A U.S. Supreme Court decision this week on gene patents means patients will benefit — and may pay less in the future to understand their risk for cancer and other inherited diseases, according to basic-science experts.
Researchers in Philadelphia were among the first group to sue Utah company Myriad Genetics over its patent for the “breast cancer genes,” BRCA1 and BRCA2.
For two decades, Myriad held the exclusive right to create — and profit from — tests that tell women if they had those mutations and a resulting higher risk for breast and ovarian cancer.
When women learn they have the gene variants, doctors sometimes counsel patients to have a preventive double mastectomy. Actress Angelia Jolie revealed last month that she had the surgery to ward off cancer.
The Supreme Court decision this week loosened Myriad’s hold on the BRCA-testing market.
“It will also spur innovation,” said Jeffrey Rosenfeld, an assistant professor of medicine at the University of Medicine and Dentistry, New Jersey. “There was a patent on almost every single gene. So, if I start a company, that involved a certain gene, I always had that halo that maybe I will get sued.”
‘Cease-and-desist’ letters, threat of suit
Rosenfeld said Myriad vigorously defended its patents.
“I had to pay Myriad, if I wanted to sequence the breast cancer gene. Nobody else could do it. Anybody else that did it would get a cease-and-desist letter, and get sued,” Rosenfeld said.
When scientists “sequence” a person’s genetic material, they read the code. That process can distinguish cancer-prone genes from healthy ones, and sometimes becomes a test for elevated disease risk.
University of Pennsylvania geneticist Arupa Ganguly received a “cease-and-desist” letter in 1998, and it had the intended chilling effect.
Soon after, her lab had to stop telling patients when researchers discovered the breast cancer genes in the process of doing other investigations.
“This meant monopoly, this meant no competition, the price can be whatever they choose it to be,” Ganguly said.
Ganguly said BRCA testing cost from $3,000 to $4,000. Sometimes that price tag is covered by health insurance, but when patients have to pay out of pocket, Ganguly said she thinks many people don’t get tested because they can’t afford it.
Gene patents have also prevented non-patent holders — sometimes academics and sometimes true for-profit competitors — from offering a second opinion on Myriad’s results.
Other implications of ruling
Today, Ganguly conducts research on a rare disease in children called hyperinsulinism. Before this week’s court ruling only Athena Diagnostics, a company in Massachusetts, could tell families if a child was at risk.
Ganguly says now she and other researchers around the country can help out too.
The ruling only blocks patents on pieces of DNA that occur in the body naturally.
Patents on synthetic genes — DNA that is manipulated in a lab — remain valid.