Fundamental Decision on Biopatents

In Austria, the independent Biopatent Monitoring Committee chaired by the President of the Patent Office has been monitoring the ethical standards in the implementation of the European Biopatent Directive for a couple of years already. The independent committee is unique in the EU. However, at the end of 2008 and after many years of legal dispute, a landmark decision was reached also at a European level: the Enlarged Board of Appeal of the European Patent Office (EPO) ruled that the prohibition on the patenting of human embryos also applies for cells obtained from embryos. The US researcher James Thomson had managed for the very first time to stabilise a culture of human embryonic stem cells over a longer period of time and simultaneously maintain their potential of differentiation. His US patent application provided the basis for the European patent application EP 770125 A1, in matters of which the Enlarged Board of Appeal of the EPO has now made a decision. What are the implications of this decision? Based on this decision, the granting of a patent for a product (in this case the primate embryonic stem cells) is ruled out even then, if at the time of the priority the production thereof was not possible other by the use and the destruction of human embryos. Any such exploitation furthermore also clearly violates the principle of maintaining the ordre public. As an appeal to the European Court of Justice was ruled out, this final stroke by the European Patent Office seems to be final.

The Austrian Biopatent Monitoring Committee welcomes the legal clarity established thereby. However, the Committee also pointed out that this ruling was not a judgment on the lawfulness of embryonic stem-cell research, but rather more exclusively on the limits of patentability. In Austria, the use of human embryos is ruled out from patenting in general (and not only the industrial and commercial utilisation of these).