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GeneDx, Myriad Settle BRCA Patent Litigation

NEW YORK (GenomeWeb) – BioReference Laboratories subsidiary GeneDx has settled litigation with Myriad Genetics and other co-owners of patents related to BRCA testing, a Myriad spokesperson told GenomeWeb.

In June 2013, the US Supreme Court decided in Association for Molecular Pathology et al. v Myriad that isolated gene sequences were patent ineligible, but synthetic or cDNA — when the gene sequences don't match those occurring in DNA segments in the body — were patent eligible. Following this ruling, a number of labs including GeneDx launched BRCA tests that competed with Myriad's tests. However, Myriad sued these firms arguing that the Supreme Court's decision still upheld the validity of IP that competing labs were allegedly infringing.

With regard to a case against Ambry Genetics, Judge Robert Shelby of the US District Court for the District of Utah denied Myriad's request for a preliminary injunction last March. At this point, several of the lawsuits Myriad was engaged in with labs performing BRCA testing were consolidated under a single banner.

Myriad challenged Shelby's decision to not grant an injunction against Ambry with the US Court of Appeals for the Federal Circuit. The appeals court in December upheld the lower court's decision and determined that claims in three patents underlying Myriad's BRACAnalysis test that the firm was asserting against competitors were patent ineligible.

Since then, Myriad has settled ongoing lawsuits with Laboratory Corporation of America, Ambry, Counsyl, Pathway Genomics, Invitae, Quest, and now GeneDx. In a statement to GenomeWeb, Myriad noted that all seven of its cases are now settled, "which ends the BRCA litigation."

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