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EU Directive on the Protection of Biotechnological Inventions

The protection of biotechnological inventions has become more effective and harmonized throughout the European Member States by the directive 98/44/EC of the European Parliament on the Legal Protection of Biotechnological inventions. At the present the German government is working on implementing this directive  into the German Patent Law which will take at least until the end of this year. The European Patent Office is already usuing this Directive as the basis for granting patents in the biotechnology field and has amended its implementing regulations to conform with the Directive.

This directive governs what is seen as patentable but also contains some exclusions. According to the Directive the following shall not be patentable: 

  1. plant and animal varieties 

  2. essentially biological processes for the production of plants or animals. 

Furthermore, inventions shall be considered unpatentable where their commercial exploitation would be contrary to the "ordre public" or morality. However, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. On this basis the following are considered to be unpatentable: 

  1. processes for cloning human beings; 

  2. processes for modifying the germ line genetic identity of human beings; 

  3. uses of human embryos for industrial or commercial purposes; 

  4. processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.     



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