Stem Cell Inventions: UK revises Examination Guidelines
07 August 2012
As reported in the October 2011 issue of the D Young & Co LLP newsletter, there was a Court of Justice of the European Union (CJEU) Decision last year which concerned the patentability of technology based on the use of human embryonic stem cells (hESC).
The UKIPO have now revised the Examination Guidelines for Biotech Inventions(1), and paragraphs 106-111 have been updated in view of the CJEU decision.
Since the WARF Decision of the EPO Enlarged Board of Appeal (G2/06)(2), the position of the UKIPO was that whereas inventions relating to human totipotent cells, which have the potential to develop into an entire human body, are unpatentable; inventions involving human embryonic pluripotent stem cells (which arise from further division of totipotent cells and do not have the potential to develop into an entire human body) may be patentable provided that, at the filing or priority date, the invention could be obtained by means other than the destruction of human embryos.
The practice of the UKIPO has thus been similar to that of the EPO in recent years. As indicated in the August 2012 issue of the D Young & Co LLP newsletter, prior to the CJEU decision, the EPO generally considered patent applications filed after May 2003 to escape the Rule 28(c) exemption on the grounds that, as deposited human embryonic stem cells lines were available, it was not necessary to destroy a human embryo as part of the practice of the claimed invention.
However, the CJEU decision indicated that the use of hESC lines as a starting point is not sufficient to escape the exemption as the cell lines themselves have involved destruction of a human embryo in their preparation. The fact that this may have happened a long time before the implementation of the invention was considered to be irrelevant.
The new UKIPO Guidelines have been revised to reflect this. Section 108 indicates that where the implementation of an invention requires the use of cells that originate from a process which requires the destruction of a human embryo, the invention will not be considered patentable by the UKIPO. It is specifically stated that if an invention uses a human embryonic cell line that was at some point derived by the destruction of a human embryo, then it is excluded from patentability.
Interestingly, however, Section 110 of the revised guidelines mentions that induced pluripotent stem (iPs) cells, which are obtained from the de-differentiation of an adult cell by the forced expression of certain genes are clearly not obtained from human embryos and cannot go on to form a human being. The Guidelines confirm that these cells are not subject to the exclusions.
It seems likely therefore that the UKIPO will revise their practice such that the date for which patent applications are considered to escape the exclusion is moved forward from the May 2003 date for availability of hESC lines, to a new date when it is considered that iPS cells were available.
The precise date is yet to be determined, but it is likely to be around 2007. It also remains to be determined whether a patent application will have to refer specifically and/or exemplify the use of iPS cells, or whether (as was the case with stem cell lines under the previous practice) it will be enough for the application to post-date iPS cell technology so that such cells were theoretically available in order to put the invention into effect.