Justice Thomas wrote for the Court in a unanimous ruling, issued on June 13, 2013, that human genes isolated by scientists are not patentable. The American Civil Liberties Union (ACLU) brought suit in 2009 against Myriad Genetics, Inc., which held a patent on genes (BRCA1 and BRCA 2) that are known to detect breast cancer. As a result of the patent, Myriad held a virtual monopoly over predictive testing for breast and ovarian cancer, to the detriment of women worried that they were at risk. Any other company was barred from examining a woman’s BRACA1 and BRACA2 genes, and Myriad charged upwards of approximately $3,000 per diagnostic test.
The ACLU claimed that the Myriad patents were overbroad and barred scientists from examining the genes, thereby implicating the First Amendment. However the central issue was whether the patents were merely abstract ideas that a person’s risk of cancer could increase depending upon how nature made the genes, or rather patentable, human-made inventions. The Court held that isolated human genes are products of nature, and merely locating and isolating them is far removed from creating the genes or altering genetic information within the genes. However, the Court held that synthetic DNA, otherwise known as complementary DNA or cDNA, is patentable as a human invention.
Biotech business interests are implicated in this decision, and there is a split in predictions about the effect this will have on innovation. Some predict that the decision will chill research and development because the monetary incentive is no longer present. However others predict that companies will still profit from their innovations. Justice Thomas wrote that companies may patent the method of isolating a gene, but that Myriad was unable to do so because geneticists were already well-aware of its process for isolating BRCA1 and BRCA2.