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.