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Myriad Sues Pathway for BRCA Testing; Pathway Readying Defense

NEW YORK (GenomeWeb) – Myriad Genetics sued Pathway Genomics on June 13 for infringement of its patent claims underlying BRCA1 and BRCA2 genetic testing.

San Diego-based Pathway issued a statement today stating that it will "vigorously defend" itself against that suit. The legal challenge was spurred by Pathway's launch earlier this month of a next-generation sequencing test for gauging alterations in BRCA1 and BRCA2 genes, called BRCATrue.

Pathway's BRCATrue performs sequencing and deletion/duplication analysis of BRCA1 and BRCA2 genes associated with breast, ovarian, and other types of cancers.

Myriad's BRACAnalysis test, utilizing Sanger sequencing and PCR, also gauges BRCA1/2 alterations. The company has also launched an NGS-based test, called myRisk Hereditary Cancer.

Myriad has taken similar legal actions against a number of other labs that launched BRCA1/2 testing following the US Supreme Court's decision in Association for Molecular Pathology vs. Myriad a year ago. In that ruling, the court struck down several of Myriad's claims drawn to naturally occurring DNA sequences. However, the court also held that complementary DNA was not naturally occurring and could be patented when its sequences didn't match genomic DNA sequences in the body.

Ambry Genetics, Laboratory Corporation of America, Quest Diagnostics, Gene by Gene, and GeneDx are among the other labs sued by Myriad for alleged infringement of its BRCA patent claims.

In the case against Ambry, a US federal district court in Utah denied Myriad and other patent holders' request for a preliminary injunction against Ambry to stop it from performing and selling tests that gauge BRCA genetic mutations.

"The court concludes plaintiffs are not entitled to the extraordinary remedy of a preliminary injunction to halt defendant from selling its own BRCA1 and BRCA2 genetic tests," Robert Shelby, district judge in the US District Court for the District of Utah, wrote in the ruling in March. "Although plaintiffs have shown that they are likely to suffer irreparable harm through erosion of their test pricing structure, loss of their share of the testing market, and loss of their exclusive patent terms if an injunction does not issue, defendant has raised a substantial question concerning whether plaintiffs' primer and method claims are directed toward patent eligible products of nature and abstract ideas under 35 U.S.C. § 101."

Myriad has said that the ruling from the Utah court is only a denial of a preliminary injunction and doesn't speak for the merits of its charges of infringement against Ambry.

Gene by Gene has settled the dispute with Myriad out of court.

Meanwhile, the US Patent and Trademark Office has issued guidelines to its examiners on how to apply the Supreme Court's rulings in AMP v. Myriad and Mayo v. Prometheus. Both decisions have implications for labs in terms of what is required to transform a naturally occurring principle or abstract idea into patent eligible subject matter.

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