DCT

1:18-cv-01535

Boston Scientific Scimed Inc v. Edwards Lifesciences LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-01535, D. Del., 10/03/2018
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant is a Delaware limited liability company that regularly transacts business and derives substantial revenue from sales within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Sapien 3 Transcatheter Heart Valve infringes a patent related to replacement heart valve systems featuring a specific type of fabric seal.
  • Technical Context: The technology relates to transcatheter aortic valve replacement (TAVR), a minimally invasive procedure to replace a diseased heart valve without open-heart surgery, a market with significant commercial value.
  • Key Procedural History: The complaint asserts claims 1-3 of the patent-in-suit. However, a subsequent inter partes review (IPR) proceeding (IPR2017-00060), initiated before this lawsuit was filed, resulted in a certificate from the USPTO, issued February 9, 2021, cancelling claims 1-4 of the patent. This post-filing development directly impacts the viability of the infringement claims as asserted in the complaint.

Case Timeline

Date Event
2004-06-16 ’608 Patent Priority Date
2015-03-31 ’608 Patent Issue Date
2016-10-12 IPR Petition Filed against ’608 Patent
2018-10-03 Complaint Filing Date
2021-02-09 IPR Certificate Issued Cancelling Claims 1-4 of ’608 Patent

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

U.S. Patent No. 8,992,608 - "Everting Heart Valve"

The Invention Explained

  • Problem Addressed: The patent’s background section identifies several drawbacks with prior art transcatheter heart valve systems, including insufficient radial strength to anchor the device, poor deployment accuracy, and the inability to assess valve function before irreversible deployment (’608 Patent, col. 2:11-34).
  • The Patented Solution: The invention is a system for replacing a heart valve that includes an expandable anchor and a replacement valve. The asserted claims focus on a specific feature: a "fabric seal" that is attached to the distal end of the valve leaflets and is configured to wrap back proximally over the exterior of the anchor during deployment (’608 Patent, claim 1). This structure, illustrated in figures such as Fig. 32-34, is designed to create flaps that fill the gaps left by the native valve leaflets, thereby preventing blood from leaking around the implant (paravalvular leak) (’608 Patent, col. 14:26-38; col. 22:33-36).
  • Technical Importance: The claimed configuration aims to provide a more effective seal against irregular native anatomy and improve device stability, addressing key technical challenges for achieving successful long-term outcomes in transcatheter valve replacement procedures (’608 Patent, col. 2:11-34).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 2 and 3 (’Compl. ¶11).
  • Independent Claim 1 requires:
    • An expandable anchor with a distal end.
    • A replacement valve commissure support element attached to the anchor.
    • A commissure portion of a replacement valve leaflet attached to the support element.
    • A fabric seal disposed around an exterior portion of the anchor, which forms flaps that extend into spaces formed by native valve leaflets.
    • Crucially, the claim requires a specific structure: "wherein a distal end of the replacement valve leaflet is attached to the fabric seal and when the expandable anchor is in the collapsed delivery configuration, the fabric seal extends from the distal end of the replacement valve and back proximally over the expandable anchor," to prevent blood flow between the seal and heart tissue (’608 Patent, col. 22:15-47).

III. The Accused Instrumentality

Product Identification

The complaint identifies the accused product as the "Sapien 3 Transcatheter Heart Valve" ("Sapien 3") (Compl. ¶1).

Functionality and Market Context

The complaint alleges that the Sapien 3 is a "transcatheter heart valve product" that is manufactured, used, sold, and imported by Defendant Edwards Lifesciences (Compl. ¶11). The complaint does not provide sufficient detail for analysis of the specific technical design, features, or operation of the Sapien 3 device. No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that the Sapien 3 directly infringes at least claims 1, 2, and 3 of the ’608 Patent (Compl. ¶11). However, it does not provide any element-by-element comparison of the accused product's features to the limitations of the asserted claims. The infringement allegations are pleaded generally without a supporting claim chart or a detailed narrative theory of infringement.

  • Identified Points of Contention:
    • Structural Questions: A central dispute would concern whether the Sapien 3 valve incorporates a "fabric seal" that meets the specific structural and positional limitations of claim 1. This raises the question of whether the Sapien 3's outer skirt "extends from the distal end of the replacement valve and back proximally over the expandable anchor" as recited in the claim.
    • Functional Questions: An analysis would require evidence demonstrating that the accused device's sealing mechanism, when implanted, actually forms "flaps that extend into spaces formed by native valve leaflets" to prevent leakage, as the claim requires. The complaint does not present such evidence.

V. Key Claim Terms for Construction

  • The Term: "fabric seal"

    • Context and Importance: This term is central to the claimed invention. The construction of "fabric seal" will be critical, as many transcatheter valves, including the Sapien 3, have an outer skirt for sealing. The dispute would likely center on whether this term covers any external sealing fabric or is limited by the patent's specific disclosure.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term itself is straightforward, and the patent does not provide an explicit, special definition that formally limits its scope beyond its plain meaning.
      • Evidence for a Narrower Interpretation: The patent consistently describes and illustrates the "fabric seal" in a very particular configuration—as a structure (380) that originates from the valve (20) and "bunches up to create fabric flaps and pockets" (’608 Patent, col. 14:26-38; Figs. 32-34). A party may argue that the term is implicitly defined by this sole disclosed embodiment and its unique "extending...and back proximally" arrangement as recited in claim 1 (’608 Patent, col. 22:40-44).

  • The Term: "extends from the distal end of the replacement valve and back proximally over the expandable anchor"

    • Context and Importance: This phrase provides the key structural definition for how the "fabric seal" must be configured in its pre-deployment state. Infringement will turn on whether the accused product's sealing skirt is constructed and arranged in this specific manner.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party might argue this language should be interpreted functionally to cover any outer seal that is attached at or near the inflow portion of the valve and covers the anchor's exterior.
      • Evidence for a Narrower Interpretation: Practitioners may focus on the precise path described. The language requires the seal to originate from the "distal end of the replacement valve" (not the anchor) and travel "back proximally," which suggests a specific folded or everted structure, not simply an attached cylinder of fabric (’608 Patent, col. 22:40-44).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement, asserting that Defendant provides instructions and marketing materials that encourage infringing use of the Sapien 3 (Compl. ¶12). It also alleges contributory infringement, claiming the Sapien 3 is a material component especially made for infringement and not a staple article of commerce (Compl. ¶13).
  • Willful Infringement: The complaint alleges that Defendant had "actual knowledge of the ‘608 patent prior to the filing of this Complaint" and that its continued infringement is "objectively reckless, knowing, deliberate, and willful" (Compl. ¶16).

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

  • Claim Viability: The primary threshold issue is the legal effect of the IPR decision cancelling all asserted claims (1-3). This raises the fundamental question of whether a viable case or controversy remains based on the complaint as pleaded, potentially rendering the infringement action moot.
  • Structural Equivalence: Should the claims be revived or otherwise remain in dispute, a central issue will be one of structural definition: can the claim phrase "fabric seal ... extend[ing] from the distal end of the replacement valve and back proximally over the expandable anchor" be construed to read on the design of the Sapien 3's outer sealing skirt, or is the claim limited to the specific everting/wrapping configuration detailed in the patent’s specification?
  • Evidentiary Sufficiency: Stemming from the notice-pleading style of the complaint, a key evidentiary question will be what proof Plaintiff can provide to establish that the accused Sapien 3 device, in actual use, meets every limitation of the asserted claims, particularly regarding the precise interaction between its sealing skirt and a patient's native anatomy.