Invitae v. Natera: DNA Sequencing Patent Dispute Dismissed With Prejudice
Invitae Corp. sued Natera, Inc. in Delaware federal court alleging infringement of US10604799B2, a patent covering DNA sequencing technology, in connection with Natera’s Signatera cancer recurrence test. After 1,663 days of litigation across two consolidated actions, the parties stipulated to dismiss all claims and counterclaims with prejudice, each side bearing its own costs.
A long-running ctDNA patent battle ends by mutual agreement
On 7 May 2021, Invitae Corp. filed suit against Natera, Inc. in the District of Delaware (Case No. 1:21-cv-00669) asserting US10604799B2, a patent directed to DNA sequencing technology. The dispute centred on Natera’s Signatera test, a personalised circulating tumour DNA (ctDNA) assay used to monitor cancer recurrence and treatment response. A related companion action (C.A. No. 21-1635) was also before Judge Gregory B. Williams, indicating a multi-front dispute over overlapping IP.
After more than four and a half years of litigation, the parties jointly stipulated to dismiss all claims and counterclaims in both actions with prejudice pursuant to Federal Rule of Civil Procedure 41(a)(1), subject to court approval. A dismissal with prejudice is a final, binding resolution: Invitae cannot re-file the same claims against Natera on these patents. Critically, the stipulation specifies that all parties shall bear their own costs, attorneys’ fees, and disbursements — a term consistent with a negotiated resolution rather than a clear courtroom winner.
The 1,663-day duration and bilateral cost-bearing arrangement suggest the case likely resolved through a commercial settlement or cross-licensing agreement, the specific terms of which remain confidential and outside the public record. The absence of any damages award or finding of liability means neither party secured a public legal victory, but Natera retains freedom to continue commercialising Signatera without an injunction or judgment on the record. What drove the parties to resolve at this stage — rather than proceeding to trial — is not disclosed in the public docket.
Filing to Dismissed with Prejudice in 1663 days
1,663 days — nearly 4.6 years, well above the median D. Del. patent case duration
Dismissed with prejudice: what the stipulated resolution means for both parties
Rule 41(a)(1) dismissal with prejudice — a permanent bar on re-filing
A stipulated dismissal with prejudice under FRCP 41(a)(1) is a mutually agreed procedural termination that carries the force of a final judgment on the merits. Unlike a dismissal without prejudice, Invitae cannot bring these same patent claims against Natera again. The bilateral nature of the stipulation — covering all claims and counterclaims in two consolidated actions — suggests a comprehensive clean-slate resolution.
Permanent bar on re-litigationInvitae surrenders its infringement claims permanently
By agreeing to a with-prejudice dismissal, Invitae relinquishes the ability to pursue US10604799B2 claims against Natera on the accused Signatera product. There is no damages award or injunction entered in Invitae’s favour. However, the patent itself remains in force and could be asserted against other parties. The mutual cost-bearing term may reflect a licensing arrangement or broader commercial deal that the parties chose not to disclose publicly.
Patent survives; enforcement rights released vs. NateraNatera clears the litigation cloud over Signatera without a liability finding
Natera exits both actions without any finding of infringement, no damages award, and no injunction. The dismissal with prejudice provides Natera with certainty that Invitae cannot revive these specific claims in US courts. For a commercial product like Signatera — with significant oncology market positioning — the removal of long-running patent litigation risk is commercially meaningful, regardless of the confidential terms that may underpin the resolution.
No infringement finding; Signatera clearedctDNA diagnostics: IP clearance without precedent leaves sector uncertainty
Because the case resolved without a merits ruling, no claim construction or validity determination was entered for US10604799B2. Competitors in the ctDNA and liquid biopsy space cannot rely on this outcome as precedent for their own freedom-to-operate positions. The 4.6-year duration and own-costs term suggest the litigation may have catalysed a commercial arrangement, and other players in personalised oncology diagnostics should treat the patent as still fully enforceable against third parties.
No claim construction precedent setFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Invitae, Corp. | Company | Genomics and genetic testing company — holder of US10604799B2 (DNA sequencing technology)Search in Eureka ↗ |
| Defendant | Natera, Inc. | Company | Natera, Inc. — genetic testing company; developer and marketer of the Signatera ctDNA assaySearch in Eureka ↗ |
| Plaintiff counsel | Barry Zhang | Attorney | Counsel for Invitae, Corp.Search in Eureka ↗ |
| Plaintiff counsel | Brian E. Farnan | Attorney | Counsel for Invitae, Corp.Search in Eureka ↗ |
| Plaintiff counsel | Concord Cheung | Attorney | Counsel for Invitae, Corp.Search in Eureka ↗ |
| Plaintiff counsel | Derek C. Walter | Attorney | Counsel for Invitae, Corp.Search in Eureka ↗ |
| Plaintiff counsel | Edward R. Reines | Attorney | Counsel for Invitae, Corp.Search in Eureka ↗ |
| Plaintiff counsel | Justin L. Constant | Attorney | Counsel for Invitae, Corp.Search in Eureka ↗ |
| Plaintiff counsel | Kaitlin Paulson | Attorney | Counsel for Invitae, Corp.Search in Eureka ↗ |
| Plaintiff counsel | Michael J. Farnan | Attorney | Counsel for Invitae, Corp.Search in Eureka ↗ |
| Plaintiff counsel | Yi Zhang | Attorney | Counsel for Invitae, Corp.Search in Eureka ↗ |
| Plaintiff law firm | Farnan LLP | Law Firm | Representing Invitae, Corp.Search in Eureka ↗ |
| Defendant counsel | Ariella C. Barel | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Brian P. Egan | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Chih-wei Wu | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Daniel J. Klein | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Derek James Fahnestock | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Eliza P. Strong | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Eric Alan Stone | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Jacob M. Berman | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Jenny C. Wu | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Joshua A. Rosefelt | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Karen Jacobs | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Nicolas Groombridge | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Robert J. Gunther , Jr. | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Defendant law firm | Morris, Nichols, Arsht & Tunnell LLP | Law Firm | Representing Natera, Inc.Search in Eureka ↗ |
| Presiding judge | Judge Gregory B. Williams | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulated dismissal language is deliberately comprehensive: it covers ‘all claims and counterclaims’ in both consolidated Delaware actions, leaving no residual dispute between the parties. The explicit invocation of FRCP 41(a)(1) and the mutual cost-bearing term are consistent with a negotiated commercial resolution. Critically, no court has made any finding on infringement, invalidity, or claim scope — meaning US10604799B2 carries no judicial gloss that third parties can rely upon for their own IP positions.
US10604799B2 — DNA sequencing technology for ctDNA detection
US10604799B2 (application number US14/250891) is directed to DNA sequencing technology, specifically methods and systems relevant to the detection and analysis of cell-free or circulating tumour DNA (ctDNA). This technology class underpins liquid biopsy platforms used in oncology for non-invasive cancer monitoring. The patent’s application date places it in the period of rapid commercialisation of next-generation sequencing (NGS) approaches to ctDNA profiling, a technically complex and heavily contested IP domain.
Strategically, US10604799B2 is positioned at the intersection of NGS methodology and clinical oncology diagnostics — a space where Invitae, Natera, Foundation Medicine, Guardant Health, and others compete intensely. Because the litigation resolved without a validity or infringement ruling, the patent’s claim scope remains untested by a court, making it a potential enforcement tool against other ctDNA platform developers. Any competitor in personalised cancer monitoring, minimal residual disease (MRD) detection, or liquid biopsy product development should treat this patent as an active risk.
Should your team run an FTO against US10604799B2?
If your R&D or product team is developing ctDNA sequencing platforms, liquid biopsy assays, or personalised cancer monitoring tools, US10604799B2 warrants direct attention. The Invitae–Natera dispute confirms this patent was considered commercially significant enough to litigate for over four years. No court ruling on validity or claim scope has emerged, so the patent retains full presumptive validity. Any product involving cell-free DNA sequencing, tumour-informed variant detection, or MRD monitoring should be screened against this patent’s claim landscape before commercial launch.
PatSnap Eureka’s FTO Search Agent can map the claim language of US10604799B2 against your product specifications, identify prior art that could inform invalidity arguments, and surface related Invitae patent families that may pose additional risk. Eureka’s litigation intelligence layer also lets you track any new enforcement actions Invitae brings on related patents in real time — essential monitoring for any team operating in the ctDNA diagnostics space.
Run a freedom-to-operate analysis on US10604799B2 to assess your product’s exposure
Run FTO in Eureka →Similar DNA sequencing and liquid biopsy patent cases in D. Del.
Cases involving ctDNA sequencing patents and liquid biopsy technology litigated in the District of Delaware, with comparable infringement claims and dismissal outcomes.
What this case signals for the liquid biopsy and ctDNA IP landscape
A four-and-a-half-year dispute between two genomics rivals ends quietly — but the IP signals are worth reading carefully.
US10604799B2 remains enforceable: third-party FTO work is still required
The dismissal with prejudice resolves the Invitae–Natera dispute only. No court has ruled on the validity or scope of US10604799B2. Any company operating in the DNA sequencing or ctDNA diagnostic space — particularly liquid biopsy developers — should treat this patent as fully live and conduct independent freedom-to-operate analysis before commercialising potentially overlapping technology.
Bilateral cost-bearing is a hallmark of a negotiated exit — watch for licensing signals
When both parties absorb their own costs after years of high-stakes litigation, it typically signals a commercial resolution rather than a defendant walkaway. Companies monitoring the ctDNA and oncology diagnostics sector should watch for licensing disclosures, partnership announcements, or cross-licensing terms between Invitae and Natera that may emerge in subsequent financial filings or regulatory disclosures.
Invitae v Natera — key questions answered
The case was dismissed with prejudice by stipulation of the parties on 25 November 2025, after 1,663 days of litigation. All claims and counterclaims across two consolidated Delaware actions were terminated, with each party bearing its own costs and attorneys’ fees. No infringement finding or damages award was entered.
Invitae asserted US10604799B2 (application US14/250891), a patent directed to DNA sequencing technology. The patent was asserted in connection with Natera’s Signatera product, a personalised circulating tumour DNA assay used for cancer recurrence monitoring.
A dismissal with prejudice under FRCP 41(a)(1) permanently bars Invitae from bringing the same patent claims against Natera on the accused Signatera product in US courts. However, US10604799B2 itself remains in force and Invitae retains the right to enforce it against third parties. No court ruling was made on validity or infringement.
Yes. Because the case was resolved by stipulated dismissal without any court ruling on validity, claim scope, or infringement, US10604799B2 carries full presumptive validity. Competitors in ctDNA sequencing, liquid biopsy, and personalised oncology diagnostics should treat the patent as an active enforcement risk and conduct independent FTO analysis.
The mutual cost-bearing term — where neither side recovers attorneys’ fees, disbursements, or costs — is consistent with a negotiated commercial resolution or licensing agreement reached between the parties. It suggests neither party secured a decisive litigation win, and that the resolution was driven by commercial considerations rather than a clear legal outcome. The specific terms of any underlying agreement are not disclosed in the public record.
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