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Myriad Sues Quest over BRCA1/2 Patents

NEW YORK (GenomeWeb News) – Myriad Genetics yesterday filed a suit against Quest Diagnostics alleging patent infringement, the fourth lawsuit Myriad has filed against a competitor following a US Supreme Court ruling on patents covering BRCA1 and BRCA2 gene testing.

The lawsuit was filed in US District Court for the District of Utah, Central Division, and in addition to Myriad, the plaintiffs include the Trustees of the University of Pennsylvania, the Hospital for Sick Children in Toronto, and Canadian firm Endorecherche.

The plaintiffs allege Quest infringes eight patents covering BRCA1/2 genes — US Patent No. 5,709,999; No. 5,747,282; No. 5,753,441; No. 5,837,492; No. 6,033,857; No. 6,051,379; No. 6,951,721; and No. 7,250,497.

This week's development follows Quest's lawsuit filed almost two weeks ago seeking a declaration that its test, called BRCAvantage and launched last week, does not infringe Myriad's patents. Myriad similarly sued GeneDx last week, claiming that that firm infringes 14 patents held by Myriad and the other plaintiffs covering BRCA1/2 testing.

During the summer, the Salt Lake City company took Ambry Genetics and Gene by Gene to court after those firms commercialized BRCA1/2 gene tests that Myriad claimed infringes its patents. The two companies have fired back with their own lawsuit accusing Myriad of antitrust violations.

Another firm, Counsyl, also sued Myriad in September and asked a California federal district court to preemptively declare it does not infringe Myriad's patents.

The impetus for the legal free-for-all is a June ruling from SCOTUS that Myriad's competitors have interpreted as a green light to enter the BRCA1/2 gene testing space, a market that Myriad had owned almost exclusively in the US.

In its decision, SCOTUS ruled that human genes cannot be patented. However, synthetic DNA, or cDNA, can be patented.

Myriad has maintained that in spite of the ruling, it still has 500 valid and enforceable claims in 24 patents underlying its test called BRACAnalysis.

In its action against Quest, Myriad seeks a jury trial, damages, a preliminary injunction against Quest from selling or marketing products that allegedly infringe Myriad's patents, and an order that Quest deliver to Myriad products that it believes infringes the patents for possible destruction.

In an e-mail to GenomeWeb Daily News a Quest spokesperson said that the firm expected Myriad's lawsuit and called it "merely the latest in a pattern of behavior toward any test provider that introduces a new option in BRCA testing that can benefit patients.

"We are confident that our offering does not violate any Myriad claims," she added. "We will vigorously defend, and continue to provide, BRCAvantage to the many patients who seek options in BRCA testing."