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 aforementioned 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 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.