath with reduced trauma.
- Evidence for a Narrower Interpretation: The claim links the dilation function directly to the structural requirement that the "outer diameter of a distal end of the delivery catheter [is] greater than an inner diameter of a distal end of the introducer catheter." (’897 Patent, cl. 1). This suggests that "dilates" is not a general function but one performed specifically because of this dimensional mismatch, potentially narrowing its scope to systems that explicitly rely on this mechanism.
VI. Other Allegations
- Indirect Infringement: For all asserted patents, the complaint alleges induced infringement under 35 U.S.C. § 271(b). The allegations are based on Defendant Medtronic providing customers, such as hospitals and surgeons, with marketing materials, product support, and "Instructions for Use" that allegedly instruct and encourage them to use the Accused Products in a manner that directly infringes the asserted method and apparatus claims. (Compl. ¶¶ 29, 37-38, 47-48, 57-58, 68-69, 80-81).
- Willful Infringement: For all asserted patents, the complaint alleges that Defendant’s infringement has been and continues to be deliberate and willful. The basis for this allegation is two-fold: (1) alleged pre-suit knowledge of the underlying technology and pending patent applications through meetings with the original patent assignee, Direct Flow Medical Inc., dating back to at least 2006 (Compl. ¶26); and (2) continued infringement after receiving notice of the patents-in-suit via the filing of the Original Complaint on March 13, 2020 (Compl. ¶¶ 27, 43, 53, 63, 76, 86).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of procedural mapping: for the asserted method claims ('118, '941, '040), the case will likely turn on whether the clinical steps enabled by Medtronic's "recapture" feature—as described in its instructions and performed in practice—align with the specific, ordered sequence of expanding, evaluating, collapsing, and repositioning recited in the patent claims.
- A key technical question will be one of structural and functional identity: for the asserted device and system claims ('897, '708), the analysis will likely focus on whether the physical characteristics of the Accused Products (e.g., the precise diameter relationship between the delivery capsule and integrated sheath) meet the letter of the claim limitations, and whether those structures perform the exact function (e.g., "dilates the access vessel") described in the patents.
- A central factual question for willfulness will be the scope of pre-suit knowledge: the court will need to examine what specific technical and patent-related information was conveyed to Medtronic during meetings with the original assignee starting in 2006, and whether that knowledge is sufficient to establish deliberate infringement of patents that issued many years later.