In its decision of 25 November 2008 the EPO Enlarged Board of Appeal (EBA) considered four questions referred to it by the EPO Technical Board of Appeal concerning a patent application by Wisconsin Alumni Research Foundation (WARF) with claims to “A cell culture comprising primate embryonic stem cells…”. The claims cover human embryonic stem cells (hESCs) and it was accepted that at the filing date the only starting point for the creation of hESCs was the destruction of a human embryo.
The Examining Division rejected the application on the grounds that the invention is excluded from patentability under Rule 28(c) of the European Patent Convention (EPC) (which excludes the patenting of “uses of human embryos for industrial or commercial purposes” and repeats Art. 6(2)(c) of Directive 98/44/EC, which in turn provides a specific example of subject matter excluded more generally under Art. 53(a) EPC on the grounds of being contrary to ordre public or morality). WARF appealed to the EPO Technical Board of Appeal (TBA), which exercised its discretion under Art. 112(a) EPC to refer four legal questions to the EBA. Representations were made to the EBA by WARF (who also requested that a reference be made by the EBA to the European Court of Justice) and the President of the EPO and amicus curiae briefs were filed by a number of third parties including the UK Intellectual Property Office (UKIPO) and The University of Nottingham (on behalf of the European Commission).
As a preliminary point the EBA refused to refer the questions before it to the ECJ, holding that it had no jurisdiction to do so as Rule 28(c) EPC merely repeats Art. 6(2)(c) of the Directive and the Directive is not a source of law to be applied directly by the EPO. Thus the referral to the EBA could not have a Community-wide effect through a decision of the ECJ, and the EBA’s decision is confined to an interpretation of the EPC (not the Directive).
The first question referred to the EBA was straightforward, namely whether Rule 28(c) EPC applies to applications filed before its entry into force (as in this case)? The EBA held that it applies to all pending applications, as was accepted by WARF.
The second, key, question was whether Rule 28(c) EPC forbids claims directed to products which at the filing date could be prepared exclusively by a method which necessarily involves the destruction of the human embryos from which the said products are derived? The EBA decided that (a) what is to be considered as an “embryo” is a matter of fact to be decided in the context of each particular patent application and (b) on the facts before it, the making of the claimed product involves the destruction of human embryos (which would be an integral part of the commercial exploitation of the invention).
The third question was not addressed as the answer to the second question resolved it. The fourth question, whether it was of relevance that after the filing date the same product could be obtained without having to recur to a method necessarily involving the destruction of human embryos, was answered in the negative (i.e. it is irrelevant).
The decision does not sit well with current practice at the UKIPO, whose practice note of April 2003 states that patents may be granted for inventions relating to pluripotent hESCs (which do not have the potential to develop into an entire human body) but not to totipotent hESCs (which can), notwithstanding that at present hESCs have to be sourced by the destruction of human embryos or by methods that arguably create “human embryos” (such as transfer of human nuclei into enucleated cells). It is understood that the UKIPO is reconsidering its practice in relation to pluripotent hESCs notwithstanding the absence of a judgment from the ECJ.