Inventions related to biotechnology have always been looked at closely when it comes to human embryonic stem cells.  Recently, there has been a referral to the European Court of Justice (ECJ, “Europäischer Gerichtshof”, EuGH) by the Federal Court of Justice of Germany that concerns the field of embryonic stem cells.

On December 17th, 2009 the German Federal Court of Justice (BGH, “Bundesgerichtshof”) issued a decision, which concerns the interpretation of Article 6 of the Directive 98/44/EC on the legal protection of biotechnological inventions with regard to the interpretation of the term “human embryo” (BGH, decision Xa–ZR 58/07, “Neural precursor cells”).

The decision recites three questions that are referred to the European Court of Justice (ECJ) under Art. 267 of the Treaty on the Functioning of the European Union for preliminary ruling:

“1. What is meant by the term “human embryos” in Art. 6 Sec.2. (c) of the Directive 98/44/EC?

a) Does this term comprise all stages of development of human life beginning from the fertilisation of the egg cell onwards, or are there other conditions that need to be fulfilled such as reaching a certain stage of development?

b) Are the following organisms also comprised by this term:

(1) unfertilised human egg cells, in which a nucleus from an adult human cell has been transplanted;

(2) unfertilised human egg cells, which have been triggered by parthenogenesis towards division and further development?

c) Does this term also comprise those stem cells, which have been derived from human embryos that were in the blastocyst stadium? 

2. What is meant by the term “use of human embryos for industrial or commercial purposes”?

Does that include any commercial exploitation in the sense of Art. 6 Sec.1 of the Directive, and does that also include a use for the purpose of scientific research?

3. Is a technical teaching also excluded from patentability under Art. 6 Sec. 2 (c) of the Directive if the use of human embryos is not part of the technical teaching claimed by the patent, but is a necessary condition for applying this teaching,

a) because the patent relates to a product, the generation of which requires the prior destruction of human embyos,

b) or because the patent relates to a method, which requires such a product as starting material?”

The run up to this decision was as follows: On April 29, 1999 the German Patent Office granted a German patent to the German stem cell researcher Oliver Bruestle on isolated and purified neural precursor cells and on a method for making such cells from embryonic stem cells.

Subsequently, Greenpeace filed a nullity suit against this patent at the Federal Patent Court (BPatG, first instance) in Munich based on an alleged violation of ordre public and morality and requested to declare nullity of the patent in as far as the claims cover neural precursor cells that have been made from human embryonic stem cells.  The Federal Patent Court declared nullity of the patent insofar.

The patentee filed an appeal against said decision at the Federal Court of Justice (BGH), which stayed the proceedings and referred the above legal questions to the ECJ.

With regard to German patent law it is all about how section 2 of the German Patent Act is to be interpreted, which excludes patents for “the use of human embryos for industrial or commercial purposes” (§ 2 (2) No.3 PatG) – which is the same wording as recited in Art. 6 No.2 (c) of the Directive, which was implemented in German Patent Law.

According to the BGH Art. 6 of the Directive is unclear and not devoid of any ambiguity with regard to several aspects – what are “human embryos”?   Is a stem cell that has been derived from a blastocyst an “embryo” even if it is not capable of developing into a human individual?   And is a “blastocyst” an “embryo” according to Art. 6 of the Directive?   The latter question will be relevant if the exclusion of “use of human embryos” in the Directive already would apply when the claimed human stem cells (which are not embryos themselves) require destroying blastocysts for making them.

If the ECJ would say that the requirement of using blastocycts/human embryos first in order to get embryonic stem cells is against Art. 6 Sec. 2 (c) of the Directive this would not come as a surprise.  In fact, such view would correspond to decision G 02/06 (“Use of Embryos”/WARF) of the Enlarged Board of Appeal of the EPO, which said that EP patents cannot be granted for products that require at the time of filing the destruction of human embryos, even if the method as such is not part of the claims.