The judgment will be a boon for the biotech and regenerative medicine industries as current EU law bans the use of patents for all research methods that involve human embryos for industrial or commercial purposes.
The case before the High Court involved a dispute between California-based biotech company International Stem Cell Corporation (ISCC) and the United Kingdom Intellectual Property Office over the patentability of processes covering the use of parthenogenetically-activated human ova.
Adam Cooke, a partner at DLA Piper UK, which represented ISCC, told BioPharma-Reporter.com, “This is a major step forward as it means that unfertilised human eggs which have been stimulated to divide notwithstanding that they lack any paternal DNA (so called parthenotes) are not ‘human embryos’ and are therefore not excluded from patentability under the EC Biotech Directive. By recognising that parthenotes are not ‘human embryos,’ the CJEU has opened the door to the patenting of stem technologies where stem cells are derived from parthenotes.”
Cooke also noted that the judgment “is great news for the regenerative medicine community. Until today's judgment, industry and lawyers had been hampered by the CJEU's controversial judgment three years ago in the Brüstle case.”
In that judgment from October 2011, the CJEU held that the concept of a “human embryo” includes unfertilised human ova whose division and further development have been stimulated by parthenogenesis, since such ova are similar to embryos created by fertilisation of an ovum and capable of developing into a human being.
“We can now look forward with renewed optimism to the availability of patent protection as a real incentive for those engaged in stem cell research and development,” Cooke told us.
Ruling
The court ruled 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 court said that 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.”
Therefore the legal protection of biotech inventions “must be interpreted as meaning that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’, within the meaning of that provision, if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being,” the court ruled.
The court specifically pointed to the activation of an oocyte, in the absence of sperm, by a variety of chemical and electrical techniques. That oocyte, referred to as a “parthenote,” is capable of dividing and further developing. However, mammalian parthenotes can never develop to term because, in contrast to a fertilised ovum, they do not contain any paternal DNA, which is required for the development of extra-embryonic tissue, the court says. Human parthenotes have been shown to develop only to the blastocyst stage, over about five days, according to the court.