Patents on genes associated with hereditary breast and ovarian cancer were ruled invalid yesterday by a New York federal court. The ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes, according to the ACLU.
The ruling follows a lawsuit brought by a group of patients and scientists represented by the American Civil Liberties Union and the Public Patent Foundation (PUBPAT).
"Today’s ruling is a victory for the free flow of ideas in scientific research," said Chris Hansen, a staff attorney with the ACLU First Amendment Working Group. "The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas."
The ACLU’s and PUBPAT’s lawsuit against Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes, as well the U.S. Patent and Trademark Office (USPTO), charged that the challenged patents are illegal and restrict both scientific research and patients’ access to medical care, and that patents on human genes violate the First Amendment and patent law because genes are "products of nature."
The specific patents that the ACLU had challenged are on the BRCA1 and BRCA2 genes. Mutations along the BRCA1 and 2 genes are responsible for most cases of hereditary breast and ovarian cancers. The patents granted to Myriad give the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes.
William L. Warren, partner at Sutherland Asbill & Brennan, believes this is a “poor decision that may have negative short-term implications for financing in the biotechnology sector, and hence the development of new diagnostics and therapeutics, until it is overturned by the U.S. Court of Appeals for the Federal Circuit in the next one to two years. Certainly, the sequencing of genes and disease-associated mutations for use in developing diagnostic probes and assays provides useful nonnaturally occurring subject matter that should qualify for patentability under the statute.
“While native genes in the body are originally products of nature, isolating portions of the DNA in order to perform a diagnosis transforms the DNA structurally and functionally into patentable subject matter,” he continues. “The isolated DNA has been markedly changed to become a useful product, even though it carries some of the same information as the native gene.
“Whether through the progress of scientific knowledge and techniques the isolation of such DNA fragments becomes routine or obvious is a separate question, which was not at issue in this case.”