Patents are the legal protection that gives inventors the right to prevent others from making, using or selling a novel device, process or application. The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years, but opponents of Myriad Genetics Inc.'s patents on the two genes linked to increased risk of breast and ovarian cancer say such protection should not be given to something that can be found inside the human body.
The company has used its patent to come up with its BRACAnalysis test, which looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer. Women with a faulty gene have a three to seven times greater risk of developing breast cancer and also have a higher risk of ovarian cancer.
Myriad sells the only BRCA gene test. Opponents of its patents say the company can use the patents to keep other researchers from working with the BRCA gene to develop other tests.
"Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park, a lawyer for the American Civil Liberties Union Women's Rights Project. "Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."
Jolie revealed last month that her mother died of ovarian cancer and that her maternal grandmother also had the disease. She said she carries a defective BRCA1 gene that puts her at high risk of developing breast and ovarian cancers, and her doctor said that the test that turned up the faulty gene link led Jolie to have both of her healthy breasts removed to try to avoid the same fate.
Companies have billions of dollars of investment and years of research on the line in this case. Their advocates argue that without the ability to recoup their investment through the profits that patents bring, breakthrough scientific discoveries to combat all kinds of medical maladies wouldn't happen.
But "genes and the information they encode area not patent eligible ... simply because they have been isolated from the surrounding genetic material," Thomas said.
In a concurring opinion, Justice Antonin Scalia said "the portion of the DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state."
A Myriad spokesman did not immediately respond to a request for comment.
The court did rule that synthetically created DNA, known as cDNA, can be patented "because it is not naturally occurring," Thomas said.
And Thomas noted there are still ways for Myriad to make money off its discovery. "Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent," he said. And he noted that the case before the court did not include patents on the application of knowledge about the two genes.
KQED Forum program from April: Who Owns Your Genes?