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US Task Force recommends free research and health care access to patented genes

18 October 2009
Appeared in BioNews 530

The US Secretary's Advisory Committee on Genetics, Health, and Society has accepted a new report from a dedicated Task Force, which recommends that scientists should be allowed to use any gene for research and patient treatment, even when it is patented.

In both the US and Europe, patents can only be awarded for inventions, not for discoveries. However, genetic testing procedures could be considered to be either of the two, leaving the floor open to more practical arguments. Advocates of gene patenting argue that patents stimulate research, investment and cooperation between industry and academia, but opponents fear that patents may limit patient access to genetic tests and prevent genetic discoveries from being further researched to their full potential.

The strong stance of the Task Force on Gene Patents and Licensing to limit the scope of gene patents comes as a surprise, as findings in the report - of which a draft version was made public in March - that lead to these conclusions seem mild. It states that patenting currently does not impede patient and clinical access to genetic tests and that it does not cause 'widespread overpricing' of these tests. On the other hand, the Task Force also found that there is no great necessity for the existence of gene patents, as they only form a minor stimulus rather than a major incentive in genetics research, and unpatented genetic findings are developed into tests as much as patented ones.

Representatives of the biotech industry fear that this undermining of the enforceability of gene patents would have grave consequences. 'Enacting these recommendations would risk thousands of jobs across the country by stifling university-industry partnerships and undermine the country's global leadership in biotech innovation', says Jim Greenwood, President of the Biotechnology Industry Organisation.

Patenting practices in the US have recently been challenged in court. A law suit was filed in May against the US Patent and Trademark Office and Myriad Genetics, the company holding the patent on the BRCA1 and BRCA2 genes, mutations in which cause susceptibility to breast and ovarian cancer. The case is ongoing. The European Patent Office revoked most of Myriad Genetics' patents on the BRCA1 and BRCA2 genes in 2004 and 2005.

BIO Highlights Serious Flaws in Recommendations of Draft Report on Gene Patents and Patient Access to Genetic Tests
Reuters |  9 October 2009
Recommendation to exempt US gene patents from infringement
PHG Foundation |  14 October 2009
SACGHS Current Meeting Information and Live Webcast Link
Office of Biotechnology Activities |  8 October 2009
Task Force Advises Making Gene Patents Exempt from Infringement
Genome Web |  8 October 2009
8 November 2009 - by Dr Marianne Kennedy 
A lawsuit challenging the patents relating to two genes linked to hereditary breast and ovarian cancer will proceed, a US federal judge ruled last week....
1 September 2009 - by Ailsa Stevens 
BioNews reporting from the British Society for Human Genetics annual conference in Warwick:...
10 August 2009 - by Antony Starza-Allen 
A Senate Committee in Australia is hearing arguments for and against gene patenting with a view to propose future law reforms in this area. Opponents of gene patents argue that it can restrict access to vital diagnostic techniques, such as breast cancer screening, which identify certain genes that indicate the presence of a disorder. On the other hand...
26 May 2009 - by Selene Kaye 
On 12 May, the American Civil Liberties Union (ACLU) and the Public Patent Foundation filed a lawsuit challenging the US government's practice of granting patents on human genes - specifically, the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer. In the last 20 or so years the...
22 May 2009 - by Heidi Colleran 
A major lawsuit in the US is challenging the right of private companies to hold patents on genes involved in diseases, as well as their right to offer exclusive genetic tests. The American Civil Liberties Union (ALCU), the Public Patent Foundation (PPF), more than a dozen universities...
17 October 2005 - by Dr Sue Mayer 
It is in patenting gene sequences that the divide between research to address health needs and research for profit is most clear. The extent of US patents granted on human genes is revealed in the 10 October edition of the journal Science. According to Jensen and Murray of the Massachusetts...
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