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Enlarged BoA to review WARF stem cell case

17 June 2008

The application for the so-called "WARF Stem Cell Patent," relating to a preparation of primate (including human) embryonic stem cells, will be subject to public oral proceedings before the Enlarged Board of Appeal of the European Patent Office (EBoA) on 24 and 25 June 2008.

The hearing concerns an appeal against the rejection of European Patent application No. 96903521.1, published as EP Nr. 0770125 under the title "Primate embryonic stem cells" filed by the Wisconsin Alumni Research Foundation (WARF) in 1995.

The patent application describes a method by which primate embryonic stem cells derived from an embryo can be maintained in vitro for a long period of time without losing their potential to differentiate into any cell of the body.

On 13 July 2004, an EPO Examining Division refused to grant a patent for the application on the grounds that it was found to be not consistent with the European Patent Convention (EPC), which regulates and harmonises patent practice across Europe.

One of the main reasons for the refusal was that the disclosed method of obtaining stem cells used as the starting material a primate (including human) embryo which was destroyed in the process.

According to the Examining Division this contravenes the provisions of the EPC and the EU Directive for the legal protection of Biotechnological inventions (98/44 EC).

This directive forms a part of the EPC and is applied by the EPO, stating that European patents shall not be granted for inventions concerning uses of human embryos for industrial or commercial purposes. The patent applicant appealed this decision.

In late 2005, the Technical Board of Appeal competent in the case referred a number of points of law to the EPO's supreme judiciary body, the Enlarged Board of Appeal, which is in charge of ensuring uniform application of the patent law.

The task of the EBoA now is to clarify open legal points regarding the patentability of human embryonic stem cells under the EPC. For that purpose, the EBoA has also invited comments from the President of the EPO and the public.

At these oral proceedings, the EBoA will hear the patent applicant and the President of the EPO. However, a decision on the case will not be announced immediately. The EBoA will hand down later its opinion on the referred points of law which then will serve as a basis for decision for the Technical Board of Appeal in charge of the WARF case.

The EBoA is the highest instance of appeal at the EPO. As all other appeal boards, it is independent from the Office in its decisions and bound only by the European Patent Convention. It consists of five legally qualified and two technically qualified members appointed by the EPO's Administrative Council for a term of five years.

Their rulings are legally binding for all instances at the EPO: the Examining Divisions and Opposition Divisions (first instance) and the Boards of Appeal (second instance).

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