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Geneoscopy Countersues Exact Sciences Over Patent Central to Cologuard

NEW YORK – Geneoscopy announced Monday that it has filed a lawsuit against Exact Sciences in federal court in Delaware in relation to a patent that is central to both companies' colorectal cancer screening tests.

The suit, filed June 28, counters a previous lawsuit filed by Exact against Geneoscopy, and includes claims of breach of contract, misappropriation of trade secrets, unfair competition, and other violations of state and federal law that Geneoscopy accuses Exact Sciences of having committed.

Geneoscopy seeks compensatory and punitive damages, payment of its attorneys' fees, and other legal and equitable remedies.

"We are taking action due to Exact Sciences' continued wrongful and malicious conduct, including the misappropriation of our proprietary information and trade secrets," Andrew Barnell, CEO and cofounder of Geneoscopy, said in a statement.

Also on June 28, Exact Sciences filed a motion for preliminary injunction against St. Louis-based Geneoscopy, seeking to bar it from making, using, selling, or offering for sale within the US its ColoSense colorectal screening test or any related product that is "not colorably different" from it, according to the legal filing.

Exact's filing "in no way affects our confidence in the strength of our intellectual property," Barnell said in a statement, adding that the company is "on track" with the commercial launch timeline for ColoSense, an RNA biomarker assay that was approved by the US Food and Drug Administration in May.

The US District Court for the District of Delaware had previously denied Geneoscopy's motion to dismiss the patent infringement lawsuit filed against it by Exact Sciences, which had alleged that Geneoscopy infringed US Patent No. 11,634,781, a central component to Exact's Cologuard assay.

Separately today, Geneoscopy noted that it also petitioned the US Patent and Trademark Office for an inter partes review challenging the patentability of the '781 patent. In its petition, it comments that "nothing in that patent is inventive. Separating a fecal sample so it can be tested for both blood proteins and nucleic acids is reported throughout the prior art. Moreover, fecal tests for detecting blood protein and nucleic acids, as recited by the claims, are standard, and the patent purports to claim only routine methods for preparing a fecal sample for the performance of well-established complementary diagnostic assays."