Human embryonic stem cells (hESC) and production methods based on destroyed human embryos or fertilized egg cells (early embryos) are – according to the European Court of Jusice (ECG) – excluded from patent protection on account of violation of morality (see News of October 19, 2011). The European Patent Office (EPO) being the competent authority for the grant of European Patents shares this opinion (see News of January 2, 2009 relating to G 2/06).
The conclusion made in G 2/06 that Rule 28 (c) EPC prohibits the patent protection of products being obtainable only under destruction of human embryos at the time of application is reflected in the Guidelines for Examination in the European Patent Office under Number 5.3 iii), Chapter II, Part G:
“A claim directed to a product, which at the filing date of the application could be exclusively obtained by a method which necessarily involved the destruction of human embryos from which the said product is derived is excluded from patentability under Rule 28(c), even if said method is not part of the claim (see G 2/06). The point in time at which such destruction takes place is irrelevant.”
In the meantime, however, there are hES-cell lines which can be obtained without the destruction of human embryos (see Chung et al., Human Embryonic Stem Cell Lines Generated without Embryo Destruction, Cell Stem Cell (2008) Feb 7; 2(2): 113-117. Doi: 10.1016/j.stem.2007.12.013).
By referring to the above-mentioned scientific publication the EPO does not necessarily assume an embryo-destroying approach as an obstacle to patentability. This holds true, in particular, if the application or priority date lies after January 10, 2008 being the electronic publication date of the above-mentioned scientific article. This practice in favour of the applicant is exercised since September 2012 and has not yet been introduced into the official EPO guidelines. In case of an objection under our Rule 28 (c) EPC therefore the initiative of the applicant or, respectively, his representative is demanded for an appropriate defence.
In relation with applications having a priority or application date before January 10, 2008 the EPO does not in general refuse the argument that non-Embryo-destructive technologies for obtaining hESC have already been available before this date. It is, however, not sufficient to point out that commercially available hES-cell lines existed at the application date. Furthermore, the proof has to be provided that these commercial cell lines have been fabricated without destroying human embryos (see T 2221/10 of February 4, 2014).