MOTION FOR A RESOLUTION
20.10.2005
pursuant to Rule 103(2) of the Rules of Procedure
by Hiltrud Breyer and Margrete Auken
on behalf of the Verts/ALE Group
on the legal protection of biotechnological inventions
B6‑0553/2005
European Parliament resolution on the legal protection of biotechnological inventions
The European Parliament,
– having regard to the Convention on the grant of European patents (European Patent Convention) of 5 October 1973,
– having regard to Directive 44/98/EC on the legal protection of biotechnological inventions,
– having regard to the Council's Explanatory Memorandum to the directive,
– having regard to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, signed in Oviedo in 1997,
– having regard to its resolution of 30 March 2000 on the decision by the European Patent Office with regard to patent EP 695 351 granted on 8 December 1999,
– having regard to the report of 14 July 2005 from the Commission to the Council and the European Parliament on the development and implications of patent law in the field of biotechnology and genetic engineering (COM(2005) 312),
– having regard to Rule 103(2) of its Rules of Procedure,
A. whereas the European Patent Office granted a patent on 2 February 2005 (EP1257168) that includes a method of selection of human stem cells and the germ cells themselves, which can certainly not be considered as an invention,
B. whereas the European Patent Office has also granted European Patents EP1121015 and EP1196153, which also cover human germ cells, and EP1121015 covering even frozen human embryos,
C. whereas the European Patent Office accepted an objection to patent EP695351 (University of Edinburgh) and made clear that patents on human embryonic stem cells cannot be granted,
D. whereas, as there is opposition to this decision, the legal situation is still unclear,
E. whereas there is ongoing discussion on the patentability of stem cells derived from human embryos,
F. whereas more than one thousand European patents have already been granted on genes from humans and animals,
G. whereas over-generous granting of patents can stifle innovation,
H. whereas patent protection on human genes on the European market cannot be seen as being harmonised since countries like France and Germany have implemented national legislation which is in keeping with EU Directive 44/98/CE but has in practice led to differing patent protection,
I. whereas research shows that human genes do not have only one function but that most of them have several, depending on the context of cells and the organism, thus making it difficult to apply Article 5 of Directive 44/98/CE properly,
J. whereas Article 6 of the directive rules out the cloning of human beings, and whereas the Council in its explanatory statements to the Parliament made clear that this patenting ban does not merely cover reproductive cloning and that the term human being covers the embryonic phase,
K. whereas about one hundred patents have already been granted on animals, most of them after the adoption of Directive 44/98/CE, without any substantial medical check from the European Patent Office,
L. whereas patent protection on seeds and plants has resulted in variety protection regulation being impeded by far-reaching and conflicting monopoly rights,
M. whereas companies such as Syngenta are seeking patent protection for substantial parts of the genome of rice and other agricultural plants (see EP139956, as an example of about a dozen other patent applications by this company),
N. whereas the Monsanto company is even claiming patents on pigs derived from normal breeding (WO 2005/017204 and WO 2005/015989),
O. whereas patents are increasingly being granted on normal plants (EP1185161 – plants with changed lipid oil content, and EP921720 – plants with normally occurring gene combinations, as examples of a few hundred patents already granted),
1. Considers that current patent law on biotechnological inventions (Directive 44/98/CE) cannot be seen as a final answer to the relevant ethical, social and legal questions;
2. Calls on the Commission to consider whether a clear interpretation of Directive 44/98/CE can be established through a recommendation to the Member States or whether the directive needs to be amended, especially with reference to Article 5;
3. Points out that patent EP1257168 constitutes a violation of the directive because it patents human germ cells (which are part of the human body and certainly not invented) and a violation of Article 14 of the Convention on Human Rights and Biomedicine which forbids the use of techniques of medically assisted procreation for the selection of a future child's sex;
4. Decides to file an objection to patent EP1257168 without delay and asks its services to immediately draft the file;
5. Insists that the practice of the European Patent Office, on the basis of Directive 44/98/CE, betrays the major lack of clear rules as regards exclusions based on ethical reasons and the distinction between plant and animal varieties on the one hand and patentable inventions on the other, and of practicable rules covering patents on genes and their functions;
6. Calls on the European Commission to come up with a proposal on how to restrict patents relating to plants and animals so that varieties can be efficiently excluded from patent claims;
7. Calls on the European Patent Office to apply current patent law in such a way that patents relating to animal or plant breeding are narrowed down to specifically technical features and that patents on whole plants and animals are thus confined to very rare exceptions, if not completely excluded;
8. Calls on the European Patent Office to refuse to grant any patents on human germ cells, human embryos and stem cells derived from human embryos;
9. Insists that the Commission propose a new draft directive on the legal protection of biotechnological inventions, placing restrictions on patents relating to living material in order to overcome legal, ethical and economic uncertainties;
10. Instructs its President to forward this resolution to the Council, the Commission, the Member States and the European Patent Office.