No European Patent for WARF/Thomson Stem Cell Application
News Nov 28, 2008
The decision reached by the Enlarged Board of Appeal of the European Patent Office (EPO) in appeal proceedings on the WARF/Thomson stem cell application, which describes a method for obtaining embryonic stem cell cultures from primates, including humans. The Enlarged Board is responsible for ensuring uniform application of patent law under the European Patent Convention (EPC), the legal basis for the EPO, and its decisions are binding in relation to patent practice at the EPO.
The Enlarged Board bases its decision (G 2/06) on the relevant provisions of the EPC and on the EU Biotechnology Directive (98/44/EC), which was implemented in the EPC in 1999. Before then the EPC already incorporated a ban on the patenting of inventions whose commercial exploitation would be contrary to public order ("ordre public") or morality (Article 53(a) EPC). In implementing the Directive, Rule 28 EPC gives specific shape to the general prohibition under Article 53(a) EPC by among other things prohibiting patents on uses of human embryos for industrial or commercial purposes. The significant point in the case of the Thomson application is that the claimed human stem cell cultures cannot be produced without the use (and destruction) of human embryos, and the provisions governing exceptions to patentability are therefore deemed to apply. The Enlarged Board does however stress that its decision is not concerned with the general question of human stem cell patentability.
The request of the appellant, the Wisconsin Alumni Research Foundation (WARF), for a preliminary ruling on the issue by the European Court of Justice was rejected by the Enlarged Board as inadmissible for lack of any legal and institutional link between the EPO appeal boards and the EU.
The Enlarged Board took its decision in response to a referral by the EPO technical board of appeal responsible for the case, which in 2006 had requested it to examine certain points of law with a view to clarifying the patentability of the WARF/Thomson application under the EPC.
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