The Supreme Court in early December agreed to hear a case challenging Myriad Genetics’ (Salt Lake City) patent of two genes linked to hereditary breast and ovarian cancer. In agreeing to hear the case, the court limited the appeal to a single question—are human genes patentable? Despite the attention the case has garnered over the past three years, there are questions over how great of an impact the decision will have on the diagnostics industry. The question of patentability of genes stirs great passion. Some, like the American Civil Liberties Union in this case, say gene patents interfere with scientific progress by slowing research, increasing clinical and research costs, and impeding access to diagnostic tests. Meanwhile, the biotech industry argues exclusive patent rights are imperative to the in vitro diagnostics industry’s success by allowing companies to recoup initial research and development costs. In 2001 the U.S. Patent and Trademark Office established utility guidelines that allowed patenting of a “genetic composition isolated from its natural state” as long as the patent applicant “discloses a specific, substantial, and credible utility for the claimed isolated and purified gene.” But as molecular diagnostics has evolved, technologies like next-generation sequencing may be making isolated gene […]