Brussels, 18 July 2005
The European Commission has adopted a second report (COM(2005)312) to the Council and European Parliament covering developments and implications of patent law in the field of biotechnology and genetic engineering. It focuses on issues in the area of patents relating to gene sequences and the patentability of inventions relating to stem cells. It also reports on the implementation of the Directive.
Internal Market and Services Commissioner Charlie McCreevy said: “The field of biotechnology research is rapidly developing. It is important that the EU continues to monitor developments in patent law in this complex and sensitive area”.
The Commission's report is the second report to the European Parliament and the Council, as required by article 16c of the Biotechnology Directive 98/44/EC . The content of the report on the two specific issues raised is based on an analysis of the provisions of the Directive and preparatory works, the detailed arguments in the Court of Justice’s ruling of 9th October 2001 (case C-377/98), and the work of the group of independent experts set up in 2002 to advise the Commission (see IP/02/1448 ).
As regards gene sequences, the report weighs the various relevant considerations It indicates that the Commission does not intend to take a position on the validity of Member States’ implementation on the basis whether they have chosen a classical or a limited scope of protection for gene sequences.
The Commission proposes to monitor whether there are any consequences of possible divergences between Member States’ legislation. The Commission has launched a study that will analyse the extent of human DNA patenting in Europe and its potential consequences on research and innovation.
The situation regarding the patentability of inventions relating to stem cells is complex. Totipotent stem cells – those capable of developing into a human being –are excluded from patentability on the grounds of human dignity as set out in the Directive.
With regard to patentability of inventions relating to embryonic pluripotent stem cells – those which can develop into other types of cell but are not capable of developing into a human being – the report concludes that it would appear premature to come to a definitive conclusion or provide for further harmonisation in this area.
The Commission therefore proposes to monitor developments in this area. It has launched a further study looking at the ethical and legal aspects of stem cell patenting.
With regard to the state of implementation, only four Member States have not implemented the Directive: Italy, Luxembourg, Latvia and Lithuania. The full text of the Commission’s report and related annexes can be found at:
and the full text of Directive 98/44/EC at: