In order to harmonize and aid in the interpretation of the requirements set out in the national patent laws of the EU member states regarding the patentability of inventions in the field of biotechnology, the Council of the European Union (EU) enacted the Directive 98/44/EC of the European Parliament and of the Council, dated July 6, 1998, on the legal protection of biotechnology inventions (Biotechnology Directive). The Biotechnology Directive holds that the use of human embryos for industrial or commercial purposes is unpatentable. In its judgment concerning case C-34/10, the European Court of Justice (ECJ) has decided on the interpretation of the terms “embryonic stem cells” and “for industrial or commercial purposes”, as used in the Biotechnology Directive.

In particular, the ECJ stipulated in the above judgement that the prohibition of the use of embryos, as prescribed in the Biotechnology Directive, also encompasses the use of cells derived from an embryo for the preparation of stem cells. This includes the use of any human ovum after fertilisation as well as non-fertilised human ovum which have the potential to develop into a fetus. According to the ECJ, the concept of “human embryo” must be understood in a broad sense since the Biotechnology Directive intended to exclude any possibility of patentability where respect for human dignity could thereby be affected.

Additionally, it has been outlined in the ECJ’s decision that a use of stem cells derived from embryonic cells for scientific research constitutes a use for industrial or commercial purposes, which is prohibited by the Biotechnology Directive. Only a use of stem cells for therapeutic or diagnostic purposes that is applied to the human embryo itself can be patented. The court also held that the rights attached to a patent are, in principal, connected with acts of an industrial and commercial nature.

The decision also explicitly states that an invention is excluded from patentability when the implementation of the invention requires prior destruction of human embryos or their use as base materials. This also includes a destruction of the embryo which may have occurred at a stage long before the implementation of the invention, for example in the case of the production of embryonic stem cells from an established lineage of stem cells. The above judgment of the ECJ is in line with opinion G 2/06 of the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) which stipulated that the patenting of products which can be prepared exclusively by a method which necessarily involves the destruction of embryos from which said products are derived is prohibited, even if said method is not part of the claims. Accordingly, even if a medical product is produced outside of Europe, no patent protection can be obtained in Europe for said product, if its production involved the use of embryonic stem cells.


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