Patent Litigation 2026

Patent Litigation Around the World

In Europe, the Unified Patent Court (UPC) is universally considered a success. Opened on 1 June 2023 around 1,100 cases had been filed by the end of 2025 and the court expects around another 1,000 cases to be filed in 2026. The court stopped reporting its filing numbers in the middle of 2025 with the introduction of the new Case Management System; therefore, detailed numbers are currently not available.

In addition to the established local and regional divisions in the 18 participating member states (PMS) an additional central division was introduced in Milan to support the two existing central divisions in Paris and Munich and additional judges were hired as well as budgets for existing judges increased. The new central division in Milan will hear cases falling into IPC class A (Human Necessities) giving it jurisdiction in particular over pharmaceutical and medical device patent validity matters (as well as counterclaims for infringement and standalone infringement actions against defendants domiciled outside the EU). The Appeal Court in Luxemburg (CoA) was also busy during 2025 and, most prominently, in two cases between Sanofi and Amgen (UPC (Court of Appeal), November 25, 2025 – UPC_CoA_528/2024), and Meril and Edwards (UPC (Court of Appeal), November 25, 2025 – UPC_CoA_464/2024), gave long awaited guidance to litigants on the assessment of inventive step by the UPC which differs from the problem-solution approach established at the European Patent Office. In Alexion Pharmaceuticals v Samsung Bioepis, the CoA addressed the correction of errors in patent claims by way of interpretation. Linguistic errors, spelling mistakes or any other inaccuracies in a patent claim can only be corrected “by way of interpretation” of the patent claim if both the existence of an error and the precise way to correct it are sufficiently certain to the average skilled person based on the patent claim, taking into account the description and the drawings and using common general knowledge. In Boehringer Ingelheim v Zentiva, the CoA held that completion of all pre-launch preparations for launching a generic medicinal product in one PMS can amount to an imminent infringement in all PMSs. In Sanofi v Amgen, the CoA also ruled on the effective service of the statement of claim and addressed the extension for lodging a preliminary objection and a statement of defence when the claimant fails to upload the annexes simultaneously with the statement of claim.

In the United States, the success rates of inter partes review (IPRs) at the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) has reached all time low levels and it is assumed this will not change under the current USPTO leadership. In the case In re Motorola Solutions, Inc., the Federal Circuit confirmed that decisions by the USPTO Director to deny or de-institute an IPR are discretionary and not judicially reviewable under 35 U.S.C. § 314(d), except in extreme circumstances not met in this case. 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 2025 and beyond.

Europe

The UK

The UK Supreme Court heard an appeal in the Summer of 2025 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 result is expected in 2026.

Plausibility continues to be a major theme of life sciences cases before the UK courts with a number due to be heard in 2026. In 2025, the Court of Appeal, in Generics (UK) Limited & Ors v AstraZeneca AB [2025] EWCA Civ 903, revoked AstraZeneca’s patent and associated SPC on dapagliflozin (Forxiga) for lack of plausibility and lack of technical contribution, and the Supreme Court refused permission to appeal.

Continuing the trend from recent years, the English Court heard a significant number of FRAND-related cases in 2025.

The Court of Appeal upheld the first instance decision in Tesla v InterDigital and Avanci [2025] EWCA Civ 193, confirming that there was no jurisdiction to determine the terms of a FRAND licence to the Avanci 5G vehicle pool. In Optis v Apple [2025] EWCA Civ 552, the Court of Appeal revised the terms of the licence settled by the High Court, increasing the lump sum payable to Optis. Both Tesla and Apple obtained permission to appeal in their respective cases, and the UK Supreme Court is due to hear these appeals in 2026.

Interaction between the English courts and other jurisdictions was also a feature of a number of FRAND-related decisions in 2025. In particular, in Samsung v ZTE [2025] EWCA Civ 1383, the Court of Appeal identified limits of the interim licence jurisdiction, refusing to uphold an interim licence sought by Samsung in favour of the English court in circumstances where ZTE had offered an interim licence to be adjusted by the Chinese court. Finally, in Amazon v InterDigital [2025] EWHC 2708 (Pat) and [2025] EWHC 3170 (Pat), the English court granted an anti-anti-suit injunction to protect Amazon’s claims for final relief, following InterDigital’s successful applications to the Munich Regional Court and the Mannheim Local Division of the UPC for anti-suit injunctions restraining the pursuit of interim licence relief in the UK.

The Netherlands

In the Netherlands, The Hague Local Division (LD) of the UPC cemented its role as the favourite non-German LD within the UPC. In 2025 there were also some high-profile appointments to the UPC with links to the Netherlands. Advocate General van Peursem, the Dutch Supreme Court’s foremost patent-specialist, is set to join the Local Division in The Hague. Readers may know him from his recent conclusions in the Apixaban saga, which further cemented the teachings of G 1/22 and G 2/22 on plausibility in Dutch case law. Meanwhile, lawyer Bart van den Broek was appointed to the recently created third chamber of the UPC Court of Appeal, following the appointment of another lawyer, Emmanuel Gougé, to the Court of Appeal in 2024.

Despite the success of the UPC and The Hague LP, the national patent courts remain very relevant and issued several noteworthy decisions. Generally, it can be observed that the courts were on a patentee-friendly track in 2025, upholding the validity of many patents, specifically in pharmaceutical cases and issuing injunctions both on the merits and in preliminary injections (PIs) where requested. Cases dealt with by the courts were certainly not limited to those fields but also concerned cases in the areas of chemical engineering, biotech, video compression codecs and agriculture. Also, patent entitlement cases seem to be on the rise in the Netherlands (with considerable attention from the press in some cases).

But there was also some not so good news from the Dutch courts, especially for supplementary protection certificate (SPC) holders, when the District Court in The Hague upheld the Dutch Patent Office’s refusal to grant an SPC for a veterinary product on the grounds that an earlier human marketing authorisation (MA) for the same active ingredient constituted the relevant “first Marketing Authorisation”. The Court relied on existing CJEU case law, treating the issue as an acte éclairé. However, the decision sits against the backdrop of further questions on this issue that have since then been posed to the CJEU by other courts. This remains an area in which developments need to be followed closely, and the courts may well change their position on this following further guidance by the CJEU.

The same applies to the view on the SPC manufacturing waiver. The Court of Appeal in The Hague issued a decision in which it adopted a broad interpretation of the manufacturing-for-export exception under the SPC directive. Although the judgement aligns closely with the interpretation given by some other national courts, such as the courts in Belgium, the position for SPC holders in Germany seems more favourable.

Also in 2025, the courts again showed why the Netherlands continues to be a highly attractive forum for patentees seeking swift and effective preliminary relief. The presiding judge of the District Court in The Hague issued an interesting decision in which the defendant raised a defence based on the proposed expansion of the Bolar exemption in the new EU Pharma Package, which would allow it to perform certain acts. The judge refused to anticipate a hypothetical future situation and assessed infringement as the facts stood on the date of the hearing, granting the preliminary injunction, which in effect even stopped the defendant from selling the product for a time after the expiry of the patent.

One of the most interesting patent decisions, however, did not come from the specialised patent courts in The Hague but rather from the District Court in Amsterdam in a case in which the underlying patent infringement occurred entirely outside of the Netherlands. The defendant co-ordinated its distribution within the EEA from the Netherlands and, as was successfully argued, knew or ought to have known that its suppliers had engaged in wrongful conduct in China. The Court enjoined the defendant from importing the products involved, emphasising that the claim was based on Dutch tort law and the defendant’s conscious participation in an unlawful supply chain. The judgement provides a roadmap for how the Netherlands can also be an interesting forum to achieve an injunction on the basis of tort law in the event direct patent enforcement is not delivering the desired result efficiently.

Spain

One of the most significant developments in Spanish patent litigation in 2025 was the landmark judgment of April 24th rendered by the Civil Chamber of the Supreme Court (Teva Pharma S.L.U. v Bristol-Myers Squibb Holdings Ireland Unlimited Company -apixaban), which addressed plausibility in light of the Decision G 2/21, of 23 March 2023, of the Enlarged Board of Appeal of the European Patent Office (EPO). This is the first Spanish Supreme Court decision dealing with plausibility, as well as the first Supreme Court judgment in Europe to have applied G 2/21 in main proceedings.

In a decision issued in record time (only nine months after the second instance judgment, and 15 months after the first instance decision), the highest Spanish court dismissed in full the appeal in cassation filed by Teva against the judgment of 18 July 2024 of the Court of Appeals of Barcelona, declaring the validity of the Bristol-Myers Squibb (BMS) patent and supplementary protection certificate protecting the anticoagulant apixaban. In short, Teva argued that the second instance court failed to properly assess the plausibility of the invention when addressing its invalidity challenges based on lack of inventive step and insufficiency of disclosure.

As regards inventive step, the Supreme Court found that:

• plausibility is inherent to the analysis of inventive step, despite not being a ground for patentability;
• “although [the court is] not bound by the decisions of the Enlarged Board of Appeal of the EPO, like so many other national courts, [it] follow[s] its opinion in view of its authority on the matter and the conviction of its reasoning”; and
• G 2/21 aligns more closely with the “ab initio implausibility” approach than with the “ab initio plausibility” approach.

Against this background, the Supreme Court noted, first, that Teva’s arguments were (incorrectly) based on the “ab initio plausibility” standard and, second, that the claims of BMS’s patent met the two conditions laid down in G 2/21.

On insufficiency of disclosure, the Supreme Court held, in line with the EPO case law, that paragraph 77 of G 2/21, which imposes a stricter plausibility standard in the context of sufficiency, applies only to second medical use claims. As the relevant claims of BMS’s patent were directed to a first, rather than a second medical use, which was claimed jointly with the product at stake (apixaban), the referenced paragraph was deemed irrelevant to the case. In any event, the court concluded that, at the priority date, the skilled person would have found it credible that apixaban could be used in therapy to treat the disorders mentioned in the claims.

Another noteworthy case in 2025 in the pharmaceutical field concerned the dispute over another anticoagulant, rivaroxaban, which was heard by the Commercial Courts and Court of Appeals of Valencia, a rather unusual venue for patent litigation in Spain, particularly in the pharmaceutical sector. The case involved several ex parte PI applications filed by Bayer against generics companies resulting in court orders preventing the rivaroxaban generics from entering the Spanish market, which, despite following different paths after the defendants opposed the PIs, were ultimately upheld by the Court of Appeals of Valencia.

Bayer’s decision to seek PIs in Valencia may have been driven by strategic considerations, including, amongst other factors, the potential impact that the outcome of foreign proceedings where the validity of the enforced patent – a dosage-regime patent – was being disputed, could have on the different courts when assessing the likelihood of success of the PI petitions. This is permitted under the flexible competence rules applicable to patent infringement proceedings in Spain, which generally allow plaintiffs to choose the venue when the allegedly infringing products are expected to be marketed throughout the country. A notable exception applies to ex parte PIs where the potential defendant has previously filed a protective brief. In such cases, according to the Supreme Court’s recent doctrine (ruling of 24 April 2024 rendered in the context of the apixaban case), the court handling the protective brief retains competence to hear any subsequent ex parte PI applications.

In the field of technology, the Mobile World Congress (MWC) will once again be held in Barcelona from 2 to 5 March 2026. As every year, the Commercial Courts in Barcelona have renewed their Intellectual Property Fast Action Protocol reiterating that the MWC could not be used opportunistically to justify the urgency required by ex parte PIs (especially when the parties had been in contact previously). The Protocol remains a very effective tool for obtaining seizure orders of presumably infringing (new) products launched at the MWC as well as PIs within 24–48 hours from filing.

On the legislative front, 2025 marked the entry into force of Organic Law 1/2025, of 2 January, on Measures for the Efficiency of the Public Justice Service, which, inter alia, introduced the use of ADR methods as a procedural requirement for the admissibility of civil claims. In practice, however, the implementation of this novel requirement has proved far from straightforward and has generated considerable uncertainty amongst practitioners and in the courts. In patent litigation, one of the most significant questions to be decided was whether a plaintiff must first attempt ADR before filing a standalone patent invalidity action. The issue has now been resolved, at least when it comes to one of the most popular venues for patent litigation in Spain, by the “Criteria on ADR in Commercial Matters” adopted in December 2025 by the Commercial Division of the Instance Courts of Barcelona. The latter confirmed that ADR is not required for this type of action, since patent validity is not a matter over which the parties have the power of disposition.

Moreover, the new law has exempted PI petitions, filed before the complaint on the merits, from the obligation to initiate an ADR procedure with the defendant. Under Spanish law, ex ante PIs are an exception to the rule, the plaintiff being required to show in its petition reasons of “urgency or necessity” to be allowed to file them before the complaint on the merits. The question – unclarified by the Criteria – is whether or not the patentee could successfully argue that the obligation to initiate an ADR procedure (and the time that would be needed to manage it) gives rise, per se, to the urgency required by the law with the effect that, if it does, ex ante PI petitions may become the rule in practice.

The same law has also entailed the largest reform in years of the Spanish judicial system, with the creation of the so-called “instance courts”. The reform – which entered into force on 1 January 2026 in the main Spanish court districts, including Barcelona and Madrid, where most patent cases are heard – introduces a single judicial office for each district designed to streamline the management of proceedings, optimise resources and improve overall efficiency. In the medium term, this new system is expected to foster greater consistency, shorter timelines and increased predictability in judicial decisions.

France

Two and a half years after the start of the UPC, French courts have remained very active on the patent litigation front in 2025, further enriching their case law on several heavily debated issues.

In the pharmaceutical field, 2025 was another particularly dense year for decisions relating to the validity of SPCs. After several rulings in 2024 suggesting a more generous approach to SPCs covering antibodies not explicitly mentioned in the basic patent, the French Supreme Court reminded French practitioners that this remains a highly fact-specific issue. It upheld a court of appeal ruling that had found an SPC invalid on the ground that identifying the monoclonal antibody at stake would have required an inventive step for the skilled person based on the disclosure of the basic patent (Cass. Com. 19 March 2025, case No. 23-20.000). By contrast, in a separate case, the Paris Court of Appeal upheld the validity of an SPC covering a combination of two active ingredients, one of which was not explicitly named in the basic patent, finding that said ingredient would at least have been identifiable for a skilled person (Paris Court of Appeal, 16 May 2025, Docket No. 22/19939).

Still in the pharmaceutical field, the Paris Court of Appeal made a noteworthy application of the French mechanism of literal infringement through the reproduction of the so-called “essential means” of the invention – ie, where the core technical features of a claim are reproduced even if certain secondary features are not. The Court found literal infringement of a patent covering a combination therapy based on two compounds, even though, for one of those compounds, the salt form used in the allegedly infringing product was different from the salt form explicitly mentioned in the claim (Paris Court of Appeal, 17 December 2025, Docket No. 24/02201).

On the procedural side, infringement-seizures (saisie-contrefaçon) continued to prove a powerful tool for claimants seeking to secure evidence prior to initiating infringement proceedings. Several decisions handed down in 2025 helped clarify certain aspects of the applicable regime. In particular, the Paris Judiciary Court confirmed that the sorting and review of the seized documents can be organised exclusively between the parties’ counsel, without granting access to the parties themselves, in order to preserve trade secrets (Paris Judicial Court, 20 February 2025, docket 24/05601; Paris Judicial Court, 27 June 2025, Docket No. 25/00271). In the same set of decisions, the Court dismissed several challenges seeking the revocation of seizure orders on the ground that the authorised measures were allegedly too broad or too invasive, thereby confirming that the strategic value of the saisie-contrefaçon as an evidentiary tool remains largely intact (see also Paris Judicial Court, 23 May 2025, Docket No. 24/05601).

Germany

In Germany, the market for national patent litigation continues to shrink, with the notable exception of the Munich local court, which seems to have had more cases in 2025 than ever before. Litigants perceive the Munich court as more patentee friendly and as faster than the other national German courts, particularly those in Mannheim, Düsseldorf or Hamburg.

On the substantive law side, German courts continue to be a “safe choice” for non-practising entities (NPEs). There were, once again, a large number of decisions in 2025 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 their reluctance to exercise any proportionality assessments when considering injunctive relief keeps Germany firmly on the map for plaintiffs.

At the beginning of 2026 the German Federal Supreme Court (Bundesgerichtshof) in KZR 10/25 dismissed a challenge by HMD against decisions from the Munich lower and Appeal courts dismissing their fair, reasonable, and non-discriminatory (FRAND) defence against VoiceAge EVS on grounds of alleged unwillingness. In the proceedings, HMD’s legal position was supported by the European Commission, which intervened in the proceedings. However, the German Federal Supreme Court takes the view that an implementer cannot rely on the absence of a FRAND offer by the standard essential patent (SEP) owner if it has not itself acted swiftly in the negotiations and/or provided security for its own offer at the amount offered by the SEP owner. There will be more opportunities for implementers to request referrals to the Court of Justice for the European Union (which the Supreme Court did not feel was necessary) but these are unlikely to come from the German courts.

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).

In a number of cases the Supreme Court refined its case law on the scope of prior art disclosure (X ZR 99/23) and sufficiency (X ZR 43/23 and X ZR 131/22), specifying in the latter case that it will deviate from its usually quite generous case law where a broad claim is only supported by a few specific embodiments and the skilled person had reasons to believe that these were the only working embodiments of the invention. In that case, the claims will have to reflect that the examples cannot be generalised and the scope of protection must be limited correspondingly.

Italy

The year 2025 saw several notable developments in Italian patent case law, with the Supreme Court providing important clarifications on co‑ownership rights, the scope of exclusive patent rights and the interpretation of infringement‑related conduct. National courts also addressed the interaction between domestic jurisdiction and the UPC during the transitional period.

Co‑ownership and unilateral exploitation

In its decision of 18 February 2025 (No 4131), the Italian Supreme Court addressed whether a patent co‑owner may exploit the invention independently in the absence of a governing agreement. The case concerned an Italian and a Slovenian company that jointly owned a patent for a spearfishing gun. After the termination of the exploitation agreement, the Italian co‑owner continued manufacturing and selling the product without securing the other co‑owner’s consent. The Venice Court of Appeal had upheld this conduct.

The Supreme Court reversed. Starting from Article 6 of the Italian Industrial Property Code (IPC), which refers to the Italian Civil Code rules on co‑ownership, the Court held that Article 1102 of the Italian Civil Code cannot be mechanically applied to patents. A patent is not merely a physical asset but a legal right whose core lies in its exclusivity. Allowing a single co‑owner to exploit the invention unilaterally would alter the nature of the shared right and undermine the other co‑owner’s entitlement to exclusivity. Accordingly, in the absence of an express agreement to the contrary, unilateral exploitation is not permitted.

Interpretation of “marketing” under Article 66 IPC

In its order No 20074 of 18 July 2025 (Boehringer Ingelheim Pharma GmbH & Co. KG v Sicor Società Italiana Corticosteroidi S.r.l.), the Supreme Court examined the scope of the patent owner’s exclusive rights – specifically the meaning of “marketing” within Article 66 of the IPC. The Court of Appeal had equated “marketing” with “sale”, limiting damages to quantities proved to have been sold for consideration.

The Supreme Court rejected this restrictive interpretation. It held that “marketing” encompasses all acts aimed at placing a product on the market, including promotional activities, free samples and any conduct facilitating market penetration. Such acts can erode the economic value of the exclusive right even in the absence of completed sales. The ruling confirms the Court’s tendency to interpret infringing acts broadly where they may dilute the patent holder’s commercial exclusivity.

UPC jurisdiction during the transitional period

The Court of Venice (decision No 5761 of 12 November 2025) provided further clarity regarding jurisdiction over European patents without unitary effect during the UPC transitional period. The Court held that where the patent owner has not filed an opt‑out under Article 83 of the Agreement on a Unified Patent Court (UPCA), jurisdiction over infringement disputes lies exclusively with the UPC – even during the transitional period.

The plaintiff had argued that the lack of an opt‑out preserved concurrent jurisdiction, enabling the patent holder to choose between national courts and the UPC. The Court disagreed. It found that the transitional regime merely offers a temporary opportunity for patent owners to depart from the UPC’s exclusive competence by filing a registered opt‑out. If no opt‑out is filed, the UPC’s exclusive jurisdiction remains fully effective.

Article 83(3) of the UPCA, which refers to “the possibility to opt out from the exclusive competence of the Court”, was deemed to support this conclusion: exclusive UPC jurisdiction is the rule; the opt‑out is the derogation from that rule.

Eurasian Economic Union (EAEU)

Patent enforcement in the EAEU continues to demonstrate a high level of activity and legal complexity. Recent years have shown that patentees remain willing to assert their rights in some EAEU member states (Kazakhstan and Russia) and are more hesitant in some other (Armenia, Belarus and Kyrgyzstan). In 2025 the Belarus courts dealt with patent cases ruling in favour of patentees, which may enhance the importance of this country for patent enforcement in the future. Manufacturers of generic products (“Gx producers”) increasingly rely on a combination of defensive and delaying strategies, including patent revocation, patent term extension (PTE) challenges and compulsory licence claims. At the same time, courts and administrative authorities are refining their approaches, particularly in relation to the threat of patent infringement and unfair competition claims.

Continued active patent enforcement

In 2025 global businesses continued enforcing patent rights in the EAEU. Patent enforcement remains robust and multifaceted. Patentees continue to seek protection via both traditional patent infringement court proceedings and unfair competition actions.

Court proceedings primarily involve claims for patent infringement and threat of patent infringement and are aimed at obtaining injunctions to prevent early market entry of Gx product. In Russia, parallel to judicial enforcement, administrative mechanisms (especially proceedings before competition authorities) continue to provide a practical tool for patentees willing to obtain injunctions against Gx products undermining patent exclusivity.

Threat of patent infringement: changing evidentiary standards

One of the most notable developments in Russia concerns the threat of patent infringement actions.

Previously, the existence of a registered MA and drug price combined with the statutory duty to commence use within three years following MA registration often played a central role in demonstrating imminence of threat. Following the Russian IP Court recommendations, the lower courts adopted a more nuanced and fact-specific approach.

In practice, courts accept, as evidence of an imminent threat, information indicating preparatory steps toward market entry such as evidence of manufacturing activities and the production of batches of Gx, even where no commercial launch has yet occurred. Courts also take into account information on a Gx producer’s prior conduct, including evidence of early launches in other cases that were recognised by courts as patent infringements.

Unfair competition actions and judicial scrutiny of FAS decisions

Since 2024, unfair competition actions have been an important supplementary enforcement mechanism for patentees in Russia. In 2025, a number of decisions issued by the Federal Antimonopoly Service (FAS) became subject to judicial scrutiny.

While the courts have overruled several FAS decisions, the majority of the 2024 decisions have not yet been reviewed by higher courts, and therefore definitive conclusions regarding long-term judicial trends would be premature. To date the courts have not questioned the very availability of unfair competition actions to patentees. On the contrary, courts have recognised that such actions may legitimately be used to protect patent rights. The concerns raised by courts have instead focused primarily on procedural shortcomings in the FAS proceedings.

Subject to higher courts’ review, unfair competition actions are likely to remain a powerful tool for patentees going forward.

Revocation and PTE challenges as defensive strategies

Gx manufacturers continue to actively challenge both national and Eurasian patents through revocation proceedings and patent term extension (PTE) challenges. However, the success rate of such actions remains relatively limited.

In many cases, these proceedings are used primarily as part of a delaying strategy aimed at slowing down or staying patent infringement proceedings.

Compulsory licence claims

Alongside revocation and PTE challenges, Gx producers have, in some cases, brought compulsory licence claims. These claims have sometimes been brought in parallel – and in a manner that is arguably contradictory – to challenges aimed at invalidating the same patents. In certain instances, compulsory licence claims have also been brought as counterclaims in patent infringement proceedings.

Courts have responded cautiously to this Gx strategy. Where compulsory licence claims are brought simultaneously with revocation or PTE challenges, courts tend to stay the compulsory licence proceedings pending the outcome of the revocation or PTE challenges.

The EAEA states where compulsory licence claims have been brought include Belarus and Russia. Gx producers currently tend to base compulsory license claims on allegations of insufficient use of the patented invention. While some of these cases have been resolved through settlements reached in closed hearings, other cases still remain unresolved. In several cases in Belarus, courts have dismissed compulsory licence claims, signalling a relatively strict approach to the statutory requirements for such licences.

Asia

Japan

Japan’s patent system remains stable and generally pro-rights-holder, but its practical operation has shifted materially over the past 12–18 months. The most consequential developments are not wholesale statutory reforms, but changes in enforcement reality and regulatory interaction, notably in SEPs, AI-driven innovation, and life sciences launch strategy (patent linkage). It appears that Japan may be positioning itself as a predictable yet strategically consequential jurisdiction requiring early integration of IP with regulatory and commercial planning as well as disciplined licensing conduct.

The courts in Japan have remained broadly pro-patentee. The IP High Court’s litigation statistics released in July 2025 in respect of 2024, highlighted that there was a 21% success rate for patentees in patent infringement cases decided between 2015 and 2024, and 37 cases in the same period in which the patentee received over JPY100 million (around USD 650,000) 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 peaking to a record 1,411 cases in 2023 and falling to 1,264 in 2024. Interestingly, the number of requests for invalidation trials has reversed its downward trend, from 106 in 2021 to 84 in 2023 and rising up to 186 in 2024, although the number remains significantly lower than the number of oppositions. 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.

Since late 2024, the JPO has been conducting a formal review of the Patent Act and Design Act to address systemic issues arising from generative AI, including:

• AI-generated disclosures destroying novelty;
• attribution of inventive contribution; and
• examination standards where AI tools are embedded in R&D.

Legislative amendments are widely expected in 2026. Importantly, this is framed not as a narrow “AI carve-out” but as a recalibration of core patent concepts for the AI era. This is likely to have major implications for pharma discovery platforms, materials science and software-driven innovation.

Continuing the trends seen in 2024, Japanese companies are arguably becoming more assertive and initiating patent litigation, particularly in the technology field and including between domestic companies. As in recent years, more disputes are expected in this sector in the next 12–24 months, 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.

Notably in 2025, the Tokyo District Court granted an injunction against Google in an SEP dispute with Pantech involving the Pixel 7 smartphone. For the first time, a Japanese court:

• granted injunctive relief for SEP infringement, and
• did so based on the implementer’s lack of good-faith FRAND negotiation.

The court focused on Google’s refusal to provide sales data and engage meaningfully in court-led mediation, concluding it was not a “willing licensee”. This decision demonstrates Japan’s emergence as a serious SEP enforcement and rate-setting venue, with the court assessing FRAND royalty rates, examining global portfolio licensing conduct and scrutinising negotiation behaviour. This development and increased involvement of the Japanese courts may affect global licensing and litigation strategy.

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 and administrative “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. So far, there have been no attempts to legislate for a formal patent-linkage system, despite some criticism of the current system’s lack of transparency and legal basis. However, in October 2025, Japan’s patent linkage system was formally expanded to cover biological products, which potentially increases regulatory complexity for biosimilar developers and heightens the need for companies to develop an integrated regulatory-IP strategy.

Once the on-going 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

China’s anti anti-suit injunction/anti-suit injunctions practice – WTO DS611

In July 2025, the WTO issued the final arbitral award in DS611 (EU v China – Enforcement of Intellectual Property Rights), a dispute initiated by the European Union through a complaint filed in 2022, alleging that China’s anti-suit injunction (ASI) practice restricted European SEP holders’ ability to enforce their rights abroad, marking the first time that China’s use of interim injunctive relief in SEP disputes was reviewed under the framework provided by the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

The WTO arbitrators affirmed that a series of ASI rulings, their treatment as guiding or representative cases, and the judicial interpretations supporting their issuance collectively demonstrated a general and ongoing ASI practice attributable to China, rather than isolated case-specific decisions.

The arbitrators adopted a broader interpretation of Article 1.1 of TRIPS, holding that it contains not only an obligation to implement TRIPS domestically, but also a negative obligation prohibiting members from adopting measures that undermine the functioning of other members’ IP enforcement systems. On this basis, the arbitrators concluded that China’s ASI practice violated Articles 28.1 and 28.2 of TRIPS, as the practice effectively restricted SEP holders’ ability to initiate infringement litigation or negotiate and conclude licensing agreements in other WTO members’ jurisdictions.

The EU had argued that Chinese ASIs undermined the fairness and effectiveness of enforcement remedies under TRIPS Article 41.1. The arbitrators rejected that theory, holding that ASIs do not fall within the scope of domestic judicial enforcement procedures and TRIPS does not regulate how courts should manage cross border litigation conflicts.

The arbitrators found that China failed to publish certain ASI decisions of general application and did not supply complete information requested by the EU, also breaching Articles 63.1 and 63.3.

The WTO DS611 ruling recommends that China refine (i) the scope and effects of ASIs, (ii) the use of coercive daily fines, and (iii) transparency rules for behaviour preservation decisions.

The ruling has lasting implications for China’s SEP litigation landscape. It does not mean China cannot issue or enforce ASIs/or anti anti-suit injunctions to protect domestic proceedings from foreign interference. However, Chinese courts and agencies are now expected to be more cautious in issuing ASI-related measures – especially as regards their extra territorial reach, justification and the scale of daily fines – and to enhance transparency for decisions of general application.

Evolution of China’s pharmaceutical patent linkage system

China’s patent linkage regime has expanded rapidly since its launch in 2021. Between 2021 and 2025, around 200 administrative complaints were filed with the China National Intellectual Property Administration (CNIPA) seeking administrative adjudication under Article 76 of the Patent Law, while far fewer matters were brought before the courts. This filing pattern demonstrates that CNIPA’s administrative pathway has become the primary forum for resolving early-stage patent–generic disputes, offering a faster and more practical mechanism for addressing infringement issues before drug approval.

According to CNIPA statistics, more than 55% of administrative complaints were withdrawn in 2024–2025. This trend suggests that once the generic applicant discloses its technical solution, both parties can promptly evaluate infringement risk and often resolve the dispute without the necessity of going through the full adjudication process. In practice, the linkage mechanism functions not only as a dispute resolution forum, but also as a risk screening mechanism and a technical information gateway for originators.

A review of CNIPA’s 2024–2025 adjudication decisions reveals several consistent themes that now define the operation of China’s patent linkage system.

Burden of proof and procedural obligations

To address pre approval information asymmetry (originators cannot obtain/test the generic product), CNIPA has established clear evidentiary rules.

• Mandatory disclosure of the full technical solution – generic applicants must submit a complete technical solution covering all patent relevant features, including formulation, manufacturing processes, and excipients.
• Evidentiary consequences for non-submission – if a generic applicant fails to provide a full technical solution, submits incomplete information, or cannot substantiate its non-infringement position, CNIPA may impose adverse evidentiary consequences, including a presumption that the product falls within the patent claim scope.

These rules effectively address the originator’s challenge of accessing pre-approval evidence.

Substantive infringement standards

Once the technical solution is disclosed, CNIPA applies the traditional infringement principles with rigour.

• All elements rule – Each and every claim element must be satisfied literally or equivalently. If the generic product omits a claim element, modifies a technical feature without equivalence, or fails to provide evidence of non-coverage, infringement is not established.
• Prosecution history estoppel – CNIPA consistently applies estoppel to prevent patentees from reclaiming subject matter surrendered during examination or invalidation proceedings.
• Narrow approach to equivalence – CNIPA is cautious in applying the doctrine of equivalents. Arguments based solely on therapeutic equivalence—such as claims that the generic exhibits the same quality or efficacy as the reference listed drug—are rejected.

As the CNIPA’s administrative jurisprudence continues to mature, the system is expected to play an even more influential role in shaping pharmaceutical patent strategies in China.

Revised patent examination guidelines: new provisions on AI-related inventions

On 10 November 2025, CNIPA issued revised Patent Examination Guidelines, which took effect on 1 January 2026. The revision updates the examination standards for AI-related patent applications (Section II-9-6), building on the trial guidelines issued in December 2024.

The terms “AI” and “Big Data” are now explicitly added to the section title, clarifying the scope of application. A new examination standard under Patent Law Article 5(1) requires that AI-related applications must not violate laws or social morality — the Guidelines cite algorithmic discrimination and unauthorised biometric data collection as examples of unpatentable subject matter. New examination examples also clarify that merely applying an existing algorithm to a different scenario without substantive technical adjustments typically lacks inventiveness. Additionally, the Guidelines specify that specifications must adequately describe model architecture, training parameters, and input-output relationships for AI-related inventions.

Hong Kong

In its 2025 policy address, the Hong Kong government highlighted the importance of intellectual property as the cornerstone of encouraging information and technology development and creativity. With this in mind, it will push forward with measures to encourage IP financing, valuation and protection, and boost IP trading. These measures include the launch of an IP financing sandbox to assist pilot sectors (particularly the technology sector) in leveraging IP for financing with the support of the banking, insurance, valuation, legal and other professions. The Hong Kong government is also providing local small and medium I&T enterprises with patent evaluation based on Chinese national standards and launching a two-year pilot programme to subsidise patent valuation as a reference for credit financing.

Changes to Hong Kong’s patent system introduced at the end of 2019 provide a direct route to seek 20-year patent protection by means of original grant patents (OGPs). For the 12-month period to 31 August 2025 there was a 32% increase in OGP filings compared to the previous year. Hong Kong’s Intellectual Property Department (IPD) currently receives some assistance from CNIPA but has a goal of acquiring institutional autonomy in conducting substantive patent examination in 2030. Proposals to introduce a new local Hong Kong patent attorney profession are currently being considered and legislative amendments to implement this are expected later this year.

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 12-month period to the end of August 2025, over 16,400 applications were filed to re-register designated patents and around 10,600 patents were granted using the re-registration route. However, the IPD wants there to be potential advantages in using the OGP route. For example, from 5 July 2026, some tax advantages (ie, assessment of qualifying profits derived from certain IP income of an owner or licensee of eligible IP are subject to the concessionary tax rate of 5% rather than the normal tax rate of 16.5%) will only be available where an OGP has been filed for the same invention. Other advantages include, 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. New procedural court rules for patent and other IP cases (“Practice Directions”) were introduced on 1 October 2025. These Practice Directions provide detailed rules for commencing and conducting patent cases. For example, parties alleging infringement of a patent are required to file a claim chart setting out which claims are alleged to be infringed and why. Claim charts are also required where a party is alleging the invalidity of a patent. In appropriate cases the Court may direct that a case be tried on an accelerated basis, including that the case be tried on affidavit/affirmation evidence alone and there be no or limited cross examination on the affidavit/affirmation evidence.

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; has a population of nearly 90 million; and is the home of many Chinese technology companies. A comprehensive mechanism now exists 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, 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.

The USA

EcoFactor, Inc. v Google LLC – Heightened “gatekeeping” duty for expert methodology reliability

On 21 May 2025, the Federal Circuit issued an en banc opinion reversing a USD20 million jury verdict, holding that the district court improperly admitted expert testimony on damages. At trial, EcoFactor’s damages expert relied collectively on three lump-sum licence agreements for EcoFactor’s entire patent portfolio to arrive at a royalty rate for the sole asserted patent. The licence agreements included a whereas clause specifying that the lump sum was based on what EcoFactor believes is a reasonable royalty calculation, but two of the licences included statements that the licensee expressly did not agree on a reasonable royalty. The expert also relied on testimony from EcoFactor’s CEO that the lump-sum payments were calculated based on each licensee’s past and future projected sales, but there was no documentary evidence supporting his testimony, and the record showed that no one at EcoFactor had access to the sales data of the licensees.

The Federal Circuit found that the testimony of EcoFactor’s damages expert was not based on sufficient facts or data as required under Federal Rules of Evidence 702(b), and that the district court’s decision to admit the unreliable testimony was prejudicial.

Following this case, patent plaintiffs and defendants should pay particular attention to the sufficiency of factual support underlying expert damages opinions.

Ingenico v IOENGINE – IPR estoppel does not apply to physical products

On 7 May 2025, the Federal Circuit resolved a split in the application of inter partes review (IPR) estoppel under 35 U.S.C. §315(e)(2) among District Courts in favour of petitioners. Under 35 U.S.C. §315(e)(2), after a final written decision on an IPR, a petitioner is estopped from asserting in a civil action or a proceeding at the International Trade Commission (ITC) that a claim in the challenged patent is invalid on any ground that the petitioner raised or reasonably could have raised during the IPR.

Ingenico filed petitions for IPR that resulted in final written decisions of unpatentability of most, but not all of IOENGINE’s patent claims. Ingenico also filed a declaratory judgment action in district court and obtained a jury verdict of invalidity of claims that had survived the IPR proceedings based on a product and documents relating to that product. IOENGINE appealed arguing that the product was entirely cumulative and substantively identical to one of the related product documents, and that document was a “printed publication” that could have been raised during IPR.

The Federal Circuit found that since IPRs are limited to “a ground that could be raised under section 102 or 103,” based on “prior art consisting of patents or printed publications”, a petitioner has no opportunity in an IPR to argue a claimed invention “was known or used by others, on sale, or in public use”. The Federal Circuit further held that the term “ground” in §315(e)(2) does not mean “prior art”, and that IPR estoppel does not preclude a petitioner from relying on the same patents and printed publications as evidence in asserting a ground that could not have been raised during the IPR.

A key takeaway from this case is that a patent defendant relying on printed publications describing system art can assert the same system art or even the same patents or printed publication in a district court action to support theories not available in IPR, such as public use, after IPR estoppel has attached. However, the impact of this case has been muted with the USPTO’s recent rescission of the 2022 FinTiv memo, and recent decisions suggesting that stipulations to IPR estoppel are less persuasive for institution decisions.

Lashify, Inc. v. ITC – Domestic industry investments in labour and capital not limited

On 5 March 2025, the Federal Circuit vacated the ITC’s determination finding that complainant Lashify had failed to satisfy the economic prong of the domestic industry requirement for the three asserted patents. The economic prong can be met by showing a “significant employment of labor or capital”. However, the Commission held that even large expenditures for domestic employment of labour or capital pertaining to patented articles are insufficient (i) when the labour or capital is used for selling and marketing, unless there exist other qualifying expenditures, and (ii) when the labour or capital is used for warehousing, quality control, and distribution, if the products are manufactured outside the United States and no additional steps occur in the United States to make them saleable. On review, the Federal Circuit held that the Court’s interpretation of Section 337(a)(3)(B) was incorrect and remanded to the Commission with instructions to count Lashify’s employment of labour and capital even when they are used in sales, marketing, warehousing, quality control or distribution.

This decision expands the categories of labour and capital that can be used to satisfy the domestic industry requirement, potentially opening the door for additional prospective complainants at the ITC.