Boston Scientific Corp., Relievant Medsystems, Inc. v. Stryker Corporation

CourtDistrict Court, D. New Jersey
DecidedJune 17, 2026
Docket2:25-cv-12700
StatusUnknown

This text of Boston Scientific Corp., Relievant Medsystems, Inc. v. Stryker Corporation (Boston Scientific Corp., Relievant Medsystems, Inc. v. Stryker Corporation) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Boston Scientific Corp., Relievant Medsystems, Inc. v. Stryker Corporation, (D.N.J. 2026).

Opinion

NOTE: This disposition is nonprecedential. United States Court of Appeals for the Federal Circuit

______________________ BOSTON SCIENTIFIC CORP., RELIEVANT MEDSYSTEMS, INC., Plaintiffs-Appellants v. STRYKER CORPORATION, Defendant-Appellee ______________________ 2026-1171 ______________________ Appeal from the United States District Court for the District of New Jersey in No. 2:25-cv-12700-EP-JSA, Judge Evelyn Padin. ______________________ Decided: June 17, 2026 ______________________ MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP, Washington, DC, argued for plaintiffs-appellants. Also represented by NICHOLAS M. NYEMAH. NATHANIEL C. LOVE, Sidley Austin LLP, Chicago, IL, argued for defendant-appellee. Also represented by MARY T. HANNON, STEPHANIE P. KOH; SHARON LEE, New York, NY. ______________________ 2 BOSTON SCIENTIFIC CORP. v. STRYKER CORPORATION

Before DYK, REYNA, and STARK, Circuit Judges. DYK, Circuit Judge. Boston Scientific Corp. and Relievant Medsystems, Inc. (together, “Boston Scientific”) appeal a decision of the United States District Court for the District of New Jersey denying Boston Scientific’s request for a preliminary in- junction. The requested injunction would restrain Stryker Corporation (“Stryker”) from launching its OptaBlate BVN product on grounds that its sale would induce infringement of claims 16 and 21 of U.S. Patent No. 12,303,166 (the “’166 patent”). Because we agree with the district court that there are substantial questions as to whether Stryker induced infringement of the asserted claims, we affirm. BACKGROUND The human spine is made of bony vertebrae separated by discs. Between the vertebrae and the discs are vertebral endplates. When these endplates are damaged, it can lead to chronic low back pain. The basivertebral nerve trans- mits those pain signals, and the pain can be decreased when that nerve is therapeutically destroyed or disrupted through a process called ablation. As relevant to this case, the ’166 patent claims a method of using a radiofrequency probe to ablate the basivertebral nerve in a vertebral body of a patient. See ’166 patent claims 16, 21. The basivertebral nerve is difficult to reach because it is located within the interior cancellous (spongy) bone of the vertebral body, which is near and anterior to the spinal cord. Therefore, to expose the basivertebral nerve to the radiofrequency energy, a physician must navigate the ra- diofrequency probe around the spinal column, through the cortical (dense) bone covering the vertebra, and into the cancellous interior of the vertebral body while also ensur- ing the probe is not too close to the spinal cord that it risks BOSTON SCIENTIFIC CORP. v. STRYKER CORPORATION 3

damaging the large and important nerves in the spinal cord. The ’166 patent claims methods for accessing and ab- lating the basivertebral nerve. A needle trocar—essen- tially a long, straight, and narrow tube for inserting instruments into the body—establishes a straight path from the outside of the body to the cancellous interior of the vertebral body. To allow the trocar to enter the body, a straight stylet with a sharp tip that pierces bone is inserted into the trocar such that the sharp point extends beyond the distal tip of the trocar. The assembly of the trocar and the stylet enter the patient’s back at an angle and is “ad- vanced through soft tissue to the surface of the [vertebral] bone” and then “through the cortical shell of [the] pedicle [a bony protrusion from the vertebra] and into the cancel- lous interior . . . of the bone.” ’166 patent, col. 7 ll. 43–48. The straight stylet is then removed, and a curved cannula is inserted into the trocar with the aid of a straightening stylet. With the aid of a curved stylet, the curved cannula is advanced beyond the tip of the trocar to generate a curved path through the cancellous bone. Then, a channel- ing stylet is used to create a working channel from the tip of the curved cannula to the target treatment zone in the center of the vertebral body. The radiofrequency probe is then delivered to the treatment site where it ablates the nerve by heating it. Figure 4F illustrates this probe at the treatment site within the vertebra, labeling the trocar (20) and the can- cellous region of the bone (124). 4 BOSTON SCIENTIFIC CORP. v. STRYKER CORPORATION

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J.A. 61.1 Claim 16 is exemplary and recites in relevant part: A method of ablating a basivertebral nerve in a ver- tebral body of a patient, the method comprising: inserting an introducer through a pedicle of the vertebral body such that an opening at a distal tip of the introducer reaches a cancellous portion of the vertebral body, the introducer having a handle coupled to a shaft defining a central channel in communication with the opening, wherein inserting the introducer comprises insert- ing a stylet into the central channel of the intro- ducer such that the stylet extends beyond the opening at the distal tip of the introducer and ad- vancing the introducer and stylet simultaneously such that the stylet pierces bone as the introducer

1 Citations to the “J.A.” refer to the corrected confi- dential joint appendix filed by the parties. Dkt. No. 34.

BOSTON SCIENTIFIC CORP. v. STRYKER CORPORATION 5

is delivered through the pedicle of the vertebral body; delivering an instrument through the central chan- nel of the introducer, the instrument comprising a proximal portion, a distal deflectable section, and a rotatable element at the proximal portion of the in- strument, wherein the distal deflectable section of the instru- ment is configured to penetrate the cancellous por- tion of the vertebral body to form a curved path; initiating a first rotation of the rotatable element; advancing the distal deflectable section of the in- strument past the opening at the distal tip of the introducer to a target area proximal to a junction of the basivertebral nerve, wherein a second rotation of the rotatable element occurs when the distal deflectable section of the in- strument is deployed at an angle of 5 degrees to 90 degrees; and applying bipolar radiofrequency energy be- tween a first electrode and a second electrode of a bipolar RF probe disposed in the curved path at a treatment location immediately adjacent to the ba- sivertebral nerve in the target area to ablate at least a portion of the basivertebral nerve. ’166 patent, claim 16 (emphasis and line breaks added). The parties agree the claimed “introducer” refers to the de- scribed trocar. Stryker’s OptaBlate BVN device is designed to ablate the basivertebral nerve to treat chronic low back pain, and Stryker sought FDA approval using Boston Scientific’s pre- viously approved product as a predicate device. Boston Sci- entific filed this action after Stryker announced FDA 6 BOSTON SCIENTIFIC CORP. v. STRYKER CORPORATION

clearance for its product and commenced plans to market the product. Boston Scientific moved for a preliminary injunction, arguing that it was likely to succeed on the merits of its theory that Stryker’s planned activities would make it lia- ble for induced infringement of claims 16 and 21 of the ’166 patent. Boston Scientific’s theory was that the OptaBlate BVN’s “access cannula” corresponded to the claimed “introducer.” Stryker argued that it did not induce infringement of that limitation because Stryker did not in- struct physicians to place the access cannula so that it “reaches” the cancellous portion of the bone. Although the parties disputed the meaning of the term “reaches,” neither party in their briefs presented any substantive argument or identified intrinsic or extrinsic evidence as to the proper construction.

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Boston Scientific Corp., Relievant Medsystems, Inc. v. Stryker Corporation, Counsel Stack Legal Research, https://law.counselstack.com/opinion/boston-scientific-corp-relievant-medsystems-inc-v-stryker-corporation-njd-2026.