The U.S. Supreme Court handed down a unanimous decision this week which may fundamentally shift the trajectory of biomedical research. In a polarizing case concerning molecular diagnostics innovator Myriad Genetics, the court invalidated the entirety of the company's patents associated with naturally occurring human DNA.
Myriad's founders were at the heart of early efforts to identify specific genetic indicators for elevated breast and ovarian cancer risks, and their research team was eventually awarded several patents covering two isolated DNA sequences with strong pathological correlations. Myriad then leveraged these assets to become the sole commercial provider of associated diagnostic screening protocols in the U.S. But according to The Wall Street Journal, critics have questioned whether the patents which attracted considerable financial backing for Myriad research truly reflect invention or justify the exclusion of market competition which could potentially spur faster medical breakthroughs.
The court's latest ruling has now comprehensively rejected the patentability of human DNA - but with one crucial caveat.
"A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but [complementary DNA] is patent eligible because it is not naturally occurring," Justice Thomas wrote in the court opinion.
According to Forbes, this distinction would suggest that Myriad's proprietary business methods centered on laboratory-created, complementary DNA should hold up as they approach their respective patent cliffs over the next few years.