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Sort out DNA patent problems, says Human Genetics Commission

Government advisors say industry-academia tensions need to be resolved

As academic researchers increasingly patent their biomarker discoveries, it is time for biomedical research funders to review their guidelines on licensing, says a report by the Human Genetics Commission, the UK government’s advisory body on developments in human genetics.

The report, published on 5 August, is based on a seminar on the impact of DNA patents on diagnostic innovation, organised by the Human Genetics Commission in October last year.

The report notes that since patents on biomarkers—biochemicals that indicate pathological states—are increasingly used in large applications, such as population screening programmes, it is time to start addressing problems in its policy framework.

The report reveals tension between industry and NHS hospitals on the issue. While industry wants to exploit the financial value of biomarker patents, NHS hospitals “routinely infringe” such IP.

The report therefore recommends setting up an office to review and monitor biomarker IP within the Department of Health. The office should investigate the efficiency and impact of current policies on biomarker-based innovation in diagnostics. It should also establish guidelines for licencing of IP by publicly funded researchers and urge private companies to contribute DNA data to public databases.

Similarly, research councils and other biomedical research funders, including the Wellcome Trust, Cancer Research UK and the British Heart Foundation, should also review their guidelines on licensing.

In addition, says the report, more research and evidence is needed on the impact of DNA patents on diagnostic innovation.

“Diagnostic patents need to be managed, not ignored,” said report author Michael Hopkins, a researcher at the Science and Technology Policy Research, University of Sussex, at a press briefing in London on 5 August. Across Europe, he said, many small labs ignore IP since they think that the use of patents on genes is unjustified.

Meanwhile, Gail Norbury, commissioning and governance director of the Genetics Laboratories at Guy’s Hospital, said she thinks patents are unnecessary.

In summary, she said, my view from the NHS is that “gene patents are unacceptable, unenforceable and detrimental”. “ I don’t think patents are going to help the NHS diagnostics service.”