The German patent DE 1975864 C1 (also called “Brüstle Patent” after the patentee Prof. Brüstle) contains claims directed to neural precursor cells derived from embryonic stem (ES) cells and methods for producing the neural precursor cells. The claims do not mention the use of embryos for producing the ES cells. Greenpeace filed a nullity action before the German Federal Patent Court for partial revocation of the German patent insofar as the claims comprise neural precursor cells derived from human ES cells.
The nullity action was exclusively based on the ground that the subject-matter claimed would not comply with the morality requirement of Section 2 (2) No. 1 in combination with Section 2 (2) No. 3 German Patent Act. The latter provision stipulates that no patents are granted for the use of human embryos for industrial or commercial purposes.
Greenpeace alleged that the practice of the invention, insofar as it related to neural precursor cells derived from human ES cells, would inevitably require the destruction of human embryos which is considered to be against public morale and in breach of current legislation.
The Federal Patent Court decided to uphold in amended form a patent containing claims directed to neural precursor cells derived from ES cells, subject to the limitation that cells are excluded which are derived from ES cells prepared from human embryos. The Patentee filed an appeal against said decision with the Federal Supreme Court. Since the wording of the relevant provision Section 2 (2) No. 3 German Patent Act is identical to Art. 6 para. 2 lit. c) of the EU Biotech Directive 98/44 and requires inter alia an interpretation of the term “human embryo”, the Federal Supreme Court decided to refer questions of law to the Court of Justice of the European Union. Submissions were filed by some of the member states. On March 10, 2011 the Advocate General rendered his opinion on the referred questions.
The first referred question relates to the meaning of the term “human embryos” in Article 6(2)(c) of Directive 98/44 and whether this term includes all stages of the development of human life, beginning with the fertilisation of the ovum, or whether further requirements, such as the attainment of a certain stage of development, be satisfied. According to the Advocate General the concept of a human embryo applies from the fertilisation stage to the initial totipotent cells and to the entire ensuing process of the development and formation of the human body including the blastocyst. The Advocate General provided this definition in the knowledge of controversy with respect to said term among the member states.
The Federal Supreme Court further inquired whether, in particular, unfertilised human ova into which a cell nucleus from a mature human cell has been transplanted, or unfertilised human ova whose division and further development have been stimulated by parthenogenesis are encompassed by the term “human embryos”. This question relates to alternative sources for creating human embryonic stem cells, i.e. therapeutic cloning and parthenogenesis. According to the Advocate General, unfertilised ova into which a cell nucleus from a mature human cell has been transplanted or whose division and further development have been stimulated by parthenogenesis are also included in the concept of a human embryo insofar as the use of such techniques would result in totipotent cells being obtained.
The referring Court in particular wanted to know whether pluripotent embryonic stem cells, obtained from human embryos at the blastocyst stage, were considered as human embryos. The Advocate General argued that isolated pluripotent embryonic stem cells are not included in that concept because they do not in themselves have the capacity to develop into a human being.
The further questions of the referral related to the expression “uses of human embryos for industrial or commercial purposes” and whether this would include any commercial exploitation within the meaning of Article 6 (1) of [Directive 98/44], especially use for the purposes of scientific research. Finally, the referring Court inquired whether a technical teaching is considered to be non-patentable pursuant to Article 6(2)(c) of the Directive even if the use of 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 (a) because the patent concerns a product whose production necessitates the prior destruction of human embryos, (b) or because the patent concerns a process for which such a product is needed as base material. In his Opinion the Advocate General suggests the Court decide that an invention should be excluded from patentability where the application of the technical process for which the patent is filed necessitates the prior destruction of human embryos or their use as base material, even if the description of that process does not contain any reference to the use of human embryos. The exception to the non-patentability of uses of human embryos for industrial or commercial purposes according to the Advocate General concerns only inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to this particular embryo.
The Decision of the Court of Justice of the European Union may be expected in summer 2011.