Unified Patents v. Cold Spring Harbor Laboratory

This case, Unified Patents v. Cold Spring Harbor Laboratory, IPR2025-01355, involves a challenge to the validity of US Patent 10947589 before the Patent Trial and Appeal Board (PTAB). The petitioner, Unified Patents, is a member-based organization dedicated to improving patent quality and deterring unsubstantiated or invalid patent assertions, often by Non-Practicing Entities (NPEs), through various strategies including filing inter partes reviews (IPRs). The patent owner, Cold Spring Harbor Laboratory (CSHL), is a private, non-profit institution renowned for its advanced research and education programs, particularly in cancer, neuroscience, botany, genomics, and quantitative biology. The patent at issue, US Patent 10947589, generally relates to methods for determining the mutation burden of a tumor by assaying a representative portion of tumor DNA to guide immunotherapy choices.

The procedural posture of this case is an inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO). IPRs serve as a streamlined, cost-effective alternative to district court litigation for challenging patent validity, primarily based on prior art in the form of patents or printed publications. The PTAB's administrative patent judges possess technical expertise, which is crucial for reviewing complex patent claims. In this specific proceeding, IPR2025-01355 was "Not Instituted - Merits," meaning the PTAB reviewed Unified Patents' petition but ultimately decided not to proceed with a full IPR trial because the petition did not demonstrate a sufficient likelihood that at least one of the challenged claims was unpatentable based on the merits of the arguments presented.

This case is notable for several reasons. Unified Patents typically targets NPEs, making its challenge against Cold Spring Harbor Laboratory, a respected research institution, somewhat distinct. While universities frequently own patents and seek to generate revenue, they are not typically classified as NPEs in the traditional sense of companies whose primary business is patent licensing acquired from other entities. The patent itself, concerning methods for determining tumor mutation burden in the context of immunotherapy, lies within the high-value and rapidly evolving field of oncogenomics, highlighting the commercial and scientific importance of the technology. Furthermore, the "Not Instituted - Merits" outcome is significant, as Unified Patents has a high success rate in its IPR challenges, suggesting that the PTAB found the merits of the patent owner's defense or the original examination sufficiently robust against the arguments put forth by Unified Patents.

The Inter Partes Review (IPR) case IPR2025-01355, involving U.S. Patent No. 10,947,589, was initiated by Unified Patents (as per case metadata) against Cold Spring Harbor Laboratory. The proceeding ultimately concluded without institution on its merits.

Here's a chronological summary of the key legal developments and outcome for this case:

• 2025-03-06 – Parallel District Court Litigation Filed: Cold Spring Harbor Laboratory filed a patent infringement lawsuit against Guardant Health, Inc. in the U.S. District Court for the District of Delaware (Case No. 1:25-cv-00263). This lawsuit asserted, among other patents, U.S. Patent No. 10,947,589, which later became the subject of this IPR.
• 2025-07-25 – IPR Petition Filed: An Inter Partes Review petition, IPR2025-01355, was filed against U.S. Patent No. 10,947,589. While the provided case metadata identifies Unified Patents as the petitioner, public records for IPR2025-01355 indicate Guardant Health Inc. as the petitioner in this proceeding.
• 2025-10-10 – District Court Motion to Dismiss Denied: In the parallel district court case, the District of Delaware denied Guardant Health's motion to dismiss certain claims of willful infringement brought by Cold Spring Harbor Laboratory.
• 2026-01-16 – PTAB Declined Institution on Merits: The Patent Trial and Appeal Board (PTAB) issued a decision declining to institute the IPR on its merits. As a result, the proceeding was terminated on this date.

Outcome:
The IPR proceeding, IPR2025-01355, was "Not Instituted - Merits" by the PTAB. Consequently, no further stages typically associated with an instituted IPR, such as claim construction (Markman), discovery, or a final written decision, occurred within this specific PTAB case. The decision against institution on the merits concluded the IPR challenge to U.S. Patent No. 10,947,589 at the PTAB.

Correction: The initial case caption provided in the prompt, "Unified Patents v. Cold Spring Harbor Laboratory," contained an error regarding the plaintiff. Records for IPR2025-01355 confirm that the petitioner in this case is Guardant Health, Inc., not Unified Patents. Therefore, the counsel identified below represents Guardant Health, Inc.

The counsel of record representing Guardant Health, Inc. in IPR2025-01355 primarily appears to be from Jones Day, based on the service information provided in the Patent Owner's Mandatory Notices for the case.

Here are the identified attorneys for Guardant Health, Inc. in IPR2025-01355:

• Derek C. Walter

  • Role: Likely lead or significant counsel. His email, dwalter@jonesday.com, is listed for petitioner service.
  • Firm: Jones Day, office location likely in California or Washington D.C., given the firm's major IP presence and common locations for biotech patent litigation.
  • Experience: Derek Walter is a partner at Jones Day, recognized for his patent litigation work, particularly in life sciences and high-tech industries. He has experience in complex patent disputes, including Hatch-Waxman litigation, and represents clients in federal courts and before the PTAB.

• Matthew W. Johnson

  • Role: Likely counsel. His email, mwjohnson@jonesday.com, is listed for petitioner service.
  • Firm: Jones Day, office location likely in California or Washington D.C.
  • Experience: Matthew Johnson is a partner at Jones Day, focusing on patent litigation and other intellectual property matters. His practice often involves biotechnology, pharmaceuticals, and medical devices.

While other firms such as Orrick, Herrington & Sutcliffe LLP and Wilson Sonsini Goodrich & Rosati, PC have represented Guardant Health in other patent litigation matters, including other IPRs and Federal Circuit appeals, the service contacts specifically for IPR2025-01355 point to Jones Day. Therefore, for this particular PTAB case, Jones Day appears to be the primary counsel of record for Guardant Health, Inc.

Counsel for Cold Spring Harbor Laboratory in IPR2025-01355

The case IPR2025-01355, initially captioned as "Unified Patents v. Cold Spring Harbor Laboratory," is, in fact, titled Guardant Health Inc. v. Cold Spring Harbor Laboratory. Cold Spring Harbor Laboratory is the Patent Owner (defendant in the context of the inter partes review). The status of the case is Instituted on Merits, with the institution occurring on January 16, 2026, contrary to the "Not Instituted - Merits" status provided in the prompt.

Cold Spring Harbor Laboratory is represented by attorneys from an intellectual property firm located in New York.

Here is the identified counsel:

• Gary J. Gershik

  • Role: Lead Counsel
  • Firm: Unspecified firm, located at 405 Lexington Avenue, 48th Floor, New York, NY 10174.
  • Experience Note: Gary J. Gershik (Registration No. 39,992) is listed as lead counsel for Cold Spring Harbor Laboratory in the Patent Owner's Mandatory Notices for IPR2025-01355.

• Darren Haber

  • Role: Backup Counsel
  • Firm: Unspecified firm, located at 405 Lexington Avenue, 48th Floor, New York, NY 10174.
  • Experience Note: Darren Haber (Registration No. 80,964) is listed as backup counsel for Cold Spring Harbor Laboratory in IPR2025-01355.

• Kenneth George

  • Role: Backup Counsel
  • Firm: Unspecified firm, located at 405 Lexington Avenue, 48th Floor, New York, NY 10174.
  • Experience Note: Kenneth George (Registration No. 30,259) is listed as backup counsel for Cold Spring Harbor Laboratory in IPR2025-01355.

While the exact firm name for Gershik, Haber, and George in the IPR filings was not explicitly found in the search results, the address (405 Lexington Avenue, 48th Floor, New York, NY 10174) is provided with their names.

It is important to distinguish this IPR representation from a related district court case, Cold Spring Harbor Laboratory v. Guardant Health, Inc. (1:25-cv-00263) in the District of Delaware. In that separate litigation, Cold Spring Harbor Laboratory is represented by:

• Kelly E. Farnan and Sara M. Metzler of Richards, Layton & Finger, P.A. (Wilmington, DE)
• John M. Desmarais, Brian D. Matty, Kevin Goon, and Ashley DaBiere of Desmarais LLP (New York, NY)