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German Brüstle decision puts spotlight on national patent guidelines

17 December 2012
By Julian Hitchcock
Counsel at Lawford Davies Denoon
Appeared in BioNews 686

On 27 November the case of Brüstle v Greenpeace was remitted to the German Federal High Court. Its decision had been awaited impatiently. How exactly would a national court interpret the controversial ruling of the Court of Justice of the European Union (CJEU), which in October 2011, had held that patent rights could not be granted in the EU for the use of any entity 'capable of commencing the process of development of a human being'?

Dubbed 'human embryos' for purposes of the Biotechnology Directive (Directive 98/44), fertilised eggs, CNR (cell nucleus replacement) eggs, parthenotes and anything else having the capacity to begin the journey of human development, could not, the CJEU declared, be patented for 'industrial or commercial purposes' (a term which it also construed broadly). All that mattered, said the CJEU, was the potential to begin development. The fact that such entities cannot complete their development (technical and legal limitations prevent them from even developing bodies) was immaterial.

Given such a comprehensive ban on patenting, many may be surprised to learn that the German court upheld, at least in part, Oliver Brüstle's patent to isolated and purified neural precursor cells, processes for their production from embryonic stem cells (ES cells) and the use of neural precursor cells for the treatment of neural defects.

While apparently applying the CJEU decision in full and restricting the scope of Brüstle's patent, the German Federal High Court fully exploited the narrow sliver of discretion that had been granted to it: to determine whether the pluripotent ES cells that are ultimately derived from 'human embryos' (in this case, blastocyst) should themselves to be classed as 'human embryos'.

In exercising its discretion, the Federal Court held that it was necessary to consider whether the entity under consideration was capable of developing into a person. Blastocysts are capable; as are ES cells. However, in vitro ES cells would be incapable of such development without significant intervention. They cannot develop under their own steam. On this basis, the Federal Court held that ES cells are not 'human embryos' for patent purposes; at least not in Germany.

The Federal High Court has therefore provided an important perspective on the CJEU's totipotency principle. In Germany, 'commencing the process of development' seems now to require the possibility - in the absence of an intervention - that an individual human being could develop from the entity in question. The court's discretion was so limited that the only relevant entity is an ES cell; nevertheless, this represents a significant improvement.

While superficially there is no conflict about subject matter, because the status of ES cells was explicitly left to national courts, the decision suggests that a philosophical difference has emerged between the CJEU and the German courts. A mere ES cell would require very significant intervention to commence the path of development towards a person (for example, the involvement of placental tissue and implantation).

However, exactly the same principle could be applied to IVF products: they, too, have no prospect of developing beyond the earliest stages of development without intervention (by implantation). The key difference appears to be simply that the German court had the discretion to decide upon ES cells in its own way and exploited that discretion to the full.

The Court appears to have used its narrow, ES cell discretion to maximum advantage in another way: by declaring that ES cell lines that do not require the destruction of a 'human embryo' (e.g. a blastocyst) remain patentable in Germany. By implication, this means that, if the ES cells in question did not - directly - require the destruction of a 'human embryo', they remain patentable.

This contrasts with the CJEU's remark that, 'the fact that destruction may occur at a stage long before the implementation of the invention, as in the case of the production of embryonic stem cells from a lineage of stem cells the mere production of which implied the destruction of human embryos is… irrelevant'.

The decision of the German Federal Court means that, at least in Germany, cell cultures that do not directly involve the destruction of blastocysts are capable of being patented. The courts in other Member States may be inclined to adopt a similar approach; and, not wishing Germany to gain the upper hand, national patent offices, including the UK Intellectual Property Office, may wish to review their existing guidelines in the light of the German decision, as should the European Patent Office.

However, whilst the German decision will undoubtedly encourage investors who may have been deterred by the CJEU ruling, its significance may be largely totemic. If nothing else, the Brüstle case had succeeded in throwing the spotlight on the value of patents, relative to far cheaper, less controversial and longer lasting forms of stem cell exclusivity.

12 January 2015 - by Antony Starza-Allen 
The European Court of Justice (CJEU) has cleared the way for the patenting of human parthenotes for industrial and commercial purposes, clarifying the definition of 'human embryo' excluded from patentability in European Law...
4 August 2014 - by Julian Hitchcock 
As BioNews 763 reported recently, Advocate General Cruz Villalón has advised the Court of Justice of the European Union (CJEU) that human parthenotes are not human embryos. The fact that he had to do so raises serious concerns about the ability of Europe's leading court to interpret bioethical legislation and challenges the authority of one of its most notorious cases....
29 April 2013 - by Antony Starza-Allen 
The UK's High Court has asked the Court of Justice of the European Union (CJEU) to clarify if human parthenotes fall under the definition of a human embryo for the purposes of patentability...
3 December 2012 - by Antony Starza-Allen 
The German Federal Court of Justice has ruled that a disputed patent held by Dr Oliver Brüstle, and the subject of a ruling by the European Court of Justice (ECJ) against the patentability of human embryonic stem cells, is valid in its revised form....
8 October 2012 - by Tom Barrow 
The future funding of human embryonic stem cell research under the European Union may be in jeopardy after its inclusion in the next research funding programme is challenged by MEPs....
25 June 2012 - by Antony Starza-Allen 
Six major UK research funding bodies have called for the continued funding of human embryonic stem cell (hESC) research in the EU's programme for research and development...
24 October 2011 - by Antony Starza-Allen 
The European Court of Justice (ECJ) has ruled that stem cell processes which require the prior destruction of human embryos or are based upon the use of human embryos are not patentable. The decision may have wide implications for scientists engaged in embryonic stem cell research....
28 March 2011 - by Nishat Hyder 
An advisor to the European Court of Justice (ECJ) has issued a preliminary opinion stating that procedures involving human embryonic stem (hES) cell lines are not patentable....
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