On Monday, the Supreme Court spooked the industry by declining to hear an appeal from Sequenom, which is a Californian company which markets prenatal tests based on screening fetal DNA. A court had ruled that Sequenom couldn’t patent the test due to its basis of natural biology. The news left many biotech entrepreneurs fearful for their inventions, because now that the Supreme Court refuses to hear the case, the prior ruling stands. Many biotech giants, such as Pfizer, Eli Lilly, and Novartis are now worried for their futures, begging justices to intervene.
According to David O. Taylor, an assistant professor at Southern Methodist University’s Dedman School of Law, justices in lower courts are leading for the Supreme Court to allow for patent eligibility in biotech, however, the court continues to stay silent. Taylor predicts that companies and investors are going to steer clear of big pharma, in fear of invalidated patents. “Their refusal to clarify this area of the law would seem to point in the direction of reduced investment in the diagnostic invention, and that is obviously problematic from a public health concern,” said Taylor.
However Sequenom’s opponent in the case, Ariosa Diagnostics, says that the fetal test is not unique enough to deserve their patent. Asking the justices would be “inviting the court to revisit and rewrite decades of jurisprudence covering the patent-eligible subject matter. In the future, there may be a case that tests the boundaries” of what’s appropriate to patent, said Ariosa in a statement, “but this is not that case.”
The ruling was based on a separate Supreme Court ruling in 2012, in the case Mayo Collaborative Services v. Prometheus Labs. In that case, the justices ruled saying that any patent that comes from a natural process, such as fetal DNA turning up in maternal blood, must “more than simply stating the law of nature while adding the words ‘apply it.”. Sequenom’s test doesn’t completely clear those rules, due to the fact that the methods in which they use to calculate fetal DNA have already been invented.