DCT

1:18-cv-00392

Board Of Regents University Of Texas System v. Boston Scientific Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-00392, D. Del., 09/17/2021
  • Venue Allegations: Plaintiffs allege that Defendant waived any venue defense by moving to transfer this action to the District of Delaware and subsequently participating in discovery and other court proceedings.
  • Core Dispute: Plaintiffs allege that Defendant’s SYNERGY line of everolimus-eluting coronary stents infringes a patent related to drug-releasing, biodegradable polymer fibers.
  • Technical Context: The technology concerns drug-eluting medical implants, specifically coronary stents that use a biodegradable polymer to release a therapeutic agent over time to prevent arterial re-narrowing (restenosis) following an angioplasty procedure.
  • Key Procedural History: The First Amended Complaint removes allegations concerning a related patent, U.S. Patent No. 7,033,603, which was the subject of a prior dismissal without prejudice. The complaint alleges that Defendant had pre-suit knowledge of the asserted patent, U.S. Patent No. 6,596,296, as early as 2007 from its own patent prosecution activities and from direct business development meetings with the inventor in 2008. The complaint further notes that Defendant did not challenge the validity of the '296 patent via an inter partes review (IPR) proceeding after the lawsuit was filed.

Case Timeline

Date Event
1999-08-06 '296 Patent Priority Date
2003-07-22 '296 Patent Issue Date
2011-11-20 Alleged Start of Infringement / Damages Period
2014-09-01 Approx. date of study using Accused SYNERGY Stents
2015-01-20 Approx. date of FDA Premarket Approval Application for SYNERGY Stents
2015-10-02 FDA Approval of SYNERGY BP Stents
2017-11-20 Original Complaint Filing Date
2020-08-18 Alleged End of Infringement / Damages Period ('296 Patent Expiration)
2021-09-17 First Amended Complaint Filing Date

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

U.S. Patent No. 6,596,296 - "Drug Releasing Biodegradable Fiber Implant"

  • Patent Identification: U.S. Patent No. 6,596,296, "Drug Releasing Biodegradable Fiber Implant," issued July 22, 2003.

The Invention Explained

  • Problem Addressed: The patent addresses limitations in tissue engineering and drug delivery, particularly for medical implants like stents (Compl. ¶¶12-13). At the time, prevailing technologies often used permanent (non-biodegradable) polymers that could cause long-term inflammation and other adverse effects, while biodegradable alternatives struggled to provide consistent, controlled release of therapeutic agents ('296 Patent, col. 2:5-14). The industry largely believed biodegradable polymers were not commercially viable for this purpose (Compl. ¶26).
  • The Patented Solution: The invention proposes a biodegradable polymer fiber for delivering therapeutic agents. The core innovation is a fiber composed of two "immiscible" phases: a continuous polymer phase (the fiber structure) and a discontinuous second phase dispersed within it, which contains the therapeutic agent(s) ('296 Patent, Abstract; Compl. ¶27). This structure allows for tunable and controlled drug release as the fiber biodegrades, providing a way to modulate both the spatial and temporal release of drugs to promote healing ('296 Patent, col. 2:40-59).
  • Technical Importance: This approach represented a departure from the industry's focus on permanent polymer coatings, proposing a fully biodegradable system designed for controlled, multi-phase drug delivery (Compl. ¶26).

Key Claims at a Glance

  • The complaint asserts independent claim 1.
  • The essential elements of independent claim 1 are:
    • A composition comprising at least one biodegradable polymer fiber
    • wherein said fiber is composed of a first phase and a second phase,
    • the first and second phases being immiscible, and
    • wherein the second phase comprises one or more therapeutic agents.
  • The complaint also asserts dependent claims 11, 12, 17, and 26, and incorporates a claim chart by reference (Compl. ¶79).

III. The Accused Instrumentality

Product Identification

  • The SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System and related models (collectively, "SYNERGY BP Stents") (Compl. ¶3).

Functionality and Market Context

  • The SYNERGY BP Stent is a metallic coronary stent featuring an "ultrathin biodegradable polymer" on its abluminal (outside) surface (Compl. ¶3). This polymer is an 85:15 PLGA [poly(DL-lactide-co-glycolide)] matrix (Compl. ¶3). The complaint alleges that this polymer coating contains the therapeutic drug everolimus in the form of "everolimus-rich domains dispersed throughout" the PLGA matrix (Compl. ¶3). The complaint highlights a field emission scanning electron microscopy (FESEM) image, attributed to the Defendant, which depicts a "PLGA rich domain" and a "Drug rich domain," allegedly showing the two-phase structure of the coating (Compl. ¶4). Plaintiffs assert that the SYNERGY BP Stent was the first FDA-approved stent in the U.S. with an abluminal bioabsorbable polymer coating, designed to overcome challenges associated with permanent polymer stents (Compl. ¶65).

IV. Analysis of Infringement Allegations

'296 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition comprising at least one biodegradable polymer fiber The accused SYNERGY BP Stent includes an "ultrathin bioabsorbable 85:15 PLGA polymer" positioned on its outside surface, which is alleged to be the claimed "fiber." ¶80 col. 1:31-33
wherein said fiber is composed of a first phase and a second phase, The polymer is alleged to be composed of a "first phase" in the form of an "85:15 PLGA polymer-rich matrix" and a "second phase" in the form of "discrete, everolimus-rich domains." ¶80 col. 2:50-52
the first and second phases being immiscible, and The PLGA polymer-rich matrix is alleged to be "not miscible with" the everolimus-rich domains dispersed throughout it. ¶80 col. 18:3-6
wherein the second phase comprises one or more therapeutic agents. The "second phase" of everolimus-rich domains contains everolimus, which is alleged to be a "therapeutic agent." ¶80 col. 2:45-47
  • Identified Points of Contention:
    • Scope Questions: A primary dispute may arise over the claim term "fiber." The infringement theory equates a polymer coating applied to a stent with the claimed "fiber." The defense may argue that the patent's specification, which describes methods of spinning discrete fibers and weaving them into scaffolds ('296 Patent, col. 22:43-47; Fig. 8), limits the term "fiber" to a pre-formed, standalone structure, not a coating.
    • Technical Questions: The complaint alleges the polymer matrix and the drug-rich domains are "immiscible." The question for the court will be what level of evidence, such as the FESEM image provided (Compl. ¶4), is required to demonstrate that the components form two distinct, immiscible phases as required by the claim, rather than a different form of mixture.

V. Key Claim Terms for Construction

  • The Term: "biodegradable polymer fiber"
  • Context and Importance: The construction of this term appears central to the dispute. The Plaintiffs' infringement case rests on the theory that the polymer coating on the SYNERGY stent is a "fiber." The Defendant will likely argue its product has a coating, not a fiber, making this term's definition critical to determining infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not provide a single, explicit definition of "fiber." A plaintiff could argue that any elongated polymer construct that performs the drug delivery function falls within the plain meaning. The patent mentions that fibers can be used "in conjunction with commercially available stents to deliver drugs" and "would not provide any mechanical support, but would only serve as a drug delivery reservoir" ('296 Patent, col. 22:48-51), which may support a functional definition not strictly limited to woven, structural elements.
    • Evidence for a Narrower Interpretation: The specification repeatedly describes fabricating fibers through extrusion and spinning processes and then weaving, braiding, or knitting them into scaffolds ('296 Patent, Example 1; Fig. 1, Fig. 8). The patent also describes applying coatings to a "pre-existing fiber" ('296 Patent, col. 20:12-14), suggesting the patentee distinguished between a "fiber" and a "coating." Further, the complaint notes that in prosecuting a separate application, BSX argued that the '296 patent taught that "the fibers themselves are used alone" (Compl. ¶52).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant induced infringement by "directing, contracting with, supporting, and/or otherwise encouraging the use" of the SYNERGY stents (Compl. ¶89). Specific alleged acts include sponsoring clinical trials, providing instructions for use, and offering education and customer support to surgeons and clinicians (Compl. ¶89).
  • Willful Infringement: The willfulness allegation is based on both pre-suit and post-suit conduct. The complaint alleges pre-suit knowledge dating back to at least 2007, when Defendant's agents allegedly cited the '296 patent during the prosecution of its own patent application (Compl. ¶47). It also alleges direct meetings in 2008 and 2009 between Defendant's executives and the inventor, Dr. Nelson, where the patented technology was discussed (Compl. ¶¶53-57). Post-suit willfulness is alleged based on Defendant’s continued infringement after the original complaint was filed in November 2017 (Compl. ¶77, ¶85).

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

  • A core issue will be one of definitional scope: can the term "biodegradable polymer fiber," as used in the context of the '296 patent's disclosure of weaving and spinning discrete filaments, be construed to read on the "ultrathin" polymer coating applied to the surface of the accused SYNERGY stent?
  • A key evidentiary question will be one of technical proof: does the evidence presented in the complaint, primarily the FESEM image showing distinct "drug rich" and "PLGA rich" domains, suffice to establish that the accused coating is composed of two "immiscible" phases as claimed, or is there a fundamental mismatch in the material's structure?
  • A central question for willfulness and enhanced damages will be the state of mind of the Defendant, hinging on the extensive pre-suit history alleged in the complaint, including Defendant's own patent prosecution history and direct meetings with the inventor concerning the technology.