Life Sciences and Pharma IP Litigation 2025

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

CAE even after the expiry of the deadline for the submission of evidence to the judge. The CAE may also conduct experiments or inspec - tions, which the parties have a right to attend. After the technical discussion is completed, the CAE produces a preliminary opinion and asks the parties to comment on it. The parties review said opinion and provide their own observations (once again, mostly in writing). Further to this, the CAE produces a final opinion for the court, and another hearing takes place to discuss it. The findings of the CAE are significant as they serve as a “primer” or guidance for the judge to adjudicate the case. Therefore, the technical phase before the CAE is crucial and must be conducted with the necessary care and deploy - ment of effort by the parties. However, the CAE opinion is not binding, and the court retains the right to overrule it and/or appoint another CTA to discuss the same technical issue. Parties are allowed to appoint their own experts and avail of their support when submitting their arguments and evidence to the CAE. However, these experts do not act as “expert witnesses”. They are professionals (mostly patent attorneys skilled in the relevant technical field) who work alongside and cooperate with lawyers when pre - Experiments can be conducted (i) during the technical phase by the CAE or (ii) “out-of-court” by the parties. In (i), the CAE and the parties agree on the specific mechanisms to perform the experiments and the results thereof are included in the CAE report. The process is normally long and complicated as it entails agreeing on poten - tially complex experimental protocols, including the selection of an independent facility suitable paring arguments for the CAE. 1.13 Use of Experiments

to run and record the experiments. Costs can also become significant. While (i) can be the one and only way in some cases, a party can submit its own experiments and related experimental report, which more often than not can become the basis for the dis - cussion with the CTA, provided that the other party is given a chance to review the experi - mental protocol and raise potential objections/ criticism. In this connection, Italian courts favour cooperation between the parties and are nor - mally not impressed by defences that merely leverage the non-independent nature of a party’s own experiments whilst not clarifying the specif - ic technical reasons as to why these should not be held as reliable. Defences of this kind have sometimes been stigmatised as “reverse-fishing expeditions”, ie, tantamount to asking the court to disprove the adversarial evidence. 1.14 Discovery/Disclosure Usually, the disclosure of documents relevant for assessing validity and/or infringement issues occurs voluntarily by the parties or upon the issue of a specific court order. In the latter case, the interested party must have established that its claims are reasonably well-founded. Also, the documents or particular piece(s) of information for which disclosure is requested must be spe - cifically identified, ie, the disclosure order cannot become a fishing expedition. Disclosure orders are also commonly issued (at the request of the interested party) with respect to the infringer’s books and accounting records when the time comes to calculate damages or infringer’s profits. Disclosure may occur through the acquisition of witness depositions or formal interrogation of the party or its legal representative; however,

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