Myriad suffers setback in attempt to block Ambry BRCA test
Genetic diagnostic company Myriad Genetics and other patent holders have been denied a motion for a preliminary injunction that would have kept rival company Ambry Genetics from selling its own test for the BRCA gene mutations that put women at risk of developing breast and ovarian cancer.
On March 10, Robert Shelby, a judge at the US District Court for the District of Utah, said that Myriad is not entitled to the remedy of preliminary injunction, and that it was unable to establish that it was likely to succeed on the merits of its claims.
While Myriad had shown it was likely to suffer “irreparable harm” if Ambry continues to offer its cheaper BRCA test, Ambry raised “substantial questions” about whether the claims at issue are patent eligible, he said.
In June last year, the US Supreme Court invalidated a number of Myriad’s patent claims directed to BRCA testing after it decided that genes are not patent eligible “simply because they have been isolated from the surrounding genetic material”.
Soon after the judgment, a number of genetic testing companies, including Ambry, started offering similar tests with a lower price tag. Myriad had been offering its BRCA test for $4,040; Ambry’s cost $2,200.
Myriad filed for a preliminary injunction against Ambry in July to stop it marketing the test, also arguing that it infringed ten of Myriad’s patent claims that were not invalidated in the Supreme Court ruling.
Four of the claims were directed to primers, or pairs of synthetic DNA strands, and six of the claims related to methods for analysing BRCA1 and BRCA2 sequences.
Ambry’s chief executive Charles Dunlop said on March 10: “Today’s win is a victory for the entire genetics community. We’ve all believed for years that products of nature should not be patentable and were thrilled with the Supreme Court ruling in June 2013 affirming this principle.
“We stood by our convictions after Myriad sued Ambry and are exhilarated by today’s ruling.”
A spokesperson for Myriad told LSIPR that the court’s ruling was not unexpected: “The court did not rule on the merits of the case – that will be decided later,” he said.
“Myriad is still in the early stages of litigation and is confident it will prevail based on the strength of the evidence,” he added. “Myriad continues to believe its patents are valid and enforceable.”
