DCT

1:16-cv-00275

Boston Scientific Corp v. Edwards Lifesciences Corp

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:16-cv-00275, D. Del., 04/19/2016
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation and, upon information and belief, 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 methods and apparatuses for endovascularly replacing a heart valve.
  • Technical Context: The technology at issue relates to transcatheter heart valve replacement (TAVR), a minimally invasive procedure to replace a diseased heart valve, which serves as an alternative to traditional open-heart surgery.
  • Key Procedural History: Subsequent to the filing of this complaint, an Inter Partes Review (IPR) proceeding (IPR2017-00060) was initiated against the patent-in-suit. The IPR concluded with the issuance of a certificate on February 9, 2021, which cancelled claims 1-4 of the patent, encompassing all claims asserted in this litigation.

Case Timeline

Date Event
2004-06-16 '608 Patent Priority Date
2015-03-31 '608 Patent Issue Date
2016-04-19 Complaint Filing Date
2016-10-12 IPR (IPR2017-00060) Filed
2021-02-09 IPR Certificate Issued Cancelling Claims 1-4

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

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

  • Patent Identification: U.S. Patent No. 8,992,608, "Everting Heart Valve", issued March 31, 2015.

The Invention Explained

  • Problem Addressed: The patent describes the significant risks and long recovery times associated with traditional open-heart valve replacement surgery (U.S. Patent No. 8,992,608, col. 1:21-51). It also notes that prior art for minimally invasive, self-expanding replacement valves suffered from poor deployment accuracy and a lack of sufficient radial strength, which could lead to device migration or improper function ('608 Patent, col. 1:60-2:34).
  • The Patented Solution: The invention is a system for endovascularly replacing a heart valve, comprising an expandable anchor and a replacement valve. A key aspect of the described solution is a "fabric seal" that, from a pre-deployment state, is configured to wrap or "evert" around a portion of the anchor to create a seal against the native heart tissue ('608 Patent, col. 13:25-30; Fig. 32-34). The system is also designed to be repositionable and retrievable before final, irreversible deployment, allowing for better placement accuracy ('608 Patent, col. 2:5-11).
  • Technical Importance: This design approach sought to provide enhanced radial force through "active foreshortening" and to improve sealing against the native anatomy, thereby addressing the critical problems of paravalvular leakage and device migration that challenged early-generation transcatheter valves ('608 Patent, col. 2:11-34).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 2 and 3 (Compl. ¶12).
  • Independent Claim 1 recites the following essential elements:
    • An expandable anchor with a collapsed and an expanded configuration.
    • 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 partially disposed around an exterior portion of the anchor.
    • The fabric seal has an undeployed and a deployed state, and in the deployed state, it comprises "flaps that extend into spaces formed by native valve leaflets."
    • A distal end of the valve leaflet is attached to the fabric seal.
    • Crucially, in the collapsed delivery configuration, the fabric seal "extends from the distal end of the replacement valve and back proximally over the expandable anchor."

III. The Accused Instrumentality

Product Identification

  • Edwards' Sapien 3 Transcatheter Heart Valve (the "Sapien 3") (Compl. ¶1).

Functionality and Market Context

  • The complaint identifies the accused instrumentality by name but does not provide any specific technical details regarding its structure, materials, or method of operation (Compl. ¶1, ¶12). It alleges that Defendant derives substantial revenue from sales of its products in the district (Compl. ¶7).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that the Sapien 3 device directly infringes at least claims 1, 2, and 3 of the ’608 patent (Compl. ¶12). However, it does not provide an element-by-element mapping of the accused product's features to the claim limitations or any substantive narrative infringement theory beyond a conclusory statement. Therefore, a claim chart summary cannot be constructed from the complaint's allegations.

Identified Points of Contention

  • Given the lack of specific infringement allegations, any analysis must focus on the claim language itself. A central dispute, had the claims remained valid, would likely have revolved around the structure and function of the "fabric seal."
    • Scope Questions: A primary question for the court would concern the structural requirements of the "fabric seal." Does the claim term, which recites that the seal "extends from the distal end of the replacement valve and back proximally over the expandable anchor" in the delivery configuration, read on the sealing skirt architecture of the accused Sapien 3 device?
    • Technical Questions: An evidentiary question would be whether the accused product’s sealing mechanism forms "flaps that extend into spaces formed by native valve leaflets" as required by the claim. This raises the factual question of whether the Sapien 3 seal creates such specific structures upon deployment or merely provides a general circumferential seal.

V. Key Claim Terms for Construction

  • The Term: "fabric seal ... extends from the distal end of the replacement valve and back proximally over the expandable anchor"
  • Context and Importance: This limitation, found in claim 1, describes a unique structural arrangement of the sealing component in its pre-deployment state. The interpretation of this phrase is critical, as it appears to define a specific "everting" or "folded-over" architecture that may distinguish the invention from other transcatheter valve designs. Practitioners may focus on this term because the infringement analysis would hinge on whether the accused Sapien 3 is assembled and delivered in this particular configuration.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue that "fabric seal" should be interpreted broadly to cover various materials, as the specification discloses that the seal may comprise "a permeable or impermeable fabric, a fabric that promotes or retards tissue ingrowth, a sealing foam, etc." ('608 Patent, col. 17:13-16).
    • Evidence for a Narrower Interpretation: The explicit geometric path described in the claim—extending distally and then folding "back proximally over the expandable anchor"—suggests a very specific structure ('608 Patent, col. 22:1-5). Embodiments like the one shown in Figure 32, depicting seal 380 extending over anchor 30, could be used to argue that the claim is limited to this precise folded-over delivery configuration and does not cover conventional sealing skirts that simply extend downward from an anchor frame.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement based on Defendant’s marketing, sale, and provision of instructions on how to use the Sapien 3 (Compl. ¶13). It further alleges contributory infringement, stating the Sapien 3 is a material part of the invention, is not a staple article of commerce, and is sold by Defendant with knowledge that it is especially made for use in an infringing manner (Compl. ¶14).
  • Willful Infringement: The complaint alleges willful infringement based on Defendant having "actual knowledge of the ‘608 patent prior to the filing of this Complaint" and continuing to infringe in a manner that is "objectively reckless, knowing, deliberate, and willful" (Compl. ¶17).

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

  1. A central and likely dispositive issue is procedural viability: Given that the U.S. Patent and Trademark Office issued an Inter Partes Review certificate cancelling all asserted claims (1-3) of the '608 patent after the complaint was filed, what legal basis, if any, remains for this infringement action to proceed?
  2. Assuming the claims were still valid, a key substantive issue would be one of structural correspondence: Does the accused Sapien 3 device possess a "fabric seal" that, in its pre-deployment delivery configuration, physically "extends from the distal end of the replacement valve and back proximally over the expandable anchor" as strictly required by Claim 1, or does its sealing architecture differ fundamentally from this claimed structure?