By ruling that naturally occurring genetic material is not subject to patent protection, the U.S. Supreme Court has drawn a useful line between what nature makes and what constitutes a man-made invention. This distinction will encourage scientific innovation by preventing companies from holding back patented genes from research, and it will bring new competition to the field of genetic testing, pushing down prices for determining a genetic propensity to disease. More people will now be able to protect their health without navigating or paying a gantlet of individual patent holders.
In the court's unanimous opinion, Justice Clarence Thomas wrote that Myriad Genetics, a company that had successfully isolated the BRCA1 and BRCA2 genes linked to an increased risk of breast and ovarian cancer, had simply found the genes as they existed in nature. "To be sure," Thomas wrote, "it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention."
This was the crux of the case. Myriad had been granted a broad patent on the genes based on the claim that by discovering their precise location and sequence and by extracting them, the company had effectively created DNA in a new form. The monopoly allowed the company to charge $3,000 or more for the genetic test that could tell if a woman had a mutation in the genes that would indicate she was at high risk for certain cancers down the road. Actress Angelina Jolie had this kind of test and decided to undergo a preventive double mastectomy after learning she had the problem gene.
Since the court opinion was released Thursday, other biotech companies have said they will start testing for the genes at a fraction of the cost.
There are good reasons to make natural phenomena, laws of nature and abstract ideas not patentable. As Thomas explained, these are the tools that scientists and researchers use to form the basis of their work. A patent might put them out of reach and stymie progress. "This would be at odds with the very point of patents, which exist to promote creation," Thomas wrote.
The court left the door open for patenting synthetic or complementary DNA, which is genetic material manipulated in a way not found in nature. That means companies that genetically engineer crops probably won't be affected, and other businesses, like the pharmaceutical industry, will still be able to reap commercial benefits from biotechnology.
But the court was right to end patents on genes themselves. Scientific research will have more freedom; more competition in genetic testing will bring down medical costs; and patients will have unfettered access to their own genome.