On 13 June 2013, the US Supreme Court rendered unanimous, landmark decision in the gene patenting case Association for Molecular Pathology v. Myriad Genetics that merely isolating genes found in nature is not a patent-eligible subject matter.
The defendant of the case Myriad Genetics is the company which first identified and isolated BRCA1 and BRCA2, genes capable of indicating a predisposition to breast and ovarian cancer. Seven of the company's twenty-three patents related to BRCA1 and BRCA2 were challenged in the case by Association for Molecular Pathology et al., covering isolated DNA sequences, methods for diagnosing propensity to cancer by looking for mutated DNA sequences, and methods for identifying drugs using isolated DNA sequences.
The question at issue is whether a company actually invents anything when it isolates a genetic sequence. Prior to the case, patents on isolated DNA sequences were accepted by the U.S. Patent Office as a composition of matter. However, according to the supreme court's interpretation, genes encoded by Myriad Genetics are not patent eligible under US Code Section 101 merely because they have been isolated from the surrounding genetic material, as the naturally occurring DNA segment is a product of nature.
In the US there were about 2,000 isolated human genes which had been patented before the start of the case. The supreme court has been careful to avoid broad, precedential decisions, by pointing out specifically that cDNA, the company's another patented but synthetic product, is patent eligible because it is created in the laboratory and not naturally occurring.
The court further stressed that the case does not involve a method claims offering innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, and there is no new application of knowledge about the BRCA1 and BRCA2 genes either.