| After a decade of heated controversies, in 1998 the Council of the European Union and the European Parliament finally adopted the European Community's Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (1). The EC Biotechnology Directive was hailed as a breakthrough in favour of the necessary incentives for research and development, especially in the area of diagnostic and therapeutic tools as well as new pharmaceuticals (2). However, recent controversies have rekindled the legal battle over patents on genes and DNA sequences. In particular, the patent on the BRCA gene (3) (related to breast cancer) raises highly plausible concerns about exclusive rights over the gene's diagnostic functions and the use of all proteins coded for by the patented DNA sequence. Within the scientific community, the call for a cautious approach to patents on DNA sequences has gathered considerable force (4). |
