The EU biotech directive - legislation for disharmony?

Author: Dr Nina White, Chartered and Euroean Patent Attorney

Seven years have passed since Directive 98/44/EC of the European Parliament and of the Council on the Legal Protection of Biotechnological Inventions, the "Biotech Directive", came into force. The Directive was introduced to harmonise the laws of the EU with regard to what is and is not patentable in the biotechnology field. As will be seen, seven years on we are perhaps further than ever from the intended goal of harmonisation.

The Biotech Directive was shrouded in controversy from the very beginning. The first draft was rejected by the European Parliament, but after much lobbying by the Biotech and Pharmaceutical industries it finally came into force on 30th July 1998¹. A subsequent legal challenge by the Dutch Government launched in November 1998 was dismissed by European Court of Justice².

Member states were set an initial deadline of 30th July 2000 for national implementation, but few complied in time. The Directive has now been fully implemented in Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, UK, Ireland, Malta, the Netherlands, Spain, Sweden, Portugal the Czech Republic, Estonia, Hungary, Poland, Slovakia and Slovenia. It is not yet implemented in Luxembourg, Italy, Latvia or Lithuania.

The European Patent Office (EPO) formally adopted the provisions of the Directive by introducing new implementing regulations 23b to 23e, equivalent to Articles 2 to 6 of the Directive, in September 1999. Not being a Community organisation, EPO was not obliged to comply with the Directive, but nevertheless felt it necessary to adopt equivalent provisions in the interests of harmonisation.

In general terms, the Directive positively confirms categories of biotechnology subject-matter that are deemed patentable within the EU, as follows:

1. Biological material isolated from its natural environment or produced by means of a technical process (Art 3(2));
   
2. Elements isolated from the human body or otherwise produced by means of a technical process (Art 5(2)).
   
3. Plants and animals if the technical feasibility of the invention is not confined to a particular variety (Art 4(2)).