Patent litigation has a pivotal role in Italy when it comes to the protection of intellectual property, especially for those sectors that are driven by technological innovation such as pharmaceuticals, biotechnology and engineering.

Patent litigation in Italy features a great deal of interplay between domestic and European law, and this adds significant complexity. The dual-layered system requires practitioners to have a thorough understanding of domestic legal provisions and the broader European patent framework, including recent developments regarding the Unified Patent System.

This article provides an overview of the patent litigation process in Italy, covering legal frameworks, different kinds of actions, procedures and key considerations for businesses and inventors.

Legal framework

Patent litigation in Italy is primarily governed by the Italian Industrial Property Code (Legislative Decree 30/2005) (IPC), which sets forth the rules that govern patents, including the principles that govern their validity and the ways in which they may be infringed.

Jurisdiction and competent courts

Jurisdiction over intellectual property matters lies with specialist sections within the ordinary civil courts that handle business matters, referred to in English as business courts.

Such sections are present in each of Italy’s regional capitals, with the exception of Lombardy, Trentino-Alto Adige and Sicily, which each have two branches, and the Valle d’Aosta, for which jurisdiction lies with the Court of Turin. Thus, there is a total of 22 courts.

The question of the proper venue is determined by the defendant’s place of residence or domicile, or alternatively by the location in which the alleged infringing activity took place.

If one of the litigants is not resident in Italy, then jurisdiction must lie with one of 11 specialist courts, namely the courts of Bari, Bolzano, Cagliari, Catania, Genoa, Milan, Naples, Rome, Trento, Turin or Venice.

Appeals of first instance judgments by the business courts are heard by the courts of appeal, which have their own dedicated business sections. Decisions on patents can be appealed under the general rules laid down in the Italian Code of Civil Procedure (ICCP), and no special rules apply.

The third and final instance for intellectual property matters is the Court of Cassation, where decisions are limited to questions of law.

Any dispute regarding a European patent that has unitary effect (a unitary patent) must be heard exclusively by the Unified Patent Court, which has three central divisions that are based in Milan, Munich and Paris. The court also has local divisions in several member countries. The local Italian division of the court is also based in Milan.

For seven years from 1 June 2023, the date on which the Unified Patent Court became active, holders of European patents or European patent applications may formally request to opt out of the regime and exclude their patent (or application) from the jurisdiction of the Unified Patent Court, provided there are no proceedings pending before the court concerning the patent in question. Non-unitary European patents continue to be governed by the terms of the European Patent Convention and the national laws of the individual contracting states, meaning that jurisdiction over those patents will continue to lie with the national courts of each state where the patent is valid.

Since July 2020, the WIPO Arbitration and Mediation Centre has had a memorandum of understanding in place with the Milan Chamber of Arbitration (CAM) for the promotion of mediation in international disputes regarding intellectual property and technology.

Types of patent disputes

Patent infringement

Generally, the scope of protection for a patent is determined by its claims (and with respect to interpretation, the assessment may include the description and the drawings).

Patent infringement may be literal or ‘under the doctrine of equivalents’. There are a number of different approaches to evaluating equivalence (the most common being the triple identity test approach; others include ‘invention as a whole’ approach and the ‘element by element’ approach).

Third parties can file preliminary proceedings, or substantive proceedings, to obtain a declaration of non-infringement from the court, confirming that their activities have not infringed a patent. Such an action, however, requires the third party to have a valid legal interest to protect.

Patent validity

Under Italy’s laws and procedures, claims seeking the revocation or cancellation of a patent and claims asserting infringement may be heard in a single set of proceedings.

A defendant may bring a counterclaim (in which revocation commonly features), as may any third party with a legal interest. A public prosecutor may also bring an action seeking to have an existing patent declared invalid or revoked. Such actions may be brought on a variety of grounds, such as lack of novelty, lack of inventive step or insufficiency of disclosure.

A patent owner can always limit the scope of the patent’s protection at any point in proceedings. Nonetheless, fair conduct would suggest that this should not be at the very end of proceedings, and there are stricter courts that, for example, do not allow more than one application for a limitation of scope.

Additional disputes

Additional disputes concern licences or similar agreements that often include know-how within their scope.

It is not uncommon to find contracts that contain arbitration clauses, which is why, although small in number, arbitration procedures regarding patent matters are becoming more common, especially in relation to contractual matters.

Types of proceedings

Protection is most commonly sought through the civil courts via preliminary actions and substantive actions on the merits.

In some cases, an infringement may be the subject of a complaint submitted to the public prosecutor’s office, local police stations or the Italian Revenue Police, where the infringement has criminal implications.

To try and prevent the entry of infringing goods into Italian territory from a country outside the European Union, customs authorities may be requested to monitor the incoming goods (in accordance with Regulation (EU) No. 608/2013) for one year, and further extensions may be sought.

The Italian Patent and Trademark office (UIBM) does not provide any administrative procedures for the opposition, revocation or nullity of patents.

In Italy, there are no strict prerequisites for an application to file a patent infringement claims.

Patents can be enforced during the period following publication of the patent application (18 months from the filing date). The law only requires that the patent be granted prior to the court’s final decision on the merits. Accordingly, preliminary measures may be adopted without having to wait out the final grant (which may take several years), on the basis of the patent application alone.

There is no need to send a cease-and-desist letter.

Sending such letters can sometimes mean that you lose the advantage of surprise, especially if an evidence preservation order is being sought in the run-up to litigation. On the other hand, commencing an action without prior notice to the other litigation may not sit well with the court, as correspondence may sometimes work to favour settlement, reducing the courts’ workload and providing more expedited justice.

Preliminary measures

The practice of Italian civil litigation is dominated by the use of preliminary measures, frequently starting with evidence preservation orders that are similar to the French saisie-contrefaçon.

Italian evidence preservation orders are typically granted and executed ex parte (ie, without requiring that all of the parties to the dispute, not least the defendant, be present) by a court bailiff who is assisted by a court-appointed expert and accompanied by counsel (which term may include any technical expert adviser) to the party bringing the claim.

The other typical measure is the preliminary injunction (PI).

Two key conditions must be fulfilled for an evidence preservation order, or a PI, to be granted:

• There must be fumus boni iuris, meaning it must be shown that: there is a likelihood of infringement; and the IP right is valid (this requirement is in general the subject of a mere presumption). Regarding demonstration of a likelihood of infringement, full evidence is not required, but arguments (based on the evidence available at the time of the claim) must be submitted that persuade the court that the alleged infringement is at least likely to have taken place. In certain cases, the Italian courts are usually inclined to grant the evidence preservation order (but not generally a PI) on the basis of the applicant’s allegations and the findings of a technical report unless they believe that the application represents a fishing expedition.
• There must be periculum in mora, which means the applicant must show that the delay that would occur in the course of ordinary litigation would result in an ‘irretrievable loss’. This requirement is generally given for granted in patent infringement cases, provided that the infringement is ongoing.

Preliminary proceedings allow a patent owner to obtain a swift decision from the courts, within six to nine months on average, including any appeal stage.

The proceedings are very flexible and, following the filing of the application and the defence, they typically comprise: an initial hearing to establish whether the urgency is justified; a technical stage on the patent’s validity and the infringement; and a final hearing that addresses both technical and legal aspects.

In addition to a preliminary injunction, other interim measures may include: seizure of the infringing goods; astreinte, which compels performance of an unperformed obligation; and market recalls.

Remedies in infringement actions

A substantive judgment on the merits that finds infringement will usually include remedies such as permanent injunctions, market recalls, astreinte and the assignment or destruction of the infringing goods.

For the assessment of awards of damages or for the return of profits, the courts usually open a further stage that is dedicated to the determination of damages by an accounting expert.

The main proceedings may be expected to last roughly three years in Italy. Reforms to Italian civil procedure introduced in 2023 have sought to simplify and abbreviate the process by restricting it to the following stages:

• first hearing;
• appointment of the court-appointed technical expert;
• discussion of the results of the expert’s findings; and
• a final hearing.

The award of damages is based on loss of profits of the patent holder, calculation of which usually takes as its starting point the royalties that the infringer would have paid to the patent holder for a licence (amounts that on occasion are increased or even doubled), up to the patent holder’s actual loss of profits as a result of the presence of the infringing products in the market.

In any event, the patent holder may request that it be paid the profits that the infringer made, and that may be awarded either in conjunction with or in the alternative to the lost profits, but only to the extent that amount exceeds the damages otherwise awarded.

Burden of proof, evidence and expert witnesses

In Italy, the burden of proof concerning the invalidity of a patent rests with the party contesting the validity, while the burden of proving infringement lies with the claimant.

In proceedings before the court, the evidence will typically include:

• the production of documents;
• the appearance of witnesses;
• expert opinions from expert witnesses instructed by the parties.

Often, much of the outcome in Italian patent litigation will revolve around the technical opinion of the court’s appointed expert.

The court appoints one expert adviser (and sometimes more than one) who is required to advise upon technical matters that usually cover both validity and infringement, and the parties’ own experts liaise with the court’s expert under an adversarial process at the offices of the court’s expert, or by videoconference.

The result is a draft opinion from the court’s experts, which is delivered to the parties and upon which they have the right to comment.

The court will often concur with the conclusions of its appointed expert, but it is not bound to do so and may reach its own conclusions.

Italian law makes allowance for discovery-like measures. In particular, where a party that has presented reasonably available evidence sufficient to support its claims and, in substantiating those claims, has identified evidence that lies in the control of the counterparty or a third party, the court may order the production of that evidence, with due consideration for the protection of confidential information. The court may also order the disclosure of banking, financial or commercial documents in the counterparty’s possession, again subject to the protection of confidential information.

A court will also typically at the remedies stage appoint an expert accountant who must, following an adversarial process involving both parties’ counsel, present a proposed quantum for the award.

Appeal and Supreme Court review

The losing party in a patent case has the right to appeal the decision. Appeals are generally resolved within two years, though matters involving urgent petitions are prioritised and may be adjudicated in a matter of months.

Beyond the second instance, parties can seek a further appeal to the Court of Cassation. The Court of Cassation, however, does not re-evaluate factual determinations but limits its review to points of law or procedural irregularities that may have affected the outcome of the case.

Mediation and arbitration as alternatives

While litigation remains the most common path for enforcing patent rights in Italy, mediation and arbitration are increasingly seen as viable alternatives. Historically, these methods were underutilised in Italy. However, recent legislative changes aimed at reducing the overall time frame for civil lawsuits have incentivised their use. Among the incentives are tax exemptions for parties that opt for mediation, along with fiscal benefits and tax credits on attorneys’ fees if an agreement is reached through these methods.

Mediation can be initiated either before or during a lawsuit. It involves a neutral third party who facilitates negotiations between the patent holder and the alleged infringer in an attempt to reach a settlement. Successful mediation can significantly reduce litigation costs and expedite dispute resolution.

Arbitration is another formal alternative, wherein a panel of experts, typically chosen by the parties, renders a binding decision. Arbitration is especially advantageous in patent cases involving complex technical matters that require specialised expertise. Although arbitration is not as widely used in patent disputes in Italy as in other jurisdictions, it is becoming more attractive, particularly in cases that require swifter resolution or where confidentiality is a priority.

Consideration of precedents and foreign judgments

Italian courts are not bound by precedent as they are in common law jurisdictions. However, courts may consider previous decisions, particularly if they originate from the same court or involve similar legal issues. When adjudicating patent cases, Italian judges frequently refer to previous rulings by specialist IP courts, especially in complex cases involving any highly technical subject matter.

Regarding foreign judgments, foreign rulings can be used as defence arguments, especially when addressing patent validity, given the interconnected nature of the European patent system.

Litigation costs and recovery of legal fees

Successful litigants, including successful defendants, have the right to recover legal costs and attorneys’ fees, as determined by the judge based on rates outlined in specific legislation. It is difficult to recover all the actual expenses, including the attorneys’ fees actually paid. This is, for example, a reason to consider arbitration as an alternative means of dispute resolution.

Although not common, if the patent holder is found to have acted with gross negligence or in bad faith (eg, conscious that the patent was invalid or that the alleged infringement did not in fact occur), successful defendants are entitled to seek compensation for damages.

Conclusion

The Italian system proves to be very efficient for patent enforcement and, especially due to the grant of evidence preservation order and the speed of the interlocutory processes, it can be very useful for defending patent.

The presence of a Unitary Patent Court office in Milan makes Italy a country deserving of consideration in any strategy for protecting a patent portfolio.