Compulsory licensing for medicinal products and medical devices in the case of a national health emergency introduced in Italy
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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) introduced Article 70-bis in the Italian IP Code. This new law provides that in the case of a declaration of a state of national emergency for health reasons, and where there is a need to address supply difficulties of specific medicinal products or medical devices which are deemed essential, a compulsory licence may be granted in compliance with international and European obligations. Such a licence would be granted on a non-exclusive and non-transferable basis and would be for the primary use of supplying the Italian market. The compulsory licence will have a term equal to the duration of the emergency period, or up to a maximum of 12 months from the end of the emergency period.
The compulsory licensing scheme will only apply to patents covering the manufacture of the required products. In order to be eligible for the scheme, the applicant must prove that they have first contacted the patent proprietor and been unable to obtain a licence on fair terms and conditions.
Under the new rules, a compulsory licence is granted via a decree of the Minister of Health, in agreement with the Minister of Economic Development. Prior to issuing a decree, the Ministers of Health and Economic Development will hear from the patent proprietors, and:
- in case of medicinal products: from the Italian Medicines Agency on the necessity and availability of the products for the emergency in question; and
- in case of medical devices: from the National Agency for Regional Health Services on the necessity and availability of the devices for the emergency in question.
The decree granting the compulsory licence also provides for the appropriate remuneration of the patent proprietor.