Myriad Genetics sued Ambry Genetics and Gene by Gene, alleging infringement on patent claims covering synthetic DNA and other methods related to testing BRCA1 and BRCA2 genes to aid in assessing cancer risk.

When the U.S. Supreme Court struck down the Myriad Genetics “isolated DNA” patent claims for the BRCA1 and BRCA2 genes on June 13, Ambry Genetics of Aliso Viejo, CA, and Gene by Gene of Houston, TX, immediately launched tests to assess breast cancer risk based on mutations in those genes.

Salt Lake City, UT-based Myriad, which declared on the day of the ruling that it still retains “more than 500 valid and enforceable claims in 24 different patents,” hit back the following month.

On July 9, Myriad sued Ambry in the U.S. District Court for the District of Utah, alleging infringement on claims in 10 patents that cover synthetic DNA and other methods related to the BRCA1 and BRCA2 genes and are not affected by the Supreme Court decision. The following day, the plaintiffs filed a similar suit against Gene by Gene. Both lawsuits sought preliminary injunctions to prevent the sale of products that include BRCA analysis for assessing cancer risk.

Gene by Gene has not issued a public response, but Ambry says it will defend itself vigorously. “We have not infringed any patents,” declares Ardy Arianpour, MBA, Ambry senior vice president for business development. “Our methodology is completely different. We use next-generation sequencing for isolated DNA, which is brand-new technology, especially in the clinic. Ambry does not accept RNA for testing nor do we have any validated protocols for isolating RNA or generating cDNA in our clinical laboratory.”

Patent attorneys point out, however, that the use of new and different technologies does not necessarily avoid infringement.

“Both Gene by Gene and Ambry are correct in saying that they are not doing sequencing the way it was done in 1996,” notes Kevin Noonan, JD, PhD, a partner with McDonnell Boehnen Hulbert & Berghoff LLP in Chicago, IL. “But is the sequencing that they are doing covered by any of the claims that Myriad is asserting? No court has ever construed the scope of those claims.”

“Even though Ambry is doing second-generation sequencing, it might still be infringing the broader methods claims just because of the way the claims are worded,” says Christine Brinckerhoff, JD, a partner with Foley & Lardner LLP in Washington, DC. “It's often the case in patent litigation that the specific way the invention is being used is not described in the patent or wasn't known at the time the patent was filed, but still the patent claims are broad enough to reach what's being done. The court has to figure out if these claims are that broad.”

Brinckerhoff gives the example of patent 5,753,441 claim 8, which covers amplifying BRCA1 DNA from a patient tissue sample for sequencing and subsequent comparison with wild-type BRCA1 DNA. “The claim is very general, and Myriad can argue that no matter how Ambry is doing sequencing, they are using this general method,” she says. “On the other hand, the court could find this claim obvious or not patentable for other reasons.”

More generally, molecular testing providers are analyzing how they can best protect their intellectual property rights. While it's still early days in evaluating the impact of the Supreme Court decision, the general attitude among patent attorneys “is that we can work around these legal decisions and in most cases protect our clients,” says Brinckerhoff. “But if cases get more broadly interpreted, that attitude could change.” The decision does create some uncertainties, which may make outside investors less willing to fund the companies and their research, she speculates.