Community Research and Development Information Service - CORDIS

Parliament votes to allow patenting of biotechnological inventions

The European Parliament voted, at first reading on 16 July 1997, to approve the proposed Directive on the legal protection of biotechnological inventions. This Directive would allow European researchers to obtain protection for their inventions throughout the Single Market, al...
The European Parliament voted, at first reading on 16 July 1997, to approve the proposed Directive on the legal protection of biotechnological inventions. This Directive would allow European researchers to obtain protection for their inventions throughout the Single Market, allowing new inventions to be placed on the market. However, it responds to ethical concerns by excluding from patentability certain discoveries and processes involving the human body.

The Commission's first proposal for a Directive in this area, dating from 1990, was rejected by the European Parliament in 1995, largely because of ethical concerns. The Commission then put forward a revised proposal which attempted to take the Parliament's concerns into account. Implementation of the Directive would be a major boost to the European biotechnology industry, and could have a significant impact on Europe's competitiveness. European companies in the field are currently at a disadvantage since major variations in conditions for patenting biotechnological inventions between Member States lead to fragmentation of the Single Market.

The Parliament adopted its report on the proposal by a large majority (388 for; 110 against; 15 abstentions). Parliament also adopted a number of important amendments to the Commission's proposal, most of which will be accepted by the Commission, according to Mario Monti, Commissioner responsible for the Internal Market.

Parliament adopted an amendment requiring an ethics committee to be established to assess all ethical aspects of biotechnology and its utilization, in particular with regard to patents. Other amendments adopted by the Parliament include:

- Plant and animal varieties, and essentially biological procedures for the breeding of plants and animals will not be patentable. However, an invention concerning plants or animals may be patented if it is not technically confined to a particular variety. In addition, inventions concerning a microbiological or other technical procedures, or products obtained by such a procedure, may be patented;

- 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 be a patentable invention. However, an element isolated from the human body or produced otherwise by means of a technical process, including the structure or partial structure of a gene, may be patented, even if the structure of that element is identical to that of a natural element. The industrial application of sequences or partial sequences of a human gene must be disclosed in the patent application;

- Inventions will not be patentable where exploitation or publication would be contrary to public policy or morality, however, prohibition by law or regulations would not, on its own, mean that exploitation is contrary to public policy or morality. In particular, the following would not be patentable:

. Procedures for reproductive cloning;
. Processes for modifying the germ line genetic identity of human beings;
. Processes for modifying the genetic identity of animals (or animals resulting from such processes) which are likely to cause them suffering or physical handicaps without any substantial medical benefit to man or animal;
. Methods in which human embryos are used;
. Methods for the artificial reproduction of human embryos containing the same genetic information as another human being or a dead person (human cloning).

Commissioner Monti welcomed Parliament's adoption of the proposal, saying, "We have found the right balance between economic requirements and sensitivity to ethical issues". The Directive, he continued, would be of particular importance for the development of applications in the health field. The proposed Directive must now be examined by the Council and then undergo a second reading in the Parliament before it can become law.

Related information

Follow us on: RSS Facebook Twitter YouTube Managed by the EU Publications Office Top