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. A team at Duke University, Durham, US, looked at case studies of genetic risk testing for ten clinical conditions, including cystic fibrosis and breast cancer. These were chosen as examples of different uses of patents, the effect of which could be isolated.
Universities held most of the patents. These were then licensed out to pharmaceutical companies, some who held exclusive rights to the gene sequence involved in disease and any tests for it. Seven of the conditions were linked to exclusive licenses, but in no case was the rights holder the first to market with a test. 'That finding suggests that while exclusive licenses have proved valuable for developing drugs and biologics that might not otherwise have been developed, in the world of gene testing they are mainly a tool for clearing the field of competition', said Dr Robert Cook-Deegan, Director of the IGSP Centre for Genome Ethics, Law and Policy at Duke University, and lead author of the study. He said the problem does not lie with patents themselves, but how they are being licensed. 'Whilst I don't want to make sweeping statements, exclusive licensing needs to be done with extreme caution', he said.
Another issue highlighted by the report was development of multi-gene - or even whole-genome - scans was being slowed by the need to get permission from many rights holders. The scientists suggest that patents and the lure of exclusivity are not required to spur the development of diagnostic tests. They say their cystic fibrosis case study shows that, although the gene sequence was non-exclusively licensed, dozens of laboratories developed tests for it and competed on the basis of service, innovation and quality.
However, Mr John Murphy, General Counsel at SkyePharma, and Chairman of the Intellectual Property Committee at the BioIndustry Association, says it's difficult to argue from one case, and that the use of patents here may not work for, and enhance, the overall industry. 'The need for patents and the monopolies they ensure has been tested over many years, we need this system to encourage innovation and investment', he said.
The report comes at a time when there are several pending legal battles around gene patents. A US judge recently overturned two patents belonging to Myriad Genetics and used in its breast cancer risk test. Dr Anton Hutter, a European Patent Attorney at Venner Shipley, said he hoped the verdict would be overruled: 'without gene patents I can't see how manufacturers will continue to develop and market these tests'.
The Duke University study is published in Genetics in Medicine.