EU Commission on Development and Implications of Patent Law in the Field of Biotechnology and Genetic Engineering.
The EU Council has published a report from the Commission to the Council and the European Parliament "Development and implications of patent law in the field of biotechnology and genetic engineering" as Document 11341/05:
"This is the second report pursuant to Article 16c of the Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions and bears the title “Developments and implications of patent law in the field of biotechnology and genetic engineering” (hereinafter the “second 16c Report”). Its purpose is to set out the key events which have occurred since publication of the first Report, and to comment on two issues identified in the latter: the scope of patents on sequences or partial sequences of genes which have been isolated from the human body; and the patentability of human stem cells and cell lines obtained from them. The Commission’s analysis is based on the Commission staff working paper SEC(2005)943.
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The first 16c Report stated that the main provisions of the Directive were clear and precise; that uncertainty could not be permitted where the patentability of plants, animals and microorganisms was concerned; and that there was no ambiguity regarding the patentability of material isolated from the human body.
This Report introduces some new, fundamental considerations. While it can be argued from a plain reading of the provisions of the Directive that there are no objective grounds for limiting the traditional protection granted by patent law to inventions relating to sequences or partial sequences of genes isolated from the human body, other issues have also been raised relating to ethics, to research and to economics. The Commission will continue to monitor whether there are any economic consequences of possible divergences between Member States’ legislation.
In the light of the Commission’s analysis, it appears that totipotent stem cells should not be patentable, on grounds of human dignity.
There is no immediate answer to the question of the patentability of embryonic pluripotent stem cells and indeed at this stage it would appear premature to come to a definitive conclusion. The Commission will continue to monitor developments in this area."
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Dipl.-Phys. Axel H Horns is Patentanwalt (German Patent Attorney),
European Patent Attorney as well as European Trade Mark Attorney. In particular, he is Member of:
Document 11341/05:
