An advisor to the European Court of Justice (ECJ) has issued a preliminary opinion stating that procedures involving human embryonic stem (hES) cell lines are not patentable.
The German Supreme Court sought clarification from the ECJ on the legal definition and scope of the term 'human embryo' under the European Directive for the legal protection of biotechnological inventions. In giving the opinion which, although is not binding, is rarely not followed by the court, Advocate-General Yves Bot said inventions that necessitate the destruction of the embryo and that use embryos as their base material should be excluded from patentability.
'The concept of a human embryo applies from the fertilisation stage to the initial totipotent cells and to the entire ensuing process of the development and formation of the human body', the Advocate-General said. Pluripotent stem cells, which do not have the capacity to turn into a human being, were specifically not included in the definition.
Under the current European Union guidelines it is unclear whether patents are available for techniques involving hES lines where they were derived from 'spare' human embryos left over from IVF that would have been otherwise destroyed. The opinion states that the only exception to the non-patentability of uses of human embryos concerns only inventions for therapeutic or diagnostic purposes, which are applied to the human embryo and are 'useful to it'.
The case concerns a patent granted in 1991 for a technique developed to generate nerve cells from hES lines to Professor Oliver Brüstle, Director of the Institute of Reconstructive Neurobiology at the University of Bonn in Germany. In November 2009, the German Federal Supreme Court referred the case to the ECJ following a challenge by Greenpeace in which the organisation claimed Professor Brüstle's patent was unethical because the hES lines were derived from human embryos.
The preliminary opinion will now be considered by the Grand Chamber, comprising of thirteen judges, and the final decision is expected in the next couple of months. However, already there is speculation among legal, commercial and research circles over the impact on investment within the European life sciences sector if the opinion is upheld.