This story has been updated to include comment from Exact Sciences.
NEW YORK – Geneoscopy said Friday that it has petitioned the US Patent and Trademark Office for inter partes review challenging the patentability of Exact Sciences' patent No. 11,634,781, which is at the heart of a lawsuit filed by Exact against Geneoscopy last November.
Geneoscopy said it moved to dismiss the suit in its entirety in December. The company's new inter partes review petition argues that the claims of the ’781 patent, titled "Fecal Sample Processing and Analysis Comprising Detection of Blood," are not inventive.
Exact's patent describes the preparation of stool samples for colorectal cancer testing, which includes removal of one portion of a fecal sample, adding a buffer to prevent denaturation of blood proteins, performing a test to detect these blood proteins in the sample portion, and then stabilizing the remaining stool sample for further genomic testing.
Geneoscopy argued that the fecal tests for detecting blood protein and nucleic acids cited in the patent were known and routine at its filing. As such, "the method claimed by the '781 patent amounts to no more than the routine use of standard methods to prepare a fecal sample for the performance of well-established complementary diagnostic assays," the company said in a statement.
Geneoscopy has positioned its ColoSense assay, which is still in development, as the first major competitor to Exact Sciences' Cologuard. Last year, it published results of its CRC-PREVENT trial, showing high sensitivity for the detection of both cancer and precancerous lesions.
"With the goal of expanding cancer screening options and improving outcomes for millions of patients, Geneoscopy seeks to ensure that Exact Sciences does not foreclose innovation and advancement in the field of cancer detection by claiming exclusive rights to diagnostic methods it did not invent," Geneoscopy CEO and Cofounder Andrew Barnell said in a statement.
Exact sciences responded in a statement that Geneoscopy’s position is the firm's second attempt to challenge this patent and "avoid answering for its infringement."
"We are confident in the strength of our intellectual property and that the Patent Office will once again reject Geneoscopy’s challenge and affirm the ‘781 patent," the company said.