such an organism for industrial or commercial purposes may, in principle, be patented. Te ISCC case concerned whether parthenotes fall within the definition of “human embryos”, thereby rendering any technology using them not patentable. In Brüstle, the CJEU interpreted “human embryo” broadly, holding that it covered any cells that are “capable of commencing the process of development of a human being” and, in answer to one of the questions referred, that it included “unfertilised human ova whose division and further development have been stimulated by parthenogenesis”.
the directive was first considered by the Enlarged Board of Appeal of the EPO in WARF (G2/06), in 2008. Te Enlarged Board held that the patenting of claims directed to a product which, at the patent’s filing date, could be prepared only by a method that necessarily involved the destruction of human embryos, was forbidden, even if the said method was not part of the claims. Following this decision, the examination division of the EPO adopted a pragmatic approach that allowed hESC-related patent applications if deposited hESC lines were available on the filing date of the patent. Tis approach was based on the following rationale: as hESC lines that did not necessarily involve the destruction of a human embryo were available, the patents in question should be accepted as patentable.
Tree years later, the CJEU went further, in
Brüstle (C-34/10). It held, inter alia, that: “An invention must be regarded as unpatentable, even if the claims of the patent do not concern the use of human embryos, where the implementation of the invention requires the destruction of human embryos. Te fact that destruction may occur at a stage long before the implementation of the invention, as in the case of the production of embryonic stem cells from a lineage of stem cells, the mere reproduction of which implied the destruction of human embryos, is in that regard irrelevant.”
In line with that decision, in February 2014, the Technical Board of Appeal of the EPO confirmed in T2221/10 that the decision of the Enlarged Board in WARF was not limited to patent applications with a filing date at which no established cell lines were available. Consequently, it held that inventions that make use of publicly available hESC lines that are initially derived by a process resulting in the destruction of human embryos, are excluded from patentability.
Te Technical Board noted that its decision was in line with the CJEU’s decision in Brüstle and, although CJEU decisions are not legally binding on the EPO or its boards of appeal, they should be considered persuasive. Following these decisions, the future of stem cell research in the European biotechnology industry, where funding for research and development is in part dependent on effective patent protection, looked uncertain.
However, the recent decision of the CJEU in International Stem Cell Corporation (ISCC), C-364/13, should provide some comfort for stem cell research in Europe. In that case, the court held that an organism that is incapable of developing into a human being does not constitute a “human embryo” within the meaning of the directive. Accordingly, use of
Struggling with that answer, the English Patents Court—which was considering an appeal from a decision by the UK Intellectual Property Office that two patent applications relating to methods of producing human stem cells using parthenogenesis should be refused based on article 6(2)(c))—asked the CJEU whether the ruling in Brüstle applies to parthenogenetically activated unfertilised human ova “which in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings”. Te court in Brüstle had not been made aware of the fundamental difference between parthenotes and non-fertilised ova subjected to somatic cell nuclear transfer and, as a consequence, was under the mistaken impression that both possessed the inherent capacity to develop into a human being (as did fertilised ova)—according to current scientific knowledge, genomic imprinting prevents human parthenotes from developing to term.
Te CJEU, following the opinion of Advocate General Cruz Villalón of July 2014, held that in order to be classified as a “human embryo”, a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being. Consequently, the mere fact that a parthenogenetically activated human ovum commences a process of development is not sufficient for it to be regarded as a “human embryo”. Te CJEU leſt it to the national court to determine, in light of current scientific knowledge, whether such a cell had acquired this capacity. Te ISCC decision will therefore be welcomed by the European biotechnology industry, and should serve to maintain the momentum in biotech research and provide hope for the development of advanced therapies for diseases. In contrast, a decision finding that parthenotes are not patentable could have seriously stifled investment in stem cell research in Europe and put the European industry at a considerable disadvantage compared with its US counterpart, where the patenting of embryonic stem cell lines and their use is currently permitted. Laura von Hertzen is an associate at Bristows. She can be contacted at:
laura.vonhertzen@bristows.com Robert Burrows is a partner at Bristows. He can be contacted at:
robert.burrows@bristows.com
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