Natera v. NeoGenomics: Federal Circuit Appeal Voluntarily Dismissed in 41 Days
Natera, Inc. and NeoGenomics Laboratories jointly dismissed their Federal Circuit appeal over three patents covering the RaDaR Minimum Residual Disease assay — a ctDNA-based cancer surveillance technology. The proceedings ended in just 41 days under Fed. R. App. P. 42(b), with each side bearing its own costs.
A 41-Day Federal Circuit Exit: Natera and NeoGenomics Step Back
Natera, Inc. filed this infringement appeal at the Court of Appeals for the Federal Circuit on 5 November 2025, targeting NeoGenomics Laboratories over three US patents — US11530454B2, US11319596B2, and US11519035B2 — all directed at cell-free DNA analysis methods underlying Natera’s proprietary RaDaR Minimum Residual Disease assay, a tumor-informed liquid biopsy test used to detect residual cancer after treatment.
The appeal was dismissed on 16 December 2025 pursuant to Fed. R. App. P. 42(b), which permits voluntary dismissal at the appellate level upon agreement of the parties. The order confirms mutual consent and specifies that each side bears its own costs. Critically, no merits adjudication occurred — the Federal Circuit issued no ruling on claim construction, validity, or infringement of any of the three patents in suit.
A 41-day lifespan is exceptionally brief for a Federal Circuit appeal, suggesting the parties had reached or were close to a resolution before or immediately after the notice of appeal was filed. The public record does not disclose whether a licensing agreement, cross-license, or settlement underlies the dismissal, and the absence of prejudice terms in the order leaves the future litigation posture between these parties ambiguous.
Filing to Voluntary dismissal in 41 days
41-day appeal — among the shortest Federal Circuit proceedings, suggesting pre-filing resolution
Voluntarily dismissed: what the Rule 42(b) exit means for both parties
Fed. R. App. P. 42(b): Agreed dismissal, no merits ruling
Rule 42(b) allows parties to a Federal Circuit appeal to jointly dismiss proceedings without a merits decision. The court acts ministerially on the agreement — it does not evaluate claim construction, validity, or infringement. The result is procedural termination only. No precedent is set, no patent is adjudicated invalid or infringed, and the underlying district court record (if any) is unaffected by this order.
Procedural exit — no meritsWith or without prejudice? The public record is silent
Fed. R. App. P. 42(b) dismissals may be with or without prejudice to refiling or re-asserting related claims. The order in this case specifies only that proceedings are dismissed and costs are split — it does not state whether the dismissal is with or without prejudice. This distinction is material: a without-prejudice exit would leave Natera free to re-assert these patents; a with-prejudice exit would bar re-litigation of the same appellate claims. The public record does not resolve this question.
Prejudice terms undisclosedNatera’s three MRD patents remain unadjudicated
Because no merits ruling was issued, Natera’s patents — US11530454B2, US11319596B2, and US11519035B2 — retain their presumption of validity and are not judicially construed. Natera can continue to assert these patents against other parties or, depending on the prejudice terms, potentially re-engage with NeoGenomics. The dismissal does not weaken or strengthen the patents on their face.
Patents survive unadjudicatedRaDaR MRD competitive landscape: uncertainty persists
The swift, agreed exit suggests the commercial dynamics between Natera and NeoGenomics may have shifted — through licensing, market repositioning, or strategic recalculation. For competitors and product teams in the MRD liquid biopsy space, this outcome does not clear the patent landscape. Natera’s three ctDNA patents remain enforceable and could be deployed against other market entrants offering residual disease monitoring assays.
IP risk unresolved for sectorFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Natera, Inc. | Company | Liquid biopsy diagnostics company — holder of US11530454B2, US11319596B2, US11519035B2Search in Eureka ↗ |
| Defendant | NEOGENOMICS LABORATORIES, INC. | Company | Oncology-focused clinical laboratory and genetic testing services companySearch in Eureka ↗ |
| Plaintiff counsel | Gabriel Ferrante | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Kevin Alexander Smith | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Kevin P. B. Johnson | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Sandra Haberny | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Tara Srinivasan | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Victoria Fishman Maroulis | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Plaintiff counsel | William M. Jay | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Goodwin Procter LLP | Law Firm | Representing Natera, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Quinn Emanuel Urquhart & Sullivan, LLP | Law Firm | Representing Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Aaron Gabriel Fountain | Attorney | Counsel for NEOGENOMICS LABORATORIES, INC.Search in Eureka ↗ |
| Defendant counsel | Daralyn Jeannine Durie | Attorney | Counsel for NEOGENOMICS LABORATORIES, INC.Search in Eureka ↗ |
| Defendant counsel | Deanne Maynard | Attorney | Counsel for NEOGENOMICS LABORATORIES, INC.Search in Eureka ↗ |
| Defendant counsel | John Franklin Morrow | Attorney | Counsel for NEOGENOMICS LABORATORIES, INC.Search in Eureka ↗ |
| Defendant counsel | Matthew Robert Stephens | Attorney | Counsel for NEOGENOMICS LABORATORIES, INC.Search in Eureka ↗ |
| Defendant counsel | Seth W. Lloyd | Attorney | Counsel for NEOGENOMICS LABORATORIES, INC.Search in Eureka ↗ |
| Defendant law firm | Morrison & Foerster LLP | Law Firm | Representing NEOGENOMICS LABORATORIES, INC.Search in Eureka ↗ |
| Defendant law firm | Womble Bond Dickinson (US) LLP | Law Firm | Representing NEOGENOMICS LABORATORIES, 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 is spare and deliberate: it records mutual agreement, invokes Rule 42(b), and splits costs — nothing more. The absence of any merits language confirms the Federal Circuit exercised no substantive jurisdiction over the three patents. The cost-neutrality provision is consistent with a negotiated resolution rather than a concession by either party, and provides no signal as to which side held the stronger appellate position.
US11530454B2, US11319596B2 & US11519035B2 — cfDNA MRD Detection Methods
The three patents at issue — US11530454B2, US11319596B2, and US11519035B2 — cover cell-free DNA analytical methods forming the scientific basis of Natera’s RaDaR (Residual Disease and Recurrence) assay. RaDaR is a tumor-informed liquid biopsy test that sequences a personalised panel of somatic mutations derived from a patient’s own tumour, enabling ultrasensitive detection of circulating tumour DNA in post-treatment blood draws. The application lineages span filings from 2019 through 2021, placing them in the wave of next-generation MRD patent activity.
These patents sit at the intersection of personalised oncology and high-sensitivity sequencing — a commercially high-stakes space attracting significant investment and competitive pressure. NeoGenomics is one of several clinical laboratory operators offering MRD monitoring services, and Natera’s decision to assert three patents simultaneously suggests it views these as foundational, not peripheral, to the RaDaR platform. Any competitor in the tumor-informed ctDNA MRD market should treat these patents as live enforcement assets regardless of this appeal’s outcome.
Should you run an FTO against US11530454B2, US11319596B2 & US11519035B2?
R&D teams and product directors developing tumor-informed liquid biopsy assays, MRD monitoring workflows, or cfDNA sequencing panels should treat these three Natera patents as active clearance priorities. The dismissal of this appeal without a merits ruling means no court has limited or construed the claims — the patents are as broad today as when filed. Clinical laboratories, diagnostics OEMs, and oncology software platforms processing ctDNA data are all potentially within scope.
PatSnap Eureka’s FTO Search Agent can map the independent and dependent claims of US11530454B2, US11319596B2, and US11519035B2 against your assay design, sequencing chemistry, and bioinformatics pipeline. Eureka identifies prior art that may support design-arounds, surfaces related continuations in Natera’s portfolio, and flags co-pending applications that could extend claim coverage — giving your team the full landscape before a product decision is locked.
Run a freedom-to-operate analysis on US11530454B2 to assess your product’s exposure
Run FTO in Eureka →Similar Federal Circuit Appeals in Liquid Biopsy & ctDNA Patent Litigation
Cases involving cfDNA diagnostic patent appeals at the Federal Circuit, including MRD assay infringement actions and liquid biopsy technology disputes.
What this case signals for the liquid biopsy MRD patent landscape
A 41-day Federal Circuit exit with no merits ruling leaves Natera’s MRD patent portfolio intact and the competitive risk landscape unresolved.
No merits ruling means no safe harbour for MRD assay competitors
The voluntary dismissal produced zero judicial guidance on the scope or validity of Natera’s three cfDNA MRD patents. Companies developing or commercialising tumor-informed liquid biopsy assays should not interpret this outcome as a clearance event — the patents remain fully enforceable with an unimpaired presumption of validity.
Speed of resolution suggests off-court activity warrants monitoring
A 41-day Federal Circuit appeal is consistent with a pre-negotiated settlement or licensing arrangement finalised shortly after filing. IP teams tracking competitive dynamics in the oncology diagnostics sector should monitor NeoGenomics’ product disclosures and Natera’s licensing announcements for signals of what drove the resolution.
Natera v NEOGENOMICS — key questions answered
The Federal Circuit appeal (No. 26-1125) was voluntarily dismissed on 16 December 2025 under Fed. R. App. P. 42(b) by agreement of both parties. No merits ruling was issued. Each side bears its own costs. The case involved three patents covering Natera’s RaDaR MRD assay and lasted only 41 days.
Natera asserted three US patents: US11530454B2, US11319596B2, and US11519035B2. All three relate to cell-free DNA analytical methods underlying the RaDaR Minimum Residual Disease assay, a tumor-informed liquid biopsy test for detecting residual or recurrent cancer from blood samples.
A Rule 42(b) dismissal is a procedural exit agreed by both parties. It does not adjudicate validity, infringement, or claim scope. Natera’s three MRD patents retain their full presumption of validity and remain enforceable. No judicial guidance was issued that could inform future claim construction or invalidity arguments.
The public order does not specify whether the Rule 42(b) dismissal is with or without prejudice. The text states only that proceedings are dismissed and costs are split. The prejudice status — which would determine whether the same claims could be re-litigated — is not disclosed in the available court record.
RaDaR (Residual Disease and Recurrence) is Natera’s tumor-informed liquid biopsy assay. It sequences a personalised somatic mutation panel from a patient’s primary tumour and uses that profile to detect circulating tumour DNA at very low allele fractions in post-treatment blood draws. The assay competes directly with NeoGenomics’ MRD monitoring offering, making the three asserted patents commercially critical to Natera’s market position.
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