The European Union (EU) Court of Justice has determined that EU patent law does not protect neural precursor cells and the processes for their production from embryonic stem cells. Brüstle v. Greenpeace e.V., Case C-34/10 ECJ (October 18, 2011).
Greenpeace, which apparently opposes patents on plants, animals, genes, and smaller parts of DNA, sought to invalidate the German patent held by stem cell researcher Oliver Brüstle, contending that such patent protection involves the commercialization of the human body. The basis of the suit was an EU law barring patents on inventions “where their commercial exploitation would be contrary to ordre public or morality.” According to the court, Brüstle’s 1997 patent, “concerns isolated and purified neural precursor cells, processes for their production from embryonic stem cells and the use of neural precursor cells for the treatment of neural defects.”
The court was asked by the referring German court to (i) interpret the term “human embryos” as used in an EU directive (98/44/EC) on the legal protection of biotechnological inventions and (ii) determine whether scientific research is included in the proscription on “uses of human embryos for industrial or commercial purposes.” The court was also asked, “Is technical teaching to be considered unpatentable pursuant to Article 6(2)(c) of the Directive even if the use of the human embryos does not form part of the technical teaching claimed with the patent, but is a necessary precondition for the application of that teaching: - because the patent concerns a product whose production necessitates the prior destruction of human embryos, - or because the patent concerns a process for which such product is needed as base material?”
The court ruled that “any human ovum after fertilisation, and 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 constitute a ‘human embryo,’” and that “it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.”
The court also determined that the use of human embryos for scientific research is covered by the “exclusion from patentability concerning the use of human embryos for industrial or commercial purposes” under Directive 98/44. Uses of human embryos “for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it” are, however, patentable, according to the court. The court further stated, “Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.”
Brüstle reportedly responded to the legal setback by stating, “Companies now will not invest in these technologies because they cannot safeguard their investment” with patent protections. Still, European inventors may be able to secure patents that would protect their work outside European markets. See The Wall Street Journal, October 18, 2011.