Is this the end of gene patenting?

A court in New York yesterday ruled that patents on two genes linked to breast cancer are invalid.

By declaring that the genes can't be patented because they are essentially products of nature rather than inventions, the US District Court for the Southern District of New York state has effectively cast doubt on whether patents on 2000 other human genes - around 20 per cent of the total - are valid, The Times of London reports.

The American Civil Liberties Union (ACLU), which brought the case, said that the victory would stop holders of gene patents from cashing in on monopolies over chemicals such as DNA that occur in nature, and so don't qualify as patentable inventions. "The human genome, like the structure of blood, air of water, was discovered, not created," said Chris Hansen, an attorney with the ACLU.

The patents that were challenged cover variants of two genes, BRCA1 and BRCA2, which raise women's chances of developing breast cancer. Myriad Genetics of Salt Lake City, Utah, developed and patented tests that enable doctors to identify women at risk by checking whether they've inherited the variants.


The ACLU and its supporters, including the American Society for Human Genetics and the American Medical Association, contend that the patents never should have been awarded because the genes are natural. They argue that women may be denied tests if they or their doctors can't afford the tests. By owning the patents, Myriad has been able to stop others developing cheaper or free versions of the tests, and to block research towards cheaper versions.

The court backed the ACLU's main rationale for challenging the patents - that they are products of nature.

"Because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter," it says in its verdict. "Purification of a product of nature, without more, cannot transform it into patentable subject matter," it argues.

The court failed to back the ACLU's contention that in awarding a patent on a product of nature, the US Patent and Trademark Office violated the US constitution.

But the verdict is the latest in a series of disputes over the patentability of genes that began in 1991 when New Scientist revealed that the US National Institutes of Health had applied for patents on genes.

The BRCA genes have since been at the centre of the row, although thousands of other genes have been patented since. The US court's decision echoes that of the European Patent Office, which in 2004 revoked Myriad's patents on both genes.

The US court's decision now challenges the validity of all other gene patents, and throws open the question of whether there are any other ways to commercialise tests and treatments based on human genes.