Natera v. CareDx: $96M Jury Award Erased as Court Invalidates cfDNA Patents
Natera filed suit against CareDx in January 2020 asserting three cell-free DNA transplant monitoring patents against CareDx’s AlloSure test. A jury awarded Natera $96,307,521 in damages in January 2024 — only for the district court to subsequently grant CareDx judgment as a matter of law, invalidating the asserted claims under § 112 for inadequate written description. Final judgment entered for CareDx across all three patents after 1,883 days of litigation.
A $96M verdict, then reversed: how § 112 sank Natera’s cfDNA patent portfolio
Natera, Inc. initiated this consolidated action in the District of Delaware on January 13, 2020, alleging that CareDx, Inc.’s AlloSure cell-free DNA (cfDNA) transplant monitoring test infringed three Natera patents: U.S. Patent Nos. 10,597,724, 10,655,180, and 11,111,544. Each consolidated complaint asserted a single count of infringement, while CareDx counterclaimed for declaratory judgments of invalidity and non-infringement in each case. The dispute centred on next-generation sequencing methods used to detect donor-derived cfDNA in transplant recipients as a marker of organ rejection.
The ‘724 Patent fell first: the court granted CareDx’s summary judgment motion that claims 1, 4, 5, and 6 were patent-ineligible under 35 U.S.C. § 101. A five-day jury trial in January 2024 then addressed the ‘180 and ‘544 Patents, with the jury finding non-infringement of the ‘180 Patent but infringement of claims 21, 26, and 27 of the ‘544 Patent, awarding Natera $96,307,521 in damages. The court then granted CareDx’s post-trial motion for judgment as a matter of law, invalidating the asserted claims of both the ‘180 and ‘544 Patents under § 112 for inadequate written description — extinguishing both the damages award and any injunctive relief. Final judgment entered for CareDx on March 10, 2025.
The case lasted 1,883 days — over five years — reflecting the complexity of consolidated multi-patent litigation and the layered motion practice that followed trial. The § 112 JMOL outcome is notably rare: juries seldom award nine-figure damages only to have the award wiped out by a post-trial written description ruling. The public record does not disclose whether settlement discussions occurred before or after verdict, what claim construction rulings shaped the written description analysis, or whether Natera intends to appeal. The case signals meaningful judicial scrutiny of written description adequacy for cfDNA diagnostic patent claims.
Filing to Judgment on the merits for Defendant in 1883 days
1,883 days — over five years from filing to final judgment, well above the median D. Del. patent case duration
Judgment for CareDx: what the post-trial invalidity ruling means for both parties
§ 112 JMOL erases a nine-figure jury award
After a jury verdict awarding Natera $96.3M, the district court granted CareDx’s Rule 50(b) motion for judgment as a matter of law, holding that claims 14–15 of the ‘180 Patent and claims 21, 26, and 27 of the ‘544 Patent lacked adequate written description under 35 U.S.C. § 112. A § 112 JMOL overrides the jury’s liability and damages findings; the patent claims are treated as if never validly issued, rendering the damages award legally moot.
Post-trial JMOL — § 112 written descriptionNatera loses damages award and all three patents in suit
Final judgment ran against Natera on all counts. The ‘724 Patent was eliminated at summary judgment under § 101; the ‘180 and ‘544 Patents were invalidated post-trial under § 112. Natera’s permanent injunction motion was denied as moot. Unless reversed on appeal, Natera holds no enforceable judgment from this litigation and CareDx faces no damages liability. The cfDNA transplant monitoring claims at issue are invalid as a matter of law.
All patents invalidated — no damages collectedCareDx prevails on invalidity across all three patents
CareDx successfully defeated all three asserted patents through different legal mechanisms: § 101 at summary judgment for the ‘724 Patent and § 112 post-trial JMOL for the ‘180 and ‘544 Patents. AlloSure can continue operating without a damages obligation arising from this litigation. CareDx’s counterclaim for non-infringement of the ‘180 Patent was also upheld; the invalidity counterclaims for the ‘180 and ‘544 Patents prevailed via JMOL.
CareDx: full invalidity win across all patentsTightening written description standards for cfDNA diagnostic claims
This outcome suggests Delaware district courts will apply rigorous § 112 scrutiny to cfDNA diagnostic patent claims, even where a jury has already found infringement and awarded substantial damages. For the transplant monitoring diagnostics sector, the case raises the bar for written description support in patent applications. Competitors should reassess the specification depth of pending cfDNA applications, while patent holders with similar claim structures should evaluate vulnerability to post-trial invalidity challenges.
High § 112 bar for cfDNA diagnostic patentsFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Natera, Inc. | Company | Genomics and cfDNA diagnostics company — holder of US10597724B2 and two related transplant monitoring patentsSearch in Eureka ↗ |
| Defendant | CareDx, Inc. | Company | Transplant diagnostics company; developer of the AlloSure cfDNA-based organ rejection monitoring testSearch in Eureka ↗ |
| Plaintiff counsel | Anthony David Raucci | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Derek James Fahnestock | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Jack B. Blumenfeld | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Sandra L. Haberny | Attorney | Counsel for Natera, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Morris, Nichols, Arsht & Tunnell LLP | Law Firm | Representing Natera, Inc.Search in Eureka ↗ |
| Defendant counsel | Anna Dwyer | Attorney | Counsel for CareDx, Inc.Search in Eureka ↗ |
| Defendant counsel | August M. Melcher | Attorney | Counsel for CareDx, Inc.Search in Eureka ↗ |
| Defendant counsel | Brian E. Farnan | Attorney | Counsel for CareDx, Inc.Search in Eureka ↗ |
| Defendant counsel | Concord Cheung | Attorney | Counsel for CareDx, Inc.Search in Eureka ↗ |
| Defendant counsel | Derek C. Walter | Attorney | Counsel for CareDx, Inc.Search in Eureka ↗ |
| Defendant counsel | Edward R. Reines | Attorney | Counsel for CareDx, Inc.Search in Eureka ↗ |
| Defendant counsel | Michael J. Farnan | Attorney | Counsel for CareDx, Inc.Search in Eureka ↗ |
| Defendant counsel | Nate Ngerebara | Attorney | Counsel for CareDx, Inc.Search in Eureka ↗ |
| Defendant counsel | Shawn Chi | Attorney | Counsel for CareDx, Inc.Search in Eureka ↗ |
| Defendant counsel | W. Sutton Ansley | Attorney | Counsel for CareDx, Inc.Search in Eureka ↗ |
| Defendant law firm | Farnan LLP | Law Firm | Representing CareDx, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The final judgment reflects three distinct dispositions across three patents decided at different procedural stages. The ‘724 Patent fell on § 101 eligibility at summary judgment — the broadest and earliest defeat. The ‘180 and ‘544 Patents survived to jury trial, with the jury finding non-infringement of the ‘180 Patent and infringement plus $96.3M damages on the ‘544 Patent, while rejecting invalidity on both. The district court then applied the JMOL standard — asking whether no reasonable jury could find adequate written description — and found that threshold met, nullifying both the damages award and all infringement findings. The denial of a new trial on the same grounds reinforces the court’s confidence in the § 112 analysis.
US10597724B2 — cell-free DNA transplant rejection monitoring methods
U.S. Patent No. 10,597,724 (and the related ‘180 and ‘544 Patents) protect methods for detecting donor-derived cell-free DNA in a transplant recipient’s bloodstream using next-generation sequencing techniques. The technology underpins liquid biopsy-style monitoring of organ rejection — a clinically significant alternative to invasive biopsy. The patents cover sequencing, genotyping, and bioinformatic analysis steps used to quantify donor cfDNA fractions, with claims directed at specific algorithmic and assay configurations. The ‘724 Patent’s priority application dates and the consolidated assertion of three patents suggest a continuation filing strategy designed to maximise claim coverage across the cfDNA workflow.
The transplant monitoring cfDNA space is commercially significant: AlloSure, CareDx’s flagship product, is among the few clinically validated cfDNA tests for kidney transplant surveillance, with Medicare reimbursement coverage. Natera’s assertion of three patents in a consolidated action signals an attempt to create a broad enforcement perimeter around cfDNA transplant diagnostics. The invalidation of all three patents under § 101 and § 112 substantially weakens Natera’s ability to exclude competitors from this market segment using this specific patent family — though Natera may hold additional cfDNA IP not at issue in this case.
Should you run an FTO against US10597724B2 and Natera’s cfDNA transplant portfolio?
Any company developing, commercialising, or licensing cfDNA-based organ rejection monitoring assays — including kidney, heart, or lung transplant surveillance products — should conduct a freedom-to-operate analysis against Natera’s cfDNA patent portfolio. While the three patents litigated here have been invalidated, Natera is an active filer with a broad molecular diagnostics portfolio. Related continuation applications, divisional patents, or patents with different claim structures may still present infringement risk for AlloSure competitors, reference laboratory developers, and hospital systems deploying cfDNA transplant tests.
PatSnap Eureka’s FTO Search Agent allows IP and R&D teams to map the full Natera cfDNA patent family, identify related applications with surviving claims, and assess claim scope against specific assay workflows. Run a landscape search across US, EP, and PCT filings to identify claim structures analogous to the invalidated claims — and to confirm whether any reissue or continuation applications have issued with strengthened written description support. Eureka’s claim chart generation and prior art surfacing tools accelerate the analysis from weeks to hours.
Run a freedom-to-operate analysis on US10597724B2 to assess your product’s exposure
Run FTO in Eureka →Similar cfDNA diagnostics patent infringement cases in D. Delaware
Explore related cell-free DNA and liquid biopsy patent disputes litigated in the District of Delaware, including § 101 eligibility and § 112 written description challenges in molecular diagnostics.
What Natera v. CareDx signals for the cfDNA diagnostics IP landscape
A $96M verdict wiped out post-trial: this case redefines the litigation risk profile for cfDNA transplant monitoring patents.
§ 112 written description is a viable post-trial weapon in diagnostics cases
CareDx’s success in obtaining JMOL on written description grounds — after a jury had already awarded nine-figure damages — demonstrates that § 112 challenges should be preserved and pursued vigorously even where infringement is found. Defendants in cfDNA and molecular diagnostics cases should treat written description as a primary invalidity vector, not a fallback argument.
§ 101 and § 112 together create a layered invalidity strategy for diagnostic patents
CareDx eliminated one patent at summary judgment under § 101 and two more via post-trial JMOL under § 112. This dual-track approach — eligibility challenge early, written description challenge post-verdict — proved decisive. IP teams defending against diagnostic method patents should build parallel invalidity arguments from the outset, preserving both tracks through trial.
Natera v CareDx — key questions answered
Final judgment entered for CareDx on March 10, 2025. All three of Natera’s asserted patents were invalidated: US10597724 under § 101 at summary judgment, and US10655180 and US11111544 under § 112 for inadequate written description via post-trial JMOL. A jury had awarded Natera $96,307,521 in damages, but the district court vacated that award through the JMOL ruling. CareDx’s AlloSure test faces no damages obligation from this litigation.
The district court granted CareDx’s Rule 50(b) motion for judgment as a matter of law, finding that claims 14–15 of the ‘180 Patent and claims 21, 26, and 27 of the ‘544 Patent lacked adequate written description under 35 U.S.C. § 112. A JMOL on invalidity can be granted even after a jury verdict if the court determines no reasonable jury could have found the written description requirement satisfied. The specific claim construction and specification analysis underlying the ruling are detailed in D.I. 558–559.
The court granted CareDx’s motion for summary judgment that claims 1, 4, 5, and 6 of US10597724 are patent-ineligible under 35 U.S.C. § 101. Section 101 challenges to diagnostic method patents — which frequently involve natural phenomena such as circulating DNA — have succeeded at the summary judgment stage with some regularity following Mayo and Alice. The ‘724 Patent’s claims were apparently found to lack an inventive concept sufficient to transform the natural phenomenon into patent-eligible subject matter.
AlloSure is a liquid biopsy test that measures donor-derived cell-free DNA (dd-cfDNA) in a transplant recipient’s blood as a non-invasive marker of organ rejection. It uses next-generation sequencing to quantify donor DNA fractions without requiring a biopsy. Natera alleged that AlloSure’s methodology — including its sequencing and bioinformatic analysis steps — fell within the scope of the three asserted patents, all of which cover cfDNA-based transplant monitoring methods.
Yes. Natera retains the right to appeal the district court’s post-trial JMOL ruling to the U.S. Court of Appeals for the Federal Circuit. At the appellate level, JMOL rulings are reviewed de novo, meaning the Federal Circuit will independently assess whether the evidence was sufficient for a reasonable jury to find adequate written description. The public record as of the case closing date does not confirm whether Natera has filed a notice of appeal. A successful appeal could reinstate the $96.3M jury verdict.
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