Biotechnological Inventions and Patentability of Life
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Biotechnological Inventions and Patentability of Life

The US and European Experience

Andrea Stazi

In today’s technological world, biotechnology is one of the most innovative and highly invested-in industries for research, in the field of science. This book analyses the forms and limitations of patent protection recognition for biotechnological inventions, with particular regard to patentability of life.
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PART IV: The evolution of the discipline and problematic issues in Europe

Andrea Stazi


The biotechnology patent law system in Europe has followed a significantly similar path to that seen in the United States, though with legislation and case law taking on different roles. In general, the roots of intellectual property in Europe are national, and the law regulating their use is delegated to the single national authorities of responsibility. Although a form of so-called ‘community patent’ should be introduced as soon as possible, to the state the concept of ‘European patent’, in effect composed by a bundle of national patents, is the dominant one. At the European level, regulations have been adopted which have shaped the subject of patents, and, with the European Patent Convention and Directive 98/44/EC, have gone so far as to provide the patentability of biotechnological inventions, with specific provisions for the exclusion of living organisms from patentability. The path was initiated, also in Europe, by the patentability of microorganisms. Later came the patentability of plants, followed by that of animals and finally of human genetic material. This step appears to be the final one, in consideration of the shared position in excluding human beings from the sphere of patentability, which is particularly supported within the European context.

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