The much-discussed "Edinburgh" patent is to be maintained in an amended form, so that it no longer includes human or animal embryonal stem cells. This was decided [on July24, 2002] after a three-day public hearing at the European Patent Office (EPO) before the Opposition Division appointed to consider the case.
The Opposition Division took the view that the granted patent failed to comply with the requirements of Article 83 and Article 53(a) in conjunction with Rule 23d(c) of the European Patent Convention (EPC). Article 83 stipulates that the invention must be disclosed in a manner sufficiently clear and complete for it to be carried out by an expert in the relevant field. Rule 23d(c) provides that uses of human embryos for industrial and commercial purposes are excluded from patentability.
The Opposition Division referred to its earlier communication, issued on 14 April 2000, stating that the subject-matter of the patent had never included the cloning of humans or animals. Long before the end of the opposition period, the patent proprietor had also voluntarily limited the patent to exclude human germ-line intervention. The Opposition Division emphasised that it was bound in its decisions by the EPC and the applicable international and European law, including the EU Biotechnology Directive. These, and not national law - such as the German Law on the Protection of Embryos - are the basis for [this] decision.
In the "Edinburgh" case, the opposition procedure, anchored in the EPC, has once again proved its worth as an effective and transparent means of reviewing patents granted by the EPO. The parties will have an opportunity to contest the outcome of the hearing by instituting second-instance proceedings before one of the EPO's Technical Boards of Appeal.
The written statement of the reasons for the Opposition Division's decision will be issued in the coming months.
European Patent Office