In Europe, the German Federal Court of Justice gave a final verdict on November 27 in the Greenpeace vs. Brüstle case, indicating that the contested Oliver Brüstle patent, which covers technology for extracting human embryonic stem cells (hESCs) at the blastocyst stage, was valid. The decision follows a controversial judgment by the Court of Justice of the European Union (CJEU) in October 2011 (Nat. Biotechnol. 29, 1057–1059, 2011), stating that stem cell processes based on the use of embryos are not patentable, which caused considerable outcry in the biotech community. Critically, however, the CJEU ruling only covered the patentability of technologies describing hESCs derived by means of embryo destruction; decisions on the patentability of hESC technologies that derive cells at the blastocyst stage were delegated to the national courts, prompting the recent German federal court case.

Julian Hitchcock, counsel at the law firm Lawford Davies Denoon in London, believes the recent ruling points to a more liberal regime, in Germany at least. “All other things aside, if you didn't destroy an embryo it should be possible to get a patent,” Hitchcock says. This should encourage investors who were deterred by the CJEU ruling. “Given the very small amount of discretion that was given to the German court by the CJEU, it has been exercised in a favorable way.” Paul Chapman, partner at the London law firm Marks & Clerk agreed that “those who want to protect inventions relating to human embryonic stem cells in Europe now have a glimmer of hope.”

The October 2011 judgment by the CJEU had an impact on the patenting regime, with both the European Patent Office and UK Intellectual Property Office putting in place guidelines prohibiting patents on stem cells derived from blastocysts. Based on those guidelines, in August 2012, International Stem Cell of Carlsbad, California, was refused a patent by the UK Intellectual Property Office on its technique for activating oocytes through parthenogenesis to produce human embryonic stem cells. The UK Patent Office found on the basis of the CJEU's Brüstle ruling that a parthenogenetically derived structure is analogous to the blastocyst stage of normal embryonic development and did fall within the definition of a human embryo. International Stem Cell is now appealing the decision and the German ruling is likely to influence the pending hearing. Chapman believes the guidelines may be revised in light of the German court's decision.

Hitchcock noted that although the ruling of the German Court opens up the prospect of patents on embryonic stem cell products that did not involve destruction of an embryo, it leaves in place the CJEU's 'totipotency rule' which states that any cell line arising from an embryonic stem cell that involved the destruction of an embryo cannot be patented. “This holds, no matter how far downstream [a product] is,” Hitchcock said.