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Myriad Sues Third Firm, BioReference's GeneDx, Alleging BRCA1/2 Patent Infringement

NEW YORK (GenomeWeb News) – Myriad Genetics and other parties are suing BioReference Laboratories' GeneDx alleging infringement of patents covering BRCA1 and BRCA2 genes.

Along with Myriad, the University of Utah Research Foundation, the trustees of the University of Pennsylvania, Toronto's Hospital for Sick Children, and Endorecherche are plaintiffs in the lawsuit, which was filed last week in US District Court for the District of Utah, Central Division.

The lawsuit substantially repeats litigation that the plaintiffs filed against Ambry Genetics and Gene by Gene in July after those firms launched their BRCA1/2 tests, which Myriad said infringes its patents.

Those defendants and GeneDx, the genetic sequencing laboratory of BioReference, began offering BRCA1/2 testing following a US Supreme Court ruling in June that found that synthetic DNA, or cDNA, can be patented, but human genes cannot.

Until recently, Myriad had the BRCA1/2 gene testing space in the US virtually all to itself, because of its patent portfolio covering the two genes and its willingness to take anyone to court that it felt infringed its patents.

The SCOTUS decision, however, seemingly gave the OK to competitors to go head to head against Myriad's test called BRACAnalysis. Following the ruling, though, Myriad emphasized that it still had 500 valid and enforceable claims in 24 patents underlying the test.

Today, Myriad said in an e-mail to GenomeWeb Daily News, "The BRCA patent owners continue to believe that patent claims related to BRCA1 and BRCA2 gene testing are valid and enforceable and will demonstrate that the testing process used by GeneDx infringes those claims.

"We believe strong patent protection is essential to innovation. Given that it guarantees a firm a period of reward, patent protection provides the research-based diagnostics industry with an incentive to invest in research and development," the company said.

Myriad's case against GeneDx involves 16 patents — US Patent No. 5,709,999; No. 5,747,282; No. 5,753,441; No. 5,837,492; No. 6,033,857; No. 5,654,155; No. 5,750,400; No. 6,051,379; No. 6,951,721; No. 7,250,497; No. 7,470,510; No. 7,622,258; No. 7,838,237; No. 7,670,776; No. 7,563,571; and No. 6,083,698.

Myriad seeks a jury trial, damages, and an account by GeneDx for "all gains, profits, advantages, and unjust enrichment derived from [its] violations of the law."

In addition, it wants GeneDx to deliver to Myriad all products that it believes infringe the 16 patents cited in the lawsuit, so that Myriad can destroy them if it wishes.

In a statement issued today, BioReference said that Myriad's lawsuit is unsurprising. It launched its BRCA1/2 test in August "after careful consideration in view of the Supreme Court's recent decisions in the field of genetic diagnostics. … BioReference is confident in its legal position and its belief that patients are better served in this evolving area of medicine by having choices and better access to alternative testing sources."

Unlike in its litigation against Ambry and Gene by Gene, Myriad is not seeking a preliminary injunction against GeneDx.

On Monday, two investment banks, Credit Suisse and Piper Jaffray issued research notes that cast doubt on the success of Myriad's requests for those preliminary injunctions. As a result of the uncertainty and the possible repercussions on the BRACAnalysis business, Credit Suisse downgraded Myriad to Underperform and lowered its price target, while Piper Jaffray lowered its price target but kept its Overweight rating on Myriad's stock.

In addition to the lawsuits Myriad has leveled at its competitors, it faces legal challenges. After it sued Ambry and Gene by Gene, those firms countersued Myriad alleging antitrust violations. Quest Diagnostics also sued Myriad earlier this month seeking a declaration that its BRACA1/2 test, launched last week, does not infringe the Salt Lake City-based firm's patents.

In afternoon trading today, shares of Myriad on the Nasdaq were down a fraction of 1 percent at $24.37.