The Supreme Court today issued its much-awaited decision in the Myriad Technologies case. At issue in the case were Myriad’s patents on the BRCA1 and BRCA2 genes — genes which are important genetic markers for determining susceptibility to breast cancer. Myriad discovered “the precise location” of the two genes (on chromosomes 17 and 13), and sequenced the two genes to determine the precise nucleotide pattern in each. That information, in turn, enabled Myriad to develop medical tests that are useful for detecting mutations in a patient’s BRCA1 and BRCA2 genes and thereby assessing whether the patient has an increased risk of cancer. Because of the patents, Myriad claimed the “exclusive right to isolate an individual’s BRCA1 and BRCA2 genes” — that is, the exclusive right to perform these diagnostic tests, because isolating the gene in any individual constituted an infringement of their patent.
Myriad also had patents covering the so-called “cDNA” — composite DNA. These are nucleotide strands derived from the genes, but not identical to them; the cDNA for the BRCA1 gene consists of only those portions of the gene (the “exons”) that are used during the process of protein production, and it omits the non-coding portions of the original gene (“introns”).
The Court (9-0, opinion by Thomas) invalidated Myriad’s patents on the genes themselves, because Myriad had not “created” anything but had rather ”discovered” the naturally-occurring characteristics (location and sequence) of the genes in question:
It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2