In a landmark ruling, the Supreme Court of the United States has declared that isolated chunks of human DNA cannot be patented. And thank goodness for that. But it's a ruling that comes with a compromise: Moving forward, companies can still patent synthetic genetic material.
The court concluded today that human DNA is a product of nature and a basic tool of scientific and technological work. It's outside the domain of patent protection and not something that can be deemed an invention or a technological discovery.
As a result of the ruling, the court struck down patents held by Myriad Genetics on a pair of genes linked to a higher risk of breast and ovarian cancer, namely BRCA1 and BRCA2.
And yes, Angelina Jolie carries the defective BRCA1 gene. She recently underwent a mastectomy to reduce her risk of developing these cancers. But up until today, Myriad Genetics was actually making a patent claim on that gene. I know — it doesn't make a hell of a whole lotta sense. Which is why this ruling is being seen as a victory for rationality.
The Guardian reports:
Justice Clarence Thomas ruled that Myriad's assertion that the DNA it isolated from the human body for its tests were patentable had to be dismissed because it violated patent rules. The court said that laws of nature, natural phenomena and abstract ideas lay outside patent protection.
"We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated," Thomas said.
He said there would be "considerable danger" that without such an exception, the granting of patent would "tie up" the use of such tools and future innovation based on them.
But the Supreme Court did say that synthetically created genetic material, known as cDNA, can be patented, including cloned genes. The court said this was okay because it involves actual work in the laboratory and manipulates what's normally found in nature. The synthetic cDNA is an edited version of a gene, stripped of non-coding regions that the court said makes it "not naturally occurring."
Critics are already saying Justice Clarence Thomas made the wrong decision to not exclude cDNA from patentability. Writing in Forbes, Daniel Fisher explains:
Critics say even the edited sequences are directly analogous to naturally occurring DNA. “That may be so,” Thomas wrote, “but the lab technician unquestionably creates something new when cDNA is made.”
[Brenda] Jarrell, who has a doctorate in biochemistry from the University of California in addition to a Harvard Law degree, said Thomas is wrong. Not only do researchers make cDNA with naturally occurring tools, but the exact same process can occur naturally in the body.
“It’s not actually correct to say cDNA is not a product of nature,” she said. “There’s nothing more inventive about making cDNA than isolating DNA.”
The DNA/cDNA distinction also could provide grist for future litigation, since cDNA is a gene sequence consisting only of exons, or nucleotides that code for amino acids.
“What if you took that same cDNA sequence and added non-functional introns?” asked Dalila Argaez Wendlandt, a partner with Ropes & Gray. Would that allow for a successful end-run around the patent?
This will likely be a big deal in the future with the advent of advanced gene therapies and the injection of novel, synthetic genes into our DNA. So we're not out of the woods yet; the day is coming when companies will own the DNA contained within your body.
Image via Sergej Khakimullin/Shutterstock.