Wednesday, August 1, 2012
Last fall, the European Court of Justice (Grand Chamber) interpreted Directive 98/44/EC of the European Parliament on the legal protection of biotechnological inventions to exclude from patentability stem cells obtained from the destruction of human embryos. The case was brought by Greenpeace and sought annulment of Oliver Brustle's patent on neural precursor cells and processes for their production. The German Bundesgerichtshof (Federal Court of Justice) referred the case to the ECJ for interpretation of Directive 98/44/EC. The ruling reasoned that embryos are not patentable and thus materials obtained through embryo destruction are not patentable. Brustle v. Greenpeace (18 October 2011), http://curia.europa.eu/juris/document/document.jsf;jsessionid=9ea7d0f130d5d4216b78fe284603bff3d470bbb043f5.e34KaxiLc3eQc40LaxqMbN4Oa3iSe0?text=&docid=111402&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=30577.
In the legal background of the decision is the TRIPS agreement provision that members may exclude from patentability inventions when their commercial exploitation would threaten public policy or morality. Article 53 of the Convention on the Grant of European Patents excludes from patentability inventions "the commercial exploitation of which would be contrary to 'ordre public' or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the contracting States." Directive 98/44/EC likewise emphasizes the non-patentability of inventions where commercial exploitation offends ordre public or morality. Article 6 of the Directive specifies that use of human embryos for industrial or commercial purposes violates ordre public or morality. Several assumptions were key to the ECJ ruling. The ECJ judged that the EU required a common standard for the definition of human embryo. The definition should be framed broadly rather than narrowly, to avoid encouraging a race to seek patents in the least restrictive jurisdictions. Patentability most be excluded whenever respect for human dignity could be affected. And dignity is affected by the treatment of any entity that could become a human being, including: "any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis." The ECJ left up to the referring court whether in light of current science stem cells themselves could become a human being and thus should be included within the ban.
Not surprisingly, the decision has generated significant controversy in the EU. Some see it as reflecting the influence of conservatives and the Catholic church, a potential harbinger of anti-abortion rulings to come. Others see it as likely to hamstring stemcell research within the EU. Still others see it as an important step in fighting unjustifiable commodification of human beings, a genuine achievement for human dignity.
Although the decision came down last fall, it has not yet been noted in this blog. I've used this post to call it to readers' attention as another illustration of the significant differences between EU and US approaches to the relationship between economic gain and research.