A federal appeals court ruled on Friday that genes can be patented, overturning a previous decision by a lower court.
The Court of Appeals for the Federal Circuit ruled that Myriad Genetics was entitled to patents on two human genes used to predict if women have a heightened risk of developing breast and ovarian cancer.
Why the change in ruling? The court said that DNA isolated from the body was eligible to be patented because its chemical structure is “markedly different” than that of DNA inside chromosomes.
Because of this distinction, isolated DNA is not a product of nature and can be patented, according to the court’s ruling.
Judge Alan D. Lourie writes:
In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified. They have to be chemically cleaved from their chemical combination with other genetic materials. In other words, in nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.
You can read the entire document here (.pdf).
Its finding defies the Obama administration’s argument that isolated DNA should not be patented. As you might expect, the U.S. Patent and Trademark Office has not entertained patents of this nature.
Despite the ruling, there’s one catch: the process to evaluate whether a patient’s genes had mutations that increased his or her risk of cancer was not patentable.
Nevertheless, the case may eventually reach the Supreme Court. The arguments on each side focus on future innovation: the biotechnology industry argues that patents are necessary to encourage it, while federal prosecutors say innovation is exactly what patents stifle.
Andrew Cohen outlines the next steps at The Atlantic:
Its going to take at least a few more years for the Supreme Court to resolve this case — and it will take longer still for the courts to resolve the new cases cropping up in this area. The law always lags behind new science. In this case, the lag is costing lives.
To date, thousands of isolated human genes have been patented.