IP Law Daily, PATENT—D. Del. Dismissal of willful infringement claims denied in early cancer screening dispute, (Oct 14, 2025)

By Kevin M. Finson, J.D.

Claims for willful and pre-suit infringement were not subject to dismissal because the patentee made specific factual allegations from which pre-suit knowledge could be found.

A research and development company stated claims for willful infringement based on pre-suit knowledge against a competitor in the early cancer screening field, the U.S. District Court in Wilmington has held. The patentee made specific allegations showing the reason for its belief that the alleged infringer had pre-suit knowledge (Cold Spring Harbor Laboratory v. Guardant Health, Inc., No. 1:25-cv-00263-JCG (D. Del. Oct. 10, 2025)).

Cold Spring Harbor Laboratory (Cold Spring) was a not-for-profit education corporation which conducted research and discovery in the areas of cancer, neuroscience, genomics, quantitative biology, and plant biology. Cold Spring was the owner of U.S. Patents Nos. 10,947,589 (the ’589 patent) and 12,234,510 (the ’510 patent), both of which were entitled “Varietal Counting of Nucleic Acids for Obtaining Genomic Copy Number Information” and related to a method of obtaining genomic copy number information from a sample of genomic material.

Cold Spring brought suit for infringement against Guardant Health, Inc. (Guardant) alleging that Guardant’s blood test products infringed the claimed method. Guardant moved to dismiss in part, arguing that Cold Spring had failed to allege sufficient facts of pre-suit knowledge to support its claim for enhanced damages for willful infringement.

Pre-suit knowledge. Cold Spring alleged that Guardant had become aware of Cold Spring’s patents during investigation of the patentability of its own inventions, from being involved in the same industry, and from its involvement in opposition proceedings to Cold Spring’s related European patents under the same name. The court found that, in isolation, any of these items would be too speculative, or would establish only knowledge of related patents and not those at issue. However, when taken as a whole and in light of the complaint’s detailed allegations, including documents and exhibits showing Guardant’s specific involvement in related research and the foreign patentability dispute, as well as the specifics of exactly how the accused product used the patented method, the court held that the allegations were sufficient to state a claim for pre-suit knowledge.

The court denied the motion to dismiss.

The Case is No. 1:25-cv-00263-JCG.

Judge: Choe-Groves, J.

Attorneys: Kelly E. Farnan (Richards, Layton & Finger, P.A.) for Cold Spring Harbor Laboratory. Brian E. Farnan (Farnan LLP) for Guardant Health, Inc.

Companies: Guardant Health, Inc.

Cases: Patent DelawareNews