U.S. Supreme Court: Human DNA Cannot be Patented. (Association for Molecular Pathology v. Myriad Genetics, U.S. Supreme Court, No. 12-398.)
On June 13, the US Supreme Court unanimously held that naturally occurring human genes cannot receive patent protection. The ruling served as a partial victory for science and biotechnology as the field fought to gain protection for the genes.
This action was commenced by a group of medical researchers, associations and patients represented by the American Civil Liberties Union against Myraid Genetics, a biotechnology company. The researchers challenged Myraid’s seven patents for isolated BRCA1 and isolated BRCA2 genes. These two genes are associated with hereditary forms of breast and ovarian cancer.
Justice Clarence Thomas wrote the opinion of the Court. The opinion states that naturally derived genes may not receive patent protection. However, synthetic DNA (cDNA) may be eligible for protection since it has been manipulated in such a way that it alters the natural state and creates something new. The Court heeded the advice of the Obama Administration when forming the opinion which provided for protection of some genes. It was thought that a complete denial of all forms of protection would have irreparable impact on the biotechnology market.
What does this mean for prospective patients?
Most directly, this ruling means that other companies and diagnostic groups will have access to these genes to begin testing. This could lead to lower prices for patients, greater access to tests for patients who cannot afford Myraid’s $3000 fee, and the ability for second opinions. More importantly, it will allow for other companies to engage in research using the genes. Expansive breast cancer and ovarian cancer gene research can only help to discover treatments and possible cures for the life threatening illnesses.
The Myraid decision will also apply to the over 4000 human genes currently receiving patent protection.
What does this mean for Myraid?
Myraid’s patents in dispute will expire in 2015. Myraid indicated that the ruling protected its most important patents. However, without patent protection there is a strong possibility that competing companies will begin to market Myraid’s once protected gene tests. Increased competition and open access to Myraid’s once monopolized gene testing could have dramatic effects on the company’s value. As with any other business or product, an oversupply of the testing at various companies will lead to a decrease in Myraid’s pricing and distinction. Additionally, all investments linked to and profits derived from the once protected genes will no doubt take a large hit as investors remove monies. Yet, some experts indicate that many of gene patents constitute cDNA as opposed to naturally derived DNA. Therefore, only time will tell the true impact of this ruling on Myraid and the world of gene testing.