2 Competitors Sued by Genetics Company for Patent Infringement

By ANDREW POLLACK

Published: July 10, 2013

Myriad Genetics is suing competitors that have begun to offer genetic testing for breast cancer risk after the Supreme Court’s ruling last month that human genes cannot be patented.

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The court’s decision invalidated patents the company had on two genes that, when mutated, meant a woman had a very high chance of getting breast or ovarian cancer.

Within hours of the decision, various companies and academic laboratories announced they would offer tests of those two genes, breaking the hold that Myriad held for nearly two decades. Many of the new tests were less expensive than the roughly $4,000 that Myriad charged for a full analysis of the two genes, BRCA1 and BRCA2.

But Myriad this week sued two of those competitors — Ambry Genetics and Gene by Gene — saying their tests infringed some of the more than 500 other patent claims that were not invalidated by the Supreme Court, for instance, on synthetic DNA used as probes and on methods of testing.

Both suits were filed in Federal District Court in Salt Lake City, where Myriad is based. Myriad is seeking preliminary injunctions to stop the competitors from offering BRCA tests. It is also seeking damages, which could be tripled if the court found that the infringement had been willful.

Still, the companies that offer testing apparently believe that the main patent claims blocking competition were the ones invalidated by the Supreme Court and that they can get around the others.

Ambry, which is based in Southern California, said it would vigorously defend itself. “We have had an overwhelming response from our clients seeking an alternative laboratory to perform BRCA testing, and Ambry is fully committed to support our clients and patients moving forward,” Charles Dunlop, the chief executive of the company, said in a statement.

Gene by Gene, which is based in Houston, could not immediately be reached for comment. Its test costs only about $1,000.

Ronald Rogers, a spokesman for Myriad, would not say whether additional lawsuits were planned.

Myriad’s new lawsuits could arouse more anger from plaintiffs in the earlier suit, who claimed that Myriad’s monopoly was impeding research and denying women testing options. Those plaintiffs included medical societies, researchers and patients.

Perhaps to soften the blow, Myriad issued a formal pledge this week that it would not impede noncommercial academic research or prevent labs from doing a test to confirm a result provided by Myriad.

Myriad was joined in its new lawsuits by the University of Utah and three other organizations that receive royalties from Myriad for BRCA-related patents they licensed to the company.