Brussels, 22/07/2005 (Agence Europe) Last week, the European Commission adopted a second report (COM (2005) 312) at Council and the European Parliament on the development and implications of patents in the field of biotechnology and genetic engineering. It answers the requirements of article 16, point C of the European directive of 6 July 1998 on the legal protection of biotechnological inventions. This document relates recent relevant events which have occurred since the publication of the first report in October 2002. It also brings elements of response to two considered themes, which are the patenting of gene sequences isolated from the human body and the patentability of inventions relating to stem cells.
For the first theme, the previous report established that uncertainty was not permitted in terms of the patentability of plants, animals and microorganisms. Nor was there any ambiguity on the one on elements isolated from human body. The second report adds new fundamental elements. Although there is still no objective reason, according to the provisions of the directive, to limit the traditional protection granted by patent law to inventions on genetic sequences (DNA sequences) isolated from human body, other questions were raised in terms of ethics, research and economy. Such as, for example, the question of whether the fact that human gene sequences had been isolated from the human body implies that they should be treated differently to chemical substances for ethical reasons. The Commission also proposed to verify whether possible differences in the legislation of the Member States may have consequences.
On the patentability of inventions relative to stem cells, the situation is a complicated one. Totipotent stem cells- which can be transformed into a human being- are absolutely excluded from patentability for reasons of respect for human dignity. When it comes to the patentability of inventions related to pluripotent embryonic stem cells- which can turn into other types of cells but not into a human being- the report indicates that it is too early, at this stage, to reach any definitive conclusions or to plan greater harmonisation in this field. The Commission intends to follow developments in these issues and has already launched a study in the ethical and legal aspects of the patenting of stem cells.
Four Member States have not yet applied the directive in question. These are Italy, Luxembourg, Latvia and Lithuania.