Commission Report: Development and implications of patent law in the field of biotechnology and genetic engineering

October 8, 2002

Brussels, 07 Oct 2002

Report from the Commission to the European Parliament and the Council - Development and implications of patent law in the field of biotechnology and genetic engineering ( COM(2002) 545 final of 07.10.2002)
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The information given in this Report allows one to conclude that the European legislator wished to lay down provisions which took account of the diverging interests of society in this field of technology. It should be noted that some of them leave the Member States with some room for manoeuvre in transposal.

The Directive appears to comply with the international agreements in force relating to biotechnological inventions. The Commission will follow with the greatest interest the treaties currently being negotiated which might have a bearing on this field (SPLT) and those to come.

As regards the actual provisions of the Directive, the European legislator has succeeded in creating a functional system which respects the major ethical principles recognised within the European Community. In this context, the European Group on Ethics is an important element in the ethical debate on these questions at Community level.

A clear distinction is drawn between animals and plants, on the one hand, which are patentable, and plant and animal varieties on the other, which are not. Similarly, while essentially biological processes cannot be covered by a patent, that is not the case with processes devised by genetic engineering which make it possible to obtain transgenic animals and plants.

In the highly sensitive field of the patentability of elements isolated from the human body, the Directive reiterates the distinction to be made between what is patentable and what is not. The principles of the dignity, integrity and non-ownership of the human body must be adhered to scrupulously, and the Directive reiterates this unambiguously. On the other hand, elements isolated from the human body or otherwise obtained by genetic engineering must be eligible for patent protection if the conditions for patentability are met.

The Directive lays down a general principle of exclusion for inventions whose commercial exploitation would be contrary to ordre public or morality. The illustrative list of what is to be understood by this concept indicates unambiguously certain processes judged ethically unacceptable (cloning, modification of the germ line genetic identity of human beings, use of human embryos for industrial or commercial purposes). These exclusions allow society to protect itself against inventions which might have negative repercussions.

Certain provisions of the Directive appear to give the Member States some leeway in its transposal into national law. In the light of the developments set out in this Report, it appears that the scope to be conferred on sequences or partial sequences of genes remains a topical subject which may give rise to differing interpretations.

Similarly, the recent and irresistible advances in the culture of stem cells of human origin has raised some questions as to the possibilities for obtaining patents on the inventions developed around them.

It is undoubtedly for the Commission to monitor and assess the scientific and legal developments visible in this field of technology and to report on them to the interested parties within the European Community. In this respect, the Commission will stimulate an exchange between scientists, lawyers and patent administrators to analyse and discuss the interplay between scientific advances and legal developments, in particular by setting up a group of experts.

These assessments comply fully with the line set out by the Commission in its Communication of 23 January 2002 entitled "Life sciences and biotechnology", which stresses that the interpretation of key concepts in the field of patents must not be left exclusively to courts and national patent offices87.

In view of the above, the Commission will therefore have to investigate the following:

· The scope to be conferred to patents on sequences or partial sequences of genes isolated from the human body.

· The patentability of human stem cells and of cell lines obtained from them.

The results of these deliberations will be communicated to the public in the next reports provided for under Article 16(c) of the Directive.


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[Related Public Info item:]
Commission Report: An assessment of the implications for basic genetic engineering research of the failure to publish, or late publication of, papers on subjects that might be patentable 15 January 2002

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