WRITTEN QUESTION E-3399/01 by Nelly Maes (Verts/ALE) to the Commission. Exploitation of patent on breast cancer gene.
Date: 2001-12-21
Institutions: European Parliament, Provisional data
Subjects: biotechnology, cancer, medical research, patent, patent law, patents licence

C 172 E/52

Official Journal of the European Communities

EN

18.7.2002

The workshop planned at the occasion of the next Joint Parliamentary Assembly is an initiative of the
Assembly, not a Commission one. The Commission is ready to assist it in its preparation as needed.

There are several programmes with information and communication technology (ICT) components in the
ACP region but no major one specifically devoted to information society. Such a programme is being
currently appraised for the Indian Ocean countries and discussions are ongoing with the Caribbean region
for them to join, with European Development Fund (EDF) funds, the @LIS programme covering Latin
America. Within the existing policy and financing frameworks, similar programmes for the African region
may be considered in the context of the 9th EDF programming exercise.

(2002/C 172 E/056)

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
to commercial
is not right
considerations?

to subordinate this aspect

it

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.
inventions (1) did not deviate from this
Directive 98/44 on the legal protection of biotechnological
the Directive does not seek to monitor research and the use or
principle and points out

that

18.7.2002

EN

Official Journal of the European Communities

C 172 E/53

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.

(2002/C 172 E/057)

WRITTEN QUESTION P-3404/01

by Carlos Ripoll y Martínez de Bedoya (PPE-DE) to the Commission

Subject: Official languages within the EU institutions

(5 December 2001)

On 10 July 2001 the Commission published in Official Journal S 130 a call for tenders (ref. D1/ASS/2001/
0053) for the provision of assistance and technical support for the tasks relating to the actions in the LIFE
environment programme which are funded in the 15 EU Member States and certain applicant countries.

Paragraph 1.6(c) of the Technical Annex to the call for tenders is concerned with the selection criteria and
the required composition of the team is clearly stated:

The team-leader and the deputy team leader as well as other staff with co-ordination responsibilities
vis-à-vis the Commission should, in addition to an active knowledge of English and/or French, have at
least a passive knowledge of the other language. These two languages will be the official languages for
all contacts with the Commission.

Pursuant to Articles 314 and 290 of the Treaty (which lay down the rules relating to language use within
the EU institutions and which are enacted by means of Article 6 of Council Regulation No 1), there are
eleven official
languages through the medium of which the EU institutions are required to work,
communicate, establish contact and divulge their activities, decisions, documents and legal acts.

Is the statement contained in the call for tenders to the effect that English and French ‘will be the official
languages for all contacts with the Commission’ in accordance with what is laid down in the Treaties?
Upon what legal basis was the call for tenders published in those specific terms?

Does the Commission not consider that it has introduced an element of linguistic discrimination into the
call for tenders and thereby caused a distortion of the market?

Will the Commission supply the details and the results of the assessment carried out of all those who
responded to call for tenders D1/ASS/2001/0053 in accordance with the selection criteria laid down in the
Technical Annex to the call?