On 13 June 2013 the United States Supreme Court ruled that human genes cannot be patented. The unanimous decision stated that isolating specific genes was not worthy of a patent.

The case considered by the high court dealt with patents held by Myriad Genetics, Inc. for two genes (BRCA1 and BRCA2) that have been linked to breast and ovarian cancer. The company uses the genes to test patients for their risk of developing cancer.

“Myriad did not create anything,” wrote Justice Clarence Thomas on behalf of the court. “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.”

“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,” Thomas wrote. “But the processes used by Myriad to isolate DNA were well understood by geneticists at the time.”

Despite striking down the patents on human genes, the Supreme Court did uphold Myriad Genetics’ right to patent cDNA, which is created from RNA that is reverse transcribed via an enzyme. As one science blogger points out, this is simply a change of media. “This is like saying you couldn’t patent a recipe on paper, but if you transfer it word for word onto sheepskin, it becomes patentable,” wrote Dr. Mark Hoffnagle on his blog about denialism.

Dr. Francis Collins, the director of the National Institutes of Health, praised the court’s decision: “The right to control exclusively the use of a patient’s genes could have made it more difficult to access new tests and treatments that rely on novel technologies that can quickly determine the sequence of any of the estimated 20,000 genes in the human genome. Such approaches form the cornerstone of the rapidly emerging field of personalized medicine, in which diagnostic, therapeutic, and preventive strategies can be tailored to each person’s unique genetic makeup.”

There are roughly 4,000 gene-related patents in the United States.

 


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