Compulsory licensing for medicinal products and medical devices in the case of a national health emergency introduced in Italy
Written By
Evelina Marchesoni
Senior Associate
Italy
I specialise in multi-jurisdictional contentious patent matters, with a particular focus on Life Sciences & Healthcare and the Tech & Comms sector.
The Italian IP Code has recently been amended to impose a compulsory licensing for patents related to certain medicinal products or medical devices in the event a national health emergency is declared.
Previous rules on compulsory licencing
Articles 70 – 74 of the Italian IP Code previously provided for a compulsory licensing scheme in Italy but only in the event of:
- a failure to work or the insufficient working of a medicinal product or medical device; or
- a ‘dependent invention’, such as in a scenario where a patentee cannot exploit its invention without infringing a prior patent.
Compulsory licences have rarely been granted in the past in Italy.
New rules on compulsory licence for medicinal products and medical devices
Law Decree 31 May 2021 no. 77 (which was converted into law on 29 July 2021 no. 108)…
