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Gene by Gene Settles BRCA Patent Infringement Suit with Myriad Genetics, Other IP Owners

NEW YORK (GenomeWeb News) – Gene by Gene and Myriad Genetics today announced that they have reached a settlement in their litigation over BRCA testing patents held by Myriad, the University of Utah Research Foundation, HSC Research and Development Limited Partnership, Endorecherche, and the Trustees of the University of Pennsylvania.

Under the agreement, Gene by Gene will stop selling in North America standalone diagnostic tests that gauge BRCA1/2 genes or tests that include the genes as part of broader diagnostic panels. However, the company will continue selling and marketing these tests outside of North America.

Gene by Gene can also globally provide its whole-genome and exome sequencing products that gauge BRCA genes, as well as its custom array products that assess variants for Mendelian disorders, including variants for BRCA1 and BRCA2.

The agreement between Gene by Gene and the BRCA patent holders will be in effect until Feb. 12, 2016, when the first crop of BRCA patents are slated to expire, or until the last valid BRCA claims expire. "In return, the patent owners have agreed to dismiss the patent infringement case against Gene by Gene without prejudice," the IP holders said in a statement announcing the settlement.

This agreement brings to a close the lawsuit Myriad and the other BRCA patent holders brought against Gene by Gene in July shortly after the US Supreme Court deemed several patent claims on isolated BRCA sequences as patent ineligible. However, the court found that several claims on cDNA were still patent eligible. Although Gene by Gene and several diagnostic firms launched BRCA tests to compete with Myriad's BRACAnalysis test based on this ruling, Myriad and the other BRCA patent holders sued most of these labs claiming that Myriad's tests are protected by a number of still valid claims.

The other labs sued by Myriad for alleged infringement of BRCA testing IP include Ambry Genetics, GeneDx, Quest Diagnostics, and LabCorp. Some of these labs have countersued Myriad and the other BRCA patent holders or have filed for declaratory judgment in their own legal jurisdictions that their BRCA tests aren't infringing Myriad's patents.

In response to being sued last summer, Ambry Genetics countersued Myriad alleging antitrust violations. Gene by Gene joined this countersuit with Ambry in August. As part of this latest settlement, Gene by Gene has dropped the antitrust charges, a Myriad spokesperson said.