The European Court of Justice (ECJ) in Luxembourg ruled on October 18, 2011, 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 parthenogenetic embryos, i.e. the products of artificial egg cell activation, is explicitly also banned (which is completely consistent with the definition of the terms as used in embryology). This ruling will have to be considered from now on in any decisions about patent applications and in national legislation, within the European Union. Background: In 2004 Greenpeace had challenged a patent (granted to Oliver Brüstle) at the Bundespatentgericht (Federal Patent Court) in Munich in order to examine the ethical boundaries of patentability. The Bundespatentgericht affirmed most of Greenpeace’s challenges. The patent owner appealed the decision. In 2009 the Bundesgerichtshof (Federal High Court) referred the case to the ECJ to clarify the definitions of basic terms used in this context, specifically the term of “human embryo”.
The final ruling of the ECJ has now elicited a wave of comments in the press. Many stem cell researchers are cited to have responded with a loud outcry (not surprisingly in particular patent holders). These voices are thus repeating a protest that had already been published at a very visible site while the decision of the ECJ was still pending, obviously with the intent to influence the decision-making of the court (A. Smith et al.: ‚No’ to ban on stem-cell patents. Nature 472 (7344): 418, 2011). This protest had been a direct response to an opinion published before by the Advocate General of the ECJ, Yves Bot (ECJ press release No. 18/11 of 19 March 2011).
The bias which the prestigious journal Nature has expressed with publishing the article by Smith et al. appears remarkable. However, any intention to influence the ECJ obviously failed. Indeed, the background on which the court based its decision was a broader one and considered facts and arguments not addressed by Smith et al. Also remarkable is that even now many authors commenting on the ECJ ruling confess that they were unprepared to consider such a decision possible. However, facts and arguments behind the ethical dilemma of research with pluripotent stem cells, neither addressed in the article by Smith et al. nor in most of the recent comments, can indeed be found in the literature since years. Moreover it would obviously have been prudent at the present timepoint to open the eyes for aspects of patenting arising since iPS cell (induced pluripotent stem cell) technology became the new focus of stem cell research. This has been addressed e.g. in a comment to the Smith et al. article (H.-W. Denker and S. Holm: Patenting and stem cell pluripotency. Comment to the open letter by A. Smith et al.; Nature 472: 418, 2011; Online Comment #22079. pdf-download (6.56 KB) Nature Website)
Already since 2004 I have explicitly published on problems of patenting arising in this field. These arguments do not focus only on the aspect of embryo destruction at ES cell derivation, but I am arguing that in addition the potentiality of the created stem cells must be seen as a most relevant aspect and should indeed be central to any decision about patentability of the cells. This has become particularly important after most laboratories around the globe have begun to concentrate on iPS cells. IPS cells are derived from ethically non-problematical somatic cells (e.g. fibroblasts) by re-programming. However, if the endpoint/goal (often called “gold standard”) is acquisition of “pluripotency”, these cells gain, in addition to general stem cell properties (so to say as a by-product), the potential to allow direct cloning of viable individuals from them via tetraploid complementation. It should be obvious that whenever human cells possess this very peculiar embryo-formation potential they cannot be patented for ethical reasons. I have developed this argument in detail in my publications, and I am sure patenting decisions will need to (and indeed will) take this into consideration in the future.
However, researchers as well as companies investing in this field certainly do not need to be in panic, neither due to the ECJ ruling nor with respect to any future rulings that are to be expected on the basis of these arguments. As I already wrote in a couple of my recent publications, routes for escape from the potentiality dilemma may well be found if one makes intelligent use of the present state of knowledge of developmental biology. It does appear possible to avoid being caught in the ethical trap if modified protocols and alternative strategies for stem cell derivation are used: I have proposed already in 2008 (Cells Tissues Organs 187: 250-256; 2008) that e.g. genes involved in early embryonic pattern formation processes (including gastrulation) could be seen as candidates to be focussed on. Today there are indeed an increasing number of publications on success with strategies “circumventing pluripotency”, demonstrating that such methods can be developed successfully. As I predicted, this appears to open an escape from the ethical (and patenting) dilemma connected with the derivation and use of “pluripotent” stem cells.
PDFs of my publications on this topic can be found on this website in the list of publications on Stem Cells and Bioethics.
Specifically relevant for the topic of stem cell patenting are the following publications:
Note: Opening the pdf-files requires a pdf-reader (e.g. Adobe Reader).
DENKER, H.-W., HOLM, S.:
Patenting and stem cell pluripotency.
(Comment on: SMITH, A.: 'No' to ban on stem-cell patents. Nature 472, 418, 2011; doi: 10.1038/472418a.)
Nature 472: 418, 2011; Online Comment #22079.
pdf-download (6.56 KB) Nature Website
Die Potenz von menschlichen ES-Zellen als Argument gegen ihre Patentierbarkeit.
Jahrbuch für Wissenschaft und Ethik, Bd. 9 (L. Honnefelder u. C. Streffer, Eds.). Walter de Gruyter, Berlin/New York, 2004, pp. 367-371. pdf-download (8.75 MB)
english abstract (0.99 MB): The developmental potential of human embryonic stem cells argues against their patentability