



When the Supreme Court handed down its ruling on contested patents held by Myriad Genetics in June, saying that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring,” several commentators said they were left somewhat confused.

But perhaps no one is more confused than Ambry Genetics and Gene by Gene, which this week were slapped with lawsuits alleging that they had infringed on patents held by Myriad related to screening for the BRCA1 and BRCA2 genes after the June 13 ruling was made.

Along with co-plantiffs the University of Utah, the University of Pennsylvania, the Hospital for Sick Children, and Endorecherche, on July 9 Myriad filed a lawsuit in the United States District Court for the District of Utah against Ambry alleging infringement of claims in patents covering synthetic DNA and methods-of-use related to the BRCA1 and BRCA2 genes.

In particular, the suit alleges that “the testing process employed by Ambry infringes claims in 10 patents owned or licensed by the Patent Owners covering synthetic primers, probes and arrays, as well as methods of testing, related to the BRCA1 and BRCA2 genes,” according to an 8-K filed with the U.S. Securities and Exchange Commission by Myriad on that same day. The suit, Myriad continued in its filing, specifically pertains to Ambry’s BRCAplus, BreastNext, OvaNext, and CancerNext tests. Myriad said the collective patent owners are seeking up to treble damages for any profits they have lost “as a result of a finding that Ambry’s infringement is willful.”

Separately, the same group of plaintiffs is suing Houston, TX-based genetic testing firm Gene by Gene. In a suit filed in the same court on July 10, Myriad et al. said Gene by Gene “is infringing, contributing to the infringement of, and/or inducing others to infringe” on claims related to its BRCA1 and BRCA2 patents—originally issued May 1998—and that they have “suffered and will continue to suffer substantial damage to its business, including, without limitation, lost profits, loss of business reputation, loss of business opportunities, and loss of market share, by reason of [the] defendant’s acts of patent infringement as alleged herein.”

In an email statement made to GEN, Myriad spokesperson Ronald Rogers said that last month’s Supreme Court decision “affirmed the patent eligibility of synthetic DNA and underscored the importance and applicability of method-of-use patents for gene-based diagnostic tests.” He added that the suits filed against Ambry and Gene by Gene show that the testing processes employed by the firms “infringes 10 patents covering synthetic primers, probes and arrays, as well as methods of testing, related to the BRCA1 and BRCA2 genes.”

Ambry has issued a statement of its own, with CEO Charles Dunlop saying the company would “vigorously defend its position.”

“We have had an overwhelming response from our clients seeking an alternative laboratory to perform BRCA testing and Ambry is fully committed to supporting our clients and patients moving forward,” Dunlop said.



























