The Supreme Court’s June ruling on gene patents is already opening the market for BRCA testing and is largely seen as a positive for clinical laboratories that have been blocked from entering this testing space. In a highly anticipated, but largely expected decision, the Supreme Court unanimously decided that isolated genomic DNA (gDNA) is not eligible for patent protection. The decision in the case, Association for Molecular Pathology v. Myriad Genetics, authored by Justice Clarence Thomas, struck a middle ground with the court declaring isolated gDNA is an unaltered “product of nature” and thus unpatentable, but patents for complementary DNA (cDNA) are still allowable. While the National Society of Genetic Counselors estimates that approximately 20 percent of all human genes are patented, not all of these patents are enforced and some early patents have expired. Unlike Myriad Genetics (Salt Lake City) few other commercial entities have built a sizable, testing monopoly around a single, human gene patent and thus, many predict the decision will not have wide-reaching impact but will open up the BRCA testing market. Impact on Myriad Many predict that Myriad will maintain its market dominance in BRCA testing in the short term, even as other laboratories rush […]