On Friday, the US Department of Justice said that genes should not be patentable, a significant reversal of longstanding policy. The opinion was delivered in an amicus brief filed in an ongoing legal battle that kicked off when the American Civil Liberties Union (ACLU) challenged the validity of patents held by Salt Lake City-based Myriad Genetics and the University of Utah on the breast cancer-linked genes BRCA1 and BRCA2. (The ACLU won the first round when a federal court ruled in its favor in March.) The new brief opines that isolating a gene does not fundamentally change its nature, much like extracting coal from the earth does not change the material.

However the chips may eventually fall in the Myriad appeal, gene patenting is still standard operating procedure. The US Patent Office has issued more than 40,000 patents for the alleles of more than 2,000 human genes. Should these patents stand, there’s a host of legal, scientific, and philosophical issues to be resolved. For instance, if a patent is issued for a gene, does that mean that the RNA transcript and the protein are patented as well? And how much wiggle room is there on the DNA sequence itself? One could imagine enterprising competitors introducing silent mutations in order to make the sequence just different enough to avoid patent infringement. Can a company use portions of patented genes to create their own sequences, the way rap artists sample other musicians? The legal precedent for the latter question doesn’t look favorable, as US courts have ruled that even a sequence of 3 musical notes can be copyrighted.

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