BioWorld International Correspondent

BRUSSELS, Belgium - Germany and eight other European Union countries have been told to strengthen their protection for biotechnology patents.

The European Commission last week instructed Germany, Austria, Belgium, France, Italy, Luxembourg, the Netherlands, Portugal and Sweden to implement the rules that should have been protecting inventions since July 2000 - but which none of these countries has introduced.

The EU directive on the legal protection of biotechnological inventions was adopted by all EU countries in 1998, but it was then up to each member state to transpose it into national law. The offending member states failed to do that, after repeated warnings. If they do not now give a satisfactory reply within two months, the Commission may decide to take them to the European Court of Justice, which could lead to fines being imposed.

The directive aims to clarify the principles of patent law applied to biotechnological inventions, to overcome the numerous discrepancies between the member states' laws. The operation of the directive is necessary, the Commission said as it announced its instruction, if Europe is "to fully exploit the medical, environmental and economic potential of biotechnology." If the EU member states do not honor their commitment to implement the directive correctly, "the European biotechnology sector will be seriously disadvantaged," since European companies will be unable to compete on level terms with their Japanese and U.S. rivals, who enjoy stronger domestic patent protection for biotechnology, the Commission warned.

Resistance to biotechnology at the national level has been at the root of much of the delay in putting the directive into effect. The European Commission acknowledged "the concerns which this directive may have aroused in public opinion in certain member states, inasmuch as it concerns the patentability of biological material." But, it insisted, the directive is framed to protect "the dignity and integrity of the person."

And, the Commission pointed out, the need for this type of protection in Europe was recognized more than a decade ago. The Commission proposal dates from the late 1980s, which makes the delay in implementing it all the more damaging for the sector, a Commission official told BioWorld International.

Meanwhile, the Commission has appointed a group of experts to assist it in monitoring the effects of the directive. The group will focus on two fields that have been identified as highly sensitive: the scope to be given to patents related to sequences or partial sequences of genes isolated from the human body, and the potential patenting of human stem cells and cells lines obtained from them.