BrainLAB v. Klarity Medical: Radiation Therapy Mask Patent Dispute Settled
BrainLAB AG and Brainlab, Inc. sued Klarity Medical Products over three radiation oncology immobilisation mask patents, alleging infringement by the Klarity Green and White Dynamic Mask sets. The parties reached a confidential settlement after 495 days, with all claims dismissed with prejudice and the court retaining jurisdiction over the settlement agreement.
Three mask patents, one settlement: BrainLAB secures prejudice dismissal
BrainLAB AG and its US subsidiary Brainlab, Inc. filed suit on 20 June 2024 in the District of Delaware against Klarity Medical Products, LLC, asserting infringement of three US patents — US11937985B2, US11278368B2, and US11642190B2 — all directed to patient immobilisation mask technology used in radiation therapy. The accused products were Klarity’s Green Dynamic Mask set and White Dynamic Mask set, both designed for patient positioning and immobilisation during radiotherapy treatment.
The action concluded on 28 October 2025 when the parties jointly moved to dismiss all claims with prejudice following a negotiated settlement covering all issues in the case. Judge Jennifer Choe-Groves retained jurisdiction over any future disputes arising under the settlement agreement, a standard mechanism that preserves enforcement rights without requiring fresh litigation if either party alleges a breach.
At 495 days, the resolution is consistent with a settlement reached after initial discovery exchanges but well before trial — a period when parties typically have enough information to assess litigation risk but sufficient incentive to avoid escalating costs. The settlement terms remain confidential, so whether Klarity obtained a licence, agreed to design around the asserted patents, or paid a lump sum cannot be determined from the public record.
Filing to Case Settled in 495 days
495 days from filing to settlement — typical for a negotiated resolution pre-trial in Delaware patent cases
Settled with prejudice: what the dismissal means for both parties
Dismissal with prejudice bars any re-filing on the same claims
A dismissal with prejudice under the settlement agreement means BrainLAB cannot reassert the same three patents against Klarity for the same accused products in a new lawsuit. The claims are extinguished on the merits, providing Klarity with finality on the specific products at issue. However, the court’s retained jurisdiction means the settlement agreement itself is enforceable by motion rather than a new complaint if either party defaults.
Dismissed with prejudiceBrainLAB resolves dispute on confidential terms — patents remain enforceable
BrainLAB’s three asserted patents survive the case fully intact — none were invalidated, limited, or subjected to IPR during the litigation window. A with-prejudice settlement typically suggests the patent holder secured commercially acceptable terms, which may include a licence, royalty, or product discontinuation by the defendant. BrainLAB retains full rights to enforce all three patents against third parties and future Klarity products not covered by any licence.
Patents remain enforceableKlarity achieves certainty on accused products under confidential terms
Klarity Medical resolved the dispute without a court ruling on infringement or validity, avoiding the reputational and financial risk of an adverse judgment. The with-prejudice dismissal protects Klarity from re-litigation of the same claims on the Green and White Dynamic Mask sets. However, the confidential settlement terms — which may include licensing obligations or design modifications — are not disclosed in the public record, leaving the long-term commercial impact on Klarity’s product line uncertain.
No infringement findingRadiotherapy mask IP landscape tightened by BrainLAB’s patent portfolio
This settlement reinforces that BrainLAB is actively enforcing its immobilisation mask patent portfolio in the US market. Competitors and distributors in the radiation oncology positioning space — particularly those supplying thermoplastic or dynamic mask systems — should treat this as a signal that BrainLAB will litigate to protect these assets. The three patents span applications filed across different periods, suggesting layered protection that would be difficult to design around without FTO analysis.
Active enforcement signalFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | BrainLAB AG | Company | Radiation oncology technology company — holder of US11937985B2, US11278368B2, US11642190B2Search in Eureka ↗ |
| Co-Plaintiff | Brainlab, Inc. | Company | Search in Eureka ↗ |
| Defendant | Klarity Medical Products, LLC | Company | Medical device manufacturer — maker of the Klarity Green and White Dynamic Mask sets for radiotherapySearch in Eureka ↗ |
| Plaintiff counsel | Andrew Colin Mayo | Attorney | Counsel for BrainLAB AGSearch in Eureka ↗ |
| Plaintiff law firm | Ashby & Geddes PC | Law Firm | Representing BrainLAB AGSearch in Eureka ↗ |
| Defendant counsel | Michael J. Flynn. | Attorney | Counsel for Klarity Medical Products, LLCSearch in Eureka ↗ |
| Defendant law firm | Morris, Nichols, Arsht & Tunnell LLP | Law Firm | Representing Klarity Medical Products, LLCSearch in Eureka ↗ |
| Presiding judge | Judge Jennifer Choe-Groves | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The joint stipulation of dismissal confirms a global settlement covering all issues across all three asserted patents, with Klarity making no admissions of infringement and BrainLAB making no concession on validity. The with-prejudice framing is the most significant legal feature: it forecloses BrainLAB from re-asserting these specific patents against these specific accused products in future proceedings. The court’s retained jurisdiction provision — standard in complex IP settlements — enables either party to enforce settlement terms by motion, without filing a new action, should a breach occur.
US11937985B2, US11278368B2 & US11642190B2 — Patient Immobilisation Masks
The three asserted patents — US11278368B2 (application US15/759690), US11642190B2 (application US17/665666), and US11937985B2 (application US18/128024) — cover patient immobilisation mask technology used in radiation therapy and radiosurgery. These systems are critical for maintaining precise, reproducible patient positioning during treatment delivery, where millimetre-level accuracy directly affects clinical outcomes. The staggered application filing numbers suggest the portfolio covers progressive iterations of the core technology.
For the radiation oncology device sector, this portfolio represents a significant IP barrier. BrainLAB’s willingness to assert all three patents simultaneously against a direct competitor’s mask products — the Klarity Green and White Dynamic Mask sets — demonstrates that the company views immobilisation as a core commercialisation area worth defending. Any manufacturer, distributor, or OEM supplying thermoplastic or dynamic mask systems in the US market should treat this portfolio as an active enforcement risk and conduct a thorough FTO analysis before product launch or expansion.
Should your team run an FTO against US11937985B2, US11278368B2, and US11642190B2?
R&D and regulatory teams developing or distributing patient immobilisation devices — including thermoplastic masks, dynamic mask sets, or head-and-neck positioning systems for radiation oncology — should treat this BrainLAB portfolio as a priority FTO target. The three patents cover overlapping aspects of a core clinical workflow step, and the successful enforcement action against Klarity’s commercial products confirms that BrainLAB actively monitors the market. Companies entering or scaling in the US radiotherapy positioning market carry material infringement risk without a documented FTO review.
PatSnap Eureka’s FTO Search Agent enables product teams to map claim scope across all three BrainLAB patents against their own device specifications in a single workflow. Eureka identifies claim language relevant to mask construction, fixation mechanisms, and material compositions — surfacing prior art, design-around opportunities, and claim differentiation pathways. For procurement teams evaluating Klarity products post-settlement, Eureka can also flag whether ongoing commercial supply is subject to residual patent exposure.
Run a freedom-to-operate analysis on US11937985B2 to assess your product’s exposure
Run FTO in Eureka →Similar patent cases: radiation oncology device IP in US District Courts
Explore related patent infringement actions involving radiation therapy positioning and immobilisation technology litigated in Delaware and other US district courts.
What this case signals for the radiation oncology device IP landscape
BrainLAB’s willingness to assert three patents simultaneously in Delaware signals a coordinated enforcement posture in the radiotherapy positioning market.
BrainLAB is building a defensive moat around patient immobilisation technology
Asserting three patents with staggered application dates — US15/759690, US17/665666, and US18/128024 — suggests a deliberate portfolio layering strategy. Each patent likely covers a different aspect or improvement of the mask technology, making it harder for competitors to design around any single claim. Companies in the radiation oncology device space should map their products against all three patents, not just the most recent.
Delaware remains the preferred venue for medical device patent enforcement
Filing in Delaware District Court is consistent with BrainLAB’s choice of a jurisdiction with an experienced patent bench and predictable scheduling. The case resolved before claim construction, which is typical when defendants face a strong multi-patent assertion and prefer settlement over the risk of an unfavourable Markman ruling. In-house teams should factor this venue preference into competitor monitoring strategies.
BrainLAB v Klarity — key questions answered
BrainLAB asserted three US patents: US11278368B2, US11642190B2, and US11937985B2. All three relate to patient immobilisation mask technology used in radiation therapy. The accused products were Klarity’s Green Dynamic Mask set and White Dynamic Mask set.
The case settled on 28 October 2025 after 495 days. All claims were dismissed with prejudice pursuant to a confidential settlement agreement covering all issues across all three asserted patents. The Delaware District Court retained jurisdiction over any future disputes arising under the settlement agreement.
Dismissal with prejudice means BrainLAB cannot re-file the same patent infringement claims against Klarity for the same accused mask products in a new lawsuit. Klarity obtained finality on the specific products at issue. However, the settlement terms are confidential — whether Klarity received a licence or agreed to modify its products is not disclosed in the public record.
Yes. All three BrainLAB patents remain fully enforceable against third parties. None were invalidated, disclaimed, or subjected to IPR proceedings during this litigation. The settlement resolved only the dispute between BrainLAB and Klarity — it has no bearing on BrainLAB’s ability to assert these patents against other competitors or future Klarity products not covered by any licence.
This case confirms BrainLAB actively enforces US11278368B2, US11642190B2, and US11937985B2 against commercial competitors in the US. Manufacturers and distributors of thermoplastic or dynamic patient immobilisation masks for radiation oncology face material infringement risk without a documented freedom-to-operate analysis. The staggered application filings suggest layered claim coverage that is difficult to design around without detailed claim mapping.
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