WRITTEN QUESTION P-0905/02 by Bart Staes (Verts/ALE) to the Commission. Patent granted to Myriad Genetics.
Date: 2002-03-25
Institutions: European Parliament, Provisional data
Subjects: DNA, European Patent Office, European patent, United States, biotechnology, cancer, genetics, invention, patent law

6.3.2003

EN

Official Journal of the European Union

C 52 E/23

In any case, the form taken by a State aid has no particular impact on the Commission’s analysis. In the
past, the Commission has authorised both reimbursable advances to the aerospace industry, for example to
Rolls-Royce (the repayable short-term loan referred to by the Honourable Member approved in 1998, aid
case N 17/98) and credit guarantees, for example to Fairchild-Dornier (N 281/99).

(2003/C 52 E/024)

WRITTEN QUESTION P-0905/02

by Bart Staes (Verts/ALE) to the Commission

(25 March 2002)

Subject: Patent granted to Myriad Genetics

The European Patent Office (EPO) has granted three patents to the US company Myriad Genetics for the
commercial exploitation of BRCA1, a DNA sequence which can be used in testing the predisposition of
women to breast cancer. BRCA1 is a naturally-occurring gene, yet despite this the EPO granted a patent
for it.

In doing so, did the EPO base its decision on Article 5(2) of Directive 98/44/EC (1)?

Does the Commission consider that no patents can be taken out on naturally-occurring substances, such as
a DNA sequence or a specific gene, and does the Commission not share my view that an identical copy of
something that originally occurs in nature should not be patentable?

Does the Commission not agree that this patent does not involve an invention, but is a discovery, namely
that of BRCA1, and will it bring pressure to bear on the EPO to annul the patent on BRCA1?

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

Answer given by Mr Bolkestein on behalf of the Commission

(24 April 2002)

The Honourable Member has drawn the Commission’s attention to three patents issued by the European
Patent Office on a test for the screening of female breast and ovarian cancer.

It should, first of all, be noted that the three contested patents referred to in this parliamentary question
were issued by the European Patent Organisation (EPO) which is a non-Community inter-governmental
organisation governed by its own provisions, namely the European Patent Convention and its associated
implementing regulation. Thus, the European Patent Office, as the body responsible for the issue of patents
within the EPO, applied the relevant provisions of the Convention and its implementing regulation in
assessing the validity of the patents referred to by the Honourable Member. It should be noted that this
implementing regulation incorporates the substance of the main provisions of Directive 98/44/EC on the
legal protection of biotechnological inventions (1).

The Commission would like to reaffirm the principles which were clearly established in the afore-
mentioned Directive. The simple discovery of an element of the human body, and of a sequence or partial
sequence of a gene cannot be the subject of a patent. On the other hand, an element isolated from the
human body or otherwise produced, including the sequence or partial sequence of a gene, may constitute a
patentable invention if the conditions traditionally required by patent law have been met (i.e. that they are
they are novel, involve an inventive step and are capable of industrial application). This genuine distinction
between a simple discovery and an invention is based on the need for human intervention to invent
something which nature by itself would not be capable of achieving. In effect, an element isolated from the
human body or otherwise produced is generally the result of technical processes which have identified,
purified, characterised and multiplied it outside of the human body. The elements arising from these

C 52 E/24

Official Journal of the European Union

EN

6.3.2003

processes can be patented if the industrial application of these elements has been disclosed in the patent
application. It should be noted that in cases where a sequence or partial sequence of a gene is used to
produce a protein or part of a protein, the applicant must specify which protein or part of a protein is
produced or what function it performs.

In this case, the patents issued to the company Myriad Genetics relate to the methods and equipment used
to isolate and detect the mutation of certain alleles of genes BRCA 1 and BRCA 2 which may cause breast
or ovarian cancer. The tests which the company plans to carry out seem more comprehensive than those
which already exist and, unlike the tests previously available, these new tests do not require samples which
have been taken from relatives who themselves have contracted breast or ovarian cancer.

In addition, the problem raised by these patents is of a technical nature and relates to the field of patent
law and, more specifically, to the scope of the protection to be afforded to these patents. This very
complex issue involving genetic sequences undoubtedly arises from a situation relating to free competition
and innovation. Whilst the Commission would point out that some of these patents are subject to an
opposition procedure with the Office, it does not feel that there are any imperative ethical reasons for it to
bring pressure to bear on the EPO.

(1) Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998, OJ L 213, 30.7.1998.

(2003/C 52 E/025)

WRITTEN QUESTION E-0934/02

by Paul Rübig (PPE-DE) to the Commission

(9 April 2002)

Subject: Earlier extension of the Pancum zone to south-east Europe

In order to speed up the inclusion of the Mediterranean countries in the system of pan-European
cumulation (Pancum), the variable geometry approach was proposed,
i.e. the inclusion of the Medi-
terranean countries is to take place in stages with agreements with at least two other partners being
sufficient for the Pancum rules to be applicable in trade between these countries;
in other words, a
Mediterranean country would not first to have concluded agreements with all other partners of the existing
Pancum area in order to take advantage of the Pancum rules. There is no sign of a comparable initiative on
the part of the Commission in relation to the countries of south-east Europe, such as Croatia and
Macedonia even though the conditions for applying variable geometry appear favourable. From the point
of view of European industry, therefore, a rapid extension of the area of pan-European cumulation to
include the countries of south-east Europe, primarily Croatia, would seem a matter of priority since
European industrialists, who have in the meantime in large numbers been exploiting the opportunities in
the Central and East European countries for manufacturing according to the principle of the division of
labour, are often unable to fulfil the requirements of origin in bilateral agreements and are consequently
faced with customs duties which would not apply under a PANCUM arrangement.

Why does the extension of the area of pan-European cumulation to the countries of south-east Europe
such as Croatia and Macedonia enjoy lower priority in the eyes of the Commission than extending this
area to the Mediterranean countries?

Answer given by Mr Patten on behalf of the Commission

(31 May 2002)

The European Council has declared that the countries of the Western Balkans are potential candidates for
Union membership and have a clear prospect of accession once the relevant conditions have been met.
The Stabilisation and Association process (SAp), which is the overall
framework for bringing these
countries closer to the standards which apply in the Union, aims to create stronger links between each of
the countries and the Union, and to encourage regional co-operation between the countries themselves.
Trade is a core element of this strategy.

As a means to foster regional integration, the Stabilisation and Association Agreements (SAAs) with both
the former Yugoslav Republic of Macedonia and with Croatia already foresee the possibility of these two
countries participating in a system of diagonal cumulation of origin. According to the declarations
annexed to the SAAs, the Community is to examine the possibility of extending such a system to both
countries once they have met the necessary conditions.