797 F.Supp.3d 580
M.D.N.C.2025Background
- Natera, Inc. filed suit against NeoGenomics Laboratories, Inc. alleging infringement of two patents ('454 and '596) related to methods for detecting cancer-specific genetic mutations in plasma samples.
- Both companies market cancer recurrence detection tests (Natera's Signatera; NeoGenomics' RaDaR).
- The court earlier issued a preliminary injunction against NeoGenomics' earlier test (RaDaR 1.0), later subject to a permanent injunction through settlement; the case proceeded regarding RaDaR 1.1 and the two patents at issue.
- NeoGenomics counterclaimed for declaratory judgment of non-infringement, invalidity, and unenforceability of the patents.
- At summary judgment, NeoGenomics argued the patents claim ineligible subject matter under 35 U.S.C. § 101, and both sides moved for summary judgment.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Patent eligibility under § 101 | Claims describe a novel method of preparing plasma/biological samples using inventive human-engineered processes. | Claims merely detect natural phenomena (SNV mutations in cell-free DNA) using conventional techniques; not patent-eligible. | Court held claims are directed to a patent-ineligible natural phenomenon. |
| Presence of an "inventive concept" | Amplification of loci in the same reaction volume and detection sensitivity are inventive. | All claim elements are conventional, known in the prior art, or use off-the-shelf products. | Court found no inventive concept; methods use standard, well-known techniques. |
| Effect of claim preambles | Preambles define claims as sample preparation rather than detection, making them patent-eligible. | Preambles don't add substantive steps; end result is still detection of natural phenomena. | Preambles don't alter § 101 analysis; claims remain ineligible. |
| Waiver of ineligibility defense | Defendant waived § 101 defense by not electing it for trial. | Elections for trial purposes don't constitute waiver at summary judgment. | No waiver; court considers ineligibility arguments. |
Key Cases Cited
- Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (framework for analyzing subject matter eligibility under § 101)
- Mayo Collaborative Servs. v. Prometheus Lab’ys, Inc., 566 U.S. 66 (two-step test for patent eligibility)
- Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (natural phenomena are not patentable)
- Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (claims directed to detecting a natural phenomenon are ineligible)
- Illumina, Inc. v. Ariosa Diagnostics, Inc., 967 F.3d 1319 (contrast between claims directed to a method versus a natural phenomenon)
- ChargePoint, Inc. v. SemaConnect, Inc., 920 F.3d 759 (specification cannot import unclaimed details to confer eligibility)