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NEWS - DECEMBER 2008Patents - EPO: G2/06 Enlarged Board of Appeal decision (WARF/stem cells) 25.11.2008 The Enlarged Board of Appeal (EBA) of the European Patent Office has released its decision on November 25, 2008, regarding the allowability of the European patent application so-called "WARF Stem Cell Patent," relating to a cell culture comprising primate (including human) embryonic stem cells. This application was filed by the Wisconsin Alumni Research Foundation (WARF) in 1995 and claimed a cell culture comprising primate embryonic stem cells with specifically defined characteristics. The application described a method of producing such stem cells using a process which required the use and subsequent destruction of human pre-implantation embryos. No alternative starting material was provided. In its decision, the EBA ruled that the legislative intention behind both Art. 53(a) EPC and Art. 27(2) of TRIPS - on which the interpretation of Rule 23d(c) EPC depends - was to outlaw protection for inventions where human embryos are destroyed. The EBA therefore confirmed that: Rule 28(c) EPC (formerly Rule 23d(c) EPC) applies to all pending applications, including those filed BEFORE the entry into force of the rule (Question 1). Rule 28(c) EPC forbids the patenting of claims directed to products which - as described in the application — at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, even if the said method is not part of the claims (Question 2). In the context of the answer to question 2, it is not of relevance that AFTER the filing date the same products could be obtained WITHOUT having to recur to a method necessarily involving the destruction of human embryos (Question 4). Therefore, the EBA’s reasoning was that the use of an embryo starter material is seen as being an industrial use of an embryo, despite the fact that the method itself was not part of the invention as claimed. In particular, EBA considered that the average skilled person following the steps of the methods specifically disclosed in the application would inevitably use and destroy an embryo. CONCLUSION: Inventions including a step involving the destruction of a human embryo are unpatentable under the EPC, independently of the fact that this step is present in the claims or not: the EBA holds unpatentable inventions concerning products (here human stem cell cultures) which can only be obtained by the use involving their destruction of human embryos. Interestingly, the EBA made it clear that this decision was not concerned with the patentability in general of inventions relating to human stem cells or human stem cell cultures. Therefore, in this decision, the EBA has not explicitly closed the door on the prospect that patentability for human stem cell inventions could be acknowledged. In the perspective of the “post-Yamanaka area” (discovery of human skin cells turned into embryonic stem cells without having to make or destroy embryos) and in the absence of any further guidance from the EPO, there may be still some optimistic views in the direction of room for patentability for inventions in relation with human pluripotent stem cell lines and cellular reprogramming. Text of the decision: http://documents.epo.org/projects/babylon/eponet.nsf/0/428862B3DA9649A9C125750E002E8E94/$FILE/G0002_06_en.pdf
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