On June 13, 2013 the United Stated Supreme Court entered a unanimous ruling in Association for Molecular Pathology v. Myriad Genetics, Inc. In this case the Association for Molecular Pathology, and other petitioners, challenged that Myriad’s patents for isolated DNA sequences associated with predisposition to different cancers and the methods to diagnose them were invalid because they covered products of nature. Oral arguments for the case were on April 15, 2013 and Justice Thomas’s opinion was a concise 18 pages.
Myriad’s patents had given them the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes and then synthetically create BRCA composite DNA (cDNA). The cDNA only contains exons, nucleotides which code for amino acids. cDNA is made from mRNA in a lab, as cDNA does not exist in the human body. Using these discoveries Myriad developed tests which could detect mutations in BRCA genes to predict an increased risk of cancer. Myriad then used its patents to stop laboratories from using similar tests on BRCA genes, giving Myriad a monopoly. The Petitioners in this case sued to invalidate the patents and therefore break down the monopoly and bring down testing prices.
The US Supreme Court held naturally occurring DNA segments are a product of nature and cannot be patented. Myriad uncovered the precise location and genetic sequence of the BRCA genes but did not create or alter the genetic information. “It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself” qualify for patent protection.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2110 (2013).
However cDNA is not a product of nature as it does not naturally occur in the body. The human body does not produce molecules composed solely of exons; scientists in a lab had to remove the introns from a normal DNA sequence. “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2119 (2013)
This ruling does not affect method claims, patents on new applications of knowledge of genes, or other patents where the order of the nucleotides in DNA have been altered. These are still situations the US Supreme Court may decide to address in the future. If you are seeking to speak with an intellectual property attorney, you can contact Stone Law at 732-444-6303 or contact us on our website.