EC Reports on Patenting of Biotechnology in Europe

As a follow-up to its first report in 2002, the European Commission has now 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. The latest report 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 Directive 98/44/EC on the legal protection of biotechnological inventions.

The report looks at whether patents on gene sequences (DNA sequences) should be allowed according to the classical model of patent claim, whereby a first inventor can claim an invention which covers possible future uses of that sequence, or whether the patent should be restricted so that only the specific use disclosed in the patent application can be claimed (“purpose-bound
protection”). It concludes that "the Commission does not at present intend to take a position on the validity of transposition according to the choice between classical and limited scope of
protection for gene sequences. The Commission will, nonetheless, continue to monitor
whether there are any economic consequences of possible divergences between Member
States’ legislation."

With regard to stem cells, the report notes a distinction between totipotent stem cells, which are capable of developing into a human being, and pluripotent stem cells, which are not:

The provisions of the Directive are clear in relation to totipotent stem cells, since each cell could develop into a human being on its own and under Article 5(1) the human body at the various stages of its formation and development cannot constitute a patentable invention. This principle has been reiterated in the practice notice issued by the UK patent office in April 2003.

For pluripotent embryonic stem cells the situation is more complex. The Group of Experts considered that the question of patenting was closely linked to the definition of what constitutes an embryo, and the scope of research allowed, which is determined by national legislation. As regards research funding under the European framework programmes, such funding may be available for projects involving human embryonic stem cell research on a case by case basis.

In the light of the clear divergences which currently exist between Member States as regards the acceptability of research relating to embryonic stem cells, the continuing and rapid developments in this field, and the fact that the Directive itself provides for Member States to refuse patents on grounds of public order or morality under Article 6(1), the Commission considers that it is premature to give further definition or provide for further harmonisation in this area. At the same time the Commission will monitor developments taking into account both the ethical aspects and the potential impact on competitiveness. It has launched a study looking at the ethical and legal aspects of stem cell patenting.

Click here for the European Commission's webpage on biotechnology inventions.