Patent Litigation 2025

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 regarding file inspection rights of the public (Court of Appeal, UPC_CoA_404/2023), security for cost (Court of Appeal, UPC_CoA_548/2024), the doctrine of equivalents (Local Division The Hague, UPC_CFI_239/2023), claim construction, novelty and inventive step (Court of Appeal, UPC_CoA_335/2023), or the discretion of the court to consider proportionality in entering injunction 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 established that users can rely upon (Munich Central 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 Initial concerns over how patentee friendly – or unfriendly – the new court was going to be have long since been replaced by a widespread view that the UPC is balanced and fair in its decision-making.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 beginning 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.

Europe

The UK

The courts continued in 2024 to be involved in a number of FRAND disputes. The Panasonic v Xiaomi [2024] EWCA Civ 1143 dispute in particular 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.

The interaction between these rate-setting disputes and wider patent litigation in other jurisdictions 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 exclusion from patentability of a program for a computer “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 judgment that it does, Emotional Perception AI Limited v The Comptroller [2024] EWCA Civ 825).

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 rendering 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 merits 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 Patent 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 particular 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 reference 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 rebuttable 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 prescribed 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 simultaneously in one step ought to be more compatible. The Dutch Supreme Court considered that the protocol was compatible with both approaches, 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 Patent 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.

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, protective 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 protection certificate (SPC) to be invalid. On 9 February 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 apixaban generics onto the Spanish market. Surprisingly, and despite the Barcelona court’s judgement declaring the patent and the SPC invalid, by orders of 12 and 15 February 2024, respectively, 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-injunction before the Barcelona court aimed at preventing 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 February 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 Spanish 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 Barcelona 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 telecommunications, SEP/FRAND litigation has remained a hot topic during 2024 as holders of standard essential 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 Commercial Courts in the weeks leading up to the 2024 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 during 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 decisions on ex parte PI and seizure petitions within hours from filing.

Finally, on the legislative front, the Spanish Parliament 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 management of resources, reducing litigiousness and streamlining court procedures. It introduces 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 number of requirements to be considered valid. No ADR attempts are required in the case of PIs prior to the complaint and inspection and inquiries 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, irrespective 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 saisie-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 differences 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 France to assert literal infringement in certain cases.

In the pharmaceutical sector, 2024 tended to confirm a recent trend towards a more generous 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 antibody which was not specifically characterised in the basic patent (and was covered by a subsequent 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 confirmed 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 amicable basis from the start of the procedure. This may streamline the course of French patent proceedings and eventually shorten their average duration.

Germany

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 Patent). However, the Munich courts in particular seem to be resisting this trend, offering extremely 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 infringement 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 opinions 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 continue 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 telecoms, 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 divisions 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 patentability of AI-generated inventions. Specifically, in a decision involving the question whether an AI-system could be named as an inventor, the Federal 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 provide information to allow the patentee to calculate damages following a determination of patent 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 embodiment, including maintenance and repair agreements 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 infringement. 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 pathways were available to solve a technical problem, 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 campaigns are under scrutiny by competition law experts following the European Commission’s decision to issue a record fine of EUR462.6 million in a case concerning the enforcement of pharma patents, including in the German patent courts (Case AT.40588).

Italy

The most significant development in Italian patent 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 companies engaged in studies directed at obtaining 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 determination 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 their employment, where the inventive activity is contemplated as the subject matter of the employment agreement and compensation 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 compensation to the employee is required.

The Court held that, with respect to non-remunerated inventions, according to Article 64 of the IPC, the fair remuneration due to the employee 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 determining the fair remuneration (the so-called “German formula”) is not applicable, since it is based on the employer’s profits. Therefore, the fair remuneration of the employee shall be determined on an equitable basis.

Eurasian Economic Union (EAEU)

The EAEU’s single pharmaceutical market continues to provide for a simplified, generic MA approval for the EAEU member states. For innovators 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 producers. 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 authorities 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 balanced manner unless the claims of patent right holders originate in countries that have introduced sanctions against Russia and Belarus. In a nutshell, international businesses have continued to enforce patent rights in the EAEU states. More than before, there have been attempts to challenge validity as well as patent term extensions (PTEs). Simultaneously, the generic producers 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 unfair competition cases against generic companies before the antitrust authorities seeking injunctions and penalties against the generics. Those originators’ efforts turned were often successful 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 countries. 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, compulsory licences are also available via government 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 compulsory 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 highlighted 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 damages), 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 patents 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 continues to decrease, from 106 in 2021 to 84 in 2023 (data from 2024 not available at the time of writing). 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 patent 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 “production” 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 servers 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 “substantially 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 committee 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 publicly available and so a fresh case will be needed 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 telecommunications standards, the internet of things and connected devices, especially in respect of connectivity in the automotive sector.

In the life sciences field, originator versus generics cases continue. Interestingly, a number of generics companies continue to appear to benefit 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), potentially conflicting with the regulator’s long-held position of seeking to ensure a stable supply of pharmaceutical products to the Japanese market. In particular, in 2023, the regulator approved generic versions of two or more drugs the active ingredients of which may still have been protected by relevant patents or patent term extensions. 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 patent 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.

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 petitions with courts, customs, or other authorities in the United States and other countries and regions, seeking to prohibit Huawei and its affiliated companies from:
1. continuing or initiating new patent infringement lawsuits against Netgear in China, related to the patents involved in these two cases; and
2. 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 petitions with courts, customs, or other authorities 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 petitions with courts, customs, or other authorities in the United States and other countries and regions against this ruling.
• Any violations of this ruling would lead to Netgear being fined CNY1 million per day starting from the date of such violation.

The SPC noted that there was evidence in the case that Netgear had already submitted petitions for anti-suit injunctions and anti-enforcement 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 procedural 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 system 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 Disputes (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 requirement 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 Beijing Intellectual Property Court (BJIPC), claiming that, as the holder of a Chinese invention patent 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 Administration (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 question 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 Tribunal 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 pharmaceutical 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 company indeed concerns a patent concerning a crystalline form which was explicitly not eligible as a legal basis to initiate the litigation in question 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 Measures, 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 pharmaceutical patent holders that not all chemical drug patents are eligible for inclusion in China’s patent linkage system under the Measures. Notably, patents related to intermediates, metabolites, crystalline forms, preparation methods, testing methods, and other such areas are explicitly 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 procedures, 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 “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 invalidation should generally be limited to responding to the grounds for invalidation. Modifying claims in a way that reconstructs them under the pretext 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 Administration for Market Supervision and Administration promulgated and enacted the “Guidelines for Strengthening the Regulation of Antitrust Behaviours 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 involving 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 provide 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 administrative adjudication of major patent infringement disputes, the early resolution mechanism for pharmaceutical patent disputes, and administrative mediation for open licence patent disputes. Additionally, they clarify the requirements for oral hearings, include provisions for adding additional parties, and introduce provisions related to technical investigations and technical appraisals. Notably, the Measures also incorporate a system of declarations of non-infringement, which are moulded on the type of procedure currently already available from the courts, allowing the warned party to request an advisory opinion regarding the alleged infringement from the patent 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 putting forward a proposal next year to enhance the Copyright Ordinance regarding the protection of AI technology development, launching a consultation in 2025 on the registered designs regime currently under review, and proposing legislative amendments to streamline IP litigation processes for the High Court to manage and hear these cases more effectively.

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 November 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 filing.

The alternative route in Hong Kong for obtaining 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 applicants 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 process 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 without 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 therefore 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 leading 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 financial, 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 technology companies. Over the last twelve months a number of large IP-related international arbitrations have taken place in Hong Kong, in some cases involving Chinese electronics manufacturers. At the end of January 2024, a comprehensive new mechanism will come into force for the reciprocal recognition and enforcement of judgments in civil and commercial matters between Hong Kong and mainland China. Although patent infringement and validity judgments are not covered by this arrangement, once the arrangement comes into force on 29 January 2024 judgments issued in disputes, such as those for breach of contract will be covered (with some limited exceptions), allowing both monetary and non-monetary judgments from Hong Kong courts in many types of technology-related contractual disputes to be registered and enforced by mainland Chinese courts.

In June 2024, the Hong Kong Government implemented a “patent box” tax incentive under which qualifying income of an owner of licensee derived from eligible IP is taxed at a concessionary rate of 5% (rather than the normal rate of 16.5%). Broadly speaking eligible IP should be generated from R&D activities of the taxpayer and may include both Hong Kong patents and patents granted outside Hong Kong. However, Hong Kong re-registration patents will no longer be eligible if filed on or after 5 July 2026 and non-Hong Kong patents will only be eligible if a corresponding Hong Kong OGP has been filed in respect of the same invention. The Hong Kong Government has been meeting the patent agent sector and other stakeholders during 2024 to discuss plans for establishing regulatory arrangements for local patent agent services, covering professional qualification requirements, registration, patent advice privilege as well as the regulatory model and framework.   

Notable Patent Decisions in the USA

LKQ Corp. v GM Global Tech. – new obviousness test for design patents

On 21 May 2024, the Federal Circuit issued an en banc opinion overturning the Rosen-Durling test for obviousness of design patents. Prior to this opinion, the design-patent obviousness test required (i) a primary reference that was “basically the same” as the claimed design, and (ii) additional reference(s) that were “so related” to the primary reference that application of disclosed ornamental features in one would suggest application of those features in the other.

The Federal Circuit, noting that design patents, like utility patents, must meet the non-obviousness requirement of 35 U.S.C. Section 103, found that the Rosen-Durling test is “improperly rigid”. In its place, the Federal Circuit adopted a factual inquiry consistent with application of the Graham factors used for utility patents, including the scope and content of the prior art, differences between the prior art designs and the design claim at issue, the level of ordinary skill in the pertinent art, and secondary considerations of indicia of obviousness or non-obviousness.

Allergen v MSN –patent not subject to ODP challenge from later child

On 13 August 2024, the Federal Circuit issued an opinion holding that a first-filed, first-issued, later expiring claim cannot be invalidated for obvious-type double patenting (ODP) by a later-filed, later-issued, earlier-expiring claim having a common priority date.

The previous year, the Federal Circuit issued an opinion in In re Cellect holding that related patents can be invalidated for ODP when they expire on different dates as a result of patent term adjustment (PTA) under 35 U.S.C. Section 154(b). Revisiting this issue and relying on the purpose of the ODP doctrine “to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter,” the Federal Circuit held that the first-filed, first-issued patent in a family “sets the maximum period of exclusivity for the claimed subject matter and any patentably indistinct variants”.