By Kevin E. Noonan —
The European Court of Justice (ECJ) is poised to make a decision regarding the patent-eligibility of human embryonic stem cells (hESCs) in Europe, and that decision will be "no" if the court follows the recommendation of the court's advocate general.
The case began in 2004, when Greenpeace sued in German federal court over a German patent to the University of Bonn involving methods for deriving neural cells from hESCs (DE 197568664 C1). While German laws regarding stem cell research have been characterized as the "most restrictive in Europe," such research is permitted provided that it is performed with pluripotent (rather than totipotent) cells, using cell lines imported from abroad and only cell lines that were made prior to May, 2007. Nevertheless, Greenpeace argued that claims to methods for using hESCs were "immoral and against public order," provisions of European law generally that define subject matter not eligible for patent (there is no corresponding provision under U.S. law).
The German federal court ruled for Greenpeace in 2006, and the university appealed to the German supreme court. That court decided that it needed to refer the question to the ECJ, since German law was closely patterned on European Union guidelines for biotechnology patenting.
On March 17, 2011, the ECJ advocate-general, Judge Yves Bot, rendered an opinion that stem cell patents were "contrary to ethics and public policy" because they required "industrial use" of human embryos. This is not a final decision of the ECJ, which will now consider the matter before the entire 13 judges of the court and render an opinion in the next several months. However, it is expected that the court will agree with the advocate-general, since it is rare that such preliminary opinions are overruled, according to a court spokesman.
This possibility prompted several stem cell scientists in Europe to send a letter to the court, published in Nature on April 28th, setting forth the case for stem cell patenting. In the letter, the scientists expressed their "profound concern" in the capacities as "coordinators of multinational European stem-cell projects." They contend that stem cells are cell lines, not embryos, and that they were derived from "surplus in vitro fertilized eggs donated after fertility treatments" that could not be maintained "indefinitely." The existence of "more than 100" established stem cell likes make concerns about embryos "misplaced," they assert, and warn that it may be "premature to suggest that human embryonic stem cells can be replaced" (by iPS cells, for example) in developing stem cell therapies. A stem cell ban in Europe will prevent scientists from "deliver[ing] clinical benefits without the involvement of biological industry," and such companies "must have patent protection as an incentive" to do their work in Europe. This will result, these scientists predict, in "European discoveries [being] translated into applications elsewhere, at a potential cost to the European citizen."
This action is the latest in a series of initiatives by individuals and groups with philosophical objections to patents involving biological materials, particularly material derived from human beings. These include the Public Patent (PubPat) Foundation's attempts to invalidate the Thomson hESC patents in the U.S. (unsuccessful with regard to U.S. Patent Nos. 5,843,780 and 6,200,806 and currently pending against U.S. Patent No. 7,029,913) as well as PubPat and the ACLU's challenge to human gene patenting in the AMP v. USPTO (Myriad) case. Opponents of such patents voice various arguments and rationales against patenting products of human biology, but ultimately the argument is the one raised in Europe, that there are moral objections to the practice. Such objections are sincerely held by many and it is neither possible nor productive to make arguments on these grounds: as it is in many public policy debates, these positions tend to be absolutes for some, not subject to merely reasoned argument. Perhaps the best rejoinder of the argument is to posit the situation if patent opponents prevail (which also comprises a part of the scientists' argument in their letter). Lack of patent protection will have two concrete and predictable consequences: lack of financial investment to translate basic scientific discoveries to useful commercial products, and (where possible) reducing or eliminating public disclosure of inventions (and where not possible, investment in other technologies). Neither outcome is conducive to reducing human morbidity or mortality or improving the human condition. It is hard to understand how advocating such an outcome can be considered the more moral position.
The Nature letter was signed by the following scientists:
• Austin Smith EuroSyStem Project, Wellcome Trust Centre for Stem Cell Research, Cambridge, UK
• Peter Andrews ESTOOLS Project, Centre for Stem Cell Biology, University of Sheffield, UK
• Clare Blackburn EuroStemCell Project, MRC Centre for Regenerative Medicine, University of Edinburgh, UK
• Anders Björklund NeuroStemcell Project, Wallenberg Neuroscience Center, Lund University, Sweden
• Elena Cattaneo NeuroStemcell Project, University of Milan, Italy
• Giulio Cossu OptiStem Project, Stem Cell Research Institute, San Rafaelle Institute of Milan, University of Milan, Italy
• Juergen Hescheler ESNATS Project, Institute of Neurophysiology, University Hospital of Cologne, Germany
• Olle Lindvall NeuroStemcell Project, Lund Stem Cell Center, Lund University, Sweden
• Marc Peschanski STEM-HD, Institute for Stem Cell Therapy and Exploration of Monogenic Diseases, INSERM, Evry, France
• Daniel Pipeleers BetaCellTherapy Project, Diabetes Research Centre, Free University of Brussels, Belgium
• David Sassoon EndoStem Project, University of Paris VI/INSERM, Pitié Salpêtrière Medical School, Paris, France
• Anna Veiga hESCreg Project, Centre of Regenerative Medicine, Barcelona, Spain
• Catherine Verfaille HemiBio Project, Stem Cell Institute, K. U. Leuven, Belgium
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