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Myriad, Others Sue Gene by Gene Alleging Infringement of BRCA 1/2 Patents

NEW YORK (GenomeWeb News) – Myriad Genetics and others have fired off another salvo against a company that began offering BRCA1 and BRCA2 testing following the US Supreme Court's decision last month invalidating Myriad's patent claims on isolated BRCA sequences.

Myriad today filed its lawsuit in US District Court for the District of Utah, Central Division against Houston-based Gene by Gene, which started offering its BRCA1/2 test shortly after the Supreme Court decision. Gene by Gene offers its test for $995 through its DNA Traits division.

According to the complaint, DNA Traits started offering BRCA 1/2 analysis as part of its testing menu on June 13, the day the Supreme Court handed down its decision.

In a press release at the time announcing it would begin offering BRCA1/2 testing, Gene by Gene said that DNA Traits had been processing BRCA1/2 genes for individuals living outside the US since 2012. The company uses Sanger sequencing for its test, it said.

Along with Myriad, other plaintiffs in the case are the University of Utah Research Foundation; the Trustees of the University of Pennsylvania; HSC Research and Development Limited Partnership, also known as The Hospital for Sick Children in Toronto; and Canadian company Endorecherche.

Today's action follows a similar lawsuit filed by the plaintiffs against Ambry Genetics on Tuesday.

While the Supreme Court said in its decision last month that human genes are not patentable, synthetic DNA, or cDNA, is because it does not occur naturally. Based on that decision, a ripple of companies and other organizations have either launched BRCA 1/2 tests or have said they plan to do so.

Those potential competitors include Pathway Genomics and the University of Washington. Quest Diagnostics has said it is interested in providing BRCA testing later this year.

Myriad and its co-plaintiffs allege Gene by Gene is infringing nine US patents: 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. 6,951,721; and No. 7,250,497.

Generally, the patents relate to methods and materials for detecting the BRCA1/2 genes; DNA sequences related to the BRCA1 gene; methods for identifying the haplotype of the BRCA1 gene; and methods for identifying genetic variants in the BRCA1 gene.

The plaintiffs are seeking a jury trial and a temporary and preliminary injunction against Gene by Gene from continued infringement of the nine patents. It also seeks "enhanced damages and/or costs" of an amount to be determined later.

A spokesperson for Gene by Gene declined to comment saying the company has not been notified that it is being sued.