The Chamber of Deputies has recently approved, on 19 July 2021, an amendment to the Industrial Property Code, as formulated by the conversion law of the so-called “Simplification Decree” (d.l. no. 77/2021), voting in favor of the introduction of Art. 70bis c.p.i., which provides for compulsory licenses in case of declared national health emergency. The next step is the eventual final approval by the Senate.
This mechanism of compulsory licenses is not new to our legal system, as it is already provided for by Art. 70 c.p.i.
What is important here is that the novelty introduced makes it possible to shorten waiting times considerably, by ensuring that a patent on an essential medicine or medical device is licensed as soon as a public health emergency is declared.
In fact, the law provides that, in any case in which a national health emergency is declared, compulsory licenses may be granted to address any difficulties in the supply of specific medicines or medical devices that may become essential.
Such licences shall confer on the licensees a non-exclusive and non-transferable right to exploit the relevant patents for productive purposes and shall be valid for the whole of the contingency period or, in any case, up to a maximum of 12 months after the end of the contingency period and shall be intended primarily for the supply of the internal market.
In addition, licenses are granted by decree of the Ministry of Health together with the Ministry of Economic Development, after hearing the owner of the intellectual property right and after an opinion (of AIFA in case of medicines, of AGENAS in case of medical devices) on the essentiality and availability of medicines or devices with respect to the emergency in progress.
The same decree also provides for remuneration in the form of adequate compensation in favour of the owner of the intellectual property right compulsorily granted to third parties, taking into account the economic value of the authorisation.