Federal Supreme Court passes stem cell case to ECJ

On 12th November 2009 the Federal Supreme Court was due to consider the patentability of methods to generate cells from embryonic stem cells.

In 1999 Dr Oliver Brüstle obtained a German patent for isolated and purified neural progenitor cells, processes for their preparation from embryonic stem cells and the use of neural progenitor cells for therapy of neural defects. According to the patent, the transplantation of brain cells into the nervous system is a promising method for the treatment of numerous neurological diseases such as Alzheimer's and multiple sclerosis. Since mature neurons have only limited capacity for regeneration, the transplantation of precursor cells is necessary, but these are found predominantly during the development of the brain. The patent describes a method to derive neural progenitor cells for transplantation from embryonic stem cells and how these progenitor cells can be used for therapy of neural defects.

In 2003 Greenpeace requested revocation of the patent before the Federal Patent Court on the grounds that the use of human embryonic stem cells for the generation of neural precursor cells is contrary to the ordre public and morality (Section 2(2) No 3 of the Patent Act). In principle, the import and utilisation of embryonic stem cells for research are prohibited in Germany by the Act on Stem Cells; however, the use of embryonic stem cells that were imported before May 2007 is permitted for high-priority research projects.

At first instance in 2006 the Federal Patent Court decided largely in favour of the plaintiffs and declared invalid those embodiments of the patent that include cells derived from embryonic stem cells from human embryos. The Federal Patent Court interpreted those embodiments as constituting inadmissible use of human embryos for industrial or commercial purposes prohibited under Section 2(2) of the Patent Act.

In a similar case, the European Patent Office recently declared that according to the corresponding regulations, a European patent may not be granted for a product which can be produced only by a method that necessarily includes the destruction of human embryos. The European Patent Office even found this valid for cases in which the method is not part of the protected technical teaching (Decision G2/06).

Brüstle appealed the Federal Patent Court decision. The Supreme Court was set to rule on the case on 12th November 2009, but declared that it intended to stay the appeal and submit questions to the European Court of Justice (ECJ) concerning the EU Legal Protection of Biotechnological Inventions Directive (98/44/EC). The Supreme Court argued that several terms of Article 6 of the directive, which has been incorporated into the German Patent Act as Section 2, are insufficiently clear. In presenting the case to the ECJ, the Supreme Court is seeking uniform EU-wide interpretation of Article 6.

The ECJ will now have to answer the following questions regarding the terminology of Article 6 of the directive:

• What exactly is meant by the term “human embryo”? In particular, the ECJ will have to decide whether a cell that is derived from a blastocyst (an early stage of development of the fertilised ovary) and does not have the ability to develop into a human being must be regarded as an embryo.
• The ECJ will have to decide whether the blastocyst itself is an embryo under the law. This will be necessary if the generation of embryonic stem cells under the patent, which necessarily results in the consumption of a blastocyst, is regarded as a “use of human embryos” in terms of the directive.
• The ECJ will have to decide whether every non-private use of human embryos, in particular for therapeutical or research purposes, should be considered to be “commercial” use according to Article 6 of the directive.

An ECJ decision on the interpretation of Article 6 would remove the existing ambiguities and harmonise decisions across the European Union. If, as a result of the decision, the first instance ruling is upheld, patent protection in Europe for any technical teaching involving embyronic stem cells would become obsolete.