By Peter O¿Donnell
BioWorld International Correspondent
BRUSSELS, Belgium ¿ The European Union¿s Court of Justice removed one of the ambiguities over EU rules on biotechnology on Tuesday when it dismissed an attempt by three European countries to overturn the EU directive providing for biotechnology patents.
As soon as this rule ¿ known as ¿the directive on the legal protection of biotechnological inventions¿ ¿ was adopted in 1998, the Netherlands brought an action seeking its annulment. The Netherlands traditionally has opposed genetic manipulation of animals and plants, and still does not allow living biological material capable of reproduction to be patented.
Over the last three years the Netherlands has been arguing before the court that the directive imposed an unacceptable obligation on EU member states to grant patents on animals or human biological material. Italy and Norway have both been supporting the position of the Netherlands.
But the EU Court ruled that the directive frames patent law in terms sufficiently stringent to ensure that the human body is unavailable for patenting and remains inalienable. The directive safeguards human dignity, the court said in its ruling. The directive sets out which inventions involving plants, animals or the human body may or may not be patented.
Member states are required to allow the patenting, under certain conditions, of inventions that may have an industrial application making it possible to produce, process or use biological material. But, as the court pointed out, the directive makes clear that all processes that offend human dignity must be excluded from patentability, in particular processes for cloning human beings and modifying the germ line or genetic identity of human beings, and uses of human embryos for industrial or commercial purposes.
The court also threw out the Netherlands¿ argument that harmonization of national laws in this area was not necessary. On the contrary, the court said, the directive enhances the smooth operation of the EU single market by bringing the laws of the member states into line and removing legal obstacles to developments in genetic engineering.
The European Federation of Pharmaceutical Industries and Associations immediately welcomed the judgement.
¿This final decision was long awaited by our industry,¿ said Brian Ager, EFPIA director general. The directive ¿gives our industry greater certainty as to the law. Its full implementation is now necessary to stimulate our confidence to go on investing in this very promising, but highly costly and risky, field of biomedicine R&D.¿
He pointed out that the directive ¿ adopted 15 years later than the U.S. and Japan ¿ has still not been implemented in 11 of the 15 EU member states, although the deadline for its implementation expired on June 30, 2000.
Ernesto Bertarelli, CEO of Serono SA and chairman of the new European lobby for smaller biotechnology firms, the Emerging Biopharmaceutical Enterprises, said: ¿Most EU member states and all the industry agree about the increasing importance of biotechnology as a key factor for enhancing the competitiveness of the industry in Europe. It is now high time to act and to follow words and good intentions with concrete actions.¿