BRCA patent owners and Gene by Gene resolve patent suit

Gene by Gene and Myriad Genetics, the University of Utah Research Foundation, HSC Research and Development Limited Partnership, Endorecherche, and the Trustees of the University of Pennsylvania have reached an agreement to settle the patent infringement lawsuit between them regarding BRCA testing.

Under the agreement and effective immediately, Gene by Gene will cease selling or marketing clinical diagnostic tests within North America that include analysis of the BRCA1 and/or BRCA2 genes as a standalone test or in conjunction with gene panels, but Gene by Gene will continue to offer such tests outside of North America.

The Parties have also agreed that Gene by Gene may continue to offer its whole genome and exome products and services, which include the BRCA genes, as well as Gene by Gene’s custom array products that test variants for inherited Mendelian disorders, including variants for BRCA1 and BRCA2, worldwide.

The agreement will continue until the earlier of February 12, 2016 or the last-to-expire valid patent claim in any of the BRCA patents involved in the case. In return, the Patent Owners have agreed to dismiss the patent infringement case against Gene by Gene without prejudice.

This settlement effectively ends the suit that was filed July 10, 2013, in which the Patent Owners alleged that the testing process employed by Gene by Gene infringes certain claims in patents owned by the Patent Owners covering synthetic DNA and methods-of-use related to the BRCA1 and BRCA2 genes.