Life Sciences and Pharma IP Litigation 2025

ITALY Law and Practice Contributed by: Daniela Ampollini, Luca Pellicciari, Elena Mannini and Andrea Beltrame, Trevisan & Cuonzo

1.6 Requirements to Bring Infringement Action Italy is one of the few jurisdictions where patents can be enforced at the application stage, both in preliminary as well as in main proceedings. While preliminary measures, including prelimi - nary injunctive relief, can be granted based on patent applications, Italian courts have to wait until the patent is granted before issuing a judg - ment in the main proceedings. As far as patent applications are concerned, a condition for their enforcement is that they must either be published or, if not yet published, offi - cially served on the defendant before the action is actually filed. Further, and importantly, in the case of EPO or international patent applications, a translation of the claim set must be filed with the Italian PTO before enforcement. A translation requirement also exists with respect to granted patents stemming from EPO or international applications: ie, an Italian translation of the pat - ent specification (description and claims) as granted needs to be filed with the Italian PTO for the patent to be validated and enforceable in Italy. There must be evidence of infringing activity taking place in the national territory for the fil - ing of an infringement action. In cases seeking preliminary relief, there should be a reasonable indication that such infringing activity may begin in the national territory and that this potential activity poses a risk of causing irreparable harm to the patent holder if a preliminary injunction is not granted. The general view shared by Italian courts is that obtaining a marketing authorisation and/or applying for price and reimbursement is not sufficient to justify an infringement claim (ie, commercial exploitation of the patented inven - tion) and/or a threat of infringement and the con - sequent irreparable harm and further elements

Additional evidence (such as witness testimo - nies deemed relevant by the judge) is typically addressed alongside, or more commonly after, the CTA opinion has been delivered. After addressing the above issues, a final hear - ing will be scheduled, which will be preceded by: • (i) the parties confirming their final requests to the court (60 days before the hearing); • (ii) the parties submitting final written plead - ings (30 days before the hearing); and • (iii) the parties submitting a final brief in reply (15 days before the hearing). Upon confirming their final requests to the court under (i), parties may request that submission of the final briefs in reply under (iii) be substituted by oral pleadings that shall take place before the panel of three judges, who will eventually adju - dicate the case. The average timeframe for first instance main proceedings is between two and two and a half years, depending on the seized court and its workload. Validity and/or infringement actions can always be filed, provided the claimant retains an inter - est. A statute of limitations of five years applies to claims for damages resulting from patent infringement; however, case law has clarified that claims for the return of profits are subject to a longer “general” statute of limitations of ten years. Claims for damages and the return of profits typically occur after a discovery of infringement. This can happen either as part of sub-proceed - ings that follow the main case — if damages or the return of profits were requested at the outset — or as separate, independent proceedings.

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