Mindful that Myriad Genetics ($MYGN) is suing two rivals over alleged violations of its BRCA diagnostic patents, Quest Diagnostics ($DGX) is preemptively pursuing court action to seek a ruling that its new test in the space doesn't cross a legal red line.
Genome Web and Patent Docs reported on the news, among others. The Wall Street Journal reported on Oct. 15 that the test has hit the market, and it's at a discount to Myriad's offering.
It's yet another sign of the upheaval the diagnostics industry has faced since the U.S. Supreme Court upheld some of Myriad's patent claims and vacated others. Myriad had argued that it had legitimate patents regarding the isolation of BRCA1 and BRCA2 genes for hereditary breast and ovarian cancers, which enabled a predictive test that measures breast cancer risk. That ruling established, in part, that human genes are products of nature and can't be patented, but manmade gene variations were fair game.
In the immediate aftermath, a number of companies, including Quest, said they would produce diagnostic tests involving BRCA1 and BRCA2 genes. Quest said it wants the U.S. District Court for the Central District of California to determine that its test doesn't violate as many as 14 patents relating to Myriad's testing of BRCA1 and BRCA2 genes, according to the Genome Web story, because Quest will be launching a two-part test designed to detect hereditary mutations in both BRCA1 and BRCA2.
In these litigious times, better safe than sorry. In July, Myriad sued Houston's Gene By Gene in a patent-infringement case alleging that the company violated 9 patent claims involving the testing process when it began to offer BRCA1 and BRCA2 tests on June 13, hours after the Supreme court quashed 5 of Myriad's patents involving isolated genes. Myriad and its fellow patent holders are suing Ambry Genetics over the same issue. In both cases, Myriad wants its rivals to stop selling the tests and is demanding damages and royalties.
At the same time, Ambry is countersuing Myriad, alleging that the company is violating the Sherman Antitrust Act by trying to stop competitors from offering analysis of BRCA1 and BRCA2 genes over claims the Supreme Court already shot down.
Wendy Bost, director, Media Relations, Quest Diagnostics, explained to FierceDiagnostics via email that the company took legal action "to ensure our BRCAvantage offering is broadly available in the United States so that patients and clinicians will have access to this new and unique BRCA option."
Quest noted in a statement to the WSJ that its new test includes a free service for both patients and physicians to helpl quicken their efforts to obtain insurance reimbursement.
Myriad said it had not received the Quest complaint and would not comment on its legal argument. But the company said in a statement: "We continue to believe that patent claims related to BRCA1 and BRCA2 gene testing are valid and enforceable. Myriad and the other owners of the BRCA patents at issue--including the University of Utah, the Hospital for Sick Children, Endorecherche, Inc., and the Trustees of the University of Pennsylvania--are prepared to defend our intellectual property rights."
Editor's note: This story has been updated to include references to coverage from The Wall Street Journal noting that Quest's new test has hit the market. Myriad's statement has also been added, as well as comments from Quest.