Natera v. Inivata: ctDNA Patent Dispute Ends in Mutual Dismissal
When genomic diagnostics pioneer Natera, Inc. filed suit against liquid biopsy competitor Inivata, Inc. in January 2021, the case immediately signaled a high-stakes collision in the rapidly expanding circulating tumor DNA (ctDNA) patent landscape. After more than five years of litigation — 1,862 days to be precise — the parties resolved Case No. 1:21-cv-00056 through a stipulated dismissal without prejudice before the Delaware District Court, with each side bearing its own costs and fees.
The dispute centered on two U.S. patents and Inivata’s commercially significant InVisionFirst-Lung cancer diagnostic test, placing it squarely at the intersection of liquid biopsy patent infringement, molecular diagnostics IP strategy, and oncology innovation. For patent attorneys, in-house counsel, and R&D leaders operating in the precision medicine sector, this case offers meaningful strategic signals — not in what the court decided on the merits, but in how the parties ultimately chose to disengage.
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📋 Case Summary
| Case Name | Natera, Inc. v. Inivata, Inc. |
| Case Number | 1:21-cv-00056 (D. Del.) |
| Court | District of Delaware, before Chief Judge Gregory B. Williams |
| Duration | Jan 2021 – Feb 2026 1,862 days (~5 years, 1 month) |
| Outcome | Stipulated Dismissal Without Prejudice |
| Patents at Issue | |
| Accused Products | Inivata’s InVisionFirst-Lung Cancer Diagnostic Test |
Case Overview
The Parties
⚖️ Plaintiff
San Carlos, California-based genetic testing and diagnostics company with a substantial patent portfolio spanning cell-free DNA analysis, prenatal testing, and oncology applications. Natera has pursued an active patent assertion strategy in the liquid biopsy space.
🛡️ Defendant
Clinical-stage liquid biopsy company focused on ctDNA-based cancer diagnostics. Its InVisionFirst-Lung test was the accused product. NeoGenomics Laboratories acquired Inivata in 2021, giving the dispute additional commercial weight.
Patents at Issue
This landmark case involved two U.S. patents directed to methods of analyzing cell-free DNA for variant detection and cancer monitoring applications:
- • U.S. Patent No. 10,262,755 — Methods of analyzing cell-free DNA for variant detection and cancer monitoring.
- • U.S. Patent No. 10,597,709 — ctDNA analysis methodologies with claims relevant to next-generation sequencing workflows.
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The Verdict & Legal Analysis
Outcome
The case concluded on February 25, 2026, via a stipulated dismissal without prejudice pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(ii). All claims and counterclaims — including Natera’s infringement allegations and Inivata’s declaratory judgment counterclaims on invalidity and non-infringement — were dismissed. No damages award was entered. No injunctive relief was granted. Each party agreed to bear its own attorneys’ fees and costs. Specific financial settlement terms, if any existed in a confidential side agreement, were not disclosed in the public record.
Legal Significance & Verdict Cause Analysis
A Rule 41(a)(1)(A)(ii) dismissal, requiring stipulation, typically reflects a private settlement, litigation risk reassessment, or strategic decision to avoid an adverse merits ruling. The without prejudice designation is particularly significant: Natera expressly preserved its right to re-assert U.S. Patent Nos. 10,262,755 and 10,597,709 in future proceedings. Inivata’s counterclaims challenged patent validity, likely on grounds of prior art or subject matter eligibility, but the resolution without adjudication means no claim construction rulings or validity determinations created binding precedent from this docket. For the liquid biopsy patent infringement landscape, this outcome leaves meaningful legal uncertainty intact.
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⚠️ Freedom to Operate (FTO) Analysis
This case highlights critical IP risks in ctDNA diagnostic development. Choose your next step:
📋 Understand This Case’s Impact
Learn about the specific risks and implications for liquid biopsy patent litigation.
- View Natera’s active ctDNA patent portfolio
- Analyze prior art challenges in diagnostics
- Understand the strategic signals of dismissal without prejudice
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High Risk Area
ctDNA analysis methods in liquid biopsy
2 Patents at Issue
Covering ctDNA analysis methodologies
Dismissal Implications
Natera’s reassertion rights preserved
✅ Key Takeaways
For Patent Attorneys & Litigators
Rule 41(a)(1)(A)(ii) without-prejudice dismissal preserves full reassertion rights — a critical strategic option in high-value IP disputes.
Search related case law →No claim construction or validity rulings emerged; practitioners should not treat this case as precedent on ctDNA patent scope.
Explore precedents →For R&D Leaders
Conduct FTO analysis covering Natera’s ctDNA portfolio before commercializing liquid biopsy-based oncology diagnostics.
Start FTO analysis for my product →Design-around strategies should be developed concurrently with product development, not after market entry triggers litigation exposure.
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