WRITTEN QUESTION P-2477/00

by Avril Doyle (PPE-DE) to the Commission

(12 July 2000)

Subject: Genetic ownership

In the wake of the recent Human Genome Project and Celera Genomics announcements of the finalisation of a draft copy of the full human genetic code, and in light of the philosophical, ethical, and moral implications of these announcements, would the Commission explain its position on the patentability of the human genome and its strategy for addressing the legal and scientific results of these announcements?

Answer given by Mr Bolkestein on behalf of the Commission

(12 September 2000)

The relevant Community legislation concerning the patentability of biotechnological inventions is Directive 98/44 of the Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions(1).

Agreement was only achieved on this Directive in 1998 after lengthy and thorough discussions within both the Parliament and Council. Much consideration was given during these discussions to the ethical aspects of biotechnological inventions. The resulting Directive seeks both to address these ethical aspects and to provide the necessary incentives to encourage research and development.

In terms of the scope of the Directive, much attention, both during the negotiations on the Directive and also since its adoption, has been focused on the distinction between discoveries and inventions in this field and also on the protection afforded to elements isolated from the body or otherwise produced by means of a technical process and in particular sequences or partial sequences of genes.

Discoveries, which do not extend human ability but only human knowledge, are by their very nature not patentable. It is often argued that all biotechnological inventions, which deal with human, vegetable or animal genes, involve materials which already occur in nature and can therefore under no circumstances be invented but only discovered. This is certainly the case with the mere sequencing of a genome which belongs to the area of discovery and for that reason alone cannot take advantage of patent protection.

It is different however if a DNA sequence is released from its natural surroundings by means of a technical procedure and made available for the first time to a commercial application. Such an element isolated from the human body or otherwise produced is not excluded from patentability since it is, for example, the result of technical processes used to identify, purify and classify it and to reproduce it outside the human body: techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing by itself. Such a gene is new in the patent sense and therefore patentable, if it was not previously accessible to the public as such and thus technically was not available.

The position that was agreed by both the Parliament and Council was that patents for inventions comprising, or based on, gene sequences should be allowed. This position took account of the opinion of the group of advisers on the ethical implications of biotechnology to the Commission. Indeed the group of advisers, while fully recognising the stimulus provided by patents for medical research, considers that patentability criteria must take also into account ethical principles and that the intended use of the patent must be sufficiently specific and identified. Furthermore, the directive gives explicitly mandate for the Group to evaluate ethical aspects of biotechnology.

The Directive therefore provides that inventions based on or comprising of, gene sequences or partial gene sequences are patentable provided that they satisfy the normal criteria for any invention namely that they are novel, involve an inventive step and are capable of industrial application. In this last respect, the Directive took note of some of the controversy surrounding some of the earlier patent applications for gene sequences that were filed and indeed granted before the Directive was agreed. In particular the Directive makes clear that patents should not be granted where the application is silent on the industrial application of the gene sequence.

In March of this year, the President of the United States and the British Prime Minister issued a joint statement which called for the basic raw data on the human genome to be made freely available whilst at the same time recognising that intellectual property protection for gene based inventions has an important role in stimulating the development of important new health care products. The approach taken by Directive 98/44/EC is entirely consistent with this statement.

The Commission will continue to monitor the development and implications of patent law in the field of biotechnology and genetic engineering and as required by Directive 98/44/EC will provide regular reports on these issues to the Council and the Parliament.

(1) OJ L 213, 30.7.1998.