The Supreme Court’s ruling that human genes cannot be patented paves the way for new, more affordable tests for breast and ovarian cancer risk.
With a unanimous decision, the high court’s ruling on Thursday ended the almost 20-year monopoly Myriad Genetics held over testing for BRCA 1 and 2 genes. Mutations to either gene indicate a high risk for breast and ovarian cancers.
The Supreme Court’s ruling invalidates about 5,500 patents on human genes. The result could be increased competition among companies to offer tests for a range of diseases. It also has implications for the future of medicine, which is becoming more personalized with advances in genetic testing.
In response to the ruling, Dr. Maurie Markman, Senior Vice President of Clinical Affairs and National Director of Medical Oncology at CTCA, said: "This is a critically important decision that has the potential to increase to pace of the introduction of exciting and beneficial developments in precision cancer medicine.”
What’s more, “this decision reaffirms the fundamental rights of the public and potential patients to their own genetic make-up,” Dr. Markman said. “It is, and has always been, inconceivable that a company could 'hold a patent' on a critical component of the basic structure of life.”
Opponents of Myriad’s BRCA 1 and 2 patents said that those patents blocked access to testing and stalled advances in medicine. Many women elected to remove their breasts or ovaries without enough information or second tests, opponents said. The company countered that patents are a critical part of what makes medical discovery possible.
Justice Clarence Thomas, writing the high court’s decision, said: "Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention."
The court, though, distinguished between naturally occurring genes and those that are manufactured in a lab. Man-made genes still can be patented, the court ruled, leaving the door open for further legal challenges.
Still, opponents of Myriad’s BRCA 1 and 2 patents celebrated the court’s ruling. Mary-Claire King, who discovered the BCRA 1 gene, said her lab at the University of Washington in Seattle will be ready with new, more affordable tests for breast and ovarian cancer risk.
“I’m as high as the flag on the Fourth of July,” King told NPR.
Learn more about ovarian cancer and breast cancer.