The Unified Patent Court 2025 Comparisons

Address and Opening Hours

The Milan Central Division (the “Milan CD”) is located in Via San Barnaba 50, in a newly refurbished building in the city centre, right behind the historical court building hosting the District Court of Milan. The Clerk’s offices of the Central Division are open Monday to Friday from 10am to 1pm local time, excluding Italian public holidays.

Contacts

The Milan CD can be contacted via email at contact_milan.ctl@unifiedpatentcourt.org and over the phone at +39 02 5433 8061.

Presiding Judge: Mr Andrea Postiglione

Judge Andrea Postiglione entered the judiciary in 2000, serving as a first-instance judge until 2011, then at the Court of Appeal of Rome until 2015 in the department for competition law and civil affairs. From 2015 to 2024, he sat at the Intellectual Property Court of Rome, dealing with IP and antitrust cases. In 2024, he was appointed Deputy Advocate General at the Italian Supreme Court, continuing to handle IP and competition law matters.

Legally Qualified Judges: Ms Anna-Lena Klein and Ms Marije Kniff

Judge Anna-Lena Klein has been a judge at the Regional Court Munich I since 2014, working in IP since 2018. She served in divisions handling patent infringement cases and currently presides over the 33rd division of the Regional Court Munich, focusing on trade marks and unfair competition. Since 2020, she has also served as a mediator in IP law.

Judge Marije Kniff completed her law degree in 2003 at Leiden University and was appointed as a judge at the District Court of The Hague in 2008. Initially serving in criminal law, she transitioned to IP in 2014 and became a senior judge in 2018.

No specific procedural issues of any noteworthy significance have yet emerged. The Milan Central Division has started operating only in June 2024, after the other sections of the Central Division, and therefore has not yet developed a significant body of case law regarding procedural issues. A number of decisions and orders are expected to be issued in the coming months in the framework of the cases already pending. Under the timetable for the conduct of actions stipulated in the Rules of the UPC, the first cases issued in the Milan Central Division will be coming to trial in the summer of 2025.

This does not apply.

The Milan Central Division is competent to hear revocation and non-infringement actions directed at patents that fall under class A of the International Patent Classification (IPC), established by the Strasbourg Agreement of 1971, concerning “Human Necessities”. Revocation and non-infringement actions directed at patents that serve as basic patents to Supplementary Protection Certificates (SPCs), as well as those directed at the SPCs themselves, are however heard by the Paris Central Division. This reallocation of responsibility is the result of political discussions within the participating countries and is of no particular significance.

The Milan CD is also competent to hear infringement actions concerning class A patents whenever the competence of the central division exists pursuant to Article 33.1, third and fourth paragraph, UPCA.

Class A is referred to as the “Human Necessities” class. As such, it encompasses a wide array of technologies spanning across fields such as agriculture, foodstuffs, tobacco, personal or domestic articles, health, life sciences, pharmaceuticals, medical devices, saving and amusement, veterinary science and hygiene, sport, jewellery, wearing apparel and others. A more detailed list is available from WIPO.

This does not apply.

The Milan Central Division opened in June 2024, one year after the other Central Divisions in Munich and Paris. This means that its current caseload is restricted and the first cases opened there are only just on the verge of reaching trial. The Paris Central Division acted as a minder for cases that would now be allocated to Milan (see classification details below). In the year from June 2023 to June 2024, there were 14 cases opened in Paris that would now be commenced in Milan. That indicates the likely rate of cases going forward.

It is also noteworthy that in the classifications allocated to the Milan Central Division are a number of areas in which patent owners have been most likely to opt out their patents – these areas include pharmaceutical and therapeutic patents. It is likely that more cases in this area will emerge as confidence in the system grows.

The current caseload of the Unified Patent Court, as updated on 31 May 2025, shows that the Milan CD has received:

• eight revocation actions, one of which was followed by a counterclaim for infringement;
• one request for a declaration of non-infringement;
• one application for provisional measures; and
• four applications for a cost decision.

Publicly available up-to-date information on hearings can be found on the UPC official website calendar. At the time of publication of this guide (30 June 2025), the following have been heard or scheduled.

Public Oral Hearings

There have been three public oral hearings held before the Milan CD:

• one held on 16 October 2024 in the framework of an application for provisional measures brought by Insulet Corporation against EOFlow;
• one held on 13 November 2024 in the framework of a revocation action brought by Szymon Spyra against Amycel; and
• one held on 4 June 2025 in the framework of a revocation action brought by Maschio Gaspardo against Spiridonakis Bros.

A number of additional public oral hearings have already been scheduled for the coming months:

• 15 July 2025 in EOFlow Co Ltd v Insulet Corporation;
• 12 September 2025 in bioMérieux UK Ltd v Labrador Diagnostics LLC;
• 7 October 2025 in Pari Pharma GmbH v Koninklijke Philips NV; and
• 27 January 2026 in Amgen Switzerland AG v Alexion Pharmaceuticals, Inc.

Interim Conferences

One interim conference was also held:

• on 13 May 2025, in the context of the revocation action brought by EOFlow against Insulet Corporation.

As said, actions filed before the central division concern patents falling under IPC class A (human necessities), excluding those with supplementary protection certificates (SPCs). The patents involved in the cases handled so far are therefore all listed under that IPC class, with some of the patents involved in such actions also being listed in other IPC classes including classes B (performing operations, transporting), C (chemistry, metallurgy), F (mechanical engineering, lighting, heating, weapons, blasting) and G (physics).

Despite being still too early to judge – the Milan CD started operating only around one year ago – the court seems to be on track with the general target set by the UPC of proceedings lasting 12–14 months from filing to issuing a first instance decision on the merits.

A significant interaction between the Milan CD and the Milan Local Division took place in the Insulet v EOFlow case, where Insulet applied for provisional measures against EOFlow (the manufacturer of the allegedly infringing product). Insulet had also commenced parallel preliminary proceedings before the Milan Local Division versus EOFlow’s local distributor, Menarini. The latter filed an application to intervene in the preliminary proceedings before the Milan CD in support of EOFlow, but the Milan CD dismissed such application (ORD_52068/2024). Although an application to intervene is in principle compatible with urgent proceedings, the Milan CD noted that the intervention cannot be allowed when it would result in proceedings being excessively slowed down, as would have happened under the specific circumstances. Adopting a similar position, in the parallel preliminary proceedings pending before the Milan Local Division, the latter also dismissed EOFlow’s application to intervene in support of the position of Menarini, citing the risk that urgent proceedings would be excessively slowed down under the circumstances (ORD_51903/2024).

Interestingly, in the two parallel cases for provisional measures before the Milan LD and the Milan CD, one of the legally qualified judges and the technically qualified judge were the same (respectively Ms Anna-Lena Klein and Uwe Schwengelbeck).

The most comprehensive decision issued by the Milan CD to date that addresses points of substantive law is an order in which the court dismissed the application for preliminary measures filed by Insulet against EOFlow. Delivered on 22 November 2024, the order (ORD_56716/2024) dismissed the application based on a finding that the patent enforced was more likely than not invalid, in light of one prior art document (a US patent) which was analysed in the decision. Consequently, the court deemed it unnecessary to address all other invalidity arguments raised by the defendant, nor the other requirements for issuing preliminary measures.

Interestingly, this decision also addresses the issue of admissibility of auxiliary requests to amend the patent pursuant to Rule 30.2 of the Rules of Procedure (RoP) in the framework of urgent proceedings. The court concluded that such requests are not admissible in proceedings for provisional measures, in accordance with the necessary expediency of the procedure, which requires urgency/imminent prejudice, and, at the same time, the necessity to respect the adversarial principle and the right of defence of the other party.

To date, the Milan CD has dealt with a number of case management and procedural issues, but has yet to issue a decision on the merits of a revocation action, having been active for less than one year. As indicated above, the cases running in the Milan Central Division appear to be on target to meet the time lines stipulated in the UPC Rules and so the first substantive decisions will emerge in the summer of 2025.

Considering that – as mentioned above – the Milan CD is still in its early stages, no leading cases in terms of substantive law issues addressed can yet be identified.

The following cases are pending before the CD Milan at the time of publication of the guide (30 June 2025).

Maschio Gaspardo v Spiridonakis Bros

Infringement action, filed 30 August 2024

The case, which involves a counterclaim for revocation, concerns a patent by Maschio Gaspardo covering a reversible tool for agricultural subsoilers and the like. Notably, in the context of this case, in order to best understand the functioning of the tool covered by the patent (which could be best evaluated when mounted on an agricultural soiler), the Milan CD decided – with order of 15 May 2025 and in accordance with Article 53 UPCA and Rule 170 RoP – to carry out an inspection of the patented machine and of the challenged embodiment at the applicant’s premises, since it would have been not feasible or very difficult to transport to the court the complete machine (weighing around 2 tons) or even just the anchor member subject of the patent (approximately 200kg). The inspection – scheduled for 10.30am on 4 June 2025 – was then followed by the continuation of the public hearing at the premises of the Milan CD, starting at 3.30pm. No information is currently available to the public on the patent law issues involved in the case, as no final judgment has yet been issued.

Biomerieux UK v Labrador Diagnostics

Revocation action, filed 5 September 2024

The case concerns the validity of Labrador Diagnostics’ patent covering a modular point-of-care device and uses thereof. No information is currently available to the public on the patent law issues involved in the case.

EOFlow v Insulet

Revocation action, filed 14 October 2024

This case, which follows a request for preliminary measures filed earlier by Insulet against EOFlow (rejected, but later granted on appeal, see 3.6 Court of Appeal Substantive Jurisprudence), concerns the alleged invalidity of one of Insulet’s patents covering a fluid delivery device with transcutaneous access, an insertion mechanism and blood monitoring capabilities. No information is currently available to the public on the patent law issues involved in the case.

Pari Pharma v Philips

Revocation action, filed 23 October 2024

The case concerns the alleged invalidity of a Philips patent covering a nebuliser head with an improved air-flow. Following filing of the case, Philips has filed an application to amend the patent together with its statement of defence. The case is scheduled to be heard at a public oral hearing on 7 October 2025. No other information on the case is yet publicly available.

Amgen v Alexion

Revocation action, filed 31 October 2024

The case concerns the alleged invalidity of an Alexion patent covering treatment of paroxysmal nocturnal haemoglobinuria patients and was filed in the context of ongoing litigation between Amgen and Alexion based on the same patent in Germany and the UPC: in Germany, Alexion had indeed obtained a PI by the Munich Regional Court, which was then overturned by the Munich Higher Regional Court; at the UPC, Alexion was denied a PI by the Hamburg LD, with a decision later upheld by the Court of Appeal in Luxembourg. At the date of publication of this guide, no public information is available regarding the case filed before the Milan CD.

Fisher & Paykel v Flexicare

Revocation action, filed 2 November 2024

This case concerns the validity of a Flexicare patent covering a nasal cannula. The case is still in its very early stages – service of the initial statement of claim only took place on 3 June 2025 – and no public information has yet been made available.

The Presiding Judge and legally qualified judge (LQJ) of the Milan CD, Mr Postiglione, is at ease in interacting with the technically qualified judges (TQJs), due to the established practice in Italian national proceedings of involving court-appointed technical advisers in the case to obtain technical inputs on the validity and infringement of the patent in suit. Such practice will likely be reflecting how the Milan CD handles its cases, resulting in a significant involvement of the TQJs appointed as part of the panel when deciding on technical issues.

Additionally, even if no decision issued to date has addressed inventive step, the role that TQJs are likely to play in the decision-making process of the Milan CD would imply a strong reliance on the problem-solution approach (PSA). The Milan CD is hence expected to lean towards a more consistent EPO-style application of the PSA, influenced by the typical practice of Italian national courts, which consistently adopt the test in assessing inventive step.

As mentioned above, the traditional approach by Italian judges of interacting with an independent technical adviser is likely to influence their interaction with technically qualified judges and their involvement/role in the decision-making process of the Milan CD.

As more and more substantive decisions are issued by the Milan CD in the coming months, substantive law issues such as the approach to claim construction, the relevance of the file wrapper history, equivalence and the assessment of the requirements to grant preliminary injunctions will be addressed by the court.

The only instance, as of June 2025, where the Court of Appeal has been called to review a substantive decision by the Milan CD was in the Insulet v EOFlow case mentioned in 3.3 Pending Cases.

The Milan CD dismissed the request for preliminary measures lodged by the applicant (on the ground that the patent was considered invalid due to lack of novelty), and in the second instance the Court of Appeal reversed the decision, finding that the patent enforced was more likely than not valid and infringed, thus granting the requested preliminary injunction.

Hearings (and interim conferences) held so far before the Milan CD have been well structured and in line with the emerging practice of other central and local divisions. The judge rapporteur provides a short introduction at the outset of the interim conference/hearing mentioning the main topics to be addressed, without providing the views of the panel on such issues. This is in line with the traditional approach of Italian judges in national practice.

Whenever during an interim conference/hearing it is necessary to discuss information or documents to be treated as confidential, the interim conference/hearing is briefly interrupted (and the audio recording thereof is paused as well) to allow any member of the public or other persons not part of the confidentiality club temporarily to exit the courtroom.

The Milan CD has also demonstrated particular flexibility to adjust to the parties’ needs, as it did in the Maschio Gaspardo v Spiridonakis Bros case, where – due to objective difficulty in transporting the machine in suit (or even only part thereof) to the premises of the court for visual inspection – it agreed to carry out an inspection at the applicant’s premises (located outside Milan) immediately before the hearing was held in order to best understand functioning and details of the tool covered by the patent in suit (see 3.3 Pending Cases for more details).

In the limited timeframe in which it has been operational, among the more important procedural issues dealt with by the Milan CD are the possibility for third parties to intervene in pending proceedings, and third party access to documents on case files.

On the first topic, the Milan CD has adopted a rather strict approach, dismissing at least two applications for intervention by third parties in proceedings pending before the court.

In the proceedings for provisional measures between Insulet (patentee) and EOFlow (manufacturer of the allegedly infringing product), an application to intervene was filed by Menarini (distributor of the product in suit) in support of EOFlow’s claims. The Milan CD dismissed the application (ORD_52068/2024) based on two main considerations, as follows.

• Due to their urgent nature, interim injunction proceedings must not be overloaded, for example with interventions that could slow down the proceedings, and that could be more efficiently done in subsequent proceedings on the merits. Intervention in interim injunction proceedings is therefore available only in exceptional cases.
• The intervener must have a legal interest in joining the proceedings, that is to say that the outcome of the same would directly affect its rights. In that case the court concluded that Menarini had not been shown to have a proper legal interest, but rather only a factual interest in the outcome of the case (in so far as it was the distributor of the allegedly infringing product in suit and could be negatively affected at a commercial level by a preliminary injunction).

In a second case pending between Accord and Novartis (now settled), Zentiva filed an application to intervene in the proceedings in support of Accord’s claims. Once again, the Milan CD dismissed such application (ORD_10348/2025). Albeit recognising the similarities between the positions of the original claimant and of the intervener, the court noted that allowing an intervention requires the applicant to prove not only a mere factual interest, but rather a legally qualified interest, determined by the need to prevent the direct impact, in its own domain, of any harmful consequences deriving from the judgment.

On the second topic concerning third-party access to documents on case files, the Milan CD also adopted a strict approach. See 4.3 Third-Party Access to Documents for more details.

So far the Milan CD has adopted a rather strict approach in scrutinising requests to access documents of the case by third parties not directly involved in the proceedings.

In the same Accord v Novartis case mentioned in 4.2 Key Procedural Issues, Stadapharm requested access under Rule 262.1(b) RoP to documents and pleadings of the case, citing an interest in reviewing the content thereof to verify the consistency of Novartis’ arguments with those put forward in other pending proceedings before a German national court against Novartis, concerning the same patent in suit.

The Milan CD reasoned that access to documents on file must be assessed on the basis of a proper balancing of the interest of the applicant – on the one hand – and the interest in the integrity of justice on the other hand, being “integrity” understood as an area of freedom for the parties to deploy their defences free from influence and any form of conditioning by third parties active on the same market. In the specific case at hand, the court concluded that Stadapharm’s specific interest relating to its defence before another court was outweighed by the general interest to safeguard the integrity of the UPC proceedings in which the access request was made, hence dismissing the application (ORD_68703/2024).

No publicly known procedural issues worth noting are pending at the time of writing.

Decisions in the limited number of cases dealt with so far do not indicate any significant influence of prior local practice on procedural issues handled by the Milan CD, except for the above-mentioned strict approach to third-party access to documents on case files, as already highlighted in 4.3 Third-Party Access to Documents, which is likely to have been influenced by traditional Italian practice.

No decisions by the Milan CD have been reformed to date by the Court of Appeal in relation to procedural issues.

So far, no specific trend has emerged before the Milan CD as regards the approach of litigants to determining the value of the case, and consequently to the level of court fees being paid. In the only substantive decision issued so far, in the mentioned Insulet v EOFlow urgent proceedings for provisional measures, the value of the case was set as per the amount proposed by the claimant (EUR2.5 million: see ORD_56716/2024). The issue will be addressed in the first decisions on the merits, which the Milan CD will start issuing soon after publication of this guide (30 June 2025).

Court fees at the UPC are generally much higher than national fees, in particular in relation to revocation actions to be brought before the Milan CD, where the fixed fee is EUR20,000. National fees for initiating patent proceedings (including revocation actions) are typically limited to around EUR1,000.

This is arguably one of the reasons why pure national Italian patent litigation has not yet shifted to the UPC (as opposed to other jurisdictions, where UPC costs are comparable to costs for national patent litigation).

Despite a number of applications for a cost decision having been filed (four), no decision has yet been issued in this regard at the time of publication of this guide.

As regards costs, it is interesting to note that the Milan CD has addressed the issue of confidentiality of information submitted by the parties to determine the amount of costs to be awarded. In an order issued in the Insulet v EOFlow proceedings for provisional measures (ORD_25720/2025), the Milan CD held that, in principle, the costs of the proceedings are not covered by confidentiality under Rule 262A RoP or by the attorney–client privilege unless they are specifically indicative of the company’s financial capacity, its commercial strategy or the importance of the patent as a corporate asset. Applying these principles, confidentiality might be granted in relation to costs incurred by the parties for legal services relating to litigation and patent protection, since such information might indicate the importance that companies attach to the patents they hold and the risks they are willing to take to protect them.

No awards of damages have yet been issued by the Milan CD.

Parties litigating before the Milan CD can expect to benefit from some of its particular features. First, the current docket remains relatively clear, with a low number of pending cases, ensuring greater efficiency and shorter time lines. Moreover, the judges appointed are highly experienced in patent litigation, benefiting from their judicial expertise in both Italian and foreign IP courts. As mentioned, in particular, the Presiding Judge Mr Postiglione is also accustomed to interacting with TQJs in light of his previous national practice, predictably resulting in significant involvement of TQJs in the decision-making process of the Milan CD.

Over the next two years, a notable trend in patent litigation before the UPC is expected to be the gradual reduction of the current concentration of cases in German local divisions, with a more balanced distribution of litigation across different UPC divisions. Such redistribution is anticipated to be facilitated by the emerging harmonisation of case law by the Court of Appeal, which will promote greater consistency and legal certainty across the participating jurisdictions, encouraging broader venue selection by litigants.

National patent litigation in Italy is likely to retain a significant role, primarily due to its substantially lower costs compared to proceedings before the Unified Patent Court. It will remain particularly relevant for disputes of local importance. Moreover, in certain sectors – such as pharmaceuticals involving secondary inventions – national litigation may continue to be preferable for patentees, allowing them to avoid central revocation risks and better manage litigation exposure tied to high-revenue products.

Additionally, in recent years since the inception of the UPC, national courts have seen significant activity in relation to actions aimed at securing the lock-out effect on opted-out patents under Article 83.4 UPCA – a trend that may further intensify in the future. Italian assertions may also continue to play a role in situations where the patentee wishes to anticipate enforcement, without waiting for grant of the patent by the EPO. This is because Italy is one of the few jurisdictions that allows courts to issue exclusionary remedies on the basis of patent applications.

One of the immediate points to be addressed to enhance the efficiency and user experience of the system is improving the handling of online case files. Significant expectations are placed in this respect on the new case management system anticipated to be operational later in 2025.

Additionally, a greater interaction between the panel and the parties during hearings would be beneficial. A mechanism to support this goal, which may be achievable across all LDs, could include the panel providing parties with a list of key questions (even refraining from setting out a preliminary view/opinion) ahead of the hearing. Inspired by practices in international arbitration, this would facilitate focused discussion without any risk of perceived anticipation of judgment by the panel.

Other, relatively more ambitious potential improvements to be considered include

• allowing a defendant to rely on invalidity arguments as a defence to infringement without requiring the defendant to file a counterclaim for revocation – doing so currently necessitates the payment of substantial court fees, which could discourage SMEs in particular from challenging the validity of a patent enforced and may be perceived as a limitation to the right of defence of the defendant; and
• expanding the scope of Article 49 of the UPCA to account for the possibility to designate a language of one of the contracting member states other than the language of the patent as the language of the proceedings.