Brüstle: what will happen next?

"Phew", said the IPKat, "for one dreadful moment I thought I'd have to write this myself …! Earlier this month the IPKat reported on the keenly-awaited ruling of the Court of Justice of the European Union in Case C-34/10 Brüstle v Greenpeace, in which the Court ruled, in interpreting the provisions of the biotech Directive (98/44), that a process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented. The IPKat's original post attracted quite a bit of comment, which is not surprising if one considers both the high level of human interest in the case and its consequences for investment in a very sensitive sector. The IPKat has since received these thoughts from Dr Philip Webber (Dehns), which he is happy to share with his readers: "Following the issuing of the recent stem cells decision from the CJEU (Brüstle v Greenpeace, C-34/10), opinions are still sharply divided as to the correctness of the decision. While it has been welcomed by Greenpeace and some church groups, many scientists have expressed deep concern about the effect that this decision may have on the stem cell industry within Europe. There are also questions about how wide the effect of the decision will be and what the European Paten Office (EPO) will do in response. Since the background to the referral and some comments on the answers given by the CJEU have already been posted by the IPKat, that material will not be reproduced here. The following thoughts will concentrate on the possible repercussions of the decision within Europe. A small amount of background is, however, appropriate. While the decision has provided some useful clarification on what is a "human embryo" (as least as far as patent law is concerned), the main impact of the decision stems from the comments made by the CJEU judges on the morality of stem cell-based inventions. It will be recalled that, for many years, the Patent Office Examiners in Europe had very little guidance on what inventions were immoral, until in 1998 the European Commission passed a directive on the patenting of biotechnological inventions (the Biotech Directive). This directive confirmed that isolated genes and cells were patentable, but it also included – for the first time – a list of inventions which were said to be immoral, hence unpatentable. This list included "uses of human embryos for industrial or commercial purposes".When the directive was passed, stem cell technology was in its infancy and the directive did not directly address the patentability – or morality – of human stem cell based inventions. In order to harmonise its practice with the Biotech Directive, the EPO incorporated the main provisions of the Biotech Directive into the EPO rules in 1999. In 2008 the EPO applied this "uses of human embryos" rule when it judged the morality of a patent held by Wisconsin Alumni Research Foundation (WARF) which related to pluripotent stem cells. In that case the EPO ruled that, although the claims of the patent did not specifically cover "uses of embryos" at the filing date of the patent application, human embryos had to be destroyed in order to produce the claimed pluripotent stem cells. Accordingly the invention could not have been put into practice at that time in a moral manner. For that reason, the WARF patent application was rejected under the morality exclusion. Subsequently, however, it has been the practice of the EPO to allow patents on stem cell inventions under circumstances where the inventions can be put into practice at the filing date without requiring the destruction of human embryos, for example if the inventions are based on human stem cells which have been grown in the laboratory (i.e. established cell lines). In particular, the EPO has established that human embryonic stem cell lines were readily available at least by May 2003; patent applications based on such material and filed after this date have generally not been deemed to be immoral. Given that the questions which were referred to the CJEU were largely similar to those addressed by the EPO in the WARF decision (G2/06), many expected the Advocate General to take a line in Brüstle which was similar to that taken by the Enlarged Board. However, an early indication that the European Court was going to depart from the WARF decision was provided by the Advocate General in March 2011 (noted briefly by the IPKat here). He hinted strongly that the full history of the invention needed to be taken into account when considering its morality — not just whether the invention could be put into practice in a moral manner at the filing date of the patent. It was these comments that sent shockwaves through the European stem cell industry, with letters of concern being published in Nature and the major UK papers. The decision of the CJEU has confirmed and clarified the comments made by the Advocate General. Essentially, the judges of the CJEU have followed the ethical line taken by the Advocate General, and they have made the point absolutely clear, stating that the full history of the invention must be considered when deciding upon the morality of that invention – "The fact that destruction may occur at a stage long before the implementation of the invention … is … irrelevant". Hence all inventions which require or have required in their past the destruction of a human embryo are now deemed to be immoral, and thus unpatentable, by the CJEU. European patents which cover such inventions will still remain in force until they are challenged, but they will become essentially unenforceable. Patentees will have to take decisions on whether such patents still have any residual value or whether they should simply be allowed to lapse due to non-payment of renewal fees. The decision will have binding effect on the courts of the EU member states but the EPO (which is not an EU institution) will have to decide whether to change its practice in light of the CJEU's decision. Implementation of the decision would not require either a change to the Articles or to the Rules of the European Patent Convention (EPC), so it could technically be implemented merely at the Directorate level. More mischievous patent attorneys will be starting to consider what patents in other areas of technology might be vulnerable as a result of this decision. Does the use of slave labour to mine metals such as tin, tantalum, tungsten and gold for the mobile phone industry mean that mobile phone patents are immoral? Moral compass On a practical level, the decision has been welcomed by Greenpeace and some church groups, who have hailed the application of a moral compass to this area of technology. In contrast, many scientists have expressed dismay about the potential effect that this decision will have on European stem cell companies. They are particularly concerned about the detrimental effect that this decision may have on investment in stem cell companies. In particular, if investors cannot obtain patent protection for such inventions in Europe, are they still going to invest in European stem cell companies? The decision should not affect the ability of such companies to obtain patents in the US and elsewhere, but in the absence of European patents, will investment dry up? Or will such companies be driven out of Europe? The irony of the situation is that the original intention of the Biotech Directive was to protect biotech inventions and to promote investment in this area in Europe, whereas the application of the Biotech Directive by the CJEU in this case could well lead to the destruction of a significant part of the European stem cell industry".

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