
U.S. Supreme Court Declines to Hear CareDx’s Lawsuit Over Organ-Rejection Tests; Maintains Status Quo on Intellectual Property for Advanced Diagnostic Patents
In a recent decision, the U.S. Supreme Court has chosen not to hear a lawsuit brought by CareDx, a biotechnology company specializing in organ transplant monitoring, against Natera and Eurofins Viracor. This decision marks another chapter in the ongoing debate over patent eligibility and its implications for medical diagnostics. The legal battle began in 2019 when CareDx, based in Brisbane, California, filed a lawsuit against Natera, located in Austin, Texas, and Viracor, a subsidiary of Eurofins Scientific in Luxembourg. CareDx alleged that both companies were infringing on its patents related to the AlloSure blood test, a diagnostic tool designed for monitoring kidney transplant patients using cell-free DNA for measuring the levels of an organ donor’s DNA in the recipient’s blood to predict risk of transplant rejection.
Last year, the Federal Circuit delivered a verdict affirming a Delaware federal judge’s decision that CareDx’s patents were invalid. The ruling concluded that the patents revolved around the unpatentable concept of detecting natural phenomena. CareDx’s subsequently appealed to the U.S. Supreme Court aimed to challenge this verdict and protect its intellectual property rights. However, the Supreme Court has chosen not to hear the case, signaling the end of this particular legal dispute.