Myriad Genetics ($MYGN) and rival Gene By Gene put to rest their patent infringement fight over BRCA gene testing, though Myriad is continuing to battle other competitors over the same issue.
The essence of the deal: Texas-based Gene By Gene won't sell or market tests in North America that cover the analysis of BRCA1 and BRCA2 as a standalone test, or along with gene panels, according to Myriad's disclosure. But the company can keep selling the products outside of North America. Myriad, the University of Utah Research Foundation, HSC Research and Development Limited Partnership, Endorecherche and the Trustees of the University of Pennsylvania hold the patents in question.
At the same time, Gene By Gene can keep offering whole genome and exome products in North America and globally (some include BRCA genes), plus the company's tests that screen variants for inherited Mendelian disorders (some include BRCA1 and BRCA2 variants).
Blame the U.S. Supreme Court for the dustup. Last summer, it ruled that genes found in nature could not be patented, but affirmed that genes altered by man faced no such restrictions. Utah-based Myriad Genetics had tried to assert patent exclusivity for both BRCA1 and BRCA2 mutations. They form the basis of its market-leading BRACAnalysis test, which helps predict the risk of breast and ovarian cancer and is a significant revenue driver.
The Supreme Court decision left Myriad with a mixed outcome. A number of companies including Gene By Gene launched their own BRCA predictive cancer tests in the wake of the ruling. Myriad sued Gene By Gene, alleging patent infringement, and then Gene By Gene countersued, alleging that Myriad was trying to monopolize the BRCA market. Myriad had claimed that Gene By Gene violated patents owned by Myriad and its partners involving synthetic DNA and method of use relating to BRCA1 and BRCA2 genes, Myriad said.
Myriad rivals LabCorp ($LH), Invitae, Quest Diagnostics ($DGX), BioReference Laboratories ($BRLI) and Ambry Genetics also launched competing BRCA tests. Myriad's patent lawsuits against all of them remained in force as of this writing.
- read the Myriad release
- here's GenomeWeb Daily News' take (reg. req)
- check out MedCity News' coverage