Duke Study Says Gene Patents Harm Innovation

Just weeks after a surprise court ruling fed into the ongoing debate over the merits and dangers of patenting genes, a study by the Duke Institute for Genome Sciences & Policy says the practice of patenting genes does more harm than good. The patents primarily served to block competition in the gene testing market, rather than encourage companies to develop new products. Duke IGSP based its findings, published this week in Genetics in Medicine, on a series of case studies looking at genetic risk testing for ten diseases, ranging from breast cancer to cystic fibrosis to hearing loss. The studies were conducted at the behest of the US Secretary of Health and Human Services Advisory Committee on Genetics, Health, and Society. The problem, said Duke IGSP, was not gene patenting itself, but the practice of giving a single entity the exclusive license on a broad patent. The majority of gene patents were originally held by universities or other non-profits, and licensing practices have varied by institution. The study comes out just weeks after a federal judge struck down patents owned by Myriad Genetics covering two genes—BRCA1 and BRCA2--associated with breast cancer. Myriad licensed the genes from University of Utah, and has since built a healthy business around selling BRACAnalysis, a $3,120 test that predicts breast and ovarian cancer risk. As we explained at the time of the ruling, U.S. District Court for the Southern District of New York Judge Robert W. Sweet said the patents were invalid because the genes were a product of nature rather than an invention. Myriad argued that plucking out the genes relevant to predicting cancer was a transformative process and therefore made the genes patentable. The company is expected to appeal, meaning Myriad's test sales will likely be safe while the case winds through the court. But the case  and Myriad's relative monopoly on BRCA analysis underscores the competition concerns highlighted in the Duke study. The Duke researchers point out the benefits of spreading the patent love:  in the case of cystic fibrosis, there is a booming market for tests to pinpoint carriers of the disease-causing gene, for which the patent was never exclusively licensed to a single company. So, to patent or not to patent? They’re already out there, but should they be valid? As more companies study the multiple genetic factors associated with diseases, will these types of broad patents held by individuals keep important tests off the market?

Author: Lisa Jarvis

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