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Protection of biotechnological inventions

Community legislation on the legal protection of biotechnological inventions has recently been adopted and will be brought into force in the Member States by 30 July 2000. This will harmonise national rules on the patenting of biotechnological inventions in order to ensure the...
Community legislation on the legal protection of biotechnological inventions has recently been adopted and will be brought into force in the Member States by 30 July 2000. This will harmonise national rules on the patenting of biotechnological inventions in order to ensure the smooth functioning of the internal market and will help maintain and encourage investment in the field of biotechnology.

This new Directive (98/44/EC) is limited in its scope and provides that neither plant and animal species nor biological processes for their production are covered by the legislation as they are essentially biological and not biotechnological processes. In addition, certain processes may not be patented on ethical grounds such as cloning humans or interventions in the human germ line nor the use of human embryos for industrial or commercial purposes. This also applies to processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit.

Provision for compulsory cross-licensing in the Directive will allow breeders and patent holders to acquire or exploit a plant variety which is already protected by patent. Applicants must however demonstrate that they have applied unsuccessfully to the patent holder to obtain a contractual licence and that the plant variety or the invention constitutes significant technical progress of considerable economic interest compared to the invention claimed in the patent.

In addition the legislation provides for exceptions to descriptions required in the patent application form where the invention involves biological material which is not available to the public and cannot be described in a manner which would avoid reproduction.

Legislative developments in this field will be followed closely and the Commission will report regularly on the compatibility with this Directive and developments in international law, implications of the failure to publish information on potential patent applications and on the development and implications of patent law in the field of biotechnology and genetic engineering.

Source: Official Journal of the European Communities

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