Myriad’s vital to advancing genetic diagnostics research at a much faster pace than patents

This Section examines the impact of the Myriad decision on genetic testing. The decision in Myriad, in conjunction with Mayo, encourages competition and innovation in molecular diagnostics and omics192 by removing “gene patents as a legal barrier to large-scale sequencing.”193 Critics against gene patenting argue that the foreclosure of gene patenting opens the door for substitute testing options from competitors, thereby driving down the costs to patients and medical providers.194 According to them, an increase in testing will also help to “reveal more genetic variants and provide insights into their biological significance”195 thanks to the resulting increase in sample size and corresponding data. This could reveal new information to be shared on ClinVar, a public database funded by the National Institutes of Health (“NIH”).196 Currently, however, Myriad and its patent licensees have exclusive access to Myriad’s proprietary database containing valuable data on BRCA mutations, which in 2015 contained at least 300,000 cases197 and is protected by the company as a trade secret.198 The wider scientific community could substantially benefit from access to Myriad’s “most valuable asset”199 to collaborate on the “cataloging and interpreting” of mutation variants.200 Together, these concerted efforts could help advance understanding in this area at a much faster speed than would otherwise be possible. There have been calls from leading medical organizations to have Myriad and other labs share their variant classification data, however, Myriad has yet to do so on ClinVar.201