Gene patenting

The EC Directive on the Legal Protection of Biotechnological Inventions (98/44/EC), adopted by the European Parliament in July 1998, required all member states of the European Union to ensure that, by 30 July 2000, their national patent laws were consistent with the terms of the directive. This directive was the culmination of debate, consultation and fierce disagreement for more than a decade and, even in its final form, has remained controversial.

Although the directive states clearly that the human body is not patentable, it goes on to say that an element isolated from the human body or otherwise produced by 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”. In order to be patentable, the application must also satisfy the criteria of novelty, of constituting an inventive step and of industrial applicability.

Shortly after the directive was passed the Dutch government appealed to the European Court of Justice following a vote by the parliament of the Netherlands against its adoption, on ethical grounds¹. The Netherlands argued on technical grounds that the directive should have been subject to unanimous rather than majority voting. The written part of these proceedings is now closed and a hearing in front of the court of justice is likely to take place towards the end of the year.

The Norwegian Medical Association is leading the World Medical Association (WMA) in its opposition to the patenting of the human genome and presented a discussion paper to the WMA's Annual Council Meeting in April. In a press release following the meeting, the chairman of the WMA called on its national medical association members to approach their governments as a matter of urgency to …