Update: Despite the U.S. Supreme Court ruling last year year, BRCA gene testing has continued to be an issue in the courts. But a patent infringement case between Myriad Genetics (Nasdaq: MYGN) and GenebyGene has been resolved and offers some guidance on the potential outcome of other cases in which Myriad is embroiled.
The terms of the settlement call for GenebyGene to stop selling or marketing “clinical diagnostic tests that include analysis of the BRCA1 and/or BRCA2 genes as a standalone test or in conjunction with gene panels within North America.”
Update: It does free the company to offer these tests in markets outside North America. In addition, the company can continue to offer, anywhere, its whole genome and exome products and services, and custom array products that test variants for inherited Mendelian disorders, including variants for BRCA1 and BRCA2.
The BRCA gene-based tests are to help assess the risk of having an inherited form of breast cancer. GenebyGene had marketed and sold its BRCA tests in markets outside the U.S. since 2012.
The agreement is due to expire February 12, 2016, or the last-to-expire valid patent claim in any of the BRCA patents involved in the case.
Another factor that is likely to impact other cases is the reimbursement rate for tests of the BRCA gene. The Centers for Medicare and Medicaid cut the reimbursement rate in half to $1,440 at the start of the year compared with $2,795 in 2013.
Among the companies Myriad has filed lawsuits against over the BRCA test are Quest Diagnostics, Labcorp and InVitae. Myriad has sued these companies, claiming their tests infringe on its 11 patents spanning tests for BRCA and MUTYH. The patents are held by Myriad and it has shared them with University of Utah Research Foundation and the Trustees of the University of Pennsylvania, among others.
