Gene by Gene and the owners of patents related to BRCA gene testing—a group that includes Myriad Genetics—said today they settled their infringement lawsuit, with Gene by Gene agreeing to stop offering the tests in North America for up to two years.
In the settlement, Gene by Gene agreed to cease selling or marketing clinical diagnostic tests within North America that include analysis of the BRCA1 and/or BRCA2 genes, either alone or with gene panels. Gene by Gene can, however, continue offering such tests everywhere else in the world.
The halt on North American testing will run until either February 12, 2016, or when the last valid patent claim of any of the BRCA patents involved in the case expires, whichever comes first.
In return, the BRCA patent owners agreed to dismiss the patent infringement case against Gene by Gene without prejudice. The group of BRCA patent owners also agreed that Gene by Gene may continue offering worldwide its whole genome and exome products and services. These include the BRCA genes as well as custom array products that test variants for inherited Mendelian disorders, including variants for BRCA1 and BRCA2.
In papers filed July 10, 2013, at U.S. District Court for the District of Utah, Central Division, Myriad contended that Gene By Gene and a second provider of gene testing services, Ambry, had infringed on 10 of 24 patents covering synthetic primers, probes, and arrays, plus testing methods related to BRCA1 and BRCA2.
Myriad owns five of the 10 patents and licenses the rest from the rest of the group, which were its co-plaintiffs in the case—University of Utah, University of Pennsylvania, Toronto’s Hospital for Sick Children, and Canadian company Endorecherche.
The lawsuit came about a month after the U.S. Supreme Court’s June 13, 2013 decision in Association for Molecular Pathology (AMP) v. Myriad Genetics, in which the high court unanimously overturned seven of Myriad Genetics’ 24 patents related to its discovery of the precise location and sequence of breast cancer susceptibility genes BRCA 1 and 2.
The high court also held that companies can patent composite DNA (cDNA) and other synthetic genetic material that does not meet the “product of nature” exemption from patentability.
Gene by Gene and Ambry were among a half-dozen companies sued by Myriad for continuing to offer BRCA tests; the others included GeneDx, Invitae, LabCorp, and Quest Diagnostics.