Ever since Samuel Hopkins received the first patent in 1790 for a process of making potash—an ingredient used in fertilizer—patents have been a cornerstone of U.S. intellectual property law. But early legislators couldn’t have predicted the swift advances in biotechnology that are challenging the way see patents today.
Take, for example, the conflict surrounding genetic material.
In 1998, the Salt Lake City diagnostics firm Myriad Genetics was awarded patents for discovering the sequences of two genes, BRCA1 and BRCA2, which reveal a woman’s risk of hereditary breast and ovarian cancer. These patents gave Myriad a monopoly on BRCA testing, preventing other researchers and clinicians from tailoring treatments to patients based on their DNA structure. Here’s Amy Maxmen, reporting for NOVA Next in March:
Genetic tests can reveal a lethal disease in an unborn baby, a risk of illness, or a dangerous reaction to a drug. They have already begun to usher in the era of personalized medicine, and technological advancements will continue to make the tests cheaper, faster, and ever more reliable. But recently, some researchers have hesitated to bring new and improved tests to the clinic for fear of infringing on a patented gene. It’s gotten to the point that Francis Collins, director of the National Institutes of Health, calls gene patents “an impediment to personalized medicine.”
In June of this year, though, the U.S. Supreme Court ruled that separating a gene from its overall genetic material does not constitute a human invention, and therefore genes cannot be patented. The decision was a victory for the American Civil Liberties Union (ACLU) and the smaller Public Patent Foundation, which had both initiated the fight against Myriad.
Maxmen updated her story on June 13 with coverage of this ruling:
Myriad’s patents on BRCA1 and BRCA2 stood for 15 years, and for the past couple of years, the company had successfully argued in appeals that isolated genes were no longer part of nature. It was an argument the Supreme Court didn’t buy. Specifically, the Supreme Court judges announced in their decision that the breast cancer genes BRCA1 and BRCA2 cannot be patented because genes are a product of nature and therefore not patentable by law. “Myriad did not create anything” with isolated DNA, Justice Clarence Thomas wrote for the court. “It found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” An estimated 5,000 to 7,000 of human genes had been patented since 1982, when gene patents were first allowed. This decision now sets those genes free.
The Court stated that cDNA—DNA that produced when researchers make a complementary copy of a sequence—is still patentable because, in lab uses, it is not naturally occurring. While the ruling doesn’t entirely eliminate patents in the field of genetics, it seems to have opened the door for many testing companies, which are now including information on more sequences in their reports to doctors and patients, including the BRCA genes.