DCT
1:18-cv-01294
Edwards Lifesciences LLC v. Boston Scientific Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Edwards Lifesciences LLC (Delaware)
- Defendant: Boston Scientific Corporation (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:18-cv-01294, D. Del., 08/22/2018
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is incorporated in Delaware and has allegedly committed acts of infringement within the district.
- Core Dispute: Plaintiff alleges that Defendant’s Watchman Left Atrial Appendage (LAA) Closure System infringes patents related to apparatuses and methods for reducing heart wall tension.
- Technical Context: The technology concerns implantable medical devices designed to treat heart failure by physically altering the geometry of a heart chamber to reduce wall stress.
- Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of the ’425 Patent because one of its subsidiaries cited the patent in an Information Disclosure Statement (IDS) during the prosecution of an unrelated patent on February 19, 2015. This is asserted as a basis for willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 1997-01-02 | ’168 and ’425 Patents Priority Date |
| 2000-12-19 | U.S. Patent No. 6,162,168 Issue Date |
| 2010-04-13 | U.S. Patent No. 7,695,425 Issue Date |
| 2015-02-19 | Defendant's subsidiary allegedly cites ’425 Patent in an IDS |
| 2015-03-01 | Alleged first date of infringement by Accused Product (approximate) |
| 2018-08-22 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,162,168 - "Heart Wall Tension Reduction Apparatus," issued December 19, 2000 (’168 Patent)
The Invention Explained
- Problem Addressed: The patent’s background section describes the pathophysiology of heart failure, where a dilated left ventricle leads to a significant increase in wall tension during the cardiac cycle, which in turn causes ongoing damage to the heart muscle (ʼ168 Patent, col. 1:41-53).
- The Patented Solution: The patent proposes a non-pharmacological, passive apparatus to reduce this wall tension. The core concept, illustrated in figures such as Figure 1, involves a mechanical splint or "tension member" that is positioned to draw at least two walls of a heart chamber toward each other, thereby reducing the chamber's radius and, consequently, the stress on its walls (ʼ168 Patent, col. 2:50-58; Fig. 1).
- Technical Importance: The invention proposed a purely mechanical, implantable solution to alter heart geometry as a treatment for heart failure, representing a potential alternative or supplement to pharmacological or cardiac-assist pump therapies (ʼ168 Patent, col. 2:42-45).
Key Claims at a Glance
- The complaint asserts infringement of at least independent Claim 29 (Compl. ¶14).
- The essential elements of Claim 29 are:
- A device comprising a static member configured to be positioned adjacent portions of a wall of a heart chamber.
- An anchoring mechanism coupled to the member to engage the wall of the heart chamber.
- The device is configured to alter a shape of the chamber during at least a portion of a cardiac cycle such that the portions of the wall remain in a non-contacting relationship.
U.S. Patent No. 7,695,425 - "Heart Wall Tension Reduction Apparatus and Method," issued April 13, 2010 (’425 Patent)
The Invention Explained
- Problem Addressed: Similar to the ’168 Patent, the technology addresses heart failure resulting from the progressive dilation of a heart chamber and the associated increase in wall stress (ʼ425 Patent, col. 1:28-34).
- The Patented Solution: This patent claims the surgical method for implanting a heart-reshaping device. It describes a procedure that includes advancing an "elongate member" (e.g., a catheter or sheath) to a target location in the heart, inserting it into a chamber, and then using it to introduce an "instrument" and an "element" (the implant) for installation within the heart (ʼ425 Patent, Abstract; col. 11:5-21).
- Technical Importance: The patent claims a specific surgical method for delivering such a device, a critical aspect for enabling less invasive, percutaneous implantation compared to traditional open-heart surgery (ʼ425 Patent, col. 3:41-54).
Key Claims at a Glance
- The complaint asserts infringement of at least independent Claim 1 (Compl. ¶23).
- The essential elements of Claim 1 are:
- Advancing an elongate member with a lumen towards a target location on a patient's heart.
- Inserting the distal end of the elongate member through a heart wall and into a heart chamber.
- Introducing an instrument and an element through the elongate member for installing the element.
- Installing the element in contact with first and second spaced apart portions of the heart, wherein the element traverses a chamber of the heart, and wherein all portions of the heart chamber remain in non-contacting fluid communication when the element is installed.
III. The Accused Instrumentality
Product Identification
- The "Watchman Left Atrial Appendage ('LAA') Closure Device, the Watchman Delivery System, and the Watchman Access System" are collectively identified as the "Accused Product" (Compl. ¶4).
Functionality and Market Context
- The complaint alleges that the Accused Product is a system for occluding the LAA (Compl. ¶4). The Watchman LAA Closure Device is described as having a "nitinol frame" and "fixation anchors" (Compl. ¶17, ¶18). This device is delivered using the Watchman Delivery System and Watchman Access System, which allegedly includes an access sheath and a delivery catheter advanced through the intra-atrial septum into the left atrium (Compl. ¶26, ¶28, ¶29). The complaint alleges the Accused Product has been sold in the U.S. since at least March 2015 (Compl. ¶13). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
- ’168 Patent Infringement Allegations
| Claim Element (from Independent Claim 29) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a static member configured to be positioned adjacent portions of a wall of a heart chamber | The Watchman LAA Closure Device has a nitinol frame that is configured to be positioned adjacent to at least a wall of the left atrium. | ¶17 | col. 8:23-25 |
| an anchoring mechanism coupled to the member to engage the wall of the heart chamber | The Watchman LAA Closure Device has fixation anchors coupled to the nitinol frame that engage at least a wall of the left atrium. | ¶18 | col. 8:26-27 |
| wherein the device is configured to alter a shape of the chamber... such that the portions of the wall remain in a non-contacting relationship | The implanted Watchman LAA Closure Device presses against at least one wall of the left atrium, thereby altering the shape of the chamber. | ¶19 | col. 8:28-33 |
- ’425 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| advancing an elongate member towards a target location on a patient's heart, wherein the elongate member includes a proximal end, a distal end, and a lumen extending therebetween | Advancing the Watchman Access Sheath, which has a proximal end, distal end, and a lumen, toward the intra-atrial septum. | ¶26, ¶27 | col. 11:7-11 |
| inserting the distal end of the elongate member through a heart wall and into a heart chamber | Inserting the distal end of the Watchman Access Sheath through the intra-atrial septum and into the left atrium. | ¶28 | col. 11:12-13 |
| introducing an instrument and an element through the elongate member for installing the element | Introducing the Watchman Delivery Catheter (instrument) and the Watchman LAA Closure Device (element) through the Watchman Access Sheath for installation of the device. | ¶29 | col. 11:14-16 |
| installing the element in contact with first and second spaced apart portions of the heart, wherein... all portions of the heart chamber remain in non-contacting fluid communication | Installing the Watchman LAA Closure Device to traverse the left atrium, where all portions of the left atrium allegedly remain in non-contacting fluid communication. | ¶30 | col. 11:17-21 |
- Identified Points of Contention:
- Scope Questions: For the ’168 Patent, a key question is whether a device designed to occlude an appendage (the LAA) constitutes altering a chamber’s shape such that "portions of the wall remain in a non-contacting relationship." The patent specification appears to describe reshaping a ventricle into a "figure eight" cross-section, which may present a different technical mechanism than occluding a side-chamber like the LAA (ʼ168 Patent, col. 5:55-58, Fig. 15).
- Technical Questions: For the ’425 Patent, the infringement analysis may turn on the final "wherein" clause. The claim requires that "all portions of the heart chamber remain in non-contacting fluid communication." It is an open question whether a procedure whose goal is to permanently seal off the LAA from the rest of the left atrium can meet this limitation, as the LAA itself is a portion of that chamber.
V. Key Claim Terms for Construction
The Term: "non-contacting relationship" (’168 Patent, Claim 29)
- Context and Importance: This term is central to the infringement theory for the ’168 patent. Its definition will determine whether a device that occludes an appendage performs the function described in the claim. Practitioners may focus on this term because the accused product's mechanism (occlusion) may differ from the patent's illustrative embodiment (ventricular reshaping).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is general and does not specify which portions of the wall must be in the relationship or the exact nature of that relationship beyond being non-contacting.
- Evidence for a Narrower Interpretation: The specification describes creating a "figure eight" cross-section where opposite lobes are formed ('168 Patent, col. 5:55-58). Figure 1 shows a splint drawing opposing walls of the main ventricular chamber closer together, suggesting the term refers to this specific reshaping action rather than blocking off a part of the chamber.
The Term: "all portions of the heart chamber remain in non-contacting fluid communication" (’425 Patent, Claim 1)
- Context and Importance: The viability of the infringement claim for the ’425 patent hinges on this limitation. The primary function of the accused product is to seal the LAA, which is part of the left atrium. Defendant may argue this act of sealing inherently violates the "all portions... remain in... fluid communication" requirement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that "portions of the heart chamber" post-installation refers only to the primary, non-occluded volume, and that the LAA is effectively removed from the chamber's fluid dynamics.
- Evidence for a Narrower Interpretation: The plain language "all portions" suggests no part of the chamber should be blocked off. A related passage in the parent '168 patent states the device is configured so that "all interior parts of the chamber remain in direct fluid communication with each other" ('168 Patent, col. 6:50-53, Claim 1), which may support an interpretation that prohibits any form of partitioning or occlusion.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement of the ’425 patent, asserting that Defendant instructs its customers on the infringing method of use through materials such as the "Watchman Directions for Use" (Compl. ¶22, ¶37). The complaint also pleads contributory infringement, alleging the Accused Product is a material part of the invention, is not a staple article of commerce, and is known by Defendant to be especially adapted for the infringing use (Compl. ¶41).
- Willful Infringement: Willfulness is alleged for the ’425 patent based on Defendant's alleged pre-suit knowledge. The complaint points to an IDS filed by a Boston Scientific subsidiary on February 19, 2015, which cited the ’425 patent, as evidence of actual knowledge prior to the lawsuit (Compl. ¶35). The complaint alleges that continued sales and instructions after this date were done with reckless disregard of Plaintiff's patent rights (Compl. ¶38, ¶44).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the ’168 Patent's claim for a device that creates a "non-contacting relationship" between chamber walls—a concept illustrated in the patent by reshaping a ventricle—be construed to cover a device whose function is to occlude the left atrial appendage?
- A key evidentiary question for the ’425 Patent will be one of functional interpretation: does a surgical method that intentionally seals off the LAA satisfy the claim requirement that "all portions of the heart chamber remain in non-contacting fluid communication," or does the act of occlusion itself contradict this express limitation?