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Myriad claims Ambry Genetics and Gene by Gene are violating up to 10 patents related to its signature test, which detects hereditary mutations on the tumor-blocking genes BRCA1 and BRCA2. Myriad is asking two federal judges to stop the companies from selling their tests. Both suits ask for jury trials.
Though the Supreme Court last month declared that companies can't patent genomic DNA, it allowed patents on genes created in the lab, or cDNA, to stand. Myriad argues "the patents at issue in this case are very different than those in the Supreme Court case," spokesman Ron Rogers said, because they deal with methods or are based on synthetic DNA.
Its competitors disagree. Elizabeth Chao, Ambry's chief medical officer, said that company's testing is based on human DNA and those patents are void.
"We don't work with cDNA," she said. "We always knew it was a risk, but we had consulted solid legal counsel ... [who said] we were not in fact violating any of the remaining patents when we chose to go public with this."
For more than a decade, Myriad has been the only company offering the test, which cost about $3,000, though much of that cost is often covered by insurance. It drew headlines in May when actress Angelina Jolie announced she had a proactive double mastectomy after the test found she carried a mutation.
Myriad attorneys say the company has invested more than $500 million to develop the test, and claim that since the introduction of the competing tests, it "has suffered and will continue to suffer substantial damage to its business."
After the Supreme Court ruling, the two genetic testing companies announced they would offer similar tests to patients for at least $1,000 less than Myriad. Chao said Ambry, based in Aliso Viejo, Calif., began receiving samples from customers the day after the ruling was announced.
DNATraits is a division of Houston-based Gene By Gene Ltd. In a statement after the ruling, company president Bennett Greenspan said it is critical to allow healthy competition to drive down the costs of the tests. Rogers disagreed, citing "economy of scale" and pointing to other markets with more competition where prices are higher.
The Ambry case has been assigned to U.S. District Judge Robert Shelby and the Gene by Gene case will be heard by U.S. District Judge Evelyn Furse. No hearings have been scheduled. Along with Myriad, the University of Utah Research Foundation, the University of Pennsylvania, HSC Research and Development and Endorecherche are also plaintiffs.