For more than 30 years, companies in the U.S. have been able to patent human genes, giving them exclusive rights to produce drugs, diagnostic tests or other tools based on those genes. But now the U.S. Supreme Court is revisiting this controversial issue. The high court heard arguments Monday in a case that has implications for medicine, agriculture, clean energy and beyond.
Myriad Genetics was the first company to identify two genes that, when defective, greatly increase a woman’s risk of breast and ovarian cancer, two of the most common and lethal forms of the disease.
The company patented the genes and used them to produce a test for the gene defects. Patent protection gave Myriad a 20-year monopoly to recoup its investment.
But outside the Supreme Court, American Civil Liberties Union attorney Chris Hansen said a part of the human body cannot be patented.
“The Supreme Court has held for 150 years that you can’t patent a product of nature. You can’t patent gold or iron. A human gene is nothing more than just the same thing. Its structure and function are dictated by nature. It’s not an invention," he said.
But isolating those genes took a great deal of work and a $500 million investment. Greg Castanias is Myriad’s attorney.
“It’s not just the work but it’s ultimately what the result of the work was, which was a new molecule that was never before available to the world, which has potentially lifesaving applications," he said.
The biotechnology industry says gene patents have led to other potentially lifesaving applications like synthetic insulin for diabetics, new treatment for anemia, and many other products.
Castanias says striking down these patents would stifle new advances.
“One possibility is that investment in the biotechnology sector might dry up. Another possibility is that inventions like these, instead of being protected by patents, companies might resort to trade secrets," he said.
Castanias says that while patents are freely available for others to study and learn from, trade secrets would push these discoveries underground.
But the ACLU’s Chris Hansen says the patents risk doing more harm than good.
“Myriad has the authority to stop all research on a piece of the human body. That ought to be sufficient harm in and of itself. But also, Myriad has, in fact, prevented women from getting a second opinion," he said.
A second opinion in the form of another test that could be more accurate.
Companies making biotech products from energy-producing algae to genetically modified cotton are watching the case closely. They are concerned that a strict ruling against gene patents could choke off innovation in the industry.
During oral arguments, the Supreme Court justices appeared to be seeking a balance. Many were skeptical that an isolated piece of DNA is substantially different from the same gene found in the body. But they seemed to be looking for ways to allow biotech patents that would protect innovation.
A decision is expected this summer.