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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.
By resolution dated February 10, 2021 the Italian Medicines Agency (AIFA) clarified the criteria for generic medicinal products to be inserted in the Substitution List (“Lista di Trasparenza”).
This is another decision in the long-running series of patent cases regarding the anti-cancer drug pemetrexed (Alimta®).
After a long legislative process, on 8 May 2021 the Italian 2019-2020 European delegation law (Law No. 53 of 22 April 2021 - Delegation to the Government for the transposition of European directives and the ...