ABSTRACT

On 13 December 1995, the Commission adopted its new proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions. The legal position regarding protection of biotechnological invention needs to be clarified because current European law was drafted 30 years ago, at a time when the possibilities offered by biotechnology were science-fiction. The legal environment regarding biotechnological inventions is unchanged and today it is of course impossible to say that this vote of the Parliament creates a kind of moratorium. The Commission has therefore to acknowledge that the issues, raised by the legal protection of biotechnological inventions, have still not been resolved. The new proposal draws a clear distinction between inventions and discoveries and does not include the famous word 'as such', in relation to elements of the human body, in order to remove the difficulties of interpretation regarding the patentability. The new proposal completely excludes from patentability methods of germline gene therapy on humans.