The United States Supreme Court will decide the question of whether genes are patentable in the coming term. The decisions has broad implications for the biotechnology industry, for researchers and for patients. The case at hand is Association for Molecular Pathology v. Myriad Genetics, Inc. originally filed in the U.S. District Court for the Southern District of New York by the ACLU and the Public Patent Foundation. The object of the case is to challenge a number of patents granted to Myriad, a Utah biotechnology company, by the U.S. Patent and Trademark Office. The patents granted were on DNA isolated from two human genes that increase the risk to women for breast and ovarian cancer.
Myriad, from a combination of venture capital and NIH funding and collaboration was able to isolate the genes and is claiming the exclusive right to use the genes in research regarding the treatment of women afflicted with these forms of cancer. The trial court ruled that the isolation did not change the essential character of the DNA and was not a new composition of matter. Along the way there were many challenges to the standing of the plaintiffs to sue on the issue, but at least one of the plaintiff remains in place to allow the case to proceed.
The Federal Circuit Court of appeals has had two whacks at the issue, both finding in favor of Myriad. The second whack came after the Supreme Court vacated the first decision and directed the Appeals Court to review its decision in light of the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, where the court struck down a patent involving the relationship between drug dosage and the concentration of defined metabolites in the blood. The Court of Appeals panel declined to alter its ultimate conclusion on patentability of the Myriad genes. The issue here is whether the Myriad DNA is fundamentally the same substance and structure as the DNA in the body and not a human invention. It is the property rights of successful researchers vs. the right to pursue unrestricted research for the public good. Stay tuned.