By Peter O¿Donnell

BioWorld International Correspondent

BRUSSELS, Belgium ¿ EuropaBio, the European Association for Bioindustries, has joined the chorus of approval from the European biotechnology industry for the European Court of Justice decision confirming the validity of the EU rules on biotechnology patents.

Noting that the court had ¿unequivocally rejected¿ all six pleas by the Netherlands against Directive 98/44/EC on the legal protection of biotechnology inventions, Hugo Schepens, EuropaBio secretary general, called for full implementation of the rule now that all ambiguities were lifted. (See BioWorld International, Oct. 10, 2001.)

¿More than a year after the deadline for member states to transpose the directive, 11 out of 15 have not yet done so,¿ he said. ¿The court¿s decision is a clear call on all of them to transpose the directive immediately, fully and unequivocally. Europe has been very late in adopting this legislation and cannot afford any further loss of time. Effective intellectual property protection remains the cornerstone of successful research and entrepreneurship.¿

Erik Tambuyzer, chairman of EuropaBio, stressed that ¿to become fully competitive in the field of biotechnology, Europe must eliminate ambiguity and uncertainty. Today¿s ruling is a powerful signal to EU and national policymakers. It is also a strong encouragement to the thousands of European researchers and entrepreneurs who are unlocking biotechnology¿s rich potential for Europe¿s welfare and well being.¿

But the European Parliament still is showing reticence about biotechnology patent rights. At its October session, the Parliament expressed concerns over the risks of intellectual property rules breaching ethical considerations. Following the granting of U.S. patents on the breast cancer genes BRCA1 and BRCA2 to Myriad Genetics Inc., of Salt Lake City, the Parliament adopted a resolution repeating its call on the European Patent Office to ensure that patent applications in Europe do not violate the principle of non-patentability of humans, their genes or cells in their natural environment.

There is a fear among Euro-MPs that the European Patent Office will grant patents for these genes. They said the European Patent Office should reconsider any such request and take into account objections from bodies such as the Institut Curie, which recently has argued against European patents being granted on such products. Euro-MPs also voted in favor of the Parliament as an institution objecting formally to the filing of such patents.

Friends Of Earth Resists Easing On GMOs

The environmentalist group Friends of the Earth is not impressed with the European Union¿s newfound determination to ease the regulatory environment for biotechnology. It has accused the European Commission of disregarding public health and environmental concerns by proposing to undermine future legislation on GMO foods and crops.

FoE says the Commission is planning to break the deadlock on new GMO authorizations in Europe by accepting ¿voluntary agreements¿ with biotechnology companies. At present, 13 new GMO crops and 11 new foods are caught by the moratorium on new GMO authorizations that EU member states put in place two years ago, pending a tightening up of EU biotechnology rules. In the meantime, the biotechnology industry has offered promises that if the logjam is broken on the products caught by the moratorium so that they can be launched now, the companies involved will bring them into line with any new EU legislation that comes into force later.

The environmentalists¿ view is that the European Commission, in abetting industry efforts to break the current moratorium on GMOs, is playing the industry¿s tune. Instead, it said, companies should not be allowed to launch until pending new rules have been implemented on testing of GMO crops, on traceability and labeling, and on labeling of GM food and feed.

Gill Lacroix, biotechnology coordinator of Friends of the Earth Europe, said she sees the Commission plan as a move to pacify the biotech industry.

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