Over the past 18 months we have reported on the Court of Justice of the European Union (CJ) decision in Brüstle v Greenpeace (C-34/10) which relates to the patentability of technology based on the use of human embryonic stem cells (hESC). To date we have reported the CJ’s decision, discussed its possible influence on the European stem cells industry and the implementation of such guidance into the European Patent Office (EPO) guidelines. At the time, the question remained as to how far the boards of appeal would implement G02/06 and whether it would follow the CJ decision. The recent boards of appeal decision T 2221/10 (Culturing stem cells/ TECHNION) has provided the response.
In refusing European application 03751238.1, the boards of appeal have confirmed what has been considered the lengthy arm of the prohibition of using of hESC wherein their preparation has involved the destruction of a human embryo. Thus, despite the claim not requiring the destruction of a human embryo, the fact that the stems cells originated from such a source was sufficient for the claims to be refused.
The invention related to the maintenance of hESC in an undifferentiated state by the addition of certain human foreskin cells and to such a culture per se. The boards of appeal considered the public availability of hESC and if available, whether they were derived from human embryos that had been destroyed. The conclusion was reached that if such hESC were derived from human embryos that had been destroyed, it was irrelevant as to how early in the performance of the invention such destruction occurred.
The boards of appeal examined the public availability of hESC cultures before the priority date and whether they were prepared by methods involving the destruction of human embryos. The evidence submitted by the appellant was not considered convincing of the fact that even if the hESC cell lines were publicly available, that such cell lines had been prepared without destroying a human embryo. All the evidence pointed to their origin in embryos that were destroyed.
The boards of appeal interpreted the guidance provided in G02/06 regarding Art 53(a) EPC and Rule 28(c) EPC that “all steps preceding the claimed use of HES cells which are a necessary precondition for carrying out the claimed invention, have to be considered.” The boards of appeal continued that there was no distinction between steps performed by the inventor or any third party, nor “between steps which took place in direct preparation of the experiments leading to the invention and steps having taken place at a point in time further remote from these experiments.”
As an interesting aside, the boards of appeal made reference to an embodiment that referred to using human embryonic germ cells ie, prepared from primordial germ cells of 8-10 day old foetuses. Without commenting as to whether such a source would comply with the requirement of Art 53(a) EPC, the boards of appeal excluded the relevance of this embodiment as the claims were limited to hESC which, by the application of accepted laws on construction, would exclude a cell line derived from germ cells (with reference made to boards of appeal decision T197/10).
With deference to the CJ, the boards of appeal acknowledged that although the EPO is not bound by such decisions (Art 23(3) EPC), such decisions “should be considered as being persuasive” as there were good reasons of policy for there to be harmony within Europe on such matter. Thus, they confirmed that the decision was in line with the 2008 boards of appeal decision G 0002/06 (Use of embryos/WARF).
The situation therefore remains that until a source of hESC can be demonstrated to have arisen from a source not involving the destruction of human embryos, inventions utilising hESC are likely to be refused under Art 53(a) EPC and Rule 28(c) EPC.
It should be remembered that the possibility of such an alternative source existing in a form that does not fall within the WARF decision is subject of a further referral to the CJ, as reported in our article ‘Stem Cell News - EPO Revokes ‘Brüstle’ Patent and New CJ Referral on the Patentability of Parthenotes’, published in the June 2013 edition of this newsletter (see useful links below).