That directive sets out which inventions involving plants, animals or the human body may or may not be patented. It requires the Member States to allow the patenting, under certain conditions, of inventions which may have an industrial application making it possible to produce, process or use biological material.

The Netherlands traditionally oppose the genetic manipulation of animals and plants and do not at present allow living biological material capable of reproduction to be patented.

The Netherlands take the view that the obligation imposed on the Member States to grant patents is unacceptable; they argue that neither plants, nor animals nor human biological material should be patentable.

That is why the Netherlands Government has asked the Court of Justice to annul this directive. Italy and Norway support the position of the Netherlands.

Contrary to the submissions of the Netherlands that harmonisation of the laws of the Member States is not necessary in this area and cannot be achieved by a Community directive, the Court takes the view that this measure does enhance the smooth operation of the internal market because it helps to bring the laws of the Member States into line and to remove the legal obstacles to the development of activities in the field of genetic engineering.

The Netherlands also argue that the directive disregards the principle of subsidiarity. The Court counters that the objective of the directive, that is to say the smooth operation of the internal market in this area, cannot be achieved by action taken by the Member States alone.

The Netherlands complain that the concepts used by the directive are unclear or even contradictory. The Court's judgment makes the point that the concepts highlighted by the Netherlands, such as ordre public or morality, are sufficiently clear, and that the supposed contradictions, particularly as regards the patentability of plant varieties, are merely apparent contradictions.

The Court also takes the view that the international obligations of the Member States do not preclude the patentability of biotechnological inventions. In the view of the Court, neither the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), nor the Agreement on Technical Barriers to Trade (TBT) nor the Rio Convention on Biological Diversity, prevent the States party to those international agreements from coordinating their practices in this field by means of a Community directive.

However, the Netherlands' chief argument is essentially that the directive, in permitting the grant of patents for isolated parts of the human body, undermines the inalienable nature of living human matter which is a component of the fundamental right to human dignity and integrity.

The Court, which has to ensure respect for fundamental rights in the application of Community law, considers that the directive affords sufficient protection since it does not allow the human body, at the various stages of its formation and development, to be a patentable invention. Nor can the discovery of elements of the human body be the subject of protection.

In line with a distinction which is well known in patent law, only inventions which combine a natural element with a technical process making it possible to isolate that element or reproduce it with a view to an industrial application may be patented. Thus, an application for a patent for a sequence or partial sequence of human genes is only acceptable if the application is accompanied by both a description of the original method of sequencing which led to the invention and an explanation of the industrial application to which the work is to lead.

Further, the protection conferred by a patent extends to biological data existing in their natural state only where necessary for the achievement and exploitation of a particular industrial application.

Finally, the directive makes clear that all processes the use of which offends against human dignity must be excluded from patentability, that is to say in particular processes for cloning human beings, processes for modifying the germ line genetic identity of human beings and uses of human embryos for industrial or commercial purposes.

Unofficial document for media use, not binding on the Court of Justice Available in all the official languages For the full text of the judgment, please consult our Internet page www.curia.eu.int  at approximately 3 pm today For further information please contact Fionnuala Connolly: Tel: (00 352) 4303 3355; Fax: (00 352) 4303 2731 Televised pictures of the hearing are available from “Europe by Satellite” European Commission, DG X, L - 2920 Luxembourg, tel: (352) 4301 35177; fax (352) 4301 35249, or B-1049 Bruxelles, tel. (32) 2 2965956, fax (32) 2 2301280

¹ Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions