In a landmark decision, the U.S. Supreme Court unanimously ruled Thursday that naturally occurring human genes cannot be patented
. However, all nine judges agreed that a synthetic version of genetic material can be patented.
The case stems from a suit filed against a Utah-based biotech company, Myriad Genetics, that was claiming patents on the BRCA1 and BRCA2 genes. BRCA stands for Breast Cancer Susceptibility gene 1 and gene 2. Mutations linked to the genes significantly increase the risk of hereditary breast and ovarian cancer.
Actress Angelina Jolie, who carries the BRCA gene, and whose mother died of ovarian cancer, had Myriad’s breast cancer test and subsequently went public with the diagnosis that she carried the defective gene. She had a preventive double mastectomy earlier this year.
The overarching legal issues pitted the scientific/business community against patient right and civil liberties groups. The medical industry argues that patents foster expensive investment in medical research and brings down the cost of testing and treatment. The patent system also provides a time limit for a company holding a patent, ensuring that extremely expensive drugs are eventually made available in less-costly generic form, for instance.
Patient advocacy groups argued that the patents limited the diagnostic care and information available to high-risk patients. The ruling will enable scientists and labs not associated with the biotech company Myriad to provide genetic diagnostic testing.
The court sided with the Obama administration position; DNA is not patentable, but cDNA, Complementary DNA artificially synthesized in a lab, can be.
"Myriad did not create anything," wrote Justice Clarence Thomas, who wrote the 9-0 decision. "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."
Both sides of the case, Association for Molecular Pathology v. Myriad Genetics (12-398), are claiming some semblance of partial victory.
Peter D. Meldrum, president and chief executive officer of Myriad, said the ruling "underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," CNN reported.
Characterizing the ruling as the elimination a major barrier to patient care and medical innovation, Sandra Park, senior staff attorney with the ACLU Women's Rights Project, said, "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."
The National Cancer Institute estimates that about 12 percent of all women will develop breast cancer at some point. For women carrying the BRCA mutation, the risk increases to 60 percent. Jolie’s doctors estimated her risk to be as high as 87 percent.
Since 1984, the U.S. Patent and Trademark Office has granted more than 40,000 patents tied to genetic material. About one-fourth of the 22,000 human genes have been patented — patents that are now invalidated.
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