The Unified Patent Court 2025

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CHAMBERS GLOBAL PRACTICE GUIDES

Definitive global law guides offering comparative analysis from top-ranked lawyers

Contributing Editor Gordon Harris Trevisan & Cuonzo

Global Practice Guides

The Unified Patent Court

Contributing Editor Gordon Harris Trevisan & Cuonzo

2025

Chambers Global Practice Guides For more than 20 years, Chambers Global Guides have ranked lawyers and law firms across the world. Chambers now offer clients a new series of Global Practice Guides, which contain practical guidance on doing legal business in key jurisdictions. We use our knowledge of the world’s best lawyers to select leading law firms in each jurisdiction to write the ‘Law & Practice’ sections. In addition, the ‘Trends & Developments’ sections analyse trends and developments in local legal markets. Disclaimer: The information in this guide is provided for general reference only, not as specific legal advice. Views expressed by the authors are not necessarily the views of the law firms in which they practise. For specific legal advice, a lawyer should be consulted. Content Management Director Claire Oxborrow Content Manager Jonathan Mendelowitz Senior Content Reviewers Sally McGonigal, Ethne Withers, Deborah Sinclair and Stephen Dinkeldein Content Reviewers Vivienne Button, Lawrence Garrett, Sean Marshall, Marianne Page, Heather Palomino and Adrian Ciechacki Content Coordination Manager Nancy Laidler Senior Content Coordinators Carla Cagnina and Delicia Tasinda Content Coordinator Hannah Leinmüller Head of Production Jasper John Production Coordinator Genevieve Sibayan

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Contents

INTRODUCTION Contributed by Gordon Harris and Vittorio Cerulli Irelli, Trevisan & Cuonzo p.4

MILAN LOCAL DIVISION Law and Practice p.79 Contributed by Trevisan & Cuonzo LISBON LOCAL DIVISION Law and Practice p.96 Contributed by NLP LJUBLJANA LOCAL DIVISION Law and Practice p.107 Contributed by Jadek & Pensa Law Firm

MUNICH CENTRAL DIVISION Law and Practice p.10 Contributed by Grünecker HAMBURG LOCAL DIVISION Law and Practice p.29 Contributed by Eisenführ Speiser MANNHEIM LOCAL DIVISION Law and Practice p.42 Contributed by Clifford Chance MUNICH LOCAL DIVISION Trends and Developments p.58 Contributed by Grünecker Patent- und Rechtsanwälte PartG mbB MILAN CENTRAL DIVISION Law and Practice p.66 Contributed by Trevisan & Cuonzo

STOCKHOLM REGIONAL DIVISION Law and Practice p.119 Contributed by Lind Edlund Kenamets Intellectual Property AB

UK Trends and Developments p.139 Contributed by Haseltine Lake Kempner

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INTRODUCTION

Contributed by: Gordon Harris and Vittorio Cerulli Irelli, Trevisan & Cuonzo

Trevisan & Cuonzo is the largest IP practice in Italy and one of the largest boutique IP prac - tices in Europe. With 11 partners and over 40 lawyers, the firm covers all aspects of IP law and practice and works with clients of all sizes – from start-ups to multinationals – in all fields of technology. The firm has already been in - volved in a number of cases before the UPC in the Central and Local Divisions in Milan, and

its lawyers have written and spoken widely on topics related to the development and practice of the UPC and its jurisdiction. As a European firm with a global reach, Trevisan & Cuonzo has three decades of experience in conducting and co-ordinating multi-jurisdictional litigation. Its cross-border teams regularly work alongside lawyers in other jurisdictions in multinational cases.

Contributing Editors

Gordon Harris is an IP lawyer with over 40 years of experience in European Patent law. He was a partner at Gowling WLG for over 30 years and headed the IP team there for 25 years. In 2024,

Vittorio Cerulli Irelli is a partner at Trevisan & Cuonzo and heads the Rome office. An expert litigator with 18 years of courtroom experience, Vittorio joined the firm in 2008. He has

he joined Trevisan & Cuonzo to contribute to the firm’s international growth, and to work with the firm’s lawyers in cases, including those in the UPC, following the withdrawal of the UK from the European Union. Gordon has conducted cases at all levels in the UK, as well as the CJEU, the EPO and OHIM. He is a mediator accredited by CEDR and WIPO and is the Contributing Editor to the Chambers Unified Patent Court Global Practice Guide 2025.

successfully represented many multinational clients before the Italian and European Union courts and agencies in a broad range of high-profile cases with an international dimension, including the first case ever filed before the Milan LD of the Unified Patent Court. Vittorio has published extensively and repeatedly provided expert opinions on Italian law to the German, Dutch and UK Courts. His contentious matters have spanned across a wide range of technologies and industries.

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INTRODUCTION Contributed by: Gordon Harris and Vittorio Cerulli Irelli, Trevisan & Cuonzo

Trevisan & Cuonzo Via Brera 6 Milan 20121 Italy Tel: +39 028 646 3313 Email: info@trevisancuonzo.com Web: www.trevisancuonzo.com

Introduction On 1 June 2023, the Unified Patent Court in Europe opened its doors for the first time. In doing so it became the first multinational juris - diction in the world to deal with private rights. At a stroke it transformed the patent law architec - ture in Europe and created the opportunity for transnational injunctions and damages awards. It was the product of years of development and negotiations across Europe. The Court’s rules were only finalised on the 19th draft and involved a great deal of bartering and compromise. How - ever, the end result is a holistic system of litiga - tion with first instance courts around Europe all operating under the same rules of procedure, and a Court of Appeal based in Luxembourg to bring together the decisions and create a con - sistent jurisprudence. This introduction aims to set out the basics of the new court and system and create the foun - dation from which other contributors can build a comprehensive model of the new court system in this overall guide to the new Unified Patent Court (UPC). History There has been a form of centralised patent sys - tem in Europe for over 50 years, based around

the European Patent Convention of 1973 (EPC). The EPC created an environment for centralised patent applications and prosecution, based in Munich and allowing for a single application that could be prosecuted in one office and would, in the end, yield a basket of national patents. There are currently 39 contracting states of the EPC. The EPC is not a treaty of the European Union, and it includes countries that are not even in the Enlarged Economic Area (EEA). The most notable example is the United Kingdom, which recently departed the European Union but remains a full member of the EPC. Other examples are Ice - land, Switzerland and Turkey. As part of the ongoing project to perfect the Sin - gle European Market within the European Union, the notion of a Unified Patents Court emerged originally from the Community Patent Conven - tion of 1975. However, it was not until February 2013 that 25 member states of the EU signed the Unified Patents Court Agreement (UPCA), which set in train the preparation of the necessary rules and structures for the Court that finally opened in June 2023. Which Countries Can Participate? Any full member state of the European Union has the option to participate, but Spain, Poland and

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INTRODUCTION Contributed by: Gordon Harris and Vittorio Cerulli Irelli, Trevisan & Cuonzo

Croatia chose not to sign the UPCA in 2013 and have not done so in the following years. To participate in the Court procedure, all the signatories of the UPCA have to formally ratify the Agreement. As of the date of publication of this guide (30 June 2025), 18 European Union member states have formally ratified the UPCA and are now participating member states of the new court. They are (in full): Austria, Belgium, Bulgaria, Denmark, Estonia, France, Finland, Germany, Italy, Lativa, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Romania, Slove - nia, Sweden. Signatories that are yet to ratify are Cyprus, Czechia, Greece, Hungary, Ireland, and Slovakia. The remaining country of the original 25 signa - tories is the United Kingdom, which withdrew in 2020 following the Brexit referendum. What Patents Are Involved? The default position is that all European patents designated in participating member states are within the jurisdiction of the UPC. However, the option exists for owners of extant patents to opt out of the system. There was a sunrise period prior to the commencement of the UPC for pat - entees to notify the court office that they wished to opt out specific patents. During a transitional period for seven years from the commencement of the UPC, patent owners can still have their patents opted out of the system. Once opted out, a patent is outside the scope of the UPC for its full life, unless the owner exercis - es its right to opt back in at any time, for example if it wishes to commence a large enforcement action. Once a patent is opted back in, it cannot be opted out again.

As of the commencement of the UPC, another option is open to new patent applicants. Instead of seeking a basket of national patents as in the previous system, they may seek a UP designa - tion, which gives rise to a single Unitary Patent across the full scope of the participating member states. National designations can still be sought for non-participating or non-EU countries. Structure of the UPC The UPC has two tiers. At first instance there are Local Divisions, a Regional Division and a Central Division. Above that sits a single Court of Appeal. Specific questions of EU law can also be referred to the Court of Justice of the Euro - pean Union. Each participating country is entitled to host a Local Division court. Due to the sheer volume of cases handled in Germany, it was allowed four Local Divisions. Some countries have not yet established a Local Division. Cases that should be commenced in those countries (see “Jurisdiction” below) must be commenced in the appropriate Central Division. If a group of countries agreed that they did not have sufficient work for individual Local Divi - sions, they were entitled to open a Regional Division – a single court that covers all of the countries involved. Only one such Regional Divi - sion has been created so far – a Baltic Division covering Sweden, Latvia, Estonia and Lithuania. The Central Division has its seat in Paris, with sections in Milan and Munich. They primarily deal with revocation actions and declarations of non-infringement, with cases allocated across sections based on the technology of the patent (see “Jurisdiction” below).

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INTRODUCTION Contributed by: Gordon Harris and Vittorio Cerulli Irelli, Trevisan & Cuonzo

The single Court of Appeal is based in Luxem - bourg, which is also the home of the CJEU. The role of the Court of Appeal is crucial. Although all the Local Divisions are operating under the same procedural rules, judges will have differ - ent backgrounds, increasing the likelihood of some divergence in the early decisions on the key patent law principles. The job of the Court of Appeal is to create consistency and to establish clear doctrines in relation to important patent controversies like the doctrine of equivalents, file wrapper estoppel and approaches to claim construction. In addition, there are two Centres for Arbitration and Mediation of patent disputes, in Lisbon and Ljubljana. In the Local/Regional Divisions, cases are heard by a panel of three legally qualified judges and typically one technically qualified judge. In the Central Division, the panel comprises two legally qualified judges and one technically qualified judge. The Court of Appeal comprises three legally and two technically qualified judges. The judges, along with the mediators and arbi - trators, are all regularly trained. The training cen - tre in Budapest is not yet operational, pending ratification of the UPCA by Hungary, and training takes place in other locations, selected by the Court on a case-by-case basis. Operation and Procedure of the UPC The Local Divisions are decentralised and oper - ated locally, though actions in all divisions can be commenced using the UPC’s Case Manage - ment System (CMS) – an online resource that governs the commencement and management of all UPC cases at all levels. More information on the CMC can be found at the UPC’s website.

All the first instance Divisions and the Court of Appeal are operated in accordance with the Rules of Procedure of the Unified Patent Court. This is a comprehensive set of rules governing all circumstances arising in the conduct of litiga - tion before the UPC. If a question of EU law is referred to the CJEU, then the rules of that court apply to the procedure. The UPC rules stipulate a strict timescale for the conduct of cases in all first instance divi - sions. The objective is to deliver effective and high-quality justice in a timely fashion. Accord - ingly, the rules stipulate that all cases should be completed approximately 12 months after they are commenced. There are rules governing the necessary content of initial pleadings, as well as detailed provisions regarding issues such as evidence gathering, the conduct of experiments, possible cross-exami - nation of witnesses, and very limited orders for the disclosure of documents. The rules are an amalgam of rules from many of the countries participating in the UPC, and indeed UK proce - dure as it was involved in the preparatory stages. There are provisions for significant cost recov - ery by the successful parties – something that is generally not common in European patent liti - gation. Jurisdiction – Commencement of Actions The Rules of the UPC provide for the nature of the jurisdiction, which is in line with the Recast Brussels Regulation and the Lugano Conven - tion. Infringement actions should be brought in the Local or Regional Division for the country where the defendant is domiciled. If that country does not have a Local or Regional Division then the

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INTRODUCTION Contributed by: Gordon Harris and Vittorio Cerulli Irelli, Trevisan & Cuonzo

infringement action can be brought in the appro - priate seat of the Central Division. Alternatively, infringement actions can be brought before the Local or Regional Division where the actual or threatened infringement has occurred or may occur. Actions for revocation or declarations of non- infringement are to be brought in the appropri - ate seat of the Central Division. The correct seat of the Central division is decided on the basis of technology types. These are divided as fol - lows, using the International Patent Classifica - tion operated by the World Intellectual Property Organisation: • Milan – Class A – Human Necessities includ - ing pharmaceuticals; • Munich – Classes C and F – Chemistry, met - allurgy and mechanical engineering; and • Paris – Classes B, D, E, G and M – Physics and electronics plus all cases regarding Sup - plementary Protection Certificates. If a counterclaim to an infringement action con - tains a request for revocation, the presumption is that the case will remain in the Local Division where the infringement action was commenced. The court has discretion to transfer the case to a Central Division if that seems appropriate. So far, this option has been exercised in a very limited number of cases, mostly in situations where a parallel revocation action was pending before the Central Division. Actions regarding Standard Essential Patents (SEPs) can be brought in the UPC, which has reserved the right to set rates for Fair, Reason - able and Non-Discriminatory (FRAND) licence terms by way of a counterclaim to an infringe - ment action.

There are comprehensive provisions for the grant of preliminary relief. Jurisdiction – Enforcement of Judgments If the court finds the patent in suit valid and infringed, it may grant an injunction covering all the participating countries, if the patent in suit was designated in each of those countries. In the case of Unitary Patents, a full injunction will be automatic. Damages may also be recovered in relation to sales in all participating countries where the patent was designated. This covers an economic area of over 300 million consumers and a total GDP of almost EUR14 trillion. A recent decision of the CJEU (BSH v Electrolux) has indicated that the jurisdiction of the UPC may extend beyond the boundaries of the par - ticipating countries. The judgment confirms that the courts of a country where a patent is grant - ed have exclusive jurisdiction over questions of validity and registration but that the courts of the country where the defendant is domiciled have a general jurisdiction over the question of infringement in any country where the patent is granted. This includes the EU states not, or not yet, participating in the UPC, and third countries, like the UK and Turkey, where a European pat - ent can be designated in the EPC system, even though they are outside the European Union. This so-called long-arm jurisdiction has been applied several times already by Local Divisions of the UPC. Summary The UPC has now been running for more than two years and appears to have already made a significant impact. The number of actions com - menced (over 700), the quality of its judgments (generally considered to be strong) and the inter -

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INTRODUCTION Contributed by: Gordon Harris and Vittorio Cerulli Irelli, Trevisan & Cuonzo

est shown from outside Europe all speak of an effective and properly functioning court. The Court of Appeal is already fulfilling its role to establish consistency across all of the Divisions of the court. This guide will now look at the progress of the UPC on a “division by division” basis, providing users with practical information regarding the operation of the divisions, along with strategic and tactical guidance from firms with know-how and experience from all over Europe.

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MUNICH CENTRAL DIVISION

Law and Practice Contributed by: Julia Traumann and Ulrich Blumenröder Grünecker

Contents 1. General Information p.13 1.1 Basic Information p.13 1.2 UPC Judges p.13 1.3 Specific Procedural Issues p.14

1.4 Regional Division Competence p.14 1.5 Central Division Competence p.14 1.6 Court of Appeal: Purpose and Procedure p.15 2. Statistical Information p.15 2.1 Types of Actions p.15

2.2 Substantive Hearings p.15 2.3 Case Classification p.16 2.4 Time Lines p.16 2.5 Interaction Between Central and Local/Regional Divisions p.16

3. Substantive Law p.17 3.1 Topics Covered p.17

3.2 Leading Cases p.18 3.3 Pending Cases p.19 3.4 Technically Qualified Judges p.20 3.5 Influence of Prior Local Practice on Substantive Legal Decisions p.20 3.6 Court of Appeal Substantive Jurisprudence p.20 4. Procedural Issues p.20 4.1 Hearing Structure p.20 4.2 Key Procedural Issues p.20 4.3 Third-Party Access to Documents p.23 4.4 Pending Procedural Issues p.23 4.5 Influence of Prior Local Practice on Procedural Issues p.23 4.6 Court of Appeal Procedural Jurisprudence p.24

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MUNICH CENTRAL DIVISION CONTENTS

5. Economic Issues and Remedies p.24 5.1 Case Value and Court Fees p.24 5.2 UPC Court Fees Compared to National Courts p.25 5.3 Costs Awards p.25 5.4 Damages p.25 6. The Future of the UPC p.25 6.1 Advantages and Disadvantages of the UPC p.25 6.2 Future Trends p.26 6.3 The Future of National Patent Litigation p.26 6.4 Improvements to the UPC p.27

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MUNICH CENTRAL DIVISION Law and Practice Contributed by: Julia Traumann and Ulrich Blumenröder, Grünecker

Grünecker is a leading IP firm with 100 years of experience and a team of over 85 patent attor - neys, more than 60 patent practitioners and over 30 attorneys-at-law. Headquartered in Munich, with offices in Berlin, Cologne and Paris, the firm serves clients worldwide across all techni - cal and legal fields. Expertise spans mechanical and electrical engineering, semiconductors, IT, AI and machine learning, software, automotive, material science, medical technology, physics, chemistry and life sciences. Grünecker’s litiga -

tion teams – combining experienced attorneys and technically skilled patent experts – are ide - ally suited for complex disputes before all Ger - man courts and the UPC. The firm was involved in shaping the UPC from its inception, develop - ing expertise early on and representing some of the first cases filed. The firm’s offering is com - plemented by expertise in patent prosecution, trademark, design and copyright law, as well as licensing, technology transfer and know-how and trade secret protection. Ulrich Blumenröder (LLM) is a partner in the patent litigation team of Grünecker. He has been representing both large international and medium-sized companies in patent infringement proceedings for many years. His primary focus is multinational disputes requiring the co-ordination of validity and infringement proceedings across multiple jurisdictions, often involving numerous patents concurrently such as in SEP proceedings. Benefitting from his extensive experience, Ulrich adeptly aligns his clients’ legal and commercial interests. He also provides guidance in settlement discussions and actively participates in mediation and arbitration proceedings. Ulrich has been familiar with the UPC since 2012 due to regular teaching activities. Since 1 June 2023, he has represented clients before the UPC.

Authors

Julia Traumann is counsel in the patent litigation team of Grünecker. She advises both large international and mid-sized companies in patent infringement proceedings, in

particular in the pharmaceutical, life sciences and tech sectors. Her practice focuses on multi-jurisdictional disputes and, since 1 June 2023, disputes before the UPC, which often require the co-ordination of validity and infringement proceedings, involving multiple patents simultaneously and including standard-essential patents (SEPs). Julia also advises on the drafting and implementation of contracts relating to IP rights. She is the (co-) author of numerous specialist publications and is a member of LES, GRUR, ChIPs Germany and Women in IP.

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MUNICH CENTRAL DIVISION Law and Practice Contributed by: Julia Traumann and Ulrich Blumenröder, Grünecker

Grünecker Leopoldstr 4 80802 Munich Germany

Tel: +49 8921 2350 Fax: +49 8922 0287 Email: blumenroeder@grunecker.de Web: www.grunecker.de

1. General Information 1.1 Basic Information

and usual closing days in Munich), it is recom - mended to refer to the official UPC website or to contact the administrative office directly. The information presented in the following chap - ter is publicly available and primarily based on decisions and orders issued by the CD Munich. It has been compiled by the authors to the best of their knowledge and belief. 1.2 UPC Judges Panels of the UPC Central Division are gener - ally composed of two legally qualified judges from different contracting member states and one technically qualified judge allocated from the pool of judges, in accordance with Article 18 (3) Unified Patent Court Agreement (UPCA), with qualifications and experience in the field of technology concerned. Only for actions under Article 32 (1)(i) UPCA (ie, actions against deci - sions of the European Patent Office (EPO) in carrying out specific administrative tasks) does the panel consist of three legally qualified judges from different contracting member states, with no technically qualified judge. The presiding judge of the CD Munich is Judge Ulrike Voß from Germany. She is notable for holding dual leadership roles, also presiding over the second panel of the Local Division Munich

The Court of First Instance has a decentralised structure. It comprises a Central Division, which has its seat in Paris and sections in Munich and Milan, as well as various local divisions and a Regional Division, located all over the contract - ing member states in the EU. This chapter will focus on and deal with the Central Division, Munich Section (referred to as the “CD Munich”). Nevertheless, it will be nec - essary at times to look at the overall UPC pic - ture by referring to decisions and orders of the other sections of the Central Division in Paris and Milan, the local divisions and the Regional Division, and the Court of Appeal. The CD Munich is located at Cincinnatistr 64, 81549 Munich, Germany (in the building of the German Federal Patent Court). The administra - tive office of the CD Munich can be contacted via email at contact_munich.ctl@unifiedpatentcourt. org, or via phone at +49 89 2620 899 60. Its reg - ular opening hours are from 9am to 12pm, and by telephone arrangement between 1pm and 4pm. For the most current information regarding opening hours and public holidays/closing days (which generally are identical to public holidays

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MUNICH CENTRAL DIVISION Law and Practice Contributed by: Julia Traumann and Ulrich Blumenröder, Grünecker

(referred to as “LD Munich”). Judge Voß brings a wealth of experience to the UPC, having previ - ously served as presiding judge of the 4b Civil Chamber (one of the patent litigation chambers) at the District Court Düsseldorf, and later of the 15th Civil Senate (one of the then-two patent senates) at the Court of Appeals Düsseldorf. She is widely recognised for her structured and effi - cient conduct of hearings, as well as her ability to manage technically complex cases with clar - ity and precision. Other legally qualified judges appointed to the CD Munich include Judge Mélanie Bessaud from France and Judge András Kupecz from The Netherlands. Judge Bessaud was appointed a French judge in 2005 and spent several years as a civil judge in intellectual and industrial prop - erty matters, dealing with patents, trademarks, industrial designs, models and unfair competi - tion at the Paris Court of First Instance, which has exclusive jurisdiction over patents. Since 2020, she has been an arbitrator at the commer - cial chamber of the Court of Cassation, where she dealt with patents and supplementary pro - tection certificates (SPCs). Judge Kupecz holds an LLM in private law from Amsterdam Univer - sity and an MSc from Utrecht University with a focus on molecular biology. Before becoming a UPC judge, he was active as a European patent litigator in private practice, dually qualified as a lawyer and a European patent attorney. That makes him one of the few UPC judges who has had their focus on the other side of the bench. 1.3 Specific Procedural Issues Procedural issues in the CD Munich follow the UPC’s Rules of Procedure (RoP), and no spe - cific procedural issues have been noted in this regard.

Case opening is primarily managed through the UPC’s case management system (CMS). In exceptional circumstances – such as techni - cal failures – documents may be lodged in hard copy at the relevant registry or sub-registry (Rule 4.2 RoP; see Amgen v Sanofi, UPC_CFI_1/2023, order delivered on 24 August 2023). Service of process is governed by Rules 270 to 275 RoP. The presiding judge of the CD Munich has issued an “Order for the organisation of oral hearings” (Rule 111 RoP), effective from 14 May 2024. The order sets out the procedures for conduct - ing oral hearings at the CD Munich. Hearings are generally held in person, although remote participation via videoconference may be per - mitted. As a rule, hearings are open to the public unless a decision is made to exclude the public in specific cases. Video and audio recordings, as well as live streaming of the hearings, are strictly prohibited. 1.4 Regional Division Competence There is no applicable information in this juris - diction. 1.5 Central Division Competence The Central Division of the UPC is divided into three sections (whereby Paris serves as the seat), each tasked with handling cases related to spe - cific fields of technology, as classified under the World Intellectual Property Organization (WIPO) International Patent Classification (IPC) sections. Following the opening of the Milan Section on 27 June 2024 – replacing the originally designated London Section – the allocation of cases within the Central Division is governed by Annex II of the UPCA, as amended by Article 1 (2) of the Administrative Committee’s decision of 26 June 2023.

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MUNICH CENTRAL DIVISION Law and Practice Contributed by: Julia Traumann and Ulrich Blumenröder, Grünecker

According to this amended allocation, the fol - lowing applies. • The Munich Section handles cases from IPC classes C (chemistry, metallurgy; without SPCs) and F (mechanical engineering, light - ing, heating, weapons, blasting). IPC class C includes areas such as pure chemistry, applied chemistry, certain marginal indus - tries, certain operations or treatments and metallurgy. IPC class F includes machines and engines in general, combustion engines, lighting, steam generation, weapons and ammunition. • Just to mention: The Paris Seat handles cases under IPC classes B (performing operations, transporting), D (textiles, paper), E (fixed constructions), G (physics) and H (electricity), and all cases involving SPCs. The Milan Section handles cases pertaining to IPC class A (human necessities) without SPCs. 1.6 Court of Appeal: Purpose and Procedure There is no applicable information in this juris - diction. Since the commencement of operations on 1 June 2023, the Court of First Instance has received a total of 883 cases (as of 31 May 2025). To date, 65 standalone (isolated) revocation actions have been filed with the UPC. Of these, ten were filed with the CD Munich, 47 with the Paris Seat, and eight with the Milan Sec - tion. 2. Statistical Information 2.1 Types of Actions

In addition, the CD Munich has received one counterclaim for revocation, referred by the LD Munich in the long-running dispute between Sanofi/Regeneron and Amgen relating to PCSK9 antibodies. 2.2 Substantive Hearings According to the calendar published on the offi - cial UPC website, four substantive hearings have so far taken place (where the authors assume that this is not a comprehensive list). • The first hearing was held on 4 June 2024 in Sanofi/Regeneron v Amgen (UPC_ CFI_1/2023, ACT_459505/2023, and UPC_ CFI_14/2023, CC_586764/2023). The panel consisted of Presiding Judge Voß, Judge- Rapporteur Kupecz and Technically Qualified Judge Casper Struve. • The second hearing, in the same matter, took place on 16 July 2024 and served as the announcement hearing. It was conducted by Judge-Rapporteur Kupecz. The decisions delivered marked the UPC’s first-ever revoca - tion judgments. • The third hearing was held on 18 September 2024 in NanoString Technologies Europe Ltd v President and Fellows of Harvard College (UPC_CFI_252/2023, ACT_551180/2023), before Presiding Judge Voß, Judge-Rappor - teur Kupecz and Technically Qualified Judge Eric André Enderlin. • The fourth hearing, an announcement hearing in the same case, took place on 17 October 2024, also led by Judge-Rapporteur Kupecz. Additionally, according to the calendar, one hearing was scheduled but later cancelled. The authors do not know whether the list is compre - hensive in all regards.

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MUNICH CENTRAL DIVISION Law and Practice Contributed by: Julia Traumann and Ulrich Blumenröder, Grünecker

Furthermore, the calendar notes an online interim conference held on 13 March 2024 in Astellas v Healios et al (UPC_CFI_80/2023, ACT_465342/2023, and UPC_CFI_75/2023, ACT_464985/2023). Interested members of the public were permitted to follow via live stream from a hearing room at the premises of the CD Munich. It can be assumed that further interim conferences and video conferences have taken place, most of which were likely not open to the public. 2.3 Case Classification Of the ten isolated revocation actions filed before the CD Munich, seven pertain to IPC class C and three to IPC class F. At this stage, no discernible industry trends can be identified. 2.4 Time Lines The CD Munich has demonstrated a strong commitment to following the timelines set out as guidelines by the Preparatory Committee. In recent cases, the judge-rapporteur has repeat - edly emphasised the “front-loaded character” of UPC proceedings, urging parties to present their full case early and declining to consider new arguments introduced – eg, only in the reply to the defence to revocation. Clear dead - lines for submissions and hearings are consist - ently established, and proceedings are system - atically streamlined. This includes, for instance, limiting the number of auxiliary requests (see Kunststoff KG Nehl v Häfele, UPC 526/2024, ACT_51533/2024, ORD_18972/2025, order issued on 18 April 2025; see also 4.2 Key Pro- cedural Issues ). The cases Sanofi/Regeneron v Amgen (UPC 1/2023, ACT_459505/2023, and UPC 14/2023, CC_586764) offer an early yet compelling exam -

ple of the CD Munich’s procedural efficiency. Sanofi filed an isolated revocation action before the CD Munich on 1 June 2023, while Amgen initiated an infringement action before the LD Munich on the same day. It was almost a race to file proceedings. It appears that the isolated revocation action had been filed first by not even an hour, meaning that Sanofi had not been forced to file the revocation action as a coun - terclaim pursuant to Article 33 (4) paragraph 2 UPCA. A counterclaim for revocation was still filed in the infringement proceedings, and it was served on 24 November 2023. With the parties’ consent, the LD Munich referred the counter - claim for revocation to the CD Munich on 2 Feb - ruary 2024 (UPC_CFI_14/2023, ORD_392/2024). Shortly thereafter, on 27 February 2024, the CD Munich ordered its joint handling of the isolated revocation action and the counterclaim. Despite the rather late joining, the revocation decisions were issued by the CD Munich on 16 July 2024 – just over a year after the isolated revocation action was filed, and about eight months after the counterclaim. This timeline was in line with the UPC’s stated goal of delivering (final) deci - sions approximately one year after proceedings begin and reflects strong adherence to the pro - cedural benchmarks. The authors do not see a trend of hearings becoming longer than anticipated. On the con - trary, the CD Munich has repeatedly indicated its intention to keep hearings concise. In this regard, the judge-rapporteur has explicitly stat - ed several times that the hearing should be com - pleted in one day, with a second day reserved only for exceptional circumstances. 2.5 Interaction Between Central and Local/Regional Divisions An interaction between the Central Division and local divisions/the Regional Division may occur

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MUNICH CENTRAL DIVISION Law and Practice Contributed by: Julia Traumann and Ulrich Blumenröder, Grünecker

3. Substantive Law 3.1 Topics Covered

in several scenarios, mostly in an indirect rather than a direct form. Many such interactions will occur against the legal background of Article 33 UPCA, in particular Article 33 (3) UPCA. Interaction between the Central Division and local or regional divisions under Article 33 (3) UPCA is not merely theoretical but appears to have become a practical procedural fea - ture of UPC litigation. Recent decisions by local divisions, including in Amgen v Sanofi/ Regeneron (LD Munich, UPC_CFI_14/2023, ORD_392/2024, order of 2 February 2024) and Labrador Diagnostics v bioMérieux (LD Düssel - dorf, UPC_CFI_314/2024, UCP_CFI_572/2924, ORD_19201/2025, procedural order of 23 April 2025), demonstrate that referrals of counter - claims for revocation to the Central Division – in decided cases where a related isolated revoca - tion action is already pending – are considered an effective means of avoiding inconsistent rul - ings and unnecessary duplication of work on validity. These cases confirm that, in cases of unanimous (or equally, unopposed) referral requests, and in the absence of compelling counterarguments, local divisions are inclined to refer the case and choose to proceed with the infringement action while maintaining procedural flexibility, including the option to suspend proceedings if needed. This evolving practice reflects a pragmatic appli - cation of Article 33 (3) UPCA, enabling prompt decisions and balancing judicial efficiency with party autonomy in procedural matters. Another kind of interaction (admission of docu - ments) will be discussed later (see 4.2 Key Procedural Plans ) with regard to the case TCL Europe v Corning.

Over the past 24 months, the Central Divi - sion Munich has addressed a (not particularly broad) range of substantive legal topics, mainly addressing the classic grounds for revocation such as lack of novelty and lack of inventive step. Assessment of Lack of Novelty In its decision delivered on 17 October 2024 in NanoString Technologies Europe v President and Fellows of Harvard College (UPC_CFI_252/2023, ACT_551180/2023), the CD Munich found that for the purposes of Article 54 of the European Patent Convention (EPC), an invention shall be considered to be new if it does not form part of the state of the art. The state of the art, in accordance with Article 54 (2) EPC, shall be held to comprise everything made available to the public by means of a written or oral descrip - tion, by use or in any other way, before the date of filing of the European patent application (or when applicable the priority date). It continued that the assessment of novelty within the mean- ing of Article 54 (1) EPC requires the determina - tion of the whole content of the prior publication. Whether the subject matter of the claim, with all its features, is directly and unambiguously dis - closed in the prior art citation is decisive (refer - ring to Court of Appeal, order of 25 September 2024, UPC_CoA_182/2024, App 21143/2024, Mammut v Ortovox). Assessment of Inventive Step The assessment of inventive step is a fundamen - tal pillar of patentability in the European patent system. Accordingly, clarity on how the UPC evaluates inventive step is of considerable rel - evance. While it may be expected that the UPC will align with the established approach of the

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MUNICH CENTRAL DIVISION Law and Practice Contributed by: Julia Traumann and Ulrich Blumenröder, Grünecker

EPO, which is responsible for granting Euro - pean patents, the UPC retains the discretion to develop its own standards and build an inde - pendent body of case law. During the first two years of the UPC, several decisions addressing the assessment of inventive step were issued, including by the CD Munich. The Court of Appeal, so far, has provided only its first thoughts in its decision in NanoString v 10x Genomics (UPC_ CoA_335/2023, App_576355/2023, 26 February 2024), without setting general guidelines. This means the UPC’s approach remains to be seen, and, for the time being, it will continue to be dis - cussed widely. Sanofi/Regeneron v Amgen In its decisions delivered on 16 July 2024 in Sanofi/Regeneron v Amgen (UPC 1/2023, ACT 459505/2023; UPC 14/2023, C_586764/2023), the CD Munich established the potential position of the UPC on the patentability of therapeutic antibody inventions and defined its criteria for assessing inventive step. It is interesting to note that the CD Munich chose not to follow the problem-solution approach classically employed at the EPO by not starting from the closest prior art – ie, the most promis - ing prior art, but only from a “realistic starting point”, where there can be several realistic start - ing points. According to the CD Munich, a start - ing point is realistic if its teaching would have been of interest to a skilled person who, at the priority date of the patent at issue, was seek - ing to develop a similar product or method to that disclosed in the prior art, which thus has a “similar underlying problem” as the claimed invention (which appears not to be the same as the “objective technical problem” for the assess - ment of inventive step under the EPO approach). The CD Munich stated that, in general, a claimed solution is obvious if the skilled person was

motivated – ie, had an incentive, to consider the claimed solution and would implement it as a next step in developing the prior art. It may be relevant as to whether the skilled person would have expected any particular difficulties in tak - ing any next step(s). The CD Munich continued by saying that, depending on the facts and cir - cumstances of the case, it may be allowed to combine prior art disclosures. A technical effect or advantage achieved by the claimed sub - ject matter compared to the prior art may be, according to the CD Munich, an indication for inventive step. A feature that was selected in an arbitrary way out of several possibilities could not generally contribute to inventive step. The CD Munich emphasised that hindsight needs to be avoided. The question of inventive step should not be answered by searching retrospec - tively, with knowledge of the patented subject matter or solution, for any (combination) prior art disclosures from which that solution could be deduced. Against this background, the CD Munich revoked the patent in its entirety, finding that the person skilled in the art was motivated to develop thera - peutic antibodies against PCSK9 and that he/ she would have arrived at the claimed antibod - ies with a reasonable chance of success without an “undue burden” (in reference to the time and resources required). With this stance, the CD Munich deviated slightly from the EPO’s posi - tions on the assessment of inventive step. 3.2 Leading Cases Given the still-limited number of cases before the CD Munich, it remains challenging to identify clear “leading cases”. However, Sanofi/Regener - on v Amgen stands out as particularly notewor - thy – not only because of its unique procedural history before the UPC, but also due to its role in a long-standing, high-stakes dispute between

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MUNICH CENTRAL DIVISION Law and Practice Contributed by: Julia Traumann and Ulrich Blumenröder, Grünecker

the parties. Amgen and Sanofi, together with Sanofi’s partner company Regeneron, have been involved in litigation over the cholesterol- lowering drugs Praluent® and Repatha® since 2014. This legal battle was initially fought before national patent courts, but on the very first day of the UPC’s operation, 1 June 2023, both parties chose to escalate the dispute to the new court system. 3.3 Pending Cases A search of the CMS reveals several newly initi - ated cases, primarily isolated revocation actions. While members of the public can identify the rel - evant patent numbers, they do not have access to the procedural documents. As a result, it is not possible to determine the specific patent law issues raised in those proceedings. However, the following can be gathered on pending cases from recent decisions and orders. One such case is the already-mentioned Kunst - stoff KG Nehl v Häfele (UPC 526/2024), con - cerning European Patent EP3 767 151 (cabinet levelling apparatus). The isolated revocation action was initiated following UPC provisional measures proceedings between the parties at the LD Munich, which were decided in favour of the claimant (the defendant in those proceed - ings) on the basis of a weighing of interests in its favour (see LD Munich, UPC_CFI_443/2024, ACT_43563/2024, order of 25 November 2024). The panel of the LD Munich (also with Presiding Judge Voß as presiding judge) had expressed the opinion that (provisionally, in summary pro - ceedings – and where the CD Munich stressed that it had of course arrived at its own opinion independently) an infringement of the patent was more likely than not, but that the validity of the patent was doubtful (see UPC 526/2024,

ACT_51533/2024, order issued on 18 April 2025). In the isolated revocation action, the claimant argues that the subject matter of all claims is not patentable – specifically, that it lacks nov - elty and/or inventive step. Furthermore, it is alleged that the patent does not disclose the invention clearly and completely enough for a person skilled in the art to carry it out, and that the subject matter extends beyond the content of the application as originally filed. The parties are currently engaged in settlement negotiations (comprising a number of proceedings in differ - ent fora), and the CD Munich has agreed to stay the proceedings pursuant to Rule 295 (d) RoP, pending the outcome of those negotiations (UPC 526/2024, ACT_51533/2024, ORD_24550/2025, order issued on 22 May 2025). Another pending case is TCL Europe v Corn - ing, which involves both an isolated revocation action (UPC 337/2025) and an infringement action, including a counterclaim for revoca - tion, and is currently before the LD Munich (UPC_CFI_819/2024). The case concerns EP 3 296 274 (related to the fining of boro-alumino silicate glasses). The isolated revocation action was filed on 22 April 2025, followed by the coun - terclaim for revocation on 15 May 2025. In this matter, the claimant appears to argue that the patent is not valid – specifically alleging lack of inventive step and the presence of added matter. The deadline for filing the defence to revoca - tion has been extended, reportedly until 7 July 2025. It remains to be seen whether the isolated revocation action and the counterclaim for revo - cation will be consolidated at a later stage (for previous similar cases, please see 2.5 Interac- tion Between Central and Local/Regional Divi- sions ).

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MUNICH CENTRAL DIVISION Law and Practice Contributed by: Julia Traumann and Ulrich Blumenröder, Grünecker

3.4 Technically Qualified Judges Technically qualified judges play a vital role within the UPC system by ensuring that com - plex scientific and technical aspects of cases are accurately understood and appropriately evalu - ated. Their significance is underscored by their growing numbers and a number of recent new appointments. In total, there are currently around 75 technically qualified judges, most of them in the fields of physics and mechanical engineer - ing. In the Central Division, the panel is typically composed of two legally qualified judges and one technically qualified judge allocated from the pool of judges in accordance with Article 18 (3) UPCA, with qualifications and experience in the field of technology concerned. This com - position fosters a high level of interdisciplinary collaboration and ensures that legal reasoning is firmly anchored in a solid understanding of the underlying technical subject matter. To the authors’ knowledge, there is nothing specific to report on the interaction with parties’ representatives and experts (if any). There are no general patterns that can be identified. 3.5 Influence of Prior Local Practice on Substantive Legal Decisions At the CD Munich, there is no discernible ten - dency for substantive legal decisions to be shaped by German or other national court prac - tices. Instead, the CD Munich is consciously developing its own legal standards, clearly aim - ing to establish a unified body of European pat - ent jurisprudence that stands independent of any single national tradition. This approach has also been publicly confirmed by Judge Voß.

3.6 Court of Appeal Substantive Jurisprudence There is no applicable information in this juris - diction.

4. Procedural Issues 4.1 Hearing Structure

It can be said that a typical hearing structure has begun to emerge, though practice is still devel - oping. In most cases, hearings follow a stream - lined and disciplined format, reflecting the UPC’s overarching aim of efficiency, its front-loaded character and the fact that an interim conference usually will have taken place already. At the outset of the hearing, the presiding judge or the panel will provide introductory remarks that outline the main issues. In most cases, the remarks will include the panel’s preliminary views and highlight specific issues that the panel con - siders particularly relevant. After these remarks, the parties are invited to respond directly to those issues. The panel expects oral arguments to be focused and responsive to the issues raised in the introduction, rather than a repetition of writ - ten submissions. If a party wishes to address an issue not mentioned in the introduction, they are allowed to do so, but the focus usually remains on issues identified by the panel. This approach appears similar to the approach known from German national proceedings. Hearings generally align with time blocks com - municated in advance, typically half-day or full- day sessions, and – so far – they tend to adhere closely to the anticipated duration. 4.2 Key Procedural Issues Over the past 24 months, the Central Division Munich has addressed a range of procedural

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MUNICH CENTRAL DIVISION Law and Practice Contributed by: Julia Traumann and Ulrich Blumenröder, Grünecker

issues. A selection of particularly notable exam - ples is outlined in the following. Admission of Late-Filed Material, Extension of Deadline (TCL Europe v Corning) In a recent procedural order issued on 13 June 2025 (UPC 337/2025, ACT_17987/2025, ORD_25882/2025), the CD Munich ruled on two contested procedural applications in the isolated revocation action TCL Europe SAS v Corning Inc. TCL, as claimant in the isolated revocation action, sought to introduce two new added-mat - ter arguments and a consulting report from the Swedish Patent Office into the action, arguing the material became available only after the ini - tial filing. Corning challenged this on both proce - dural and substantive grounds, arguing that the proper route for such amendments would have been under Rule 263 RoP, and that the delay lacked sufficient justification. Concurrently, Corning filed an application seek - ing a four-week extension to file its defence to revocation and any potential application to amend the patent. The rationale was to accom - modate the new arguments (if admitted) and co-ordinate its procedural strategy across both the revocation and the parallel infringement pro - ceedings. TCL opposed the extension. Follow - ing a partial agreement between the parties, the CD Munich (Judge-Rapporteur Kupecz) admit - ted the late-filed material and granted a partial extension of the deadline for filing the defence to revocation. The CD Munich emphasised that the court generally respects party agreements on procedural matters unless exceptional con - cerns arise. Notably, the court did not engage in a detailed Rule 263 RoP analysis, implicitly endorsing the parties’ pragmatic approach to

incorporating the new material and adjusting timelines. Security for Legal Costs, Release of Security (NanoString Technologies Europe Ltd v President and Fellows of Harvard College) In its order of 17 December 2024 (UPC 252/2023, ACT_551180/2023, ORD_56957/2024), the CD Munich ruled that it has the power to release a security for legal costs imposed under Rule 158 RoP by applying Rule 352.2 RoP, even though Rule 158 RoP does not explicitly provide for such a release. In this case, NanoString Technologies Europe Ltd requested the release of a security deposit, arguing that its financial situation had materially changed due to a corporate restruc - turing and acquisition by Bruker Corporation, a financially sound entity. The CD Munich rejected the request. It empha - sised that the relevant financial position is that of the party itself – not its parent company or corporate group, whereby NanoString failed to provide evidence of its own independent finan - cial capacity. The CD Munich also noted that the original cost risk remains until a decision becomes final and non-appealable, which had not occurred. The decision appears to reinforce a strict inter - pretation of financial independence in cost secu - rity matters under the UPC framework. It clari - fied that while Rule 352.2 RoP can be used to release securities imposed under Rule 158 RoP, the burden lies on the applicant to prove that the underlying risk has ceased. The CD Munich also resisted factoring in the procedural stage of the case (eg, a favourable first-instance decision) when the potential for appeal remains.

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