WRITTEN QUESTION E-3399/01

by Nelly Maes (Verts/ALE) to the Commission

(21 December 2001)

Subject: Exploitation of patent on breast cancer gene

Around seven years ago, the American firm Miread deciphered the genetic code of a breast cancer gene, and thereby acquired the right to patent the gene which it had found. Belgian genetics centres do not dispute this right, but they do object to the shameless way in which the firm intends to exploit the patent. It intends to enforce its monopoly very strictly. Everyone except Miread is to be compelled to stop testing for the breast cancer gene. This will give the firm the exclusive right to screen women for mutations in breast cancer genes, in return for hefty payments of course. This will constitute an enormous deterioration in the level of service to patients, as DNA testing forms an integral part of a clinical diagnosis. The European Parliament does not consider methods of diagnosis to be patentable. Moreover, the firm uses a computerised test which, according to a spokesman for the Marie Curie Institute in France, detects only 10 to 20 % of mutations in genes.

Ought not freedom of testing to be guaranteed? Should not the public benefits available from medical screening always be paramount, so that it is not right to subordinate this aspect to commercial considerations?

If the Commission does not agree with these points, then does it approve of the high costs arising from the use of patented information, which are an obstacle to diagnostic and therapeutic testing?

Will not the result be a monopolistic system for exploitation of the gene?

If this is true, what measures will the Commission take against this precedent?

Answer given by Mr Bolkestein on behalf of the Commission

(27 March 2002)

The Honourable Member has drawn the Commission's attention to a patent granted by the European Patent Office on a test for the screening of female breast cancer.

It should, first of all, be noted that as a result of the appeals lodged against this patent by third parties, it is for the Opposition Division and Boards of Appeal of the European Patent Organisation to decide on the validity of the patent awarded and on the scope of protection to be granted.

The Commission would like to stress that Directive 98/44 is not intended to call into question the general principle of exemption for research which exists in the legislation of the Member States of the European Community. In view of the information at the Commission's disposal and in accordance with this principle, acts done privately and for non-commercial purposes, as well as acts done for experimental purposes relating to the subject-matter of the patented invention do not constitute acts of infringement. Directive 98/44 on the legal protection of biotechnological inventions(1) did not deviate from this principle and points out that the Directive does not seek to monitor research

and the use or commercialisation of its results, since national, European or international law in this field continues to apply. Similarly, the draft regulation on the Community patent(2) embraces the concept of the freedom of research.

In any event, if research results are commercialised and these results use a technique which has already been patented, a sub-licence should be obtained from the holder of the patent. If the latter refuses to grant this licence on reasonable grounds, a compulsory licence could be granted in accordance with the applicable national provisions in the Member States' legislation.

In addition, it should be pointed out that the national legislation in most of the Member States of the European Community contains the principle of exempting prior use, which allows any person who had already used the invention in the European Community, or had made effective and serious preparations for such use, before the patent was filed(3) to continue such use or to use the invention as envisaged in the preparations. Once again, the draft regulation on the Community patent includes this principle in its entirety.

Finally, the Commission intends to conduct a detailed study into the issue of the scope of protection for inventions relating to genetic sequences and will send its observations to the Council and to the Parliament in the reports provided for under Directive 98/44.

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

(2) COM(2000) 412 final.

(3) Or, where priority has been claimed, before the priority date of the application on the basis of which the patent is granted.