GERMAnY
An EMBRYonIC stEM CELL tHAt Is not ABLE
to DEVELoP Into A CoMPLEtE InDIVIDUAL Is
not An EMBRYo, ACCoRDInG to GERMAn LAW
the use of human embryos for industrial or commercial purposes. Th e 3. If the answer to Question 2 is yes, is the use of embryos within the meaning
regulation is identical to Article 6, paragraph 2 of the European Directive of the law already the case, if obtaining the stem cells to be used according to
98/44 on the legal protection of biotechnological inventions, which has been the invention necessarily implies ‘use’ of blastocysts?
implemented into national law.
4. Is any commercial (i.e. non-private) use within the meaning of the Patent
On December 5, 2006, the Federal Patent Court decided to maintain the Act a “use for industrial or commercial purposes”? In particular, is any use
patent in an amended version that excludes neural precursor cells derived for research purposes or for therapeutic purposes a “commercial” use within
from ES cells produced on their part from human embryos. Th e patent the meaning of the Article 6 of the Directive?
proprietor fi led an appeal against this decision with the German Federal
Court of Justice (BGH). Oral hearings were held on November 12, 2009.
Questions 1 and 2 refer to the interpretation of the term ‘embryo’—in
As a result of these hearings, the BGH stayed the proceedings and will
particular, to whether a cell (stem cell) removed from a development
submit questions on the interpretation of the Biotechnology Directive to the
stage of the fertilised egg cell (blastocyst) or the blastocyst itself are to be
European Court of Justice (ECJ). Th e Federal Court of Justice’s press release
considered embryos. Th e EU Directive does not include any defi nition of
of November 12, 2009 raises the following questions:
the term ‘embryo’. Th erefore, the ECJ will need to determine how to construe
this term. According to Section 8 of the German Embryo Protection Act
1. Is a stem cell obtained from the blastocyst to be considered an embryo, (ESchG), the defi nition of an embryo is the fertilised egg starting from the
even though it no longer has the capacity as such to develop into a human point in time of the fusion of the nuclei and any totipotent cell removed from
individual? there. Th us, an ES cell that is not able to develop into a complete individual
is not an embryo, according to German law.
2. Is the blastocyst to be considered an embryo within the meaning of the law?
www.worldipreview.com World Intellectual Property Review Digest 2009 79
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