Doubts raised over US gene patents

The US Department of Justice (DOJ) has weighed in on the complex issue of gene patenting against the principle that genes should be eligible for patent protection, reversing the government's position on the matter and causing consternation for many biotechnology companies. This week it issued a legal brief as a 'friend of the court' joining a lawsuit challenging the rights of companies to patent genetic technologies.

The American Civil Liberties Union and Public Patent Foundation recently organised a lawsuit to challenge a specific patent held by biotechnology company Myriad Genetics. The court ruled in March 2010 that patents on tests for BRCA1 and BRCA2 genes, which are both implicated in increased risk of breast and ovarian cancer in women, were invalid. Myriad's patent allows them to charge $3,000 for the use of their exclusive diagnostic technology. The company has now taken the case to the higher Court of Appeal which is yet to pass judgment. In the meantime, gene patenting in the country continues and the US Patent and Trademark Office has said it will not reject patents for genes whilst litigation is pending.

The US does not permit patents for actual genes but on genetic sequences identified by researchers, on genetic tests for those sequences, and on correlations between sequences and specific diseases like Alzheimer's. The US Patent and Trademark Office has issued 35,000 patents involving around 2,000 human genes. The government has generally supported the rights of researchers and companies to patent their research but the latest move effectively sides DOJ with the plaintiffs in this matter, say lawyers for the American Civil Liberties Union.

In the brief, lawyers from the DOJ stated: 'The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is 'isolated' from its natural environment than are cotton fibres that have been separated from cotton seeds or coal that has been extracted from the earth'.

The US Biotechnology Industry Organisation (BIO) is not pleased. 'If adopted, the Department of Justice's position would undermine US global leadership and investment in the life sciences', said BIO president Jim Greenwood. Hans Sauer, a lawyer working for BIO, explained: 'Gene patents are no different than patents granted to antibiotics extracted from fungus or to adrenaline purified from cow tissue'. He asked how companies are expected to recoup the costs of their research without patent protection, with development costs for a new drug costing on average $1.2 billion.

The US government says it awards patents to promote scientific progress. Without them, it says researchers might not want to pursue research for fear that others would duplicate and sell off their work without compensation. But it has tried to find a balance between granting patent protection and allowing access to genetic research. In October, a committee from the Department of Health and Human Services recommended changing federal law so that those who use genetic sequences patented by others to diagnose patients cannot be sued for patent infringement.