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PubMedDate not supplied

[Legal protection of biotechnological inventions. The European Parliament's perspective].

In 1996, the European Commission put forward a proposal for a Parliament and Concil Directive on the legal protection of biotechnology inventions. The article looks at vicissitudes which characterised the progress of the proposal in the Council and the European Parliament. The future directive will regulate the patentability of biological material, which is a particularly sensitive issue when the material is of human origin. The article also seeks to set the proposed directive in a wider context by referring to forthcoming international Convention Law on biotechnology and to the legal situation in Spain at present.

Biotechnology↗
PubMedDate not supplied

Patenting biotechnologies: the European Union Directive 98/44/EC of the European parliament and of the council of 6th July 1998 on the legal protection of biotechnological inventions.

Before the Directive 98/44/EC of the European Parliament and the Council of 6th July 1998, notwithstanding some decisions of the European Patent Office (still presently under opposition) and some patents already granted by the Italian Patent Office, the existing legal framework did not allow the patentability of living organisms in the European Community countries. The Directive has dramatically changed the perspectives. It ensures free circulation of patented biotechnological products harmonising the national legal system of each Member State, guaranteeing compliance with the European Patent Convention signed in Munich on 5th October 1973, the Trade-Related Aspects of Intellectual Property Rights agreement of 15th April 1994 and the Rio de Janeiro Convention on Biological Diversity of 5th June 1992. The legal basis of the Directive and the fundamental principles of protection are that discoveries as such are not considered patentable. Plant and animal varieties as such, as well as essentially biological procedures for the production of plants and animals are excluded from protection by patent. On the contrary, the new field of patentability covers plants and parts of animals with new introduced genetic characters. Methods of surgical and therapeutic treatment and diagnostic methods applied to animal bodies are not considered inventions suitable for industrial applications and excluded from protection by patents. Biological materials and material isolated from its natural environment and isolated elements of the human body with technical processes may be patented. Excluded from patentability are inventions that are contrary to law and order or public morality as well as processes for human cloning for reproductive purposes and for modifying the germ-line genetic identity of human beings, as well as the use of human embryos. The processes for modifying the genetic identity of animals without any substantial medical benefit for man (with the exception of studying new medicinal products useful for treating serious diseases such as cancer, hepatitis or AIDS, by means of Oanimal modelsO) are also excluded. The rights of farmers are also guaranteed, by allowing them to re-sow seeds and freely use breeding stock covered by patents on their farms, without paying costly royalties to the holders of patents.

Animals↗
PubMed2006

Magnetic fields of induction heaters in the framework of directive 2004/40/EC of the European Parliament and of the Council.

The spectrum and the polarization of the magnetic flux density (B-field) of 6 induction heaters and 1 arc oven were measured by means of a PMM (Italy) spectrum analyser. The spectrum analysis showed that no substantial harmonics were observed while the polarization analysis revealed that the operator's exposure was non-homogeneous within a distance of 1.5 m from the heater. When the distance was larger, the body was homogeneously exposed. In general we can state that the B-field strongly varied between heaters and that exposure exceeded the occupational reference levels recommended by the International Commission on Non-Ionizing Radiation Protection (ICNIRP) (1998) and European Directive 2004/40/EC in 5 of the 7 heaters. Within the framework of the Directive some protection actions should be taken. Whereas mitigation of existing/old induction ovens is difficult, the design of new induction heaters and their housing should be based, among others, on electromagnetic reducing engineering concepts.

Electromagnetic Fields↗