The Supreme Court’s decision that struck down patents for genes isolated from the body but affirmed patents for synthetized DNA is likely to make genetic tests more affordable and may have implications for synthetic biology, say Hastings Center scholars.
The unanimous decision invalidated several patents held by Myriad Genetics on the BRCA1 and BRCA2 genes, mutations of which increase the risk of breast and ovarian cancer. The court held that a gene isolated from the body cannot be patented because it is a “product of nature.” Myriad’s patents on the BRCA1 and BRCA2 genes gave it the exclusive right to study the genes and test for them. With those patents invalidated, tests for the BRCA 1 and BRCA2 mutations, as well as other genetic tests, should become more affordable, says Josephine Johnston, a Hastings Center research scholar and director of research operations, who is a New Zealand-trained lawyer. “The patenting of naturally occurring genes has never made sense,” says Johnston. “With this unanimous decision, the Supreme Court has corrected a misinterpretation of the law, and removed a barrier to research and care.”
The decision may also have implications for synthetic biology, says Gregory Kaebnick, a research scholar and investigator on the Hastings Center’s research project on synthetic biology. “Many genes on which patents have been filed are actually not human genes but bacterial genes, which are then combined with other genes in novel ways to create new biological systems,” explains Kaebnick. “Exactly how the decision will affect this work remains to be seen.”
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