Ambry Genetics started offering diagnostic testing for BRCA gene mutations, which show an increased risk of breast and ovarian cancer, after the US Supreme Court ruled that Myriad's patents over isolated sequences of the BRCA1 and BRCA2 genes were invalid (reported in BioNews 709) . Myriad filed a claim last July for patent infringement against Ambry (reported in BioNews 713), however, arguing that the company had infringed ten remaining patents associated with the tests. Ambry responded by filing an anti-trust counterclaim against Myriad.
A US federal district court this month rejected Myriad's application for a preliminary injunction saying that it had failed to establish that it is likely to succeed in its claim. District Judge Robert Shelby said: 'The court concludes plaintiffs are not entitled to the extraordinary remedy of a preliminary injunction to halt the defendant from selling its own BRCA1 and BRCA2 genetic tests'.
Commenting on the ruling, Ambry's CEO, Charles Dunlop, said: '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'.
The ruling allows Ambry and other competitors to market BRCA testing products pending a full trial in the US District Court in Utah. Myriad said it was confident that it would prevail based on the full evidence. A date for the trial has not yet been set.
'It is important to maintain perspective', Myriad spokesperson Ron Rogers told GenomeWeb Daily News. 'The ruling is a denial of the preliminary injunction only and it isn't a ruling on the underlying merits of the case. We remain in the early stages of the litigation and look forward to presenting our case in court'.
Judge Shelby also drew attention to Myriad's business practices, highlighting Myriad's policy of keeping information about crucial gene variants in a private database. 'In doing so, Myriad distorts rather than serves the patent system's goal of public disclosure in exchange for exclusive rights', the judge said. 'In this way, Myriad has chosen a commercial path that turns much of our patent system policy on its head'.
In a telephone interview with Bloomberg, Rogers said that the company 'did not block or hinder research; in fact the opposite is true'. 'A strong patent system made that all possible', he said.
Another company sued by Myriad and others for infringing its BRCA related patents, Gene by Gene, reached a settlement with Myriad last month and agreed to stop the sale of its sequence-based test in North America - although Gene by Gene can still provide BRCA related information to customers using its broader whole genome test, reports GenomeWeb BioArray News.
Myriad is also suing other companies who have entered the market with BRCA testing products, including LabCorp, Quest Diagnostics, and GeneDx. According to Reuters, Myriad's shares were down 12 percent by the end of the Tuesday following news of the ruling.