End of an era for human DNA patenting, finds EU study
The patenting of human DNA is not the barrier to medical and scientific innovation that many feared, a study has concluded. The PATGEN project, funded under the EU's Sixth Framework Programme (FP6), researched 15,600 cases of inventions where patents claiming human DNA sequences had been filed at patent offices in the US, Europe and Japan, between 1980 and 2003. The researchers, from the University of Sussex, UK, then interviewed 30 patent holders - including some of the world's leading pharmaceutical companies - to find out what they intended to do with their patents. The project found that the tightening of guidelines and rules at patent offices, combined with commercial priorities and the growing volume of genetic information publicly available on the internet, had significantly raised the bar on the patentability of genes. 'A combination of policy change and developments in the commercial and scientific environment means that obtaining patents on DNA sequences has become generally more difficult and in some cases less commercially attractive,' write the authors of the study. 'We believe these changes are in the interests of academic and commercial researchers, as well as patients.' The study, entitled: 'DNA Patenting: The end of an era? Debates on patenting DNA must evolve to reflect the global decline in filings and the regional disparities in patenting activity.', found that the US patent office had granted far more patents than its European and Japanese counterparts. This was explained by the more stringent rules applied in Europe and in Japan on rejecting patent applications not supported by sufficient biological evidence. The study noted that 'the number of patent applications in decline, more stringent examination procedures, and the likely restriction of the scope of granted patents by case law, suggest that the negative impact of DNA patenting may turn out to be more limited than some had feared.' For when scientists started unravelling the human genetic code in the early 1980s, biotech companies, pharmaceutical companies and universities began a race to file patent applications. This led to fears that DNA sequences for research into the causes of diseases such as cancer or diabetes would no longer be available for study. The authors of the report also conclude by calling for further research into the disparity between the number of US and European patents to find out whether this has adversely affected the potential competitiveness of some European companies.