The Court has been asked one question by the High Court in London in a dispute between International Stem Cell Corporation and the UK’s Comptroller General of Patents.
The question is: Are unfertilised human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings included in the term “human embryos” in Article 6(2)(c) of Directive 98/44/EC on the Legal Protection of Biotechnological Inventions?
Clarification of Brüstle
In answering the question, the judges in Luxembourg should clarify the Court’s ruling in the Brüstle case, which concerned the patentability of procedures for extracting stem cells. In October 2011, Europe’s highest court decided that a process that involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented.
The Court was interpreting the Biotech Directive, which says that some biotechnology inventions are not patentable if their commercial exploitation would be contrary to public policy or morality. In practice this means that the human body, at any stage of its formation and development, cannot be patented, but that an element isolated from it or reproduced by a technical process may be.
In 2006 International Stem Cell Corporation applied for a patent in the UK for “parthenogenetic activation of oocytes for the production of human embryonic stem cells”. This involves the activation of the ovum without fertilisation by a sperm cell, instead using chemical and electrical methods. The cell starts to divide as it would in theblastocyst stage of normal embryonic development, from which stem cells can be obtained. The applicant then used these stem cells to obtain corneal tissue.
The applicant argued that this kind of parthenogenetically-stimulated human oocyte is not“capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so” because they have an inherent biological limitation that prevents those activated oocytes from developing into a viable human being.
This is because the cells do not have the paternal DNA that a normal fertilised ovum would have. The applicant said that as a result, the activation cannot lead to the creation of a viable human being.
The hearing officer at the UK Intellectual Property Office referred to the Brüstle ruling in his decision. He said that the claimed methods of producing stem cell lines and the claimed stem cell lines as well as the claimed methods of producing synthetic corneas or corneal tissue and the claimed synthetic corneas or corneal tissue in International Stem Cell Corporation’s two patent applications constitute uses of human embryos for industrial or commercial purposes. As a result, they cannot be patented.
Definition of human embryo
The decision was appealed to the High Court. It referred a question to the CJEU, asking the judges to clarify their decision in Brüstle. The question asks whether the process used by the patent applicant can be excluded from patentability as a “human embryo”, if it cannot ultimately produce a human being. In the Brϋstle case the Court of Justice answered that even a non-fertilised ovum whose division and further development has been stimulated by these other methods must be considered a “human embryo”. It said it is because they are “capable of commencing the process of development of a human being”.
The UK Court has asked whether, for these activated ova to be defined as “human embryos”, they need to be capable of starting a process able to result in a human being, or, alternatively, do they need to be capable of simply starting the process of development which need not have the potential for completion and production of a human being?
If the second option is correct, this would exclude the process used by International Stem Cell Corporation from patentability. If, however, it must be at least possible for a human being to result, as the patent applicant claims, the process may be patentable. The applicant argues that the decision in Brϋstle must have been based on the mistaken belief that these cells can complete the process of development to form a human being.
Barrister Piers Acland QC and DLA Piper advised International Stem Cell Corporation before the High Court. Barrister Tom Mitcheson QC represented the Comptroller General of Patents.
