Three weeks ago, on March 10, the Advocate General of the European Union’s Court of Justice, issued a non-binding preliminary opinion “in complete independence” on the question of the meaning of the term “human embryo” in the 1998 European Commission directive on the patentability of biotechnology inventions. This opinion concludes that “an invention cannot be patentable where the application of the technical process for which the patent is filed necessitates the prior destruction of human embryos or their use as base material, even if the description of that process does not contain any reference to the use of human embryos.” In a sense, this case may be the European version of Sherley v. Sebelius, the U.S. case where two adult stem cell researchers are seeking the U.S. federal courts to prevent the National Institutes of Health from funding research with cell lines derived from human embryonic stem cells, arguing that such funding is prohibited by the Dickey-Wicker Amendment, dating back to 1995. The Advocate General’s non-binding opinion arises in the patent law case of Brüstle v. Greenpeace eV (European Union Court of Justice Case C-34/10). The German patent in question in this case claims isolated and purified neural precursor cells, produced from human embryonic stem cells, used for the treatment of neural defects. The application for this patent was filed in December 1997 by Dr. Oliver Brüstle (the director of the Institute of Reconstructive Neurobiology at the University of Bonn). In 2004 Greenpeace eV applied to the Bundespatentgericht (Federal Patent Court, Germany) to object to the patent, arguing that because the neural precursor cells referenced in the patent originated from fertilized human eggs, the patent violated the 1998 European Directive 98/44/EC on the legal protection of biotechnology inventions. This Directive prohibits the industrial or commercial use of human embryos, but does not define the term “human embryo”. In 2006, the Bundespatentgericht agreed with this objection, and Brüstle appealed the consequent invalidation of his patent to the Bundesgerichtshof (Federal Court of Justice, Germany). Three years later, in 2009, the Bundesgerichtshof stayed the proceedings in order to refer to the European Court of Justice concerns “whether the exclusion of the human embryo from patentability concerns all stages of life from the fertilisation of the ovum or whether other conditions must be satisfied, such as the attainment of a certain stage of development.” After opining that both the totipotent cells “represent[ing] the first stage of the human body” and the blastocyst constitute human embryos for purposes of the European Directive 98/44/EC, the Advocate General reasons that even though “pluripotent embryonic stem cells, taken in isolation, do not fall within the definition of an embryo, since, individually, they are no longer capable of developing into a complete human being…[i]t it is not possible to ignore the origin of these embryonic stem cells [and] inventions relating to pluripotent stem cells can be patentable only if they are not obtained to the detriment of an embryo, be that it’s[sic] destruction or its modification. To make an industrial application of an invention using embryonic stem cells would amount to using human embryos as a simple base material, which would be contrary to ethics and public policy.” (The Advocate General’s non-binding preliminary opinion regarding totipotent cells also extends to SCNT and parthenogenesis “in so far as totipotent cells would be obtained in those ways”.) As a technical matter, the reference by the Bundesgerichtshof to the European Court of Justice of the question as to the meaning of the term “human embryo” is a means by which the Bundesgerichtshof can obtain an interpretation by which to align with European Union guidelines the ultimate decision on the appeal of the invalidation of the Brüstle patent, which the German Court ultimately must make. As noted in the March 10 press release announcing the Advocate General’s non-binding opinion, “The [European] Court of Justice does not decide the dispute itself. It is for the national court or tribunal to dispose of the case in accordance with the Court’s decision, which is similarly binding on other national courts or tribunals before which a similar issue is raised.” Dr. Brüstle, quoted by Nature in a March 10 news article, views the Advocate General’s non-binding preliminary opinion as “the worst possible outcome”. This same news article in Nature notes that a final decision from the European Court of Justice on the interpretative question referred to it “is expected within a couple of months,” but also notes that “few preliminary opinions are reversed.” We recognize that this case only involves the validity of a patent, but as the Nature article suggests, a ruling that adopts the conclusions of the preliminary opinion may foretell “difficulties beyond the issue of patenting”, not only for stem cell researchers in Europe but, recognizing the importance of cross-border collaboration in stem cell research and its translation into regenerative medicine, on a global basis.
* We express appreciation to the members of the GPI Legal Advisory Board who contributed to this analysis.
Bernard Siegel | Genetics Policy Institute (GPI)
GPI is 501c3 nonprofit foundation, serving to advance public awareness and education of stem cell science and field of regenerative medicine, while reducing roadblocks hindering progress) | www.genpol.org