On 18 October 2011, the Court of Justice of the EU ("CJEU") handed down its long-expected decision in Case C-34/10 Oliver Brüstle v Greenpeace. To the dismay of the biotech industry in the EU, the ECJ took a broad view of the scope of the exclusion from patentability for "uses of human embryos for industrial or commercial purposes" in Directive 98/44/EC on the legal protection of biotechnological inventions (the "Biotechnology Directive"). The decision effectively prohibits the patenting of any inventions derived from human embryos, and
Mr Oliver Brüstle is the holder of a German patent for neural precursor cells, a method of producing purified neural precursor cells from pluripotent human embryonic stem cells, and the use of such precursor cells to treat a variety of neural defects, such as Parkinson's disease.
The method in question involves the extraction of human embryonic stem cells ("hESC") from a blastocyst. (A blastocyst is the structure that develops 4-5 days after fertilisation of a human ovum, consisting of 50-150 cells.) Such hESC are known as pluripotent, as they are capable of developing into various types of cells and tissues. However, they are not themselves capable of developing into a human embryo - only stem cells at pre-blastocycst stage of embryonic development, known as totipotent cells, have that capability.
The patent was examined centrally before the European Patent Office ("EPO"), and was granted by it. It entered into force across Europe, including in Germany. Greenpeace applied to the Bundespatentgericht (German Patent Court) to revoke the patent in Germany, on the ground that Article 6(2) of the Biotechnology Directive prohibits EU member states from granting patents for "uses of human embryos for industrial or commercial purposes". These uses are deemed to be contrary to "ordre public or morality". When the Biotechnology Directive was adopted in 1998, stem cell therapies were in their infancy and so are not expressly mentioned in the directive.
The German Patent Court agreed with Greenpeace, revoking the patent. On appeal, the Bundesgerichtshof (German Supreme Court) referred some questions about the meaning of the Biotechnology Directive to the CJEU.
The CJEU gave some useful clarification on what a "human embryo" is (at least for the purposes of patent law). It includes: (a) any human ovum after fertilisation (including a blastocyst); and (b) any non-fertilised human ovum which has been artificially stimulated or manipulated, provided the fertilisation, stimulation or manipulation is such as to "commence the process of development into a human being".
The question of whether the definition covers individual pluripotent stem cells (which are not of themselves capable of developing into a human being) was left unanswered by the CJEU, which said this was a question for the Bundesgerichtshof to answer in light of scientific developments.
However, the main impact of the decision came from the Court's comments on the meaning of "use .... in industrial or commercial matters" of such embryos.
The Court ruled that all the precursor stages of the invention claimed in the patent application must be considered when considering whether it involves the use of human embryos. Controversially, it decided that an invention will not be patentable if the subject matter of the patent application requires the prior destruction of human embryos or their use as a base material, "whatever the stage at which that takes place". This will be so even if the subject matter claimed in the patent application makes no reference to the use of human embryos.
The decision of the CJEU was not a surprise, as it largely followed the opinion of the Advocate-General (which happens in 80% of cases). However, it has still been greeted with dismay in some quarters.
The implications of the decision are being hotly debated. However, the following points can be made already:
- hESC are readily available from established cell lines grown in the laboratory and stored in stem cell banks. The EPO accepts that this has been the case since about May 2003. This means that stem cell inventions based on such material have since that date been able to be implemented without any further destruction of human embryos. However, such stem cells lines would typically have been derived originally from a small number of human embryos, resulting in their destruction. The decision of the CJEU to take into account this historic use of human embryos as the source of these human stem cell lines means that inventions which could be implemented using such material, without further destruction of human embryos, are not patentable in the EU.
- This is inconsistent with the position to date in the EPO (despite the CJEU's comments to the contrary). Rule 28(c) of the Implementing Rules of the European Patent Convention contains an identical "use of embryos" exception to that in Article 6(2) of the Biotech Directive. In 2008, the Enlarged Board of Appeal of the EPO considered the meaning of this exception in relation to a patent application filed by the Wisconsin Alumni Research Foundation (Case G2/06) relating to a culture of pluripotent stem cells. See Biobriefs here. In that case it ruled that, although the patent claims did not expressly cover the "use of embryos", the state of technology at the filing date of the patent application meant that the stem cell culture could be prepared exclusively by a method which necessarily involved the destruction of an embryo. As a result, it found that the invention was "contrary to morality or order public" and could not be patented. However, following this decision, the EPO adopted the practice of allowing patents for inventions which were based on hESC from established cell lines and which were filed after May 2003, as such inventions could have been put into practice on the filing date without destruction or use of an embryo.
- The EPO, including the Enlarged Board of Appeal, is not bound by the decision of the CJEU. It is not clear whether the EPO will change its practice to bring itself in line with the new approach. In any event, hESC patents granted by the EPO may now be unenforceable in the national courts of the EU member states, leaving the patent owners with a tough decision about whether to carry on paying the renewal fees or filing new applications.
- European patent law is almost exclusively a product of the European Patent Convention, and not of EU law. This means that the CJEU has previously had little involvement in patent law. Indeed, the only technical field in which it has jurisdiction over patenting is biotechnology (as a result of the adoption by theh EU of the Biotech Directive). This is the first ever case in which the CJEU has had to decide on patentability.
- It is ironic that Germany has one of the toughest regulatory regimes in the EU restricting stem cell research. Mr Brüstle would have had to comply with this regime in carrying out his research, but was still unable to obtain patent protection in Germany.
- Patent protection is still available in the EU for stem cell therapies which do not involve the use of hESC derived originally at some point in the past from the destruction of embryos. These alternative therapies include iPS cell therapy (which generates stem cells from human adult skin cells - so called "induced pluripotent stem cells") and techniques based adult stem cells or hESC collected from amniotic fluid or from the umbilical cord. These technologies may now gain new significance.
- Patent protection in the US and Far East is not affected by this decision. This means that EU biotech companies can still in principle obtain patent protection in those jurisdictions for their hESC inventions. Nevertheless, the EU biotech industry is protesting vehemently that the Br?stle decision will make it harder for EU biotech companies to attract investment for research on human embryonic stem cells. This in turn could lead to a could lead to a 'brain drain' of researchers to jurisdictions where it is easier to attract investment funding. Indeed, earlier this year the US Supreme Court upheld President Obama's overturning of the Bsuh administration's ban on federal funding for stem cell research, making the US a far more attractive place for hESC research than was previously the case.