The Supreme Court issued a GVR (grant, vacate, and remand) in the much-watched patent case regarding the patentability of isolated human genes in Association for Molecular Pathology v. United States Patent Office, remanding the case to the Federal Circuit for further consideration in light of the recent decision in Mayo v. Prometheus.
On June 15, 2012, the American Civil Liberties Union, the U.S. Department of Justice, and others filed amicus briefs challenging patents on Myriad’s human breast and ovarian cancer genes, BRCA1 and BRCA2. The U.S. takes a position that the isolated genes are not patent-eligible because they are products of nature, not man-made inventions. The U.S. states that patents on isolated but unmodified genes would significantly preclude the public from using a product of nature, and the financial incentives do not make them patent-eligible. The Federal Circuit will hear the oral arguments on July 20, 2012.
Gene patenting has two sides: One side view is that patents may restrict doctors and scientists to use genetic information to treat patients with personalized medicine. The other side view is that in the most gene patents, the genes are taken out from the plants or patients to study and create better ways to grow crops or develop drugs for diseases. The company patenting the genes has the exclusive rights to sell or make those gene-based products for a short period of time. If a company is not allowed to patent the isolated genes or methods of manipulating the genes, they do not have the incentive to do research in those fields, which in turn will impact the modern medicine.
It will be interesting to see how the Federal Circuit will apply Mayo decision to Myriad‘s isolated DNA sequence claims. Both these decisions will likely have a significant effect on the biotechnology and pharmaceutical industries.