EBA holds that stem cell invention which requires destruction of human embryos is unpatentable

In G2/06 WARF/Stem Cells, the EBA held that a patent for stem cells which necessarily involved the destruction of human embryos was unpatentable as it was contrary to r.23d(c) (now. r.28(c)). The TBA had referred a number of questions concerning the interpretation of r.23d(c) (now r.28(c)) (see para 2-115 in book). In particular, the EBA held

• it had no power to refer questions on the rule to the ECJ despite the fact that such a rule was intended to correspond to provisions in the Biotech. Directive
• r.23d(c) applied to all applications regardless whether they were filed prior to the rules coming into force
• it did not matter whether there was no claim to a human embryo provided that it was necessary to use (a fortiori destroy) human embryos in carrying out the invention
• the fact that the human embryos themselves were not being for industrial or commercial purposes was irrelevant. The destruction of them was an integral part of the working of the invention which was for commercial purposes. Equally, such an interpretation did not make r.23d(c) ultra vires on the basis that it went beyond ARt.53(a) (not patentable if commercial exploitation contrary to ordre public and morality) and Art.27 TRIPS which only permits exceptions to patentability if such falls within Art.53(a). It was not contrary to Art.53(a) to interpret r.23d(c) as applying to the performing of the invention
• It was irrelevant that subsequently, the invention could be made without the step of destroying human embryos. Any other conclusion would lead to legal uncertainty and risk being to the detriment of any third party who later provided an innocuous way to carry out the invention.

Importantly, the EBA was at pains to point out that the decision was not concerned with the patentability in general of inventions relating to stem cells but simply the invention in casu which could only be made by the destruction of human embryos.

The EBA's decision is a welcome clarification of this difficult (and indeed political) area of the law and in particular, avoids a narrow approach to matters of very real and public importance. In doing so, it recognises implicitly if not explicitly the strength of feeling on patenting in this area and which led to very considerable debate when the biotechnological directive was going through the Community legislative pipeline. As it said (para.31), it said that the legislators both of the EPC and Directive wanted to exclude such inventions from being patentable. This must be correct.

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