On June 13, 2013, the U.S. Supreme Court answered the question "Are human genes patentable?" The Court, in Association of Molecular Pathology et al. v. Myriad Genetics, Inc. et al., ruled that isolated DNA is a product of nature and not patentable subject matter, and that claims to synthetic DNA (cDNA), made by laboratory methods, are patentable.
Myriad Genetics' patents have claims directed to BRCA1 and BRCA2 genes and tests for determining the risk of breast cancer or ovarian cancer. With this genetic information, a person at risk could take affirmative actions to avoid the cancer, as actress Angelina Jolie did recently. The Court found that to be patentable, the DNA claimed must be distinguishable from natural DNA, though it remains an open question as to how distinctive a nucleic acid will have to be to avoid being considered natural DNA, a product of nature.
Justice Thomas, writing for the Court, found that if valid, Myriad's patents would give only Myriad the exclusive right to isolate the BRCA1 and 2 genes from an individual and to create synthetic DNA from those genes. Isolating the genes is a necessary step in the testing for the BRCA mutations, and patent infringement would be triggered if anyone other than Myriad isolated the genes or made cDNA. The Court discussed balancing the competing concerns of providing for patents that exist to promote creation and preventing the patenting of laws of nature and natural phenomena, which are the basic tools for scientific and technological work. Creation and invention result in patents, whereas even "groundbreaking, innovative or even brilliant discovery" may not result in patentable subject matter. The Court gave no deference to the fact that for more than 30 years the U.S. Patent and Trademark Office had allowed patents with claims to "isolated DNA," which was supported by the United States arguing that isolated DNA is not patent-eligible.
As cDNA is created in the laboratory, it meets the criteria for patentability because it is not naturally occurring, and as long as it is distinguishable from natural DNA, claims to cDNA remain patentable. However, if the cDNA is short and no introns were removed from the original sequence to create it, that cDNA would be similar to natural DNA and may "be indistinguishable" and not patentable subject matter.
The ruling was clear that method claims and new applications of knowledge about BRCA1 and 2 were not included, and claims to DNA with alterations to the nucleotide sequence were not addressed. How far the finding will be taken has raised questions about the patentability of inventions based on isolation of other chemical compounds, particularly those for natural products or those purified from plants or animals.