On Monday, the U.S. Federal Appeals Court in Washington D.C. heard testimony in a case that may well set legal precedent on the ability of companies to obtain patents on natural materials. The case centers on two patents held by Myriad Genetics that cover the BRCA1 and BRCA2 genes, mutations in which are highly linked to breast cancer. The company is being sued by a consortium of research and patient advocates who argue that the patents illegally allow Myriad to develop exclusive genetic tests for the mutations, thus limiting diagnosis and treatment options.
The majority of Monday’s hearing centered on whether the act of identifying and isolating a gene is a patentable act of human ingenuity, or whether a gene is a product of nature, regardless of whether it has been isolated or not. The three-judge panel peppered lawyers on both sides with highly technical questions on the science behind genetic manipulation, but offered no hint as to how they intended to rule.
The case has produced the extremely unusual circumstance of having the government argue against itself. The U.S. Patent Office was named a defendant along with Myriad, as government policy has, actively or not, allowed patenting of genetic material ever since the Supreme Court ruled in Diamond v. Chakrabarty that products of genetic engineering were eligible for protection. However, the Department of Justice has now taken a stand against that position, first filing an amicus brief in favor of the plaintiffs back in November, and then testifying on their behalf in front of the Appeals Court.
The Appeals Court is expected to deliver their decision over the summer.