University of Washington v. Guardant Health: Federal Circuit Appeal Voluntarily Dismissed
University of Washington brought a patentability challenge involving US10752951B2 — a patent covering error-reduction methods in massively parallel DNA sequencing — to the Federal Circuit against Guardant Health, Inc. The appeal was dismissed in 82 days under Fed. R. App. P. 42(b), with each side bearing its own costs, leaving the merits unresolved on the public record.
A rapid voluntary exit from the Federal Circuit — merits left open
University of Washington filed this Federal Circuit appeal on 20 March 2024 in Case No. 24-1583, challenging a patentability determination involving US10752951B2 (application no. US16/514931). The patent covers methods of lowering the error rate of massively parallel DNA sequencing using duplex consensus sequencing — a technology with direct commercial relevance to liquid biopsy and cell-free DNA diagnostics. Guardant Health, Inc., a leading oncology liquid biopsy company, was the respondent.
The appeal closed on 10 June 2024 — just 82 days after filing — when both parties jointly agreed to dismiss the proceeding under Federal Rule of Appellate Procedure 42(b). The court’s order reflects a mutual agreement: the dismissal is voluntary, and each side bears its own costs. Critically, the public record is silent on whether the dismissal was with or without prejudice; the order does not specify either, and the distinction carries significant practical consequences for future enforcement or re-filing.
An 82-day resolution at the Federal Circuit level is notably swift and suggests the parties reached an accommodation outside the court’s merits docket — potentially a licensing arrangement, settlement, or strategic recalibration — though none of this is confirmed in the public record. The absence of a merits ruling means the validity of US10752951B2 remains judicially unresolved at the appellate level, which may matter for competitors and potential licensees in the liquid biopsy sequencing space.
Filing to Voluntary dismissal in 82 days
82 days — resolved faster than the median Federal Circuit appeal lifecycle
Voluntarily dismissed: what the Fed. R. App. P. 42(b) exit means for both parties
Fed. R. App. P. 42(b): a joint exit with no merits ruling
Rule 42(b) allows parties to stipulate to dismissal of a Federal Circuit appeal without the court reaching the underlying merits. Here, both University of Washington and Guardant Health agreed to the dismissal, and the court ordered it accordingly. This procedural exit means the appellate court issued no opinion on patentability, validity, or claim construction — the legal questions that triggered the appeal remain formally unanswered.
No merits adjudicationWith or without prejudice? The public record is silent
A voluntary dismissal ‘with prejudice’ bars re-filing of the same claim; ‘without prejudice’ preserves the right to raise the same issues again. The court’s order in Case 24-1583 does not specify either. This distinction is legally material: if University of Washington retains the right to refile or pursue validity in a different forum, the patent dispute may not be fully resolved. Practitioners should not assume finality from the dismissal language alone.
Prejudice unspecifiedUS10752951B2 validity remains unresolved at appellate level
For University of Washington, voluntary dismissal halts the appeal but does not definitively confirm or invalidate the patent. The underlying patentability challenge — an invalidity or cancellation action — was never decided on the merits at this appellate stage. The patent nominally remains in force, but the validity cloud raised by the proceeding has not been judicially cleared. This may affect licensing negotiations and enforcement posture in the duplex sequencing space.
Patent status unresolvedNo appellate precedent set for duplex sequencing IP
Because the Federal Circuit issued no merits opinion, companies operating in the liquid biopsy, cell-free DNA, and massively parallel sequencing sectors cannot rely on this case for guidance on the scope or validity of duplex consensus sequencing claims. Competitors and potential entrants should treat US10752951B2 as an active patent and conduct independent freedom-to-operate analysis rather than drawing conclusions from the dismissal.
No binding precedentFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | University of Washington | Individual | Research university and patent holder of US10752951B2 — duplex consensus sequencingSearch in Eureka ↗ |
| Defendant | Guardant Health, Inc. | Company | Guardant Health, Inc. — oncology liquid biopsy and cell-free DNA diagnostics companySearch in Eureka ↗ |
| Plaintiff counsel | Christopher Michael Gallo | Attorney | Counsel for University of WashingtonSearch in Eureka ↗ |
| Plaintiff counsel | David Holman Esq. | Attorney | Counsel for University of WashingtonSearch in Eureka ↗ |
| Plaintiff counsel | Ralph Wilson Powers III | Attorney | Counsel for University of WashingtonSearch in Eureka ↗ |
| Plaintiff law firm | Sterne, Kessler, Goldstein & Fox, PLLC | Law Firm | Representing University of WashingtonSearch in Eureka ↗ |
| Defendant counsel | Jad Allen Mills | Attorney | Counsel for Guardant Health, Inc.Search in Eureka ↗ |
| Defendant counsel | Michael T. Rosato | Attorney | Counsel for Guardant Health, Inc.Search in Eureka ↗ |
| Defendant counsel | Richard Torczon | Attorney | Counsel for Guardant Health, Inc.Search in Eureka ↗ |
| Defendant counsel | Sonja Rochelle Gerrard Ph.D. | Attorney | Counsel for Guardant Health, Inc.Search in Eureka ↗ |
| Defendant law firm | WilsonSonsini Goodrich & Rosati LLP | Law Firm | Representing Guardant Health, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Court of Appeals for the Federal CircuitSearch in Eureka ↗ |
Official order — verbatim text
The court’s order is narrow and procedural: it records mutual consent to dismissal under Rule 42(b) and allocates costs symmetrically. Notably, it does not contain any finding on patentability, claim validity, or claim construction. At the Federal Circuit level, a Rule 42(b) dismissal carries no precedential weight and establishes no legal standard. The equal cost allocation is consistent with a jointly negotiated exit rather than a concession by either party, though the public record does not confirm the underlying commercial or legal rationale.
US10752951B2 — Duplex Consensus Sequencing Error-Reduction Methods
US10752951B2 (application US16/514931) protects methods of reducing the error rate of massively parallel DNA sequencing through duplex consensus sequencing — a technique that sequences both strands of a DNA duplex independently and compares them to filter out sequencing artefacts. This approach is foundational to high-sensitivity liquid biopsy applications where rare variant detection in circulating cell-free DNA demands error rates orders of magnitude below standard next-generation sequencing platforms.
The commercial stakes around this patent are substantial. Duplex consensus sequencing is a core enabling technology for detecting low-frequency somatic mutations in plasma — directly relevant to Guardant Health’s oncology liquid biopsy product line and to the broader class of ultra-sensitive ctDNA assays. Any company developing or commercialising massively parallel sequencing workflows for clinical diagnostics, minimal residual disease monitoring, or early cancer detection should assess their exposure to this patent’s claims before launch.
Should your sequencing platform run an FTO against US10752951B2?
If your organisation is developing or commercialising duplex consensus sequencing methods, ctDNA liquid biopsy assays, or error-correction pipelines for massively parallel DNA sequencing, US10752951B2 is a patent you need to assess. The University of Washington holds this patent and has demonstrated willingness to pursue patentability challenges to the Federal Circuit level — suggesting active enforcement interest. The absence of a merits ruling in Case 24-1583 does not diminish the patent’s enforceability.
PatSnap Eureka’s FTO Search Agent enables R&D and IP teams to map claim-level overlap between US10752951B2 and their specific sequencing workflows — identifying freedom-to-operate gaps, potential design-arounds, and prior art that could support future validity challenges. With the University of Washington’s enforcement posture still uncertain post-dismissal, running a targeted FTO now is lower cost than responding to a new proceeding later.
Run a freedom-to-operate analysis on US10752951B2 to assess your product’s exposure
Run FTO in Eureka →Similar Federal Circuit appeals involving DNA sequencing and liquid biopsy patents
Cases involving duplex sequencing, ctDNA diagnostics, and massively parallel sequencing IP at the Federal Circuit and PTAB, with comparable patentability and invalidity postures.
What this case signals for the liquid biopsy and DNA sequencing IP landscape
A swift Federal Circuit exit with costs split often signals negotiated resolution — but the silence on prejudice leaves strategic ambiguity for the sector.
Split costs and 82-day exit suggest mutual accommodation, not capitulation
When both sides bear their own costs in a voluntary Federal Circuit dismissal, it typically signals a negotiated outcome rather than one party abandoning a weak position. University of Washington’s decision to file and then withdraw within 82 days is consistent with parallel licensing talks or a commercial agreement that made continued appellate litigation unnecessary.
US10752951B2 remains enforceable — FTO analysis is still required
The absence of a merits ruling at the Federal Circuit means no judicial finding of invalidity has been entered. Companies developing duplex consensus sequencing methods, liquid biopsy assays, or error-correction approaches for massively parallel sequencing should treat this patent as fully in-force and run current FTO analysis before product launch or scale.
Washington v Guardant — key questions answered
The Federal Circuit appeal in Case 24-1583 was voluntarily dismissed under Fed. R. App. P. 42(b) on 10 June 2024, 82 days after filing. Both parties agreed to the dismissal, and each side bore its own costs. The court issued no merits ruling on the patentability of US10752951B2.
Yes — the voluntary dismissal in Case 24-1583 did not result in any finding of invalidity or cancellation. The patent remains in force. No appellate court ruled on its validity, meaning US10752951B2 should be treated as enforceable by competitors and potential licensees in the sequencing and liquid biopsy space.
Rule 42(b) permits parties to jointly dismiss a Federal Circuit appeal without the court addressing the merits. It leaves the record of the underlying proceeding — typically a PTAB or district court decision — undisturbed at the appellate level. The public order in Case 24-1583 does not specify whether the dismissal was with or without prejudice, leaving open the question of whether the same issues could be relitigated.
US10752951B2 covers methods of reducing sequencing errors in massively parallel DNA sequencing using duplex consensus sequencing — a technique that reads both DNA strands to filter artefacts. This is a core enabling method for ultra-sensitive ctDNA liquid biopsy assays used in early cancer detection and minimal residual disease monitoring, making it directly relevant to companies including Guardant Health and others in the clinical sequencing sector.
The court’s order allocates costs symmetrically — each side bears its own — which is consistent with a mutually agreed voluntary dismissal rather than a unilateral concession. Under Fed. R. App. P. 42(b), parties can agree on cost allocation as part of a stipulated dismissal. The equal split typically suggests a negotiated resolution, though the specific commercial terms, if any, are not disclosed in the public record.
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