When Patenting biotechnology becomes contra-productive to the aim of the Biotech Directive

Abstract: Biotechnology has been regarded as the problem child of modern Patent Law for a long time. The legislation concerning biotechnology is in constant fluctuation, changing as the case law constantly develops. This leads up to uncertainty regarding what is to be considered as patentable, and what is not. Even today, no stable solution has been found. Furthermore, ethical concerns are given a place within the written legislation, which per se is something uncommon and quite problematic. Initially I wanted to know how this worked in practise, I wanted to know more about if a limping legislation functioned contra productive to the main goals of the Biotech Directive. The Biotech Directive aims to balance the protection of dignity and integrity of the Human being, with the need to keep the social function of patents as a protector for the competiveness of the European Biotech-industry. The Principal Rule is that patents may not be granted for inventions which commercial exploitation would be contrary to public order or morality. Moreover a specific type of invention that always is regarded as contrary to public order and morality is the use of embryos for industrial or commercial purposes. The key question here is what the term Human embryo really mean, and if it is up to the Member States to decide that, or if it should be decided with consensus throughout the EU on a multinational level. Milestone cases such as the Edinburgh-, WARF-, Brüstle-, and finally the latest, International Stem Cell-case serves as illustrations of the direction that the interpretation of the written legislation has taken and if this direction in the long run, when the Member States are given some power back, is consistent with the original goals of the Biotech Directive. Finally this is being analysed, and a few alternatives to a more consistent interpretation is suggested. The Motto - United in Diversity cannot be the case when deciding upon this matter, instead the Diversity has to be subordinated to the main goal of achieving a homogenous legislation and interpretation throughout the EU. It is time for more clarity and less uncertainty. Otherwise the core aim with a Single Market and a competitive Europe indeed will be hindered, or at least reduced.