Boston Scientific Corp v. Stryker Corp

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Boston Scientific Corporation and Relievant Medsystems, Inc. (Delaware)
  • Defendant: Stryker Corporation (Michigan)
  • Plaintiff’s Counsel: Arnold & Porter Kaye Scholer LLP
• Case Identification: 2:25-cv-12700, D.N.J., 07/02/2025
• Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Stryker is subject to personal jurisdiction there, will imminently commit acts of infringement in the state, and maintains a regular and established place of business in the district, specifically its Stryker Orthopaedics division in Mahwah, New Jersey.
• Core Dispute: Plaintiffs seek a declaratory judgment that Defendant’s imminent commercial launch of its OptaBlate BVN System will infringe a patent related to methods for accessing and ablating the basivertebral nerve within a vertebra to treat chronic pain.
• Technical Context: The technology involves minimally invasive surgical systems that create a curved path through vertebral bone to deliver radiofrequency (RF) energy for ablating nerves, a procedure known as basivertebral nerve ablation (BVNA).
• Key Procedural History: This is a declaratory judgment action filed before the accused product's commercial launch. The complaint notes that Defendant Stryker obtained FDA 510(k) clearance for its accused OptaBlate product by claiming it is "substantially equivalent" to Plaintiff Boston Scientific’s own Intracept® product, which embodies the patented technology. Plaintiff Relievant Medsystems, the original patent owner, was acquired by Boston Scientific Corporation in 2023.

Case Timeline

Date	Event
2006-01-01	Relievant founded (approximate, based on complaint)
2008-09-26	’166 Patent Priority Date
2009-01-22	Relievant receives FDA clearance for INTRACEPT Flexible Bi-Polar RF Probe
2011-01-01	Relievant begins SMART Trial (approximate, based on complaint)
2016-07-01	Intracept® Procedure receives 510(k) clearance based on SMART Trial results (approximate, based on complaint)
2017-07-01	Relievant begins INTRACEPT clinical trial (approximate, based on complaint)
2021-10-01	CDC designates new ICD-10-CM diagnosis code for vertebrogenic low back pain
2023-11-17	Boston Scientific Corporation acquires Relievant Medsystems, Inc.
2025-05-15	Stryker receives 510(k) FDA clearance for OptaBlate BVN product
2025-05-20	’166 Patent Issues
2025-07-02	Complaint for Declaratory Judgment filed
2025-07-17	Planned commercial launch of Stryker's OptaBlate BVN product

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

U.S. Patent No. 12,303,166 - Methods for Accessing Nerves Within Bone

• Patent Identification: U.S. Patent No. 12,303,166, "Methods for Accessing Nerves Within Bone," issued May 20, 2025.

The Invention Explained

• Problem Addressed: The patent describes the technical difficulty of accurately and predictably navigating a surgical instrument through the varying densities of cancellous bone to reach specific target areas, such as the posterior midline section of a vertebral body where the basivertebral nerve (BVN) is located (’166 Patent, col. 1:36-52). A straight, linear access route is often insufficient or difficult, particularly for certain spinal segments (’166 Patent, col. 1:40-44).
• The Patented Solution: The invention is a system and method for creating a predictable, curved path within bone. This is achieved using a "tube-within-tube" system, typically comprising an outer introducer (trocar) and an inner, pre-curved but flexible cannula (’166 Patent, col. 2:37-45). The cannula is straightened to be inserted through the introducer and then regains its pre-formed curve upon deployment, creating a supported channel through which a treatment device, like an RF probe, can be reliably guided to the target nerve tissue (’166 Patent, col. 2:53-60; Fig. 4F).
• Technical Importance: This method allows for targeted, minimally invasive access to intraosseous nerves for therapeutic treatment, such as ablation, which was previously difficult to achieve with precision (’166 Patent, col. 2:6-10).

Key Claims at a Glance

• The complaint asserts exemplary independent method claim 21 (’166 Patent, Compl. ¶52).
• The essential elements of independent claim 21 include:
  • Selecting an introducer and one or more instruments after a pre-surgical evaluation.
  • Inserting the introducer through a pedicle of a lumbar or sacral vertebral body until its opening reaches a cancellous portion.
  • Delivering the one or more instruments, which have a distal deflectable section, through the introducer's central channel.
  • Advancing the distal deflectable section past the introducer's opening to traverse the cancellous portion of the vertebral body in a curved path.
  • Positioning the distal deflectable section at a target area near a junction of the basivertebral nerve in the posterior midline.
  • Delivering energy from a bipolar RF probe to ablate at least a portion of the basivertebral nerve.
• The complaint does not explicitly reserve the right to assert dependent claims, but this right is standard practice.

III. The Accused Instrumentality

Product Identification

• Stryker's OptaBlate® BVN Basivertebral Nerve Ablation System ("OptaBlate BVN product") (Compl. ¶4).

Functionality and Market Context

• The OptaBlate BVN product is described as a system for performing basivertebral nerve ablation to provide relief from chronic vertebrogenic low back pain (Compl. ¶54). The complaint alleges the system includes an introducer (cannula), an "introducer with conduit" comprising a distal deflectable section, and is used with a radiofrequency generator (Compl. ¶¶57-58, 48). Marketing materials cited in the complaint describe the system as having a "steerable, dynamic curved introducer for targeted performance" and enabling a "controlled curve in the vertebral body" (Compl. p. 18; p. 20). The complaint highlights that Stryker received FDA 510(k) clearance by claiming its product is "substantially equivalent" to Boston Scientific's Intracept® product, and on that basis, is entering a market pioneered by the Plaintiffs (Compl. ¶¶2, 28). A figure from Stryker's product page shows the system components, including the RF generator, a handle-based instrument, and various tools (Compl. p. 16).

IV. Analysis of Infringement Allegations

’166 Patent Infringement Allegations

Claim Element (from Independent Claim 21)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of ablating a basivertebral nerve... selecting an introducer and one or more instruments after a pre-surgical evaluation...	Stryker's OptaBlate BVN product is used for basivertebral nerve ablation and includes an introducer and instruments selected by a surgeon.	¶54, ¶56	col. 19:40-45
inserting the introducer through a pedicle of the vertebral body such that the opening at the distal tip of the introducer reaches a cancellous portion of the vertebral body...	The procedure involves inserting the introducer through the pedicle to reach the cancellous portion of the vertebral body. A diagram from Stryker's product page illustrates this step.	¶59	col. 7:22-30
delivering the one or more instruments through the central channel of the introducer;	The physician delivers instruments through the central channel of the introducer.	¶61	col. 8:10-24
advancing the distal deflectable section of the one or more instruments past the opening at the distal tip of the introducer to traverse the cancellous portion of the vertebral body in a curved path...	The physician advances the instrument’s distal deflectable section on a curved path through cancellous bone. An annotated marketing image shows this trajectory.	¶62	col. 8:36-44
...and to position the distal deflectable section at a target area proximal to a junction of the basivertebral nerve in a posterior midline section of the vertebral body;	The distal deflectable section is positioned at a target proximal to a basivertebral nerve junction in the posterior midline. An annotated image from Stryker's materials depicts this positioning.	¶62	col. 7:6-14
and delivering energy from a first electrode of a bipolar RF probe to a second electrode of the bipolar RF probe to ablate at least a portion of the basivertebral nerve...	The physician delivers energy from a bipolar RF probe to ablate the nerve. An annotated image shows the RF probe with its electrodes in the created curved path.	¶63	col. 9:11-15

Identified Points of Contention

• Scope Questions: A central question will be whether the claim term "advancing the distal deflectable section of the one or more instruments... in a curved path" is limited to the patent's specific tube-within-tube embodiment (i.e., a separate curved cannula creating the path) or if it can be construed to read on Stryker's allegedly more integrated "steerable, dynamic curved introducer" (Compl. p. 18). The dispute may focus on whether creating the curved path and traversing it are performed by the same component or, as taught in the patent, by separate components.
• Technical Questions: What evidence will demonstrate that the accused product's operation meets the claim limitation of traversing a "curved path"? The patent emphasizes creating a predictable path supported by a guiding structure to overcome variations in bone density (’166 Patent, col. 2:48-60). The court may need to determine if Stryker’s "steerable" device functions in this specific manner or if it navigates bone via a different mechanism that falls outside the claim's scope.

V. Key Claim Terms for Construction

• The Term: "advancing the distal deflectable section of the one or more instruments past the opening at the distal tip of the introducer to traverse the cancellous portion of the vertebral body in a curved path"
• Context and Importance: This limitation is the inventive core of the claimed method. Its construction will likely determine infringement. Practitioners may focus on whether this requires a multi-step, multi-tool process for creating and then following a path, or if it can cover a single, steerable instrument that creates its own path as it advances.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The claim language uses the general phrase "one or more instruments," which could be interpreted to include a single, multi-function instrument. The language does not explicitly require a separate cannula and stylet.
  • Evidence for a Narrower Interpretation: The specification repeatedly and almost exclusively describes a system where a curved path is first established by a dedicated instrument (a curved cannula), which then guides a separate treatment device (’166 Patent, Abstract; col. 2:37-60). The patent distinguishes its invention from the prior art by its ability to create a predictable path, which it attributes to the support provided by the curved Nitinol tube (’166 Patent, col. 2:48-52). A party could argue these detailed descriptions limit the claim to a system that provides such structural guidance, not just a steerable tip.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both inducement and contributory infringement. The inducement theory is based on Stryker's alleged intent for physicians to infringe by following its product marketing, step-by-step procedural guides, product brochures, and other instructions for use (Compl. ¶¶ 5, 55, 66). The contributory infringement allegation is based on the assertion that the OptaBlate product is a non-staple article especially made and adapted for the infringing use with no substantial non-infringing uses (Compl. ¶67).
• Willful Infringement: The complaint alleges Stryker’s infringement will be willful and deliberate (Compl. ¶51). The basis for knowledge includes constructive notice via Boston Scientific's public patent markings and actual notice as of the filing of the complaint (Compl. ¶¶ 49-50). The allegations also suggest pre-suit knowledge by framing Stryker's market entry as "piggybacking" off Plaintiffs' research, clinical trials, and FDA-cleared predicate device (Compl. ¶¶ 2, 28).

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

• A core issue will be one of claim scope: can the method steps for "travers[ing]... in a curved path," which are described in the patent specification via a multi-component tube-within-tube system, be construed to cover the allegedly integrated "steerable, dynamic curved introducer" of the accused OptaBlate system?
• A key evidentiary question will be one of technical operation: does the accused OptaBlate product function to create a predictable, structurally-guided channel through bone as taught by the patent, or does its "steerable" mechanism operate in a fundamentally different way that falls outside the boundaries of the asserted claims?
• Given that the suit was filed before the product launch, a central focus will be on injunctive relief. The court will likely weigh the allegation that Stryker's product is "substantially equivalent" to Plaintiffs' own product for FDA purposes when considering the balance of hardships and the public interest.