Decision regarding patents for embryonic stem cells in Europe

On October 18, 2011, the European Court of Justice (ECJ) rendered its decision which many within the Biotech field had been waiting for: The ECJ now also puts an end to patents to pharmaceuticals and research which includes embryonic stem cells.

The basis for this decision is to be found in an EU directive from 1998 (Article 6.2(c)) on the legal protection of biotechnological inventions. This states that a patent should not be granted to an invention which is contrary to “ordre public and morality”. The ECJ chooses to do the interpretation that patents concerning stem cells which originate from embryos are encompasses by the embryos which would be contrary to ordre public and morality. 

The ECJ also decided to interpret the term human embryo as every human ovum from the moment it is fertilized. An unfertilized human ovum in which a cell nucleus from a mature cell from a human has been transplaned, and an unfertilized human ovum which has been stimulated to cell division and further development through parthenogenesis, shall also be considered a human embryo.

The Court also considered the question whether the concept of ‘uses of human embryos for industrial or commercial purposes’, which use is not patentable, also covers the use of human embryos for the purposes of scientific research. The Court concluded that scientific research entailing the use of human embryos cannot access the protection of patent law, but the patentability of uses of human embryos for industrial or commercial purposes is not prohibited where it concerns the use for therapeutic or diagnostic purposes which are applied to the human embryo and which are useful to it – for example to correct a malformation and improve the chances of life of the embryo.

The Court also stated that an invention is excluded from patentability where the implementation of the process requires either the prior destruction of human embryos or their prior use as a base material, even if, in the patent application, the description of that process, as in the present case, does not refer to the use of human embryos.

It remains to be seen how this decision will affect the inventors and research intense companies within this field and also how the different European Patent Offices will treat pending patent applications relating to the same subject.

// Camilla Lidén & Ellen Setréus