Italy – Guide to Preliminary Injunctions in Patent Litigation

Introduction

Preliminary injunctions play a pivotal role in the enforcement of patent rights, as they enable rights holders to secure swift and effective judicial protection against ongoing or imminent acts of infringement. In technology-driven markets, where innovation cycles are rapid and competitive dynamics can change in a very short time, timely enforcement is essential. Even a temporary continuation of an infringement may result in irreversible effects on market structure and competitive positioning. Against this background, preliminary injunctions often represent the most appropriate instrument to prevent the consolidation of a potentially infringing market presence before the court is able to reach a final decision on the merits.

Triggers for seeking a preliminary injunction in Patent matters

Under Italian law, in order to obtain a preliminary injunction, the patentee must demonstrate the existence of two cumulative requirements: (i) the so-called fumus boni iuris, meaning the likelihood of success on the merits of the case, and (ii) the periculum in mora, i.e. the risk that a delay in the proceedings would cause irreparable harm.

Where the patentee seeks an ex parte order, it must also demonstrate that giving the defendant prior notice of the proceedings would allow the defendant to take steps capable of frustrating the effectiveness or enforceability of the measure, such as by accelerating market entry, creating an irreversible market situation, or otherwise undermining the practical value of the injunction.

In is worthwhile to remark that in Italy preliminary injunctions may also be granted on the basis of a pending patent application (i.e: no need to wait for the grant of the patent), provided that the application has been published or has otherwise been notified to the alleged infringer.

When ruling on an application for a preliminary injunction, courts shall carry out a balancing of interests, weighing the rights of the patentee against the potential disproportionate prejudice that the injunction could cause to the defendant or to third parties, so as to ensure that the measure remains equitable and proportionate.

The criteria as set out in the case law

Case law reveals that the above-mentioned requirements operate as factors to be assessed in a factual and context-specific manner. In this regard, judicial practice has progressively shaped a structured yet flexible framework for evaluating applications for preliminary injunctions in patent disputes.

As regards fumus boni iuris, the measure requires a prima facie assessment that the enforced patent is both valid and infringed. Under Italian law, a granted patent enjoys a statutory presumption of validity, meaning that the party seeking to invalidate it bears the burden of proof. This principle also applies in summary proceedings, where defendants can challenge the validity of the patent only by way of objection. In light of this presumption, the validity of the asserted patent usually is not subject to scrutiny in preliminary injunction proceedings, unless the defendant presents credible and sufficient evidence to overcome such presumption (see, among others, Court of Milan, 17 July 2025).  

The scrutiny of validity usually becomes more relevant where the injunction is sought on the basis of a pending patent application, which does not enjoy a presumption of validity and therefore requires a more cautious assessment of the likelihood that a valid and enforceable right will ultimately arise.

Due to the technical nature of patent cases courts frequently rely on court-appointed technical experts to assist them in the assessment of both validity and infringement before issuing a decision. Such technical opinions, albeit formally limited in scope and depth, often play a decisive role in informing the court’s prima facie evaluation.

With respect to the urgency requirement (periculum in mora), earlier case law tended to consider the ongoing infringement as sufficient, per se, to establish urgency. The underlying rationale was that any continued violation of an intellectual property right was assumed to cause harm that could not be easily remedied, particularly because such damage might exacerbate over time. However, more recent and prevailing case law tends now to perform a more nuanced assessment, requiring patentees not only to allege but also to substantiate a real and actual risk of serious or irreparable harm arising from the persistence of the infringing conduct (among others, Court of Turin, 10 August 2021, and Court of Turin, 30 November 2021).

When assessing urgency, courts also consider the lapse of time between the occurrence of the alleged infringing conduct and the filing of the application for a preliminary injunction; in this connection, compared to other jurisdictions, Italian courts adopt a relatively flexible, yet case-specific, approach. In particular, national case law often considers such temporal proximity to be satisfied even where several months have elapsed, and no rigid or statutory time limit is provided for.

Furthermore, Italian courts have consistently held that unilateral undertakings by the defendant to cease the allegedly infringing activities, or not to resume them in the future, are not sufficient, per se, to undermine the existence of the urgency. The same applies to declarations asserting the withdrawal of allegedly infringing products from the market. According to the case law, such circumstances are not regarded as having the capacity to eliminate the risk of repetition of the unlawful conduct. At the same time, granting interim relief cannot harm an infringer who is genuinely willing to refrain from further unlawful conduct. This approach is confirmed by the prevailing case law, among the others, of the Milan court, which has repeatedly established that the mere cessation of the unlawful conduct does not, in itself, suffice to eliminate the persistence of periculum in mora, where the conduct may be reiterated in the future and the party responsible for the infringement fails to demonstrate that it has implemented measures capable of rendering the cessation of the unlawful conduct substantially irreversible (inter alia, Court of Milan, 24 June 2022 and Court of Milan, 16 May 2022).

Preliminary injunctions may also be granted in case of imminent infringement, where the unlawful conduct has not yet occurred but is about to materialize. In such a case, the patentee must bring forward factual elements demonstrating a real and immediate risk that the unlawful conducts are about to take place, going beyond mere assumptions.

In this regard, specific complexities may arise in the pharmaceutical sector, due to the highly regulated framework and the industry-specific dynamics. In particular, as in many other jurisdictions, courts have been called upon to determine what is required to establish the imminence of an infringement that justifies a preliminary injunction, in a context where the need to protect pharmaceutical innovation must be carefully balanced against ensuring timely access to generic and biosimilar medicines.

Italian courts have consistently held that the mere granting of a marketing authorization is not sufficient, per se, to establish an imminent market entry capable of justifying a preliminary injunction. However, injunctive relief may be granted where the marketing authorization is accompanied by additional preparatory acts indicating an actual  intention to launch, such as the inclusion of the generic drug the regulator’s pricing lists, the stocking of products, pre-launch communications or initiatives, the lack of (satisfactory) response to a warning letter, as well as the establishment of a distribution network. The assessment is therefore carried out on a case-by-case basis, also taking into account the overall conduct of the generic or biosimilar manufacturer.

The temporal effects and the territorial scope of preliminary injunctions

Until recently, a distinctive feature of the Italian system compared to other European jurisdictions has been the so-called stability of preliminary injunctions. In particular, pursuant to Article 132(4) of the Italian Intellectual Property Code, preliminary injunctions do not automatically lapse if the patentee does not initiate proceedings on the merits, which remain optional.

However, in its judgment of 23 April 2026 in case M.M. Ristorazione v Villa Ramazzini (C 132/25), the CJEU - seized by way of a reference for a preliminary ruling from the Italian Supreme Court - clarified that Article 9(5) of Directive 2004/48/EC must be interpreted as precluding the application of a national provision that allows the maintenance of certain interim measures, such as those anticipating the effects of a decision on the merits, even though the patentee has not instituted proceedings leading to such a decision within the period laid down in Article 9(5) and the defendant requests that those provisional measures be revoked or otherwise cease to have effect. 

The Court of Justice’s decision, which aligned the Italian legal system with those of other European countries, is going to reshape litigation strategies and the use of preliminary injunctions as a standalone tool for the enforcement of patent rights.

Beyond their temporal effects, the effectiveness of preliminary injunction is strictly related to their territorial reach.

In this respect, Italian courts have traditionally been reluctant to grant cross border injunctions, even where the defendant was domiciled in Italy. This restrictive approach stemmed from the view that Article 24(4) of the Brussels I Recast deprived national courts of jurisdiction over the infringement of foreign parts of European patents whenever the defendant raised, even incidentally, an invalidity objection.

Nonetheless, following the CJEU’s decision in BSH v Electrolux (C-339/22), which clarified, inter alia, that a national court retains jurisdiction to hear an infringement claim even if the defendant raises an invalidity defence regarding the national portions of the same patent validated in other EU Member State, this stance will necessarily have to evolve.

As a result, Italian courts are expected to start issuing cross border injunctions where the applicable factual and legal conditions are met.

Is a bond or cross-undertaking payable when filing a preliminary injunction application?

The filing of an application for a preliminary injunction does not require the patentee to provide a bond or cross undertaking. However, the potential harm to the defendant resulting from an injunction that is later revoked or modified must be carefully considered. For this reason, it is not uncommon for the defendant to request that the court order the provision of a security. In fact, pursuant to Article 669‑undecies of the Italian Code of Civil Procedure, the court may, at its discretion, require the patentee to provide an appropriate security to cover potential damages suffered by the defendant in the event the interim measure is later revoked or found to be unjustified. The provision of a security is therefore not a prerequisite for obtaining the interim measure, but rather a discretionary measure assessed by the court on a case-by-case basis.

Right to Appeal

Appeals against preliminary injunctions (reclamo) are handled through a fast-track procedure to ensure efficiency. The appeal may challenge the order in full or in part. Proceedings are usually resolved within few weeks and are decided by a Panel of three judges of the same court, other than the judge who issued the order. The appeal must be filed within 15 days from communication of the interim order, underscoring the time-sensitive nature of preliminary relief proceedings. Filing the appeal does not automatically suspend the enforceability of the order. The Panel may confirm, modify or revoke the interim order. Its decision is final, without prejudice to the subsequent decision on the merits, which ultimately may supersede the interim measure.

Takeaways

Overall, the Italian system offers an efficient and reliable tool that ensures meaningful and timely protection for patentees, although courts tend to treat the urgency requirement with increasing scrutiny to prevent misuse of the preliminary measures in circumstances where the patentee could reasonably have acted earlier.

The interaction between national and European law will continue to shape the future of litigation strategies, particularly as the recent CJEU’s decisions in BSH v Electrolux and M.M. Ristorazione v Villa Ramazzini cases will recalibrate the territorial scope and temporal reach of the injunctions.

For practitioners, the key remains to act promptly, present robust technical and factual support and frame the request within a clear proportionality rationale.

For further details about patent law in Italy, see our Patent Litigation Comparator Guide.