Thursday, June 13, 2013

Human Genes Can't Be Patented Unless They're Custom Made

In one of the most important rulings on its calendar, the Supreme Court today ruled that human genes, even those isolated by biotech companies, cannot be patented. The unanimous decision hinged on the fact that while a company can develop the process to isolate a gene, it didn't create it in the first place, which makes patenting them impossible.

It's a nuanced decision that has huge implications for researchers and medical patients, and still leaves open the possibility that custom genes could still be patented.

Justice Clarence Thomas wrote the Court's opinion for Association for Molecular Pathology v. Myriad Genetics, Inc., which pitted patient advocates against Myriad Genetics. Myriad held patents for the location and sequence of a pair of genes that, when mutated, can be a precursor to breast and ovarian cancer.

The key point in the case was the difference between naturally occurring DNA and complimentary DNA, or cDNA, which is synthetically created. Stating that "groundbreaking, innovative, or even brilliant discovery" doesn't by itself satisfy patent requirements, Thomas wrote, "Myriad did not create anything. 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." Essentially, the Court held genes to the same patent standards as anything else: You can patent something only if you created it.

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