Bioindustry disappointed by Commission's uncertain position on patenting
The European association for bioindustries, EuropaBio, has expressed its disappointment at the failure of the European Commission to take a position on the patenting of human DNA and human stem cells, which were not clarified in the EU Biotechnology Patents Directive. Directive 98/44 entered into force in July 2000 after ten years of debate between the EU institutions. In 2002, the Commission charged a group of experts with clarifying two topics within the Directive: the scope to be conferred to patents on sequences or partial sequences of genes isolated from the human body; and the patentability of human stem cells and of cell lines obtained from them. It was expected that the Commission would propose new guidelines in its second report on the Directive, which was published on 14 July. However, the report actually states that, with regard to DNA sequences, 'The Commission will continue to monitor whether there are any economic consequences of possible divergences between Member States' legislation.' On stem cells, the Commission makes a differentiation between totipotent stem cells, which can develop into a human being, and pluripotent stem cells, which do not have this ability. 'In the light of the Commission's analysis, it appears that totipotent stem cells should not be patentable, on grounds of human dignity. There is no immediate answer to the question of the patentability of embryonic pluripotent stem cells and indeed at this stage it would appear premature to come to a definitive conclusion. The Commission will continue to monitor developments in this area,' states the report. The EU Member States currently have different laws with regard to the patenting of human gene sequences. France has prohibited the patenting of human gene sequences outright, while Germany has limited the scope of patent protection for human gene sequences to the specific use disclosed in a patent application. Other countries provide absolute protection for human gene sequences where there is scope for using the sequence for different uses in the future. EuropaBio is disappointed that the Commission has not taken a firmer stand on the uneven implementation of the Directive. 'The main objective for introducing the Directive in 1988 and in 1995 was to harmonise the patent laws of the EU Member States in respect of biotechnological inventions and clarify certain aspects in this respect in order to support the internal markets,' said Bo Hammer Jensen, Chair of EuropaBio's intellectual property working group. 'We have to conclude that the actual result is a situation with more disharmony than ever, and with the possibility that the four remaining states [Italy, Luxembourg, Lithuania and Latvia are yet to implement the Directive] may implement the Directive in yet unknown ways.' 'Patent rights are of extreme importance in the biotech industry, especially for SMEs that often only have these rights as their most important assets,' Mr Hammer Jensen continued. The divergences in how certain Member States have implemented the Directive and the uncertainties about how national courts in these Member States will interpret a company's patent may discourage investment in developing promising research into commercial products.' EuropaBio considers that embryonic stem cell research must be permitted in order to advance knowledge of biomedicine and its applications in healthcare.