The much-contested question of whether or not a gene can be patented is under judicial scrutiny once again. The U.S. Supreme Court listened to oral arguments today regarding Myriad Genetic’s patent of two genes, BRCA1 and BRCA2, which have been linked to increased cancer risk in both women and men. The American Civil Liberties Union is challenging this patent on behalf of a group of researchers, medical groups and patients. The timing of the hearing is rather serendipitous, just one day after the 10th anniversary of the completion of the Human Genome Project. The Human Genome Project, a jointly funded venture from the Department of Energy and the National Institutes of Health, has opened the door to a wide array of genetic tests and targeted interventions.
The BRCA patent grants Myriad exclusive rights to test the sequence of these two genes and determine if a patient carries a deleterious mutation. BRCA mutations have been shown to lead to a three to seven-fold higher risk of ovarian or breast cancer in women and higher risk of prostate, pancreatic and other cancers in men.
The heart of the arguments before the Supreme Court is whether the identity of DNA is the same when it is within the context of a living cell, existing as a natural entity, or when it is a fragment, isolated outside of the cell. In the process of isolating the individual gene in order to determine the sequence, has Myriad created something novel that warrants patent protection? The company claims genes can be patented because DNA isolated from the body has a “markedly different chemical structure” from DNA within the body. The implications of this case can be far-reaching. Patent supporters argue there is an advantage to allowing patents as incentives for the biotechnology industry to invest in genetically targeted treatments. Opponents fear that these patents will hamper biomedical research, limit the opportunity for patients to receive a second opinion regarding their genetic risk and reduce the beneficial impact of future genomic testing if the results of patented genes cannot be disclosed.
Genetics experts interviewed by the Washington Post and the New York Times say that so far, it does not appear that research has been hampered by gene patents, but they do not deny the potential impact of a Supreme Court decision – expected later this summer – on the development of vaccines and other medical treatments. The patent for the BRCA genes is due to expire in two years.