NeoGenomics v. Natera: Federal Circuit Appeal Dismissed in 20 Days
NeoGenomics Laboratories filed a Federal Circuit appeal against Natera over three patents covering the RaDaR Minimum Residual Disease assay. The parties agreed to dismiss the proceedings under Fed. R. App. P. 42(b) just 20 days after filing, with each side bearing its own costs — suggesting a negotiated resolution outside the appellate record.
A 20-day Federal Circuit exit: settlement signals behind the RaDaR MRD dispute
NeoGenomics Laboratories, Inc. filed this infringement appeal at the Court of Appeals for the Federal Circuit on 26 November 2025, asserting three patents — US11530454B2, US11319596B2, and US11519035B2 — against Natera, Inc. All three patents relate to cell-free DNA-based minimum residual disease (MRD) detection technology, commercialised by Natera under the RaDaR assay brand. The case was filed as an infringement action targeting RaDaR and any products or assays using the same or similar technology.
The appeal was dismissed on 16 December 2025 — just 20 days after filing — pursuant to Fed. R. App. P. 42(b), which governs voluntary dismissals agreed to by the parties. The order specifies that the dismissal was by mutual agreement and that each side bears its own costs. No merits ruling was issued; the Federal Circuit made no determination on validity, infringement, or claim construction. The public record does not disclose whether a settlement agreement, licensing deal, or other commercial arrangement underlies the dismissal.
A 20-day lifespan is exceptionally short even for stipulated Federal Circuit dismissals, and the mutual cost-bearing arrangement is consistent with a negotiated outcome rather than a unilateral capitulation by either party. Whether NeoGenomics obtained licensing or commercial concessions from Natera — or vice versa — remains unknown from the public record. The three asserted patents remain issued and enforceable unless separately challenged, meaning the underlying IP dispute over MRD assay technology may resurface in a different venue or form.
Filing to Voluntary dismissal in 20 days
20-day appeal — among the shortest Federal Circuit proceedings on record; median appeal runs 18–24 months
Stipulated dismissal: what Fed. R. App. P. 42(b) means for both parties
Rule 42(b) dismissal: no merits, no precedent
Fed. R. App. P. 42(b) permits parties to jointly stipulate to dismissal of an appeal at any time. The Federal Circuit issues no ruling on infringement, validity, or claim scope. This procedural exit leaves the underlying district court record undisturbed and creates no appellate precedent — preserving optionality for both parties in future proceedings.
No merits adjudicationThe public record is silent on prejudice terms
The order states only that proceedings are dismissed under Rule 42(b) with each side bearing its own costs. It does not specify whether the dismissal is with or without prejudice. Under Rule 42(b), the default is typically without prejudice unless the parties agree otherwise — but the public record here does not confirm either. Practitioners should not assume re-filing is barred, nor that it is expressly permitted, without reviewing any underlying stipulation filed by the parties.
Prejudice terms undisclosedNeoGenomics retains three issued, enforceable MRD patents
NeoGenomics’s three asserted patents — US11530454B2, US11319596B2, and US11519035B2 — remain issued and enforceable. No Federal Circuit ruling limits their claim scope or validity. The voluntary dismissal is consistent with NeoGenomics having achieved a commercial objective (such as a licensing arrangement) that made continued litigation unnecessary, though this is not confirmed in the public record.
Patents intact and enforceableMRD assay IP conflict unresolved — sector remains on watch
The rapid, cost-neutral dismissal suggests the parties reached an accommodation, but the absence of any public settlement terms means the competitive and IP landscape for liquid biopsy MRD assays remains uncertain. Competitors and acquirers in the ctDNA diagnostics space should monitor these three patents closely — their enforceability is undiminished, and NeoGenomics retains full standing to assert them again.
MRD IP landscape unresolvedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | NEOGENOMICS LABORATORIES, INC. | Company | Oncology diagnostics company — holder of US11530454B2, US11319596B2, US11519035B2Search in Eureka ↗ |
| Defendant | Natera, Inc. | Company | Natera, Inc. — genetic testing company, developer of the RaDaR MRD assaySearch in Eureka ↗ |
| Plaintiff counsel | Deanne Maynard | Attorney | Counsel for NEOGENOMICS LABORATORIES, INC.Search in Eureka ↗ |
| Plaintiff law firm | Morrison & Foerster, LLP | Law Firm | Representing NEOGENOMICS LABORATORIES, INC.Search in Eureka ↗ |
| Defendant counsel | William M. Jay | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant law firm | Goodwin Procter LLP | Law Firm | Representing Natera, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Court of Appeals for the Federal CircuitSearch in Eureka ↗ |
Official order — verbatim text
The order’s language — ‘The parties having so agreed’ — confirms this was a joint stipulation, not a unilateral withdrawal. Rule 42(b) dismissals at the Federal Circuit carry no merits weight: the court made no finding on infringement, validity, or claim construction. The cost-neutral disposition (‘each side shall bear their own costs’) is notable; it suggests neither party was in a dominant litigation position, or that any economic resolution was captured in a separate, non-public agreement. The three underlying patents are unaffected.
US11530454B2, US11319596B2 & US11519035B2 — ctDNA MRD assay technology
The three asserted patents — US11530454B2, US11319596B2, and US11519035B2 — cover methods and compositions related to cell-free DNA (cfDNA) analysis for detecting minimum residual disease (MRD) in cancer patients. MRD assays identify trace amounts of circulating tumour DNA (ctDNA) remaining after treatment, enabling earlier detection of relapse than conventional imaging. The patents span application numbers US17/738354, US16/288351, and US16/934407, suggesting a family prosecuted across multiple continuation filings to build layered claim coverage around the core technology.
NeoGenomics’s RaDaR assay competes directly with Natera’s assay of the same name in the fast-growing personalised MRD testing market. The broad product scope asserted — covering ‘any products or assays that use the same or similar technology’ — signals NeoGenomics’s intent to use this patent family as a broad competitive moat. For oncology diagnostics companies developing tumour-informed liquid biopsy products, all three patents represent meaningful freedom-to-operate risk, particularly given that no court has narrowed their claims.
Should you run an FTO against US11530454B2, US11319596B2 & US11519035B2?
Any organisation developing, commercialising, or acquiring a ctDNA-based MRD assay — particularly personalised, tumour-informed approaches — should treat these three NeoGenomics patents as priority FTO targets. The case’s product scope (‘same or similar technology’ to RaDaR) is intentionally broad, and with no appellate claim narrowing, the patents’ reach is at maximum. This applies to diagnostics companies, hospital laboratory developers, and pharma firms building companion diagnostics.
PatSnap Eureka’s FTO Search Agent can map the independent and dependent claims of US11530454B2, US11319596B2, and US11519035B2 against your product’s technical architecture in minutes. It surfaces prior art, identifies claim elements most likely to be asserted, and flags related continuation applications that may extend the family. Use Eureka to benchmark your assay design against the full NeoGenomics ctDNA MRD portfolio before your next development milestone.
Run a freedom-to-operate analysis on US11530454B2 to assess your product’s exposure
Run FTO in Eureka →Similar Federal Circuit cases: ctDNA diagnostics and MRD assay patent disputes
Explore Federal Circuit appeals and district court infringement actions involving cell-free DNA, liquid biopsy, and minimum residual disease assay patents — the same technology domain at issue here.
What this case signals for the liquid biopsy and MRD assay IP landscape
A 20-day Federal Circuit exit over three MRD patents raises questions every ctDNA diagnostics player should be asking.
Three MRD assay patents survive with zero appellate limitation
No Federal Circuit ruling touched US11530454B2, US11319596B2, or US11519035B2. Their claims are intact. Any competitor whose product reads on RaDaR-style ctDNA MRD technology faces the same infringement exposure Natera faced — without any narrowing precedent from this proceeding.
Speed of resolution is a settlement signal, not a legal one
Twenty days is not enough time for Federal Circuit briefing to begin. The mutual cost-bearing dismissal is consistent with a parallel commercial negotiation reaching resolution before the appellate process engaged. Companies tracking this dispute should look for licensing, partnership, or M&A activity between NeoGenomics and Natera as a possible explanation.
NEOGENOMICS v Natera — key questions answered
The Federal Circuit appeal was voluntarily dismissed by stipulation under Fed. R. App. P. 42(b) on 16 December 2025, just 20 days after filing. No merits ruling was issued. Each party bears its own costs. The three asserted patents — US11530454B2, US11319596B2, and US11519035B2 — remain issued and enforceable.
NeoGenomics asserted three patents: US11530454B2 (application US17/738354), US11319596B2 (application US16/288351), and US11519035B2 (application US16/934407). All relate to cell-free DNA-based minimum residual disease detection — the core technology of the RaDaR MRD assay.
A Fed. R. App. P. 42(b) dismissal means the Federal Circuit issued no ruling on infringement, validity, or claim construction. All three asserted patents remain fully enforceable with their claims intact. The dismissal creates no appellate precedent and does not preclude NeoGenomics from asserting the patents again in district court, subject to any terms in the parties’ underlying stipulation.
The public record — specifically the court’s order — does not specify whether the dismissal is with or without prejudice. The order states only that proceedings are dismissed under Rule 42(b) and that each side bears its own costs. The default under Rule 42(b) is typically without prejudice, but practitioners should review any underlying stipulation filed by the parties before drawing conclusions.
The case targeted Natera’s RaDaR Minimum Residual Disease Assay and, by explicit scope, ‘any other products or assays that use the same or similar technology.’ RaDaR is a personalised, tumour-informed ctDNA MRD assay used in oncology. The broad product definition suggests NeoGenomics intended the patents to cover the technology category, not just a single named product.
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