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Doubts raised over US gene patents

8 November 2010
Appeared in BioNews 583

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.


A Patent Mistake? DOJ’s Reversal on Genes Raising Questions.
Wall Street Journal |  2 November 2010
Gene Patent Ruling Raises Questions for Industry
New York Times |  2 November 2010
Has the US government abandoned gene patents?
Nature: The Great Beyond |  1 November 2010
Justice Department Raises Doubt on Gene Patents
ScienceInsider |  1 November 2010
US government wants limits on gene patents
Nature News |  2 November 2010
U.S. Govt Backs ACLU and PUBPAT in Gene-Patenting Case
GEN |  1 November 2010
US justice department raises doubt over gene patents
New Scientist |  3 November 2010
U.S. Says Genes Should Not Be Eligible for Patents
New York Times |  30 October 2010
1 October 2012 - by Ruth Saunders 
The American Civil Liberties Union has asked the US Supreme Court to reconsider its decision to uphold the patent held by Myriad Genetics on two human genes associated with hereditary breast and ovarian cancers...
20 August 2012 - by Dr Sarah Spain 
In the latest instalment of a highly contested case, the US Federal Circuit Court of Appeals in Washington DC upheld Myriad Genetics' right to patent two genes, BRCA1 and BRCA2,which are associated with the risk of breast and ovarian cancer....
2 April 2012 - by Dr Sarah Spain 
The US Supreme Court has ordered that the two gene patents held by Myriad Genetics be sent back to the US Court of Appeals for the Federal Circuit, to be re-examined...
23 January 2012 - by Ayesha Ahmad 
Myriad Genetics, a leading US molecular diagnostic company, has been granted exclusive rights to an analysis of the RAD51C gene. Mutations of the gene have been associated with an increased risk for hereditary breast and ovarian cancer and the company now hopes to develop a commercial test for RAD51C....
14 November 2011 - by Martin Turner 
In what appears to be the end of a long running legal saga, a ruling by the UK's Supreme Court has found in favour of a patent for a gene and the protein sequence it encodes. Lawyers say that the ruling will make it easier to patent discoveries which do not have a clear demonstrated application, a result that will largely please the private bioscience industry but may alarm many who believe that human genes should not be patentable....
14 June 2010 - by MacKenna Roberts 
The Australian Federal Court in Sydney is considering groundbreaking legal action of whether private companies can obtain patents on human genes....
19 April 2010 - by Harriet Vickers 
Researchers examining gene patents used in diagnostic tests say these can block competition and slow innovation, rather than spur development of new technologies for assessing the risk of genetic diseases...
6 April 2010 - by Dr Vivienne Raper 
A US judge has invalidated a genetic testing company's patents on two breast cancer genes...
15 February 2010 - by Nisha Satkunarajah 
A Californian biotechnology company has obtained the first US patent for developing a method to create stem cells from adult cells....
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