An Australian company is suing Grail in US federal court, alleging patent infringement, even though it no longer performs the test that Grail’s Galleri test allegedly infringes.
In a complaint filed Sept. 14 in the US District Court for the District of Delaware, Clinical Genomics alleged that Grail’s method of analyzing methylation of cell-free DNA infringes US Patent Nos. 10,590,468 “Method for methylation analysis” and 10,941,449 “Method of screening for colorectal cancer.” Clinical Genomics said it holds an exclusive license to the patents.
In 2016, the company launched a blood-based colorectal cancer test named Colvera, performed at a CLIA lab in New Jersey; however, it does not offer it anymore.
“Although Clinical Genomics is no longer engaged in commercial operations, the methods for detection and analysis of methylation patterns that it developed in collaboration with [Australia’s Commonwealth Scientific and Industrial Research Organisation] CSIRO and Flinders University remain the core science underlying methylation-based circulating tumor DNA cancer detection,” the company wrote in its complaint, “and the Asserted Patents that protect those methods remain in force.”
Clinical Genomics has asked the court for a judgment against Grail and an award of damages as well as for a jury trial.