The European Biotechnology Directive - implementation update

The current situation

It will be 3 years in June since the deadline for the implementation of the European Biotechnology Directive (98/44/EC) (the "Directive") has passed. To date, only 6 European Member States (Denmark, Finland, United Kingdom, Ireland, Spain and Greece) have implemented the Directive, whilst the European Commission has threatened 9 Member States with the possibility of being taken to the European Court of Justice, should they not implement the Directive as soon as possible.

The Member States who have not implemented the Directive are Austria, Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Portugal and Sweden. Both Austria and Germany have to re-submit draft legislation due to general elections. In relation to Belgium and France, their proposed law is still being debated although France has gone one step further and approved a bill which appears to prohibit the patenting of genes. Luxembourg has had its bill blocked by its Parliamentary Committee on Ethics, whilst the Netherlands is seeking to amend its draft law. The status of implementation in both Italy and Sweden remains unclear. Portugal plans to adopt implementing legislation in July 2003.

Drug makers and regulators have both agreed that compliance with the Directive by all Member States is essential for industry competitiveness, especially against European competition. Lack of implementing laws and widely varying national rules make it less attractive for biotech firms, especially smaller ones, to pursue new product approvals.

What does the Directive cover?

The Directive covers the following aspects:

• Plants and animals are patentable but plant and animal varieties are not (the former can be made by non-biological processes).
• The human body at various stages of its formation and its development (including the embryo) is not patentable, but an element isolated from the human body, including the gene sequence or partial gene sequence, may be patented.
• Inventions where the commercial exploitation of which would be contrary to ordre public or morality are not patentable. These include:
  • processes for cloning human beings;
  • processes for modifying the germ line of human beings;
  • uses of human embryos for industrial and commercial purposes; and
  • processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal.
• Patents for biological inventions also protect the material produced by propagation and multiplication of the product.
• Patents for genetic information extend to all material in which the product is incorporated, where the genetic information performs its function.
• There are also provisions relating to patented seeds and animal materials as well as criteria for when compulsory licensing can occur.
• There are provisions relating to the deposit, access and re-deposit of biological material.
• The Commission has also set up a group of experts to advise and assist it in preparing future annual reports on the impact of patent law on biotechnology and genetic engineering.

For further information please contact Stephen Whybrow on 020 7367 2175, [email protected] or Nick Beckett on 020 7367 2490, [email protected] or Andrew Whitworth on 020 7367 3470, andrew.whitworth@cmck