On June 13, 2013, the Supreme Court ruled unanimously that natural human genes, including isolated genes, cannot be patented, but cDNA that is substantially different from the naturally occurring DNA is patentable. Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al.
The case involved the Salt Lake City company Myriad Genetics, which is the owner of patents for two isolated human genes, known as BRCA1 and BRCA2, whose mutations are highly linked to increased risk for breast and ovarian cancer. The company markets diagnostic tests for those particular mutations. The patents were challenged by scientists and doctors alleging that their research and ability to help patients had been hampered by the existence of those patents.
The central issue in this case was whether “isolated” DNA is patentable. Myriad argued that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally-occurring molecule. But the Court disagreed, reasoning that the claims are not written in terms of chemical composition, nor do they rely on the chemical alteration of the genes. Instead, the claims are focused on the genetic information encoded in the BRCA1 and BRCA2 genes. Although the encoded information is important and useful, such “groundbreaking, innovative, or even brilliant discovery” does not by itself guarantee patent eligibility.
Myriad also argued that it has long been the United States Patent and Trademark Office’s practice to allow patents for isolated genes. But the Court said that this long-standing practice was not a “sufficient reason to hold that isolated DNA is patent-eligible.”
With respect to cDNA, the Court held that cDNA is patentable because it cannot be isolated from nature and must be created in the laboratory, as long as the introns that are found in the native gene are removed. But at the same time, the Court said that very short sequences of cDNA may not be patentable because no intervening introns need to be removed when creating them.
Notably, the Court stated that this decision should not be applied to claims for methods of using human genes, or for human genes that have been mutated to be different from the naturally occurring genes