Axonics v. Medtronic (24-1702): Federal Circuit Appeal Voluntarily Dismissed
Axonics, Inc. challenged Medtronic, Inc.’s US8036756B2 — a patent covering implantable medical electrical stimulation lead fixation — in a patentability/invalidity proceeding that reached the Federal Circuit. The appeal was voluntarily dismissed by agreement of the parties under Fed. R. App. P. 42(b) after 302 days, with each side bearing its own costs.
Axonics and Medtronic agree to end Federal Circuit patent appeal
Filed on 16 April 2024, Case No. 24-1702 brought Axonics, Inc. before the United States Court of Appeals for the Federal Circuit in a patentability challenge against Medtronic, Inc. The dispute centred on US8036756B2, a patent directed to methods and apparatus for fixing implantable medical electrical stimulation leads — technology directly relevant to sacral neuromodulation and similar implantable device markets in which both companies compete.
The appeal concluded on 12 February 2025 when the parties jointly agreed to dismissal under Federal Rule of Appellate Procedure 42(b). The Federal Circuit’s order records that ‘the parties having so agreed’ the proceeding is dismissed, with each side bearing its own costs. Because the dismissal was voluntary and the order does not specify whether it was with or without prejudice, the public record alone does not resolve that question.
The 302-day duration is notably shorter than a typical Federal Circuit appeal proceeding through to merits briefing and oral argument, suggesting the parties reached a resolution — whether commercial, licensing, or otherwise — before the court had occasion to rule on the underlying invalidity questions. The precise terms driving the agreement are not disclosed in the public record, leaving open whether the underlying patent’s validity was conceded, licensed, or simply mooted by other developments.
Filing to Voluntary dismissal in 302 days
302 days — faster than many Federal Circuit appeal resolutions, which typically exceed 12–18 months to merits decision
Voluntarily dismissed: what the agreed exit means for both parties
Fed. R. App. P. 42(b) dismissal: what it actually means
Rule 42(b) allows parties to a Federal Circuit appeal to stipulate to dismissal at any time. Unlike a merits ruling, this produces no precedential judgment on patentability, invalidity, or claim construction. The underlying dispute is ended at the appellate level by party agreement, not by judicial determination. No findings on the merits of US8036756B2’s validity are made or implied by this order.
No merits adjudicationPublic record is silent on prejudice designation
A voluntary dismissal can be entered with or without prejudice, carrying materially different consequences: dismissal with prejudice bars re-litigation of the same invalidity claims, while dismissal without prejudice preserves the right to challenge again. The Federal Circuit’s order in this case does not specify which applies. Practitioners and competitors monitoring this patent should not assume either outcome from the public docket alone.
Prejudice designation unknownAxonics exits the appeal without a validity ruling in its favour
As the challenging appellant, Axonics pursued an invalidity or cancellation action against Medtronic’s US8036756B2. The agreed dismissal means Axonics did not obtain a court finding that the patent is invalid. Whether it secured alternative relief — such as a licence or covenant not to sue — through the agreement that prompted the dismissal is not disclosed in the public record.
No invalidity finding securedMedtronic’s patent survives appeal without judicial validation
Medtronic’s US8036756B2 remains in force as a granted patent, but the voluntary dismissal does not amount to a judicial affirmation of its validity. The patent has not been adjudicated valid by this proceeding. For competitors in the implantable lead fixation and sacral neuromodulation space, the patent’s enforceability posture is unchanged — and the absence of a merits ruling keeps future challenge pathways open depending on the prejudice question.
Patent intact, validity unconfirmedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Axonics, Inc. | Company | Implantable neuromodulation device company — appellant challenging validity of US8036756B2Search in Eureka ↗ |
| Defendant | Medtronic, Inc. | Company | Global medical technology leader — patent holder defending US8036756B2 lead fixation patentSearch in Eureka ↗ |
| Plaintiff counsel | Samantha A. Jameson | Attorney | Counsel for Axonics, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Tensegrity Law Group LLP | Law Firm | Representing Axonics, Inc.Search in Eureka ↗ |
| Defendant counsel | Naveen Modi | Attorney | Counsel for Medtronic, Inc.Search in Eureka ↗ |
| Defendant law firm | Paul Hastings, LLP | Law Firm | Representing Medtronic, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Court of Appeals for the Federal CircuitSearch in Eureka ↗ |
Official order — verbatim text
The Federal Circuit’s order is expressly procedural: it records party agreement and effects dismissal under Rule 42(b), making no findings on patentability, claim construction, or the merits of the invalidity action. The cost-neutrality provision — ‘each side shall bear their own costs’ — is consistent with a negotiated exit. The order does not state whether the dismissal is with or without prejudice, which is the pivotal legal question for any future challenge to US8036756B2 or related enforcement actions.
US8036756B2 — Implantable electrical stimulation lead fixation
US8036756B2, filed as application US11/352552, protects methods and apparatus for fixing implantable medical electrical stimulation leads in place within a patient’s body. Lead fixation is a technically critical element of neuromodulation systems — inadequate anchoring leads to lead migration, loss of therapeutic effect, and revision surgery. The patent addresses a long-standing clinical challenge in sacral neuromodulation and related implantable stimulation device platforms where lead stability directly determines device efficacy.
Medtronic’s position in sacral neuromodulation — marketed under the InterStim brand — makes this patent strategically significant in a market that Axonics entered with its own rechargeable sacral neuromodulation implant. A valid, enforceable lead fixation patent in Medtronic’s hands creates design-around pressure for any competitor developing or iterating implantable lead technology. The patent’s continued in-force status, without a merits invalidity ruling, means it retains full enforcement potential against future product generations in this space.
Should you run an FTO against US8036756B2 before launching a lead fixation product?
Any company developing implantable electrical stimulation devices — particularly sacral neuromodulation, spinal cord stimulation, or peripheral nerve stimulation systems — that incorporate lead anchoring or fixation mechanisms should treat US8036756B2 as a priority clearance item. The patent covers both method and apparatus claims, meaning product design, surgical technique instructions, and physician training materials may all fall within scope depending on claim construction.
PatSnap Eureka’s FTO Search Agent can map US8036756B2’s claim landscape against your product architecture, identify published prior art that may inform invalidity arguments, and surface related Medtronic continuation or divisional applications that may extend the same inventive concept. Given the unresolved prejudice question in this dismissal, knowing your exposure before any enforcement action is commercially essential for R&D and regulatory teams targeting this device category.
Run a freedom-to-operate analysis on US8036756B2 to assess your product’s exposure
Run FTO in Eureka →Similar Federal Circuit appeals in implantable neuromodulation patent disputes
Federal Circuit cases involving patentability challenges to implantable electrical stimulation and neuromodulation device patents, including voluntary dismissals and invalidity appeals.
What this case signals for the implantable neuromodulation IP landscape
An agreed Federal Circuit exit before merits briefing is complete often signals commercial resolution. Here is what practitioners and device companies should monitor.
Voluntary dismissal without a merits ruling leaves US8036756B2 challengeable
Because the Federal Circuit made no invalidity finding, US8036756B2 remains a live enforcement risk for any company operating in the implantable electrical stimulation lead fixation space. Competitors should not interpret the dismissal as a green light — the patent’s validity has simply not been tested to judgment at this level.
Cost-neutrality suggests a negotiated resolution rather than capitulation
Agreed dismissals with each side bearing its own costs are a classic hallmark of a negotiated commercial settlement or cross-licensing arrangement. The absence of a cost award to either party is inconsistent with one side simply abandoning a strong position, and suggests mutual concessions were made off the public record.
Axonics v Medtronic — key questions answered
The dismissal under Fed. R. App. P. 42(b) ends the Federal Circuit appeal by party agreement without any merits ruling. US8036756B2 remains a granted, in-force patent. No court found it valid or invalid. The public order does not specify whether the dismissal was with or without prejudice, which determines whether the same invalidity challenge can be re-litigated.
The Federal Circuit’s order in Case No. 24-1702 does not specify. It records only that the parties agreed and that each side bears its own costs. Practitioners cannot determine the prejudice designation from the public docket. Any private settlement agreement containing that term would not ordinarily be filed with the court.
US8036756B2 is a Medtronic patent (application US11/352552) covering methods and apparatus for fixing implantable medical electrical stimulation leads. It is relevant to sacral neuromodulation, spinal cord stimulation, and related implantable device systems where lead stability is critical to therapeutic performance and patient outcomes.
Potentially yes, depending on the prejudice designation and the terms of any private agreement between the parties. If the dismissal was without prejudice and no binding covenant or estoppel applies, further post-grant or invalidity challenges may remain available. IPR estoppel rules and any contractual restrictions would need to be assessed on the specific facts.
Axonics was represented by Tensegrity Law Group LLP, with Samantha A. Jameson listed as counsel. Medtronic was represented by Paul Hastings LLP, with Naveen Modi listed as counsel for the appellee.
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