Invitae v. Natera: DNA Sequencing Patent Dispute Dismissed With Prejudice After 4 Years
Invitae Corp. brought a patent infringement action against Natera, Inc. in Delaware, asserting two DNA sequencing patents against Natera’s Signatera liquid biopsy product. After 1,465 days of litigation, both parties stipulated to dismiss all claims and counterclaims with prejudice, each bearing its own legal costs.
Four-Year Genomics Patent Battle Ends in Bilateral Dismissal
Invitae Corp., a genetic information company and holder of US11149308B2 and US11155863B2, filed suit against Natera, Inc. in the Delaware District Court on 21 November 2021, alleging infringement of two patents covering DNA sequencing technology. The accused product was Natera’s Signatera, a tumour-informed circulating tumour DNA assay used in cancer monitoring. The case was assigned to Judge Gregory B. Williams and was consolidated or coordinated with related Case No. 21-669.
The litigation concluded on 25 November 2025 when the parties filed a joint stipulation under Federal Rule of Civil Procedure 41(a)(1) dismissing all claims and counterclaims with prejudice across both related actions. Critically, the stipulation specified that all parties would bear their own costs, disbursements, and attorneys’ fees, meaning no fee-shifting was awarded to either side. A dismissal with prejudice bars Invitae from re-filing the same patent infringement claims against Natera on these two patents.
The case ran for 1,465 days — approximately four years — before resolution without a public merits ruling, which is consistent with either a confidential commercial settlement reached between the parties or a business decision to exit litigation. The precise commercial terms, if any, underlying the stipulation are not disclosed in the public record. The mutual cost-bearing provision and absence of any recorded damages or injunction suggests neither party extracted a publicly visible concession, though undisclosed licensing or business arrangements cannot be ruled out.
Filing to Dismissed with Prejudice in 1465 days
1,465 days — well above the median time-to-resolution for Delaware patent cases, suggesting protracted pre-trial litigation
Dismissed with prejudice: what the stipulated outcome means for both parties
Rule 41(a)(1) dismissal with prejudice: the case is permanently closed
Under Federal Rule of Civil Procedure 41(a)(1), parties may jointly stipulate to dismiss an action. Here, the stipulation specifies dismissal ‘with prejudice,’ meaning the claims are extinguished permanently. Invitae cannot re-file these same infringement claims against Natera on US11149308B2 or US11155863B2. This is a final disposition on the merits as a matter of preclusion law, even though no court judgment on the substance was issued.
Permanent bar on re-filingInvitae’s claims are extinguished — patents remain valid but unenforceable against Natera
A with-prejudice dismissal forecloses Invitae from pursuing the same infringement claims against Natera on these two patents. The patents themselves remain in force and could theoretically be enforced against third parties, but Invitae has permanently surrendered its right to sue Natera under US11149308B2 and US11155863B2. Whether Invitae obtained any commercial consideration — such as a licensing arrangement — in exchange is not disclosed in the public record.
Claims permanently waived vs. NateraNatera gains permanent litigation peace on these two patents
Natera secures freedom from future infringement suits by Invitae under the two asserted patents. The dismissal with prejudice and mutual cost-bearing provision means Natera avoids any publicly recorded damages or injunction. Signatera can continue to operate without the cloud of this specific litigation. However, because the dismissal is stipulated rather than a merits ruling, Natera does not obtain a judicial finding of non-infringement or invalidity that could be used offensively in other proceedings.
Litigation cleared; no invalidity findingBilateral resolution leaves the liquid biopsy patent landscape unsettled
Because neither validity nor infringement was adjudicated, competitors in the cell-free DNA and liquid biopsy space cannot rely on this outcome as precedent. The two Invitae patents remain live and could be asserted against other market participants. For companies operating in the ctDNA, MRD monitoring, or DNA sequencing space, this case suggests that even well-resourced parties prefer negotiated exits over protracted merits trials in complex genomics litigation.
Patents still enforceable vs. third partiesFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Invitae, Corp. | Company | Genetic information and diagnostics company — holder of US11149308B2 and US11155863B2Search in Eureka ↗ |
| Defendant | Natera, Inc. | Company | Natera, Inc. — cell-free DNA testing company; developer of the Signatera liquid biopsy 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 | 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 stipulation invokes Rule 41(a)(1) to achieve a bilateral exit from both consolidated actions (21-669 and 21-1635). The with-prejudice specification is significant: it transforms a consensual procedural mechanism into a permanent merits bar. The mutual cost-bearing clause indicates no party extracted fee-shifting, which under 35 U.S.C. § 285 would require a finding of exceptionality. The public record is silent on any underlying commercial terms, leaving open the possibility of a confidential resolution driving the stipulation.
US11149308B2 & US11155863B2 — DNA sequencing methods for cell-free DNA analysis
US11149308B2 and US11155863B2 are both utility patents in the DNA sequencing and cell-free DNA analysis domain. The application numbers (US17/322610 and US17/322587) indicate these are likely continuation or related filings in a common family, suggesting overlapping claim scope. Both patents were asserted against Natera’s Signatera product — a tumour-informed minimal residual disease (MRD) assay that analyses circulating tumour DNA from blood samples. The technical domain sits at the intersection of molecular biology, next-generation sequencing, and oncology diagnostics.
In the competitive liquid biopsy market, patent portfolios covering sequencing methods and ctDNA detection protocols are strategically critical. Signatera competes directly with Guardant, Foundation Medicine, and emerging players, making freedom-to-operate clearance essential. The survival of these two patents post-dismissal means any company developing tumour-informed sequencing assays or MRD monitoring products should conduct a targeted FTO analysis against the Invitae patent family, particularly given the uncertain status of Invitae’s IP assets following its 2024 bankruptcy proceedings.
Should your product team run an FTO against US11149308B2 and US11155863B2?
Any R&D team developing cell-free DNA sequencing assays, ctDNA-based cancer monitoring tools, or tumour-informed MRD products should treat these two patents as live enforcement risks. The dismissal with prejudice in this case provides no invalidity precedent — a court never ruled on claim scope or validity. If your product falls within the liquid biopsy, next-generation sequencing, or oncology diagnostics space, an FTO analysis is warranted, especially given potential portfolio ownership changes arising from Invitae’s restructuring.
PatSnap Eureka’s FTO Search Agent can map your product’s technical features against the claim landscape of US11149308B2 and US11155863B2, identify related family members and continuations, and flag any ownership transfers that may have occurred post-dismissal. Eureka’s litigation analytics layer also surfaces co-pending actions and prosecution history estoppel that could narrow or expand claim interpretation — giving your legal and product teams actionable clearance intelligence before product launch or market expansion.
Run a freedom-to-operate analysis on US11149308B2 to assess your product’s exposure
Run FTO in Eureka →Similar DNA sequencing and liquid biopsy patent cases in Delaware District Court
Browse related cell-free DNA and liquid biopsy patent infringement cases filed in Delaware District Court involving sequencing technology and oncology diagnostics.
What this case signals for the liquid biopsy and ctDNA IP landscape
A four-year dismissal with prejudice in a high-stakes genomics patent dispute carries important signals for IP strategy in precision oncology.
With-prejudice dismissal extinguishes claims but not the patents themselves
US11149308B2 and US11155863B2 remain in force. Any company operating in DNA sequencing or cell-free DNA testing should treat these patents as active enforcement risks against their own products — this outcome provides no invalidity shield for third parties.
Four-year duration signals early investment in pre-trial skirmishing
1,465 days to a stipulated dismissal in Delaware is consistent with extensive claim construction, expert discovery, and potentially IPR proceedings running in parallel. Competitors planning to enter the liquid biopsy space should budget for multi-year litigation timelines if challenged by either party.
Invitae v Natera — key questions answered
The dismissal with prejudice permanently bars Invitae from re-filing infringement claims against Natera under US11149308B2 and US11155863B2. Entered by joint stipulation under Rule 41(a)(1), it operates as a final disposition on those claims. The patents themselves remain valid and could be asserted against other parties.
Invitae asserted US11149308B2 (application no. US17/322610) and US11155863B2 (application no. US17/322587). Both patents relate to DNA sequencing technology and were asserted against Natera’s Signatera tumour-informed ctDNA assay used in minimal residual disease monitoring.
No. The stipulation expressly states that all parties shall bear their own costs, disbursements, and attorneys’ fees. No damages award or fee-shifting under 35 U.S.C. § 285 is recorded in the public record.
No. The case was resolved by a joint stipulation of dismissal with prejudice — no court adjudicated the validity or invalidity of US11149308B2 or US11155863B2. The patents remain presumptively valid and are potential enforcement risks for third parties in the liquid biopsy and ctDNA space.
The case ran for 1,465 days, from filing on 21 November 2021 to closure on 25 November 2025 — approximately four years. This duration is consistent with extensive pre-trial activity including claim construction, expert discovery, and potentially parallel inter partes review proceedings, though specific docket events are not detailed in the available record.
PatSnap Eureka searches patents and litigation data to answer instantly.