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Patent Law

German Federal Supreme Court decides on the patentability of human embryonic stem cell-related inventions (decision of November 27, 2012 – Case X ZR 58/07 – Stem cells)

Reported by Dr. Thomas Friede

On November 27, 2012, the Federal Supreme Court finally decided on the controversial Brüstle case. 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, i.e. embryonic germ cells (EGC) and unfertilized eggs in which a cell nucleus from a mature cell has been implanted (“dolly method”).

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 December 5, 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” cover also scientific research, thus the use of human embryos for scientific research cannot avoid the exclusion from patentability (cf. BARDEHLE PAGENBERG IP Report 2009/5).

The Federal Supreme Court had to apply this ruling of the CJEU to its Brüstle case. The Federal Supreme Court reversed the judgment of the Federal Patent Court and maintained the patent with the proviso that the embryonic stem cells are not obtained by destruction of human embryos. The Federal Supreme Court clarifies that the patent is maintained insofar as the human stem cells are obtained by other methods. The patent as maintained by the Federal Supreme Court is therefore broader than the version maintained by the first instance, since it now encompasses human embryonic stem cells obtained by methods which do not lead to the (entire) destruction of the human embryo.

The reasoning of the decision of the Federal Supreme Court is not available yet. However, from the discussion in the oral proceedings the following arguments can be derived. The patent-in-suit contains a broad definition of stem cells including embryonic germ cells, the production of which does not rely on the destruction of embryos. Even at the filing date, the patent-in-suit could be worked without (entire) destruction of human embryos. After the filing date of the patent-in-suit, methods for the production of hES cells became available which do not require the (entire) destruction of living human embryos. These methods include the generation of hES cells from so-called arrested embryos which, due to genetic defects, are impaired in their capacity to divide. Further, methods have been developed where only a few cells are removed from the blastocyst stage of the human embryo without affecting the capacity of the remaining blastocyst cells to develop into a living organism.

Remarks
The Federal Supreme Court’s decision therefore clarifies that stem-cell related inventions based on non-destructive methods are not excluded from patentability, which provides perspectives for applicants in this field. Notwithstanding this, the CJEU’s decision and also the subsequent
Federal Supreme Court’s decision do not question the patentability of ips (induced pluripotency stem cells), i.e. cells which have ES-like pluripotency but are derived from human reprogrammed adult cells.

Published on
November 2012
Author
Dr. Thomas Friede