NEW YORK (GenomeWeb News) – Myriad Genetics has filed a lawsuit against Laboratory Corporation of America alleging infringement of 11 US patents covering its BRCA 1 and 2 testing franchise.
The suit, filed yesterday in the US District Court for the District of Utah, Central Division, followed LabCorp's launch on Monday of its Comprehensive BRCAssure BRCA 1/2 Analysis for identifying patients with BRCA mutations who are at risk of developing breast, ovarian, and other cancers. LabCorp said the analysis includes full gene sequencing of BRCA1/2 genes and duplication/deletion testing, with a variant of unknown significance rate of less than 5 percent.
According to Myriad's lawsuit the offering of the BRCAssure testing service infringes several patents, including Nos. 5,709,999; 5,747,282; 5,753,441; 5,837,492; 6,033,857, held by various owners — including the University of Utah, the University of Pennsylvania, Endorecherche, and others, all of whom are listed as plaintiffs in this action —and exclusively licensed to Myriad. In addition, the suit alleges infringement of US Patent Nos. 5,654,155; 5,750,400; 6,051,379; 6,951,721; 7,250,497; and 6,083,698, which are all owned by Myriad.
Myriad is asking the court to rule that LabCorp has infringed these patents and that it be enjoined from selling its BRCAssure service, as well as unspecified damages.
This latest suit follows a series of patent infringement actions Myriad has filed against others who have launched BRCA tests and services in recent months following the US Supreme Court's decision this past summer that patent claims on isolated gene sequences were invalid.
However, the court also found several of Myriad's claims on synthetic, or cDNA, patent eligible. With this two-part ruling, Myriad believes its patent suite for BRACAnalysis is still intact and competitors cannot perform BRCA testing without infringing its still-valid IP. As such, when competing firms, such as Ambry Genetics, Gene by Gene, GeneDx, and Quest Diagnostics, launched BRCA testing, Myriad sued them. The most recent firm to be sued by Myriad, before LabCorp, was Invitae, which followed this week with a countersuit against Myriad.