Wednesday, August 22, 2012

Human Genes ARE Patentable (At Least for Now)

In yet another installment of the long-standing battle, over whether human genes are patentable, the U.S Court of Appeals for the Federal Circuit has affirmed its earlier ruling that human genes ARE patentable once they are isolated and sequenced. But first they had to get past a Supreme Court ruling that “products of nature” cannot be patented.

A company called Myriad Genetics believed that it held valid patents on two important gene variants; the BRCA1 and BRCA2 genes that confer an especially high risk of breast cancer in women. Myriad Genetics argued successfully this time around that once a gene has been isolated and sequenced, it is in a form that never appears in nature! Technically, they are right; in nature a gene is always associated with histone proteins and is always part of a much larger DNA sequence that constitutes a chromosome. An isolated and fully sequenced gene, according to Myriad Genetics, is a chemically altered structure produced by man, and hence is patentable. The Court of Appeals agreed. An analogy would be that a baseball bat (a form invented by man) is patentable, but a tree trunk (a “product of nature”) is not.

Not everyone likes the ruling, for it appears to stand on a technicality; that “in nature” genes are associated with histone proteins. Everyone knows that it’s knowing and controlling the nucleotide sequence of genes that’s going to be important commercially – not the presence or absence the histones. But for now the ruling stands, and Myriad Genetics can continue to control the market for BRCA1 and BRCA2 gene test kits. And that’s the point of patents, isn’t it? Patents provide the incentive for companies to spend money developing important new technologies, such as tests for a high-risk genes.

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