The UPC's Dual Challenge: Forging Rules for Front-Loading and Public Access

The Unified Patent Court (UPC) is the most significant development in European patent litigation in a generation. Efficiency and predictability are the central pillars of the procedural framework of the UPC, and two of the main features of this framework are the “front-loaded” approach and the discipline governing public access to written pleadings and evidence pursuant to Rule 262.1 (b) RoP.

This article focuses on these key legal challenges: first comparing the application of the "front-loaded" approach across two different UPC divisions, and then shifting to the analysis of a recent decision by the UPC Milan Local Division regarding public access to procedural materials.

Striking a Balance: The UPC’s Front-Loaded Approach in Theory and Practice

An Analysis of Emerging Case Law from Milan and Brussels

The "front-loaded" approach demands that parties present the entirety of their case, including all facts, arguments, and evidence, at the earliest possible stage of the proceedings. This principle is enshrined in the UPC's Rules of Procedure (RoP), and marks a departure from the more iterative, and often protracted, litigation styles common in many national jurisdictions across the European Union.

As the UPC concludes its second year of operation, a body of jurisprudence is beginning to form, providing critical insight into how its judges will interpret and apply this and other foundational principles. Two recent orders, one from the Central Division in Milan in EOFLOW Co., Ltd. v. Insulet Corporation (UPC_CFI_597/2024) and another from the Local Division in Brussels in OrthoApnea (UPC_CFI_376/2023), offer a compelling diptych on the practical application of the front-loaded system.

While on the surface these decisions appear to signal divergent approaches—one strict, the other flexible—a deeper analysis reveals a nuanced and coherent doctrine emerging, seeking balance between procedural efficiency and the fundamental rights of the parties. These two key decisions provide essential guidance for litigants navigating this new judicial landscape on how the Courts are interpreting the boundaries of the UPC Rules of Procedure.

The philosophy of the UPC procedure is clearly articulated in the Preamble to the Rules of Procedure (Paragraph 7) which states, "Parties shall cooperate with the Court and set out their full case as early as possible in the proceedings". This is not merely an aspirational statement; it is a directive that is woven into the fabric of the procedural rules.

The primary instruments for enforcing this principle are the rules governing the initial written pleadings. Rule 13 RoP dictates the content required in a Statement of Claim, which is exhaustive. For example, in infringement actions, a claimant must provide not only the patent claims alleged to be infringed but also a detailed "indication of the facts relied on”, the "evidence relied on", and the "reasons why the facts relied on constitute an infringement of the patent claims, including arguments of law and where appropriate an explanation of the proposed claim interpretation". The defendant faces a parallel obligation to be comprehensive in its Statement of Defence under Rule 24 RoP.

This structure is designed to ensure that from the very outset, the scope of the dispute is clearly defined, enabling the defendant to understand the allegations made against it and to prepare an adequate defence and allowing the Court to efficiently manage the case. The principle is further supported by rules on evidence, such as Rules 171 and 172 RoP, which specify that a party asserting a fact must (contemporaneously) indicate the means of proving it. Moreover, if a party does not indicate the means of evidence supporting a contested fact, the Court shall take this omission into account when deciding the issue in question.

The critical question for practitioners, however, is where the line is drawn. To what extent can a party supplement or amend its case in response to arguments raised by the opposing party? It is here that the EOFLOW and OrthoApnea decisions provide crucial, and complementary, clarifications.

Case Analysis 1: EOFLOW v. Insulet – A Strict Stance on Foundational Evidence

In the proceedings before the Milan Central Division, the Court presided over a revocation action brought by EOFLOW Co., Ltd. against a patent held by Insulet Corporation. The procedural timeline included the filing of a revocation application, a revocation defence, a reply to the revocation defence, and a rejoinder to the revocation application. In its reply to the revocation defence, thus well into the written procedure, EOFLOW introduced a new prior art document, US '159 (Flaherty), for the first time. Insulet objected to the reference as not timely, and the Court was tasked with deciding on the admissibility of this prior art.

The Court’s decision was unequivocal: the prior art document was inadmissible. The reasoning behind this ruling constitutes a powerful affirmation of a strict interpretation of the front-loaded approach, particularly in the context of revocation actions.

In so ruling, the Court stated that "… whenever a party proposes to bring an action before the UPC, it must take care to collect in advance the documents supporting the claim. The procedure before the UPC is in fact a front-loaded procedure, where the written procedure allows the parties to confront with replies and rejoinders based on a wealth of knowledge and documents that are supposed to be stable and consolidated from the very moment the claim is filed. In general, the parties are obliged to present their complete case as early as possible (RoP Preamble, para. 7, last sentence)."

In other words, the Court holds that, at least in a revocation action, the claimant has an obligation to collect all documents supporting its claim in advance. Introducing prior art at a late stage was deemed to be contrary to this principle, as it fundamentally "prevents the opponent from filing full observations... on a crucial point of the legal assessment".

The Court took the position that ruling otherwise would violated the adversarial principle enshrined in Article 76 of the UPC Agreement (UPCA), which requires that decisions be based only on facts and evidence on which the parties have had an opportunity to comment. To successfully introduce a prior art document later in the proceedings, EOFLOW would have had the burden to prove that the document could not have been submitted earlier, which it failed to do. To the contrary, the Court noted that EOFLOW had ample time since the initial preliminary injunction action was filed in July 2024 to conduct a thorough prior art search and, thus, EOFLOW was in a position to file all of the relevant prior art documents with its revocation application.

The Court also rejected EOFLOW’s reliance on Rule 263 RoP ("Leave to change Claim or amend its case"), clarifying that this rule "clearly refers to the modification/amendment of legal claims and cannot be used to introduce new evidence on the same legal claim (revocation)". It interpreted the late filing of new prior art not as a mere supplementation of evidence, but as an attempt to modify the subject-matter of the dispute, which would require a formal, and justified, application under Rule 263.

The Milan decision sends a clear message: foundational evidence, such as prior art forming the basis of a revocation claim, must be part of the initial "front load" provided by a litigant before the UPC. A party cannot hold such evidence in reserve to be deployed later in the proceedings.

Case Analysis 2: OrthoApnea – A Flexible Approach to Responsive Arguments

The case before the Brussels Local Division presented a different scenario. The claimant – a Belgian individual and patent owner – filed an infringement action against the Spanish company OrthoApnea S.L. and Vivisol B BV. During the course of the procedure, the claimant filed a Generical Procedural Application entitled “Objections against Equivalence”, and sought, in its Reply to the Statement of Defence, to (i) supplement the factual framework, (ii) supplement the infringement claim with an equivalence argument and (iii) amend the requests for remedies. In support, the claimant cited the application (or non-application) of the following rules: R. 13.1.(l) to (o) RoP: "Content of Statement of Claim"; R. 24 (b) to (g) RoP: "Contents of Statement of Defense"; R. 29 (b) and (c) RoP: "Lodging of Defense to the Counterclaim for revocation, Reply to the Statement of Defense and Rejoinder to the Reply"; and R. 263 RoP: "Leave to Change claim or amend case".

The defendants objected, arguing that these acts constituted impermissible amendments under the front-loaded system.

The Judge-Rapporteur rejected the defendants' objection, offering a more flexible interpretation of the rules that emphasizes fairness and the natural evolution of a legal dispute.

The Court's reasoning was grounded in the purpose of the rules. In particular, found that the goal of Rule 13 RoP is to "avoid... overly summary and/or unsubstantiated argumentation, in which a claimant would be limited to raising general pleas without elaborating them sufficiently and/or without substantiating them sufficiently factually so as to place a defendant in the practical impossibility of defending himself concretely. In testing this standard objective against the concrete Statement of Claim ("Statement of Claim"), the standard should be a reasonable and prudent person (claimant) placed in the same circumstances.”

Most importantly, the Brussels Court explicitly acknowledged the "procedural-evolutive course of a judicial dispute". It recognized that a claim is followed by a defense, and the claimant must be given an opportunity to respond to that defense. This right to respond may naturally involve elaborating on existing claims or developing alternative pleas. The Court saw this flexibility as inherent in the system, noting that "the right of defense therefore allows an opposing party to adapt or supplement its arguments... in the sense that it deems necessary in the light of the defense."

In this context, the new arguments based on infringement by equivalence were not seen as an impermissible modification of the subject matter of the dispute. Instead, they were considered a direct "response to the Statement of Defense that fit into the procedural-evolutionary course of a judicial dispute." As such, it was not necessary for the claimant to make a formal application under Rule 263 RoP to add this theme to the scope of the dispute. The Court stressed that the procedural framework itself contains mechanisms to ensure fairness, such as the judge's ability to extend time limits or organize additional rounds of submissions to safeguard the rights of defense.

Two Sides of the Same Coin

At first glance, the Milan Court's strict refusal to admit new prior art evidence and the flexible allowance of new arguments exhibited by its counterpart in Brussels might seem contradictory. However, these decisions are better understood as defining the two sides of a single, coherent boundary: the subject matter of the dispute.

The EOFLOW decision establishes that evidence which defines the subject matter of the claim - such as the prior art relied upon for a patent revocation action - must be front-loaded. The introduction of new prior art later in the proceedings is not merely the supplementation of an argument or a position, but fundamentally alters the basis of the legal action, thereby changing the subject matter of the dispute itself. This is prejudicial because the defendant has not had a fair opportunity to formulate a defense on the basis of all prior art and cannot necessarily respond adequately to the new evidence during the procedural stages of the case.

Meanwhile, the OrthoApnea decision clarifies that arguments and facts introduced in direct response to the other party's pleadings, which remain within the confines of the originally defined subject matter, are permissible. In the view of the Brussels court, raising an argument for infringement by equivalence in response to a defense challenging literal infringement does not change the core subject matter of the dispute - which remains the question of whether a specific product infringes a specific patent. It is an evolution of the argument within that established scope.

The key distinction lies between introducing a new foundation for the case (which is impermissible without leave under Rule 263 RoP) and building upon the existing foundation in response to the opposing party’s actions (permissible as part of the procedural dialogue).

The EOFLOW and OrthoApnea decisions provide invaluable early guidance on the UPC’s front-loaded procedural approach. They demonstrate that while the UPC Courts are serious about enforcing procedural discipline to ensure efficiency, this will not be allowed at the expense of fairness or the fundamental right of defense. The emerging doctrine is one of principled flexibility.

For parties litigating before the UPC, the practical takeaways are clear:

1. Meticulous Preparation is Non-Negotiable: The front-loaded system places an immense burden on parties to prepare their entire case before filing. For revocation claimants, this means conducting an exhaustive and definitive prior art search from the outset. For infringement claimants, it means fully articulating all grounds for infringement, including – where possible – pleading in the alternative (e.g., literal infringement and infringement by equivalence) in the initial Statement of Claim.
2. Understand the Scope of Your Dispute: The concept of the "subject matter of the dispute" is paramount. Any evidence or argument that could be seen as defining or modifying this subject matter must be included in the first filing.
3. Frame Responsive Submissions Carefully: When introducing new arguments or facts in a Reply, it is critical to frame them as direct and necessary in response to the points raised in the Statement of Defence, to position new material not as an ambush, but as a legitimate part of the procedural dialogue.
4. Do Not Rely on Rule 263 as a Safety Net: As the Milan Court made clear, Rule 263 RoP is not a tool for correcting a failure to front-load foundational evidence. It is intended for genuine and justifiable changes to a party's legal claims, and leave to amend will not be granted lightly.

As the Unified Patent Court continues to hear cases, its jurisprudence will undoubtedly add further texture to these principles. However, the early signals from Milan and Brussels suggest the Court is successfully forging a path that honours the efficiency goals of its front-loaded system while preserving the procedural fairness essential to robust and just adjudication of disputes.

The Milan Local Division on Rule 262.1(b): A New Chapter for Public Access within the UPC

Shifting gears, there are interesting clarifications emerging from the UPC case law on the rules on public access to materials filed within the scope of a dispute before the UPC.

The rules governing public access to pleadings and evidence filed in a specific case are set out in Rule 262.1(b) RoP, which states that third parties may, under certain conditions, gain access to the contents of UPC case files. However, the Rules of Procedure do not specify the grounds on which such a request may be granted, leaving its scope to be defined by judicial interpretation.

This rule is an expression of the principle of transparency and public access which has been developed at the European level, aimed at allowing the public to exercise a degree of control over public authorities, including the judiciary.

Consequently, while the right to access case documents and pleadings within the UPC system is theoretically clear, the UPC Courts have diverged on its practical application. The different approaches adopted by local UPC Courts that have dealt with access requests may also be closely linked to the legal traditions of the judges presiding over these requests.

This section will provide a brief overview of the first round of decisions on public access to case materials issued by the different UPC divisions, and then analyse a particularly interesting order issued by the Local Division Milan in February 2025.

Munich and the Nordic-Baltic Divisions Present Divergent Approaches

One of the first important rulings on third-party access to court files came from the Central Division in Munich Division in the case UPC_CFI_1/2023, Sanofi-Aventis Deutschland GmbH and others v. Amgen Inc. In this case, a third party applicant had requested access to the case documents declaring that the purpose of his request was to form an opinion on the validity of the disputed patent.

The Court rejected the request, arguing that access to a case file must be subject to the existence of a legitimate, concrete, and verifiable reason, which in the case at issue was not sufficiently proved. Specifically, the Court stated that “the mere ‘wish’ from a natural person to form ‘an opinion’ on the validity of a patent out of a ‘personal and a professional interest’ cannot be accepted as a sufficiently concrete, legitimate reason to make available all pleadings and evidence in this case”. The Court went further, specifying that an opinion on the validity of a patent can be formed on the basis of its prosecution history and the prior art, without needing access to the court file.

The reasoning behind the Court’s decision lies in the clear distinction between the public nature of the proceedings, guaranteed by Article 45 UPCA, and that of the files of the proceedings, which are not considered automatically public. Access to such files requires a case-by-case assessment of the grounds for access presented by the applicant.

Conversely, about a month after the publication of the decision of the Central Division Munich, in the case UPC_CFI 11/2023, Ocado Innovation vs Autostore, the Nordic-Baltic Local Division adopted a broader interpretation of the principle of public access.

In that case, the third party applicant filed a request to access specific materials from the proceedings, including the statements of claim and all orders from the infringement action, as well as all orders from parallel cases between the same parties in others UPC local divisions. The applicant justified its request on the grounds that it wanted to see how the claim was framed, also putting forward public interest argument, emphasizing that granting access would allow for public scrutiny and discussion in light of the launch and development of the new UPC system as a whole. The request was granted by the Court, holding that court files should in principle be accessible to third parties, and access should only be denied in the presence of valid reasons for keeping them confidential, such as—for example—the interest of one of the parties or broader reasons of justice and public order.

The Court of Appeal's Decision: A Compromise

The decision of the Nordic-Baltic Division granting third party access to court files in the Ocado Innovation vs Autostore case was appealed to the Luxembourg Court of Appeal.

In its decision, the Court of Appeal first affirmed that transparency is a principle applicable not only to the proceedings themselves, but also to the documents within the proceedings. However, judges are still required to verify that the third party's request is supported by adequate reasoning and, in particular, that the request specifies the purpose for which the documents are to be consulted.

Furthermore, the Court adopted a compromise position between the arguments used by the UPC Divisions that had previously dealt with the issue, shifting the reasoning to the interests at play both during the pendency of proceedings and upon its conclusion. Specifically, the Court of Appeal stated that while an action is ongoing, the principle of integrity of the action should prevail, as public access to documents could prejudice the parties' ability to freely present their arguments. Therefore, to be successful in a Rule 262.1(b) request for access to materials while a case is still ongoing, the applicant must demonstrate a direct interest in the outcome of the dispute. Conversely, once the proceedings have concluded, whether by settlement or a court order, the general interest in transparency prevails and creates a strong presumption in favour of granting access to the documents, unless the parties have specific reasons to claim confidentiality for the requested materials.

While not delving extensively into the specific arguments that should guide the courts in deciding whether to grant or deny a request for access, the Court of Appeal's decision has quickly become a cornerstone of the UPC's legal framework.

The Milan Local Division: A Decision in Favor of Procedural Integrity

The Milan Local Division soon followed the lead of the approach of the UPC Court of Appeal in a recent decision rejecting a third party request for access while proceedings are in course. With Order No. ORD_4166/2025 of February 20, 2025, in the case Bhagat Textile Engineers vs. Oerlikon Textile GmbH & CO KG and Himson Engineering Private Limited, the Milan Local Division provided a crucial interpretation of Rule 262.1(b) RoP.

Taking its cue from the Court of Appeal's decision in Ocado Innovation vs. Autostore, the Milanese order focused on the criteria the Court must follow to balance a third party applicant's interest in accessing materials from pending proceedings with the need to protect the integrity of that action as a whole.

In this particular case, the Court rejected a third party application for access to the pleadings and evidence of pending proceedings submitted by an applicant that was a party to parallel patent infringement proceedings pending on the same patent,. While it had the opportunity to do so, the applicant did not appeal the Milan Division’s order denying access.

The two parallel cases were connected by subject matter, in the sense that the same patent owner filed infringement actions enforcing the same patent against different defendants. However, the two actions were pending at different stages: the case in which the applicant filed a request for access to materials was still in the first instance, while the applicant's own case was already on appeal. Another key difference between the two cases was that in the first instance action from which the applicant sought materials, the defendant had filed a counterclaim to revoke the patent. In contrast, in the applicant own case on appeal, they had only raised limited defenses, and did not file a revocation counterclaim.

Having lost at the first instance of its own patent infringement action, the applicant appealed the decision. Before the Court of Appeal in Luxembourg, the applicant requested a stay of proceedings, arguing that the validity of the same patent was pending in the parallel case. However, the Court of Appeal rejected this request, on the grounds that the applicant's arguments were too generic and merely referenced a pending counterclaim in another proceeding.

Consequently, the third party applicant lodged a request for access to the pleadings and evidence of the parallel case pending before the Milan Local Division. The justification for the requests for access as per Rule 262.1(b) RoP was that the applicant specifically needed the requested materials and information in order to respond to the Court of Appeal’s refusal and build a stronger basis for its stay request.

Based on a thorough analysis of the case, and considering the relevant jurisprudence and the rationale behind the tool provided to allow third party access to materials from UPC proceedings, the Milan Local Division rejected the applicant’s request. The refusal was based on a series of reasons that can be summarized in the following five points:

1. Alternative Access to Information. The Local Division pointed out that the applicant could – but did not – seek to obtain some of the requested information by simply consulting the published decisions and orders on the UPC Registry, namely the status of the proceedings, some relevant procedural developments, and the identification of two prior art documents invoked by the defendant for the revocation of the patent. The Court noted that the applicant had not used this available information to support its stay request, and this was specifically one of the reasons the stay request was rejected.
2. Protection of Integrity of Proceedings. The Court emphasized the need to protect the integrity of the pending proceedings as an expression of the superior interest of justice. According to the Milanese judges, this principle also includes safeguarding the parties' freedom to make unconditional strategic decisions, such as initiating negotiations for an amicable settlement of the dispute, without being influenced by a potential assessment of the disputed patent's validity that is made by the appeal or other first-instance judges.
3. Imminent Conclusion of the Main Proceedings. The Court noted that the oral hearing for the proceedings before the Milan Court was scheduled to take place before the likely conclusion of the applicant’s appeal proceedings. Consequently, if the patent was revoked, the applicant could simply file the decision – which would be public – in its appeal proceedings. This would eliminate any risk of conflicting judgments and also make it unnecessary to grant the requested access.
4. Previous Negative Ruling by the Court of Appeal. The order also noted that the Court of Appeal had already rejected the applicant's request for a stay on several grounds, including the applicant’s failure to provide information about the status of the proceedings and the applicant's previous procedural choices. Consequently, granting the applicant’s request for access would not be beneficial, as it would not have resolved the other reasons behind the Court of Appeal’s rejection of the stay.
5. Lack of a Specific and Qualified Interest. The Court emphasized that the applicant, in its parallel proceedings, had not challenged the validity of the patent nor the claim for infringement, which precluded its right to challenge the patent on appeal. The Milanese Court thus drew a sharp distinction between the applicant's position and that of a competitor who is actively challenging the patent in a parallel proceeding (before national courts, the UPC, or the EPO), as well as that of a market player who needs information on the patent to guide their business decisions. These two situations were offered as examples of cases that may be deemed worthy of protection, while the applicant’s situation was not.

To summarize, the decision by the Milan Local Division is particularly noteworthy for several reasons.

First, it reaffirms and better outlines the need to balance the protection of the integrity of proceedings and the interests of the parties to those proceedings when a request for access to a file is made during a pending case. This principle was previously addressed by the Luxembourg Court of Appeal in Ocado Innovation v. Autostore, however, while the Luxembourg Court defined certain examples of situations in which the applicant may have a direct interest in the subject-matter of the proceedings, the Milan Local Division went further. Building on this category, it conducted a more in-depth analysis to verify whether the applicant had an actual interest to assert in the specific situation outlined in the application.

Additionally, the Milan Court’s examination of the procedural and defensive conduct adopted by the third party applicant in the parallel proceedings provide a useful insight. It suggests that a request for access to files should be assessed not merely on the basis of the reasons stated by the applicant, but on a holistic basis that also considers cross-procedural factors that may be relevant across different cases.

The Milanese decision therefore represents a starting point for a new interpretation and application of the reasons that underlie the granting or denial of access under Rule 262.1(b) RoP. Now, all that remains is to wait and see how the other UPC Local and Central divisions will rule on similar issues.

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Appendix: A Snapshot of Growth at the UPC Local and Central Divisions in Milan

A closer look at the UPC's own statistics reveals the growing importance and activity of the Milan Local and Central Divisions, which is particularly interesting as we pass the one-year anniversary of the inauguration of the Milan Central Division. By comparing the court's case load reports from the end of November 2024 with the update from May 31, 2025, there is a clear upward trend that emerges just in this six-months period, particularly in the Milan Local Division.

The Milan Local Division has experienced significant growth in its core activities between November 2024 and May 2025.

• The number of infringement actions has more than doubled, increasing from 7 to 15.
• Similarly, counterclaims for revocation increased threefold, jumping from 2 to 7.
• Applications for provisional measures also saw a modest increase from 4 to 5.

After its opening at the end of June 2024, Milan Central Division has also seen a strong development in its caseload, consisting primarily in stand-alone revocation actions:

• The number of stand-alone revocation actions increased from 7 to 8.
• While the number of infringement actions remained stable at one, the division saw the addition of new case types by May 2025, including one counterclaim for infringement, one request for damages, and one declaration of non-infringement.This data underscores that the Milan divisions are not only active but are attracting new cases of different types. The substantial growth in infringement actions at the Local Division, in particular, signals its establishment as a key venue for patent enforcement within the new UPC system for European patent litigation.

Article published on Legal500 and written by Jacobacci Avvocati.