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  1. Legal news
    22 March 2021
    “Patent linkage” in Italy: only patents/SPCs on the active ingredient per se are relevant for the purpose of reimbursement of generic medicinal products
    www.twobirds.com/en/news/articles/2021/italy/patent-linkage-in-italy

    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”).

  2. Legal news
    11 December 2018
    Pemetrexed: Italian Court reversed the first instance decision ordering a PI on the basis of Eli Lilly's patent
    www.twobirds.com/en/news/articles/2018/italy/italian-court-reversed-the-first-instance-decision-ordering-a-pi-on-the-basis-of-eli-lillys-patent

    Diverging from the previous decision, the Court pointed out that the relevance of the file history to construe the scope of protection of a patent and then the infringement of equivalence has to be carefully and ...