With the recent Conversion Law (Law July 29, 2021, no. 108) of the so-called “Decreto Semplificazioni” (Decree-Law May 31, 2021, no. 77), an important amendment to the Italian Industrial Property Code (Legislative Decree February 10, 2005, no. 30) was approved: following the proposal of the former Minister of Health Giulia Grillo, Art 56 quater as inserted in the “Decreto Semplificazioni” innovates the Italian Industrial Property Code, introducing, for cases of declaration of a state of national emergency motivated by health reasons, a case of granting of compulsory licenses for the non-exclusive use of patents relevant to the production of medicines or medical devices.

According to letter a) of paragraph I of Art. 56 quater, Art. 70 bis is inserted in the Italian Industrial Property Code, according to which it is provided that, in case of a declaration of a state of national emergency motivated by health reasons, in order to address proven difficulties in the supply of specific medicines or medical devices deemed essential, it is possible to grant, in compliance with international and European obligations, compulsory licenses for the use, not exclusive, not alienable and directed mainly to the supply of the domestic market, of patents relevant to production purposes, having a validity bound to the duration of the emergency period or up to a maximum of twelve months from the end of the same.

Such compulsory license is granted by decree of the Minister of Health, in agreement with the Minister of Economic Development, after consultation with the owner of the intellectual property rights, subject to the opinion of the Italian Drug Agency regarding the essentiality and availability of medicines, or subject to the opinion of the National Agency for Regional Health Services regarding the essentiality and availability of medical devices, always with respect to the emergency in progress.

The aforementioned decree also establishes the appropriate remuneration to be paid to the owner of intellectual property rights, determined taking into account the economic value of the authorization.

It should be noted that the system of compulsory licensing is not new to the Italian Industrial Property Code, as it is already regulated by Articles 70 – 74 of the same. However, the substantial innovation of Art. 70 bis consists in shortening the waiting time, ensuring that a patent on medicines or essential medical devices can be licensed as soon as a period of health emergency begins: in fact, compared to the common regime, in case of emergency context the procedure for granting the special compulsory license can be activated without waiting for the expiry of the period of three years from the granting of the patent or four years from the filing of the application, as happens instead, in particular, in ordinary cases of compulsory license for lack of or insufficient implementation regulated by Art. 70 of the Italian Industrial Property Code.

The introduction of Art. 70 bis in the Italian Industrial Property Code stems from the objective of encouraging the production of and access to vaccines, an objective that has been pursued so far through various measures, including the COVID-19 Vaccines Global Access Program (COVAX), the COVID-19 Technology Access Pool (C-TAP) and, in particular, the Waiver from certain provisions of the TRIPs Agreement for the prevention, containment and treatment of COVID-19 proposed by India and South Africa.

However, some of the measures taken, including the new Art. 70 bis of the Italian Industrial Property Code, may give rise to some concerns. The crucial question is whether the compression of intellectual property is actually justified and can guarantee the achievement of the intended result. Indeed, many commentators have noted that the protection resulting from intellectual property is not only consistent with the objectives of safeguarding health, even during a health emergency, but that it is itself the main driver of such safeguarding, as demonstrated by the very fact that the development of effective vaccines was achieved in a very short time.

Filippo Ponso