DCT
1:10-cv-11646
Boston Scientific Corp v. Cook Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Boston Scientific Corporation, et al. (Delaware)
- Defendant: Cook, Inc., et al. (Indiana)
- Plaintiff’s Counsel: Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
- Case Identification: 1:10-cv-11646, D. Mass., 09/27/2010
- Venue Allegations: Venue is alleged to be proper in the District of Massachusetts because Defendants are subject to personal jurisdiction in the district, conduct business there, and a substantial part of the events giving rise to the claims allegedly occurred in the district.
- Core Dispute: Plaintiff alleges that Defendants’ endoscopy stents and delivery systems infringe four patents related to the design and construction of medical stents used to treat diseases of the digestive system.
- Technical Context: The technology concerns self-expanding medical stents, which are mesh-like tubes used to hold open constricted passages (strictures) in the body, particularly the esophagus.
- Key Procedural History: The complaint does not reference any prior litigation, Inter Partes Review (IPR) proceedings, or licensing history concerning the patents-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 1992-05-08 | U.S. Patent No. 5,876,448 Priority Date |
| 1993-12-28 | U.S. Patent No. 6,007,574 Priority Date |
| 1995-12-29 | U.S. Patent Nos. 6,533,810 & 6,818,015 Priority Date |
| 1999-03-02 | U.S. Patent No. 5876448 Issued |
| 1999-12-28 | U.S. Patent No. 6007574 Issued |
| 2003-03-18 | U.S. Patent No. 6533810 Issued |
| 2004-11-16 | U.S. Patent No. 6818015 Issued |
| 2010-09-27 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,007,574 - “Stent,” issued December 28, 1999
The Invention Explained
- Problem Addressed: The patent describes prior art stents as having drawbacks related to either being too rigid or lacking uniform pressure distribution. Furthermore, stents constructed from multiple threads joined by methods like welding can have altered physical-mechanical properties at the joints, creating weak points and potential for unreliability (’574 Patent, col. 2:46-58). Free ends of threads can also cause injury to tissue (’574 Patent, col. 2:25-33).
- The Patented Solution: The invention proposes a stent formed by interlaced elastic threads arranged in helical turns. Critically, the ends of the stent are not created by joining separate threads, but by having the turns of one helical line "merge into those of the other," appearing as a continuous "bend of a single thread segment" (’574 Patent, col. 3:1-7; Abstract). This construction avoids welds or joints, aiming to preserve uniform mechanical properties throughout the stent and eliminate injurious free ends.
- Technical Importance: This design sought to create a stent with high elasticity and the ability to be compressed into a small-diameter delivery system, while maintaining the requisite structural rigidity and uniform pressure distribution necessary for effective treatment (’574 Patent, col. 4:30-47).
Key Claims at a Glance
- The complaint does not specify which claims are asserted. Independent claim 1 is representative of the core technology.
- Independent Claim 1 requires:
- A stent shaped as a three-dimensional body formed from two groups of elongated elastic threads in a helical configuration with opposite winding directions.
- The threads of the first group are interwoven with the threads of the second group.
- At least one elongated element is made of the same thread as at least one other elongated element.
- The portion of the thread connecting these elements is a "curvilinear segment" with a shape and orientation "substantially different" from the elongated elements.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 6,533,810 - “Conical Stent,” issued March 18, 2003
The Invention Explained
- Problem Addressed: The patent identifies stent migration as a significant problem, particularly for stents placed at the junction of the esophagus and stomach, where peristaltic movements are common and one end of the stent may not be anchored against a vessel wall (’810 Patent, col. 1:16-27). Stents can also deform in curved body passages, creating a risk of closing the passage (’810 Patent, col. 1:31-33).
- The Patented Solution: The patent describes a flexible, self-expanding braided stent with a "differential geometry." It comprises a proximal segment with a larger diameter and a distal segment with a smaller diameter, connected by an intermediate "truncated cone" segment (’810 Patent, col. 2:45-54). This design is intended to create a stronger anchoring force at the wider proximal end while allowing the narrower distal end greater flexibility to navigate curves (’810 Patent, col. 2:54-65).
- Technical Importance: The conical design aimed to provide a more secure anchor to prevent migration in high-movement areas of the body, while simultaneously improving flexibility to reduce the risk of kinking or vessel closure in curved anatomies (’810 Patent, col. 3:1-4).
Key Claims at a Glance
- The complaint does not specify which claims are asserted. Independent claim 1 is representative of the core technology.
- Independent Claim 1 requires:
- A body insertable stent.
- A flexible self-expandable tubular wall incorporating at least one "truncated conical segment."
- The segment has a distal end with a certain diameter and a proximal end with a larger diameter.
- The "radial force of the tubular wall increases in the proximal direction" along the segment.
- The complaint does not explicitly reserve the right to assert dependent claims.
Multi-Patent Capsule: U.S. Patent No. 6,818,015
- Patent Identification: U.S. Patent No. 6,818,015, "Conical Stent," issued November 16, 2004 (Compl. ¶36).
- Technology Synopsis: Continuing the work of the related ’810 Patent, this patent describes a stent with a differential geometry, featuring a wider tubular segment and a second, narrower segment. The invention aims to provide a high radial force for strong anchoring in one portion of the stent while allowing for greater flexibility in another portion, thereby addressing the technical problems of stent migration and deformation in curved body passages (’015 Patent, col. 1:10-34; col. 2:47-64).
- Asserted Claims: The complaint does not specify which claims are asserted.
- Accused Features: The complaint alleges that the "EVOLUTION," "NITI-S," and "BONASTENT" stents and delivery systems infringe the ’015 Patent (Compl. ¶¶ 37-39).
Multi-Patent Capsule: U.S. Patent No. 5,876,448
- Patent Identification: U.S. Patent No. 5,876,448, "Esophageal Stent," issued March 2, 1999 (Compl. ¶43).
- Technology Synopsis: This patent addresses the dual problems of tumor ingrowth through the open mesh of a stent and stent migration. The proposed solution is a self-expanding stent with distinct regions: a coated "barrier region" in the middle to block tumor ingrowth, and uncoated "fixation region" cuffs at the proximal and distal ends. The cuffs are designed to have a larger relaxed diameter than the medial region to better engage the esophageal wall and resist migration (’448 Patent, Abstract; col. 3:13-35).
- Asserted Claims: The complaint does not specify which claims are asserted.
- Accused Features: The complaint alleges that the "EVOLUTION stents and delivery devices" made and sold by the Cook Defendants infringe the ’448 Patent (Compl. ¶44).
III. The Accused Instrumentality
- Product Identification: The accused instrumentalities are identified by their brand names:
- "EVOLUTION® stents and delivery devices" (sold by Cook Defendants) (Compl. ¶11).
- "NITI-S™ stents and delivery devices" (sold by Taewoong Defendant) (Compl. ¶13).
- "BONASTENT® stents and delivery devices" (sold by Standard Sci-Tech Defendants) (Compl. ¶17).
- Functionality and Market Context:
- The complaint describes these products generally as "endoscopy products for the treatment of diseases of the digestive system" (Compl. ¶¶ 11, 13, 17).
- No probative visual evidence provided in complaint.
- The complaint does not provide specific technical details about the construction, materials, or method of operation of the accused stents or delivery systems. It also makes no specific allegations regarding the products' market share or commercial importance, other than to state that Defendants "make, use, offer for sale, sell... and/or import" them into the U.S. (Compl. ¶¶ 11, 13, 17).
IV. Analysis of Infringement Allegations
The complaint does not assert specific claims or provide claim charts. The following tables summarize the allegations for representative independent claim 1 of the lead patents, mapping the claim elements to the general allegations against the accused product lines.
’574 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A stent shaped as a three-dimensional body...formed by two groups...of elongated elements (1), each...being formed from an elastic thread extending in a helical configuration...the elements of the first group having a common first direction of winding and the elements of the second group having a common second direction of winding opposite to the first direction | The complaint alleges that the EVOLUTION, NITI-S, and BONASTENT stents are three-dimensional bodies formed from helically wound elastic threads. | ¶¶ 23, 24, 25 | col. 5:1-4 |
| the elongated elements (1) of the first and second groups (2, 3) are...interwoven with the elongated elements of the same group; the elongated elements of the first group (2) are interwoven with the elongated elements of the second group (3) | The complaint alleges that the accused stents feature interwoven threads. | ¶¶ 23, 24, 25 | col. 5:2-4 |
| each portion of the thread for connecting elements made of the same thread is formed as a curvilinear segment (5) having a length substantially less than a length of the body...and a shape and orientation substantially different from shape and orientation of any of the elongated elements (1). | The complaint alleges that the accused stents practice the claimed invention, which includes the feature of connecting thread elements via a curvilinear segment rather than a separate joint. | ¶¶ 23, 24, 25 | col. 3:1-7 |
’810 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A body insertable stent, including: a flexible self-expandable tubular wall incorporating at least one truncated conical segment disposed about a longitudinal axis; | The complaint alleges that the EVOLUTION, NITI-S, and BONASTENT stents are flexible, self-expanding tubular walls that incorporate a conical or tapered segment. | ¶¶ 30, 31, 32 | col. 2:45-54 |
| wherein the truncated conical segment has a distal end with a distal end diameter, and a proximal end with a proximal end diameter larger than the distal end diameter; | The complaint alleges that the accused stents have a tapered geometry where one end is wider than the other. | ¶¶ 30, 31, 32 | col. 2:48-51 |
| and wherein a radial force of the tubular wall increases in the proximal direction along the at least one truncated conical segment. | The complaint alleges the accused stents practice the claimed invention, which requires that the radial force increases along the tapered section toward the wider end. | ¶¶ 30, 31, 32 | col. 2:54-58 |
- Identified Points of Contention:
- Pleading Sufficiency: A threshold legal question is whether the complaint's allegations, which identify product lines but do not specify accused models or describe how they meet each limitation of any asserted claim, satisfy the plausibility pleading standard established by Bell Atlantic Corp. v. Twombly and Ashcroft v. Iqbal.
- Technical Questions: A key technical question for the ’574 Patent will be whether the accused stents form their ends using a continuous "curvilinear segment" of a single thread, as claimed, or if they use other means of joining or terminating threads. For the ’810 Patent, a central question will be whether the accused stents exhibit the claimed functional relationship where "radial force... increases in the proximal direction" along the tapered segment, and what evidence Plaintiff can marshall to prove this functional limitation.
V. Key Claim Terms for Construction
- Term from ’574 Patent: "curvilinear segment"
- Context and Importance: This term is central to the asserted novelty of the ’574 Patent, which distinguishes itself from prior art by avoiding welded or joined ends. The definition of this connecting segment will be critical to determining whether a stent made of woven threads infringes.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states the segment can have "various shapes, e.g. of a circular arc, a loop or an U-shaped" (col. 4:7-9), suggesting the term is not limited to a single geometry.
- Evidence for a Narrower Interpretation: The abstract and detailed description repeatedly emphasize that these segments appear "as a bend of a single thread segment" (col. 3:6-7), which may support a narrower construction requiring a smooth, continuous bend rather than any non-linear connection between helical portions.
- Term from ’810 Patent: "truncated conical segment"
- Context and Importance: This term defines the "differential geometry" that is the core of the ’810 Patent's solution to stent migration. Its construction will determine the scope of stent shapes that fall within the claims.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the goal of creating a "differential geometry" and a "varying steep angle" (col. 2:56-58), which could be read to encompass any structure that achieves a gradual taper, including one formed by multiple, discrete sections. Figure 5 shows an intermediate segment (78) formed of two consecutive truncated cones (79, 90).
- Evidence for a Narrower Interpretation: The primary embodiment shown in Figure 1 depicts a single, continuous tapered segment (15) between the cylindrical portions. A defendant might argue that the term requires this specific, unitary structure, and that a stepped or multi-part transition does not meet the limitation.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants are "actively inducing and/or contributing to infringement by others under 35 U.S.C. §§ 271(b) and (c)" (Compl. ¶23). It does not, however, plead any specific facts to support the knowledge and intent elements of these claims, such as referencing user manuals, product instructions, or marketing materials that would allegedly instruct others to infringe.
- Willful Infringement: The complaint does not contain an explicit count for willful infringement or use the term "willful." However, the prayer for relief requests "a judgment holding that this is an exceptional case under 35 U.S.C. § 285 and awarding Plaintiffs reasonable attorneys' fees" (Prayer ¶(d)). The complaint does not allege any facts, such as pre-suit knowledge of the patents, to support a finding of willfulness or exceptionality.
VII. Analyst’s Conclusion: Key Questions for the Case
- Pleading Sufficiency: A foundational issue will be whether the complaint, filed prior to the 2015 abrogation of Form 18, pleads sufficient factual content to state a plausible claim for relief under the Twombly/Iqbal standard, given its identification of broad product categories without specifying claims or mapping claim elements to accused features.
- Definitional Scope: The case may turn on claim construction, particularly the scope of terms defining the unique geometries of the inventions. A key question for the court will be one of structural interpretation: does the ’574 Patent’s term "curvilinear segment" require a specific type of continuous bend, and do the ’810 and ’015 Patents’ claims to a "truncated conical segment" read on stents with stepped or multi-part tapers?
- Evidentiary Proof of Function: A central evidentiary challenge for the plaintiff will be to prove the functional limitations of the claims. For example, regarding the ’810 patent, can the plaintiff demonstrate through testing or technical analysis that the accused conical stents actually exhibit an increasing "radial force... in the proximal direction" as required by the claims?