"Myriad Genetics, which lost a closely watched Supreme Court case last year involving the patenting of genes, has suffered another setback in its efforts to protect its main genetic test from competition.
A federal judge on Monday denied Myriad’s request for a preliminary injunction that would have immediately stopped a rival company, Ambry Genetics, from offering a similar test.
Myriad’s lucrative monopoly on testing for mutations in two genes linked to breast cancer risk was shattered last June by the Supreme Court’s ruling that genes were not eligible for patents because they were products of nature.
Several laboratory companies, including Ambry, quickly began offering tests, in most cases undercutting the $4,000 Myriad charged for a full analysis of the two genes, which are known as BRCA1 and BRCA2. Ambry announced a price of $2,200.
Myriad sued most of these companies, contending their tests infringed other patent claims that were not invalidated by the Supreme Court.
But Judge Robert J. Shelby of the United States District Court in Salt Lake City said in an opinion on Monday that Ambry had raised “substantial questions” concerning whether those remaining claims were eligible for patents. He said therefore that Myriad had not established that it was likely to succeed in the case on the merits of its arguments, which is a legal requirement to win a preliminary injunction.
The upshot is that Ambry can continue to offer its test pending the outcome of a trial or a settlement, said Dr. Robert M. Cook-Deegan, a research professor at Duke University who has closely followed the case and the issue of gene patents.
Charles Dunlop, chief executive of Ambry, called the ruling “a victory for the entire genetics community.” He said in a statement that Myriad’s lawsuit, after last year’s Supreme Court decision, “was a blatant attempt to maintain a monopoly state. We idealistically stood by our convictions throughout this process and are exhilarated by today’s ruling.”
Ronald Rogers, a spokesman for Myriad, said Myriad looked forward to presenting its case in court. Monday’s ruling, he said in an email, “is a denial of the preliminary injunction only” and “isn’t a ruling on the underlying merits of the case.”