ITALY Law and Practice Contributed by: Daniela Ampollini, Luca Pellicciari, Elena Mannini and Andrea Beltrame, Trevisan & Cuonzo
within 100 days (see Article 12(5-bis) of the Bal - duzzi Decree). Lastly, in the absence or pending centralised authorisation by the EMA, access to an orphan drug may be granted in Italy also on the basis of Law No 648/1996, Law No 94/1998 relating to the prescription of drugs on a nominal basis and Law No 326/2003 concerning the so-called “Compassionate Use”.
Italian PIs are “stable”; there is generally no need to file subsequent main proceedings to stabilise the PI if the latter has been requested or granted without ancillary measures (such as saisie-type measures or seizures). When merits proceed - ings are necessary because the PI is coupled with those other measures, then the deadline for commencing them may be set by the judge granting the PI. If the judge does not set such a deadline, merits proceedings must be com - menced within 20 working days, or 31 calendar days if longer, from the grant of the order or its subsequent communication to the parties. PIs are self-executing orders, and there is no need for the patentee to attend to any additional formality (such as making a payment) to enforce a PI. PIs often also include penalties. 5.2 Final Injunctive Relief Enforcement of final injunctions follows the same rules as those outlined in 5.1 Preliminary Injunc- tive Relief and applies to enforcing preliminary injunctions. Final injunctions are also immedi - ately effective, although the defendant may file, together with the appeal, a motion requesting the Court of Appeal to order that the appealed judg - ment be stayed. The Court of Appeal decides whether or not to grant the request by assess - ing if there are serious and well-founded reasons (eg, the risk of insolvency of one of the parties). The decision on the suspension usually takes place during the first oral hearing. Upon showing an actual urgency, the defendant may file an ex parte motion before the President of the Panel, asking for an early decision on the matter. In this case, the President can suspend enforcement of the decision even prior to the first hearing. Regardless of the moment at which the court decides on the stay of the order (ie, prior to or during the first oral hearing), the decision is not appealable. The court may provide for the pay -
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
Italian law does not require the patentee to give any undertaking as to damages in exchange for a preliminary injunction. However, the judge might order the petitioner to post a bond to cov - er potential liabilities in case the PI is lifted, but this provision is almost never applied in prac - tice. This is because, unlike in other European jurisdictions, there is no automatic liability for the petitioner where the PI is granted and sub - sequently lifted following a finding of invalidity/ non-infringement. Findings of liability on the part of the petitioner are only reached in exceptional cases of negligence and bad faith, ie, when it can be demonstrated that the latter has taken legal action out of due diligence. Regardless of the type of proceedings (either ex parte or inter partes), PIs are immediately enforceable, and the possible subsequent appeal does not suspend the execution of the preliminary decision. However, the appeal judge may suspend the measure or order the petition - er to provide a bond where the PI would cause serious harm to the defendant due to superven - ing circumstances. The bond amount may vary depending on the case’s value.
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