University Duisburg-Essen Institute of Anatomy, Essen
Hans-Werner Denker
University Duisburg-Essen

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Hans-Werner Denker
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Stem Cell Patents: Ruling of the German Bundesgerichtshof (BGH) - a Missed Chance (December 2012)

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Introduction

On 27 November 2012, the German Federal Court of Justice (Bundesgerichtshof, BGH) in Karlsruhe has finally ruled in the stem cell patenting case Greenpeace vs. Brüstle (background information). The Court had to take action in response to the previous ruling of the European Court of Justice (ECJ) of October 18, 2011 (see this website, News November 2011, Stem Cell Patents): The ECJ had ruled that stem cells cannot be patented if their derivation involves/d sacrificing human embryos (as typical for the derivation of embryonic stem cells, ES cells). The use of e.g. parthenogenetic embryos, i.e. the products of artificial egg cell activation, was explicitly also banned by the ECJ (which is completely consistent with the definition of the terms as used in embryology). The BGH has now basically affirmed this for German jurisdiction. For the present case (Greenpeace vs. Brüstle) it was ruled that as a consequence some of the specific claims of Brüstle's patent cannot be maintained. Claims must be limited to cells whose derivation does not/has not involve(d) sacrificing human embryos.

In press releases both parties have declared this ruling as an (at least partial) victory (Greenpeace; VBIO; Süddeutsche).

In the meantime the complete text of the ruling is also available.

Résumé from a scientist's point of view:
If anyone had hoped that this High Court trial would lead to a wise, forward-looking decision taking into account what is really going on in stem cell research right now, he must feel disappointed. At a first glance the ruling may give the impression that it can be of some help for stem cell researchers and patent applicants, clarifying what types of cells (and related procedures) can be protected by patents and which cannot. The ruling gives the impression that patenting is generally non-problematical with pluripotent (ES) cells whenever they can be / have been derived without sacrificing human embryos. Indeed the destruction of embryos is the only criterion the Court has dealt with in detail and which it has considered when drawing its conclusions. However, the Court totally refrained from adequately discussing other aspects of patenting that arise when considering the potentiality of the cells. This is a serious shortcoming of this ruling: What is being done in most stem cell laboratories these days, and what granting agencies and industry are most actively supporting financially right now (including filing patents) is reprogramming of cells (in particular, generating induced pluripotent stem sells, iPS cells). As was predictable already many years ago, the "classical" approach how to derive human pluripotent cells from embryos (ES cells) now does not play any major role anymore. The Court, however, has concentrated totally on the Brüstle patent at hand and on its narrow focus on ES cell (and not iPS cell) derivation. A chance was missed to widen the view, in this High Court decision, and to consider the needs of most researchers actually involved in stem cell research: to define patenting rules with regard to inducing pluripotency in human cells vs. inducing lower levels of potentiality (direct conversion, strategies bypassing pluripotency; see DENKER, H.-W.: Time to reconsider stem cell induction strategies. Cells 1: 1293-1312 (2012) (Open Access). Cells Website   pdf-download (222 KB)).

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