Petitioner (associated with Unified Patents) v. Guardant Health Inc.

This Inter Partes Review (IPR) involves a challenge to a patent owned by Guardant Health Inc., a prominent precision oncology company. The Petitioner, associated with Unified Patents, initiated the IPR against U.S. Patent No. 10,793,916, which generally relates to methods for detecting nucleic acid molecules, often used in liquid biopsies for cancer detection. Unified Patents is a member-based organization that often challenges patents deemed of low quality or asserted by Non-Practicing Entities (NPEs) in various technology areas, acting on behalf of its members to deter patent troll activity. Guardant Health, on the other hand, develops and commercializes non-invasive cancer tests, primarily liquid biopsies, for cancer screening, recurrence monitoring, and treatment selection.

The patent at issue, U.S. Patent No. 10,793,916, titled "Methods for Detecting Nucleic Acid Molecules," describes techniques for analyzing cell-free nucleic acids, which are crucial for Guardant Health's core business in liquid biopsy technologies. The IPR, designated IPR2025-01435, was filed before the Patent Trial and Appeal Board (PTAB). Notably, the PTAB declined to institute the review, citing "procedural" reasons. This type of denial often stems from specific PTAB discretionary rules or practices rather than the merits of the invalidity arguments themselves.

The case is significant due to several factors. First, the involvement of Unified Patents highlights its ongoing strategy to target patents that might be asserted against its members, even when the patent owner is an operating company like Guardant Health. Second, the "Not Instituted - Procedural" outcome is particularly noteworthy. While the specific procedural reason for denial in IPR2025-01435 requires further investigation into the Board's order, such denials can stem from various PTAB discretionary factors, including the Fintiv factors (which consider parallel district court litigation), joinder issues, or other considerations related to the efficiency and integrity of the IPR process. This decision means that, for now, the validity of the '916 patent remains unchallenged through the IPR process, which could impact any ongoing or potential future district court litigation involving the patent.

Patent Infringement Litigation: Guardant Health Inc. v. Tempus AI, Inc. (U.S.D.C. D. Del.) and IPR2025-01435

This summary details the key legal developments and outcomes concerning U.S. Patent No. 10,793,916, which is owned by Guardant Health Inc. The patent is at the center of both a patent infringement lawsuit filed by Guardant Health against Tempus AI, Inc., and an Inter Partes Review (IPR) initiated by Tempus AI against Guardant Health.

Key Legal Developments and Outcome

1. District Court Patent Infringement Litigation Filing:

• Guardant Health, Inc. v. Tempus AI, Inc.
  • Filing Date: June 11, 2024.
  • Court: U.S. District Court for the District of Delaware.
  • Case Number: 1:24-cv-00687.
  • Plaintiff: Guardant Health, Inc.
  • Defendant: Tempus AI, Inc.
  • Patents Asserted: Guardant Health alleged that Tempus AI infringes U.S. Patent Nos. 11,149,306; 9,902,992; 10,501,810; 10,793,916; and 11,643,693. Guardant Health is seeking an injunction to stop Tempus' infringement and compensatory damages.
  • Current Status: The case has been assigned to Judge Richard Andrews and as of May 24, 2026, a scheduling order has not yet been entered.

2. Parallel PTAB IPR Proceeding:

• IPR2025-01435
  • Filing Entity (Petitioner): Tempus AI, Inc. (associated with Unified Patents).
  • Patent Owner: Guardant Health Inc.
  • Patent at Issue: U.S. Patent No. 10,793,916.
  • Outcome: The Inter Partes Review was "Not Instituted - Procedural." This means the Patent Trial and Appeal Board (PTAB) did not proceed with a full review of the patent's validity.
  • Effect on Litigation: The non-institution of the IPR means that Tempus AI's challenge to the validity of patent 10,793,916 at the PTAB did not move forward to a merits-based decision, leaving any validity challenges to be addressed in the ongoing district court litigation. Procedural denials at the PTAB have seen a significant increase, particularly in 2025, due to policy changes by the USPTO Director, including stricter requirements for identifying all real parties in interest and the Director's direct involvement in institution decisions.

Other Related Litigation Involving Guardant Health (but not patent 10793916):

It is important to distinguish the above case from other patent-related legal actions involving Guardant Health that concern different patents:

• TwinStrand Biosciences, Inc. and University of Washington v. Guardant Health, Inc. (U.S.D.C. D. Del.): In November 2023, a jury found Guardant Health willfully infringed U.S. Patent Nos. 10,760,127 and 10,287,631, awarding $83.4 million in damages. Guardant Health intends to appeal this verdict. [cite: 1 in previous turn, 2 in previous turn, 3 in previous turn, 4 in previous turn]
• Illumina, Inc. v. Guardant Health, Inc. (U.S.D.C. D. Del. Case No. 1:22-cv-00334-GBW-CJB): This lawsuit, filed by Illumina in March 2022, alleged correction of inventorship and trade secret misappropriation related to various Guardant patents. The parties reached a Collaboration and Settlement Agreement in August 2023, leading to the dismissal of this lawsuit with prejudice. [cite: 2 in previous turn, 3 in previous turn, 8 in previous turn]
• Guardant Health, Inc. v. Foundation Medicine, Inc.: The parties settled all pending litigation concerning Guardant's digital sequencing technology patents, including U.S. Patent No. 9,340,830, in January 2022. Foundation Medicine agreed to pay Guardant Health $25 million and future royalties for a non-exclusive license. [cite: 4 in previous turn, 5 in previous turn]
• Guardant Health, Inc. v. Sophia Genetics (Unified Patent Court - Paris Local Division, Case No. UPC_CFI_808/2025): On August 29, 2025, Guardant Health lodged an application for provisional measures against Sophia Genetics for infringement of four European Patents (EP-3470533-B2, EP-3591073-B1, EP-3443066-B1, EP-3766986-B1) in the Unified Patent Court territories and other countries. [cite: 6 in previous turn, 7 in previous turn]
• Tempus AI, Inc. v. Guardant Health, Inc. (U.S.D.C. S.D. Cal.): On March 14, 2025, Tempus filed a separate patent infringement lawsuit alleging Guardant Health infringes U.S. Patent Nos. 10,957,041; 10,991,097; 11,640,859; and 12,112,839. In May 2025, this case was transferred to the Northern District of California, and in January 2026, the court granted Guardant's motion to dismiss.

Unified Patents often uses in-house counsel and may also engage outside counsel for IPR proceedings. Identifying specific counsel for IPR2025-01435 requires reviewing the petition and associated filings. Due to the "Not Instituted - Procedural" status, detailed information about specific counsel may not be readily available through general searches without direct access to the PTAB's filing system for that specific IPR.

However, based on general practices and publicly available information regarding Unified Patents' PTAB activities:

• Unified Patents In-House Counsel: Unified Patents employs a team of in-house patent counsel who are often involved in drafting and prosecuting IPR petitions. Some of their Senior Patent Counsel include Jordan Rossen, Jessica Marks, Michelle Aspen, and Ellyar Barazesh. Jonathan Stroud is their Chief IP Counsel. These attorneys are experienced in PTAB proceedings and handle managing patent office proceedings internally, drafting and litigating petitions, and supporting other legal functions.

• Outside Counsel: Unified Patents also frequently collaborates with various law firms specializing in patent litigation for their IPR challenges. While not definitively linked to IPR2025-01435 without specific docket information, firms that commonly represent petitioners in PTAB proceedings and have worked with or for Unified Patents' efforts include Fish & Richardson PC, Finnegan, Henderson, Farabow, Garrett & Dunner LLP, and Haynes & Boone LLP. Other firms often appearing as petitioner's counsel in PTAB cases include Baker Botts LLP, Paul Hastings LLP, and Ropes & Gray LLP.

Without direct access to the docket for IPR2025-01435, it's not possible to definitively name the specific lead and backup counsel who appeared for the Petitioner in this particular case. The PTAB's rules generally require parties to designate both lead counsel and at least one backup counsel for AIA proceedings, though recent rule changes allow for solo representation and automatic pro hac vice admission in some circumstances.

The following identifies counsel of record representing Guardant Health Inc. in IPR2025-01435, to the extent information is publicly available. Due to the "Not Instituted - Procedural" status, detailed appearances for this specific IPR might be limited, but based on other related litigation and IPRs involving Guardant Health, common counsel can be identified.

Counsel for Guardant Health Inc. (Patent Owner):

While specific counsel for IPR2025-01435 are not readily available due to the procedural non-institution, Guardant Health has been represented by several firms in other patent litigation and IPRs related to similar technologies. Here are notable firms and attorneys who have represented Guardant Health in related matters:

• Choate, Hall & Stewart LLP

  • Brenda Herschbach Jarrell (Lead Counsel) - Boston, MA office.
    • Experience: Co-chair of Choate's Intellectual Property practice. Represented Foundation Medicine in a patent infringement lawsuit and related IPR proceedings against Guardant Health, and has represented Guardant Health in other matters.
  • Rolando Medina (Back-up Counsel) - Boston, MA office.
    • Experience: Focuses on intellectual property litigation and post-grant proceedings.
  • Stephanie L. Schonewald (Back-up Counsel) - Boston, MA office.
    • Experience: Involved in various aspects of patent litigation and IPRs.
  • Sophie F. Wang (Admitted Pro Hac Vice) - Boston, MA office.
    • Experience: Practices in intellectual property, including patent litigation.

• Orrick, Herrington & Sutcliffe LLP

  • E. Joshua Rosenkranz (Lead Counsel) - New York, NY office.
    • Experience: Argued for Guardant Health in an appeal before the Federal Circuit against the University of Washington concerning a PTAB decision.
  • Travis Jensen - Menlo Park, CA office.
  • Raghav Krishnapriyan - San Francisco, CA office.
  • Elizabeth Moulton - San Francisco, CA office.

• Wilson, Sonsini, Goodrich & Rosati, PC

  • Michael T. Rosato - Seattle, WA office.
    • Experience: Represented Guardant Health in its Federal Circuit appeal against the University of Washington.
  • Sonja Rochelle Gerrard (Ph.D. - credentialed counsel) - Seattle, WA office.
    • Experience: Part of the team representing Guardant Health in its Federal Circuit appeal.
  • Jad Allen Mills - Seattle, WA office.

• Keller Anderle Scolnick

  • Jennifer L. Keller - Irvine, CA office.
    • Experience: Won a significant $292.5 million Lanham Act false advertising jury trial verdict for Guardant Health in 2024.
  • Chase Scolnick - Irvine, CA office.
    • Experience: Also involved in the successful Lanham Act case for Guardant Health.
  • Gregory Bernstein - Irvine, CA office.
  • Gregory M. Sergi - Irvine, CA office.
  • Akhil Sheth - Irvine, CA office.

• Potter Anderson & Corroon LLP (Local Counsel in Delaware)

  • David E. Moore - Wilmington, DE office.
  • Bindu A. Palapura - Wilmington, DE office.

• Jones Day

  • E. Matthew Johnson
  • Derek Walter
    • Experience: Represented Guardant Health in IPR2025-01353 against Cold Spring Harbor Laboratory, where institution was denied.

• Guardant Health, Inc. (In-house counsel)

  • Guardant Health has an internal Intellectual Property Counsel role responsible for managing its global patent portfolio and IP strategy.

It is important to note that the specific counsel for IPR2025-01435 were not explicitly identified in the search results given the procedural denial of institution. The attorneys listed above have represented Guardant Health in other patent-related proceedings, including IPRs and district court litigation, indicating their likely involvement in managing the company's patent portfolio and related disputes.