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Myriad Settles BRCA Patent Case with Quest; Only GeneDx Lawsuit Remains

NEW YORK (GenomeWeb) – Quest Diagnostics and Myriad Genetics have settled their patent dispute related to BRCA testing.

Myriad along with its co-patent holders and Quest have agreed to "dismiss their lawsuits, claims, counterclaims, and disputes related to Myriad's patent claims on BRCA1 and BRCA2 in the litigation," Quest said in a statement today.

On October 2013, Quest filed a lawsuit against Myriad in the Central District of California asking for declaratory judgment that it wasn't infringing 14 patents owned or exclusively licensed to Myriad. A few weeks later, Myriad countersued Quest alleging patent infringement in the US District court for the District of Utah.

Around this time, Quest had launched a next-generation sequencing testing service, called BRCAvantage, which aimed to help doctors assess their patients' risk of breast and ovarian cancer based on whether they carried mutations in BRCA1/2 genes. Under the terms of the settlement with Myriad, Quest is free to sell its BRCAvantage and other BRCA-related testing services, and develop additional testing products based on the patents asserted by Myriad in the lawsuit.

"We … look forward to continuing to develop new innovations that provide patients with insight into their genetic risk of cancer, so they can take actions to safeguard their health," Jon Cohen, senior VP of Quest's diagnostic solutions business, said in a statement. 

As part of the settlement, Myriad also provided Quest, its customers and business partners, "a covenant not to sue with respect to the patents at issue." Myriad spokesperson Ron Rogers explained that this part of the settlement addresses patent claims at issue that may not have been invalidated by the Supreme Court or by subsequent district court litigations. But based on the similarity of those remaining patent claims to the ones already invalidated or based on the expiration of these patents, Myriad decided that it was in the best interest of the company to settle the lawsuit once and for all, Rogers 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 Quest 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 infringing.

Gene by Gene was the first lab sued by Myriad and last February became the first to settle its dispute out of court. With regard to the 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 it was asserting against competitors were patent ineligible.

Since then, Myriad has settled six out of seven ongoing lawsuits with the Laboratory Corporation of America, Ambry, Counsyl, Pathway Genomics, Invitae, and now with Quest.

There has not yet been any announcement with regard to GeneDx. Myriad sued BioReference Laboratories, GeneDx's parent firm, in 2013, alleging infringement of 16 patents underlying its hereditary cancer risk tests. GeneDx's lawyers last year filed petitions for inter partes review, challenging the validity of the patents with the US Patent and Trademark Office.

Rogers declined to provide a timeline for when this case might be settled.

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