Posted by Gianluigi Marino on Monday 07 May 2012
A Law Decree introducing the so called electronic health record, online examination record and in general the digitalization of the medical sector is about to be ratified by the Italian Parliament.
Posted by Giulio Coraggio on Tuesday 27 Mar 2012
The collection of medical personal data relating to health conditions of patients in cloud databases is recently becoming more and more frequent, but relevant privacy issues are triggered.
[Read More] Posted by Giulio Coraggio on Sunday 29 Jan 2012
The draft decree on liberalization and consumer protection, discussed in these days by the Italian Governemnt, contains a provision (Art. 27) according to which the Italian Medicines Agency (AIFA) "does not have the power to assess the existence of patent or industrial protection" within the proceeding for the granting of a marketing authorization to a generic medicine.
[Read More]Posted by Gualtiero Dragotti on Monday 23 Jan 2012
If this case law is confirmed by the other Italian IP Courts, originators will benefit from a straightened level of patent protection. In fact, while generics producers will be entitled to conduct pre-patent expiry testing work, they will not be allowed to apply for marketing authorization until 1 year before the expiry of the patent on the active principle. As a result, in light of the duration of the marketing authorization process, originators will likely benefit from a further period of exclusivity after patent expiry.
[Read More]Posted by Alessandro Ferrari on Friday 22 Apr 2011