On December 18, 2014, the Court of Justice of the EU (Court) opened the door for more stem cell patents by fine-tuning its definition of a “human embryo” (Case C-364/13, availablehere). The Court ruled that an unfertilized human ovum whose division and further development have been stimulated by parthenogenesis (i.e., without paternal DNA) does not constitute a human embryo if it does not have the inherent capacity, in itself, of developing into a human being.
The interpretation of the concept “human embryo” is pivotal for the patentability of inventions using human ova, because Article 6(2)(c) of the Biotechnology Directive 98/44/EC stipulates that an invention for which a human embryo was used is not patentable, since such an invention would breach ordre public and morality.
In 2011, the Court’s landmark judgment in Brüstle v Greenpeace (available here) defined a human embryo broadly as cells having the capability to commence the process of development of a human being. Based on that judgment, the UK Intellectual Property Office (UK IPO) refused two patent applications for the production of pluripotent stem cells from parthenotes. The applicant, however, argued that no embryos were involved, since the parthenotes used could not develop into a human being due to the absence of paternal DNA.
The Court has now established that the decisive factor of what constitutes an embryo is theinherent capacity of developing into a human being. By adding the term “inherent”, the Court accepts patentability for inventions using parthenotes which, in themselves, would never be able to develop into a human being, unlike defected fertilized ova which do have such inherent capacity.
While this decision is a breakthrough in many ways, it does not guarantee that patents will be granted for inventions using parthenotes. Member States retain a wide margin of discretion to refuse patents which, in their view, breach ordre public and morality.
