Stem cells: A germ of comfort
Stem cell research is advancing at an incredibly fast pace. Technology based on the use of human embryonic stem cells (hESCs) is being employed in an attempt to tackle a wide variety of conditions including vision loss, diabetes, heart disease and skin disorders. However, with such cutting-edge research comes moral considerations, which in turn have implications for the type of technology that
is patentable.
The potential ethical implications associated with biotechnological inventions were acknowledged as early as the late 1980s, and resulted in the adoption of the Biotechnology Directive 98/44/EC in July 1998. Article 6(2)(c) of the directive—incorporated into the European Patent Convention by rule 28(c)—is targeted at stem cell research, and prohibits the patenting of human embryos.
While the directive provides some clarity on one aspect of stem cell research, it leaves many more questions unanswered. It is no surprise, then, that in recent years the patentability of technology based on hESCs has been the subject of significant consideration, including by the Court of Justice of the European Union (CJEU), the European Patent Office (EPO) and national courts.
In these decisions, the courts have inevitably tried to strike a balance between, on the one hand, the promotion of potentially beneficial research by means of patent law, and on the other hand, respect for the fundamental principles of safeguarding the dignity and integrity of the person, objectives that are set out in the preamble to the directive.
What constitutes a “human embryo” under the directive was first considered by the Enlarged Board of Appeal of the EPO in WARF (G2/06), in 2008. The 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.
"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."
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. This 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.
Three 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. The 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.
The 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.
A welcome decision
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 such an organism for industrial or commercial purposes may, in principle, be patented.
The 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”.
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”.
The 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.
The 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”. The CJEU left it to the national court to determine, in light of current scientific knowledge, whether such a cell had acquired this capacity.
The 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
