Inventions which necessarily involve the destruction of a human embryo are excluded from patentability in Europe. However, in recent years there have been a number of significant and somewhat unexpected developments regarding the patentability of inventions relating to human embryonic stem cells.
The European Patent Office (EPO) was recently required to tackle this issue, but instead of taking a stand on the patentability of human embryonic stem cells, the EPO apparently decided to hide behind a technicality.
European Patent No. 1040185, also known as the "Brüstle patent" relates to neural progenitor cells that are derived from embryonic stem cells. The patent granted in 2006, but it was opposed for allegedly contravening the morality provisions of European patent law (Article 53(a) and Rule 28(c) EPC).
In parallel, a corresponding German patent was challenged by Greenpeace on similar grounds and the German proceedings culminated in a referral to the Court of Justice of the European Union (CJEU) of several questions concerning the exclusion from patentability of inventions that relate to uses of human embryos.
In its judgement published in October 2011(1, for commentary see 2), the CJEU held that if the implementation of an invention necessitates the destruction of a human embryo, it is excluded from patentability. In a significant deviation from what was up until then established practice in Europe, the CJEU opined that it is immaterial how far removed the destruction of a human embryo is from the invention. Thus, according to the CJEU, the exclusion applies not only to those inventions which directly involve the destruction of an embryo, but also to those requiring the use of a human embryonic stem cell which was originally derived through the destruction of a human embryo. Consequently, any methods or products which involve as their base material cells taken from an established cell line which was originally obtained through the destruction of a human embryo are excluded from patentability, no matter how long ago that destruction took place.
Prior to this ruling, the EPO and many national patent offices had taken the view that the exclusion did not apply to inventions which at the filing date of an application could be put into practice by using cells from an established cell line, even if that cell line had originally been generated by destroying a human embryo.
The ruling of the CJEU is binding on all EU member states, so several member states have revised their patent practice to implement this ruling. Moreover, the EPO, although not bound by decisions of the CJEU, also revised its practice by revising the Guidelines for Examination(5) to set out explicitly that the point in time at which the destruction of a human embryo took place is immaterial. These changes in patent practice dealt a significant blow to the stem cell community.
In November 2012, the Federal Court of Justice of Germany (Bundesgerichtshof), having considered the ruling of the CJEU, issued its decision on the German Brüstle patent(3). The Bundesgerichtshof held the patent to be valid in amended form, indicating that patents may be granted in Germany in the field of human embryonic stem cells provided that it is clear that the patent claims do not encompass methods that involve the destruction of a human embryo. The claims of the German Brüstle patent were amended to include a proviso that no human embryonic stem cells obtained through the destruction of a human embryo are used to perform the claimed method or to arrive at the claimed products. Thus, the Bundesgerichtshof found a way of respecting moral considerations without denying inventors the right to obtain patent protection for those aspects of an invention which do not require the destruction of a human embryo.
The German ruling offered a glimmer of hope to stem cell scientists and companies seeking protection for their inventions, so the decision of the EPO relating to the corresponding European patent was eagerly awaited.
However, in a Hearing which took place on 11 April 2013, the EPO's Board of Opposition seemingly shield away from tackling the issue of how to ensure that patents are not granted for those inventions or aspects thereof that are contrary to morality, but that they are granted for those inventions or aspects thereof that do not contravene the morality provisions.
Instead, the EPO focussed on the fact that the proposed proviso to make it explicit that the claims do not encompass methods that destroy human embryos or products obtained thereby was not recited in the application as filed. Although case law of the EPO (G1/03)(6) has established that it is permissible to introduce an appropriate new proviso into a claim to deal with an exclusion from patentability, the EPO held that the proposed proviso would contravene the EPO's provisions on added matter (Article 123(2) EPC). On this basis, EP1040185 was revoked(4).
The EPO's decision, being at odds with the Decision of the German court, signals that at least for now we are a long way off harmonisation of this issue across Europe.
Although the EPO's decision on EP1040185 seems to signal that the outlook for inventions relating to human embryonic stem cells is rather bleak, there are two important issues to bear in mind. Firstly, the EPO's decision is open to appeal, so this issue may well be put before the EPO's Appeal Board. Secondly, it is worth noting that in light of the decision of the CJEU the EPO has considered human embryonic stem cell technology in some detail, concluding that since February 2008 it has been possible to isolate human embryonic stem cells without destroying a human embryo. The EPO's position is based on an article disclosing a method of human embryonic stem cell isolation which does not involve the destruction of any human embryos(7). Consequently, patent applications concerning inventions which involve human embryonic stem cells are typically not excluded under the morality provisions provided that they were filed after February 2008.