European Parliament resolution on the patenting of BRCA1 and BRCA2 ('breast cancer') genes
Date: 2001-10-04
Institutions: European Parliament
Subjects: DNA, European Patent Office, European patent, bio-ethics, medical research, patent law

11.4.2002

EN

Official Journal of the European Communities

C 87 E/265

Thursday 4 October 2001

Stresses that the military regime in Rangoon needs to understand that the EU does not regard

10.
minimal concessions as a sign of real change;

Urges the SPDC to take steps to improve the human rights situation and to put an end to the
11.
widespread practice of torture, extra-judicial executions, the repression of ethnic minorities, as well as to
massive forced relocations and civilian abuse; strongly condemns the violation of the rights of the Shan,
Karenni and Karen people;

Stresses the need to implement strictly the law of October 2000 banning the use of forced labour

12.
and to ensure the actual end of this widespread practice;

Calls on the Commission to investigate how humanitarian aid can be delivered to the areas most in

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need of it with minimum political interference by the military;

Instructs its President to forward this resolution to the Council, the Commission, ASEAN member

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states, the NLD and Aung San Suu Kyi and the SPDC.

22. Patenting of human genes

B5-0633, 0641, 0651 and 0663/2001

European Parliament resolution on the patenting of BRC A1 and BRC A2 (‘breast cancer’) genes

The European Parliament,

/ recalling its resolution of 30 March 2000 on the decision by the European Patent Office with regard
to patent No EP 695 351 granted on 8 December 1999 (1), calling on the EPO ‘to ensure that all …
patent applications in Europe do not violate the principle of non-patentability of humans, their genes
or cells in their natural environment …’,

/ having regard to the ‘Advice on the patentability of the human genome’, adopted by consensus by the
International Bioethics Committee of Unesco (IBC) at the conclusion of its Eighth Session on 14 Sept-
ember 2001 which states ‘that there are strong ethical grounds for excluding the human genome from
patentability’ and further recommends ‘that the World Trade Organisation (WTO), in its review of the
TRIPS Agreement, clarify that, in accordance with the provision of Article 27(2)1, the human genome
is not patentable on the basis of the public interest considerations set out therein, in particular, public
order, morality and the protection of human life and health’,

A. whereas a US company, Myriad Genetics, has been granted US patents on the so-called ‘breast cancer
genes’ BRC A1 and BRC A2 and has applied to the European Patent Office for patents on these genes
as well,

B. whereas, in the US, genetic laboratories are licensed by Myriad Genetics to test for a very limited
number of mutations of BRC A1 and 2 only (with a fee payable) and are obliged to refer for any
further testing to Myriad Genetics, thus incurring further and considerable expense,

C. whereas cheaper and more effective methods of testing for breast cancer genes BRC A1 and BRC A2
exist in the European Union and whereas the existing US patents are already impeding their use,

D. whereas the European Patent Convention, in particular its Article 52.2(a), stipulates that no patents
shall be granted for discoveries, and Article 53(a) excludes from patentability inventions, the pub-
lication or exploitation of which would be contrary to public order or morality,

(1) OJ C 378, 29.12.2000, p. 95.

C 87 E/266

Official Journal of the European Communities

EN

11.4.2002

Thursday 4 October 2001

E. whereas the granting of similar patents by the EPO could create a monopoly for the firm in question
within the European Union as well, which could seriously impede or even prevent the further use of
existing cheaper and more effective tests for the breast cancer genes BRC A1 and BRC A2; whereas
this development could have an unacceptable detrimental effect on the women concerned and con-
stitute a serious drain on the funds of public health services; whereas, moreover, it could seriously
impede the development of and research into new methods of diagnosis,

F. whereas the EPO granted patents on BRC A1 to Myriad Genetics in the form of Patent No 699 754 of
10 January 2001 and Patent No 705 903 of 23 May 2001 and is considering granting further patents
on the breast cancer genes BRC A1 and BRC A2,

G. whereas the time limit for lodging objections to Patent No EP 699 754 of 10 January 2001 expires on
10 October 2001, and whereas the Institut Curie and the French Ministry of Health intend to lodge an
objection to this patent,

Expresses its dismay at the possible consequences of the granting by the European Patent Office of a

1.
patent on a human gene;

Reiterates its call on the European Patent Office ‘to ensure that all … patent applications in Europe
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do not violate the principle of non-patentability of humans, their genes or cells in their natural environ-
ment …’;

3.
Calls on the EPO to reconsider patenting these genes and associates itself with those tabling objec-
tions to the granting of these patents, such as the Institut Curie, and reiterates its demand for a review of
the operations of the EPO to ensure that it becomes publicly accountable in the exercise of its duties, and
for amendment of the European Patent Convention to ensure that the EPO may revoke patents on its own
initiative;

Reiterates its call on the Council, the Commission and the Member States to adopt the measures
4.
required to ensure that the human genetic code is freely available for research throughout the world and
that medical applications of certain human genes are not impeded by means of monopolies based on
patents;

Asks its competent services to prepare without delay an objection to be filed to European patents
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No 699 754 and No 705 903 and calls on the other institutions of the EU and Member State governments
to do likewise;

Instructs its President to forward this resolution to the Council, the Commission, the European Patent

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Office and the governments of the Member States.

23. Community guarantee for EIB loans to the Federal Republic of Yugoslavia *

A5-0300/2001

Proposal for a Council decision amending Decision 2000/24/EC so as to extend the Community
guarantee granted to the European Investment Bank to cover loans for projects in the Federal
Republic of Yugoslavia (COM(2001) 356 5 C5-0335/2001 5 2001/0143(CNS))

The proposal was approved.