Looking forward: what is on the agenda for European patent litigation in 2026?

This year is set to be a busy one in the world of patent litigation and supplementary protection certificates (SPCs). The Court of Justice of the EU (CJEU)'s landmark decision in BSH v Electrolux and the continued popularity of the Unified Patent Court (UPC) have reshaped the patent litigation landscape in Europe over the past year and that is likely to continue in 2026.

Standard essential patent (SEP) licensing disputes will continue to be a mainstay in English and European courts and whether and how comity tensions will be reduced remains to be seen.

The EU will also see sweeping pharmaceutical regulatory reforms, which will affect regulatory exclusivities and see the Bolar exemption extended, with the aim of facilitating earlier access to market for generics and biosimilars. The EU is also looking to turbocharge the biotechnology sector, offering incentives such as a 12-month extension for SPCs for medicinal products produced by biotechnology processes. With no similar concrete measures announced for the UK, this could lead to regulatory divergence between the UK and EU markets.

In the UK, the UK-US pharmaceutical trade deal will lead to an increase in medicine pricing for branded medicines, widening access to cutting-edge medicines for NHS patients. Despite this, the government is also focused on speeding up market access for generics and biosimilars, although clear plans on how this will be achieved have not yet been forthcoming.

What are the main patent-related issues for businesses to look out for this year?

Jurisdiction

Prior to the CJEU's decision in BSH v Electrolux, EU and UK courts declined jurisdiction over claims relating to infringement of IP rights (IPRs) if validity was put in issue – a party could sue (or seek a declaration of non-infringement) for both "local" and "foreign" infringements in a national court but as soon as the validity of the rights was in issue, the court declined jurisdiction.

BSH v Electrolux represented a major change in practice and broke the link that required infringement and validity to be heard together. Although the case itself concerned patent rights, the CJEU's reasoning could apply more broadly to other IPRs as the ruling relates to the interpretation of Article 24(4) recast Brussels Regulation. This concerns the exclusive jurisdiction (regardless of the parties' domicile) over "the registration or validity of patents, trade marks, designs, or other similar rights required to be deposited or registered".

Infringers can now be sued in their EU state of domicile (under Article 4(1) recast Brussels Regulation) even if the IPR was granted by another state. In the case of the IPR originating from another EU state (or Lugano state), EU courts cannot rule on validity of the right but retain infringement jurisdiction and may stay infringement proceedings if there is a "reasonable non-negligible chance" of invalidity.

However, in the case of IPRs originating from a non-EU "third country" (for example, the UK), EU courts can rule on both infringement and – on an inter partes basis – validity when validity is raised as a defence. An inter partes validity ruling does not affect the existence or contents of the IPR and does not cause the national register to be amended.

The CJEU's decision has already seen a major change to the patent litigation landscape in Europe, with implications for parties (via creative use of anchor defendants) and potentially infringements worldwide. The decision has facilitated cross-jurisdictional litigation and EU courts are endorsed to rule inter partes on validity of non-EU patents, which has led to cross-border preliminary injunctions and permanent injunctions.

The UPC has already enthusiastically expanded its long-arm jurisdiction and this can be expected to continue in 2026, although its competence is limited to European Patents. The decision is also being applied by the German national courts in the patent context. It is likely other EU national courts, whose competence is not constrained to European Patents, will begin expanding their jurisdiction as well, perhaps not just in relation to patents but also other IPRs.

The Swiss Federal Patent Court has taken steps to expedite its validity proceedings where the validity of a Swiss patent is challenged abroad. It remains to be seen how the English courts will respond, or whether the UK government might seek to intervene, for example, perhaps by considering attempting to join the Lugano Convention again.

UPC

As noted above, the UPC has repeatedly flexed its long-arm jurisdiction, with implications for non-participant jurisdictions, including the UK. Thus far, it has expanded its jurisdiction during the course of proceedings to include non-UPC states, taken jurisdiction over non-UPC EU and Lugano state infringements and non-EU infringements, taken jurisdiction over non-EU entities, issued final injunctions affecting non-UPC EU and Lugano states and non-EU countries, made inter partes rulings on the (in)validity and limitation of non-EU EP designations, and granted a preliminary injunction against alleged infringements in a non-UPC EU state by a non-EU entity using a UPC anchor defendant. The flexing of its long-arm jurisdiction is now no longer a surprise and it is a trend that will continue this year.

The UPC has also been clear that it is willing to enforce injunctions granted by way of hefty fines. This is more nimble and quicker than enforcement would be in the UK, which would require costly contempt proceedings to be brought. This creates an asymmetry of enforcement where there is infringement of UK designations based on inter partes validity findings. This is an issue the English courts have yet to address, but may have to grapple with this year.

Beyond the UPC's long-arm jurisdiction, the UPC Court of Appeal clarified a number of substantive concepts during the course of 2025, including: inventive step, added matter, director liability for patent infringement, and a number of the criteria applied in deciding whether to grant a preliminary injunction, including the test for imminent infringement.

The Court of First Instance (Düsseldorf LD) dealt with the first second medical use claim, setting out what must be shown to prove infringement of a second medical use claim. This test will need to be affirmed (or otherwise) by the Court of Appeal, which could be on the horizon for 2026.

Other substantive issues require Court of Appeal guidance, such as the doctrine of equivalence – a test for which has been set by The Hague LD and applied in another case by The Hague LD but not yet considered by the Court of Appeal, and the extent to which prosecution history can be used in claim construction – the issue has come before the Court of Appeal before but it did not need to be decided on the facts of the case. We have yet to see any detailed judgments on damages calculations. Again, these issues (and more) could be up for consideration in 2026.

SEP licensing

In 2025, SEP licensing disputes continued to occupy the English courts – a trend that will continue this year. In 2026, the UK Supreme Court will hear important appeals in Optis v Apple and Tesla v InterDigital & Avanci (in both of which Osborne Clarke is acting) and (F)RAND trials will be heard in Samsung v ZTE and InterDigital v Amazon.

However, since the English courts' decision to grant interim licence declarations in SEP licensing disputes, there have been escalating jurisdictional and comity tensions between the English courts and the UPC and other European courts.

In 2025, the UPC and Munich I Regional Court both granted the first anti-interim-licence injunctions (AILIs) (a particular form of anti-suit relief), which prompted anti-anti-suit relief being granted by the English courts. The granting of the AILIs was notable because of the significant emphasis placed on judicial sovereignty and the national nature of patent rights. This presents an interesting dichotomy when contrasted with the approach to long-arm jurisdiction taken by both the UPC and the Munich I Regional Court in the wake of BSH v Electrolux. In exercising long-arm jurisdiction, both courts have taken an expansive approach to jurisdiction and shown a willingness to assess infringement and validity of foreign patent rights.

In light of the various anti-suit applications, a number of English court decisions have called for a de-escalation of the jurisdictional tensions, with Mr Justice Mellor most recently calling for de-escalation to avoid ASIs and AASIs becoming the norm.

As acknowledged by the Court of Appeal, in the absence of a global dispute resolution mechanism for SEP disputes, how the courts deal with more than one court being seised in a matter will have to be worked out over time. If multiple courts proceed with their own (F)RAND determinations in parallel, there is a risk of irreconcilable judgments.

Against this backdrop, the UK government launched a consultation on SEPs and potential measures to address challenges in the licensing ecosystem. The consultation closed on 7 October 2025, shortly before the first AILIs were granted. The government has promised a response to the consultation in 2026, but will this take into account the recent judicial escalations?

In the EU, the European Commission had introduced a draft regulation that would have drastically changed the SEP litigation and licensing landscape in the EU (with potentially global ramifications). The proposal was highly contentious, with the European Parliament and Council of the EU failing to reach an agreement on the proposal. This led the Commission to withdraw the proposal in early 2025 due to a "lack of foreseeable agreement" between the Parliament and Council.

After some months of disputes, the Parliament voted to sue the Commission over the withdrawal of the regulation and an action to annul the Commission's withdrawal has been filed before the CJEU. Although a decision from the CJEU may not come until after 2026, it is certain that the SEP licensing landscape will continue to evolve and this may add political pressure on the Commission to resurrect the proposal or propose something new.

EU pharma package

In the EU, widescale reform of pharmaceutical legislation is on the horizon. At the end of 2025, the European Parliament and Council of EU reached a provisional agreement on the pharmaceutical policy framework, which is intended to boost the EU's competitiveness, innovation and security of medicines supply.

The provisional agreement proposes the following changes:

• Data and market exclusivity. A move from "8+2+1" formula to "8+1(+1+1)": eight years of regulatory data protection plus one year of market protection as the baseline after marketing authorisation. Up to two additional 12‑month increments of market protection available if specified conditions are met, with the overall cap for combined regulatory protection remaining at 11 years.
• Triggers for additional protection. 1) Unmet medical need; 2) containing a new active substance that fulfils a combination of conditions including comparative clinical trials, trials conducted in several Member States, and filing for EU authorisation within 90 days of the first non EU approval; and 3) securing approval for one or more new therapeutic indications that provide significant clinical benefit.
• Orphan medicinal products (OMPs). A move from 10 years of market exclusivity (plus two for paediatric extension) to nine years market exclusivity (plus two year for "breakthrough" OMPs meeting highly unmet medical need (total 11 years)).
• Antimicrobials. An additional one year transferable data exclusivity voucher for "priority" antimicrobials.
• Bolar exemption. Expanded to include marketing authorisations, health technology assessments, pricing and reimbursement approval, and participation in public tenders.

These changes will potentially lead to generics and biosimilars being able to enter the market earlier, and therefore accelerating competition, compared to the current rules. The expanded Bolar exemption will also facilitate earlier preparatory activities, aiming to facilitate day one availability of generics and biosimilars once patent protection or data and market exclusivity ends.

The provisional agreement needs to be endorsed by both the Council and the Parliament, before being formally adopted, which is likely to take place this year. However, most provisions are not expected to apply until around 2027-2028 after a transition period. It is not clear whether the UK intends to implement similar reforms or whether this will be a point of regulatory divergence in the future.

EU Biotech Act

At the end of 2025, the European Commission published its long-awaited EU Biotech Act, with the aim of increasing the EU's biotechnology potential by supporting the transition of innovative ideas from the lab to market.

Among the key proposals, which had not been trailed in the lead up to its release, is a 12-month extension to SPCs for medicinal products developed by means of biotechnology processes and for "advanced therapy medicinal products". Certain conditions must be met to secure this extension: 

• the medicinal product must contain a new active substance distinctly different from that of any authorised product in the EU;
• the medicinal product must have a distinctly different mechanism of action and show a level of safety and efficacy at least equivalent to any authorised medicinal product in the EU for the same disease;
• clinical trials evaluating the efficacy of the medicinal product and supporting the marketing authorisation must be conducted in more than two Member States, and
• at least a manufacturing step, excluding packaging, quality testing and certification, must be performed in the EU.

It is proposed that the European Medicines Agency (EMA) assesses compliance with these conditions as part of the marketing authorisation procedure. The extension of the SPC is intended to incentivise the development of drugs using innovative biotechnology processes to bring therapeutic advantages to patients.

The Act also seeks to enhance competitiveness in biosimilars by encouraging the development of (non-binding) EMA guidelines on a tailored regulatory approach for the development of biosimilars, which reflect the advances in manufacturing and analytical testing. The guidelines will consider a potential reduction in clinical data required for the development and approval of biosimilars, without affecting their quality, safety and efficacy.

In addition, the Act includes measures to support strategic health biotechnology projects focused on biosimilars research, development, manufacturing and marketing authorisation, and promotes international cooperation between economic operators and biotechnology clusters in this area.

Other provisions concern the adoption and integration of AI in actions supporting biotechnology. For example, there is provision for the EMA to issue guidance on the use of AI across the medicinal-product lifecycle and for the development of trusted AI testing environments to advance safe AI-enabled biotechnology. The Act also proposes new regulatory tools for novel health biotechnology products, for example, products that fall outside of existing health legal frameworks or borderline products.

EU compulsory licensing

In 2025, the European Parliament and Council of the EU reached a provisional agreement on compulsory patent licensing for crisis management. A compulsory licence allows the use of a patent right without authorisation of the rightsholder in certain specified circumstances, often crisis-type scenarios. The regulation sets out an EU-wide compulsory licensing framework to address current fragmentation, but emphasises the last resort nature of compulsory licensing and does not contain an obligation for rightsholders to disclose their trade secrets.

The regulation was published in the official journal on 30 December 2025, meaning it will come into force on 19 January 2026. 

SPCs

In the EU, the supplementary protection certificate regulation provides for an SPC manufacturing waiver that allows generics and biosimilars makers in the EU to manufacture a medicinal product protected by an SPC without the SPC holder's agreement, if the product is either for export to a non-EU country (the export waiver) or for storage in the EU until the SPC expires (the stockpiling waiver).

Under the regulation, the Commission was supposed to have reviewed the effectiveness of the SPC manufacturing waiver by 2024. This, however, did not happen. Last year, the Commission announced that it was preparing a consultation to receive stakeholder feedback on it, but the date has still not been confirmed. Following this feedback, the Commission will decide whether the legislation needs to be changed in any way, with a view to adopting any amending measures in the fourth quarter of 2027. It is likely that the Commission will commence the stakeholder feedback period in 2026.

In the UK, at the end of last year, Mr Justice Meade delivered a judgment concerning the information needed to obtain an SPC manufacturing waiver for export under the UK SPC Regulation (the EU regulation (as amended) is assimilated law, subject to some tidying-up provisions). The judgment turned on the information to be provided in the notice that must be given to benefit from the waiver provisions.

A notification was given by the defendants to the SPC holder, Regeneron, which Regeneron alleged was invalid as it did not include the published marketing authorisation reference numbers for the country of export. In this case, if this was correct it would have meant that no manufacture could commence before the expiry of the SPC.

There is conflicting law on the point in the EU (for example, German courts have found that marketing authorisation numbers are required, whereas the courts in Belgium and the Netherlands have decided the other way). Mr Justice Meade concluded that, giving the regulation its ordinary meaning, the marketing authorisation reference number is not required for a valid SPC manufacturing waiver notification for export in the UK. This decision aligns the UK with the Belgian and Dutch approaches to the issue, but could be a future point of further divergence elsewhere in the EU.

The EU's progress on the introduction of a Unitary SPC has been slow going. Various documents, including partially revised text and a steering note from the Presidency, were issued at the end of 2025 (although they are not yet publicly available). The Unitary SPC Regulation remains on the Commission's work programme for 2026 and therefore we can expect work to continue on the proposal this year.

As noted above, under the Biotech Act the European Commission has also proposed a 12-month extension to SPCs for medicinal products developed by biotechnology processes.

UK-US pharmaceutical deal

Following strong calls from industry to raise cost-effectiveness thresholds at which new medicines are assessed for use by the NHS, the government agreed a landmark UK-US pharmaceuticals deal at the end of last year to drive pharmaceutical investment, generate job opportunities and secure access to medicines access for NHS patients.

The reported measures agreed include 0% tariffs on UK medicines to the US, a 25% increase in medicine pricing for branded medicines as well as a reduction in the rebate tax that pharmaceutical companies pay the NHS from 23% to 15%. Although the deal will result in increased NHS spending on branded medicines in future, it means that patients will have access to treatments that might otherwise have been declined by NICE on cost-effectiveness grounds.

Osborne Clarke comment

This year will be full of changes and decisions across a range of areas, affecting patent litigation in a range of sectors, including the life sciences and technology. Due to the changing nature of the patent litigation landscape in Europe, patent enforcement and drug launch strategies will need to develop as case law and policy changes filter through.