Myriad targets 3rd company with BRCA cancer test lawsuit

Myriad Genetics ($MYGN) is suing a third company for allegedly violating patents concerning its signature predictive cancer diagnostic test. This time, the Utah company is targeting New Jersey's BioReference Laboratories ($BRLI), which disclosed that it had been expecting legal action in the wake of a U.S. Supreme Court decision that invalidated some Myriad patents but upheld others, opening the door to competition.

Myriad is already suing Gene By Gene and Ambry Genetics in similar complaints filed after each company launched separate tests relying on BRCA1 and BRCA 2 genes, which are the basis for Myriad's BRACAnalysis test for hereditary breast and ovarian cancer. Both companies have subsequently countersued, alleging violation of federal antitrust laws. Separately, Quest Diagnostics ($DGX) is preemptively suing Myriad to seek a ruling that its new test in the same space doesn't violate any Myriad patents.

In BioReference's case, the company's gene sequencing laboratory GeneDx is at issue, because the division began offering a test in August for inherited cancers including mutations involving BRCA1 and BRCA2 genes. Myriad filed its lawsuit in the U.S. District Court in Utah.

"The latest action against BioReference is not unexpected and … [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," the company said in a statement.

Myriad issued a statement of its own confirming that it had filed the lawsuit against BioReference. Myriad is suing along with fellow patent-holders including the University of Utah, the Hospital for Sick Children and the Trustees of the University of Pennsylvania.

"The BRCA patent owners continue to believe that the patent claims relating to BRCA1 and BRCA2 gene testing are valid and enforceable and will demonstrate that the testing process used by GeneDx infringes those claims," Myriad said. "We believe strong patent protection is essential to innovation. Given that it guarantees a firm period of reward, patent protection provides the research based diagnostics industry with an incentive to invest in research and development."

- read BioReference Laboratories' full statement
- here's GenomeWeb's take (reg. req)