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  1. Legal news
    12 November 2019
    PI for Tadalafil Dosage Patent refused in Italy
    www.twobirds.com/en/news/articles/2019/italy/pi-for-tadalafil-dosage-patent-refused-in-italy

    By decisions dated 30 July 2018, then confirmed in the appeal by decisions dated 30 August 2018, the Court of Milan dismissed PI requested by ICOS and its licensee Eli Lilly against Sandoz, ascertaining the prima facie ...

  2. 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”).

  3. Legal news
    19 April 2021
    Hoffman-La Roche – Novartis dispute over Avastin drug referred back to the ECJ for the second time
    www.twobirds.com/en/news/articles/2021/italy/hoffman-la-roche-novartis-dispute-over-avastin-drug-referred-back-to-the-ecj-for-the-second-time

    On 18 March 2021, the Italian Supreme Administrative Court (“Consiglio di Stato” or “CdS”) wrote a new episode in the long-lasting Hoffman La Roche - Novartis saga related to the Avastin drug, which may have serious ...

  4. Legal news
    13 December 2017
    Italian Court in contrast with United Kingdom Supreme Court in pemetrexed battle
    www.twobirds.com/en/news/articles/2017/italy/italian-court-in-contrast-with-united-kingdom-supreme-court-in-pemetrexed-battle

    This is another decision in the long-running series of patent cases regarding the anti-cancer drug pemetrexed (Alimta®).

  5. Legal news
    04 December 2020
    New Provision of the Italian Revenue Agency: news regarding the transfer pricing documentation
    www.twobirds.com/en/news/articles/2020/italy/alert-tax-transfer-pricing

    On 23 November 2020, the Italian Revenue Agency published the new Administrative Provision n. 360494 (the “Provision”), endorsed in the Decree of the Ministry of Economy and Finance of 14 May 2018 (the “Decree”) which ...

  6. Legal news
    12 March 2021
    SACE - Green New Deal
    www.twobirds.com/en/news/articles/2021/italy/green-new-deal-sace

    On 15 September 2020, Law no. 120 dated 11 September 2020, converting, with amendments, Law-Decree no. 76 of 16 July 2020 (the “Semplificazioni Decree”), containing urgent measures for simplification and digital ...

  7. 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 ...

  8. Legal news
    10 July 2019
    Italy: "Growth Decree 2019" – Tax impacts for Italian entities
    www.twobirds.com/en/news/articles/2019/italy/italy-growth-decree-2019-tax-impacts-for-italian-entities

    Our tax alert will provide an outline of the main tax provisions having an impact for the Italian entities.