The U.S. Supreme Court (SCOTUS) ruled today that isolated human genes could not be patented, while synthetic DNA can be patented. This ruling is viewed by some as a compromise in a case that will change the playing field for research in the agriculture and pharmaceutical industries. The ACLU brought the lawsuit on behalf of several groups in order to prevent Myriad Genetics Inc. from holding patents on human genes linked to breast and ovarian cancer. According to a June 13 Washington Post article, Myriad Genetics may have isolated naturally occurring BRCA1 and BRCA2 genes for breast and ovarian cancer, but that does not give the company the right to patent them. The court ruled that researchers created cDNA, so they can patent it.
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The case was Association for Molecular Pathology v. Myriad Genetics, No.12-398. The question was whether isolated human genes are “products of nature” or not. Products of nature cannot be patented while “human-made inventions” may have patent protection.
The decision is being called a split decision or compromise that will stop firms like the Utah based Myriad Genetics from slapping patents on natural human genes. Such patents inflate costs and interferes with other research projects. Scientists will be able to do genetic research without a patent holder coming along to sue them. As for synthetic genes, patents should go to the first lab to make that gene.
Justice Clarence Thomas wrote the opinion for the court, saying
“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. Groundbreaking, innovative or even brilliant discovery does not by itself satisfy the criteria.”
Myriad expected to rake in a lot of money for their gene isolation discovery. Angelina Jolie had a genetic test to help her to determine her chances of having breast cancer. Jolie made news when she wrote about the test and her decision to have a double mastectomy. BRCA1 and BRCA2 are very rare genes that cause a very high likelihood of developing breast cancer. Thanks to Myriad’s patent, the tests were too expensive for most women.
According to a June 13 New York Times article, Jolie’s test could cost about $3,000. This is partially because of Myriad’s patents. Myriad was also suing anyone who was studying the gene, claiming patent infringement. The SCOTUS ruling will stop Myriad’s interference and lawsuits for good. A better result is that the costs for the tests should go down.
On the other hand, research companies will complain about the costs of isolating human genes. One threat is that no one will bother to isolate human genes because there is no money in it. That is unlikely, since isolating human genes is an important step toward creating synthetic genes. Researchers can reap their profits from the synthetic versions.
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