NHS doctors are in trouble for over use of diagnostic genetic tests as these infringe upon patents. The British law now recognizes patents on the application of DNA discoveries. But doctors developing genetic tests in NHS hospitals tend to pay no heed to intellectual property.
The Human Genetics Commission (HGC), an independent group that advises the U.K. government, issued a plea to health and research institutions to develop a coherent policy on intellectual property, particularly patents on diagnostic tools. The message came in a new report, “Intellectual Property and DNA Diagnostics”.
According to Dr Michael Hopkins, an expert in science and technology policy at the University of Sussex, “The fact that they have not been enforced in the UK so far is that generally the amounts of money have been small and many companies shy away from suing hospitals. But as the sums of money increase it's more likely companies will assert their intellectual property rights.”
Gail Norbury, consultant clinical scientist at Guy's Hospital in London, maintained that gene patents for medical diagnoses were “unacceptable and unenforceable”. “People will find ways around having to pay the patent…It will be a cat and mouse game. The only people who benefit are the lawyers,” she said.
The HGC report made several recommendations: First, Research Councils U.K. and other funding agencies should review their licensing requirements. The Department of Health needs to find a way to monitor how IP involving biomarkers affects diagnostics, and NHS should be given governmental support in managing these issues. Finally, the report recommends that data should be gathered on what kind of impact IP has on innovation to bring clarity to what is now a heated and often confused debate on the value of patents.
Speaking for the diagnostics industry, Berwyn Clarke, chief scientist of Cambridge-based Lab21, lamented the attitude of the NHS – in contrast to the US where patents were taken more seriously. “The UK should be one of the best countries in the world to operate but at the moment it is one of the worst,” he said. Economist Stuart Hogarth of Kings College London agrees that companies are getting itchy to start getting some returns on their R&D investments, especially as many U.K. regulatory agencies are strengthening their evidence demands. But because patent issues affecting diagnostic tests are case-specific, he couldn't envision a single law or approach resolving the matter.
Understanding the role of genetic variants in male infertility