DCT
1:10-cv-00039
Cordis Corp v. Boston Scientific Corp
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Cordis Corporation (Florida / New Jersey)
- Defendant: Boston Scientific Corporation (Delaware / Massachusetts) and Boston Scientific Scimed, Inc. (Minnesota / Minnesota)
- Plaintiff’s Counsel: Ashby & Geddes
- Case Identification: 1:10-cv-00039, D. Del., 01/15/2010
- Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant Boston Scientific Corporation is incorporated in Delaware and both defendants conduct systematic and continuous business in the district, including the sale of the accused medical devices.
- Core Dispute: Plaintiff alleges that Defendant’s PROMUS® drug-eluting stent infringes three patents related to flexible coronary stent designs featuring undulating connecting members.
- Technical Context: The technology concerns vascular stents, expandable mesh tubes used to treat constricted arteries, a cornerstone of modern interventional cardiology.
- Key Procedural History: The three asserted patents are part of a single family and claim the same earliest priority date. All three patents stem from a chain of continuation applications originating from an application filed in February 1994, which may be relevant to determining the scope of applicable prior art.
Case Timeline
| Date | Event |
|---|---|
| 1994-02-25 | Earliest Priority Date ('604', '817', '240' Patents) |
| 2000-07-11 | U.S. Patent No. 6,086,604 Issues |
| 2003-04-15 | U.S. Patent No. 6,547,817 Issues |
| 2004-04-06 | U.S. Patent No. 6,716,240 Issues |
| 2008-07-02 | Alleged First Date of Accused Activity (Import of PROMUS® Stent) |
| 2010-01-15 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,086,604 - "Stent Having a Multiplicity of Undulating Longitudinals" (Issued Jul. 11, 2000)
The Invention Explained
- Problem Addressed: The patent's background describes a challenge in stent design: achieving sufficient "hoop strength" to prevent a treated vessel from collapsing (elastic recoil) while maintaining enough flexibility for the stent to be delivered through small, tortuous arteries (Compl., Ex. A, '604' Patent, col. 1:17-25). Prior art designs like open helical coils or those without closed circular structures were identified as having suboptimal hoop strength (Compl., Ex. A, '604' Patent, col. 1:25-34).
- The Patented Solution: The invention proposes a stent constructed from a series of closed, zig-zag ring segments joined by longitudinal connectors. To solve the flexibility problem, the patent discloses that at least one of these longitudinal connectors has an "undulating shape" (Compl., Ex. A, '604' Patent, col. 3:47-53). This design, illustrated in Figure 8, allows the stent to bend more easily during delivery without sacrificing the radial strength provided by the closed-ring structure upon expansion (Compl., Ex. A, '604' Patent, Abstract).
- Technical Importance: This design sought to provide a superior balance between the competing demands of flexibility for deliverability and radial strength for therapeutic efficacy, a critical consideration for stents placed in curved coronary arteries (Compl., Ex. A, '604' Patent, col. 1:59-64).
Key Claims at a Glance
- The complaint asserts "one or more claims" of the '604' patent without specification (Compl., Prayer for Relief ¶1). Independent Claim 1 is representative and includes the following key elements:
- A predeployment stent comprising a thin-walled metal cylinder.
- A multiplicity of continuous closed circumferential zig-zag segments.
- The segments are joined by one or more longitudinals.
- At least a portion of at least one longitudinal has an "undulating shape."
- The first and second end segments are formed at least in part from a radiopaque metal.
U.S. Patent No. 6,547,817 - "Stent Having a Multiplicity of Undulating Longitudinals" (Issued Apr. 15, 2003)
The Invention Explained
- Problem Addressed: As with the '604' patent, the invention addresses the need to design a stent that can be percutaneously delivered through a curved vessel while providing strong radial support once deployed (Compl., Ex. B, '817' Patent, col. 1:15-42).
- The Patented Solution: This patent refines the concept of the flexible connector. The claims describe a "longitudinally extending connector" that joins adjacent circumferential rings. The key feature is that this connector has "at least one circumferentially extending turn back portion" that can "expand or contract in length" as the stent navigates a curve (Compl., Ex. B, '817' Patent, Abstract). This specific geometry, shown in Figure 8, provides a mechanism for accommodating the compression and tension forces experienced during delivery through a curved path (Compl., Ex. B, '817' Patent, col. 3:54-58).
- Technical Importance: The claimed connector design provides an explicit mechanical solution for achieving longitudinal flexibility, allowing the stent's overall length to change dynamically during delivery.
Key Claims at a Glance
- The complaint asserts "one or more claims" of the '817' patent without specification (Compl., Prayer for Relief ¶2). Independent Claim 1 is representative and includes the following key elements:
- A generally cylindrical stent with sufficient flexibility for delivery to a curved coronary artery.
- At least two longitudinally spaced apart circumferential rings with closed ends.
- At least one longitudinally extending connector fixedly connecting the adjacent rings.
- The connector has at least one "circumferentially extending turn back portion" between its ends.
- This turn back portion can "expand or contract in length" while being passed through a curved coronary artery.
U.S. Patent No. 6,716,240 - "Stent Having a Multiplicity of Undulating Longitudinals" (Issued April 6, 2004)
- Patent Identification: U.S. Patent No. 6,716,240, "Stent Having a Multiplicity of Undulating Longitudinals," Issued April 6, 2004 (Compl. ¶9).
- Technology Synopsis: This patent, part of the same family, also describes a stent designed for flexibility and strength. Its claims are directed to a stent made of a "thin-walled metal cylinder" with "circumferentially relatively rigid portions" joined by "longitudinals," at least a portion of which has an "undulating shape" to facilitate placement in curved vessels (Compl., Ex. C, '240' Patent, Abstract; col. 5:1-10). The claims further detail various structural configurations and relationships between these components.
- Asserted Claims: The complaint asserts "one or more claims" without further specification (Compl., Prayer for Relief ¶3). The patent contains multiple independent claims, including claims 1, 8, 19, 21, 31, 40, 49, and 58.
- Accused Features: The complaint makes a general allegation that the PROMUS® stent infringes, without identifying specific features corresponding to the claims of the '240' patent (Compl. ¶20).
III. The Accused Instrumentality
Product Identification
The accused product is the PROMUS® drug-eluting stent (Compl. ¶10).
Functionality and Market Context
The complaint identifies the PROMUS® stent as a "drug/device combination for the treatment of coronary artery disease" that directly competes with Plaintiff's own CYPHER® stent (Compl. ¶¶1, 13). The complaint alleges that Defendant imports, offers for sale, and sells the PROMUS® stent in the United States (Compl. ¶10). No probative visual evidence provided in complaint. The complaint does not provide sufficient detail for analysis of the specific technical structure or design of the PROMUS® stent.
IV. Analysis of Infringement Allegations
The complaint does not contain specific factual allegations or claim charts. The following tables summarize the infringement theory that is necessarily implied by the complaint's allegation that the PROMUS® stent infringes the representative independent claims of the '604' and '817' patents.
'604 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a multiplicity of continuous closed circumferential zig-zag segments... | The PROMUS® stent is constructed from multiple, continuous, ring-like segments that form the main body of the device. | ¶12 | col. 5:6-8 |
| ...the zig-zag segments being joined one to the other by one or more longitudinals... | The ring-like segments of the PROMUS® stent are interconnected by one or more struts that run generally along the stent's length. | ¶12 | col. 5:8-10 |
| ...at least a portion of at least one of said longitudinals having an undulating shape; | At least one of the connecting struts on the PROMUS® stent has a non-straight, wavy, or curved geometry. | ¶12 | col. 5:10-12 |
'817 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| at least two longitudinally spaced apart circumferential rings having closed ends... | The PROMUS® stent is comprised of at least two distinct, closed-loop structural rings. | ¶16 | col. 5:6-8 |
| at least one longitudinally extending connector having a first end portion and a second end portion... fixedly connected to a first... and... an adjacent circumferential ring... | The rings of the PROMUS® stent are joined by a distinct connecting element. | ¶16 | col. 5:12-18 |
| ...said connector having at least one circumferentially extending turn back portion... that can expand or contract in length... | The connecting element of the PROMUS® stent includes at least one bend or curve that allows it to flex and change its effective length when navigating a turn. | ¶16 | col. 5:18-22 |
- Identified Points of Contention:
- Evidentiary Questions: The complaint's lack of factual detail raises the primary question of what evidence Plaintiff will adduce to show that the physical structure of the PROMUS® stent practices each limitation of the asserted claims. The specific geometry and material composition of the accused stent will be central.
- Scope Questions: A likely point of dispute is whether the specific connector geometry of the PROMUS® stent falls within the scope of the patent claims. For the '604' patent, this raises the question of what constitutes an "undulating shape." For the '817' patent, the dispute may focus on whether the accused connector has a "turn back portion" and whether it "expand[s] or contract[s] in length" in the manner required by the claim.
V. Key Claim Terms for Construction
The Term: "undulating shape" ('604' Patent, Claim 1)
- Context and Importance: This term is central to the novelty asserted in the '604' patent. The infringement analysis will depend heavily on whether the shape of the connectors on the PROMUS® stent is properly characterized as "undulating." Practitioners may focus on this term because its construction will likely define the boundary between the patented invention and prior art or non-infringing designs.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification uses the term without a rigid definition, referring generally to "undulating shaped longitudinals," which may support a construction covering a wide variety of non-linear connector shapes (Compl., Ex. A, '604' Patent, col. 3:51-53).
- Evidence for a Narrower Interpretation: The primary embodiment illustrating this feature is Figure 8. A defendant could argue the term should be limited to the specific, repeating S-curve geometry depicted in that figure (Compl., Ex. A, '604' Patent, Fig. 8).
The Term: "circumferentially extending turn back portion" ('817' Patent, Claim 1)
- Context and Importance: This term appears to be a more specific definition of the flexible connector concept. Its construction will be critical for determining infringement of the '817' patent and distinguishing it from the '604' patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The language could be interpreted to mean any part of the connector that reverses its directional path along the stent's circumference, such as a simple U-shaped bend. The abstract's focus is on the ability to "expand or contract in length" (Compl., Ex. B, '817' Patent, Abstract).
- Evidence for a Narrower Interpretation: The associated functional language requiring that the portion "can expand or contract in length... while being passed through a curved coronary artery" may be used to narrow the term to structures that demonstrably perform this specific mechanical function, potentially limiting it to the S-shaped embodiment in Figure 8 (Compl., Ex. B, '817' Patent, col. 5:18-22).
VI. Other Allegations
- Willful Infringement: The complaint alleges that Defendant’s infringement has been willful and deliberate. This allegation is based "upon information and belief" that Defendant "has been aware" of the patents-in-suit and has "knowledge of the infringing nature of its activities" (Compl. ¶¶14, 18, 22). The complaint does not plead specific facts to support this knowledge, such as prior correspondence or litigation.
VII. Analyst’s Conclusion: Key Questions for the Case
- A threshold issue will be one of evidentiary proof: given the complaint's bare-bones nature, can Plaintiff produce technical evidence demonstrating that the specific physical architecture of the PROMUS® stent maps onto each structural limitation of the asserted claims?
- The case will likely turn on claim construction: how will the court define the scope of key terms describing the connector geometry, such as "undulating shape" ('604' patent) and "circumferentially extending turn back portion" ('817' patent)? The relative breadth or narrowness of these definitions will be a determinative factor in the infringement analysis.
- A central strategic question will be one of patent differentiation: as the three asserted patents originate from the same specification and claim similar subject matter, the parties will have to articulate, and the court will have to resolve, how the scope of the asserted claims of each patent is distinct, which will be critical for proving separate acts of infringement for each patent.