DCT
1:19-cv-00149
Abbott Cardiovascular Systems Inc v. Edwards Lifesciences Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Abbott Cardiovascular Systems, Inc. (California) and Evalve, Inc. (Delaware)
- Defendant: Edwards Lifesciences Corp. (Delaware) and Edwards Lifesciences, LLC (Delaware)
- Plaintiff’s Counsel: Shaw Keller LLP; Kirkland & Ellis LLP
- Case Identification: 1:19-cv-00149, D. Del., 03/08/2019
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendants are incorporated in Delaware and thus reside in the district.
- Core Dispute: Plaintiff alleges that Defendant’s PASCAL transcatheter mitral valve repair system infringes five patents related to Plaintiff's MitraClip medical device and associated technologies for minimally invasive heart valve repair.
- Technical Context: The technology concerns transcatheter-delivered devices designed to treat mitral regurgitation, a condition where the heart's mitral valve does not close properly, by clipping the valve's leaflets together in a procedure known as "edge-to-edge repair."
- Key Procedural History: The complaint notes that on March 5, 2019, the Court issued an Order in the case stating that "it appears that Abbott may be able to establish a case on the merits" regarding its patent infringement claims. It also alleges that Defendant cited all five patents-in-suit in an Information Disclosure Statement during the prosecution of its own patent application in May 2018, an event which may be relevant to allegations of pre-suit knowledge.
Case Timeline
| Date | Event |
|---|---|
| 1998-09-14 | ’097 Patent Priority Date |
| 1999-04-09 | ’813, ’267, ’388, ’493 Patents Priority Date |
| 2004-06-22 | ’813 Patent Issue Date |
| 2007-10-30 | ’097 Patent Issue Date |
| 2008-01-01 | MitraClip receives CE-Mark approval in Europe |
| 2009-07-21 | ’267 Patent Issue Date |
| 2010-06-15 | ’388 Patent Issue Date |
| 2011-11-15 | ’493 Patent Issue Date |
| 2013-01-01 | MitraClip receives FDA approval in the United States |
| 2019-02-01 | PASCAL system launched in Europe |
| 2019-03-08 | First Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,288,097 - “Surgical device for connecting soft tissue”
The Invention Explained
- Problem Addressed: The patent addresses the risks and trauma associated with conventional surgical treatments for heart conditions like mitral valve regurgitation, which typically require open-heart surgery and cardiopulmonary bypass (Compl. ¶39, 41; ’097 Patent, col. 1:26-33).
- The Patented Solution: The invention provides a surgical device that can be delivered percutaneously through a patient's vasculature to the heart. The device includes a clipping system with distinct sets of elements designed to grasp a pair of valve leaflets from both the atrial (upper) and ventricular (lower) sides, fastening them together to correct the defect without open-chest surgery (’097 Patent, Abstract; col. 2:1-8). This approach emulates the established "Alfieri" or "edge-to-edge" surgical repair technique in a minimally invasive manner (Compl. ¶40, 60).
- Technical Importance: This technology enabled the creation of a first-in-class transcatheter treatment, allowing high-risk patients who are ineligible for open-heart surgery to receive effective therapy for mitral regurgitation (Compl. ¶4, 44-45).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶117).
- The essential elements of Claim 1 include:
- A tube suitable for introduction through a patient's vasculature and into a chamber of a heart.
- A clipping system including a first pair of elements adapted to be brought up beneath a pair of valve leaflets from the ventricular side.
- A second pair of elements adapted to be brought down over the pair of valve leaflets from the atrial side.
- The first pair of elements engages the ventricular side of both leaflets, and the second pair of elements engages the atrial side of both leaflets.
- The first and second elements may be left in place to attach the free edges of the leaflets together.
- The complaint states that Defendant infringes "one or more claims" of the patent, reserving the right to assert additional claims (Compl. ¶124).
U.S. Patent No. 6,752,813 - “Methods and devices for capturing and fixing leaflets in valve repair”
The Invention Explained
- Problem Addressed: The patent’s background describes mitral valve regurgitation, where retrograde blood flow from the left ventricle to the left atrium reduces the heart's pumping efficiency, and notes the trauma and morbidity associated with treating this condition via open-heart surgery (’813 Patent, col. 1:19-51).
- The Patented Solution: The invention provides devices and endovascular methods for repairing cardiac valves. A key aspect is an interventional tool with a capture device, advanced through the vasculature, that can atraumatically grasp and reposition valve leaflets by applying force to their downstream (ventricular) surface. The tool can include distal elements, such as loops or bars, that protrude radially to press against the leaflets, and may also include proximal elements to hold the leaflet between them (’813 Patent, Abstract; col. 3:56-col. 4:10). The position can be adjusted before the device is detached to serve as a permanent implant (Compl. ¶61; ’813 Patent, col. 4:56-61).
- Technical Importance: The invention provides a framework for a repositionable and retrievable transcatheter valve repair system, allowing physicians to optimize leaflet coaptation in a beating heart before committing to permanent implantation (Compl. ¶61).
Key Claims at a Glance
- The complaint asserts at least independent claim 113 (Compl. ¶118).
- The essential elements of Claim 113 include:
- An interventional catheter comprising at least one guide conduit.
- A capture device on the catheter comprising at least one distal element.
- The distal element is protrudable radially outward and has a "loop shape" configured for pressing against a downstream surface of at least one leaflet.
- The complaint alleges infringement of "one or more claims," reserving the right to assert others (Compl. ¶129).
U.S. Patent No. 7,563,267 - “Fixation device and methods for engaging tissue”
- Technology Synopsis: This patent describes a fixation device for engaging tissue, such as heart leaflets. The device includes opposing distal and proximal "fixation elements" that are movable between open and closed positions to capture tissue, along with an actuation mechanism to control them.
- Asserted Claims: At least Claim 1 (Compl. ¶119).
- Accused Features: The complaint alleges that the PASCAL system's mechanism for grasping mitral valve leaflets, including its paddles and clasps, infringes the ’267 patent (Compl. ¶84, Fig. 6).
U.S. Patent No. 7,736,388 - “Fixation devices, systems and methods for engaging tissue”
- Technology Synopsis: This patent, from the same family as the '267 patent, further details fixation devices with movable elements. It describes specific features for enhanced tissue grip and various locking mechanisms to hold the device in a closed position after implantation.
- Asserted Claims: At least Claim 1 (Compl. ¶120).
- Accused Features: The PASCAL device's leaflet capture and fixation functionalities are alleged to infringe the ’388 patent (Compl. ¶84, Fig. 6).
U.S. Patent No. 8,057,493 - “Fixation devices, systems and methods for engaging tissue”
- Technology Synopsis: This patent continues the themes of the '267 and '388 patents, disclosing additional embodiments of fixation devices. It describes different configurations of the grasping elements, actuation systems, and delivery catheters for performing tissue approximation and repair.
- Asserted Claims: At least Claim 1 (Compl. ¶121).
- Accused Features: The PASCAL system's components for engaging and securing mitral valve leaflets are alleged to infringe the ’493 patent (Compl. ¶84, Fig. 6).
III. The Accused Instrumentality
Product Identification
- The Edwards PASCAL Transcatheter Mitral Valve Repair System ("PASCAL") (Compl. ¶3, 83).
Functionality and Market Context
- The PASCAL system is a catheter-delivered medical device for performing edge-to-edge repair of the mitral valve to treat mitral regurgitation (Compl. ¶83). A diagram in the complaint illustrates its key components, including wide, curved "Paddles" designed to engage the leaflets, "Clasps" that allow for independent leaflet capture, and a central "Spacer" intended to fill the gap between leaflets and reduce regurgitation (Compl. p. 20, Fig. 6). The device is delivered through a guide sheath and is designed to be left in the heart as a permanent implant (Compl. p. 20, Fig. 6).
- The complaint alleges that Edwards is marketing PASCAL as an "alternative" to Abbott's MitraClip and is targeting the same hospitals and physicians (Compl. ¶9, 91). It further alleges that Edwards is leveraging the clinical success of MitraClip to enter a "built-in market that's already been developed over time" by Abbott (Compl. ¶93).
IV. Analysis of Infringement Allegations
’097 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a tube suitable for introducing through a patient's vasculature and into a chamber of a heart | The PASCAL system is delivered to the heart via a catheter and a "22 French Guide Sheath" through the patient's vasculature. | ¶84 | col. 6:1-8 |
| a clipping system including a first pair of elements adapted to be brought up beneath a pair of valve leaflets from the ventricular side | The PASCAL device includes "Paddles" that are positioned on the ventricular (downstream) side of the mitral valve leaflets to engage them. | ¶84 | col. 6:1-8 |
| and a second pair of elements adapted to be brought down over the pair of valve leaflets from the atrial side | The PASCAL device includes "Clasps" that are positioned on the atrial (upstream) side to capture the leaflets. | ¶84 | col. 6:1-8 |
| wherein the first pair of elements engages the ventricular side of both leaflets and the second pair of element engages the atrial side of both the leaflets | The PASCAL device allegedly functions by capturing the leaflets between the ventricular-side Paddles and the atrial-side Clasps. | ¶84 | col. 6:1-8 |
| wherein the first and second elements may be left to attach the free edges of the leaflets together | The PASCAL "Implant" is the component of the system that remains in the heart to permanently connect the leaflets. | ¶84 | col. 6:1-8 |
’813 Patent Infringement Allegations
| Claim Element (from Independent Claim 113) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an interventional catheter comprising at least one guide conduit | The PASCAL system is delivered using a steerable "Guide" and a "Guide Sheath" which function as guide conduits. | ¶84 | col. 32:38-39 |
| a capture device on the interventional catheter comprising at least one distal element, wherein the distal element is protrudable radially outward and has a loop shape configured for pressing against a downstream surface of at least one leaflet | The PASCAL device's "Paddles" are alleged to be distal elements that extend outward from the catheter and have a curved, loop-like shape designed to press against the ventricular (downstream) surface of the valve leaflets to capture them. | ¶84 | col. 32:40-47 |
Identified Points of Contention
- Scope Questions: For the ’097 Patent, a potential point of contention is whether the accused PASCAL device, which is described as having "Paddles," "Clasps," and a central "Spacer" (Compl. p. 20, Fig. 6), meets the claim limitation of "a first pair of elements" and "a second pair of elements." The defense may argue that these components constitute a single, integrated grasping mechanism that is structurally and functionally distinct from the claimed two-pair system.
- Technical Questions: For the ’813 Patent, the analysis may focus on whether the PASCAL device’s "Paddles" have a "loop shape" as required by the claim. The complaint’s visual evidence depicts them as broad, curved surfaces (Compl. p. 20, Fig. 6), which raises the question of whether this structure falls within the scope of "loop shape" as that term is defined by the patent's specification, which illustrates more traditionally enclosed loops (’813 Patent, Fig. 10A).
V. Key Claim Terms for Construction
The Term: "clipping system" (’097 Patent, Claim 1)
- Context and Importance: The definition of this term is central to the infringement analysis of the ’097 Patent. The question is whether the combination of the PASCAL device's "Paddles," "Clasps," and central "Spacer" constitutes a single "clipping system" as recited in the claim. Practitioners may focus on whether the claim requires two distinct pairs of elements operating in concert or can read on a more integrated multi-component grasper.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent describes the invention in general terms as a "device for connecting soft tissue" and a "clipping system," without limiting the system to a specific unitary structure (’097 Patent, col. 2:1-5). This may support an interpretation that covers any system performing the claimed function, including a multi-component one.
- Evidence for a Narrower Interpretation: The patent's figures and description of the operation, where one set of elements engages the ventricular side and another engages the atrial side, could be used to argue that the "clipping system" must have this specific two-sided, two-pair architecture, potentially distinguishing it from the accused device's configuration.
The Term: "loop shape" (’813 Patent, Claim 113)
- Context and Importance: The literal infringement of claim 113 of the ’813 Patent may depend entirely on the construction of "loop shape." The dispute will likely center on whether the PASCAL "Paddles," which are depicted as open, curved structures, meet this limitation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The ’813 patent specification describes distal elements taking numerous forms, including "bars, rods, flaps, sheets, blocks or loops," and having shapes such as "rectangular, circular, oblong, elliptical and petal" (’813 Patent, col. 13:60-65). This broad disclosure may support construing "loop shape" to encompass generally curved or petal-like structures, not just fully enclosed ones.
- Evidence for a Narrower Interpretation: The primary embodiment illustrating a "loop" in the ’813 patent shows a distinct, wire-form closed loop (e.g., ’813 Patent, Fig. 10A, element 212). This specific example could be cited to argue for a narrower definition that excludes the broader, paddle-like structure of the accused device.
VI. Other Allegations
- Indirect Infringement: The complaint's formal counts focus on direct infringement under 35 U.S.C. § 271(a) (Compl. ¶124, 129). However, the prayer for relief seeks to enjoin Defendant from "inducing others to infringe the Patents-in-Suit," suggesting a potential future assertion of indirect infringement theories (Compl. p. 31, ¶(b)).
- Willful Infringement: The complaint alleges that Defendant’s infringement has been willful, wanton, and egregious (Compl. ¶103, 117). The asserted basis for willfulness includes allegations that Defendant: (1) studied Plaintiff's MitraClip device to develop the PASCAL system (Compl. ¶96); (2) cited all five patents-in-suit in an Information Disclosure Statement during the prosecution of its own patent application on May 24, 2018, demonstrating pre-suit knowledge (Compl. ¶97); and (3) continued to manufacture and sell PASCAL even after receiving the complaint and a court order stating that Abbott appeared to have a case on the merits (Compl. ¶98, 100-101).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "loop shape," as used in the '813 patent, be construed to cover the broad, curved "Paddles" of the accused PASCAL system, or is its meaning constrained by patent figures depicting more conventional, wire-form loops?
- A key question of structural interpretation will be central to the '097 patent analysis: does the PASCAL device—with its distinct paddles, clasps, and central spacer—embody the claimed "clipping system" comprising a "first pair of elements" and a "second pair of elements," or does its multi-component design represent a fundamentally different structure?
- A critical issue for damages and potential enhancement will be willfulness: given the complaint's specific allegations of pre-suit knowledge, including Defendant's citation of the patents-in-suit during its own patent prosecution, the court will likely scrutinize the objective reasonableness of any non-infringement or invalidity defenses that Defendant presents.