Untitled case

This patent infringement litigation, Cold Spring Harbor Laboratory v. Guardant Health, Inc., Case No. 1:25-cv-00263, was filed on March 6, 2025, in the District of Delaware. The plaintiff, Cold Spring Harbor Laboratory, is a not-for-profit educational and research institution renowned for its contributions in cancer, neuroscience, genomics, quantitative biology, and plant biology. The defendant, Guardant Health, Inc., is a commercial entity specializing in precision oncology, with its blood test products, including the flagship Guardant 360, being the accused infringing technology. These products are alleged to infringe methods related to obtaining genomic copy number information from biological samples, which is a key aspect of early cancer detection and monitoring.

The asserted patents are U.S. Patent No. 10,947,589 and U.S. Patent No. 12,234,510. Both patents are titled "Varietal Counting of Nucleic Acids for Obtaining Genomic Copy Number Information" and describe methods for analyzing nucleic acids to derive genomic copy number information from a sample of genomic material, representing an advance in the field of early cancer detection. The case is currently before Judge Jennifer Choe-Groves, a U.S. District Court Judge sitting by designation from the United States Court of International Trade. The District of Delaware is a prominent venue for patent litigation, largely due to a significant number of major U.S. technology and pharmaceutical companies being incorporated in the state, coupled with its experienced patent bench, which often results in a substantial volume of patent filings in this court.

This case is notable for several reasons. It pits a venerable research institution against a leading commercial company in the high-impact field of liquid biopsy for cancer diagnostics, highlighting the intersection of fundamental scientific discovery and its commercial application. A recent procedural development saw the court deny Guardant Health's partial motion to dismiss claims of willful infringement for the pre-suit period. The court found that Cold Spring Harbor Laboratory had sufficiently alleged pre-suit knowledge on the part of Guardant, citing Guardant's involvement in related European patent opposition proceedings and its participation in the relevant industry. This ruling underscores the court's stance on pleading standards for willful infringement, particularly in cases involving industry competitors with awareness of related intellectual property.

Key Legal Developments and Outcome for Cold Spring Harbor Laboratory v. Guardant Health, Inc.

This patent infringement litigation, Case No. 1:25-cv-00263, was filed in the U.S. District Court for the District of Delaware by Plaintiff Cold Spring Harbor Laboratory against Defendant Guardant Health, Inc., asserting infringement of U.S. Patent No. 10,947,589. The case was filed on March 6, 2025, and is presided over by Judge Jennifer Choe-Groves.

Filing & Initial Pleadings

• Complaint Filed: Cold Spring Harbor Laboratory filed its complaint for patent infringement against Guardant Health, Inc. on March 6, 2025, in the District of Delaware. The nature of the suit is listed as "830 Property Rights - Patent," with the cause of action being "35:271 Patent Infringement."

Pre-trial Motions of Substance

• Motion to Dismiss Pre-Suit Willful Infringement: On October 10, 2025, the District of Delaware denied Guardant Health's partial motion to dismiss pre-suit willful infringement claims from the litigation. The court found that the plaintiff's allegations, which included the defendant's involvement in a related foreign opposition proceeding and participation in the relevant industry, provided sufficient factual support to plausibly plead pre-suit willfulness at the pleading stage.

Parallel PTAB IPR/PGR Proceedings

A search for parallel PTAB IPR/PGR proceedings for US Patent 10,947,589 did not yield any immediate results, indicating no public IPR or PGR petitions have been filed or instituted against this specific patent at the USPTO Patent Trial and Appeal Board (PTAB) as of the current date.

Current Posture

As of the current date, May 23, 2026, the case remains active. The most recent significant public development identified is the denial of the defendant's partial motion to dismiss pre-suit willful infringement on October 10, 2025. The case has not yet reached claim construction (Markman), discovery milestones with strategic significance, trial, or final disposition such as settlement, dismissal, or judgment.## Key Legal Developments and Outcome for Cold Spring Harbor Laboratory v. Guardant Health, Inc.

This patent infringement litigation, Case No. 1:25-cv-00263, was initiated in the U.S. District Court for the District of Delaware by Plaintiff Cold Spring Harbor Laboratory against Defendant Guardant Health, Inc. The case, which asserts infringement of U.S. Patent No. 10,947,589, was filed on March 6, 2025, and is overseen by Judge Jennifer Choe-Groves.

Filing & Initial Pleadings

• Complaint Filed: Cold Spring Harbor Laboratory filed its complaint for patent infringement against Guardant Health, Inc. on March 6, 2025. The case is classified under "Property Rights - Patent" with a cause of action for "Patent Infringement" under 35 U.S.C. § 271.

Pre-trial Motions of Substance

• Motion to Dismiss Pre-Suit Willful Infringement: On October 10, 2025, the District of Delaware denied Guardant Health's partial motion to dismiss claims of pre-suit willful infringement. The court determined that Cold Spring Harbor Laboratory had provided sufficient factual allegations, including Guardant Health's involvement in a related foreign opposition proceeding and its participation in the relevant industry, to plausibly plead pre-suit willfulness at the pleading stage.

Parallel PTAB IPR/PGR Proceedings

As of May 23, 2026, searches of the USPTO Patent Trial and Appeal Board (PTAB) for U.S. Patent No. 10,947,589 did not reveal any active or concluded Inter Partes Review (IPR) or Post-Grant Review (PGR) proceedings.

Present Posture

The litigation remains active in the District of Delaware. The most recent substantive development identified is the court's denial of the defendant's motion to dismiss pre-suit willful infringement, issued on October 10, 2025. The case has not yet progressed to stages such as claim construction (Markman), significant discovery milestones, trial, or a final disposition including settlement, dismissal, or judgment.

The plaintiff in this patent infringement case, Cold Spring Harbor Laboratory, is represented by the following counsel:

Farnan LLP (Wilmington, DE)

• Brian E. Farnan (Local Counsel)
  • Farnan LLP is a Delaware-based law firm frequently acting as local counsel in patent litigation cases in the District of Delaware.
• Michael J. Farnan (Local Counsel)
  • Farnan LLP often serves as local counsel in patent infringement actions within the District of Delaware.

Jones Day

• Edward R. Reines (Lead Counsel)
  • Firm: Jones Day, Palo Alto, CA office.
  • Edward Reines is a well-known patent litigator, recognized for his work on numerous high-profile patent cases, particularly in the technology sector.
• Derek C. Walter (Of Counsel)
  • Firm: Jones Day, San Francisco, CA office.
  • Derek Walter's experience at Jones Day includes representing clients in complex patent litigation matters.

The defendant, Guardant Health, Inc., is represented by the following counsel in Cold Spring Harbor Laboratory v. Guardant Health, Inc., Case No. 1:25-cv-00263:

Richards, Layton & Finger, P.A. (Wilmington, DE)

• Kelly E. Farnan (Local Counsel)
  • Kelly E. Farnan is an attorney with Richards, Layton & Finger, P.A., a Delaware-based firm often serving as local counsel in high-stakes patent litigation in the District of Delaware.
• Sara M. Metzler (Local Counsel)
  • Sara M. Metzler is also with Richards, Layton & Finger, P.A., providing local counsel services in patent cases in Delaware.

Desmarais LLP (New York, NY)

• John M. Desmarais (Lead Counsel)
  • John M. Desmarais is a prominent patent litigator known for handling complex intellectual property disputes.
• Brian D. Matty (Of Counsel)
  • Brian D. Matty is an attorney at Desmarais LLP with experience in patent litigation.
• Kevin Goon (Of Counsel)
  • Kevin Goon is an attorney at Desmarais LLP.
• Ashley DaBiere (Of Counsel)
  • Ashley DaBiere is an attorney at Desmarais LLP.

It is worth noting that while the previously generated summary identified Farnan LLP and Jones Day as representing the plaintiff, Cold Spring Harbor Laboratory, the Opinion and Order dated October 10, 2025, from the District Court of Delaware clearly lists Brian E. Farnan and Michael J. Farnan of Farnan LLP, and Edward R. Reines and Derek C. Walter of Jones Day, as "Attorneys for Defendant Guardant Health, Inc.". This contradicts the earlier information regarding plaintiff representation. For the purpose of this response, I will prioritize the information from the court's opinion.

Farnan LLP (Wilmington, DE)

• Brian E. Farnan (Local Counsel)
  • Farnan LLP is a Delaware-based law firm frequently acting as local counsel in patent litigation cases in the District of Delaware.
• Michael J. Farnan (Local Counsel)
  • Farnan LLP often serves as local counsel in patent infringement actions within the District of Delaware.

Jones Day

• Edward R. Reines (Lead Counsel)
  • Firm: Jones Day, Palo Alto, CA office.
  • Edward Reines is a well-known patent litigator, recognized for his work on numerous high-profile patent cases, particularly in the technology sector.
• Derek C. Walter (Of Counsel)
  • Firm: Jones Day, San Francisco, CA office.
  • Derek Walter's experience at Jones Day includes representing clients in complex patent litigation matters.

Guardant Health also has in-house legal counsel specializing in patent litigation. John Saia is the Chief Legal Officer at Guardant Health. Gulshan Shaver is the Senior Vice President of Legal Affairs and Chief Compliance Officer at Guardant Health, with a background in intellectual property. Michael Wiley also serves as Chief Legal Officer. Guardant Health actively seeks experienced patent litigation counsel for its in-house IP team to manage and execute its patent dispute, enforcement, and defense strategy. The company has been involved in several other patent disputes, including a case against the University of Washington and TwinStrand Biosciences regarding DNA sequencing patents, where they were represented by Orrick, Herrington & Sutcliffe LLP and Wilson, Sonsini, Goodrich & Rosati, PC in the Federal Circuit appeal. They also previously settled a patent suit with Illumina.