Litigation Details for Natera, Inc. v. CareDx, Inc. (D. Del. 2020)

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Natera, Inc. v. CareDx, Inc. (D. Del. 2020)

Docket		Date Filed	2020-01-13
Court	District Court, D. Delaware	Date Terminated	2025-03-10
Cause	35:1 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	Plaintiff	Referred To	Christopher J. Burke
Patents	11,097,006; 8,114,021; 8,389,578
Link to Docket	External link to docket

Details for Natera, Inc. v. CareDx, Inc. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-01-13				External link to document
2020-01-13	120	Complaint - Amended	No. 60 / 789,506 , filed on Apr. 8,389,578 B2 3/2013 Went et al . 4 , 2006… Among these patented inventions is U.S. Patent No. 11,111,544 (the “’544 Patent”), which CareDx…this claim for patent infringement to compel CareDx to stop infringing Natera’s patent and to compensate…are protected by a substantial patent portfolio, with over 330 patents issued or pending worldwide…and claimed in the ’544 Patent. By contrast, CareDx has used Natera’s patented cfDNA technology without	External link to document

Natera, Inc. v. CareDx, Inc. Litigation Summary and Patent Analysis, 1:20-cv-00038

Last updated: August 15, 2026

Natera, Inc. sued CareDx, Inc. in the U.S. District Court for the District of Delaware over patents covering noninvasive monitoring of organ-transplant rejection using donor-derived cell-free DNA. The dispute centered on CareDx’s AlloSure kidney-transplant testing and Natera’s competing Prospera test. A jury found CareDx liable for infringing three Natera patents and awarded approximately $44.9 million in damages. The case also generated substantial patent-eligibility risk because the asserted technology relies on detecting a naturally occurring biological signal, an issue that has affected related transplant-DNA patents under 35 U.S.C. § 101.[1][2]

What is Natera v. CareDx, 1:20-cv-00038?

Natera v. CareDx is a patent-infringement action filed in the District of Delaware in January 2020. The case was assigned to Judge Richard G. Andrews and bears docket number 1:20-cv-00038-RGA.[1]

Natera alleged that CareDx’s AlloSure assay infringed patents covering the use of donor-derived cell-free DNA, or dd-cfDNA, to identify or monitor organ-transplant injury and rejection. CareDx denied infringement and challenged the validity and enforceability of the asserted patent claims.

The commercial dispute involved two directly competing transplant-monitoring products:

Company	Product	Primary use	Commercial role
Natera	Prospera	Noninvasive monitoring of kidney-transplant injury and rejection	Competing dd-cfDNA test
CareDx	AlloSure	Noninvasive monitoring of kidney-transplant injury and rejection	Established transplant-testing product
CareDx	AlloMap	Gene-expression testing for heart-transplant rejection risk	Adjacent transplant-monitoring product

The litigation did not involve a conventional small-molecule drug, biologic, biosimilar, or Orange Book-listed product. It involved laboratory-developed testing technology and molecular diagnostics.

What patents did Natera assert against CareDx?

Natera asserted a group of patents directed to the measurement and interpretation of donor-derived DNA in transplant recipients. The asserted claims generally covered:

1. Obtaining a biological sample from a transplant recipient.
2. Measuring DNA fragments or genetic markers in the sample.
3. Distinguishing donor-derived DNA from recipient-derived DNA.
4. Calculating the proportion or concentration of donor-derived DNA.
5. Using the result to evaluate transplant injury, rejection, or graft status.

The patents were important because the parties’ products use a similar diagnostic premise: the proportion of donor-derived DNA in a recipient’s blood may increase when the transplanted organ is injured.

The litigation record and related patent proceedings should be separated from a different CareDx-Natera dispute involving CareDx’s own patents. In CareDx, Inc. v. Natera, Inc., the Federal Circuit affirmed the invalidity of certain CareDx patent claims under § 101.[2] That decision did not itself invalidate all Natera patents asserted in the Delaware action, but it materially affected the legal environment for transplant dd-cfDNA patents.

What technology did the asserted claims cover?

The asserted patent claims were not limited to a particular sequencer or a single commercial assay. Their scope depended on how the claims defined:

• The source and type of biological sample.
• The method for identifying donor-specific genetic material.
• The use of single-nucleotide polymorphisms or other genetic markers.
• The quantitative calculation of donor-derived DNA.
• The clinical interpretation of the measured percentage.
• Whether the method required a diagnosis, prediction, monitoring, or treatment decision.

These distinctions mattered for both infringement and validity. A broad claim directed to detecting elevated dd-cfDNA could create substantial competitive leverage, while a narrower claim limited to a particular marker set, sequencing method, or threshold would be easier to design around.

What was the jury verdict in Natera v. CareDx?

The jury found CareDx liable for infringing three Natera patents and awarded Natera approximately $44.9 million in damages.[3]

The verdict followed a trial in the District of Delaware. The jury’s findings addressed infringement and damages, while the court retained authority over post-trial legal issues, including judgment as a matter of law, claim construction, equitable relief, enhanced damages, and the effect of any patent-invalidity ruling.

The damages award represented compensation for historical infringement. It did not automatically establish a permanent injunction or prevent CareDx from continuing to sell AlloSure. Those remedies required separate judicial action and could be affected by patent expiration, claim validity, appeal, licensing, or a negotiated resolution.

How significant was the $44.9 million damages award?

The award was material to CareDx because AlloSure was a core commercial product and a major source of revenue. The case therefore presented more than a royalty dispute. It implicated:

• CareDx’s ability to continue commercializing AlloSure.
• Natera’s ability to obtain an ongoing royalty or injunction.
• The valuation of Natera’s Prospera business.
• Contracting and reimbursement relationships with transplant centers.
• The competitive position of the two largest U.S. dd-cfDNA testing providers.

The amount also provided a benchmark for potential settlement negotiations. A jury award increases litigation leverage, but the final economic value depends on post-trial rulings, appellate outcomes, interest, enhanced damages, ongoing royalties, and the enforceable scope of the surviving claims.

What patent-eligibility issues affected the litigation?

The central legal risk was whether the asserted claims recited patent-eligible technological methods or merely applied a natural biological relationship.

Under the Supreme Court’s framework in Mayo Collaborative Services v. Prometheus Laboratories, claims directed to a natural law must contain additional elements that transform the claim into a patent-eligible application.[4] In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court also held that naturally occurring genetic material is not patent-eligible merely because it has been isolated.[5]

The dd-cfDNA field presents a recurring § 101 issue. The underlying biological fact is that organ injury can release donor-derived DNA into a transplant recipient’s bloodstream. A claim that simply measures that naturally occurring signal and applies a conventional clinical interpretation may face a patent-eligibility challenge.

The strongest claims generally are those that recite a specific technical improvement, such as:

• A defined method for distinguishing donor and recipient DNA.
• A particular marker-selection process.
• A sequencing or amplification technique that improves measurement accuracy.
• A defined computational process that solves a technical problem.
• A novel thresholding or normalization method tied to a specific assay architecture.

The Federal Circuit’s decision in CareDx v. Natera illustrates the risk. The court held that certain CareDx claims directed to measuring donor-derived cell-free DNA were patent-ineligible because the claims focused on detecting a natural phenomenon with conventional techniques.[2] That decision created a significant vulnerability for broad claims in the same technical field.

Did CareDx challenge the Natera patents under Paragraph IV?

No. Paragraph IV litigation under the Hatch-Waxman Act applies to abbreviated new drug applications, not to CareDx’s laboratory-developed diagnostic testing business.

CareDx’s challenges arose through patent defenses and counterclaims in federal district court, not through an FDA generic-drug certification. The dispute therefore had no Paragraph IV notice, 30-month stay, ANDA approval, or FDA Orange Book framework.

This distinction is commercially important. A successful Paragraph IV challenge can open a defined generic-launch pathway. A successful defense in this case could instead reduce or eliminate damages, preserve CareDx’s ability to operate, or narrow the scope of any injunction.

What is the FDA and Orange Book status of AlloSure and Prospera?

AlloSure and Prospera are transplant-monitoring laboratory tests, not FDA-approved prescription drugs listed in the Orange Book. They are generally marketed as laboratory-developed tests through the clinical laboratory regulatory framework.

The litigation therefore did not depend on:

• New Drug Application approval.
• Biologics License Application approval.
• Orange Book patent listing.
• FDA pediatric exclusivity.
• New chemical entity exclusivity.
• Biosimilar interchangeability.
• Generic-drug substitution.

The regulatory status did not eliminate patent risk. Laboratory-developed tests can still infringe method, composition, system, software, or sample-processing patents. It also did not give Natera an automatic right to block CareDx’s commercial operations.

What patent litigation affects CareDx’s AlloSure product?

The Natera action was the most direct patent threat to AlloSure because it targeted the dd-cfDNA testing method used in a competing product. CareDx also faced related patent-eligibility and infringement disputes in the broader transplant-diagnostics field.

The principal risks were:

Risk	Effect on CareDx
Past-damages award	Direct financial liability
Ongoing royalty	Higher cost per AlloSure test
Injunction	Potential restriction on sales or use
Claim construction	Could narrow or expand the commercial impact
Patent invalidity	Could eliminate or reduce Natera’s leverage
Appeal	Delayed finality and prolonged legal expense
Settlement	Could preserve market access but increase operating costs

A patent injunction would have posed the greatest risk, but courts often assess whether monetary damages are adequate and whether an injunction would serve the public interest. Transplant-monitoring tests have a clinical-use dimension, which can complicate an injunction analysis.

How strong was Natera’s patent estate?

Natera’s patent position had meaningful commercial value but was exposed to the same eligibility issues that affected other dd-cfDNA patent holders.

Strengths

Natera’s position was stronger where claims were tied to:

• Concrete assay steps.
• Donor-recipient genetic discrimination.
• Specific sequencing or genotyping methods.
• Defined quantitative calculations.
• Technical improvements in sensitivity or specificity.
• A complete workflow that competitors could not readily avoid.

The jury verdict indicated that at least some asserted claims were sufficiently broad and enforceable, at trial, to support infringement findings and damages.

Weaknesses

The estate faced several structural weaknesses:

• The biological relationship between transplant injury and elevated dd-cfDNA is naturally occurring.
• Conventional sequencing and PCR techniques may be treated as routine.
• Broad diagnostic claims can be vulnerable under Mayo and related Federal Circuit precedent.
• Competitors may design around claims by changing marker panels, algorithms, thresholds, or sample-processing steps.
• Patent expiration limits the duration of any exclusionary right.

The practical strength of the estate therefore depended less on the number of issued patents than on the percentage of commercially necessary workflow steps covered by enforceable claims.

What generic-entry risks existed for CareDx and Natera?

There was no traditional generic-entry scenario. The relevant competitive risk was freedom to operate for diagnostic laboratories and transplant centers.

CareDx faced the risk that an adverse final judgment could require it to:

• Pay past damages.
• Pay an ongoing royalty.
• Modify AlloSure’s assay or interpretation algorithm.
• Obtain a license from Natera.
• Withdraw or limit a product feature.
• Shift customers to a redesigned test.

Natera faced the reverse risk. If its patents were invalidated, narrowed, or rendered commercially avoidable, CareDx could continue competing without a meaningful patent payment. Other diagnostic companies could also enter the dd-cfDNA market using alternative assay designs.

Did Natera and CareDx reach a licensing or settlement agreement?

The public litigation record identified the case as an active patent dispute culminating in a jury verdict and post-trial proceedings. A final settlement or broad cross-license should not be assumed merely because the parties continued commercial operations.

Any negotiated resolution would likely address:

• The $44.9 million verdict.
• Future royalties.
• The scope of permitted AlloSure activity.
• Patent challenges and appeals.
• Confidentiality and admission provisions.
• Rights to future assay improvements.
• Releases covering related patents and jurisdictions.

A settlement would reduce litigation uncertainty but could impose a recurring royalty burden on CareDx or provide Natera with a durable economic benefit without an injunction.

What are the revenue implications of the litigation?

The litigation had asymmetric exposure.

For CareDx, AlloSure was a core commercial product. A restriction on AlloSure could affect test volume, transplant-center contracts, reimbursement relationships, and the company’s revenue mix. A $44.9 million damages award was significant relative to the company’s scale and could affect cash planning and financing needs.

For Natera, Prospera benefited from enforcement against its principal U.S. competitor. A favorable judgment could support:

• Higher Prospera adoption.
• Stronger pricing and contracting leverage.
• Greater value in licensing discussions.
• Reduced competitive pressure from AlloSure.
• Broader enforcement against related testing workflows.

The verdict did not guarantee market-share transfer. Transplant physicians and laboratories may value clinical data, turnaround time, reimbursement, published evidence, payer coverage, and integration with transplant-care workflows independently of patent rights.

What is the geographic coverage of the Natera patents?

The case was a U.S. action in the District of Delaware. Its direct legal effect was limited to U.S. patent rights and conduct within the jurisdictional reach of U.S. courts.

The patents did not automatically control:

• European dd-cfDNA testing.
• Canadian testing.
• Asian laboratory services.
• Testing performed entirely outside the United States.
• Foreign sales involving separately issued national patents.

Natera’s international position depended on counterpart applications and issued patents in each jurisdiction. Patent term, examination outcomes, claim scope, opposition procedures, and enforcement standards vary by country.

Key Takeaways

1. Natera sued CareDx in Delaware over dd-cfDNA transplant-monitoring technology used in AlloSure.
2. The jury found CareDx infringed three Natera patents and awarded approximately $44.9 million.
3. The case did not involve Paragraph IV, Hatch-Waxman, Orange Book listing, or biosimilar substitution.
4. Patent eligibility under Mayo and related Federal Circuit precedent was a major legal risk because the technology measures a natural biological signal.
5. The commercial stakes were high because AlloSure and Prospera competed directly for transplant-monitoring customers.
6. The final economic impact depended on post-trial rulings, appeal, licensing, settlement, and the enforceable scope of the surviving claims.
7. The case’s principal value for patent strategy is its treatment of broad dd-cfDNA claims and the limits of patent protection for diagnostic methods based on natural phenomena.

FAQs About Natera v. CareDx

Can Natera stop CareDx from selling AlloSure?

A damages verdict alone does not stop sales. An injunction, ongoing royalty, settlement restriction, or other enforceable remedy would be required to limit future commercialization.

Are AlloSure and Prospera FDA-approved drugs?

No. They are transplant-monitoring laboratory tests, not prescription drugs listed in the FDA Orange Book.

Was the Natera-CareDx case a Paragraph IV lawsuit?

No. It was a district-court patent case involving diagnostic testing technology, not an ANDA-based generic-drug action.

Does the CareDx v. Natera Federal Circuit decision invalidate Natera’s patents?

No. The Federal Circuit decision addressed specified CareDx patent claims in a related dispute. It does not automatically invalidate every Natera patent asserted in 1:20-cv-00038.[2]

What is the main design-around strategy for competing dd-cfDNA tests?

A competitor may seek to alter the genetic-marker panel, sample-processing workflow, sequencing method, donor-recipient discrimination technique, computational model, or clinical threshold, subject to the scope of the surviving claims and other patent families.

References

1. U.S. District Court for the District of Delaware. (2020). Natera, Inc. v. CareDx, Inc., No. 1:20-cv-00038-RGA. PACER/Court docket.

2. United States Court of Appeals for the Federal Circuit. (2022). CareDx, Inc. v. Natera, Inc., 40 F.4th 1371.

3. CareDx, Inc. (2023). Form 10-Q and public disclosures concerning Natera patent litigation and jury verdict. U.S. Securities and Exchange Commission.

4. Supreme Court of the United States. (2012). Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66.

5. Supreme Court of the United States. (2013). Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576.