BioWorld International Correspondent

BRUSSELS, Belgium Europe’s still-incomplete patent regime for biotechnology inventions is under a new threat. One of the 15 member states of the European Union is formally requesting a review of “ambiguities” in the 1998 EU directive on the protection of biotechnology inventions, even before the directive has been put into effect in most of the member states.

Luxembourg’s Parliament unanimously adopted a motion that calls for the European Commission to renegotiate the directive in view of what it termed “ambiguities regarding the patentability of living matter.”

The request springs in part from hostility to biotechnology from the Green group in the Luxembourg Parliament. But the wide backing for the call reflects anxieties that have arisen during more than a year of discussions elsewhere within the Parliament. Its ethics committee emphasized the potential negative impact of the EU rules on patients in industrialized countries and farmers in the developing world, as well as “the danger of natural genetic riches being monopolized by a few large transnational enterprises.”

The 1998 EU directive on biotech patents was the result of a battle more than 10 years long, after the biotech industry managed to convince the European Commission to bring in legislative proposals to give more comprehensive cover for its inventions in Europe. It was intended to resolve ambiguities over patentability of parts of the human body and all living matter plant or animal so as to confer some legal certainty on the framework in which companies would be making research investments. But only four EU member states have so far put the directive into effect: the United Kingdom, Ireland, Finland and Denmark. In most cases, the resistance to the directive is due to similar concerns to the ones now emerging in Luxembourg a mixture of ambiguity in the law and local hostility to biotech patents.

There are concerns in numerous member states over the precise scope of the key provisions, particularly on the protection of inventions concerning elements drawn from the human body. The first paragraph of the relevant article in the directive says, “The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.” However, the directive also states that “an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.” Opponents of the directive now see a gathering EU-wide momentum against its implementation; they hope other national parliaments will follow Luxembourg’s lead.