UF expert: High court ruling barring patents on human genes to have big impact
Published: Thursday, June 13, 2013 at 4:49 p.m.
Last Modified: Thursday, June 13, 2013 at 4:49 p.m.
WASHINGTON — The Supreme Court ruled Thursday that companies cannot patent parts of naturally occurring human genes, a decision with the potential to profoundly affect women and the emerging and lucrative medical and biotechnology industries, experts at the University of Florida and nationwide said.
The high court's unanimous judgment reverses three decades of patent awards by government officials. It throws out patents held by Salt Lake City-based Myriad Genetics Inc. on an increasingly popular breast cancer test brought into the public eye recently by actress Angelina Jolie's revelation that she had a double mastectomy because of one of the genes involved in this case.
Justice Clarence Thomas, who wrote the court's decision, said Myriad's assertion — that the DNA it isolated from the body for its proprietary breast and ovarian cancer tests was patentable — had to be dismissed because it violates patent rules. The court has said that laws of nature, natural phenomena and abstract ideas are not patentable.
"We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated," Thomas said.
The court's ruling will have a profound impact on women and genetics researchers, said Bill Allen, an associate professor and director of the Program in Bioethics, Law and Medical Professionalism at the University of Florida.
"First of all, it means women who couldn't afford the BRCA1 and BRCA2 (cancer risk and genetic) tests may now be able to get the tests," Allen said, because other people will be able to create the tests now, without having to buy Myriad's test kit.
Researchers no longer will have to worry about potential patent infringement suits, he said.
"Now they are free to pursue their research instead of figuring out how to get around patent blockades," Allen said.
While the implications for testing are clear, the relationship to how synthetic drugs might be used in gene therapy drugs is unclear, said Dr. Barry Byrne, director of the UF Powell Gene Therapy Center. "The question will certainly be addressed as progress is being made toward commercialization."
The court did give Myriad a partial victory, ruling that while naturally occurring DNA was not patentable, synthetically created DNA could be patented. The court said synthetically created DNA, known as cDNA, can be patented "because it is not naturally occurring," Thomas said.
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' 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.
Myriad Genetics 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.
Angelina 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 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.
The court's ruling on synthetic DNA leaves the door open for future genetic patent work for companies like Myriad, lawyers said.
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 Thomas noted that the case before the court did not include patents on the application of knowledge about the two genes.
Most biotech companies have already moved on from trying to patent isolated DNA, instead looking at synthetic options and other ways of protecting their multimillion-dollar investments, said Matthew McFarlane of Robins, Kaplan, Miller & Ciresi LLP.
"On a day-in and day-out basis, I don't see this changing that part of the industry," McFarlane said. "Isolated DNA itself is not something that companies seek to protect anymore."
Myriad's stock price jumped 10 percent after the ruling and was above $36 a share in early afternoon trading.
The Associated Press and staff writer Jeffrey Schweers contributed to this report.