European Commission Report on biotechnology and genetic engineering

Article 16(c) of Directive 98/44/EC on the legal protection of biotechnological inventions requires the European Commission to report annually to the European Parliament and the Council on the developments and implications of patent law in the field of biotechnology and genetic engineering.

The second 16(c) report issued 18 July 2005 considers the findings of the Group of Experts on two issues:

• The scope of patents on human gene sequences or partial gene sequences . The Commission does not intend to take a position on the possible divergences in transposing the Directive in Member States. It has commissioned a study that will analyse the extent of human DNA patenting in Europe and its potential consequences on research and innovation.
• The patentability of human stem cells . Totipotent stem cells which have the potential to develop into an entire human body are excluded from patenting, Article 5 of the Directive. In relation to pluripotent stem cells which do not have the potential to develop into an entire human body, the report concluded it was too soon to reach a definitive conclusion, or to provide for further harmonisation in this area. A further study looking at the ethical and legal aspects of stem cell patenting has been launched.