On October 18, 2011, the Court of Justice of the European Union (CJEU) published its decision in Brüstle v. Greenpeace. The Court ruled that processes that involve the derivation of stem cells from a human embryo at the blastocyst stage, entailing the destruction of that embryo, could not be patented.
This article presents a brief synopsis of the CJEU decision and compares the current differences in the patentability of stem cells in Europe and the United States. The article further considers the implications of these differences on the future of research involving human embryonic stem cells (hESC) throughout Europe and the United States.
Central to this case was the interpretation given to Article 6(2)(c) of Directive 98/44/EC (the Biotechnology Directive), which excludes inter alia, the patentability of inventions involving “the use of human embryos for industrial or commercial purposes.”
The Court held that the concept of “human embryo” must be understood to encompass any ovum once fertilized, including whether created by transfer of a nucleus from another mature cell or stimulated to cell division by parthenogenesis.
The Court went on to state that the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of the Biotechnology Directive also covered the use of human embryos for purposes of scientific research.
However, the Court did provide a carve out from this exclusion by stating that use of a human embryo for therapeutic or diagnostic purposes that were applied to the human embryo and were useful to it are prima facie patentable.
This exception is narrow and applies only where the invention is for the therapeutic or diagnostic purposes applied to and useful to that embryo, for example to correct a malformation and to improve its chances of survival. In this instant case, the use of human embryos for purposes of scientific research was indistinguishable from industrial and commercial use and was, thus, unpatentable.
Lastly, the Court found that where an invention does not itself “use” human embryos but relates to a product whose production necessitates the prior destruction of a human embryo or a process that requires a base material obtained from such destruction, that invention would not be patentable because it would constitute use within the meaning of Article 6(2)(c) of the Directive.