14 July 1997 00:00 [Source: ICB]
The European Parliament is due to vote this week on the European patent directive - the outcome of which will have a major impact on the future of the European biotechnology industry.
The debate takes place on 15 July with the vote the day after. According to Nick Scott-Ram, chairman of EuropaBio's patent task force, the industry is happy with the directive as it stands. The directive was voted through by the legal affairs committee last month with 64 amendments. The concern is that further amendments could be voted through (more than 300 amendments have been proposed) which could seriously weaken the directive.
'What is happening now is very similar to what happened the last time. There is a very emotional campaign going on,' said Scott-Ram. 'However, this time there is a deeper understanding within the European Parliament of what is involved.'
The most important parts of the directive are Articles 3 and 9 which, respectively, clarify the issue of patenting of human genes and ethical concerns around issues such as cloning, gene therapy and transgenic animals. The directive was originally rejected by the European Parliament in March 1995.
Industry has pushed for the adoption of the directive despite the fact that it is already covered by the European Patent Convention. It was felt the existing legislation could not adequately deal with new developments in biotechnology.
'The intention is to bring European law up to the levels of protection available in the US and Japan. It is questionable whether this will be realised,' said patent consultant Steve Crespi. 'The industry has good protection from the European Patent Convention, which is unaffected by this directive. If it ends up with all these negatives we could well end up with less protection than we have already.'
Should the directive be adopted as it stands it will be brought into force by 1999.
VFA, the industry association for Germany's research-orientated drugmakers, has warned that more European R&D will shift to the US and Japan if the revised biotechnology patent directive fails again to pass the European Parliament in the 16 July vote.
Speaking for the VFA, Professor Rolf Krebs, pharma chief of Boehringer Ingelheim, one of the few German firms working with transgenic animals, said the association actively supports the amended legislation.
Although some passages are less liberal than comparable rules in the US, he said 'it is a compromise we can live with'. But he added 'we will not allow it to be watered down further'.
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