WRITTEN QUESTION E-3472/01

by Dorette Corbey (PSE)and Ria Oomen-Ruijten (PPE-DE) to the Commission

(4 January 2002)

Subject: Interpretation of Directive 98/44

The basic aim of Directive 98/44/EC(1) is to clarify the distinction between what may and what may not be patented in the field of biotechnological inventions. However, the directive itself is unclear in some respects, particularly Articles 4, 5 and 6. In one of its resolutions, the European Parliament recently objected to the patenting of the breast cancer genes BCRA1 and BCRA2. Thus Parliament has made it clear that it objects to excessively broad patent definitions.

Directive 98/44 is currently being transposed in the Member States. Four Member States have already completed the process. In the Netherlands, there is a difference of opinion between the government and parliament about the implementation of the directive.

Does the Commission agree that, when implementing Directive 98/44, it is possible to:

- expressly forbid the patenting of plants and animals as such;

- expressly forbid the patenting of manipulated embryos;

- make patenting conditional upon the provision of a concrete and sufficiently workable description of the function of the sequence or partial sequence;

- draw up a supplementary list of inventions which cannot be patented because they are contrary to ordre public or morality?

(1) OJ L 213, 30.7.1998, p. 13.

Answer given by Mr Bolkestein on behalf of the Commission

(25 February 2002)

The Honourable Members draw the Commission's attention to the issue of how to interpret Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.

First of all, it should be noted that the two contested patents to which the Honourable Members refer were issued by the European Patent Office (EPO) which is a non-Community international organisation.

However, the articles which deal with the material conditions for patentability (novelty, inventive step, industrial application) in the European Patent Convention have been supplemented by the EPO Administrative Council with rules revised in 1999 which incorporate the substance of the relevant provisions in Directive 98/44/EC. The amendment of the Implementing Regulations to the European Patent Convention has made it possible to introduce a harmonised scheme applicable for patents covering biotechnological inventions, regardless of whether these are issued by the European Patent Office (hereinafter called the Office) or the national offices.

Once the European patent has been issued by the Office, it then changes into a number of national patents which are valid in all the countries stated in the application for a European patent. These national patents are then subject to the same national arrangements as exist for patents issued directly by the national offices. For the Member States, these patents will also be governed by the relevant Community provisions, which in the case of biotechnological inventions is Directive 98/44/EC.

Thus, in practice, the national courts will be able to revoke patents covering biotechnological inventions if these do not comply with the provisions of this Directive insofar as this is compatible with the Member States' obligations stemming from international conventions.

The Commission can also confirm that one of the objectives of the Directive is to clarify the rules to be applied in the field of patent law regarding biotechnological inventions. Articles 4, 5 and 6 of Directive 98/44/EC mentioned in the question make it possible inter alia to distinguish the simple discovery which is not patentable from the invention which may be entitled to patent protection. These clarifications are given in the very sensitive field of biology and relate in particular to elements of the human body.

It is also important to point out that with the Directive having been transposed in Greece since 22 October 2001, five Member States have now implemented it (Denmark, Ireland, Finland, United Kingdom, and Greece).

Finally, the Commission would like to offer the following information in response the questions asked by the Honourable Members:

- although plant and animal varieties are not patentable, the Directive does not rule out the patentability of animals and plants;since processes for cloning human beings are not patentable, it is clear that reproductive cloning cannot be covered by a patent;

- with regard to elements isolated from the body, the industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application. A mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention. In order to comply with the industrial application criterion it is necessary, in cases where a sequence or partial sequence is used to produce a protein or part of a protein, to specify which protein or part of a protein is produced or what function it performs;

- the Directive makes provision for a non-exhaustive list of inventions which should be considered as contrary to ordre public and morality and are thus unpatentable. It is up to each Member State to transpose this list into national law.