Tempus AI Inc. v. Guardant Health Inc.

Tempus AI Inc. v. Guardant Health Inc. is an inter partes review (IPR) proceeding (IPR2025-01434) before the Patent Trial and Appeal Board (PTAB) concerning U.S. Patent No. 11,149,306. The PTAB declined to institute the review due to procedural reasons.

Tempus AI Inc. is a health technology company founded in 2015, specializing in artificial intelligence (AI) solutions and precision medicine services, including diagnostics for oncology, cardiology, radiology, and depression. It develops genomic testing and AI tools to analyze clinical and molecular data, aiming to improve oncology care. Guardant Health Inc. is a precision oncology company established in 2011, known for its liquid biopsy tests that detect cancer from blood samples. The company's key products include Guardant360 for genomic profiling, Reveal for molecular residual disease testing, and Shield for colorectal cancer screening. Both parties are operating companies and direct competitors in the cancer diagnostics and precision medicine market.

The patent at issue, U.S. Patent No. 11,149,306, is titled "SYSTEMS AND METHODS FOR IDENTIFYING SOMATIC VARIANTS IN CANCER." It generally relates to computational methods for analyzing tumor-derived genomic data, which are foundational to liquid biopsy and tissue-based cancer testing platforms. While an IPR directly challenges the patentability of claims rather than alleging infringement, this IPR likely arose in the context of broader intellectual property disputes between the two companies. Indeed, Tempus AI had previously filed a patent infringement lawsuit against Guardant Health in the U.S. District Court for the Northern District of California (Case No. 3:25-cv-06622), asserting four other patents covering computational genomics and AI-assisted data analysis against Guardant's products like Guardant360 CDx and Guardant INFINITY. That district court case was notably dismissed in January 2026.

The IPR was filed on August 15, 2025, with its status marked as "Not Instituted - Procedural." This designation typically means the PTAB declined to initiate a full review based on a procedural requirement, rather than on the merits of the patentability challenge. Common procedural grounds for denying institution include issues related to the real party in interest, statutory bars, or the PTAB's discretionary denial policies, such as those articulated in Fintiv or subsequent Director review decisions, which consider parallel district court litigation. The PTAB, an administrative tribunal within the USPTO, serves as an alternative forum to district courts for challenging patent validity, offering a potentially faster and less expensive route for resolving such disputes. Its decisions on institution are generally final and non-appealable. The case is notable as it reflects the ongoing high-stakes patent battles within the rapidly evolving field of AI-driven precision oncology and liquid biopsy technologies.Tempus AI Inc. v. Guardant Health Inc. is an inter partes review (IPR) proceeding (IPR2025-01434) before the Patent Trial and Appeal Board (PTAB) involving U.S. Patent No. 11,149,306, which was ultimately not instituted due to procedural reasons. Tempus AI Inc. is a Chicago-based health technology company that leverages artificial intelligence to develop precision medicine services, including advanced diagnostics for cancer, cardiology, and other conditions through genomic testing and data analysis. Guardant Health Inc. is a Redwood City, California-based precision oncology company specializing in liquid biopsy tests for cancer detection, monitoring, and treatment selection, with products such as Guardant360, Reveal, and Shield. Both entities are operating companies and direct competitors in the rapidly expanding field of AI-driven cancer diagnostics and genomic analysis.

The IPR challenged the patentability of U.S. Patent No. 11,149,306, titled "SYSTEMS AND METHODS FOR IDENTIFYING SOMATIC VARIANTS IN CANCER." This patent generally describes new techniques for detecting genetic variants, such as copy number variations, in cell-free DNA for early disease detection. While IPRs focus on the validity of patent claims against prior art, this proceeding is set against a backdrop of broader litigation between the parties. Tempus AI previously filed a patent infringement lawsuit against Guardant Health (Case No. 3:25-cv-06622) in the U.S. District Court for the Northern District of California, asserting four other patents related to computational genomics and AI-assisted data analysis against Guardant's commercially prominent products like Guardant360 CDx and Guardant INFINITY. That district court case was dismissed swiftly on January 21, 2026, based on a granted motion to dismiss, potentially involving arguments of patent-ineligible subject matter under 35 U.S.C. § 101 and the Alice/Mayo framework. Separately, Guardant Health initiated a Lanham Act dispute against Tempus AI in the District of Delaware (Case No. 1:2025cv00082) concerning alleged false advertising related to their respective liquid and tissue biopsy tests.

The procedural posture of IPR2025-01434 is at the Patent Trial and Appeal Board, which declined to institute the review. The status "Not Instituted - Procedural" indicates that the PTAB denied the petition based on a procedural ground rather than the substantive merits of the patentability challenge. While the specific procedural reason for non-institution in this particular IPR is not detailed in the available public information, common procedural grounds for discretionary denial by the PTAB include considerations of parallel district court litigation (e.g., under the Fintiv framework), statutory bars, or issues related to identifying the real party in interest. This case is notable due to the intense competition and active litigation landscape in the precision oncology sector, where both companies are vying for market share through advanced diagnostic technologies. The interplay between PTAB challenges and district court patent infringement actions, as well as broader competitive advertising disputes, underscores the strategic legal maneuvering in this high-value industry.

This case involves an inter partes review (IPR) proceeding, IPR2025-01434, filed by Tempus AI Inc. against Guardant Health Inc. concerning U.S. Patent No. 11,149,306, which was not instituted due to procedural reasons. IPRs are proceedings before the Patent Trial and Appeal Board (PTAB) and are often filed in response to an underlying patent infringement lawsuit in district court.

In this instance, two related district court patent infringement litigations are ongoing or have concluded between these parties:

1. Guardant Health, Inc. v. Tempus AI, Inc. (District of Delaware, C.A. No. 24-687-RGA), where Guardant Health is asserting U.S. Patent No. 11,149,306, the same patent at issue in IPR2025-01434, among others.
2. Tempus AI, Inc. v. Guardant Health, Inc. (U.S. District Court for the Northern District of California, Case No. 3:25-cv-06622), where Tempus AI asserted patents against Guardant Health.

The primary litigation directly related to the patent in the IPR is the Delaware case.

Key Legal Developments and Outcome

Parallel PTAB IPR Proceeding: IPR2025-01434

• Filing: Tempus AI Inc. filed IPR2025-01434 against Guardant Health Inc. on August 15, 2025, challenging U.S. Patent No. 11,149,306.
• Outcome: The IPR was "Not Instituted - Procedural." This means the PTAB declined to initiate a formal review of the patent's claims due to a procedural deficiency in the petition, rather than on the merits of patentability.

Primary Patent Infringement Litigation: Guardant Health, Inc. v. Tempus AI, Inc. (D. Del., C.A. No. 24-687-RGA)

This litigation was filed by Guardant Health, Inc. against Tempus AI, Inc. and is directly related to U.S. Patent No. 11,149,306.

• Filing & Initial Pleadings:
  • 2024-06-11: Guardant Health, Inc. filed a patent infringement lawsuit against Tempus AI, Inc. in the U.S. District Court for the District of Delaware.
  • 2024-11-04: Guardant Health filed its First Amended Complaint for Patent Infringement, alleging that Tempus AI infringed U.S. Patent Nos. 11,149,306, 9,902,992, 10,501,810, 10,793,916, and 11,643,693.
  • Tempus AI filed counterclaims against Guardant Health, asserting violations of the Lanham Act, California Unfair Competition Law, and the Uniform Deceptive Trade Practices Act, primarily related to false advertising claims.
• Pre-trial Motions of Substance:
  • 2025-11-10: Tempus AI filed a Motion for Preliminary Injunction seeking to prevent Guardant from disseminating allegedly false advertisements about Tempus's cancer biopsy products.
  • 2026-02-20: The District Court of Delaware denied Tempus AI's Motion for Preliminary Injunction.
  • Guardant Health has also filed motions to dismiss some of Tempus AI's counterclaims.
• Present Posture: The case remains active. As of February 20, 2026, Tempus AI was granted leave to amend its Answer and Counterclaims, which required a discussion of its impact on the existing scheduling order. Guardant Health argued that this patent action should proceed to trial first, ahead of a related patent action.

Related Patent Infringement Litigation: Tempus AI, Inc. v. Guardant Health, Inc. (N.D. Cal., Case No. 3:25-cv-06622)

This separate litigation involved Tempus AI asserting its own patents against Guardant Health.

• Filing & Transfer:
  • 2025-03-14: Tempus AI, Inc. filed a patent infringement action against Guardant Health, Inc. in the U.S. District Court for the Southern District of California (Case No. 3:2025cv00621).
  • The case was subsequently transferred to the U.S. District Court for the Northern District of California (Case No. 3:25-cv-06622).
• Patents at Issue: Tempus AI asserted four U.S. patents covering genomic data analysis and liquid biopsy technologies: US12112839B2, US10957041B2, US10991097B2, and US11640859B2.
• Pre-trial Motions & Outcome:
  • 2026-01-21: The court granted Guardant Health's motion to dismiss the case.
  • Final judgment was entered in favor of Guardant Health, Inc. and against Tempus AI, Inc. by stipulation, and the case file was ordered closed. This dismissal was notably swift, concluding just 187 days after filing, and bypassed claim construction, discovery, and trial. The dismissal was likely based on a determination of patent-ineligible subject matter under 35 U.S.C. § 101.

Here is the counsel of record representing Tempus AI Inc. in its patent disputes, drawing on information from related district court cases, as direct counsel for the IPR (IPR2025-01434) was not explicitly listed due to its "Not Instituted - Procedural" status. It is common for the same legal teams to handle both district court litigation and related inter partes review (IPR) proceedings.

External Counsel

From Sterne Kessler Goldstein & Fox (for cases including 5:25-cv-06622 N.D. Cal.):

• Byron L. Pickard - Managing Director, Trial and Appellate Group Leader.
  • Firm & Office: Sterne Kessler Goldstein & Fox, Washington, D.C.
  • Experience: An experienced first-chair trial lawyer and appellate advocate, specializing in complex IP litigation, including over 100 IPR proceedings at the PTAB, across various technologies like biotechnology and high-tech sectors.
• Hadia Ahsan - Attorney.
  • Firm & Office: Sterne Kessler Goldstein & Fox (office location not specified in provided snippets, but firm is DC-based).
  • Experience: Listed as representing Tempus AI in a patent infringement case.
• William Milliken - Attorney.
  • Firm & Office: Sterne Kessler Goldstein & Fox (office location not specified).
  • Experience: Listed as representing Tempus AI in a patent infringement case.
• Brady Gleason - Attorney.
  • Firm & Office: Sterne Kessler Goldstein & Fox (office location not specified).
  • Experience: Filed a joint report on the parties' selected mediator and mediation schedule for Tempus AI.
• Robert H. Sloss - Attorney.
  • Firm & Office: Sterne Kessler Goldstein & Fox (office location not specified).
  • Experience: Listed as representing Tempus AI in a patent infringement case.
• Ralph Wilson Powers III - Attorney.
  • Firm & Office: Sterne Kessler Goldstein & Fox (office location not specified).
  • Experience: Listed as representing Tempus AI in a patent infringement case.
• Jacqueline Bonilla - Attorney.
  • Firm & Office: Sterne Kessler Goldstein & Fox (office location not specified).
  • Experience: Listed as representing Tempus AI in a patent infringement case.

From Quinn Emanuel Urquhart & Sullivan, LLP (for cases including 5:25-cv-06622 N.D. Cal. and 3:25-cv-00621 S.D. Cal./N.D. Cal.):

• Kevin P.B. Johnson - Partner, Founder of Quinn Emanuel's patent practice.
  • Firm & Office: Quinn Emanuel Urquhart & Sullivan, LLP, Redwood Shores, California (Silicon Valley office).
  • Experience: Specializes in patent infringement, trade secret, and unfair competition litigation; he secured a $1.1 billion jury verdict for California Institute of Technology in a patent infringement lawsuit and has extensive experience in federal courts and the ITC.
• Andrew Jonathan Bramhall - Partner.
  • Firm & Office: Quinn Emanuel Urquhart & Sullivan, LLP, Redwood Shores, California (Silicon Valley office).
  • Experience: Focuses on high-stakes intellectual property disputes, including patent and trade secret litigation, with experience in federal courts and post-grant proceedings before the USPTO.
• Margaret Shyr - Partner.
  • Firm & Office: Quinn Emanuel Urquhart & Sullivan, LLP, Silicon Valley office.
  • Experience: Specializes in high-stakes business disputes involving complex technologies, particularly patent and trade secret matters; registered to practice before the USPTO and has experience prosecuting patents.
• Brian Paul Biddinger - Partner.
  • Firm & Office: Quinn Emanuel Urquhart & Sullivan, LLP, New York, NY.
  • Experience: An experienced trial lawyer specializing in complex intellectual property disputes in district court, ITC, and PTAB, across various technical fields including healthcare technology and medical devices.
• Louis Panzica - Attorney.
  • Firm & Office: Quinn Emanuel Urquhart & Sullivan, LLP (office location not specified).
  • Experience: Listed as representing Tempus AI in a patent infringement case.
• David Haars - Attorney.
  • Firm & Office: Quinn Emanuel Urquhart & Sullivan, LLP (office location not specified).
  • Experience: Listed as representing Tempus AI in a patent infringement case.

From Bartlit Beck LLP (for case 25-82-GBW D. Del.):

• Sean W. Gallagher - Partner.
  • Firm & Office: Bartlit Beck LLP, Chicago, IL.
  • Experience: An accomplished trial lawyer with experience in a broad range of complex commercial litigation, including intellectual property (patent infringement and Lanham Act claims) and trade secret misappropriation.
• Brian C. Swanson - Partner.
  • Firm & Office: Bartlit Beck LLP, Chicago, IL.
  • Experience: Represents clients in high-stakes litigation across the country, with extensive trial experience in intellectual property and general commercial disputes.
• Anastasiya Maione - Attorney.
  • Firm & Office: Bartlit Beck LLP (office location not specified, but firm has Chicago and Denver offices).
  • Experience: Listed as counsel for Tempus AI in a Delaware district court case.
• Lee Mason - Partner.
  • Firm & Office: Bartlit Beck LLP, Chicago, IL.
  • Experience: Has represented plaintiffs and defendants in a wide range of high-stakes cases, including trade secrets and breach of contract disputes, and has successfully handled commercial arbitrations involving patent rights.
• Grace Kavinsky - Associate.
  • Firm & Office: Bartlit Beck LLP, Chicago, IL.
  • Experience: A litigator with experience in high-stakes matters, serving as trial counsel for Tempus AI in a false advertising and unfair competition case against Guardant Health.

In-House Counsel

• Andy Polovin - EVP, General Counsel & Secretary.
  • Firm & Office: Tempus AI Inc., Chicago, IL.
  • Experience: Oversees various legal and business issues for Tempus AI; prior to joining Tempus, he was General Counsel of an AI software company and an equity partner at Bartlit Beck, specializing in trial litigation.
• Tom Ferrone - Deputy General Counsel.
  • Firm & Office: Tempus AI Inc., Chicago, IL.
  • Experience: Has extensive experience in corporate law and previously represented technology companies at Quinn Emanuel as an Associate, focusing on intellectual property litigations.

Guardant Health Inc., as the defendant (Patent Owner) in IPR2025-01434, likely engaged both in-house and potentially outside counsel, even though the IPR was not instituted for procedural reasons. Specific outside counsel of record for Guardant Health Inc. in IPR2025-01434 could not be definitively identified through public web searches of dockets or case summaries for this particular IPR. This may be due to the procedural non-institution, which could limit the extent of formal appearances and filings.

However, Guardant Health maintains an in-house Intellectual Property team responsible for managing its patent portfolio and addressing IP challenges. Tim Hott serves as the Director of Intellectual Property at Guardant Health. He has been with Guardant Health since September 2017, progressing through roles including Senior IP Counsel and Corporate IP Counsel, and has previous experience as Legal and Patent Counsel at Membrane Technology and Research, Inc., and as a Patent Attorney at Peters Verny, LLP, drafting numerous patent applications. Guardant Health actively recruits for Intellectual Property Counsel roles, seeking experienced professionals with backgrounds in patent prosecution and an understanding of genomic data analysis relevant to cancer diagnostics. These in-house counsel would typically oversee and coordinate any external legal representation for PTAB proceedings.

In other related patent litigation, Guardant Health has been represented by:

• Wilson Sonsini Goodrich & Rosati and Orrick, Herrington & Sutcliffe LLP in a Federal Circuit appeal (Case No. 24-1129) where Guardant Health was the challenging party against the University of Washington concerning a DNA sequencing patent. Michael T. Rosato and Sonja Rochelle Gerrard (Ph.D.-credentialed counsel) were part of the nine-attorney team from these firms. Wilson Sonsini Goodrich & Rosati, specifically Michael T. Rosato, Jad A. Mills, and Sonja R. Gerrard, also represented Guardant Health as the petitioner in IPR2022-00817 against the University of Washington.
• Jones Day, with attorneys Edward R. Reines (Silicon Valley office) and Derek C. Walter (San Francisco office), is defending Guardant Health in a patent infringement case brought by Cold Spring Harbor Laboratory in the District of Delaware (No. 1-25-cv-00263) related to DNA sequencing for cancer diagnostic testing.
• Bartlit Beck LLP (Chicago, IL), including Sean Gallagher, Brian Swanson, Anastasiya Maione, Lee Mason, and Grace Kavinsky, and Young Conaway Stargatt & Taylor, LLP (Wilmington, DE), including Pilar G. Kraman and Jennifer P. Siew, represented Guardant Health Inc. as the plaintiff/counterclaim-defendant in a preliminary injunction motion in the District of Delaware against Tempus AI, Inc. [cite: 11 of previous search]