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Quest Sues Myriad in Advance of BRCA1/2 Assay Launch

NEW YORK (GenomeWeb News) – In advance of a launch of its BRCA1 and BRCA 2 assay, Quest Diagnostics has asked a federal court to declare its test does not infringe patents held by Myriad Genetics.

Quest filed its complaint in US District Court Central District of California on Thursday, asking the court to find that it and the Quest Diagnostics Nichols Institute do not infringe 14 US patents held by Myriad covering BRCA1/2 testing.

In an email to GenomeWeb Daily News, Ron Rogers, a spokesman for Myriad, said the company has not received Quest's complaint "and it would be premature to comment. However, we continue to believe that patent claims related to BRCA1 and BRCA2 gene testing are valid and enforceable. Myriad and the other owners of the BRCA patents at issue — including the University of Utah, the Hospital for Sick Children, Endorecherche, Inc., and the Trustees of the University of Pennsylvania — are prepared to vigorously defend our intellectual property rights."

In June, the US Supreme Court found that human genes are not patentable, but that synthetic DNA, or cDNA, can be patented because it does not occur naturally. That decision appeared to loosen Myriad's tight grip on the BRCA testing market and to clear the path for competitors to offer BRCA1/2 tests. Almost immediately a number of firms said they would be launching products and services to go head to head with Myriad's test called BRACAnalysis.

Following the ruling, though, Myriad emphasized that it still had 500 valid and enforceable claims in 24 patents underlying BRACAnalysis, and during the summer, Myriad and other assignees sued Ambry Genetics and Gene by Gene, alleging the two companies infringed the Salt Lake City-based company's BRCA1/2 patents.

Ambry and Gene by Gene have countersued Myriad accusing it of antitrust violations.

After the SCOTUS ruling, Quest also said that it planned on providing BRCA testing, and in its complaint this week, said that it "will soon commercially launch … a novel two-part assay to detect hereditary alterations in … BRCA1 and BRCA2.

"After launch, Quest's BRCA Assay will be made available to doctors and patients as part of the complete portfolio Quest offers as part of its diagnostic testing services," the company said. It added, though, that "Myriad's conduct, including Myriad's litigation history, threatens Quest's legal rights and ability to market Quest's BRCA Assay."

In addition to the lawsuits leveled by Myriad against Ambry and Gene by Gene, Quest said in its complaint that in July, Nicolas Conti, its VP of licensing and alliances, met with Sam LaBrie, VP of corporate development at Myriad RBM, a wholly owned subsidiary of Myriad. In the meeting, LaBrie indicated that Myriad would assert its patents if Quest were to launch a BRCA test, Quest said.

"In that conversation, Mr. LaBrie indicated that the public does not understand how strong Myriad's patent claims are," according to the complaint. "He further stated that the notion that Quest would enter the market 'scared the [Myriad] team' and he confirmed that Myriad would be 'sending letters' to any labs who offered BRCA1 or BRCA2 tests.

"When making the statement, Mr. LaBrie knew that Quest was planning to offer some sort of BRCA testing. Therefore … he intended to advise that Quest would also receive a letter from Myriad objecting to Quest's offer of those tests. Moreover, the above statement applied to any BRCA1 and BRCA2 testing and related services. When making the above statements, Mr. LaBrie did not concede that any BRCA1 or BRCA2 test would not infringe," Quest said.

Quest asks the court to find that it does not infringe US Patent Nos. 5,747,282; 5,693,473; 5,709,999; 5,710,001; 5,753,441; 5,837,492; 6,038,857; 7,250,497; 6,083,698; 5,750,400; 5,654,155; 6,951,721; 6,492,109; and 6,051,379.

Last month, Counsyl also sought to preempt Myriad from suing it on claims of patent infringement when the South San Francisco, Calif.-based genetic testing firm filed with the US District Court Northern District of California asking it to find that "Myriad has no rights against Counsyl" regarding eight BRCA1/2 patents held by Myriad.