WRITTEN QUESTION E-3668/98

by Doeke Eisma (ELDR) to the Commission

(7 December 1998)

Subject: Applicability of the directive on the legal protection of biotechnological inventions to human research with embryonic tissue

1. Is the Commission familiar with the latest breakthroughs in medical technology in which two research teams at the University of Wisconsin and John Hopkins University have succeeded in growing embryonic stem cells in the laboratory?

2. Can the Commission confirm that this invention of a method of growing embryonic stem cells is not patentable in the EU by reason of Article 5 of the Directive on the legal protection of biotechnological inventions (COM(97) 0446(1) because the method was invented using embryonic material?

3. If Article 5 of that Directive is not applicable to this invention can the Commission state why not, and whether there exist other restrictions that would rule out the patentability of such scientific research with embryonic tissue in the EU?

Answer given by Mr Monti on behalf of the Commission

(16 February 1999)

The Commission is aware of the research of the University of Wisconsin and The Johns Hopkins University.

As regards the patentability of the methods developed by such research, Directive 98/44/EC of the Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions(2) lays down in Article 5 (1) that "the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions". The simple discovery of embryonic stem cells is not, therefore, patentable in itself.

However, Article 5 (2) states that "An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element". Consequently, it cannot be ruled out that a method for growing embryonic stem cells as an element isolated from the human body, which observes the conditions for patentability, may have the right to protection. However, as far as the Commission is aware, no application for a patent has been made in this respect in Europe.

Apart from the provisions of Article 5, Article 6 (2) c) rules out the patentability of uses of human embryos for industrial or commercial purposes because their commercial use would be contrary to ordre public or morality. Recital 42 states that this exclusion does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it. It is probably primarily in this context that the patentability of the methods developed by the two US universities should be considered. However, the Commission is not in a position to judge in this matter. Should the case arise, it would be the patent offices of the Member States and the national judges before whom the matter was brought that would decide.

The European Group on Ethics in Science and New Technologies, which was given the task under Article 7 of Directive 98/44/EC of evaluating all the ethical aspects of biotechnology, issued Opinion No 12 on 23 November 1998 concerning the ethical aspects of research involving the use of human embryos in the context of the fifth research framework programme. Basically the Group stressed that respect of the pluralism of cultures and ethical approaches in Europe, which had led to an extreme diversity of national regulations, meant that the granting of EU financial aid for embryo research in countries where it was allowed could not be totally ruled out. However, the Group said that observance of pluralism did not mean there should be no restrictions. It was therefore important to make the financing of such research subject to the observance of strict legal and ethical conditions, particularly regarding the prior agreement of any ethical committees and observance of the fundamental ethical principles common throughout Europe, such as the respect of human life from its beginnings and the need to obtain the consent of the women or couples who produced the embryos that might be used for research.

Finally, the Commission wishes to stress that if the patent system comes up against a difficult question concerning the patentability of human embryo tissue or the methods concerning it, the Commission will report on it in the annual reports on the development and implications of patent law which it has to submit to the Parliament and the Council as of 30 July 2000.

(1) OJ C 311, 11.10.1997, p. 12.

(2) OJ L 213, 30.7.1998.