Stem-cell ruling provides perspective

Stem-cell-ruling-photo
The German Federal Supreme Court has ruled on the patentability of human embryonic stem cell-related inventions, as Dr Thomas Friede reports.

On 27 November 2012, the German Federal Supreme Court finally decided on the controversial Brüstle case (X ZR 58/07 – Stem cells). In this case, a nullity action was filed by Greenpeace with respect to a patent of the stem cell researcher Professor Brüstle.

The patent contains claims directed to neural precursor cells derived from embryonic stem cells and methods for producing them. The scope of the claims of the granted patent encompasses neural precursor cells obtained from stem cells produced from the blastocyst stage of human embryos (hES). This latter method is also recited in the description. The claims do not mention the use of embryos for producing the ES cells. As alternative sources for stem cells, stem cells are mentioned which are derived from unfertilized human egg cells, in other words embryonic germ cells (EGC) and unfertilized eggs in which a cell nucleus from a mature cell has been implanted (“dolly method”).

The action

The nullity action was exclusively based on Section 2 (2) No 3 German Patent Act, which is identical to Art. 6 (2)(c) of the EU Biotech-Directive 98/44 and Rule 28 c) EPC stipulating that no patents shall be granted for inventions directed to the use of human embryos for industrial or commercial purposes. In its decision dated 5 December 2006, the Federal Patent Court decided to maintain the patent, with the proviso that the embryonic stem cells are not obtained from human embryos. Professor Brüstle appealed this decision to the Federal Supreme Court. The Federal Supreme Court referred the case to the Court of Justice of the European Union (CJEU) for a preliminary ruling on the interpretation of the respective provision in the EU Biotech Directive.

In its case C-34/10, the CJEU ruled that the exclusion from patentability is independent from the fact that the prior destruction of human embryos is not contained in the claims if it is required by the technical teaching of the patent. Even if the destruction is not mentioned in the specification at all, the exclusion from patentability can apply. The term “embryo” includes any human egg cell after fertilization, any non-fertilized human egg cell into which either a cell nucleus has been implanted or undergoing parthenogenesis. The CJEU left it for the national court of the member states to determine whether an hES as such represented an embryo. “Industrial or commercial purposes” also covers scientific research, thus the use of human embryos for scientific research cannot avoid the exclusion from patentability.

The Supreme Court ruling

The Federal Supreme Court had to apply this ruling of the CJEU to its Brüstle case. It reversed the judgment of the Federal Patent Court and maintained the patent, with the proviso that the embryonic stem cells are not obtained by ….click here to subscribe and read the whole article

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Thomas Friede

Thomas is a Partner, European Patent Attorney and German Patent Attorney at BARDEHLE PAGENBERG in Munich, Germany. He holds a Ph.D in Biochemistry and concentrates on Life Sciences and pharmaceutical inventions. His practice encompasses patent prosecution before the EPO and patent litigation before the District Courts and the Federal Patent Court. He has particular litigation experience with drug-eluting stents, diagnostic assays, cosmetics, vaccines and antibodies. Thomas is recommended for patent prosecution and patent nullity matters by Intellectual Asset Management (IAM).

Email: thomas.friede@bardehle.de

Tel: +49 (0)89 928 05-0