Biotechnology

ITALIAN LAW

EU Directive 98/44 on the protection of biotechnological inventions has been ratified in Italy by legislative decree 2006/3, converted in Law 2006/78 (publication G.U. 58 on 10 March 2006).

In 13 articles, the legislative decree first identifies its purposes, list the definitions (Art. 2) and patentable inventions (Art. 3). Particularly, the Law establishes that to patent a DNA sequence or a protein, total or partial, it is necessary to disclose and claim its function and industrial applicability (Art. 3).

Further, the law establishes the exclusion from patentability for ethical reason such as safeguard of humans and environment, preservation of plants and biodiversity and prevention of environmental damages. Among the invention excluded from patentability (Art. 4):

- human body from the moment of its conception and during the various stage of its development,
- all the process for cloning human beings whichever the development stage of the cloned organism and the cloning purposes is
- any use of human embryos , including human embryonal stem cell lines;
- processes for modifying genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animals;
- genetic screening protocols having eugenic purpose and not diagnostic.

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