The Content of the New Paragraph 1-bis

The proposal expressly includes data, algorithms and mathematical methods used for training AI systems among the business information and technical-industrial know-how that may qualify as trade secrets, provided that the traditional requirements of secrecy, economic value and reasonable protection measures are met.

Scope of the Provision: Inclusion and Definition

The amendment operates on two complementary levels. First, it expressly clarifies that AI-related assets may fall within the scope of trade secret protection. Secondly, it provides a definition of algorithms and mathematical methods, including model architectures, optimisation functions, training procedures and configurations, as well as any other technical-computational element functional to the development of AI systems.

A Clarification Rather than a New Intellectual Property Right

The amendment does not create a new intellectual property right over AI models, nor does it alter the existing requirements for trade secret protection. Rather, it provides legal certainty by confirming that AI assets may benefit from the existing trade secret regime.

Objective Limits of Protection

Protection remains conditional upon the fulfilment of the requirements set out in Article 98. Consequently, publicly available model weights, openly accessible datasets, and generally known architectures or optimisation functions will not automatically qualify for protection.

Why Trade Secrets Rather than Copyright?

The legislative choice reflects the difficulties of relying on copyright law to protect AI assets. Copyright remains tied to human authorship and individual creative contribution, whereas many AI-related assets derive their value primarily from investment, data collection, engineering effort and technical development rather than creative expression.

From this perspective, trade secret protection appears better suited to preserving the economic value of large-scale AI investments through an objective and technology-neutral legal framework.

Procedural Aspects: The Specialised Business Courts

Disputes concerning training datasets, algorithms and model weights benefiting from trade secret protection would fall within the jurisdiction of the Italian Specialised Business Courts, ensuring continuity with existing case law on trade secrets and confidential business information.

Critical Perspectives: The Transparency Challenge

The proposal is not immune from criticism. Some commentators argue that recognising AI data, architectures and parameters as potential trade secrets may increase opacity at a time when both EU and national legislation are moving towards greater transparency and explainability requirements.

However, a distinction must be drawn between the explanation of a specific automated decision and disclosure of the underlying model. The former concerns the intelligibility of a decision affecting an individual, whereas the latter concerns access to datasets, model weights, architectures and training configurations. These are distinct legal and technical issues.

A more delicate tension may arise where verification of an AI system requires access to training data or the model itself in order to investigate bias, discrimination or malfunction. In such circumstances, trade secret protection may operate not as a barrier to explanation, but as a limitation on full inspection of the system.

Conclusion

By expressly recognising the potential trade secret protection of AI assets, the proposed amendment provides businesses with valuable guidance for structuring research and development investments and designing protection strategies. It confirms a clear policy choice in favour of an objective form of protection based on secrecy rather than a creativity-based model centred on authorship. The effectiveness of this choice will ultimately depend on how courts and regulators balance innovation, legal certainty, transparency and accountability in the AI ecosystem.

For more information, please visit our Intellectual Property and Digital and Data practice areas.

1. Background: the C-132/25 judgment

The case arose from a preliminary injunction issued by the Court of Rome prohibiting the use of the sign “Mò Mò Pizza, Sapori e Salute”, deemed to interfere with the trademark “Mò Mò”. No proceedings on the merits were subsequently commenced, and the Italian Supreme Court referred the matter to the CJEU.

The Court held that the “anticipatory” nature of a measure does not remove it from the scope of the European rules governing provisional measures. Even an injunction capable of producing effects similar to those of a final judgment remains a provisional measure and must therefore be accompanied by the safeguards provided by Directive 2004/48/EC (the Enforcement Directive), including the defendant’s right to seek revocation or termination of the measure where the claimant fails to pursue the substantive proceedings. Accordingly, the exemption from the obligation to commence proceedings on the merits contained in Article 132(4) of the Italian Industrial Property Code was found to be incompatible with Article 9(5) of the Directive.

2. Legislative intervention: Decree-Law No. 100/2026

Through the first three paragraphs of Article 2, the Decree-Law amends Article 132(4) of the Industrial Property Code and Article 162-bis(4) of the Copyright Act, while also introducing transitional provisions.

Under the new regime, preliminary measures capable of anticipating the effects of a judgment on the merits in intellectual property matters may be declared ineffective where proceedings on the merits are not commenced within the statutory time limit or, after commencement, are subsequently discontinued. Such declaration may be issued upon application by the party subject to the measure, provided the application is filed within thirty days from either the expiry of the deadline for commencing proceedings on the merits or the termination of those proceedings.

3. Transitional provisions

The transitional regime applies to anticipatory preliminary measures already in force on 12 June 2026, the date on which the Decree-Law entered into force, and therefore governed by the previous wording of Article 132(4) of the Industrial Property Code or Article 162-bis(4) of the Copyright Act.

Parties subject to such measures may seek their revocation or a declaration of ineffectiveness, under the procedure set out in Article 669-novies of the Italian Code of Civil Procedure, within sixty days from the entry into force of the Decree-Law. Failure to act within that period results in forfeiture of the right to challenge the measure.

The Decree-Law further provides that, where such an application is filed, the party benefiting from the measure may request reinstatement of the deadline for commencing proceedings on the merits.

4. Assessment: balancing compliance and stability

The legislative reform aligns Italian law with the principle established by the CJEU, namely that the failure to commence proceedings on the merits must render anticipatory preliminary measures in industrial property matters ineffective, upon request of the affected party.

At the same time, ineffectiveness is not automatic. It depends on the filing of a specific application within a strict time limit. In practice, this preserves the stability of existing preliminary measures in situations where neither party has a genuine interest in pursuing substantive litigation. The legislature has therefore implemented the European judgment without causing the automatic collapse of injunctions already granted, consistently with the CJEU’s own reasoning, which links the termination of the measure to an initiative taken by the defendant.

5. Conditional stability of IP preliminary measures

The reform does not eliminate the stability traditionally associated with anticipatory injunctions in industrial property disputes; rather, it changes its legal basis. The new Article 132(4) establishes a form of “conditional stability”. The preliminary measure continues to produce effects even where proceedings on the merits are not commenced, but it becomes vulnerable to a declaration of ineffectiveness upon application by the party subject to it.

The defining feature of the new regime is that ineffectiveness is not automatic. Failure to commence proceedings on the merits, or their subsequent discontinuance, does not by itself terminate the measure. A specific application must be filed within thirty days. If no such application is made, the injunction remains fully effective.

From a systemic perspective, the legislature has attempted to reconcile the requirements of the CJEU judgment with the traditional function of industrial property injunctions, which often resolve the dispute in practical terms. The new rules preserve the effectiveness of interim protection while ensuring that defendants are not indefinitely bound by measures that are never tested in substantive proceedings.

6. Practical implications

For holders of existing injunctions

The transitional regime does not grant beneficiaries of existing measures an independent opportunity to commence proceedings on the merits. Their only route to substantive proceedings is through a request for reinstatement, which may be filed only if the opposing party first challenges the measure. The practical approach is therefore reactive rather than proactive.

If the party subject to the injunction allows the sixty-day challenge period to expire, the injunction effectively becomes permanently stabilized without any need for proceedings on the merits. If, however, a challenge is brought, the beneficiary should promptly seek reinstatement and commence substantive proceedings.

Where the injunction has already exhausted its practical commercial impact and no residual economic interests remain, it is likely that the affected party will refrain from acting, allowing the measure to become definitively consolidated through the passage of time.

For newly issued injunctions

For measures granted after the entry into force of the Decree-Law, the situation is reversed. To preserve the effectiveness of an anticipatory injunction, the beneficiary must commence proceedings on the merits within the statutory deadline. Failure to do so exposes the measure to a declaration of ineffectiveness upon application by the affected party. In such cases, the timely commencement of substantive proceedings once again becomes the preferred strategy.

For parties subject to injunctions

The Decree-Law clearly defines both the timing and procedural requirements for challenging injunctions, including a strict forfeiture period for existing measures. Parties affected by such injunctions should therefore promptly review their position and take action where appropriate.

7. Conclusions and next steps

The Decree-Law must now be submitted to Parliament for conversion into law. Further amendments remain possible during the legislative process, including potentially significant changes to the final structure of the regime and, in particular, to the transitional provisions applicable to measures already in force. Close monitoring of the parliamentary process is therefore advisable.

Yesterday, the European Commission published the final version of the Code of Conduct on the marking and labelling of AI-generated content, a strategic tool within the European regulatory framework for AI. The Code represents the operational response to the transparency obligations set out in Article 50 of the AI Act, which will come into force on 2 August 2026.

The AI Act, moreover, has identified transparency as one of the most urgent systemic risks to be addressed. When machine-generated content is indistinguishable from human-generated content — journalistic texts, deepfake videos, synthetic voices — it creates fertile ground for disinformation, the manipulation of public opinion and a loss of trust in the information ecosystem. Consider, for example, an apparently authentic video of a political leader circulated during an election campaign, a voice recording used to impersonate a company executive and authorise a bank transfer, or images of events that never took place circulating on social media during crisis situations. In all these cases, the ability to identify the artificial origin of the content plays an essential role in preserving user trust.

The Code of Conduct is the practical tool through which the Commission seeks to translate these regulatory principles into concrete actions.

What the Code provides for: obligations and target audience

The Code is voluntary in nature, but carries significant legal weight: companies that sign up to it will be able to rely on shared standards to more easily demonstrate compliance with the obligations set out in the AI Act in the areas covered by the Code itself. This mechanism makes it particularly attractive to industry.

There are two target groups.

Providers, i.e. those who develop (generative) AI systems. They are under an obligation to ensure that the content produced (audio, images, video, text) is marked in a machine-readable format and detectable as artificially generated or manipulated. The technical solutions adopted must be effective, interoperable, robust and reliable, in line with the state of the art and implementation costs.

Deployers, i.e. those who make generative AI systems available to end users. They are subject to disclosure obligations in two specific cases:

• Deepfakes: audio, image or video content depicting real people, objects, places or events in such a way as to appear authentic, but which is not. In practical terms, this category would include a video showing a person making statements they have never actually made.
• Texts of public interest: articles, press releases or publications generated by AI on matters of public relevance, unless they have undergone a process of human review with editorial responsibility. The most obvious example is an article generated by an AI system commenting on election results, health measures or government decisions. Conversely, a text that has undergone substantial human review and been published under the editorial responsibility of a journalist or editorial team could benefit from the exception provided for in the AI Act.

There is also a requirement to inform users when they interact with an interactive AI system, such as a chatbot or a virtual assistant.

The process: how the Code was developed

The Code is the result of a participatory process launched in September 2025 by the AI Office, involving a public consultation and a call for expressions of interest. The process involved two thematic working groups (one for providers and one for deployers), led by independent chairs and vice-chairs, and included a wide range of stakeholders: developers of detection technologies, trade associations, civil society organisations, academics and major online platforms.

Over seven months — from November 2025 to June 2026 — three interim drafts were produced and put out for consultation before the final version was finalised. In parallel, the Commission published interpretative guidelines to clarify the scope of regulatory obligations and cover aspects not addressed by the Code.

Practical implications: what changes for businesses and users

For technology companies, signing up to the Code means adopting technical standards for content labelling and traceability, such as digital watermarking, signed metadata and provenance standards such as C2PA, as well as implementing appropriate disclosure systems for end users.

For example, an image generated by an AI model could contain metadata that allows platforms and verification tools to automatically identify its artificial origin, even if the label visible to the user has been removed.

Companies that do not sign up will still have to comply with the obligations of the AI Act from 2 August 2026, but without the benefit of being able to refer to the shared standards identified by the Code.

For the public, the expected impact is significant: deepfakes and AI-generated texts on matters of public interest will have to be clearly identified, making it easier to recognise when one is dealing with synthetic content.

The question of technical feasibility remains open. Watermarks and metadata can be removed or altered, and the detection of synthetic content in distributed environments still poses a significant technological challenge. The Code itself acknowledges this limitation, requiring the adoption of ‘technically feasible’ solutions in light of the state of the art.

Outlook: a model for the rest of the world?

The European initiative comes at a time of intense global regulatory competition over artificial intelligence. Whilst the United States is proceeding with a more fragmented approach and China has adopted specific rules on synthetic content, the European Union aims to build a model based on transparency and the accountability of operators.

A scenario that is far from unlikely is one in which a global platform chooses to apply European labelling standards to all users, rather than developing different systems for each national market. This is a phenomenon already observed in the past with European data protection legislation.

The challenge will be to maintain a balance between transparency and innovation, ensuring that excessive compliance burdens do not put European businesses at a disadvantage compared to their global competitors. The Code of Conduct on represents a significant attempt to strike this balance, with August 2026 serving as the first real-world test.

The dispute

The proceedings originated from a claim brought by Unidis Jolly Film S.r.l. – the owner of the copyright in the film “A Fistful of Dollars” – against the film production and distribution company Paramount Pictures Corporation and other defendants (including composer Hans Florian Zimmer, directors Gregor John Verbinski and James Ward Byrkit, and screenwriter John David Logan), alleging unauthorised exploitation, in the animated feature film “Rango”, of the character known as “The Man with No Name”.

In support of its claims, the claimant argued that “The Man with No Name”, the protagonist of the well-known western trilogy directed by Sergio Leone and portrayed by Clint Eastwood, was eligible for independent copyright protection pursuant to Article 1(1) of the Copyright Act, and that this character had been reproduced, without licence or authorisation, in the character of the “Spirit of the West” in “Rango”, produced by Paramount.

On this basis, Unidis maintained that the character had been unlawfully used in “Rango” and sought a declaration that the defendants had infringed its copyright through plagiarism. It further sought a declaration of unfair competition and damages for the unauthorised exploitation of the character. In the alternative, it argued that the use did not fall within the statutory exception for lawful quotation under Article 70 of the Copyright Act and, in a further alternative plea, relied on unjust enrichment.

The decisions on the merits

The Court of Rome dismissed all of Unidis’ claims, finding no plagiarism in respect of “The Man with No Name”. According to the first-instance court, the reference in “Rango” was to the actor Clint Eastwood himself – whose physical features and personality traits were reproduced – rather than to the character claimed by the plaintiff.

By judgment of 31 August 2022, the Court of Appeal of Rome dismissed the appeal filed by Unidis, upholding the reasoning of the first-instance court. In particular, it observed that “Rango” did not evoke “The Man with No Name” as such, but rather the figure of Clint Eastwood, evoked by references to his physical features and to the characteristics that have shaped his image in the popular imagination.

The appellate court further held that it was not possible to draw a clear distinction between the character and the actor who portrayed him, since the very identity of “The Man with No Name” was inextricably bound to Eastwood’s screen presence and performance. It also considered that the character lacked the requisite level of originality for copyright protection, being no more than a reworking of narrative and visual archetypes deeply rooted in the western tradition, without having developed a distinct creative identity over time.

Finally, the Court of Appeal observed that, even leaving aside the issue of protectability, the reference contained in “Rango”could in any event be regarded as a lawful quotation under Article 70 of the Copyright Act, given the absence of any commercial exploitation competing with that of the copyright holder.

The appeal before the Supreme Court

Unidis filed an appeal to the Supreme Court against the Court of Appeal’s decision, raising six distinct grounds of appeal. The challenges were primarily focused on the finding that “The Man with No Name” was not eligible for copyright protection, and the consequent exclusion of plagiarism. The appellant also contested the interpretation of Article 1 of the Copyright Act upheld by the lower court, arguing that the Court of Appeal had implicitly introduced a requirement of separability between the character and the actor portraying it as a precondition for copyright protection.

The Supreme Court’s decision

The Supreme Court dismissed the appeal in its entirety, holding that the grounds of appeal were partly inadmissible and partly unfounded.

Reaffirming its settled case law, the Court recalled that the protection of a character constitutes an autonomous form of protection, distinct from that afforded to the work in which the character appears. The decisive factor is not the fame of the work, but rather the degree of characterisation, which must display sufficiently original and recognisable traits to qualify as an independent intellectual creation.

On this basis, the Court upheld the lower courts’ assessment that “The Man with No Name” does not possess a degree of distinctiveness sufficient to distinguish it meaningfully from traditional western archetypes. The figure of the solitary, taciturn gunslinger was considered a reworking of narrative models already well established in the genre, lacking the requisite creative contribution necessary for copyright protection.

It is precisely this lack of sufficient characterisation that gives rise to the most significant aspect of the decision. According to the Supreme Court, the character’s identity has become inextricably associated with that of Clint Eastwood, who portrayed it across several films and played a decisive role in its public success. In such circumstances, a subsequent reference may ultimately evoke not the character as a protected intellectual creation, but rather the actor and the public image associated with him.

From this perspective, the Court excluded any finding of plagiarism. Any evocation in “Rango” was held to refer to Clint Eastwood, rather than to a character endowed with distinct creative identity.

As to the Court of Appeal’s reference to the lawful quotation exception, the related ground of appeal was declared inadmissible for lack of interest. According to the Supreme Court, that reasoning was merely ancillary to the principal ratio decidendi, namely the finding that the character was not entitled to copyright protection. In light of that conclusion, any further issue concerning Article 70 of the Copyright Act was irrelevant to the outcome of the dispute.

Concluding remarks

Italian Supreme Court case law has long recognised that a fictional film character may enjoy autonomous copyright protection, independently of the work in which it is embodied. Such protection, however, requires that the character display sufficiently original and distinctive characteristics to qualify it as an independent intellectual creation, rather than a mere reiteration of figures already belonging to the narrative tradition of a given genre.

The case of “The Man with No Name” highlights the limits of this principle. According to the Court, the character does not display a sufficient degree of characterisation to distinguish it meaningfully from traditional western archetypes. Moreover, its fame is closely linked to Clint Eastwood’s performance, to the extent that, in the public imagination, character and actor tend to overlap.

This is where the most interesting aspect of the decision lies. The Supreme Court clarified that the identification of the character with the performer does not constitute an additional requirement for copyright protection. Rather, it is the consequence of the absence of genuinely autonomous creative elements. When the public perceives a character primarily through the face, style and personality of the actor who portrays it, it becomes difficult to distinguish the fictional creation from the real-life performer.

In such circumstances, a subsequent reference may relate not to the character as such, but to the image of the actor who made it famous. The decision therefore draws a clear boundary: copyright law cannot be invoked to extend protection to characters that, rather than embodying an autonomous creative identity, are perceived by the public as inseparable from the actor who brought them to prominence.

The Digital Omnibus — the legislative package through which Brussels is streamlining the EU’s digital rules — has been moving in the same direction for years: more sharing, more portability, fewer silos. A legitimate objective, but one with a side effect that many companies have not yet fully grasped: every data-sharing obligation creates an additional window through which know-how that has not been — or cannot be — patented may escape.

The package includes two main texts: one amending existing rules on data, cybersecurity, and privacy (the “digital acquis”), still under negotiation; and another concerning artificial intelligence, for which a provisional political agreement was reached on 7 May 2026. The dates of official publication remain subject to completion of the formal process.

What changes in practice

The most relevant amendments to the digital acquis for those handling sensitive information include:

– Public data and large operators. Public administrations may impose special conditions on Very Large Enterprises and DMA gatekeepers reusing public-sector data, in order to prevent privileged access to data from reinforcing already dominant positions.

– Data intermediaries. The mandatory regime under the Data Governance Act would become voluntary, with lighter separation requirements. More actors in the chain means more points of contact.

– Cloud switching. Simplified regimes for certain categories, but with explicit safeguards regarding trade secrets and risks of exposure to third-country jurisdictions.

– Smart contracts for data sharing. The essential requirements under Article 36 of the Data Act would be removed: fewer technical constraints, greater reliance on contractual governance.

The starting point: the Data Act

Already applicable since 12 September 2025, the Data Act grants users of connected devices the right to have their data shared with third parties. For manufacturers, this exposes a delicate perimeter: the data may contain operational logic, configuration parameters, performance information — everything that makes up know-how without ever having been labelled as such. Moreover, the Data Act disapplies the sui generis protection of databases in this context, shifting the burden of protection onto trade secrets.

Consider a practical example. A manufacturer of connected industrial equipment receives a request from a customer to share 18 months of operational logs with an independent maintenance provider that directly competes with its after-sales service. Those logs contain calibration parameters and control sequences developed over years of R&D and never patented. The Data Act does not allow for a blanket refusal, but it does permit the manufacturer to require proportionate technical measures before sharing the data (Article 4(6)): NDAs with anti-reverse-engineering clauses, sensitive data disclosed only in aggregated form, and contractual prohibitions on using the data to develop competing services (Article 6(2)(e)). If the third party refuses those measures, the manufacturer may block the sharing, but must provide written reasons and notify the competent authority. These two steps are not optional: they are the formal conditions for a lawful refusal.

The Regulation also provides for the possibility of refusing disclosure where sharing would make serious economic harm highly likely. The threshold is high, and the practical problem is that the harm must be demonstrated before the disclosure occurs, based on data that has not yet left the company. Those who have not documented the value of their trade secrets will find themselves without arguments when they are most needed.

The Digital Omnibus novelty: the jurisdictional factor

If approved in its proposed form, the amendment to the Data Act would introduce a new basis for refusing disclosure: the risk of unlawful acquisition by entities operating in third countries with insufficient safeguards — or with formally equivalent safeguards lacking effective enforcement.

This represents a concrete shift in perspective. Today, many leaks do not originate from cyberattacks or disloyal employees: they arise because data lawfully shared reaches a legitimate recipient operating in a jurisdiction where a local authority may require disclosure — and where obtaining an injunction is slow or impossible. The secret is lost because of a structural systemic issue, not because of malicious intent. The proposal seeks to turn this asymmetry into a legal lever: refusal is legitimate, but it must be justified in writing and notified to the competent authority.

Five things to do now

– Map data from a competitive standpoint. Not for GDPR purposes: which datasets, if analysed, reveal proprietary processes or logic? Which fall within the scope of the Data Act?

– Build a trade secret registry. A trade secret exists if it is not generally known, has economic value because it is secret, and is protected through reasonable measures. NDAs, access controls, audit logs, internal policies: everything documented and updated.

– Structure responses to data-sharing requests. What is needed is a process, not a case-by-case assessment. Clear criteria are required regarding when to refuse disclosure, how to justify the refusal, and how to notify it.

– Conduct a jurisdictional assessment of data flows. Who receives the data? Where do they operate? Where are their subcontractors located? What is the actual level of enforcement in those jurisdictions?

– Monitor the legislative process. The Digital Omnibus for the digital acquis will evolve. Those working with sensitive data need to know how, and when.

The direction of the Digital Omnibus will not change: more circulation, more portability. But companies that have built their competitive advantage on data and unpatented processes cannot wait for the legislation to stabilise. The trade secret that survives is the one already structured as such before someone asks for it to be shared.

The problem

Over time, thousands of Italian companies have built their ESG communications around “self-produced” sustainability labels and logos: names registered as European or national trademarks, “green” pictograms, product labels with environmental claims – all created and managed by the company itself without the involvement of a third-party verifier. These are the so-called “self-declared” labels.

From 27 September 2026, their continued use in commercial communications is seriously at risk.

What the new legislation says

Legislative Decree No. 30 of 20 February 2026, transposing Directive (EU) 2024/825 ("Empowering Consumers for the Green Transition"), introduces into the Consumer Code a particularly strict ban on the use of sustainability labels or marks not based on independent and transparent certification schemes, or not approved by recognised public authorities.

The legislation is unequivocal on a point that many businesses tend to underestimate: registration as a trade mark with the EUIPO or the UIBM does not equate to sustainability certification. The registered trade mark enjoys protection as a distinctive sign, not as a certification of the environmental qualities it conveys. These are two entirely distinct legal matters.

A self-declared sustainability trademark, however duly registered and however long it has been on the market, may therefore be classified as a prohibited commercial practice under the Consumer Code, regardless of the company’s subjective intention.

Individual, collective and certification marks: a distinction that matters

The Industrial Property Code distinguishes between individual trademarks, collective trademarks and certification marks. In practice, however, the vast majority of ESG environmental trademarks are registered as individual trademarks, the category that is structurally most exposed, as it does not involve any third-party verifier. The certification mark, entrusted by law to an independent body and accompanied by rules of use, is the model that most closely meets the requirements of the new legislation, but only if the rules provide for scientifically sound criteria and audits by accredited bodies. The collective mark occupies an intermediate position that requires a case-by-case assessment.

Requirements for approved certification schemes

For a sustainability label to continue to be used legitimately in commercial communications, the underlying system must cumulatively meet requirements of independence, transparency and verifiability, including:

• objective, scientifically sound and publicly accessible criteria;

• management by a third party independent of the beneficiary company;

• periodic audits and verifications by accredited bodies;

• a complaints mechanism accessible to third parties;

• regular updating of the criteria in light of scientific and technical progress.

These elements reflect the structure of the certification systems referred to in the Directive and in European regulations on sustainability labels and certification schemes.

It is not sufficient to entrust the verification to a formally external body: it is the overall structure of the system that must be compliant.

Options for businesses

Companies holding self-declared labels essentially have two options:

1. Establishing their own compliant certification system The label is retained but linked to a bespoke independent verification system, involving an accredited body (Bureau Veritas, DNV, TÜV, SGS or equivalent). This is the solution that preserves brand value, but typically requires 6–12 months of implementation— s incompatible with the 27 September 2026 deadline for those who have not already started the process—as well as entailing potentially significant implementation and maintenance costs.

2. Withdraw the mark and migrate to an existing certified system For businesses that are not yet in a position to meet the requirements, the precautionary suspension of the mark pending completion of the compliance process is strongly recommended.

Reviewing B2C and B2B contracts: an often-overlooked step

Risk exposure is not limited to commercial communications. In B2C relationships, general terms and conditions of sale and product sheets often refer to the product’s environmental characteristics: if based on a self-declared label that is non-compliant, they expose the company to consumer claims as well as AGCM proceedings. In B2B relationships, supply and distribution contracts frequently contain representations and warranties regarding regulatory compliance, the breach of which may trigger indemnity or termination clauses; similarly, tender specifications with ESG clauses impose certification standards on suppliers, the failure to meet which constitutes a breach of contract. The review of active contracts is therefore an integral — and not merely ancillary — part of ESG due diligence.

Time is running out: ESG due diligence can no longer be postponed

Implementing corrective measures typically requires 1–2 months of structured work. Those who have not yet initiated a systematic review of their environmental brands and claims now face a real risk, given that the 27 September 2026 deadline allows for no extensions.

Targeted ESG due diligence must cover: mapping all environmental trademarks and claims used in communications; verifying their compliance with the new requirements; assessing compliance options; identifying active contracts — B2C and B2B — containing references to environmental trademarks or claims and analysing the relevant warranty and compliance clauses; and defining a prioritised remediation plan.

The penalties for non-compliance are significant — potentially up to 4% of annual turnover generated within the European Union in cases covered by the Consumer Code — and are compounded by the reputational risk arising from the publication of the AGCM’s penalty decisions.

This Note forms part of a global suite of country-specific resources helping private practice and inhouse lawyers and attorneys navigate different jurisdictional frameworks for the transfer of IP rights as part of an asset or share purchase transaction.

Overview of Asset and Share Purchase Transactions in Italy

Corporate transactions are commonly structured as either asset or share purchases in Italy. There is no publicly available data on the most common structure, but in practice the share deal is the predominant choice. 

In a share purchase transaction, the purchaser acquires the shares or equity interests of the target company, depending on whether it is a joint-stock company (S.p.A.) or a limited liability company (S.r.l.). The parties formalise a share deal through a notarial deed of transfer, or by endorsing share certificates, which are then notarised and recorded in the shareholders' ledger. 

In an asset purchase transaction, the purchaser buys a business or a business branch, provided that the assets are organised as a business under Article 2555 of the Civil Code (Codice civile) (meaning a collection of assets that the business owner has brought together to carry out business operations). Both parties execute a notarial deed of transfer identifying the business.

Read the full document here

With decision No. 31864, the Italian Competition Authority (AGCM) addresses one of the most delicate aspects of generative AI services: managing the risk of inaccurate outputs (“hallucinations”) from a consumer protection standpoint.

Proceeding PS12968 concerns the “Le Chat” service by Mistral AI. The Authority alleged a potential infringement of Articles 20, 21 and 22 of the Consumer Code, taking the view that users were not informed in a sufficiently clear, immediate and intelligible manner about the possibility that the system could generate incorrect or misleading responses. The issue was not so much the absence of information per se — which was available in the terms of service and help centre — but rather its actual accessibility and visibility within the user experience.

The decision fits within an increasingly consolidated approach: in digital practices addressed to consumers, relevant information must be effective, not merely formal. In other words, it is not enough for a risk to be described in contractual documents if those documents are not readily accessible or do not reach the user at the moment decisions are made or the service is used.

In this context, Mistral AI offered commitments under Article 27(7) of the Consumer Code, thereby avoiding a formal finding of infringement. The commitments — deemed suitable to address the concerns — develop along four main lines: (i) inclusion of disclaimers directly within chat interfaces (“Le Chat may make mistakes. Please check responses”); (ii) strengthening and Italian localisation of the terms of service, with explicit reference to the potential unreliability of outputs and the need for verification; (iii) improved accessibility of the terms throughout the user journey (homepage, login, registration, app store, interface); and (iv) full translation of the website and help centre into Italian.

The distinctive feature of the decision is the affirmation of “contextual” transparency: users must be warned of risks not only “somewhere”, but at the time and place where those risks materialise — i.e. during interaction with the system. This marks a shift towards a compliance-by-design logic, already familiar in other regulatory domains.

The decision also has a broader systemic implication: “hallucinations” are no longer merely a technological limitation, but become a legally relevant factor in assessing the fairness of a commercial practice. A generative AI system that — even implicitly — leads users to consider its outputs as reliable may be regarded as misleading, unless accompanied by clear and appropriate warnings.

Practical takeaways

For operators developing or integrating generative AI solutions:

• disclaimers on potential errors should be embedded in the interface, not buried in terms and conditions;
• messaging must be simple, visible and immediate;
• terms of service should be easily accessible and properly localised;
• in sensitive areas (legal, medical, tax), enhanced warnings are advisable.

1. Scope of the decision: anticipatory vs. non-anticipatory measures
The judgment concerns only preliminary injunctions and, more broadly, anticipatory measures under Article 132(4) of the Italian IP Code. It does not affect the regime applicable to preservative measures.

Non-anticipatory measures (inspection and seizure). For these measures, the obligation to commence proceedings on the merits already existed prior to the judgment. Article 132(2) and (3) of the IP Code provides that, if the merits are not pursued within the peremptory time limit (20 working days or 31 calendar days), the measure automatically lapses. Judgment C-132/25 introduces no change in this respect.

Anticipatory measures (injunctions). Article 131 of the IP Code empowers courts to prohibit the continuation or repetition of an infringement. This type of measure had been exempted from the obligation to bring proceedings on the merits by Article 132(4), which left it to the parties’ discretion—rather than imposing a duty—to initiate such proceedings. It is precisely this exemption that the CJEU found incompatible with Article 9(5) of Directive 2004/48/EC.

2. The Court’s ruling
The case originated from a preliminary injunction issued by the Court of Rome prohibiting the use of the sign “Mò Mò Pizza, Sapori e Salute”, deemed to interfere with the “Mò Mò” trademark. Proceedings on the merits were never initiated. The Italian Supreme Court (Corte di Cassazione) stayed the proceedings and referred the question to the CJEU.

The Court held that the “anticipatory” nature of a measure does not remove it from the EU framework governing provisional measures. Even an injunction capable of anticipating the effects of a final judgment remains a provisional measure and, as such, must be accompanied by the safeguards set out in the Enforcement Directive. These include the defendant’s right to seek revocation or cessation of the measure if the claimant does not pursue the case on the merits.

The Court emphasized the need to strike a balance between effective enforcement of IP rights and the protection of defence rights: provisional measures must be swift and effective, but cannot become de facto final remedies in the absence of a full assessment on the merits. Considerations of procedural economy cannot override the safeguards enshrined in Articles 3 and 9 of Directive 2004/48, read in conjunction with Article 50 TRIPS and Articles 47 and 48 of the EU Charter of Fundamental Rights.

3. Retroactive effect
The possibility that the judgment affects past decisions is consistent with the CJEU’s settled case law, according to which interpretations of EU law have retroactive (ex tunc) effect: they clarify the meaning of EU provisions as they should have been understood from the outset. Consequently, incompatible national rules must be disapplied also in relation to situations arising prior to the judgment.

4. Practical guidance for existing injunctions
Importantly, the judgment does not automatically invalidate injunctions already granted. Article 9(5) of Directive 2004/48— as expressly clarified by the Court—requires an initiative by the defendant: absent an application for revocation or a declaration of ineffectiveness, the injunction continues to produce its effects.

It is also essential to note that an application for revocation does not amount to proceedings on the merits and does not trigger them. It is a request addressed to the court that issued the provisional measure, to be decided within the interim proceedings, without opening a full trial on ownership or validity of the right.

Subject to further developments in practice, a first operational assessment may be outlined depending on the specific circumstances:

• Ongoing situation: where the injunction remains practically relevant, an economic interest persists, and the defendant may be incentivised to react, the risk of a revocation application is not negligible. In such cases, commencing proceedings on the merits may be a prudent strategy to consolidate the right holder’s position and reduce uncertainty.
• No longer active situation: where the injunction has exhausted its practical effects, the defendant has complied or is no longer active in the market, and no residual economic interest appears to justify a reaction, the risk of revocation may be considered limited. In such circumstances, initiating proceedings on the merits may not be necessary.

5. Conclusions
The ruling marks a significant realignment of Italian law with the EU framework: urgency may justify immediate and incisive protection, but cannot indefinitely replace a full determination on the merits. For IP right holders, this entails greater strategic attention in managing interim litigation and, for existing injunctions still in force, a careful assessment of whether to initiate proceedings on the merits. For defendants, the judgment opens new avenues to challenge measures that have remained effective without subsequent judicial scrutiny on the merits.

It is against this backdrop that Directive (EU) 2024/825, known as "Empowering Consumers for the Green Transition", was adopted, with the aim of strengthening consumer protection against unfair commercial practices of an environmental nature. Legislative Decree No. 30 of 20 February 2026, which came into force on 24 March 2026, transposed the provisions of the Directive into Italian law, setting 27 September 2026 as the deadline by which economic operators must comply with the new requirements.

This measure has a significant impact on the Consumer Code (Codice del Consumo), introducing into Article 18(1) the definitions of key terms — including "environmental claim", "generic environmental claim", "sustainability label" and "certification schemes" — which are essential for interpreting the new provisions, which expand the scope of misleading commercial practices, misleading omissions and practices deemed misleading in all cases.

Specifically, Legislative Decree No. 30/2026 has made the following amendments:

(i) Extension of Article 21(1) of the Consumer Code. The provision introduces an explicit reference not only to the traditional characteristics of products, but also to their environmental and social characteristics and aspects of circularity, such as durability, reparability and recyclability. It follows that any practice likely to mislead the consumer on these points is classified as misleading.

(ii) New categories under Article 21(2) of the Consumer Code. The categories of "environmental claims regarding future performance without an implementation plan" (letter b-ter) and "advertising of irrelevant benefits" (letter b-quater) are introduced. Environmental claims relating to future performance that are not supported by a defined and independently verifiable plan are therefore considered misleading, as is the promotion of characteristics common to all products in the same category that are unduly presented as distinctive from an ecological perspective.

(iii) Strengthening of the rules on misleading omissions (Article 22 of the Consumer Code). The new paragraph 5-terof Article 22 of the Consumer Code provides that, in product comparison services where environmental, social or circularity-related information is provided, the following are deemed essential — with the consequence that their omission constitutes an offence: the comparison method used, the products and suppliers involved, and the measures put in place for updating the information.

(iv) Expansion of the list of practices that are misleading in all cases (Article 23 of the Consumer Code). The most significant change concerns the expansion of Article 23 of the Consumer Code, which lists commercial practices considered misleading in all cases. These include, amongst other things, the use of sustainability labels not based on recognised certifications and generic environmental claims that cannot be substantiated.

Enforcement of the legislation is entrusted to the Italian Competition and Market Authority (AGCM), which has been granted specific sanctioning powers and has always been particularly active in combating so-called greenwashing.

Conclusions

Legislative Decree No. 30/2026 marks a turning point in the regulation of corporate environmental communications, introducing specific obligations for those who make such claims. With the compliance deadline set for 27 September 2026, companies are called upon to act promptly, reviewing their communication strategies in light of the new regulatory framework.

At an operational level, it is essential that companies conduct an audit of the environmental claims currently in use, ensuring that each is supported by verifiable evidence and, where necessary, by recognised certifications. It is also essential to establish a permanent interdisciplinary task force — involving the legal, marketing, compliance and sustainability functions — responsible for the prior approval of content and the continuous monitoring of communications.

In particular, alongside Annex A – which provides a systematic summary of the relevant legislative and regulatory sources governing both substantive and procedural aspects relating to the Authority’s obligations and powers – a dedicated guide (Annex B) has also been published, which instead contains a series of FAQs aimed at clarifying the application of existing obligations on online commercial communications by influencers.

As expressly stated by the Authority, such document does not introduce any new requirements, but merely provides interpretative and operational guidance, forming part of the framework set out by the TUSMA and the IAP Digital Chart Regulation, and complementing the already adopted Guidelines and Code of Conduct.

The issue

The regulatory framework governing advertising transparency has already been established under Italian law. The critical issue lies, rather, in its practical application in a context, such as social media, which is characterised by a progressive overlap between editorial content and commercial communication.

In such a scenario, there is a risk that the disclosure obligation, although formally complied with, may be substantially circumvented, through information placed in non-immediately visible positions, ambiguous wording, or the use of the platform-native tools instead of clear and explicit communication. The aim of the FAQs is therefore to reduce such areas of uncertainty, ensuring proper compliance with the applicable rules.

Who is subject to the rules

The Annex defines as an influencer any person who creates or selects content intended for an online audience, exercising editorial control and deriving an economic or other benefit from such activity.

The status of “relevant influencer” instead applies upon reaching at least 500,000 followers (measured on the 30^th day prior to the publication of the promotional post) or 1 million average monthly views on a single platform. For such subjects, additional obligations apply, including registration in the register kept by AGCOM.

However, influencers below the threshold, although not subject to the registration obligation, remain fully bound by the rules on transparency and fairness.

Disclosure procedures

The key principle is that any content with a promotional purpose must be immediately recognisable as such.

Advertising exists whenever there is a benefit, even non-economic, linked to the visibility of a brand, product or service. This calls for clear, explicit and unambiguous wording such as “Advertisement”, “AD” or equivalent terms.

Operational procedures vary depending on the format but follow a consistent principle: the information must be perceivable without requiring action from the user.

These methods follow a consistent logic: the information must be perceivable without any action by the user. For example, in posts, the indication must appear at the beginning of the caption; in videos, both as on-screen overlay in the first scenes and in the description; in stories, on each individual piece of content; and in live streams, continuously and repeatedly.

Furthermore, where social media platform rules differ from legal rules the latter prevail, and in case of doubt the most cautious approach is adopted.

The absolute prohibitions laid down by the legislation obviously remain in force, including those relating to gambling, tobacco products and prescription-only medicines. In addition, strengthened obligations regarding the protection of minors remain in place, prohibiting any form of exploitation of their inexperience or their representation in inappropriate contexts.

Common cases

The FAQs address certain situations frequently encountered in practice. For example, gifting, consisting of the receipt of free products, requires, the indication “gifted by” or equivalent. With regard to events, a distinction must be made between participation within a promotional relationship, which requires the use of wording such as “AD” – and a simple invitation, for which “invited by” is sufficient.

Of particular interest is the clarification, also contained in the FAQs, that in the case of commissioning relationships between influencers and brands for content creation, expressions such as “in collaboration with / in partnership with” are not considered appropriate because they do not make the advertising nature clear.

The disclosure obligation also extends to content published after the event, where the brand remains identifiable.

The Annex also specifies that, even after a collaboration has ended, it is advisable to maintain the disclosure for a reasonable period, indicatively three months, where the content remains associated with the brand. However, self-promotional content is excluded when the commercial purpose is immediately evident, as are spontaneous charitable initiatives without any benefit or form of solicitation.

Risk profiles for brands

Covert advertising is the main risk area. Content that appears neutral but includes strongly positive tones, repeated product exposure, or calls to action may constitute a breach in the absence of adequate disclosure. The risk does not concern only the influencer, but also the commissioning brand.

Concluding remarks

Although not regulatory in nature, the FAQs are of paramount importance as they define, with increasing precision, the interpretative approach that the Authority will adopt in assessing specific cases, turning already established principles into operational criteria that are difficult to evade.

For influencers, brands and agencies, this is no longer merely a formal update, but a substantive check of existing practices. The resulting framework combines existing obligations with increasingly detailed operational guidance, significantly reducing ambiguity, with a corresponding rise in the risk of regulatory scrutiny.

FAQs, Guidelines and Code of Conduct for Influencers (Annex B – AGCOM)

To facilitate the correct application of the Guidelines and Code of Conduct of the Italian Communications Authority (Resolution 197/25/CONS), the Authority has issued supplementary documents designed to meet the needs of the various target audiences.

In particular, Annex B (FAQ – Guidelines and Code of Conduct for Influencers) provides practical guidance for the uniform application of rules on advertising transparency, protection of minors, and user protection in audiovisual content distributed on social media. These rules are framed within the Consolidated Act on Audiovisual Media Services (TUSMA), the IAP Digital Chart Regulation, as well as the aforementioned Guidelines and Code of Conduct. These guidelines are purely indicative and non-binding, and the Authority retains the power to assess individual cases.

From a subjective perspective, an influencer is any person who creates or selects content intended for an online audience, exercises editorial control, and receives a financial or other benefit (money, products, services, or other advantages). The status of “relevant influencer” applies upon reaching at least 500,000 followers (measured on the 30^th day prior to the publication of the promotional post) or 1 million average monthly views on a single platform, resulting in additional obligations. It should be noted that even those below the threshold are fully required to comply with transparency and fairness rules; however, unlike relevant influencers, they are not required to register in AGCOM’s Register of Influencers.

As regards the practical application of advertising rules, the central principle is that any content intended for promotional purposes must be immediately recognisable as such. Advertising exists whenever there is a benefit – even if non-financial – linked to the visibility of a brand, product or service.

In such cases, explicit and unambiguous wording such as “Advertising”, “AD” or equivalents must be used. Phrases such as “in collaboration with” are not considered sufficient to make the commercial nature clear. Similarly, simply tagging the brand, including links, or using platform-native tools is not sufficient in the absence of a textual disclosure that is immediately visible.

The method of disclosure varies depending on the content format but follows a consistent principle: the information must be visible without any action from the user (specific cases are detailed in the summary table below). In summary, in posts the disclosure must appear at the beginning of the caption; in videos, both as on-screen overlay in the first scenes and in the description; in stories, on each individual piece of content; and in live streams, continuously and repeatedly.

Furthermore, the Annex clarifies that, if platform rules do not align with transparency rules, both must be complied with; in particular, the provisions of the law and the Code prevail and must always be respected. In the event of a discrepancy, the clearest and most cautious solution applies (for example, platform tools plus text disclosure).

Particular attention is also required in cases of gifting, participation in events, or offered experiences. Products received free of charge must be labelled “gifted by” or equivalent, while for events a distinction must be made between promotional relationships (requiring the use of “AD”) and simple invitations (for which “invited by” is sufficient). The same rules also apply to content published after the event, if the brand remains identifiable. As a general rule, in case of doubt, it is preferable to include disclosure in any event.

Even after a collaboration has ended, it is advisable to retain advertising disclosure for a reasonable period (approximately three months) if the content remains associated with the brand. However, self-promotional content is excluded from disclosure requirements where the commercial intent is evident, as are charitable initiatives that do not involve any form of benefit or solicitation. 

A particularly relevant issue for brands is covert advertising, which occurs when promotional content appears neutral. Elements such as strongly positive tones, repeated product exposure, or calls to action may, in the absence of clear disclosure, result in a breach.

Finally, the absolute prohibitions laid down by law (including gambling, tobacco and prescription-only medicines) and the strengthened obligations regarding the protection of minors, which prohibit any form of exploitation of their inexperience or their representation in inappropriate contexts, remain in force.

Summary table

The Problem

Generative AI systems are trained on vast quantities of content gathered from the internet without authorisation and without compensation for those who produced it. The result, according to the European Parliament, is that authors find themselves competing in the market with systems trained on their own content, without having been asked for consent or receiving any compensation. This dynamic raises significant issues both in terms of authors' individual rights and the economic sustainability of the European cultural sector as a whole.

Measures Requested of the Commission

Transparency. AI providers should provide a detailed list of the protected content used in training — an obligation based on the principle of sufficient disclosure: the disclosure must be sufficiently detailed to allow rights holders to verify whether and how their content has been used. This measure builds on the provisions of the AI Act for GPAI models, which requires the publication of summaries of training data, whilst going a step further towards a significantly higher level of detail.

No geographical loopholes. An AI system that uses protected content outside the EU should not be marketed in the European market. This principle reflects the extraterritorial approach already adopted by the AI Act, which applies to all systems placed on the European market regardless of where they were developed.

Traceable crawlers. Those who collect data from the web should be identifiable by website operators and should keep detailed records of their activities.

Digital watermarks. Rights holders would be able to mark their content; AI providers would be obliged to keep watermarks intact and to offer tools to detect them. This issue intersects with the provisions of the AI Act on the labelling of synthetic content and the automated detection of deepfakes.

Right of exclusion. The Parliament proposes that rights holders should be able to exclude their content from model training, using standardised formats managed by the EUIPO. This would constitute an operational strengthening of the opt-out mechanism already provided for in the Digital Single Market (DSM) Directive, which the AI Act refers to but does not regulate in detail.

Collective licences. The EUIPO could coordinate a sector-specific licensing system. For content already used without authorisation, fair and proportionate transitional remuneration is envisaged.

Labelling. The proposal suggests introducing an obligation to distinguish content "generated by AI" from that "produced by a human being", with a code of good practice to be drawn up by the Commission — in line with the transparency obligations already introduced by the AI Act for systems that generate synthetic content or interact directly with users.

A Fundamental Principle

Content protection should remain anchored to human authorship: content generated entirely by AI would not be protectable and would remain in the public domain.

Why It Matters Now

Read alongside the AI Act, the resolution contributes to shaping a regulatory mosaic still under construction. The AI Act laid the foundations — transparency obligations, risk management, model governance — but deferred the issue of content protection to subsequent developments. This resolution indicates the form those developments might take. For those working in the cultural or technology sectors, now may be the time to assess their practices in light of a regulatory framework which, between existing obligations and measures still being defined, appears set to evolve significantly in the years ahead.

On 17 February 2026, the European Commission opened formal proceedings against Shein, designated as a Very Large Online Platform (VLOP) under the Digital Services Act (DSA). The initiative falls within the framework of the supervisory powers conferred on the Commission to verify compliance with the obligations imposed on large digital platforms, in particular with regard to the circulation of illegal and counterfeit products within online marketplaces. Among the issues under examination is the possible presence on the platform of goods infringing intellectual property rights, including trade marks, designs and copyright. Shein was formally designated as a VLOP by the European Commission in October 2023.

2. DSA Obligations Concerning Illegal Products and IPR

The Digital Services Act introduces a system of responsibility and due diligence for online platforms, directly affecting the circulation of counterfeit products as well. The DSA replaces the previous intermediary liability regime established by the E-Commerce Directive (2000/31/EC), significantly strengthening the obligations placed on platforms.

The most relevant obligations include:

a) Notice-and-action mechanisms (Art. 16 DSA): platforms must establish systems enabling rights holders to easily report illegal content or products, including items that infringe intellectual property rights. The system must be easily accessible, equipped with a direct electronic channel, and capable of allowing sufficiently precise reports. The platform is required to communicate its decision to the reporting party, with an obligation to provide reasons in the event of a refusal.

b) Trader traceability (Art. 30 DSA): marketplaces must collect and verify information on professional sellers operating on the platform — including business name, VAT number and bank details — in accordance with the "Know Your Business Customer" (KYBC) principle, with a view to reducing the presence of operators selling counterfeit products. Sellers who have not provided the required information or whose verification has failed may not operate on the platform.

c) Enhanced obligations for VLOPs (Arts. 34–35 DSA): very large online platforms must: i) assess systemic risks, including the spread of illegal products, on an annual basis; ii) adopt mitigation measures, such as more effective control systems and enhanced moderation; iii) undergo independent audits of compliance with the measures adopted (Art. 37 DSA).

d) Transparency and data access: VLOPs must provide information on how their systems operate and on the measures taken to counter illegal content and products, as well as share data with the Commission and authorised researchers (Arts. 40–42 DSA).

3. The Focus of the Investigation: Counterfeit Products

With specific regard to Shein's activity as a third-party marketplace, the Commission's investigation concerns in particular the possible inadequacy of the measures adopted by the platform to: prevent third-party sellers from selling products that infringe registered trade marks or designs; promptly remove items reported as counterfeit through notice-and-action mechanisms; ensure the traceability and proper identification of third-party sellers pursuant to Art. 30 DSA.

In this context, the DSA serves as a complementary instrument to traditional IP rights enforcement, since it does not target the individual act of counterfeiting carried out by the third-party seller, but rather the governance of the platform that enabled the commercialisation of such goods.

4. Possible Consequences of the Investigation

Should the Commission find violations of the Digital Services Act, it could impose:

• corrective measures to strengthen the platform's control systems (modification of notice-and-action systems, enhanced seller verification, periodic reporting obligations);

• fines of up to 6% of the company's annual global turnover (Art. 74 DSA);

• periodic penalty payments of up to 5% of average daily turnover for each day of non-compliance;

• in cases of serious and repeated infringement, interim measures and, as a last resort, temporary suspension of access to the service in the EU (Art. 76 DSA).

   

5. Conclusions

The investigation into Shein provides a significant opportunity to reflect on the role that the Digital Services Act may play, indirectly, in the enforcement of intellectual property rights in the digital economy.

The DSA strengthens the procedural responsibility of online platforms, imposing more stringent due diligence obligations in the management of potentially counterfeit products. This represents a step forward compared to the previous regime, but it does not eliminate the structural difficulties of IP enforcement in the digital context: the fragmentation of supply chains, the speed with which dishonest sellers reconstitute themselves under new identities, and the complexity of verification at a global scale remain open challenges.

For rights holders, the mechanisms introduced by the DSA — in particular notice-and-action and trader traceability — offer additional protective tools, which complement rather than replace traditional IP remedies. The practical effectiveness of these tools will depend, however, on actual implementation by platforms and on the rigour with which the Commission exercises its supervisory powers.

The outcome of the investigation into Shein will provide valuable guidance on the practical scope of the DSA in this area, but it is premature to regard it as a consolidated model: this is one of the first enforcement cases against a VLOP, and regulatory practice is still taking shape.

Published in The Legal 500 Country Comparative Guides 2024 - Italy: Patent Litigation  

Structural and procedural framework

1. What is the forum for the conduct of patent litigation? 

Patent litigation is subject to the jurisdiction of specialized business sections established in first and second instance courts of major Italian cities, namely Bari, Bologna, Catania, Florence, Genoa, Milan, Naples, Palermo, Rome, Turin, Trieste, and Venice. Generally, actions related to patents (and other IP rights) are filed in the jurisdiction where the defendant resides or is domiciled (forum rei). If the defendant lacks residence, domicile or abode in Italy, actions may proceed in the jurisdiction of the plaintiff’s residence, domicile or abode (forum actoris). If neither party is domiciled in Italy, the Court of Rome has jurisdiction. For invalidity actions, the competent forum is based on the patentee's chosen domicile upon registration, serving as an exclusive domicile for jurisdiction and document service.

In addition, infringement and non-infringement actions can be initiated at the court where the infringement occurred (forum commissi delicti). This system allows parties to choose between general forums or the forum commissi delicti for infringement cases. If the chosen court lacks a specialized business section, the case is deferred to a regional court with such a section. Specialized judges bring significant expertise in patent and IP litigation, though they typically lack technical backgrounds and rely on court-appointed experts.

2. What is the typical timeline and form of first instance patent litigation proceedings? 

Patent litigation can proceed as either interim or main proceedings, depending on the claim.

In interim proceedings, claimants can seek urgent relief measures, such as preliminary injunctions, seizure, and description orders, to secure immediate protection and evidence of infringement or non-infringement which can be then used in following main proceedings to get a declaration of liability and compensation for damages. Interim proceedings require fumus boni juris (likelihood of the right's existence) and periculum in mora (risk of prejudice implied in waiting a decision on the merits). Interim proceedings apply to infringement or non-infringement claims but not to validity or revocation actions.

Certain interim measures, like preliminary injunctions, do not require follow-up confirmation in main proceedings, while others, such as seizure or description, require main proceedings within the timeframe set by the judge or, if unspecified, within 20 working days or 31 calendar days, whichever is longer. Without main proceedings, the granted measures (seizure and description) become ineffective.

Main proceedings cover the full scope of the case, allowing judges to issue judgments on validity, revocation, infringement, or non-infringement and address compensation for damages and other remedies like a final injunction. Typically, infringement and invalidity proceedings are bifurcated, though infringement cases often see a counterclaim for invalidity. If separate invalidity proceedings begin, the infringement trial is usually stayed pending the validity decision, as the assessment on validity precedes both logically and legally the assessment on possible infringement (Italian Supreme Court No. 15339/2016).

Rulings on liability and damages are typically issued together, but courts may deliver a partial ruling on liability, with the trial proceeding to quantify damages. A first-instance decision in interim patent litigation proceedings generally takes about a year (possibly including a witness expertise), while a decision on the merits can take around three years.

3. Can interim and final decisions in patent cases be appealed? 

Both interim and final decisions can be appealed under general Italian civil procedure rules. Interim decisions are appealable to the first instance Court in a collegial seatwithin 15 days of issuance. Final decisions can be appealed to the Court of Appeal within 30 days of service by either party or, if not served, within six months of publication (save for a suspension of the deadline from the 1^st to the 31^st of August).

No permission is required for appeal, but appellants must have an “interest”, meaning they cannot appeal a case they have completely won. Furthermore, Italian law provides mechanisms to streamline appeals, whereby judges of the Court of Appeal can dismiss an appeal deemed inadmissible or manifestly unfounded.

The typical appeal timeframe in interim proceedings is about two months, whereas main proceedings appeals take approximately three years. First-instance judgments are provisionally enforceable. The appellant may request the judge to suspend the provisional enforceability or execution of the appealed judgment only for serious reasons.

Basic legal framework

4. Which acts constitute direct patent infringement?

Under Article 66.2 of the Italian Industrial Property Code, the exclusive rights of a patent owner include:

• For a product patent: the right to prevent third parties from making, using, marketing, selling, or importing the product for such purposes.

• For a process patent: the right to prevent third parties from applying the process and from using, marketing, selling, or importing the product obtained directly from the process.

These actions constitute direct patent infringement if they exploit all the essential and typical elements of the patented invention, excluding secondary or ancillary elements.

5. Do the concepts of indirect patent infringement or contributory infringement exist? If so, what are the elements of such forms of infringement? 

The Italian Industrial Property Code addresses contributory infringement in Article 66, paragraphs 2 bis-2 quater. Contributory infringement occurs when the conduct, while not being a direct infringement nor a preparation to it, is instrumental to enabling the infringing activity of others. This the case when a party supplies or offers to supply third parties with essential elements of a patented invention, knowing the means are suited for implementing the invention.

Essential elements include:

1. A direct infringement.

2. An act contributory to the infringement by a different person.

3. Awareness by the contributor of facilitating infringement.

Article 66.2 ter clarifies that the supply to third parties of means relating to an indispensable element of the invention and necessary for its implementation does not qualify as contributory infringement if such means are common commercial items, unless the contributory infringer knowingly induces the recipient to perform acts of direct infringement.

6. How is the scope of protection of patent claims construed? 

Under Article 52 of the Italian Industrial Property Code, the scope of a patent is strictly defined by the claims. Independent claims must include all essential features of the invention, while dependent claims cover specific embodiments. The description and drawings in the patent document aid in interpreting claims, as they provide context on how the invention is to be executed and help clarify claim content.

In Italy, there is no file-wrapper estoppel; statements made by the patent owner during prosecution do not generally affect the scope of the patent. However, some case law treats these statements as presumptive evidence in restricting the patent’s scope.

Italian law also recognizes infringement by equivalents, whereby a product or process can infringe a patent if it incorporates elements functionally equivalent to those claimed. Italian courts have recently adopted the “triple-test” approach to determine equivalence, which requires that the product or process in question performs the same function, in the same way, and achieves the same result as the patented invention.

7. What are the key defences to patent infringement? 

Key defenses against patent infringement claims include:

1. Possible invalidity of the patent: Defendants often argue that the enforced patent lacks novelty, inventive step, or other validity requirements.

2. Non-infringement: The defense asserts that the requirements for direct, contributory, by equivalent or evolutive infringement are not met in the case at hand.

3. Legal exclusions: Italian law provides specific exceptions to infringement under Article 68 of the Industrial Property Code, such as:

• Acts performed privately and for non-commercial purposes.

• Acts performed on an experimental basis relating to the subject matter of the patented invention, or to the use of biological material for cultivation purposes, or to the discovery and development of other plant varieties.

• Studies and experiments aimed at obtaining a marketing authorization for a medicine.

• Preparation of medicines in pharmacies on a per-unit basis based on prescriptions.

• Actions on software allowed under copyright law.

• Use of a dependent patent (i.e. a patent for invention, the implementation of which involves the use of inventions protected by earlier patents still in force, with the consent of the owners of those patents).

• Prior secret use (any person who, during the 12-month period prior to the filing date of the patent application or priority date, has made use in his business of the invention may continue to use it within the limits of the prior use).

8. What are the key grounds of patent invalidity? 

Under Article 76 of the Italian Industrial Property Code, a patent is invalid if:

• The invention is not patentable as: 

• it has a subject matter which cannot constitute patentable invention (e.g., discoveries, scientific theories, mathematical methods, etc.); and/or

• it lacks patentability requirements (novelty, inventive step, industrial application, lawfulness).

• The invention is not described in a sufficiently clear and complete manner to enable an experienced person to implement it.

• The subject matter of the patent extends beyond the content of the initial application or the patent protection has been extended.

• The patentee was not entitled to obtain the patent.

The Italian case law considers the invalidity grounds above exhaustive.

9. How is prior art considered in the context of an invalidity action? 

Under Article 46 of the Italian Industrial Property Code, prior art includes everything made publicly available in Italy or abroad before the patent application date. This can include written or oral descriptions, uses, or any means of disclosure.

Prior art is evaluated differently for assessing novelty and inventive step:

• Novelty: Prior art is assessed on an absolute basis, meaning it includes all publicly known information across fields. A single prior art reference must entirely coincide with the patented invention to negate novelty, while consideration of multiple prior art documents is not allowed. Prior art relevant for the assessment of novelty includes:

• common general knowledge (all that is generally known to an expert);

• enhanced knowledge (which is obtained though research);

• hidden knowledge (which is theoretically possible - but unlikely - to obtain); and

• prior applications (which includes non-published prior Italian, EU – designating Italy – and international – designating and effective in Italy – patent applications).

• Inventive step: the assessment of inventive step (so called inherent novelty) aims at understanding whether the solution presented to the problem in the patent application is obvious or not to the person skilled in the art. Differences with novelty assessment are the following: a) prior art sub iii) and iv) are not considered; b) different and unrelated prior documents can be combined with a mosaic approach to exclude inventive step; and c) the person skilled in the art is an expert of the field(s) to which the invention belongs, while for novelty reference is made to a cross-fields expert. 

In order to assess inventive step, Italian courts have recently started to adopt the EPO method called “problem-solution approach”, which consists of (i) determining the “closest prior art”, (ii) establishing the “objective technical problem” to be solved, and (iii) then inferring whether or not, starting from the closest prior art and the objective technical problem, it would have been obvious for the expert of the field to land on the claimed invention. According to this approach, the closest state of the art for assessing inventive step should be represented by a document, which, with regard to the claimed invention and from the point of view of a skilled person at the priority date applicable, pertains to the same or to a closely related technical field, discloses subject-matter conceived for the same purpose, has most technical features in common, i.e. requires the minimum of structural modifications, and relates to the same or a similar technical problem (Board of Appeal EPO, 14 October 2004, T 650/01).

10. Can a patentee seek to amend a patent that is in the midst of patent litigation? 

Under Article 79 of the Italian Industrial Property Code, a patent owner may seek to limit the patent. This can be done either through the Italian Patent and Trademark Office, submitting a modified description, claims, and drawings, or directly in court during an invalidity trial by proposing a reformulation of claims. These amendments must not extend the protection originally conferred by the granted patent.

No opposition mechanism is available to third parties against limitations. Limitation requests are examined by the Office, which usually focuses on avoiding that limitations extend the scope of the claims or merely consist in formal amendments. 

However, when amendments are made in court, the opposing party may still challenge the validity of the patent as amended.

Amendments are effective from the date they are requested and do not retroactively affect the scope of the patent.

11. Is some form of patent term extension available? 

Under Article 60 of the Italian Industrial Property Code, the term of a patent for invention is 20 years from the filing date, while utility model patents last 10 years. Extensions are not available, except for pharmaceutical patents, which can be extended via a supplementary protection certificate (SPC). The SPC provides additional protection for the time between the patent application filing and the date the product received market authorization, with a maximum extension of 5 years.

Evidence

12. How are technical matters considered in patent litigation proceedings? 

In patent litigation proceedings, technical matters are typically assessed through expert opinions. Court-appointed experts provide an impartial evaluation of the patent’s validity or infringement. Parties may nominate their own technical consultants to assist them during this process.

As the expert opinion is not a means of evidence available to the parties, the judge retains a discretionary power of appointment, independently from parties’ request. However, a judge, upon receiving a party’s request explaining why the expert opinion is material for the decision on the matter, cannot reject the request without justification.

Experts generally submit a written report after considering written input from the parties’ experts. Given that judges usually lack technical backgrounds, they significantly rely on the court-appointed expert’s findings. Witness testimony and documentary evidence are also admissible, but expert opinion remains central due to the technical complexity of patent cases.

13. Is some form of discovery/disclosure and/or court-mandated evidence seizure/protection (e.g. saisie-contrefaçon) available, either before the commencement of or during patent litigation proceedings? 

Yes, Italian law allows for urgent measures for preservation of evidence (e.g., description order, seizure, information orders), obtainable through interim proceedings. To grant such measures, the court requires fumus boni juris (likelihood of the right’s existence) and periculum in mora (risk of prejudice in waiting for legal protection until the decision on the merits).

More specifically, description orders aim at obtaining visual evidence of the infringement by means of a bailiff’s report describing, also with images, the infringing items and the means to create them, while seizures preserve evidence by putting goods under custody; information orders are meant to obtain information on the origin, on distribution networks of infringing products or on infringing services supply networks.

Another measure for gathering evidence, which prevailing case law deems admissible only in main proceedings and not in interim ones, is the exhibition order. This order may be issued by the judge upon the parties' request to obtain specific documents. 

To grant an exhibition order, the requesting party must provide compelling evidence supporting the merits of their claim and specifically identify the document in question, including details on its origin and content. In this sense, the exhibition order differs from description: while description seeks to uncover evidence, the exhibition order aims to introduce already identified evidence into the trial.

The urgency measures above, if obtained in interim proceedings, must be followed by main proceedings initiated within the timeframe set by the interim judge or, if no timeframe is specified, within twenty working days or thirty-one calendar days, whichever is longer. If main proceedings are not started within this period, the granted measures become ineffective, resulting in their revocation and the return of any seized materials to the defendant.

14. Are there procedures available which would assist a patentee to determine infringement of a process patent? 

Article 67 of the Italian Industrial Property Code presumes that a product identical to one obtained through a patented process was made using that process, unless proven otherwise. This happens if, alternatively, a) the product obtained by the process is new in the market, or b) despite reasonable efforts, the patentee could not prove that the process used to manufacture the identical product corresponded to the patented one but, nonetheless, provided evidentiary elements for a substantial likelihood that the identical product was manufactured through the patented process.

The defendant can rebut this presumption by providing evidence of an alternative manufacturing process. In these circumstances, courts are required to respect the defendant’s trade secrets and typically use confidentiality measures to protect sensitive information shared by the defendant.

15. Are there established mechanisms to protect confidential information required to be disclosed/exchanged in the course of patent litigation (e.g. confidentiality clubs)? 

Italian law provides mechanism to protect confidential information. 

Article 121 ter of the Italian Industrial Property Code contains a special provision for proceedings concerning the unlawful acquisition, use or disclosure of trade secrets. Trade secrets are defined by Articles 98-99 of the Italian Industrial Property Code as information which are secret, have economic value as secret and are subject to appropriate secrecy measures. 

In trade secrets proceedings the judge may prohibit individuals appointed or delegated by him, the parties and their representatives and consultants, defense counsel, administrative personnel, witnesses, and other persons who in any capacity have access to the measures, acts and documents in the office file, from using or disclosing the trade secrets deemed confidential. This prohibition order, issued upon request of a party, remains effective even after the conclusion of the proceedings in which it was issued. The court may also adopt additional confidentiality measures, such as restricting access to hearings, records and documents to a limited number of individuals and redacting or omitting portions containing trade secrets in the final orders.

These measures become ineffective if, through a final judgment, it is determined that the trade secrets at issue in the case do not meet the requirements of Article 98 or if they become generally known or easily accessible to experts and practitioners in the field.

Jurisdiction and other fora

16. Is there a system of post-grant opposition proceedings? If so, how does this system interact with the patent litigation system? 

Italian law does not provide for post-grant opposition proceedings, however European patents can be opposed before the European Patent Office within 9 months of the grant. Since European patents designating Italy can be challenged before Italian courts under the transitional regime of Article 83 the UPCA and Article 345 bis of the Italian Industrial Property Code, if the EP is opposed, an EPO opposition proceeding may overlap with a pending patent litigation in Italy. 

In such cases, Article 120 of the Italian Industrial Property Code provides that the court shall, taking into account the circumstances, order the suspension of the trial, once or several times, and set the date for the trial’s resumption. This allows litigation to be stayed pending administrative opposition proceedings. 

As for the interaction between the opposition proceedings against a European patent and proceedings before the Unified Patent Court, Article 33.10 of the UPCA requires that parties shall inform the UPC of any opposition, limitation or revocation proceedings pending before the EPO. The UPC may stay proceedings when a rapid decision may be expected from the EPO. The Court may also request that the EPO expedite opposition proceedings.

17. To what extent are decisions from other fora/jurisdictions relevant or influential, and if so, are there any particularly influential fora/jurisdictions? 

Italian courts are not bound by foreign decisions, but they may consider them to support their reasoning, if the matter at stake has been already decided by a foreign jurisdiction (especially if by the court of another EU country or by the EPO Board of Appeal).

18. How does a court determine whether it has jurisdiction to hear a patent action? 

General rules on jurisdiction dictate that patent actions must be brought before the court in the jurisdiction of the defendant's residence, domicile or abode (forum rei). If the defendant lacks residence in Italy, the action may proceed where the plaintiff is domiciled (forum actoris), or in Rome if neither party is domiciled in Italy. For infringement cases, the action may also be filed where the infringement occurred (forum commissi delicti).

With respect to foreign patents, under international law rules, Italian courts do not have jurisdiction over actions concerning validity and registration. However, they may assert jurisdiction in cases if where the defendant is domiciled in Italy. For infringements occurring within EU member states Article 4.1 of Bruxelles I bis Regulation applies, while for infringement occurred in non-EU member states jurisdiction is governed by Article 3.1 of Law no. 218/1995).

Italian Courts do not grant anti-suit injunctions.

19. What are the options for alternative dispute resolution (ADR) in patent cases? Are they commonly used? Are there any mandatory ADR provisions in patent cases? 

Patent cases in Italy can be subject to arbitration, provided they involve rights that can be freely transferred or waived (diritti disponibili). Issues such as authorship or inventorship, therefore, are excluded from arbitration.

In general, arbitration is not commonly used in patent cases, which are typically handled through lengthy and complex trials.

However, there are specific instances in patent law where arbitration is explicitly provided for. For example, Article 64.4 of the Italian Industrial Property Code stipulates that, while the ordinary court retains jurisdiction to determine the existence of the right to fair premium, fee or price, if the parties cannot agree on the amount, it may be set by a panel of arbitrators. This panel is composed of three members: one appointed by each party and a third member chosen by the first two. In the event of disagreement, the third arbitrator is appointed by the president of the specialized section of the competent court where the service provider regularly conducts their duties.

Commencing patent litigation

20. What are the key procedural steps that must be satisfied before a patent action can be commenced? Are there any limitation periods for commencing an action?

Patent actions can be initiated at any time once the patentee has sufficient evidence of infringement (for infringement actions) or upon filing the patent (for invalidity actions). There are no procedural preconditions, such as pre-litigation steps, before commencing a patent action in Italy.

The statute of limitations for patent infringement follows general Italian law on non-contractual damages, with a five-year limit. The period begins when the patentee is reasonably informed of the act of infringement and its potential damage, requiring an active role in monitoring the market for unauthorized uses.

21. Which parties have standing to bring a patent infringement action? Under which circumstances will a patent licensee have standing to bring an action?

Licensees can bring infringement actions. Exclusive licensees, who hold the sole economic exploitation rights over the patent, may initiate actions independently unless the license agreement states otherwise. Non-exclusive licensees may only bring an infringement action with the patent owner’s consent. The patentee does not need to join an action brought by the licensee.

In addition, assignees of a patent may bring actions for infringements that occurred prior to the assignment.

22. Who has standing to bring an invalidity action against a patent? Is any particular connection to the patentee or patent required?

Under Article 122 of the Italian Industrial Property Code, invalidity claims against a patent for failure to meet mandatory requirements can be brought by i) any party with a legal interest including any entrepreneur – current or potential – who perceives the patent as an obstacle to their business; and ii) the Public Prosecutor. Invalidity claims based on the ground that the registration was granted to a non-entitled person may only be brought by the rightful owner within two years of the patent grant. After this two-year period, such claims can be initiated by any party with a legal interest. 

Examples of plaintiffs in invalidity claims for lack of mandatory requirements include i) the licensee of the patent (seeking to avoid paying royalties under the license); ii) the assignee of the patent (to avoid the consideration for assignment); iii) the defendant in infringement cases; and iv) “enti esponenziali di interessi di categoria” (i.e., entities legally dedicated to defending specific public interests.).

Remedies 

23. Are interim injunctions available in patent litigation proceedings? 

Yes, interim injunctions are available in Italian patent litigation and are commonly granted when there is a significant risk of irreparable harm or economic prejudice that could escalate uncontrollably. Standard requirements for interim relief (fumus boni juris and periculum in mora) must be met.

Interim injunctions can be obtained on an ex parte basis if the court believes that notifying the opposing party may compromise the effectiveness of the measure. Ex parte injunctions are relatively rare (orders for evidence preservation - e.g., description - to prevent tampering are more likely to be granted ex parte).

Inter partes injunction, instead, are generally granted when Courts make a positive assessment of patent infringement.

Typically, an ex parte injunction can be granted within two weeks, while an inter partes injunction usually takes three to six months. Courts do not require cross-undertakings for damages before granting interim injunctions.

24. What final remedies, both monetary and non-monetary, are available for patent infringement? Of these, which are most commonly sought and which are typically ordered? 

The final remedies available for patent infringement include:

1. Injunctions: Prohibit manufacturing, marketing, or using infringing products, often with penalties for non-compliance.

2. Market removal orders: Mandate the removal of infringing items from the market.

3. Destruction orders: Require the destruction of infringing goods.

4. Assignment orders: Transfer ownership of infringing items to the right holder.

5. Seizure of infringing products and manufacturing equipment.

6. Publication of the decision: Public disclosure of the judgment.

7. Compensation for damages: Monetary relief for losses incurred.

Injunctions, removal orders, and compensation for damages are the most commonly sought remedies, with injunctions and damages typically granted.

25. On what basis are damages for patent infringement calculated? Is it possible to obtain additional or exemplary damages? Can the successful party elect between different monetary remedies?

Under Article 125 of the Italian Industrial Property Code, infringers can be held liable for both monetary and non-monetary damages.

Monetary damages are calculated by considering both actual loss (danno emergente) and loss of profit (lucro cessante). 

In patent litigation, actual losses typically include:

• Enforcement costs: Expenses incurred for enforcing rights, including investigative activities, monitoring and gathering evidence of infringement, legal and technical consultancy fees, and costs for analyses and technical tests, as well as internal expenses dedicated to patent enforcement.

• Investment costs: Costs incurred for investments jeopardized by the infringement, such as advertising expenses and venue rentals.

• Remedial expenses: Costs for mitigating the negative effects of the infringement, including press releases and promotional activities.

• Commercial standing damage (danno normativo): Detriment to the patentee’s monopoly position in the market.

Loss of profit in patent cases is typically calculated using one of three alternative methods:

• Lost profit of the patentee: Calculated by multiplying the quantity of infringing products sold by the price set by the patentee, minus manufacturing costs. Case law sometimes adds additional profit considerations, such as:

  • Convoyed sales: Sales of ancillary products.

  • Price erosion: Discounts applied by the patentee to compete with infringing products.

  • Bridge-head sales: Losses due to the infringer’s market positioning at the patentee's expense.

• Infringer’s profits: Calculated based on gross operating margin or net profit.

• Royalty rate: Applying an industry-standard royalty rate (typically 5% for mechanical patents) to the infringer’s revenue generated by exploiting the infringing product.

The patentee can also request restitution of profits (retroversione degli utili) as an alternative to loss of profit or to cover any excess profit not accounted for by this type of damages.

Non-monetary damages in patent cases account for non-economic harm suffered by the patentee, which the court can grant only “where appropriate.” Examples include inconvenience caused by infringement to the patentee’s internal operations and harm to the patentee's reputation or public image.

If damages cannot be precisely quantified, despite the patentee demonstrating harm, the court may assess them based on equitable considerations. Additional or exemplary damages are not available under Italian law.

26. How readily are final injunctions granted in patent litigation proceedings? 

Final injunctions are generally granted if the court finds infringement and valid patent rights. Public interest or proportionality considerations do not typically affect the decision. The scope of the injunction is tailored to prevent ongoing infringement. 

27. Are there provisions for obtaining declaratory relief, and if so, what are the legal and procedural requirements for obtaining such relief? 

Under Italian law, there are no specific provisions concerning actions for a declaration of non-infringement; however, Italian case law has recognized such actions, and they are referenced in Article 120.6 bis of the Italian Industrial Property Code regarding jurisdiction criteria.

Non-infringement action generally requires that the claimant demonstrate a legal interest in obtaining clarification, often by showing that the existence of the patent creates significant uncertainty about the legality of their business activities.

Costs

28. What are the costs typically incurred by each party to patent litigation proceedings at first instance? What are the typical costs of an appeal at each appellate level?

Typical costs in first instance proceedings including a witness expertise are approximately EUR 30,000-50.000 for interim measures and EUR 40,000-70.000 for main proceedings, plus 10.000-25.000 for technical consultants. Appeals to the Court of Appeal cost between EUR 45,000 and EUR 75.000, while appeals to the Italian Supreme Court generally cost over EUR 50,000. Costs are indicative only and may increase due to the complexity of the matter, amount of evidence to be examined, and in case of multiparty litigation. Court fees may vary, up to a maximum of EUR 2,072 for cases with an unidentifiable monetary value, with higher fees applying to cases with a specified value.

29. Can the successful party to a patent litigation action recover its costs? 

Under Italian procedural law, the losing party is typically required to cover the winning party’s costs, including legal fees, as calculated by an official table of fees approved by the Italian State. However, these reimbursable costs are generally lower than the actual expenses incurred. 

Policy

30. What are the biggest patent litigation growth areas in your jurisdiction in terms of industry sector?

The main growth areas in Italian patent litigation currently include mechanical engineering, pharmaceuticals and biotechnology.

31. How has or will the Unified Patent Court impact patent litigation in your jurisdiction? 

The UPC is expected to centralize and streamline patent litigation across multiple jurisdictions. However, Italian SMEs, who may struggle to sustain the costs of opting into the UPC, might still prefer traditional national litigation.

32. What do you predict will be the most contentious patent litigation issues in your jurisdiction over the next twelve months?

Foreseeable new contentious issues in Italian patent litigation in the coming year may include AI-related inventions and enforcement of biotech patents. Additionally, the UPC practice will bring new procedural challenges and possibly influence also the case law of national courts.

33. Which aspects of patent litigation, either substantive or procedural, are most in need of reform in your jurisdiction?

Introducing an administrative opposition system for patent challenges would streamline patent invalidation and reduce the burden on the courts. Establishing such a mechanism would lower costs for plaintiffs and make patent disputes more accessible, especially for small companies. 

34. What are the biggest challenges and opportunities confronting the international patent system?

A unique challenge for the international patent system will be how to handle inventions created autonomously by AI. AI systems challenge the concept of human inventorship, which is the legal cornerstone of current IP frameworks, and requires new solutions. Patent system may then need to adopt new legal definitions of inventorship, that might include qualifying AI as co-inventor.

The regulation requires providers of such models to make publicly available a sufficiently detailed summary of the data used for training – that is, the informational corpus employed to tune and optimize the model’s parameters. From the outset, the expression “sufficiently detailed” has sparked intense debate: what does “sufficient” mean, exactly? And more importantly, what criteria should guide providers in drafting this summary?

It is precisely on the elasticity or rigidity of the interpretation of what constitutes “sufficiently detailed” that a decisive legal battle will unfold between content owners and AI platforms. On one side, rights holders demand meaningful and verifiable access to information about the data used, as a prerequisite for enforcing their rights. On the other, providers will likely advocate for a more flexible approach that protects their strategic assets and avoids disclosing too much, also for competitive reasons. The boundary between genuine transparency and mere formal compliance will be fine, and it will inevitably be drawn by the first court rulings.

The rationale behind the obligation is clear: to enable holders of legitimate interests to more effectively exercise their rights. The most immediate reference is, of course, to copyright holders, who may use the disclosed information to verify whether and how their content was used without authorization.

But the scope of protected interests goes well beyond copyright. Also at stake are personal data protection, the right to scientific research, and the increasingly urgent need to detect and mitigate bias – with implications across a wide range of contexts, from service platforms to public decision-making systems, to commercial AI products.

Recital 107, in laying out the modalities of compliance, also underscores the need to strike a balance: on one hand, the interest of stakeholders in knowing what data was used; on the other, the legitimate concern of providers to avoid disclosing strategic assets such as trade secrets, algorithms, or data collection and processing methods.

To offer initial practical guidance, the European Commission published in January 2025 a template designed to assist providers in preparing the required summary. The model was developed through a broad consultation process involving both AI sector representatives and rights holders already engaged in drafting the Code of Practice on General-Purpose AI (CPAI).

The template guides providers through all stages of the data lifecycle – from pre-training to fine-tuning – and requires clear and comprehensible language, designed to be accessible even to those without advanced technical knowledge.

It is structured into three sections:

1. General Information
   This section collects general details about the model: who developed it, when it was released, and what the knowledge cut-off date is (i.e., the date of the last content update). It also requires information on the overall size and characteristics of the data (number of images, minutes of audio, languages, and geographic origin).
2. List of Data Sources
   Here, providers must list the sources of data used: public datasets, third-party datasets, data collected via web crawling (with an indication of the tools used), user-submitted data, or data self-generated by the provider.
   A controversial aspect is that the template focuses only on “major” or “large” datasets – defined as those representing more than 5% of the total. This could distort the picture, as:
   • some providers might artificially split large datasets into smaller subsets to avoid disclosure;
   • visual datasets (images/videos), due to their nature, are larger than textual ones, potentially leading to unjustified technical discrimination.
3. Relevant Data Processing Aspects
   This section requires a description of the measures taken to protect copyright, such as the identification and removal of protected content, as well as the handling of inappropriate materials.
   However, some criticisms have emerged: the section appears overly focused on copyright protection, while overlooking crucial aspects such as pre-processing steps – particularly methods of anonymization or data filtering.

The final publication of the template and accompanying guidelines is expected in the second quarter of 2025, ahead of the full entry into force of the obligations, scheduled for August 2, 2025.

What is certain is that this regulation, and its practical implementation, will have a significant impact on the choices of AI providers worldwide. Some countries may choose to align with the European model, thereby creating an international standard. Others, conversely, may opt for more flexible regulations to attract research, investment, and development to their own jurisdictions.

However, the real test will come with the first legal disputes, which will give concrete form to the principles currently set forth in the regulation. Those rulings will shape the future direction of European AI regulation.

This guide provides a practical overview of patent litigation law across jurisdictions, covering key topics like:

• Patent infringement (direct and indirect)
• Patent invalidity
• Injunctions and opposition proceedings
• Future trends in litigation

Click here to view the guide

Summary

With ruling no. 12563/2024, the Italian Court of Cassation addressed the dispute between Duca di Salaparuta S.p.A., the Ministry of Agricultural Policies, various wine producers, and the Consortium for the Protection of Salaparuta PDO wines. Duca di Salaparuta argued that the registration of the term “Salaparuta” as a national DOC in 2006, and as a European PDO in 2009, conflicted with its well-known "Salaparuta" trademark, which had been used to identify its wines since the 19th century. The appellant claimed the national DOC and European PDO registrations were deceptive and/or made in bad faith. The Court of Cassation deemed it necessary to refer a preliminary question to the European Court of Justice (“CJEU”) to resolve the conflict between well-known trademarks and PDOs under EU law.

Legal Controversies and Background of the Proceedings

In 2016, Duca di Salaparuta sued various wineries in Milan that used the "Salaparuta" label, the Salaparuta PDO Wines Protection Consortium, and the Ministry of Agricultural, Food, and Forestry Policies (the authority that had granted the national DOC registration).

Firstly, the appellant argued that the defendants' use of "Salaparuta" on their labels constituted both trademark infringement and unfair competition. Duca di Salaparuta also sought the annulment of the Italian PDO granted in 2006 and the subsequent EU registration granted in 2009. It claimed these designations were deceptive and/or made in bad faith and, in any case, interfered with its prior trademarks.

In particular, the appellant based its nullity request on Article 43.2 of Reg. (EC) No. 479/08 – essentially reproducing Article 118 duodecies, 2, of Reg. (EC) No. 1234/07 – stating that “A name is not protected as a designation of origin or geographical indication if, due to the renown and reputation of a commercial trademark, such protection could mislead consumers about the true identity of the wine.”

In ruling no. 1384/21, issued on February 16, 2021, the Milan Court upheld the appellant's claims regarding trademark infringement and unfair competition. The Court believed that the defendants' use of "Salaparuta" on labels could mislead consumers about the origin of the wines.

However, the Milan Court dismissed Duca di Salaparuta's request to annul the national DOC and European PDO, as the provision invoked by the appellant – Article 43.2 of Reg. 43.2 (EC) No. 479/08, establishing the primacy of the well-known prior trademark over the subsequent PDO – was not in effect when "Salaparuta" received national DOC protection in 2006.

Duca di Salaparuta appealed the first-instance decision before the Milan Court of Appeal. In ruling no. 1453/23, the Court of Appeal dismissed the appeal, confirming the lower court's decision. The Court of Appeal noted that in this case, it was necessary to apply the transitional rule under Article 51 of Regulation (EC) No. 479/08, providing automatic EU protection for a national origin designation already protected under the previous regulation.

Additionally, the Court of Appeal emphasized that "Salaparuta" had been registered as a national designation of origin under Reg. (EC) No. 1493/1999, which – in section "F," paragraph 2(b) of Annex VII – established a principle giving precedence to the designation of origin over the trademark, even if the latter was prior and contained identical terms, provided that the well-known trademark had been registered at least twenty-five years before the official recognition of the geographical designation by the member state.

The appellant thus appealed the decision before the Court of Cassation, which suspended the proceedings and referred the following two questions to the CJEU:

1. Are PDO registrations for wine designations existing prior to EU Regulation 1234/2007 (later replaced by Regulation 1308/2013), like the "Salaparuta" PDO (registered in 2009), subject to the rule denying protection to a PDO/PGI if it could mislead consumers due to the renown and reputation of a previous trademark? Or does this rule not apply to designations already protected nationally before receiving EU recognition, based on the legal certainty principle (as mentioned in the CJEU’s Bayerischer Brauerbund ruling)?
2. If previous legislation (Regulation 1493/1999) applies to the facts of this case, can subsequent PDOs be invalidated or lose protection under the general principle of non-deception for distinctive signs?

Conclusions

This decision underscores the need for further clarification on how EU law should balance the interests of well-known trademarks and geographical indications.

Suspension of IP related deadlines as of 24 March 2020