On 10 March 2011, Advocate General Bot delivered his opinion in relation to Case C-34/10, a reference to the Court of Justice of the European Union (CJEU) from the German Federal Court of Justice (Bundesgerichtshof) in Oliver Brüstle v Greenpeace eV. The facts of the case and this opinion were discussed in the March 2011 edition of our Intellectual Property E-Bulletin.
On 18 October 2011, the CJEU gave its decision in relation to Case C-34/10 on the three referred questions from the German Bundesgerichtshof regarding the interpretation of certain terms used in European Directive 98/44 on the legal protection of biotechnological inventions (Biotech Directive) and provisions which include those terms. In relation to the three questions, the CJEU ruled as follows:
Question 1: the definition of “embryo”
The CJEU stated that it is not to rule on medical or ethical questions, but that a legal definition of the term is needed in order to attempt to bring harmonisation of interpretation of the law across the Member States. Article 6 of the Biotech Directive, which states that inventions involving the use of human embryos for industrial or commercial purposes would be considered unpatentable as contrary to morality, provides additional security to Article 5 which prohibits patenting of inventions in relation to the human body at the various stages of its formation and development. No invention can be considered patentable as far as affects human dignity. Therefore, the concept of “human embryo” must be understood in the widest possible sense.
The CJEU went on to state that this meant an “embryo” within the meaning of Article 6(2)(c) of the Biotech Directive means any fertilised human embryo. It also includes unfertilised human ova which have been stimulated to develop by parthenogenesis (somatic cell nuclear transfer or cell nuclear replacement). These cells were totipotent and therefore, capable of becoming a human being (in theory) and thus fell foul of the Directive.
However, the CJEU differed from the Advocate General’s opinion when it came to the use of blastocysts. As blastocyst cells cannot be categorised as a whole as either totipotent (capable of forming any part of a human) or pluripotent (capable of forming a particular organ or part of a human only) and therefore, fall easily within the (above) definition of “embryo” for the purposes of the Biotech Directive, the CJEU decided that this was a question for the relevant national court at the time to decide as to whether a human being was capable of developing from such cells in light of then current scientific developments. However, the Advocate General had stated that if embryos were destroyed in the process of obtaining the blastocyst cells, inventions relating to those cells cannot be patentable and the CJEU affirmed this opinion. The slight difference in opinion between the CJEU and the Advocate General was surprising and has now left the blastocyst question again up in the air (perhaps another referral to the CJEU at some stage will rectify this).
Question 2: “uses of human embryos for industrial or commercial purposes”
The CJEU ruled that the grant of a patent always implies some form of industrial or commercial use of the invention. Therefore, although the invention may have a purpose of pure scientific research, this could not be separated from the other possible uses to avoid the exclusion from patentability under Article 6. However, the CJEU ruled that if the invention concerned the use of the embryo for therapeutic or diagnostic purposes as applied to the human embryo itself that may be a patentable invention.
Question 3: the use of human embryos does not form part of the technical teaching claimed in the patent but is a necessary precondition for the application of that teaching
The CJEU agreed with the Advocate General and ruled that where the removal of stem cells from a blastocyst caused the destruction of the blastocyst, an invention that relies on those stem cells or derived products of those stem cells will also be excluded from patentability. It is irrelevant that the patent does not mention stem cells (or method of retrieval) or seek to patent them or a use of them in some manner. If the claimed invention is reliant on stem cells in the background in some manner, the invention will not be patentable.
It is the ruling on question 3 that is posing great changes in patent law and which may affect the validity of many registered patents. How far back into the history of the components or method used to produce an invention, must an applicant search to ensure patentability of his invention in this field? It is current practice of the European Patent Office (EPO) to allow inventions where the applicant did not have to destroy any embryos itself at the relevant time of application or destruction of an embryo was not incorporated into the invention itself. Therefore, if the invention used or relied upon human stem cells that could be derived from already established stem cell lines, this was patentable (as confirmed in decision G2/06 of the EPO’s the Enlarged Board of Appeal in Wisconsin Alumni Research Foundation of 25 November 2008). Now the fact that destruction occurred at a stage long before implementation of the invention has become irrelevant. All of these inventions are deemed immoral and therefore, unpatentable under EU law.
What the EPO does next in terms of its own practice is to be determined (as it is not a member of the EU) and the effect of this decision on the value of patents already registered in this field has yet to impact. Although the CJEU is not there to decide ethical issues, this decision has forced the ethical debate to take another turn.