Distributing the future: The weak justifications for keeping human genomic databases secret and the challenges and opportunities in reverse engineering them

Myriad Genetics, founded in 1991 as a spin-off from the cancer genetics epidemiology unit at the University of Utah and initially funded in part by publicmoney, went on to build amulti-billion-dollar business bydiscovering andpatenting two genes that,whenmutated, predispose to hereditary breast and ovarian cancer (HBOC) (Williams-Jones, 2002; Allison, 2014). While Myriad's reputation as a competent test provider was generally exemplary and there was no apparent price premium attributable to the patents, the company's monopoly on the two genes kept patients from obtaining second opinions or confirmatory testing. Moreover, researchers were prevented from returning results on the two genes to research participants (Carbone et al., 2010; Cook-Deegan et al., 2010). In 2009 the American Civil Liberties Union sponsored litigation against Myriad on behalf of twenty plaintiffs (including HBOC patients), seeking to overturn Myriad's US service monopoly on genetic testing for HBOC. In 2013 the United States Supreme Court ruled that genomic DNA was a product of nature and therefore not patentable (Association for Molecular Pathology et al., 2013), while engineeredDNAmoleculeswere eligible to patent. Almost immediately, a spate of other genetic testing firms announced that they would begin testing for the two genes, BRCA1 and BRCA2, that were once the exclusive province of Myriad (Karow, 2013). But, as Conley et al. describe in their reviewof theHBOC genetic testing landscape post-Myriad, whatever the legal precedent the Supreme Court established, in the immediate aftermath of the decision the HBOC marketplace only became messier and more confusing (Conley