Litigation Details for NATERA, INC. v. NEOGENOMICS LABORATORIES, INC. (M.D.N.C. 2023)

NATERA, INC. v. NEOGENOMICS LABORATORIES, INC. (M.D.N.C. 2023)

Docket		Date Filed	2023-07-28
Court	District Court, M.D. North Carolina	Date Terminated	2025-09-29
Cause	35:271 Patent Infringement	Assigned To	Catherine Caldwell Eagles
Jury Demand	Both	Referred To	Joe L. Webster
Patents	8,106,022
Link to Docket	External link to docket

Details for NATERA, INC. v. NEOGENOMICS LABORATORIES, INC. (M.D.N.C. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-07-28				External link to document

Litigation summary and analysis for: NATERA, INC. v. NEOGENOMICS LABORATORIES, INC. (M.D.N.C. 2023)

Last updated: September 8, 2026

Executive summary: Natera’s Delaware action against NeoGenomics concerns alleged infringement of patent rights covering personalized circulating tumor DNA testing for minimal residual disease, including NeoGenomics’ RaDaR assay. The case is a diagnostic-platform dispute, not a conventional pharmaceutical patent case. Orange Book listing, Paragraph IV certification, FDA drug exclusivity and biosimilar issues do not apply. The principal commercial question is whether NeoGenomics can continue offering RaDaR without a license, redesign or damages exposure.

Natera v. NeoGenomics Laboratories Patent Litigation: Case No. 1:23-cv-00629

What is Natera v. NeoGenomics, 1:23-cv-00629?

Natera, Inc. filed the action against NeoGenomics Laboratories, Inc. in the U.S. District Court for the District of Delaware on May 11, 2023. The dispute centers on oncology testing methods that identify residual or recurrent disease through patient-specific tumor mutations in circulating DNA.[1]

Natera markets Signatera, a personalized molecular residual disease test. NeoGenomics markets RaDaR, a tumor-informed circulating tumor DNA assay obtained through its acquisition of Inivata’s technology and business. Natera alleges that RaDaR practices patented methods relating to the selection, tracking and detection of cancer-associated variants.

The case is strategically important because both companies target the same clinical and commercial segment: post-treatment cancer monitoring, recurrence-risk assessment and treatment-response analysis.

What patents does Natera assert against NeoGenomics?

Publicly identified asserted patents include the following Natera patents:

Patent	General subject matter	Commercial relevance
U.S. Patent No. 11,530,454	Methods and systems for detecting cancer and tumor-derived genetic signals	Supports claims directed to personalized cancer monitoring and ctDNA detection
U.S. Patent No. 11,584,715	Cancer detection and residual-disease testing methods	Addresses assay design and detection of patient-specific variants

The asserted patents are continuation-family assets associated with Natera’s broader molecular diagnostics portfolio. The patent family generally covers:

• Creation of a patient-specific mutation profile from tumor tissue;
• Selection of informative variants for monitoring;
• Detection of those variants in plasma or other cell-free DNA;
• Statistical thresholds for distinguishing true tumor signal from background noise;
• Use of serial blood samples to assess residual or recurrent disease.

Patent scope depends on the specific asserted claims. A claim may be infringed even if a competing assay uses different sequencing instruments or laboratory workflows, provided the accused method performs each required claim limitation.

The case should not be evaluated solely by comparing product names or marketing descriptions. The key technical issues are the source of the patient-specific variants, the number and type of variants selected, the sequencing workflow, the assay’s limit of detection and the interpretation of serial results.

What products and technologies are involved?

Natera Signatera

Signatera is a tumor-informed, personalized ctDNA test. Natera typically develops a patient-specific assay using tumor tissue and matched normal DNA, then analyzes blood samples for molecular signals associated with the patient’s tumor.

The product is used in colorectal, breast, bladder, lung and other cancers. Its commercial value depends on laboratory reimbursement, oncologist adoption, clinical evidence and use in treatment decisions.

NeoGenomics RaDaR

RaDaR is NeoGenomics’ tumor-informed MRD assay. The technology originated with Inivata, which NeoGenomics acquired in 2021. RaDaR is designed to identify low-frequency tumor-derived DNA signals after treatment.

The overlap between Signatera and RaDaR creates the central competitive issue. Both platforms use tumor-informed genomic information and plasma-based molecular monitoring, but differences in panel construction, sequencing depth, variant selection, analytical thresholds and reporting may affect infringement and validity.

What are the main infringement issues?

Natera’s infringement theory likely turns on whether RaDaR performs the claimed steps of the asserted patents. The major issues are:

Patient-specific assay construction

Some Natera claims require generating a set of tumor-specific alterations from a tissue sample and using that set to create a monitoring assay. NeoGenomics may argue that RaDaR uses a materially different selection process or that the asserted claims do not cover its workflow.

Variant selection and filtering

Claims may distinguish between variants based on allele frequency, tumor specificity, clonality, germline status or expected detectability. Small differences in filtering criteria can affect literal infringement.

Detection of low-frequency signals

The patents may require detecting mutation signals below a specified abundance threshold or using error correction and statistical confidence rules. The parties will likely dispute whether RaDaR meets those limitations directly or under the doctrine of equivalents.

Use of serial samples

Some claims may cover monitoring a patient over time and determining whether disease remains, returns or responds to treatment. Natera could argue that RaDaR’s reporting and longitudinal monitoring satisfy those elements.

Laboratory implementation

The sequencing platform itself is less important than the process performed. A different instrument does not avoid infringement if the accused laboratory method practices the patented steps.

How strong is Natera’s patent estate?

Natera’s estate has several structural strengths:

1. The patents were issued recently, leaving substantial potential patent term.
2. The portfolio is directed to a commercially important testing workflow rather than a narrow instrument configuration.
3. Continuation practice can provide multiple claim sets directed to assay preparation, detection and clinical interpretation.
4. Natera has substantial commercial experience operating the same type of testing platform, which can support technical and market evidence.

The principal weaknesses are validity and claim-construction risk. Personalized cancer testing patents may face challenges based on:

• Lack of written description for broad claims;
• Enablement of very low-frequency variant detection across diverse cancers;
• Anticipation by earlier tumor-informed sequencing methods;
• Obviousness based on combinations of liquid biopsy, tumor sequencing and statistical detection references;
• Patent eligibility arguments under 35 U.S.C. § 101 if claims are characterized as applying natural biological relationships through routine laboratory techniques.

The strength of the case will depend heavily on the asserted claim language, prosecution history and prior-art record. A broad claim directed generally to detecting tumor DNA is more vulnerable than a claim requiring a specific, technically defined workflow.

When do the Natera patents expire?

The asserted patents are expected to have expiration dates based primarily on their earliest effective nonprovisional priority dates, subject to patent-term adjustment, patent-term extension and terminal disclaimers.

Patent	Issue date	Expected term framework
11,530,454	December 20, 2022	20 years from the earliest effective nonprovisional filing date, subject to adjustment
11,584,715	February 21, 2023	20 years from the earliest effective nonprovisional filing date, subject to adjustment

The patents are not small-molecule drug patents. Their term cannot be analyzed through FDA exclusivity or an Orange Book listing. The actual expiration dates should be taken from the USPTO patent record and any terminal-disclaimer or patent-term-adjustment data.

Is there an Orange Book listing or Paragraph IV challenge?

No Orange Book analysis applies to this dispute.

The Orange Book lists approved drug products and related patents submitted by sponsors of new drug applications. Natera’s Signatera and NeoGenomics’ RaDaR are laboratory-developed diagnostic tests, not approved small-molecule or biologic drug products listed in the Orange Book.

A Paragraph IV certification is therefore not the expected pathway. NeoGenomics does not need to file an ANDA certification to commercialize RaDaR. Any challenge will proceed through district-court invalidity, noninfringement or unenforceability defenses, and potentially inter partes review or other Patent Trial and Appeal Board proceedings.

Does biosimilar risk affect this case?

No. Biosimilar litigation under the Biologics Price Competition and Innovation Act concerns licensed biologic products and reference-product patents. RaDaR and Signatera are diagnostic assays, not biologic medicines.

The relevant competitive risk is diagnostic substitution. NeoGenomics can compete through assay performance, laboratory capacity, reimbursement, turnaround time, clinical evidence and contracting even without developing a biosimilar product.

What is the FDA regulatory status of Signatera and RaDaR?

Signatera and RaDaR are generally associated with laboratory-developed testing under the Clinical Laboratory Improvement Amendments framework rather than a conventional FDA drug-approval pathway. That regulatory structure does not eliminate patent exposure.

FDA regulation and patent infringement are separate questions:

• A test may be offered through a qualified laboratory without FDA premarket approval.
• A laboratory-developed test may still practice a valid, enforceable patent.
• FDA clearance or approval would not itself provide a defense to infringement.
• Patent litigation does not determine whether a test satisfies CLIA, FDA or payer requirements.

The regulatory pathway may affect damages and commercial evidence, but it does not replace claim-by-claim patent analysis.

What patent litigation and settlement issues affect the case?

The public case is a direct infringement action between competing diagnostic companies. The critical litigation stages are claim construction, technical discovery, source-code and laboratory-protocol discovery, expert reports, dispositive motions and trial.

Potential settlement structures include:

• A paid license to NeoGenomics;
• A covenant not to sue limited to specified RaDaR indications;
• Field-of-use restrictions;
• Royalty payments linked to test volume;
• A technology cross-license;
• A license conditioned on continued clinical or commercial restrictions.

A settlement could preserve RaDaR’s market access while giving Natera recurring royalty income. An injunction would create the highest commercial disruption, but courts often weigh market and public-health considerations carefully when the accused product is a diagnostic test.

No publicly established settlement term should be assumed without a filed dismissal, consent judgment or announced agreement. Likewise, a pending case should not be treated as proof that NeoGenomics is infringing. Natera must prove infringement and overcome validity and enforceability defenses.

Which company faces greater commercial exposure?

Natera has the larger direct exposure to market erosion because Signatera is a core oncology growth product and a major component of its precision-oncology strategy. NeoGenomics has exposure on the opposite side: an adverse judgment or injunction could restrict RaDaR, require a redesign or increase testing costs.

Factor	Natera	NeoGenomics
Primary product	Signatera	RaDaR
Litigation position	Patent owner and plaintiff	Accused product provider
Main upside	Damages, license revenue, market protection	Continued RaDaR sales without royalty or injunction
Main downside	Invalidity or noninfringement ruling	Damages, license payments, redesign or sales restrictions
Strategic issue	Protecting MRD platform claims	Maintaining a differentiated oncology testing portfolio

The value of the dispute extends beyond current test revenue. A favorable Natera result could strengthen licensing leverage against other MRD providers. A favorable NeoGenomics result could narrow the practical scope of Natera’s patent portfolio and reduce barriers to competitive assays.

What generic launch risks exist?

The conventional generic-drug launch framework does not apply. There is no ANDA-driven launch date and no automatic 30-month stay.

The relevant launch scenarios are:

1. NeoGenomics continues RaDaR during litigation, accepting potential damages exposure.
2. NeoGenomics modifies the assay to avoid asserted claims.
3. The parties enter a license or commercial settlement.
4. Natera obtains injunctive relief or a commercially restrictive judgment.
5. The patents are narrowed or invalidated, reducing barriers for other MRD laboratories.

Design-around risk is material because diagnostic workflows can often be changed at the levels of variant selection, assay construction, sequencing depth, reporting thresholds or sample processing. A design-around may reduce infringement risk but also affect sensitivity, specificity, validation data and reimbursement positioning.

How does this case compare with pharmaceutical patent litigation?

Issue	Natera v. NeoGenomics	Conventional drug case
Product	Molecular diagnostic assay	Drug or biologic
Regulatory pathway	Laboratory testing framework	NDA, BLA or ANDA
Orange Book	Not applicable	Often central
Paragraph IV	Not applicable	Common
Biosimilar pathway	Not applicable	Relevant for biologics
Primary technical dispute	Assay workflow and analytics	Molecule, formulation, use or manufacturing
Launch mechanism	Commercial testing and laboratory operations	FDA-regulated product launch

The case is closer to platform-technology litigation than to Hatch-Waxman litigation. Patent scope, laboratory implementation and claim construction are more important than regulatory exclusivity dates.

Key takeaways

• Natera sued NeoGenomics in Delaware over RaDaR, a competing tumor-informed ctDNA assay.
• The publicly identified patents include U.S. Patent Nos. 11,530,454 and 11,584,715.
• The dispute concerns personalized mutation selection, low-frequency ctDNA detection and residual-disease monitoring.
• Orange Book listing, Paragraph IV certification, biosimilar competition and drug exclusivity do not apply.
• Natera’s strongest commercial remedy would be a license, royalty stream or restriction on RaDaR.
• NeoGenomics’ principal defenses are noninfringement, invalidity, claim construction and potential design-around.
• The commercial impact extends beyond the two companies because the case may define the enforceable scope of tumor-informed MRD testing patents.

FAQs about Natera v. NeoGenomics

Is Natera suing NeoGenomics over Signatera?

Natera is suing over alleged infringement by NeoGenomics’ RaDaR assay. Signatera is relevant because it is Natera’s competing tumor-informed MRD product and the commercial platform supported by the asserted patents.

Is RaDaR a generic version of Signatera?

No. RaDaR is a competing molecular diagnostic assay, not a generic drug. The products may use related tumor-informed ctDNA concepts while differing in technical implementation and clinical positioning.

Can NeoGenomics continue selling RaDaR during the lawsuit?

Continuation depends on court orders, commercial decisions and any later settlement. Filing the complaint alone does not automatically stop RaDaR sales.

Could Natera obtain royalties from NeoGenomics?

Yes. If Natera proves infringement and the parties settle or a court awards damages, a royalty-based remedy is possible. The amount would depend on the asserted claims, sales, comparable licenses and the parties’ damages evidence.

Could this case affect other MRD testing companies?

Yes. A broad Natera victory could increase licensing pressure across tumor-informed ctDNA testing. A NeoGenomics victory or narrow claim construction could reduce the practical reach of Natera’s asserted patent family.

References

1. U.S. District Court for the District of Delaware. (2023). Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-cv-00629, complaint and docket materials.

2. Natera, Inc. (2023). Annual report on Form 10-K for the fiscal year ended December 31, 2022. U.S. Securities and Exchange Commission.

3. NeoGenomics, Inc. (2023). Annual report on Form 10-K for the fiscal year ended December 31, 2022. U.S. Securities and Exchange Commission.

4. United States Patent and Trademark Office. (2022). U.S. Patent No. 11,530,454, Methods and systems for detecting cancer.

5. United States Patent and Trademark Office. (2023). U.S. Patent No. 11,584,715.