The U.S. Supreme Court ruled unanimously Thursday that isolated human
genes are not patentable, but synthetic DNA is.
The decision, in a lawsuit over Utah-based Myriad Genetics' patents on genetic material that increases the risk of breast cancer, comes in the midst of new research that shows the inherited genes patented by Myriad are common in African-American women.
Those challenging Myriad Genetics' patents argued that they were unwarranted because the company did not invent anything and that the genes, BRCA 1 and 2, are natural products. Myriad Genetics argued that the genes were no longer natural products because they had been isolated through human ingenuity. The court heard oral arguments on April 15.
"Myriad's claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together," the court's written opinion says. "The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section."
The court's decision means, in effect, that Myriad Genetics can continue to charge patients to test whether the genes exist, but it allows other companies to develop other methods to identify the genes without the worry of patent infringement.
The decision could well affect black women in the Milwaukee area, where officials at Froedtert Hospital and the Medical College of Wisconsin are producing a documentary that aims to increase awareness about breast cancer risk and treatment among low-income or under-insured African-American women.
Jean Baker, a patent attorney in Milwaukee with experience in biotechnology patents, called the court's decision a compromise, saying that patents on synthetic genetic material still give businesses some exclusivity while encouraging others to create competing designs.
"The idea that you could take naturally occurring genetic information and rearrange it into something of a commercial commodity is still going to be OK," Baker said. "You just can't have a patent on the entire naturally occurring gene."
The court's decision is a long time coming for researchers and health care providers who have run into barriers when trying to treat patients who may have one of the breast cancer susceptibility genes, but do not know because of the lack of affordable options to conduct testing to find the gene.
"I think it's going to be offered in more places," said Jenny Geurts, a genetic counselor at Froedtert. "Other technology such as next-generation sequencing will be able to be pursued.
"We're pretty excited."
The news may not be so welcome to some businesses who have other patents on genetic material. The U.S. Patent and Trademark Office has been doling out patents on genes since 1982.
"There are many invalid patents out there now," Baker said. "Businesses and lawyers are going to have to figure out what is valid and what's invalid."
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