World Intellectual Property - IP Laws - Italy

 

 

New law on biotech inventions:

Italy has ratified Directive 98/44/EC which aimed at harmonizing the laws of the member states to promote investment in the field of biotechnology and avoid barriers to trade and introduced the new Directive 78/2006 in order to define what is patentable; compulsory licences; the scope of protection of patents; the deposit, access and new deposit of biological material.

The differences with respect to the directive mostly tend to restrict its scope.  In fact, while the non-patentability of human embryos in the directive is limited to cases of industrial or commercial purposes, in the Italian law non-patentability is absolute and includes lines of human embryonal stem cells.  However, the new law adds among the non-patentable inventions genetic screening protocols the use of which could be discriminating  or have eugenic and non-diagnostic purposes.

The Law 78/2006 also determines the procedure for obtaining a patent and perplexities arise as to the actual tasks of the Italian Patent Office in assessing the patentability of requirements.  Another limitation introduced by the new law concerns the patentability of elements isolated from the human body or otherwise produced and of sequences or partial sequences of gene, where the industrial applications must be not only be disclosed but specifically claimed in the patent applications.

However, the new law does not clarifies about the non-patentability of inventions relating to new plant varieties, as the prohibition conflicts with the Italian Code of Industrial Property.

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