On July 29, a federal appeals court ruled that individual genes may be patented, overturning a lower court decision that had reached the opposite conclusion. The case centered on the question of whether genes were inherently products of nature. In its ruling, the court found that genes were isolated DNA, having “been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body,” thus making them unique from “naturally-occurring” DNA.
The case revolved around patents held by Myriad Inc. for the BRCA1 and BRCA2 genes that are often mutated in breast cancer. The plaintiffs in the case, which included several researchers and the American Civil Liberties Union, challenged the right of the company to hold exclusive rights to what they felt were products of nature. While upholding the right of companies to patent individual genes, the appeals court actually invalidated Myriad’s BRCA patents, stating that the patents… “are directed to the abstract mental processes of comparing two nucleotide sequences” and therefore unpatentable.
The ruling reaffirms the judicial standard regarding gene patenting that had, until last year, held since 1980, when the first gene patents were approved by the Supreme Court. The U.S. Department of Justice upset this standard by filing a brief last fall in support of the plaintiffs in the case, thus awkwardly pitting the administration against the U.S. Patent and Trademark Office. The current ruling restored the previous standard, stating that “an entire industry [had] developed in the decades since the Patent Office first granted patents to isolated DNA,” and warning that “disturbing the biotechnology industry’s settled expectations now risks impeding, not promoting, innovation.”
An appeal to the Supreme Court is likely. ASBMB will continue to monitor the case.