On 19 July, the Italian House of Representatives approved the amendment of the current Intellectual Property Code (“IPC”), as proposed by the conversion law of the so-called Recovery Law Decree (law decree 31 May 2021, no. 77). Upon proposal of the former Minister of Health, MP Giulia Grillo, the House of Representatives voted in favor of introducing Article 70-bis into the IPC. The new Article 70-bis, compulsory licensing in the event of a national health emergency, shall read as follows:
- If a national health emergency is declared compulsory licenses may be granted in order to overcome proven difficulties in supplying essential medicines or medical devices and in compliance with international and European obligations. These compulsory licenses shall grant licensees a non-exclusive and unalienable right to exploit production-relevant patents, mainly for supplying the Italian market, and shall be valid as long as the emergency period lasts or up to a maximum of twelve months from the end of the same;
- The compulsory license for the medicinal products referred to in paragraph 1 is granted by decree of the Minister of Health, in agreement with the Minister of Economic Development, subject to the opinion of the Italian Medicines Agency on the medicinal products’ essentiality and availability with respect to the current health emergency and after having heard the patentee. The same decree shall also provide the IPRs owner with appropriate compensation, which must take into account the economic value of the authorization;
- The compulsory license for the medical devices referred to in paragraph 1 is granted by decree of the Minister of Health, in agreement with the Minister of Economic Development, after having heard the opinion of the National Agency for Regional Health Services on the devices’ essentiality and availability with respect to the current health emergency, as well as the patentee. The same decree shall also provide the IPRs owner with appropriate compensation, which must take into account the economic value of the authorization.
The IPC is already familiar with the mechanism of compulsory licensing, which, according to Article 70, can be granted when the patentee has not exercised his patent rights within three years from grant or four years from filing (whichever is later), by manufacturing the patented product in the Italian territory, or importing patented products manufactured in a EU/EEA/WTO country, or when the patentee has implemented the invention in such a way as to result in serious disproportion to the country’s needs. The purpose of the new Article 70-bis is therefore to shorten the waiting time, ensuring that a patent covering essential medicines or medical devices can be licensed as soon as the emergency period arises and up to a maximum of twelve months after its end.
The amendment specifies both the competent authority and the procedure for issuing the compulsory license. In particular, the compulsory license shall be issued by decree of the Minister of Health, in agreement with the Minister of Economic Development, after having heard the patent owner, and after obtaining the opinion of the Italian Medicines Agency (“AIFA”), in case of medicinal products, or the National Agency for Regional Health Services, in case of medical devices. Moreover, Article 70-bis acknowledges appropriate compensation in favour of the patent owner; such compensation must take into account the economic value of the authorization.
Once the House of Representatives will have completed the legislative process, the amended bill will return to the Senate for final approval.
The amendment is available at the following link (see Article 56, still only available in Italian): http://documenti.camera.it/apps/emendamenti/getProposteEmendativeSeduta.aspx?contenitorePortante=leg.18.eme.ac.3146&tipoSeduta=1&sedeEsame=referente&urnTestoRiferimento=urn:leg:18:3146:null:null:com:0108:referente&dataSeduta=20210719&tipoListaEmendamenti=1