By Julie Nixon
I have blogged previously about the decision in Brüstle v Greenpeace which ruled that inventions and processes derived from human embryos could not be patented. However a new ruling by the ECJ now allows for processes based on unfertilized human eggs to be patented.
The CJEU’s decision in Brüstle gave a broad interpretation of the term “human embryo”, and for a stem cell not to be regarded as a human embryo it must not be capable of developing into a human being. There was concern that the decision would seriously damage stem cell research in Europe with investment in this field moving to the US.
The latest ECJ decision came after a US firm, International Stem Cell Corporation, initiated a case in the UK. The UK Intellectual Property Office refused to grant the firm two patents which used human eggs that had been subject to parthenogenesis. Parthenogenesis is a form of asexual reproduction in which growth and development of embryos occurs without fertilization. International Stem Cell Corporation’s parthenogenetic stem cells have potential for treating diseases of the eye, the nervous system and the liver.
The Chancery Division (Patents Court) of the High Court of Justice of England and Wales requested a preliminary ruling from the ECJ on the question of whether parthenogenetically activated unfertilised human ova “‘which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings” are “human embryos”. The ECJ ruled 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'.”
Andrey Semechkin, CEO of International Stem Cell Corporation said after the decision that the company now has “the ability to obtain patent protection for its parthenogenetic stem cell technology in the EU, as it has already done in the US. A strong intellectual property estate is important for investors and potential partners as we begin our upcoming clinical study using human neural stem cells derived from parthenotes using the technology described in the patent applications."
With the news that the European Medicines Agency has approved the first stem cell therapy for widespread medical use in the EU, the commercial opportunities in the sector may start to be realised by investors. Investors traditionally like to see patents in place regarding their investee company’s core intellectual property, so these recent developments in respect to stem cells may go some way to incentivizing the financing of new stem cell therapies.