Patent Litigation 2025

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

CHAMBERS GLOBAL PRACTICE GUIDES

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

Contributing Editor Andreas von Falck Hogan Lovells International LLP

Global Practice Guides

Patent Litigation Contributing Editor Andreas von Falck Hogan Lovells International LLP

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. GPG Director Katie Burrington Content Management Director Claire Oxborrow Content Manager Jonathan Mendelowitz Senior Content Reviewer 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

Published by Chambers and Partners 165 Fleet Street London EC4A 2AE Tel +44 20 7606 8844 Fax +44 20 7831 5662 Web www.chambers.com

Contents

INTRODUCTION Contributed by Andreas von Falck, Hogan Lovells International LLP p.5

HUNGARY Law and Practice p.198 Contributed by Danubia Patent & Law Office INDIA Law and Practice p.220 Contributed by Saikrishna & Associates Trends and Developments p.243 Contributed by Saikrishna & Associates ISRAEL Law and Practice p.251 Contributed by Reinhold Cohn Group ITALY Law and Practice p.277 Contributed by EY Tax & Law Trends and Developments p.297 Contributed by EY Tax & Law

AUSTRALIA Trends and Developments p.20 Contributed by Maddocks BELGIUM Law and Practice p.27 Contributed by Osborne Clarke LLP

BRAZIL Law and Practice p.49 Contributed by Kasznar Leonardos Intellectual Property Trends and Developments p.70 Contributed by Kasznar Leonardos Intellectual Property CANADA Law and Practice p.78 Contributed by Cassels Brock & Blackwell LLP

JAPAN Law and Practice p.302 Contributed by TMI Associates Trends and Developments p.322 Contributed by Chuo Sogo LPC MACAU SAR Law and Practice p.333 Contributed by Riquito Advogados NETHERLANDS Law and Practice p.349 Contributed by Freshfields Trends and Developments p.372 Contributed by Freshfields

CHINA Law and Practice p.98

Contributed by Fangda Partners Trends and Developments p.118 Contributed by Wanhuida Intellectual Property

FINLAND Law and Practice p.127 Contributed by Roschier Trends and Developments p.137 Contributed by Roschier FRANCE Law and Practice p.144 Contributed by Gowling WLG Trends and Developments p.172 Contributed by Schertenleib Avocats GERMANY Law and Practice p.182 Contributed by Boehmert & Boehmert

PHILIPPINES Law and Practice p.378 Contributed by Cruz Marcelo & Tenefrancia Trends and Developments p.400 Contributed by Cruz Marcelo & Tenefrancia

PORTUGAL Trends and Developments p.407 Contributed by Abreu Advogados

CHAMBERS.COM

Contents

ROMANIA Law and Practice p.413 Contributed by Cabinet M. Oproiu and The Office Litigation & Enforcement

UK Law and Practice p.505 Contributed by Kirkland & Ellis Trends and Developments p.527 Contributed by Kirkland & Ellis UKRAINE Law and Practice p.535 Contributed by Mamunya IP Trends and Developments p.559 Contributed by Mamunya IP

SOUTH AFRICA Law and Practice p.426 Contributed by KISCH IP Trends and Developments p.447 Contributed by KISCH IP SWEDEN Law and Practice p.453 Contributed by Advokatfirman Vinge KB SWITZERLAND Law and Practice p.475 Contributed by Pestalozzi Trends and Developments p.498 Contributed by MLL Legal

USA Law and Practice p.566 Contributed by Rothwell, Figg, Ernst & Manbeck PC Trends and Developments p.587 Contributed by Rothwell, Figg, Ernst & Manbeck PC

USA - TEXAS Trends and Developments p.594 Contributed by Spencer Fane LLP

CHAMBERS.COM

INTRODUCTION

Contributed by: Andreas von Falck, Hogan Lovells International LLP

Hogan Lovells International LLP offers clients a full range of legal services. In a fast-changing and interconnected world, the firm provides fresh thinking combined with proven experi- ence. Located in the world’s key hubs, Hogan Lovells advises on a range of intellectual prop- erty matters as well as litigation, M&A, corpo- rate, and capital markets transactions. Its expe- rience in cross-border and emerging economies gives the firm the necessary market perspective to be a global partner to its clients. With more than 45 offices worldwide, the firm’s practice groups co-operate closely with each other, pro-

viding clients the full resources of a global firm from a single, local point of contact. The author would like to thank the contributors from the various Hogan Lovells offices: Daniel Brook (London); Dr Frederick Ch’en (Tokyo); Ana Castedo and Inmaculada Lorenzo (Ma- drid); Stanislas Roux-Vaillard (Paris); Gertjan Kuipers and Ruud van der Velden (Amsterdam); Luigi Mansani, Giovanni Ghirardi and Giovanni Trabucco (Milan); Katie Feng (Shanghai); An- drew Cobden (Hong Kong); Natalia Gulyaeva (Dusseldorf); and David Perlman and Tej Singh (San Francisco).

Contributing Editor

Andreas von Falck is part of Hogan Lovells’ award-winning global patent litigation practice. Andreas is an experienced courtroom advocate and litigates patents in all areas of

patent law, with a particular focus on the life sciences, chemical, and hi-tech industries. He has advised many of the world’s leading companies on patent litigation in Germany and in all parts of Europe.

Hogan Lovells International LLP Dreischeibenhaus 1 40211 Dusseldorf Germany Tel: +49 2111 3680 Fax: +49 211 136 8100 Email: andreas.vonfalck@hoganlovells.com Web: www.hoganlovells.com

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

Patent Litigation Around the World Following the opening of the Unified Patent Court (UPC) on 1 June 2023, 2024 was the first full year of operation of the new court with its own new law and procedure. And what a year it was. With around 600 cases filed and almost 600 decisions rendered in 2024 alone, the UPC, through its local divisions, its regional division in Stockholm, and its Appeal Court in Luxemburg, has had a chance to shape the case law. While the Rules of Procedure are relatively detailed, the substantive patent law of the Court has yet to be fully developed and will ultimately be based on a combination of EU member state law and the Court’s own decisions. Accordingly, decisions related to all areas of the law, whether regard- ing file inspection rights of the public (Court of Appeal, UPC_CoA_404/2023), security for cost (Court of Appeal, UPC_CoA_548/2024), the doc- trine of equivalents (Local Division The Hague, UPC_CFI_239/2023), claim construction, nov- elty and inventive step (Court of Appeal, UPC_ CoA_335/2023), or the discretion of the court to consider proportionality in entering injunc- tion against defendants (Local Division Munich, UPC_CFI_15/2023). In the area of patentability in particular, the developments have been fast, and strong guidelines have now been estab- lished that users can rely upon (Munich Cen- tral Division, UPC 1/2023). Initial concerns over how patentee friendly – or unfriendly – the new court was going to be have long since been replaced by a widespread view that the UPC is balanced and fair in its decision-making. Still, ongoing appeals from the Local Divisions and the Regional Division as well as new cases will help sharpen the law in 2025 and will give users even more legal certainty in 2025. In the United States, 2025 also marks the begin- ning of the Trump administration. If anything, there appears to be a belief that President Trump

will support stronger rights for IP owners and more efficient proceedings at the USPTO. The following report looks around the world and analyses events and decisions since our last update that will impact on users of the various patents systems in 2024 and beyond. The courts continued in 2024 to be involved in a number of FRAND disputes. The Panasonic v Xiaomi [2024] EWCA Civ 1143 dispute in particu- lar provided a number of firsts at the beginning of October 2024: • a conclusion that the patentee was in breach of its obligation of good faith under clause 6.1 of the ETSI IPTR Policy; • a determination of the terms of an interim licence; and • a declaration that a willing licensor would grant the implementor a licence on those terms. Europe The UK The interaction between these rate-setting dis- putes and wider patent litigation in other jurisdic- tions will no doubt continue to evolve in 2025. The court continues to be involved in a number of multinational life sciences disputes, including those arising out of COVID-19 vaccines. The UK Supreme Court is due to hear an appeal in the Summer in relation to whether the exclu- sion from patentability of a program for a com- puter “as such” by Section 1(2) of the UK Patents Act 1977 has any application to artificial neural networks (following the Court of Appeal’s judg- ment that it does, Emotional Perception AI Lim- ited v The Comptroller [2024] EWCA Civ 825).

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

The Netherlands As mentioned above, 2024 marked the first full year of UPC decisions. The Netherlands was strongly represented amongst the judges, with Dutch judges ranking amongst those with the highest number of decisions. In parallel, Dutch courts (relying, in part, on the same judges) continued to deal with patent cases render- ing decision that will have an impact not only domestically but also beyond the borders of the Netherlands. Following a decision of the Court of Appeal in preliminary injunction (PI) proceedings of 15 August 2023, on 30 October 2024, the District Court of The Hague in proceedings on the mer- its now had to deal with the patentability of the compound apixaban. The District Court applied the tests of decisions G 2/21 (plausibility) and G 1/22 and G 2/22 (entitlement to priority) of the Enlarged Board of Appeal of the European Pat- ent Office (EPO). The test of G 2/21 entails that the patentee can rely on the invoked technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention. According to the Court, the term “would derive” does not mean anything different than “derivable” and “technical teaching” is an instruction addressed to a skilled person as to how to solve a particu- lar technical problem using particular technical means. There is no general requirement that an application must contain evidence of the effect and in the case at hand the skilled person would also not have reasons to doubt it. With refer- ence to decisions G 1/22 and G 2/22, the District Court noted that there were no indications put forward that would lead to the strong rebutta- ble presumption of entitlement to priority being

set aside. The 2003 decision in PI proceedings is being appealed to the Supreme Court, the recent advice of the Advocate General being that the appeal should be rejected. Stay tuned. Earlier in the year, on 1 March 2024 the Dutch Supreme Court in a case on a children’s toy issued a decision on claim interpretation and equivalence. Central to the appeal was whether a “two-step-approach” to infringement, in which literal infringement is assessed separately from infringement by equivalence, was compatible with the fair protection for the patentee pre- scribed by the protocol attached to Article 69 of the European Patent Convention (EPC). The appellant felt that a “one-step-approach”, in which both literal infringement and infringement by equivalence were to be assessed simultane- ously in one step ought to be more compatible. The Dutch Supreme Court considered that the protocol was compatible with both approach- es, upholding an earlier decision of the Court of Appeal of The Hague. This marks the first Dutch Supreme Court decision which explicitly upholds a Court of Appeal decision that uses the equivalence test introduced by the Court of Appeal of The Hague in the permetrexed case. Noteworthy is that this is the same test that the Local Division The Hague of the UPC applied in the Plant–E/Arkyne case. It may shortly prove influential in UPC Divisions across Europe. Finally, following amendments to the Dutch Pat- ent Act to bring it in line with certain provisions of the UPC Agreement, new amendments are being proposed. The new amendments would introduce a fully examined Dutch patent (where currently the Netherlands only has a registration system for national patents). This follows earlier changes in surrounding countries. Consultation on the proposal is ongoing.

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

Spain Among the most significant developments in the field of patent litigation in Spain in 2024 was the legal dispute over apixaban, an anticoagulant. The litigation – invalidity proceedings, protec- tive actions, PIs and infringement proceedings, which all ran/are running in parallel – involved the Barcelona and Madrid Commercial courts and reached the Supreme Court as a result of a conflict about competence amongst them. The case involved relevant procedural intricacies which will impact future litigation strategies of both patentees and potential defendants. At the request of Teva, on 15 January 2024 the Commercial Court No 4 of Barcelona declared BMS’s apixaban patent and supplementary pro- tection certificate (SPC) to be invalid. On 9 Feb- ruary 2024, Teva filed a protective brief before the same court aimed at preventing ex parte PIs on 9 February, which was formally admitted on 13 February. In parallel, BMS (and other entities) requested ex parte PIs before the Commercial Courts of Madrid against Sandoz (6 February 2024), extended to Teva and Normon (12 February 2024) to prevent the launch of the latter’s apixa- ban generics onto the Spanish market. Surpris- ingly, and despite the Barcelona court’s judge- ment declaring the patent and the SPC invalid, by orders of 12 and 15 February 2024, respec- tively, the Commercial Court No 13 of Madrid granted the PIs arguing that: • the Barcelona invalidity judgment was not final; • the validity of other designations of the same patent and SPC had been held valid in other jurisdictions; and • no oppositions or invalidity actions had been filed for 20 years against them.

Subsequently, Teva filed for an anti-suit-injunc- tion before the Barcelona court aimed at pre- venting the enforcement of the PIs ordered by the Madrid court against it. Teva argued that BMS’s PIs should have been filed before the Barcelona court because of the protective brief. Teva’s petition was granted by order of 26 Feb- ruary 2024. Against this backdrop, both the Barcelona and the Madrid courts referred their competence dispute to the Supreme Court. By a ruling of 24 April 2024, Spain’s highest court declared that the Barcelona court should retain jurisdiction over the PI requests against Teva on the grounds that a court in front of which a protective brief had been filed retains competence to hear PIs on that brief if any are filed. It further declared that anti-suit-injunctions are not allowed under Span- ish law since they exceed the scope of what can be considered a PI and impinge on other courts’ jurisdictional powers. If a party wants to overturn a court decision, it must appeal it – just as the first instance judgement declaring the invalidity of BMS’s patent and SPC had been appealed. In fact, Section 15 of the Court of Appeals of Bar- celona overturned that decision in record time, by judgement of 18 July 2024, with the effect of the withdrawal of the apixaban generics from the market whilst the case is subject to extraordinary appeal proceedings before the Supreme Court. In the field of technology and telecommunica- tions, SEP/FRAND litigation has remained a hot topic during 2024 as holders of standard essen- tial patents (SEPs) sued implementers in Spain as part of their global litigation strategy. Some of the pending cases have, as a result, been settled in the context of global licences being signed in 2025. Implementers were also active filing protective briefs before the Barcelona Commer- cial Courts in the weeks leading up to the 2024

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

edition of the MWC Barcelona (an annual trade show dedicated to the mobile communications industry). Implementers have been looking to obtain protection against potential ex parte PIs and product seizures, typically taking place dur- ing the early morning of the first day at the fair. The Barcelona Commercial Courts, along with the EU Trademark and Design Court, based in Alicante, remain fully committed to acting swiftly before and during the MWC and issue their deci- sions on ex parte PI and seizure petitions within hours from filing. Finally, on the legislative front, the Spanish Par- liament has approved Organic Law 1/2025, of 2 January, on Measures for the Efficiency of the Public Justice Service, which will enter into force in April 2025. The aim of the law is to improve the administration of justice by optimising the man- agement of resources, reducing litigiousness and streamlining court procedures. It introduc- es far-reaching organisational and procedural changes, including the replacement of current single-judge courts by collegial courts with specialised sections (ie, the so-called Instance Courts) in each judicial district, a substantially different legal costs regime, and new rules for the service of claims upon legal entities. One of the most significant developments is the establishment of ADR methods as a procedural requirement for the admissibility of civil claims, including patent-related claims. Evidence in the form of a certificate showing that ADR has been attempted must be filed with the complaint. ADR methods include mediation, conciliation, intervention of independent experts, binding confidential offers, collaborative processes and direct negotiation between the parties or their lawyers. Direct negotiations must meet a num- ber of requirements to be considered valid. No ADR attempts are required in the case of PIs

prior to the complaint and inspection and inquir- ies proceedings. France In 2024, French Courts clarified and reaffirmed some of the distinctive legal mechanisms which are available to patentees asserting their rights in France. With respect to evidence gathering, the Paris Court of Appeal ruled that in the context of French evidentiary seizures (“ saisie-contrefaçon ”), it is possible to seize any digital file that is accessible from the computers located on the French premises where the seizure takes place, including the source code of a software, irre- spective of the location of the servers on which the files are stored (Paris Court of Appeal, 25 October 2024, Docket Number 23/17701). In the same decision, it also clarified that a sai- sie-contrefaçon cannot be denied on the sole ground that the applicant may seek to use the seized evidence for parallel proceedings abroad, as long as such use abroad is not the “sole purpose” of the seizure. This makes the saisie- contrefaçon an interesting tool in the context of cross-border litigation strategies. In terms of substantive law, the French Supreme Court reaffirmed that, as a matter of principle, infringement is present when the so-called “essential means” of the invention are found in the accused product (Cass. Com. 20 March 2024, case 22-22.406). This decision confirms that under French law, literal infringement may be invoked even in the presence of differences in secondary features, as long as these differ- ences do not relate to the “core” of the patent’s inventive contribution. At a time when the criteria for infringement by equivalence are a hot topic across Europe, this is an interesting reminder that an alternative route may be available in

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

France to assert literal infringement in certain cases. In the pharmaceutical sector, 2024 tended to confirm a recent trend towards a more gener- ous position of the French courts regarding the validity of SPCs. The French Supreme Court confirmed an appeal ruling which recognised the validity of an SPC covering a monoclonal anti- body which was not specifically characterised in the basic patent (and was covered by a subse- quent patent), notably holding that the discovery of the antibody did not involve an independent inventive step with respect to the basic patent (Cass. Com. 31 January 2024, case 22-18.374). In another case, the Paris Court of Appeal con- firmed a preliminary injunction ordered on the ground of an SPC covering the combination of two compounds, after ruling that the validity challenges raised in defence were not serious (Paris Court of appeal, 12 January 2024, docket 22/16673). Finally, on the procedural side, French courts have begun to implement a mechanism recently created by a reform of French law, whereby the parties are invited and incentivised to agree on the complete procedural schedule on an ami- cable basis from the start of the procedure. This may streamline the course of French patent pro- ceedings and eventually shorten their average In Germany, the market for patent litigation seemed to converge further in 2024 and it is expected that the number of patent cases filed in German national courts will be seen to have consolidated at the relatively low levels of 2023 (less than 700 cases altogether as per JUVE Pat- ent). However, the Munich courts in particular seem to be resisting this trend, offering extreme- duration. Germany

ly short litigation timelines that beat even the UPC with its “one year to trial” schedule. A lot of the perceived benefits for plaintiffs available in Germany through the bifurcation of infringe- ment and validity (with validity being on a much slower track to trial resulting in the well-known “injunction gap”) were reduced, if not removed, by the 2021 reform, obliging the German Federal Patent Court to issue so called preliminary opin- ions on validity within six months from service of a nullity action on the patentee. However, the Munich courts currently offer timelines to trial in the region of six to nine months, which is often faster than the time it takes that Federal Patent Court to issue its preliminary opinion. While that makes life arguably very difficult for defendants, the new patentee-friendly offering by the Munich courts means in practice that much national German patent litigation is now started before the patent courts in Munich. On the substantive law side, German courts con- tinue to be a “safe choice” for non-practicing entities (NPEs). There were, once again, a large number of decisions in 2024 that held in favour of NPEs and which ultimately led to settlements. Most global patent litigation campaigns of NPEs, particularly in the field of technology and tele- coms, include infringement actions in Germany. The speed of the German courts combined with the reluctance to exercise any proportionality assessments when considering injunctive relief keeps Germany firmly on the map for plaintiffs. In an inevitable reflection of the rise of the UPC and the importance of the German local divi- sions in Dusseldorf, Munich, Mannheim and Hamburg, there were fewer important decisions from the German national courts in 2024. However, the Federal Court of Justice issued a landmark decision concerning the patentabil-

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

Italy The most significant development in Italian pat- ent litigation in 2024 was the Italian Supreme Court decision issued on 5 July 2024, No 18372, on the scope of the Bolar exemption under Article 68(b) of the Italian Intellectual Property Code (IPC). It is believed to be the first Supreme Court decision in Europe to have interpreted the exemption. The Court found that the Bolar exemption applies not only to generic com- panies engaged in studies directed at obtain- ing a marketing authorisation (MA), but also to third-party manufacturers of patented active pharmaceutical ingredients (APIs) that supply the drug to those who intend to obtain an MA. However, in relation to third-party suppliers, the Court established that the rationale of the Bolar exemption is complied with only if: • the fact that the API manufacture is directed at obtaining an MA is clear from the start; • the generic company has requested the third- party supplier to provide the API; and • there are contractual limitations in place so that the use of the API is limited to obtaining the MA, in line with the Bolar exemption. In the absence of these conditions, the Bolar exemption cannot be invoked and, therefore, the activity will be considered infringing. Another interesting decision was issued by the Appeal Court of Milan (decision No 976, issued on 2 April 2024). The case concerned the deter- mination of the fair remuneration to be awarded to an employee pursuant to Article 64 of the IPC when the employer does not make use of the invention. As a general note, Article 64 of the IPC distinguishes between • remunerated inventions – the inventions developed by an employee in the course of

ity of AI-generated inventions. Specifically, in a decision involving the question whether an AI- system could be named as an inventor, the Fed- eral Court of Justice came out with a clear “no” (German Federal Court of Justice, X ZB 5/22). Another decision published in 2024 concerned the scope of the defendant’s obligation to pro- vide information to allow the patentee to calcu- late damages following a determination of pat- ent infringement. The Federal Court of Justice made it clear that the obligation included any commercial agreements the patent infringer had entered into in relation to the accused embodi- ment, including maintenance and repair agree- ments for patent infringing products, or sales of consumables, simply on the basis that there is a reasonable likelihood that these sales would not have been made without the patent infringe- ment. This decision makes it clear that what are often characterised as “convoy sales” must also be included in the damages calculation (Federal Court of Justice, X ZR30/21). In a further decision on patentability the Federal Court of Justice clarified that when several path- ways were available to solve a technical prob- lem, several pathways towards the invention may be obvious. There is no rule of law saying that only the “first” pathway is obvious (Federal Court of Justice X ZR 51/22). In the pharma space, patent enforcement cam- paigns are under scrutiny by competition law experts following the European Commission’s decision to issue a record fine of EUR462.6 mil- lion in a case concerning the enforcement of pharma patents, including in the German patent courts (Case AT.40588).

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

their employment, where the inventive activ- ity is contemplated as the subject matter of the employment agreement and compen- sation for such inventive activity has been expressly agreed between the employer and the employee, and regularly granted to the latter; and • non-remunerated inventions – the inventions developed by an employee in the course of the employment relationship, where no compensation has been previously agreed or granted for the inventive activity and where, in light of that circumstance, a fair compensa- tion to the employee is required. The Court held that, with respect to non-remu- nerated inventions, according to Article 64 of the IPC, the fair remuneration due to the employ- ee does not depend on whether the invention was actually exploited by the employer or not. This is because patents may hold value (at least, against third parties) even if they are not exploited. Fair remuneration is thus due even if the employer did not profit from the invention. In such cases, the traditional method for determin- ing the fair remuneration (the so-called “German formula”) is not applicable, since it is based on the employer’s profits. Therefore, the fair remu- neration of the employee shall be determined on an equitable basis. Eurasian Economic Union (EAEU) The EAEU’s single pharmaceutical market con- tinues to provide for a simplified, generic MA approval for the EAEU member states. For inno- vators this means a need to closely monitor the Unified EAEU Register of drugs and the national registers of the EAEU member states (Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia) as well as information on bioequivalence studies in those territories. To date, a search through the Unified EAEU Register of drugs will not provide

full information on the activities of generics pro- ducers. Hence, only careful checking of national registers (often combined with inquiries to the local healthcare authorities) can identify in which member state a generics producer has taken steps aimed at obtaining an MA for the whole of the EAEU territory. Simultaneously the Russian regulatory data protection (RDP) regulation has been amended by reference to the EAEU MA; allowing right holders to use it as a basis for RDP claims. The regional RDP court practice is yet to be developed. The Eurasian Patent Office’s pharma patents register, introduced in 2022, has proved useful in 2024. The recordals of Eurasian pharma patents with the register were accepted by state authori- ties considering disputes between originators and manufacturers of generic pharmaceutical products as sufficient evidence of wrongdoing by generics businesses. There is a hope that this register may be used for patent linkage purposes going forward. Pharma patent disputes in the EAEU member states are largely decided by the courts in a bal- anced manner unless the claims of patent right holders originate in countries that have intro- duced sanctions against Russia and Belarus. In a nutshell, international businesses have contin- ued to enforce patent rights in the EAEU states. More than before, there have been attempts to challenge validity as well as patent term exten- sions (PTEs). Simultaneously, the generic pro- ducers have demonstrated more willingness to negotiate amicable settlements with originators. Obtaining PIs in the EAEU remains a challenge. It seems, however, that a need for a change in the availability of PIs in the region is understood by the state authorities. While PIs have remained unavailable in patent disputes before the courts, several international originators have initiated

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

unfair competition cases against generic com- panies before the antitrust authorities seeking injunctions and penalties against the generics. Those originators’ efforts turned were often suc- cessful in 2024 resulting in injunctions and high penalties (up to over EUR9 million) imposed on Russian generic businesses. The granting of compulsory licences remains a matter that requires monitoring in EAEU coun- tries. Compulsory licences have been sought before the courts due to patent non-use or insufficient patent use or based on rights to dependent patents. In Belarus and Russia, com- pulsory licences are also available via govern- ment authorities. Compulsory licences granted by governments remain an exception. Constant monitoring of the Eurasian and national patent applications in the EAEU countries remains a must, as such a precaution may substantially help in shielding originators from potential com- pulsory licence grants (eg, by proceeding with a patent invalidity claim against “dependent” patents filed by generics businesses as soon as the relevant patent application is granted). It remains equally important to proactively react to requests from generics companies for licences since originator silence only enhances a generic producer’s chance of obtaining a compulsory licence. Asia Japan In Japan, the courts have continued to become increasingly pro-patentee. Although at the time of writing (February 2025) there does not yet appear to be any update on the IP High Court’s statistics released in June 2023, which high- lighted that there was a 30% success rate for patentees in patent infringement cases decided between 2014 and 2022, and 35 cases in the same period in which the patentee received over

JPY100 million (around USD 700,000) in dam- ages), it appears that patentees have continued to be generally successful before the Japanese courts in 2024. Before the Japan Patent Office (JPO), recent data show the number of oppositions to pat- ents increasing from 1,260 cases in 2021 to a record 1,411 cases in 2023 (data from 2024 not available at the time of writing). Interestingly, the number of requests for invalidation trials contin- ues to decrease, from 106 in 2021 to 84 in 2023 (data from 2024 not available at the time of writ - ing). The popularity of oppositions rather than invalidation trials likely reflects the relative cost- effectiveness and anonymity of oppositions, although there is an important time constraint to be aware of: oppositions must be filed within six months of the date of publication of the pat- ent being opposed. In 2024, the Japanese government appears to have started to consider the impact of digital transformation in the light of the 2023 decision of the Special Division of the IP High Court that explored the principle of territoriality (case No 2022 (ne) 10046). In that 2023 decision, the IP High Court held that the act of creating a general client/server system can amount to “produc- tion” in Japan (ie, as used in Article 2(3)(i) of the Japan Patent Act) – even where the server and the operator are outside of Japan – provided that certain conditions are met and pursuant to a so- called “comprehensive consideration theory”. In this context, according to the JPO, the Japanese government is contemplating a revision of the applicable patent law that would permit patents that claim a system to be enforced against an infringer’s system even if part of the infringer’s system (such as a server) is physically outside of Japan. The issue in the underlying case related to an online computer program hosted on serv-

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

ers in the USA but provided to users based in Japan. Having set out a four-part test to assess the circumstances and co-defendants’ activities, the IP High Court held that the co-defendants’ acts could be regarded as having been “sub- stantially and wholly” conducted in Japan. Also in 2024, a long-running case in respect of a potential compulsory (non-exclusive) licence was settled. The JPO had established a special committee to assess whether such a licence should be granted on public policy grounds and substantial evidence and opinions had been submitted for consideration. No compulsory licence based on public policy has ever been granted in Japan; here, it appears that the com- mittee formed a tentative view that a narrow compulsory licence might be possible, which when shared with the parties was sufficient to encourage settlement. The details of the case and the committee’s deliberations are not pub- licly available and so a fresh case will be need- ed before the relevant criteria for a compulsory licence in Japan are properly understood. Other developments in 2024 include Japanese companies arguably continuing to become more assertive and initiating patent litigation, particularly in the technology field and including between domestic companies. More disputes may arise in this sector in the coming year or so, potentially in respect of 5G and other telecom- munications standards, the internet of things and connected devices, especially in respect of connectivity in the automotive sector. In the life sciences field, originator versus gener- ics cases continue. Interestingly, a number of generics companies continue to appear to ben- efit from Japan’s non-statutory “patent linkage” system and the regulator’s apparent readiness to grant a generic MA in certain cases (for instance,

where a patent has been held invalid by the JPO but not all avenues of appeal have yet been exhausted and the decision finalised), poten- tially conflicting with the regulator’s long-held position of seeking to ensure a stable supply of pharmaceutical products to the Japanese mar- ket. In particular, in 2023, the regulator approved generic versions of two or more drugs the active ingredients of which may still have been pro- tected by relevant patents or patent term exten- sions. In one case, a preliminary injunction order was granted promptly after the grant of such generic MAs; at least one other case is on-going. Once the cases are fully resolved, there may be important changes to the regulator’s practice in the future in favour of originators and patentees, as well as potentially in respect of the scope of patent term extensions in Japan. Finally, a number of biologics and biosimilar pat- ent cases continue to be the subject of dispute resolution in Japan, somewhat mirroring cases in the USA and Europe. It is still unclear whether the Japanese courts will take similar positions in respect of issues already litigated elsewhere. For instance, in respect of antibody patenting in Japan, the current approach appears to be more similar to that of Europe than that of the United States, in that the Japan Patent Office tends to focus on the new functions or properties of the claimed antibody in finding an inventive step or non-obviousness. Notably, expert evidence seems to have made a significant contribution in certain disputes. In any event, it is expected that the number of such biologics patent cases will increase, and it will be important to monitor Japan-specific developments in due course.

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

China The first anti-anti-suit injunction issued by the SPC On 22 December 2024, the Supreme People’s Court of China (SPC) issued its first anti-anti- suit injunction (AASI) in two patent infringement cases between Huawei and Netgear and other companies. The ruling resulted in a number of orders against Netgear and the other involved companies: • Throughout the duration of these two cases and after the judgments were rendered, they were barred from filing applications or peti- tions with courts, customs, or other authori- ties in the United States and other countries and regions, seeking to prohibit Huawei and its affiliated companies from: (a) continuing or initiating new patent infringement lawsuits against Netgear in China, related to the patents involved in these two cases; and (b) enforcing the judgments made by the courts of the People’s Republic of China in these two cases. • If Netgear and the other companies involved had already filed such applications or peti- tions with courts, customs, or other authori- ties in the United States and other countries and regions, they were obliged to withdraw or suspend such applications within 24 hours after receiving this ruling. • Netgear and other companies were forbidden from filing any opposing applications or peti- tions with courts, customs, or other authori- ties in the United States and other countries and regions against this ruling. • Any violations of this ruling would lead to Net- gear being fined CNY1 million per day start- ing from the date of such violation.

The SPC noted that there was evidence in the case that Netgear had already submitted peti- tions for anti-suit injunctions and anti-enforce- ment injunctions to the US courts. The SPC considered that if the US courts were to grant these applications, it would not only affect or even deprive Huawei of its substantive and pro- cedural rights, but would also have an impact on and even interfere with the litigation in China. Therefore, the SPC granted the AASI as it was held to essentially safeguard China’s judicial sovereignty over the relevant cases. It is also worth mentioning in this regard that the Munich Local Division of the Unified Patent Court and the District Court of Munich have both issued AASIs in the case of Huawei v Netgear. New developments in China’s pharmaceutical patent linkage system China formally established a patent linkage sys- tem on 1 June 2021, through the newly amended Patent Law, implemented by the Measures for the Implementation of the Mechanism for the Early Resolution of Pharmaceutical Patent Dis- putes (for Trial Implementation) (the “Measures”). The Measures essentially provide a process for resolving patent disputes at an early stage in the drug approval process. This includes a require- ment for MA holders to register relevant drug patent information on a designated platform and a requirement for applicants for generic drug MAs to declare relevant patents during the approval process. The SPC further has refined the judicial practice in this area with a key civil ruling, which has been included in the People’s Court Casebook as a reference case. The case can be summarised as follows: a Swedish company filed a lawsuit with the Bei- jing Intellectual Property Court (BJIPC), claiming that, as the holder of a Chinese invention patent

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

for a chemical drug, it had registered Claim 9 of the patent on the China Patent Information Registration Platform for Listed Pharmaceuticals as required under the Measures. This claim was associated with an originator drug that had been approved by the China National Drug Adminis- tration (CNDA). Subsequently, a pharmaceutical company in Sichuan submitted an application for an MA for a generic drug to the CNDA, using the originator drug as the basis for the generic drug and making a Class 4.1 declaration, which had also been accepted. However, the Swedish company argued that the generic drug in ques- tion fell within the scope of protection of Claim 9 of its patent and requested the court to make a declaratory judgment in this sense. On 18 November 2022, the BJIPC issued a judgment affirming that the technical solution for the allegedly infringing generic drug filed by the Sichuan company fell within the scope of protection of the Claim 9 of the patent. The Sichuan company appealed to the IP Tribu- nal at the SPC, arguing that Claim 9 of the patent concerned a patent for a substance in crystalline form, which, it argued, was explicitly excluded from the scope of pharmaceutical patent linkage cases in China under the Measures. The SPC heard the case and held that Claim 1 of the patent in question indeed seeks protection for a crystalline structure and that Claim 9, on the other hand, related to the specific use of this crystalline structure, rather than the pharmaceu- tical use of the active ingredient compound or the pharmaceutical composition containing the active ingredient. Therefore, the SPC confirmed that the claim registered by the Swedish com- pany indeed concerns a patent concerning a crystalline form which was explicitly not eligible as a legal basis to initiate the litigation in ques-

tion under Article 5 of the Measures and Article 76 of the Patent Law. The SPC confirmed that in pharmaceutical patent linkage disputes, the People’s Courts are required to assess whether the patent in question qualifies as a registrable patent type and is not explicitly excluded under the Measures. Any litigation filed under Article 76(1) of the Patent Law must arise from a dispute regarding the patent rights of a pharmaceutical product for which registration has been sought. If the patent asserted by the parties does not qualify as a registrable patent under the Meas- ures, the People’s Court is obliged to dismiss the case. Based on the foregoing analysis, the SPC ultimately rejected the civil ligation brought by the Swedish company. This case serves as a reminder to pharmaceu- tical patent holders that not all chemical drug patents are eligible for inclusion in China’s pat- ent linkage system under the Measures. Notably, patents related to intermediates, metabolites, crystalline forms, preparation methods, test- ing methods, and other such areas are explic- itly excluded. Therefore, such patents should undergo thorough analysis and evaluation before being registered on the platform, particularly before initiating any infringement litigation. Determination of acceptable claim amendments in patent invalidation proceedings In April 2024, the SPC announced its list of the top ten most influential IP cases in China for 2023. The only patent case selected was an administrative patent invalidation case in which the SPC ruled that, in patent invalidation proce- dures, the extent of claim amendments must not exceed (i) the scope of information disclosed in the original patent document, or (ii) the original patent’s scope of protection. The determination of whether a claim amendment constitutes a

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

“further limitation” of the original claim should be based on whether: • the modified claim fully encompasses all the technical features of the original claim; • the modified claim introduces new technical features; and • these additional features are supported by other claims in the original patent. The SPC further clarified that claim modifications in the administrative procedure for patent invali- dation should generally be limited to responding to the grounds for invalidation. Modifying claims in a way that reconstructs them under the pre- text of overcoming the deficiencies cited in the grounds for invalidation will not be accepted. The Guidelines to Strengthen Regulations on Antitrust Behaviours Pertaining to SEP come into effect on 4 November 2024 On 4 November 2024, the State Administra- tion for Market Supervision and Administration promulgated and enacted the “Guidelines for Strengthening the Regulation of Antitrust Behav- iours Related to Standard Essential Patents”, which clarify issues such as the disclosure of information, licensing commitments, good-faith negotiations, as well as monopoly agreements, abuse of market dominance, and mergers involv- ing SEPs. The Guidelines specifically list the following abuses of market dominance related to SEPs: licensing SEPs at unfairly high prices, refusing to license SEPs, tying the sale of SEPs, attaching other unreasonable trading conditions to SEPs, engaging in discriminatory treatment with respect to SEPs, and abusing remedial measures related to SEPs. The Guidelines pro- vide clear guidance on whether the behaviour of a SEP owner constitutes a monopoly.

The Measures for Administrative Adjudication and Mediation of Patent Disputes will be implemented on 1 February 2025 On 26 December 2024, the China National Intellectual Property Administration (CNIPA) promulgated the “Measures for Administrative Adjudication and Mediation of Patent Disputes,” which will take effect on 1 February 2025. The Measures introduce new provisions on adminis- trative adjudication of major patent infringement disputes, the early resolution mechanism for pharmaceutical patent disputes, and administra- tive mediation for open licence patent disputes. Additionally, they clarify the requirements for oral hearings, include provisions for adding addition- al parties, and introduce provisions related to technical investigations and technical apprais- als. Notably, the Measures also incorporate a system of declarations of non-infringement, which are moulded on the type of procedure cur- rently already available from the courts, allowing the warned party to request an advisory opinion regarding the alleged infringement from the pat- ent management authority. Hong Kong In its 2024 policy address, the Hong Kong government highlighted the importance of IP- intensive industries for economic growth and its intention to continue to support and expand IP protection measures for products in the IT and creative industries. Measures include put- ting forward a proposal next year to enhance the Copyright Ordinance regarding the protec- tion of AI technology development, launching a consultation in 2025 on the registered designs regime currently under review, and proposing legislative amendments to streamline IP litiga- tion processes for the High Court to manage and hear these cases more effectively.

CHAMBERS.COM

INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP

A new patent system was introduced in Hong Kong at the end of 2019 providing a direct route to seek 20-year patent protection by means of original grant patents (OGPs). As at 30 Novem- ber 2023, around 810 applications for OGPs had been filed at Hong Kong’s Intellectual Property Department (IPD) and around 80 OGPs had been granted, some within less than 18 months of fil- ing. The alternative route in Hong Kong for obtain- ing 20-year invention patent protection requires a patentee first to obtain a UK, European (UK) or Chinese patent (“designated patents”) and then re-register the designated patent at the IPD without the need for any local substantive examination. The re-registration route operates in parallel with the OGP system, so patent appli- cants can choose between the OGP system or re-registration. In the 11-month period to the end of November 2023, over 16,400 applications were filed to re-register designated patents and around 9,750 patents were granted using the re-registration route. However, the IPD wants there to be potential advantages in using the OGP route. For example, if an applicant agrees not to request any amendments and requests early publication of the application, and if the application progresses smoothly, the entire pro- cess to grant may be completed in around 12–18 months. Further, under an IPD pilot scheme an OGP applicant can request the deferral of the formality examination for a period of up to 12 months from the filing or priority date. The effect of this scheme has some similarities to a US provisional patent application and allows an applicant to establish an early filing date with- out having to file claim(s), giving applicants more time to assess the patentability and commercial potential of their invention. Such requests are granted at the Registrar’s sole discretion and must satisfy certain requirements. If a request is

granted, the processing of the OGP application will be suspended during the deferral period. The Hong Kong High Court IP specialist list was set up in 2019 with a small number of designated judges who can hear patent and other IP cases. The intention of the IP specialist list is to have more judge-led case management, to improve the level of judicial expertise for dealing with IP cases and to increase efficiency in – and there- fore accelerate – IP litigation. New procedural court rules for patent and other IP cases are expected to be introduced soon. China’s 14th five-year plan (2021—2025) affirms the Chinese government’s support for the future development of Hong Kong in a wide spectrum of areas, including developing Hong Kong into a regional IP trading centre, an international innovation and technology hub, and as a lead- ing centre for international legal and dispute resolution services in the Asia-Pacific region. The Hong Kong government wants to leverage Hong Kong’s advantages in international finan- cial, legal and dispute resolution services within China’s Greater Bay Area (GBA), which covers Hong Kong and Macao, as well as nine major cities in mainland China including Guangzhou and Shenzhen, the home of many Chinese tech- nology companies. Over the last twelve months a number of large IP-related international arbitra- tions have taken place in Hong Kong, in some cases involving Chinese electronics manufactur- ers. At the end of January 2024, a comprehen- sive new mechanism will come into force for the reciprocal recognition and enforcement of judg- ments in civil and commercial matters between Hong Kong and mainland China. Although pat- ent infringement and validity judgments are not covered by this arrangement, once the arrange- ment comes into force on 29 January 2024 judgments issued in disputes, such as those for

CHAMBERS.COM

Page i Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44 Page 45 Page 46 Page 47 Page 48 Page 49 Page 50 Page 51 Page 52 Page 53 Page 54 Page 55 Page 56 Page 57 Page 58 Page 59 Page 60 Page 61 Page 62 Page 63 Page 64 Page 65 Page 66 Page 67 Page 68 Page 69 Page 70 Page 71 Page 72 Page 73 Page 74 Page 75 Page 76 Page 77 Page 78 Page 79 Page 80 Page 81 Page 82 Page 83 Page 84 Page 85 Page 86 Page 87 Page 88 Page 89 Page 90 Page 91 Page 92 Page 93 Page 94 Page 95 Page 96 Page 97 Page 98 Page 99 Page 100 Page 101 Page 102 Page 103 Page 104 Page 105 Page 106 Page 107 Page 108 Page 109 Page 110 Page 111 Page 112 Page 113 Page 114 Page 115 Page 116 Page 117 Page 118 Page 119 Page 120 Page 121 Page 122 Page 123 Page 124 Page 125 Page 126 Page 127 Page 128 Page 129 Page 130 Page 131 Page 132 Page 133 Page 134 Page 135 Page 136 Page 137 Page 138 Page 139 Page 140 Page 141 Page 142 Page 143 Page 144 Page 145 Page 146 Page 147 Page 148 Page 149 Page 150 Page 151 Page 152 Page 153 Page 154 Page 155 Page 156 Page 157 Page 158 Page 159 Page 160 Page 161 Page 162 Page 163 Page 164 Page 165 Page 166 Page 167 Page 168 Page 169 Page 170 Page 171 Page 172 Page 173 Page 174 Page 175 Page 176 Page 177 Page 178 Page 179 Page 180 Page 181 Page 182 Page 183 Page 184 Page 185 Page 186 Page 187 Page 188 Page 189 Page 190 Page 191 Page 192 Page 193 Page 194 Page 195 Page 196 Page 197 Page 198 Page 199