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Federal Appeals Court Upholds BRCA1/2 Decision Against Myriad Genetics

NEW YORK (GenomeWeb News) – The US Court of Appeals for the Federal Circuit today upheld an earlier decision denying Myriad Genetics' request for an injunction against Ambry Genetics to prevent it from marketing a BRCA1 and BRCA2 gene test.

The US District Court for the District of Utah denied Myriad's motion for a preliminary injunction in March. In addition to Myriad, the plaintiffs in the case are the University of Utah Research Foundation, the Trustees of the University of Pennsylvania, Hospital for Sick Children Research and Development Limited Partnership, and Endorecherche.

In its decision, the appeals court essentially ruled that three patents — US Patents No. 5,753,441; No. 5,747,282; and No. 5,837,492 — which cover Myriad's BRACAnalysis test, should not have been issued and "the district court properly denied Myriad's motion for preliminary injunction." Specifically, the court said today that certain claims contained in the three patents covering primers and methods are patent ineligible.

"We are disappointed with the Court's ruling," Myriad said in a statement emailed to GenomeWeb. "We currently [are] reviewing the decision and will consider all our options."

Ambry CEO Charles Dunlop said in an email, "I knew intellectually that we were right, and our basic arguments were correct. I have cancer, and I could not believe – I found it offensive, actually – that somebody with cancer would not have options for genetic testing.  Because we believed our position was correct under the law, we decided move forward and defend Ambry from Myriad’s claims."

Myriad and the other plaintiffs originally sued Ambry in July 2013 alleging the Aliso Viejo, Calif.-based firm's BRCA testing process for gauging mutations in BRCA1/2 associated with breast and ovarian cancer risk infringed a total of 10 patents owned or licensed by them. The lawsuit followed a decision by the US Supreme Court a month earlier that human genes cannot be patented but synthetic DNA, or cDNA, is patent eligible because it does not occur naturally.

After the SCOTUS decision, a number of competitors launched their own BRCA1/2 tests. Myriad and its fellow plaintiffs responded by suing them, accusing them of patent infringement. Along with Ambry, other firms that Myriad has sued include Laboratory Corporation of America, Quest Diagnostics, GeneDx, InVitae, and Gene by Gene.

In February, Gene by Gene settled its dispute with Myriad.