A technician loads patient samples into a machine for testing at Myriad… (Douglas C. Pizac / Associated…)
A small O.C.-based company that rushed to offer genetic testing for breast cancer risk, fresh out of a Supreme Court ruling that human genes can’t be patented, is now caught in a new legal battle over its methodology.
Ambry Genetics and Houston-based Gene by Gene were sued by Myriad Genetics Inc. this week for their methods in analyzing potential cancer-causing mutations in two genes, BRCA1 and BRCA2.
“The testing process employed by Ambry and Gene-by-Gene infringes ten patents covering synthetic primers, probes and arrays, as well as methods of testing, related to the BRCA1 and BRCA2 genes,” Myriad said in a statement.
Myriad Genetics, in Salt Lake City, held patents on both genes and a monopoly on testing for the genes. However last month’s Supreme Court decision changed that after it ruled that human genes cannot be patented and held for profit, opening the doors for other companies to conduct the test.
In fact, hours after the high court’s decision, both companies being sued released statements saying they would offer BRCA1 and BRCA2 testing. The test also gained popularity following Angelina Jolie’s announcement that she underwent a double mastectomy after learning she had a mutation.
The lawsuit claims Myriad suffered and will continue to suffer substantial damage to its business and reputation as a result of the patent infringements.
However, this week’s lawsuit has nothing to do with the Supreme Court’s decision, said Ron Rogers, spokesman for Myriad Genetics.
“We believe the testing process employed by Ambry and Gene by Gene are infringing on the patents covering the testing process,” Rogers said.
Myriad Genetics was joined in both lawsuits, filed in federal court, by the University of Utah, trustees of the University of Pennsylvania, HSC Research and Endorecherche Inc. The company is also seeking a preliminary injunction, which could take 120 days, to stop Ambry and Gene by Gene from offering the tests.
Kate Croft, spokeswoman for Gene by Gene, said the company wasn’t commenting on the lawsuit.
However Ambry Chief Executive Charles Dunlop said his company would defend itself.
“I was shocked at the lawsuit’s merits,” Dunlop said. “These companies claimed they owned our genes and even worse that they owned the right to diagnose what’s happening to our genes. That offends me.”
The privately held company was established in 1999 and employs 200 people. Since the Supreme Court’s ruling, testing for the mutations is about 10% of all their analysis, said Dunlop, adding they do hundreds of tests daily.
“We’ve taken a chunk of their business overall,” Dunlop said.
[Update, July 11, 4:18 p.m.: Ardy Arianpour, senior vice president of Ambry, said his company's testing methods do not infringe on any of Myriad's cDNA patents. Their methods utilize isolated genomic DNA and any primers or probes used are identical to those sequences found in nature, making them patent ineligible.]
Ambry charges about $2,200 for the test and Gene by Gene’s costs about $1,000. Myriad’s has a $4,000 price tag, but the company argues patients would be mostly covered through insurance plans, Medical and Medicare.
Rogers said he couldn’t speculate on whether Myriad would file additional lawsuits. The company released a pledge stating it would not go after noncommercial academic researchers using their patents and laboratories confirming a test result provided by Myriad.
[For the record, July 11, 4:18 p.m.: A previous version of this post said Ambry employed 2,000 people, it employs 200. It also incorrectly referenced Ambry as Ambien.]