In a landmark decision, the Supreme Court has decided in favor of the Association for Molecular Pathology in its case against Myriad Genetics, ruling that naturally occurring DNA is not patentable, while synthetic DNA is.
The case, heard in April 2013, concerned patents held on two genes, BRCA 1 and BRCA2, which are closely linked to a woman's risk of breast and ovarian cancer. Myriad Genetics, a biotechnology company, owned the patent rights to the use of the two genes, which it used to make a considerable sum of money licensing the use of diagnostic tools used to inform patient treatment.
But the Association for Molecular Pathology and other groups filed a lawsuit again the company - the same the Supreme Court ruled on today - concerning a difficult question: Is the genetic code of the human body a patentable entity?
Myriad had argued that it was, and that without sufficient protections for intellectual property, incentives would not exist to permit investment in the discovery of genes linked to diseases. Meanwhile AMP and others argued that Myriad had in effect patented parts of the human body itself - "products of nature" - to which it had no claim, interrupting basic science.
In a widely anticipated decision issued on 13 June 2013, the Supreme Court decided in favor of AMP, holding that "a naturally occurring deoxyribonucleic acid (DNA) segment is a product of nature and not patent eligible merely because it has been isolated."
"Myriad's DNA claim falls within the law of nature exception," the court wrote. "Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes," but this failed a patent eligible standard since it lacked "markedly different characteristics from any found in nature."
So while the court held that Myriad had found an important and useful gene, a "groundbreaking, innovative or even brilliant discovery does not by itself satisfy [patent requirements]," it said. In addition, though the court recognized Myriad's considerable effort in discovering the BRCA genes, it noted that "extensive effort alone is insufficient" to hold a patent as valid.
However, in a nod to Myriad's argument, the Supreme Court also held that composite DNA (cDNA) - a synthetic isolate - is patent eligible "because it is not naturally occurring."
"cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments," the court explained. "Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA."
The court's decision, landmark in its effect, is also remarkable in one other respect: The opinion was joined by all nine justices, with only Justice Antonin Scalia filing an opinion concurring in part with the judgment. The overwhelming support makes it unlikely that the case will be revisited in the future.
The case has already won strong support from Francis Collins, the director of the National Institutes of Health (NIH), who immediately sent out a message on Twitter exclaiming: "Woo Hoo!!!"
SCOTUS Decision -- PDF