Litigation

Untitled case

Active

1:25-cv-00263

Patents at issue (1)

12234510PTAB institution denied

Summary

This is an active district court case identified by Google Patents related to patent 12234510.

Case overview & background

Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.

This patent infringement litigation, Cold Spring Harbor Laboratory v. Guardant Health, Inc., Case No. 1:25-cv-00263-JCG, is currently active in the District of Delaware. The plaintiff, Cold Spring Harbor Laboratory (CSHL), is a not-for-profit educational corporation engaged in research and discovery across various biological fields, including cancer, neuroscience, genomics, quantitative biology, and plant biology. The defendant, Guardant Health, Inc., is an operating company in the early cancer screening field, known for its blood test products.

CSHL has accused Guardant Health's blood test products of infringing U.S. Patent Nos. 10,947,589 and 12,234,510. Both patents are titled "Varietal Counting of Nucleic Acids for Obtaining Genomic Copy Number Information" and broadly relate to methods for obtaining genomic copy number information from a sample of genomic material, a technology pertinent to cancer screening. The case, filed on March 6, 2025, is presided over by Judge Jennifer Choe-Groves. The District of Delaware is a prominent venue for patent litigation due to its specialized court and well-developed body of patent law.

The procedural posture of the case saw a notable development on October 10, 2025, when the court denied Guardant Health's partial motion to dismiss claims for willful infringement. The court found that CSHL had made specific factual allegations supporting pre-suit knowledge of the patents by Guardant Health, including Guardant's involvement in related research and opposition proceedings to CSHL's related European patents. This case is notable within the early cancer screening industry, particularly regarding the intersection of academic research and commercial products, and the scrutiny around allegations of pre-suit willful infringement. An Inter Partes Review (IPR2025-01355) was also filed by Guardant Health Inc. challenging U.S. Patent No. 10,947,589, indicating parallel PTAB proceedings for at least one of the asserted patents.

Key legal developments & outcome

Major rulings, motions, claim construction, settlements, and the present posture or final disposition.

The case Cold Spring Harbor Laboratory v. Guardant Health, Inc., Case No. 1:25-cv-00263-JCG, has seen several key legal developments since its filing in March 2025.

Filing & Initial Pleadings

  • Complaint: Cold Spring Harbor Laboratory (CSHL) filed its complaint for patent infringement against Guardant Health, Inc. on March 6, 2025, in the District of Delaware. CSHL accused Guardant Health's blood test products of infringing U.S. Patent Nos. 10,947,589 and 12,234,510.
  • Amended Complaint: An amended complaint was filed, which included claims for willful infringement.

Pre-trial Motions of Substance

  • Motion to Dismiss Willful Infringement Claims: Guardant Health filed a partial motion to dismiss claims for willful infringement, arguing that CSHL failed to allege sufficient facts of pre-suit knowledge to support enhanced damages.
  • Denial of Motion to Dismiss: On October 10, 2025, Judge Jennifer Choe-Groves denied Guardant Health's motion to dismiss. The court found that CSHL had made specific factual allegations supporting pre-suit knowledge, including Guardant's involvement in related research and opposition proceedings to CSHL's related European patents. The court noted that while any of these items in isolation might be too speculative, taken collectively, they were sufficient to support the claim of pre-suit willful infringement.

Parallel PTAB IPR/PGR Proceedings

  • IPR2025-01355: Guardant Health Inc. filed an Inter Partes Review (IPR2025-01355) challenging U.S. Patent No. 10,947,589. While the status of IPR2025-01355's institution decision is not explicitly detailed in the provided search results, other IPRs filed around the same time have seen institution decisions in late 2025. It is worth noting that the PTAB under Director Squires has increasingly denied IPR petitions on discretionary grounds, with a focus on factors like "settled expectations" and the age of the patent. This trend has seen petitions for patents less than six years old more likely to be instituted.

Plaintiff representatives

Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

I'll research plaintiff's counsel of record, starting with the docket and opinion appearances.

Strong primary-source hit already (the Amended Complaint signature block). Let me verify current firm affiliations, admission numbers, and whether the team has changed since.

Plaintiff's Counsel of Record — Cold Spring Harbor Laboratory

Bottom line: CSHL is represented by Desmarais LLP (New York) as lead/national patent trial counsel, with Richards, Layton & Finger, P.A. (Wilmington) as Delaware counsel. Four Desmarais lawyers are named on the pleadings ("OF COUNSEL" block) — John M. Desmarais, Brian D. Matty, Kevin Goon, Ashley DaBiere — and two RLF lawyers sign for the plaintiff — Kelly E. Farnan (#4395) and Sara M. Metzler (#6509). This confirms, and puts names to, the prior section's statement that "CSHL uses Desmarais LLP with Richards, Layton & Finger as local counsel."

Delaware / Local Counsel — Richards, Layton & Finger, P.A.

Name Role Firm & Office Notes
Kelly E. Farnan (#4395) Delaware counsel of record; signs all filings for CSHL; credited as plaintiff's attorney in the Oct. 10, 2025 willfulness opinion Richards, Layton & Finger, P.A., One Rodney Square, 920 N. King St., Wilmington, DE 19801 Heads RLF's Intellectual Property Group; Chambers USA Band 1; named Managing IP's 2025 Delaware Litigator of the Year (rlf.com, Apr. 25, 2025). Deep Delaware patent-trial bench (e.g., Scale Biosciences v. Parse Biosciences, C.A. No. 22-1597-CJB, as Delaware counsel).
Sara M. Metzler (#6509) Delaware counsel of record (co-signer on the amended complaint and infringement contentions) Richards, Layton & Finger, P.A., Wilmington, DE Second-seat Delaware counsel on this matter. Verification flag: I confirmed Ms. Metzler's signature and bar number from the May 1, 2025 amended complaint and July 11, 2025 infringement-contentions signature blocks, but I could not independently confirm her current RLF profile page or whether she remains on the case as of late 2026.

Lead / National Counsel — Desmarais LLP (230 Park Avenue, New York, NY 10169)

Name Role Firm & Office Notes
John M. Desmarais Founding partner; named first in the OF COUNSEL block on the complaint and amended complaint Desmarais LLP, New York Founder of the firm (formerly presiding partner of Kirkland & Ellis). The firm's trial record includes the $272.5M Ravgen v. Labcorp verdict + $100M enhanced damages, a $57M Ravgen v. Natera verdict, and $82.5M in IBM v. Groupon — all life-sciences/diagnostic-adjacent or willfulness-heavy wins that map onto CSHL's theory here (willfulness is the live fight in this case). Note: I infer his role as relationship/lead partner from the signature-block ordering; I did not retrieve a docket entry formally designating lead trial counsel.
Brian D. Matty (USPTO Reg. No. 70,358) Partner; the Desmarais attorney with the deepest substantive footprint on the record Desmarais LLP, New York Practice focused on diagnostic genetic testing plus PTAB work; led Ravgen's defense of ten IPRs (all claims upheld, affirmed by the Federal Circuit) and argued those appeals — directly relevant because Guardant has challenged the '589 patent in IPR2025-01355. Profile: desmaraisllp.com/brian-matty.
Kevin Goon Associate (New York) Desmarais LLP, New York IP/technology litigation; New York bar No. 6070312 (admitted Sept. 2023). IPR experience on gene-sequencing matters, e.g., Molecular Loop Biosciences (IPR2024-00965 and D. Del. 2:24-cv-00680 — note the Illumina/Verinata sequencing adversary overlap). Profile: desmaraisllp.com/kevin-goon.
Ashley DaBiere Associate/attorney listed in the OF COUNSEL block Desmarais LLP, New York Listed on both the amended complaint and the infringement contentions. Caveat: I could not retrieve a firm profile page or confirm her bar admission/role from an independent source within the search budget — treat her as a confirmed signatory but unconfirmed as to title.

In-house counsel

No CSHL in-house attorney appears in any filing I reviewed. CSHL is a not-for-profit research institution and, consistent with practice, appears to litigate entirely through outside counsel here. I cannot confirm a negative from a full docket sheet (see caveat below).

Record trail grounding these identifications

  • D.I. 1 — Complaint, filed March 6, 2025 (signed by RLF for CSHL).
  • D.I. 15 — First Amended Complaint, May 1, 2025, signature block: "OF COUNSEL: John M. Desmarais, Brian D. Matty, Kevin Goon, Ashley DaBiere, Desmarais LLP, 230 Park Avenue, New York, NY 10169 /s/ Kelly E. Farnan (#4395), Sara M. Metzler (#6509), Richards, Layton & Finger, P.A. … Attorneys for Plaintiff Cold Spring Harbor Laboratory." (Reproduced in the IPR2025-01355 exhibit set on PTACTS: uspto.gov artifact)
  • CSHL's Disclosure of Asserted Claims and Infringement Contentions, July 11, 2025 — same two-tier signature block (Desmarais OF COUNSEL + Farnan/Metzler), citing the Third Amended Scheduling Order (D.I. 37) and accusing Guardant360 Liquid, Guardant360 Tissue, and Guardant360 CDx, asserting '589 claims 1–3, 6–15, 17–19 and '510 claims (Exs. A–B).
  • D.I. 46 (Oct. 10, 2025 opinion denying D.I. 24) counsel listing: "Kelly E. Farnan (Richards, Layton & Finger, P.A.) for Cold Spring Harbor Laboratory" (IP Law Daily, Oct. 14, 2025); opinion PDF at ded.uscourts.gov/…/25-263.pdf and Justia D.I. 46.

Contradiction / correction check against earlier sections

  • No contradiction. The earlier "Defendant representatives" section's cross-reference (Desmarais + RLF for CSHL) is now confirmed with named attorneys and bar numbers.
  • One carry-forward flag on the case metadata: the metadata lists only patent 12,234,510, but the pleadings and the Oct. 10, 2025 opinion confirm two asserted patents (10,947,589 and 12,234,510) — as the earlier sections already noted.

What I could not verify (stated explicitly, not inferred)

  1. No PACER docket sheet was retrieved. Docket Alarm and the ExParte/AI case pages surfaced in search are explicitly incomplete ("The docket is incomplete"), so I cannot certify the complete appearance list (e.g., later-added Desmarais associates) as of today, October 17, 2026.
  2. Pro hac vice orders for the Desmarais lawyers. In D. Del., the Desmarais attorneys' formal appearance would come via motions for pro hac vice admission (typically filed with the complaint). I did not retrieve those entries, so I cannot state the D.I. numbers or confirm that all four were admitted; the signature blocks establish they are counsel on the pleadings, not their admission status.
  3. Ashley DaBiere's title/bar and Sara M. Metzler's current status at RLF (see table caveats).
  4. Nothing in the record reviewed indicates any sealed appearance or CJA/appointment issue; the filings I reviewed are public.

Recommended verification steps: (a) pull the PACER docket for 1:25-cv-00263 and list every "MOTION for Pro Hac Vice" and its order — that is the definitive Desmarais roster; (b) check page 1 of the D.I. 1 and D.I. 15 PDFs for the full appearance caption; (c) check the IPR2025-01355 Patent Owner's mandatory notices for CSHL's designated lead/back-up PTAB counsel, which may include Desmarais attorneys not yet on the district court appearance list.

Defendant representatives

Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

I'll research the defendant's counsel of record for this case.

Defendant's Counsel of Record — Guardant Health, Inc.

Bottom line: Guardant Health is represented by Jones Day as lead (national) trial counsel, with Farnan LLP in Wilmington as Delaware/local counsel. This is directly corroborated by two independent sources: Jones Day's own experience page for this matter (jonesday.com, March 2025) and the attorney listing accompanying the October 10, 2025 willfulness ruling, which credits "Brian E. Farnan (Farnan LLP) for Guardant Health, Inc." (VitalLaw/IP Law Daily, Oct. 14, 2025).

Note the contrast with CSHL's side (already covered): CSHL uses Desmarais LLP with Richards, Layton & Finger as local counsel — i.e., two of Delaware's rival "Farnan" shops are on opposite sides here (Kelly E. Farnan at RLF for plaintiff; Brian E. Farnan at Farnan LLP for defendant). This is a recurring alignment in Delaware patent practice and worth watching for conflicts/logistics issues (e.g., pro hac vice motions, scheduling stipulations).

Delaware / Local Counsel

Name Role Firm & Office Notes
Brian E. Farnan Local counsel; the attorney credited on the docket for Guardant in the Oct. 10, 2025 opinion's counsel listing Farnan LLP, 919 N. Market St., 12th Fl., Wilmington, DE Dean of Delaware patent local counsel. Long-standing outside Delaware counsel to Guardant: filed the 2017–20 Guardant Health v. Personal Genome Diagnostics and Guardant Health v. Foundation Medicine litigations and Guardant's 2020 preliminary injunction motion against Foundation Medicine (D. Del. C.A. No. 20-1580, D.I. 7). Bar No. 4089.
Michael J. Farnan Likely local counsel team member (Farnan LLP) — not confirmed by an appearance in this docket Farnan LLP, Wilmington, DE Bar No. 5165; routinely appears alongside Brian E. Farnan for Guardant in the earlier D. Del. cases. Include only as a probable team member; I could not verify an appearance in 1:25-cv-00263.
Joseph J. Farnan, Jr. Of counsel / firm founder (not confirmed for this case) Farnan LLP, Wilmington, DE Former U.S. District Judge (D. Del.); listed as lead attorney in Guardant's earlier Delaware suits. No verified appearance here.

Lead / National Trial Counsel

Name Role Firm & Office Notes
Jones Day (team) Lead counsel for Guardant Jones Day, with the life-sciences IP group; likely drawn from the San Diego / Silicon Valley / New York offices, though the specific office for this engagement is not disclosed Jones Day's public experience entry, "Guardant Health defends patent infringement allegations in DDE over its cancer testing technology," identifies this exact case (No. 1-25-cv-00263) and describes the defense of the Guardant360 product against two copy-number patents. (jonesday.com)

Important sourcing caveat: I was unable to confirm, from a primary source (PACER docket sheet, the pro hac vice motions, or the opinion's full appearance block), the individual Jones Day attorneys of record in 1:25-cv-00263. The docket entries I could retrieve (D.I. 24 partial motion to dismiss; D.I. 46 order denying it) are cited in the opinion text but the appearance caption was not reproduced in the available search results. I am therefore not naming individual Jones Day partners — doing so would require the pro hac vice motions/ECF appearance entries, which are the usual vehicle for adding national counsel in D. Del.

One lead worth verifying directly on PACER: the PTAB docket for IPR2025-01355 (Guardant v. CSHL, '589 patent, filed July 25, 2025) lists petitioner counsel as "Walter, Derek, et al." (per IP Verse/GreyB). I could not verify Derek Walter's firm affiliation or whether he is Jones Day counsel also appearing in the district court case; treat that as an unverified lead, not a finding.

In-house counsel

No Guardant in-house attorney has appeared on the docket in this case as of the sources reviewed. Guardant's legal department is presumably supervising but has not entered an appearance — so none is named here.

Procedural detail tying counsel to the record

  • D.I. 24 — Guardant's Partial Motion to Dismiss the Amended Complaint (pre-suit willfulness only), filed by defense counsel; briefing at D.I. 24–26 and response/reply.
  • D.I. 46 — Order (Oct. 10, 2025), Judge Jennifer Choe-Groves (sitting by designation from the U.S. Court of International Trade), denying D.I. 24. Opinion PDF, D. Del. | Justia copy
  • Guardant's Initial Invalidity Contentions (asserting '589 claims 1–3, 6–15, 17–18 and '510 claims 1–12, 15–23, 26–29, 31–34) were served by this same defense team and are now an exhibit in the IPR (EX2011).
  • Defense in the parallel PTAB track: IPR2025-01355 was instituted-denied on January 16, 2026, following a Director discretionary decision to refer on November 20, 2025 (IP Verse). This updates the earlier section of this case summary, which stated that the institution status of IPR2025-01355 "is not explicitly detailed in the provided search results." Two flags: (a) the source is a third-party PTAB aggregator, not the PTAB's own docket, so confirm on PTAB E2E before relying on it; (b) it is worth confirming whether the January 16, 2026 denial was merits-based or discretionary under § 314(a)/§ 325(d), because a discretionary denial would materially affect Guardant's invalidity strategy in Delaware (i.e., invalidity would be litigated only in the district court).

Suggested next verification steps

  1. Pull the PACER docket sheet for 1:25-cv-00263 and list every "MOTION for Pro Hac Vice" order — that is the definitive list of Jones Day personnel admitted.
  2. Check the appearance block on the opinion at D.I. 46 (page 1 of the PDF) and on D.I. 24, which will name lead trial counsel.
  3. Confirm Derek Walter's firm and role via the IPR2025-01355 Petition's mandatory notices (which list petitioner's lead and back-up counsel and their firms).