13. November 2009

German patent law

In its press release No. 231/2009, dated November 13, 2009, the Federal Court of Justice (FCJ) in Germany reported on its decision Xa ZR 58/07, issued November 12, 2009. In the decision, the FCJ referred questions to the European Court of Justice (ECJ) regarding the interpretation of the term “embryonic stem cells” as used in 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). In order to harmonize the requirements set out in the national patent laws of the EU member states regarding the patentability of inventions in the field of biotechnology and the interpretation of said laws, the Council of the European Union (EU) enacted the Biotechnology Directive. Adherence to the Biotechnology Directive is monitored by ECJ.

In particular, the ECJ was asked to comment on whether the prohibition of the use of embryos as stipulated in the Biotechnology Directive also encompasses the use of cells derived from an embryo for the preparation of stem cells. Additionally, the question arises as to whether a use of stem cells derived from embryonic cells for scientific research or therapeutic purposes constitutes a use for industrial or commercial purposes, which is prohibited by the Biotechnology Directive.

By introducing amendments which entered into force on September 1, 1999, the European Patent Convention (EPC) was brought in line with the provisions of the Biotechnology Directive. In its opinion G 2/06, the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) was faced with similar questions concerning the patentability of inventions relating to the use of embryonic cells. In contrast to the FCJ, the EBA refused to refer the above questions to the ECJ, since the EPO is not a member state of the EU and therefore, the ECJ was not considered to be competent to provide interpretation of the EPC. The answers of the EBA to the questions above were as follows: 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, it will be of interest to see whether the ECJ will offer an opinion on the questions above which differs from the opinion given in G 2/06 of the EBA of the EPO. In particular, the judgement of the ECJ will be binding for the interpretation of the wording of the Biotechnology Directive by national courts in the EU. Therefore, if the judgement of the ECJ differs from the opinion of the EPO, national Patent Offices might take a different approach regarding the patentability of inventions in the field of embryonic stem cell research than the EPO.

Download the full text of the decision Xa ZR 58/07 “embryonic stem cells” of the FCJ of December 17, 2009 under:

http://www.mueller-bore.de/tl_files/Decisions_BGH/Embryonic_Stem_Cells.pdf