The US Supreme Court invalidated three decades-worth of gene patents in today’s unanimous ruling on the case of Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al.
From the decision, written by Justice Clarence Thomas:
We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.
The ruling that naturally occurring DNA can’t be patented but synthetic DNA can inspired immediate celebration. The Center for Genetics and Society praised the ruling, calling it “a hugely important step toward reclaiming biotechnology for the common good” and the American Medical Association called it a “clear victory for patients.” In the wake of the ruling, which Myriad also claimed as a victory, the genetics company’s stock rose to a four-year high.
But later in the day, caution set in. Science writer Ricki Lewis applauded the spirit of the ruling, but criticized the science. Myriad’s stock share price slumped. Daniel Fischer, of Forbes, seized on the trouble with trying to define natural versus synthetic DNA, and Harvard Law Professor Noah Feldman highlighted the same issue in an article for Bloomberg, saying:
There is nothing that a 6-year-old would consider “invented” about the patentable cDNA. It is nothing more than the messenger RNA flipped into a DNA sequence that omits unnecessary elements that nature already excluded. The sequence that codes the proteins is just as naturally occurring as the original DNA itself, which the court held couldn’t be patented because it was naturally occurring. The distinction is, to put it bluntly, a lawyer’s distinction, not a scientist’s.
This ruling is certainly an important milestone in the ongoing debate about genetic patents and the regulatory balancing act that pits protecting public welfare against the support of innovation. But there’s no unambiguous scientific definition for “natural” and “synthetic,” and therefore plenty of room for confusion and reinterpretation.