Compulsory licensing for medicinal products and medical devices in the case of a national health emergency introduced in Italy

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)…