Patent Struggle Over Breast Cancer Test Continues Even After Supreme Court’s Decision

Following last month’s ruling by the U.S. Supreme Court in Assoc. for Molecular Pathology v. Myriad Genetics, Inc., which held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it was isolated, Myriad Genetics filed two lawsuits against competitors that have begun to offer genetic testing for breast cancer risk.

The decision spurred various competitors to announce that they would bring to market tests for the two genes BRCA1 and BRCA2 that were indicators of future breast cancer. Myriad had controlled the testing for almost two decades and the newly announced tests were expected to cost less than the $4000 that Myriad charged for full analysis.

Myriad’s lawsuits filed this week against Ambry Genetics and Gene by Gene did not assert claims based on the two genes, but instead focused on the other patent claims that were not invalidated by the Supreme Court, including the synthetic DNA used as probes and on methods of testing that the high court noted in its opinion were not invalid. Myriad had already received backlash from some segments of the public, as the original litigants, comprised of patients, medical societies, and researchers, argued that Myriad’s monopoly on the tests impeded research and denied women options to test for breast cancer susceptibility. Earlier last week, Myriad had announced that it would not impede noncommercial academic research or stop labs from doing a test to confirm results produced by Myriad.

The lawsuit was filed in the U.S. District Court for the District of Utah where the company is based. The company was joined by the University of Utah and three other organizations that receive royalties from Myriad for BRCA-related patents licensed to it. Myriad is seeking a preliminary injunction to stop the further marketing of competitor products.