This year alone has seen the arrival of three noninvasive tests for analyzing the DNA of a fetus, with a fourth expected to become available in the coming months. These new tests can detect genetic abnormalities, such as Down syndrome, as early as 10 weeks into the pregnancy, and could soon represent a market of more than $1 billion, according to Nature. With such high financial stakes, the four companies that have made these tests available are currently embroiled in a legal battle over who can patent the underlying technique, which involves scanning maternal blood for fetal DNA.
Back in January, Sequenom, a genetic diagnostics manufacturer based in San Diego, California, filed a lawsuit against San Jose-based Ariosa for patent infringement. Sequenom released its MaterniT21 test in October of last year and Ariosa launched the Harmony™ prenatal test in early May. Both tests detect Down syndrome and other common fetal trisomies. In response to the lawsuit, Ariosa, along with Stanford University and two other companies in California, countersued, arguing that there were enough differences in their techniques to not be classified as a breach of patent.
“If a single company has a monopoly on the market, it will essentially be able to dictate the standard of care and the quality of care,” Mildred Cho, a bioethicist at the Stanford University School of Medicine in California, told Nature. “The bigger policy issue is whether society should allow monopolies on medical practice, especially for medical technologies that benefited from public funding.”