Munich, 24 July 2002
Result of oral proceedings on the "Edinburgh" patent, held in Munich, 22 - 24 July
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 today 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 or 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 today's 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.
Notes to journalists
1. The "Edinburgh" patent is European patent No. EP 0695351, with the title "Isolation, selection and propagation of animal transgenic stem cells". The grant of the patent had led to fierce protests and triggered a major public debate on the patenting of stem-cell technology.
The contested patent describes a method of using genetic engineering to isolate stem cells - including embryonic stem cells - from more differentiated cells in a cell culture in order to obtain pure stem cell cultures. The public debate centred on whether the patent extended to humans.
2. The hearing is part of the opposition procedure provided for under the European Patent Convention. This legal right enables anyone to contest European patents. Oppositions are filed against about 6% of the European patents granted each year. The opposition period ends nine months after the patent is granted. In a special procedure similar to a court hearing, involving the patent proprietor and the oppponents, the Opposition Division of the EPO decides as an impartial arbiter whether the opposed patent should be maintained, amended or revoked.
In the "Edinburgh" case, the Opposition Division comprised three patent examiners and a legal expert.
3. For further information, please contact: Rainer Osterwalder, Press Department, European Patent Office, D-80298 Munich
Telephone: (+49-89) 2399-5012
Fax: (+49-89) 2399-2850
Mobile: (+49-173) 9461630
4. Background documents and press releases on this case, together with general information on the Office, may be obtained from the EPO website: www.european-patent-office.org