Tempus AI vs. Guardant Health: Dismissal in Liquid Biopsy Patent Dispute
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📋 Case Summary
| Case Name | Tempus AI, Inc. v. Guardant Health, Inc. |
| Case Number | 3:25-cv-06622 (N.D. Cal.) |
| Court | U.S. District Court for the Northern District of California |
| Duration | Aug 2025 – Feb 2026 6 months 3 days |
| Outcome | Defendant Win — Case Dismissed |
| Patents at Issue | |
| Accused Products | Samsung Galaxy S Series Smartphones |
Case Overview
In a significant development for the oncology diagnostics patent landscape, the U.S. District Court for the Northern District of California dismissed Tempus AI, Inc.’s patent infringement action against Guardant Health, Inc. on January 21, 2026. The case, Tempus AI, Inc. v. Guardant Health, Inc. (Case No. 3:25-cv-06622), concluded in favor of Guardant Health just 187 days after filing — a notably swift resolution at the district court level.
At stake were four U.S. patents covering genomic data analysis and liquid biopsy technologies, asserted against some of Guardant Health’s most commercially prominent products, including Guardant360 CDx and Guardant INFINITY. The rapid dismissal via a successful Motion to Dismiss raises important questions about pleading standards in AI-driven diagnostics patent litigation and signals strategic considerations for companies operating in the competitive cancer genomics space. For patent attorneys, in-house IP counsel, and R&D leaders in precision medicine, this outcome warrants careful examination.
The Parties
⚖️ Plaintiff
Chicago-based AI-powered precision medicine company that applies machine learning to genomic and clinical data to improve oncology care. The company holds a growing patent portfolio spanning AI-assisted diagnostics, genomic sequencing analysis, and clinical data integration.
🛡️ Defendant
Leading liquid biopsy company headquartered in Redwood City, California. Its products are widely used for comprehensive genomic profiling of cancers through blood-based testing, serving oncologists, biopharma researchers, and clinical laboratories globally.
Patents at Issue
This landmark case involved four U.S. patents covering computational genomics, AI-assisted data analysis, and clinical interpretation methods — technologies foundational to modern liquid biopsy platforms and precision oncology workflows.
- • US12112839B2 — Genomic data analysis and liquid biopsy technologies
- • US10957041B2 — Computational genomics and AI-assisted data analysis
- • US10991097B2 — Clinical interpretation methods for precision oncology
- • US11640859B2 — AI-driven diagnostics and genomic sequencing analysis
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The Verdict & Legal Analysis
Outcome
On January 21, 2026, the Court granted Guardant Health’s Motion to Dismiss. Final judgment was subsequently entered in favor of Guardant Health, Inc. and against Tempus AI, Inc. by stipulation. No damages were awarded, no injunctive relief was granted, and the case file was ordered closed.
The 187-day lifecycle from filing to final judgment is notably short for patent infringement litigation, which typically spans 2–3 years at the district court level. Guardant Health’s successful Motion to Dismiss — decided at ECF 82 — bypassed claim construction, discovery, and trial entirely. Final judgment was entered by stipulation pursuant to Federal Rule of Civil Procedure 58, suggesting the parties agreed to formalize the dismissal without further procedural contest.
Verdict Cause Analysis & Legal Significance
The granting of a Motion to Dismiss in patent litigation typically signals one of several threshold deficiencies: inadequate pleading of infringement under Iqbal/Twombly standards, patent-ineligible subject matter under 35 U.S.C. § 101, or a failure to sufficiently map patent claims to accused products at the pleading stage.
Given the nature of the asserted patents — which cover AI-driven genomic data analysis and clinical interpretation methods — § 101 subject matter eligibility under the *Alice/Mayo* framework represents a plausible basis for dismissal. Method claims directed to computational analysis of genomic data have faced sustained invalidation pressure in federal courts when they do not demonstrate a sufficiently inventive technical application beyond abstract mathematical or analytical concepts.
This accelerated timeline underscores the strategic effectiveness of early dispositive motions in patent cases when the pleading record is vulnerable. The case contributes to a growing body of district court outcomes where AI-assisted diagnostics and genomic data processing patents face early dismissal challenges.
Freedom to Operate (FTO) Analysis
This case highlights critical IP risks in AI diagnostics and liquid biopsy. Choose your next step:
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High § 101 Risk Area
Abstract AI/ML method claims
4 Patents Asserted
In AI diagnostics space
Early Dismissal Strategy
Successful defense playbook
✅ Key Takeaways
Motion to Dismiss remains a high-value early strategy against AI/ML diagnostic patents with § 101 exposure.
Search related case law →Pleading standards under *Iqbal/Twombly* create meaningful pre-discovery dismissal opportunities in patent litigation.
Explore precedents →Frequently Asked Questions
Four U.S. patents were asserted: US12112839B2, US10957041B2, US10991097B2, and US11640859B2. These patents cover AI-assisted genomic data analysis and liquid biopsy technologies.
The U.S. District Court for the Northern District of California granted Guardant Health’s Motion to Dismiss (ECF 82) on January 21, 2026. Final judgment was subsequently entered by stipulation on February 9, 2026. While specific legal grounds are not fully detailed in the public record, common bases for early dismissal in such cases include 35 U.S.C. § 101 subject matter eligibility challenges or inadequate pleading of infringement.
This outcome reinforces that early dispositive motions, particularly those challenging patent eligibility under § 101, remain viable and potent strategies against AI-method patents in the diagnostics space. It underscores the importance of robust claim language that ties AI/ML methods to specific, concrete technical implementations rather than abstract analytical concepts.
Companies can protect themselves by conducting comprehensive freedom-to-operate (FTO) analysis before finalizing product development, thoroughly documenting the technical evolution of AI/ML models, considering design-around strategies for high-risk computational elements, and filing their own patents with strong claim language addressing potential § 101 challenges. PatSnap Eureka’s FTO tools help R&D and IP teams identify potentially blocking patents early.
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References
- PACER Case 3:25-cv-06622 (U.S. District Court for the Northern District of California)
- USPTO Patent Full-Text Database (via Google Patents)
- Cornell Legal Information Institute — 35 U.S.C. § 101
- PatSnap — AI Diagnostics Solutions
This article is for informational purposes only and does not constitute legal advice. All case information is drawn from publicly available court records. For platform capabilities, visit PatSnap.