New FASEB Member Society wins its challenge to gene patenting in the Supreme Court Created by on 6/21/2013 12:00:00 AM
By Meghan McCabe
In a unanimous opinion issued on June 13, the US Supreme Court ruled on the patentability of human genes. The named plaintiff in the case, new FASEB member society the Association of Molecular Pathology (AMP), brought its challenge against Myriad Genetics, a Utah based company. Myriad owned patents on the BRCA1 and BRCA2 genes (indicating a high likelihood of breast and ovarian cancer in women with the marker), which allows it to have a monopoly on testing for the genes.
The case involved two questions: (1) whether a section of DNA is patent eligible by virtue of removing it from the human body; and (2) whether laboratory-created complementary DNA (cDNA) is patent eligible. With regard to human genes, the Court wrote that “groundbreaking, innovate or even brilliant discovery does not by itself satisfy [the requirements for patentability under the Patent Act],” which invalidated Myriad’s patents on the BRCA1 and BRCA2 gene sequences.
In contrast, the Court found that “the lab technician unquestionably creates something new when cDNA is made.” This means that cDNA is sufficiently modified to be considered distinct from naturally occurring DNA, and can therefore be patented. Both conclusions by the Court agreed with the positions taken by National Institutes of Health Director Dr. Francis Collins and the U.S. Department of Justice.
AMP President Dr. Jennifer Hunt was pleased with the decision, and stated in an AMP press release, “There is no question that this is a critical and right decision for the future of medicine and science. Biomedical researchers, clinicians, and most importantly patients will see great benefit from this development.”
The full opinion of the Court can be found on the Supreme Court website.