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Utah Court Dismisses Two More BRCA Testing Patent Lawsuits against Labcorp, Ambry

NEW YORK (GenomeWeb) – Myriad Genetics, Laboratory Corporation of America, and Ambry Genetics have decided to settle BRCA testing IP litigation and the lawsuits have been dismissed by an Utah court.

Judge Robert Shelby of the US District Court for the District of Utah signed a court order dismissing University of Utah Research Foundation, et al v. Labcorp and University of Utah Research Foundation et al v. Ambry. The parties have agreed to drop their claims and counterclaims against one another. In a statement issued yesterday, Ambry noted that Myriad and other patent owners “grant a covenant to not sue Ambry under the patents asserted in the litigation proceedings.”

GenomeWeb previously reported that the parties in Invitae v. University of Utah Research Foundation et al had settled litigation between them regarding testing of BRCA1/2 genes and MUTYH genes. And last Friday, Myriad and Pathway Genomics, also embroiled in a BRCA testing lawsuit, dropped their claims and counterclaims against each other.

The cases involving Labcorp, Ambry, and Invitae, according to the order signed by Shelby, were dismissed with prejudice. University of Utah Research Foundation, et al v. Pathway was dismissed without prejudice.

A dismissal with prejudice means that the court's determination is final and the plaintiff cannot sue the defendant again based on the same claims. When a court dismisses a case without prejudice, the plaintiff can sue the defendant again based on the same grounds if the terms of the settlement aren't followed. For each of these cases, the parties have not made public the terms of the settlements.

Myriad sued labs performing BRCA testing after the US Supreme Court ruled in 2013 that isolated gene sequences were patent ineligibile, but held that cDNA – when the sequence isn't the same as naturally occurring DNA sequences – were patent eligible. Myriad maintained that based on this decision, its BRCA testing patent claims covering primers and diagnostic methods were still valid.

Gene by Gene was the first lab sued by Myriad and the first to settle its dispute out of court last February. Under that agreement, Gene by Gene had to stop selling standalone diagnostic tests that gauge BRCA1/2 genes or tests that include the genes as part of broader diagnostic panels in North America. However, the company could still sell these tests outside of North America, its custom arrays for Mendelian disorders, as well as whole-genome and exome sequencing tests that assess BRCA genes. The agreement is effective until 2016, when the first set of BRCA patents are slated to expire, or until the last valid BRCA claims expire.

As of this article, no announcement had been made as to the status of the other cases that Myriad is involved in with GeneDx, Quest, and Counsyl.

Ambry was also among the first labs sued by Myriad in July 2013. In March 2014, Judge Shelby denied Myriad's request for a preliminary injunction against Ambry. At this point, several of the lawsuits Myriad was engaged in with labs performing BRCA testing were consolidated under a single banner – In Re: BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation.

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 it was asserting against competitors were patent ineligible.

The spate of case dismissals and settlements follow the federal appeals court's ruling. For the time being, it's unclear whether the cases involving GeneDx, Quest, and Counsyl will follow the same path.