By Bio-IT World Staff
December 5, 2013 | Myriad Genetics has launched a new lawsuit over its ownership of genetic tests for BRCA mutations, this time against Laboratory Corporation of America (LabCorp), whose BRCAssure test was launched commercially earlier this week.
Myriad Genetics has been trying to thread the needle of corporate ownership of DNA sequences ever since the Supreme Court ruled in the landmark case Association for Molecular Pathology v. Myriad Genetics that naturally-occurring DNA is patent ineligible. (See "The Price of Free Data.") In the same decision that invalidated Myriad's patents on variants of the BRCA 1 and BRCA 2 genes, the Court upheld Myriad's patents on synthetic DNA derived from the same sequences. Armed with these latter patents, Myriad has sought to aggressively enforce its unique right to sell and license tests for breast cancer susceptibility based on BRCA mutations.
Previous filings have left Myriad entangled in suits and countersuits with half a dozen companies, but LabCorp offers a particularly stark view of the tightrope Myriad is walking. With only a 5% chance of returning a variant of unknown significance, the BRCAssure test is dangerously approaching the level of precision that Myriad, with its unmatched proprietary database of knowledge on the clinical significance of BRCA variants, provides with its BRACAnalysis test. LabCorp is not the only company catching up to Myriad, which will only find it harder and harder to stand out on quality alone if its patents are not held to cover its competitors' technology.
Conscious of this, Myriad has been busily expanding its product line into new genes and conditions, preparing to continue without a monopoly even as it seeks to enforce one.