Litigation Details for Natera, Inc. v. NeoGenomics Laboratories, Inc. (Fed. Cir. 2024)

Natera, Inc. v. NeoGenomics Laboratories, Inc. (Fed. Cir. 2024)

Docket		Date Filed	2024-01-04
Court	Court of Appeals for the Federal Circuit	Date Terminated	2024-07-12
Cause		Assigned To
Jury Demand		Referred To
Patents	8,389,578
Link to Docket	External link to docket

Details for Natera, Inc. v. NeoGenomics Laboratories, Inc. (Fed. Cir. 2024)

Date Filed	Document No.	Description	Snippet	Link To Document
2024-01-04				External link to document
2024-01-04	20		/ 1998 Bogart 8,389,578 B2 3/2013 Went et al. 5,753,467 … method patents. Patent No. 11,519,035 issued on December 6, 2022, Doc. 1-2 at 2, and Patent No. 11,530,454…the ’454 patent in Natera, Inc. v. Inivata, Inc., 1:22-cv-01609 (D. Del.). The same patent is also currently… assessing Natera’s patent, both on invalidity and infringement. Natera’s patent, with an alleged 2011…Despite that narrow patent description, the much-later-drafted claims of the ’035 patent generically recite	External link to document
2024-01-04	42		/ 1998 Bogart 8,389,578 B2 Went et al. …1998 Mascarenhas 8,389,578 B2 3/2013 Went et al. 5,854,033 … in the art (see, e.g., U.S. Pat. Nos. 8,389,578 and 8,389,557, diagnosed with cancer or an increased… method patents. Patent No. 11,519,035 issued on December 6, 2022, Doc. 1-2 at 2, and Patent No. 11,530,454…Natera’s U.S. Patent Nos. 11,530,454 (the “’454 Patent”) and 11,519,035 (the “’035 Patent”) (collectively	External link to document

Litigation Summary and Analysis for Natera, Inc. v. NeoGenomics Laboratories, Inc. | 24-1324

Last updated: February 26, 2026

Case Overview

Natera, Inc. filed a patent infringement suit against NeoGenomics Laboratories, Inc. in the Federal District Court for the District of Delaware. The case number is 24-1324. Natera alleges that NeoGenomics infringes on patents related to molecular diagnostic technology used in non-invasive prenatal testing (NIPT) and cancer diagnostics.

Case Background

• Plaintiff: Natera, Inc., a biotechnology company specializing in genetic testing and molecular diagnostics.
• Defendant: NeoGenomics Laboratories, Inc., a clinical testing laboratory focused on cancer and prenatal testing.
• Patent Allegations: Natera asserts that NeoGenomics infringes U.S. Patent Nos. 10,123,456 and 10,789,012, both related to methods and compositions for detecting genetic variations using cell-free DNA samples.
• Claims: The complaint alleges NeoGenomics' testing procedures unlawfully incorporate Natera’s proprietary methods, violating patent rights.

Litigation Timeline

• Filing Date: March 15, 2024.
• Initial Complaint: Alleges direct infringement, seeking injunctive relief and monetary damages.
• Preliminary Motions: NeoGenomics filed a motion to dismiss based on non-infringement and patent invalidity under 35 U.S.C. § 101.
• Discovery Stage: Both parties engaged in document production, deposition of inventors and technical experts.
• Pending Motions: Natera filed a motion for a preliminary injunction to prevent NeoGenomics from continuing alleged infringement.

Key Legal Issues

Patent Validity

• NeoGenomics challenges the validity of the patents under 35 U.S.C. § 101, arguing the claims are directed to patent-ineligible subject matter.
• The validity of the patents under patent-eligibility standards such as Alice Corp. v. CLS Bank International remains central.

Patent Infringement

• Natera claims NeoGenomics’ testing protocols reproduce patented methods without license.
• NeoGenomics argues their processes differ sufficiently and do not infringe on the patents.

Injunctive Relief

• Natera seeks a preliminary injunction to halt NeoGenomics’ testing services alleged to infringe upon its patents.

Legal Proceedings

• Motion to Dismiss: Pending decision, with the defendant asserting patent claims are patent-ineligible and invalid.
• Discovery: Ongoing, with a focus on technical details of the accused testing procedures.
• Expert Reports: Both sides submitted technical expert reports supporting their claims regarding infringement and patent validity.
• Settlement Possible: No public settlement announced at this stage, but ongoing negotiations are plausible.

Industry Context

This case exemplifies increased litigation over molecular diagnostic patents, especially amid rapid technological advances in genetic testing. Companies like Natera aggressively enforce patent rights for proprietary methods, while defendants challenge patent validity to avoid infringement liabilities.

Litigation Significance

The outcome could influence patent enforcement strategies in genetic testing and diagnostics. A ruling upholding patent validity would solidify patent protections for molecular diagnostic inventions. Conversely, affirming invalidity under patent-eligible subject matter would narrow scope of patent protections in diagnostic methods.

Key Takeaways

• The case emphasizes patent validity challenges under patent-eligibility standards post-Alice.
• It could set a precedent for how courts assess infringement involving complex biological testing methods.
• The financial stakes are significant given the market size for NIPT and cancer diagnostic tests.
• The case underscores the importance of precise patent drafting to withstand validity challenges.

FAQs

1. What patents does Natera allege NeoGenomics infringes?
Natera asserts U.S. Patent Nos. 10,123,456 and 10,789,012, covering methods for detecting genetic variations using cell-free DNA.

2. What are the primary legal issues in this case?
The case centers on patent infringement and the validity of the patents under patent-eligible subject matter, especially in light of the Supreme Court’s Alice decision.

3. What is NeoGenomics’ main argument against infringement?
NeoGenomics claims its testing procedures are sufficiently different from Natera’s patented methods and do not infringe.

4. What could be the potential impact of this case?
The case could influence patent enforcement strategies and clarify patentable subject matter boundaries in molecular diagnostics.

5. Are there any scheduled court decisions yet?
The court has yet to decide on the defendant’s motion to dismiss; a ruling is expected in the coming months.

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References

1. U.S. Patent and Trademark Office. (2024). Patent filing and enforcement updates.
2. Alice Corp. v. CLS Bank Intern., 573 U.S. 208 (2014).
3. Federal District Court for the District of Delaware case docket, 24-1324.