Life Sciences & Pharma IP Litigation 2026

A Global Overview of Life Sciences and Pharma IP Litigation

We are delighted to introduce the Life Sciences & Pharma IP Litigation Chambers Global Practice Guide, which provides an overview of litigation in the life sciences and pharmaceutical sectors in a number of countries, and an update to the trends and developments expected in the coming year by leading lawyers in each jurisdiction.

Technological developments continue at pace in the life sciences and pharmaceutical sectors, driving litigation across all jurisdictions. The great commercial and social importance of healthcare products, along with the increasing costs of developing and marketing them, puts pressure on innovators to extend exclusivity to the maximum extent possible. At the same time, health systems across the world remain more financially challenged than ever, making generic and biosimilar alternatives a compelling and cost-effective proposition. Striking the right balance is a difficult and ongoing task for governments, regulators and courts, contributing to a dynamically changing global IP landscape. Such challenges are likely to remain for the foreseeable future, making it as important as ever to stay on top of the latest developments.

Large-scale, cross-jurisdictional patent litigation remains a key part of this space. In addition to more traditional small-molecule generic pharmaceutical litigation, biosimilar litigation continues to increase in prominence and to throw up new and complex factual and legal issues. This reflects both the dominance of biologics amongst the current crop of blockbuster drug products and their greater complexity compared to small-molecules. Additionally, increasingly ubiquitous consumer-facing wearable medical technology including watches and glucose monitors have emerged over recent years, joining more typical medical devices as an important battleground for patent, trade mark and other IP disputes.

A key development has been the emergence of cross-jurisdictional injunctions both inside the EU and beyond its borders, following the CJEU’s decision in BSH Hausgeräte v Electrolux in early 2025. This has further tied in with the contentious question of infringement of formulation patents under the doctrine of equivalents by biosimilars in litigation concerning blockbuster drug Aflibercept, which is likely to become an increasingly important issue as more basic patents for biologics expire over the coming years.

Meanwhile, the EU General Court has clarified the limits of extended market exclusivity for re-purposed pharmaceuticals, while the European Commission issued fines after it found that an innovator’s conduct of filing divisional patents to extend exclusivity was anti-competitive. In Australia, patent term extension was held to no longer cover pharmaceutical formulation patents, whilst in Brazil there was an abortive attempt to introduce new guidelines requiring results of in vivo tests to be included in any patent application in respect of second medical-use claims. Additionally, the EU’s long-awaited “pharma package” appears to be nearing completion, including reforms to regulatory data protection and market exclusivity periods. All these developments may indicate increasing desire from authorities to push back against some of the practices employed to increase exclusivity periods, while continuing to reward “true” innovation. This in turn highlights the continuing importance of well-considered product life cycle management across the globe.

Enforcement and cross-jurisdictional injunctions

Enforcement considerations remain an essential piece of any commercial IP strategy, with patent rights usually being backed by the ability to obtain a preliminary injunction preventing launch of an infringing generic, biosimilar or other product within the jurisdiction. We are now seeing a potentially major shift in this area following BSH Hausgeräte v Electrolux, which opened the gates for new cross-border “long-arm” injunctions provided an anchor defendant is domiciled in the jurisdiction of the court which is being asked to exercise this power. Both the Unified Patent Court (UPC) and some EU national courts have already exercised this power and issued injunctions to restrain infringing product launches not just within the court’s own jurisdiction but also in other countries.

In addition to examples of injunctions covering several EU countries (both within and outside the UPC contracting states), there have been decisions affecting products in jurisdictions which are members of the European Patent Convention (EPC) but not the EU, such as the UK. This has been the case notwithstanding that the defendant sought to raise the defence that the relevant patent is invalid – prior to the BSH Hausgeräte v Electrolux decision, this would have precluded a cross-border injunction being granted. It will be important to follow how this area evolves over the coming year, with some speculating that such cross-border jurisdictions could even extend to patents of countries outside EPC countries, including to the US (a matter that is already presently before the European courts, albeit not in a life sciences context).

Notably, to date the courts which have been prepared to grant such cross-border “long-arm” injunctions have generally applied their own local laws and procedures in their decision-making, adopting the rebuttable presumption that the outcome would be the same under the law of each of the other jurisdictions to which the injunction is proposed to extend and placing the onus on the defendant to convince the court otherwise. Arguably, that is a significant shift in the burden of proof from claimant to defendant, with major implications for litigants. It remains to be seen, as the jurisprudence develops, whether or not this will remain the position, and in practice what standard of evidence will be required to rebut the presumption to the satisfaction of the court.

Given the extensive scope, along with the procedural and evidential economy, of such injunctions, we would expect to see these features increasing prominently in the litigation strategy of patentees across all industries, including life sciences. These tactics also raise accompanying considerations of forum shopping between the UPC and different EU national courts. Conversely, we may also begin to see a response from the courts of countries whose patents are subject to cross-border injunctions, particularly where patent validity is in dispute. In that regard, the recent uptick in anti-suit injunctions and jurisdiction challenges in the SEP/FRAND arena may be a precursor of what is to come in life sciences and pharmaceutical cross-border disputes.

Continuing evolution of the UPC

The UPC turned two years old in June 2025 and continues to shift the European patent litigation landscape, across the 18 contracting EU member states and beyond. In addition to extending its jurisdiction beyond the contracting states (as discussed above), the UPC’s influence has continued to grow as it gains more experience of dealing with cases and patentees gain more confidence in its practice and procedures. The number of infringement and revocation actions filed at the UPC continues to grow steadily, including an increasing number of pharmaceutical companies choosing to opt-in and use the court. As a result, we have had the first preliminary injunction to restrain sales of a generic pharmaceutical across the UPC states. On the other hand, innovator-against-innovator actions continue to be filed, including in relation to COVID-19 treatments, highlighting the wide range of potential court users.

The UPC has been busy over the past year, dealing with a variety of procedural and substantive issues as they have fallen to be considered at first instance and at appeal level for the first time. Significant questions being considered have included claim construction, infringement (including under the doctrine of equivalents and in relation to second medical-use patents), declarations of non-infringement, the requirements for granting preliminary injunctions, and various aspects of patent validity including two appeals in life sciences disputes which have resulted in the UPC Court of Appeals’ latest decisions on inventive step (in which they adopted a “holistic” approach rather than the “problem–solution” approach, and emphasised that, for an inventive step attack to succeed, it had to be established that the skilled person would, not just could, have arrived at the claimed invention as the next step from the prior stage). Given the decentralised nature of UPC first-instance decisions, some inconsistencies are still appearing between different Local Divisions, with the associated risk of forum shopping by parties. Practitioners will be keen to follow how these and other issues are ultimately resolved by the Court of Appeals. Further, the somewhat uncertain extent of the UPC’s jurisdiction in relation to the European Patent Office (EPO) and national rights in both contracting and non-contracting states, remains an important consideration for parties developing and updating their product IP strategies.

Diverging views on patent plausibility

Following the decision of the Enlarged Board of Appeal of the EPO in G2/21 (handed down in March 2023), European jurisdictions have started to diverge somewhat in relation to the idea that a technical contribution should be plausible for there to be an inventive step as required for patentability. Several decisions over the past year have largely entrenched these differences, with the UK Court of Appeal in the Dapagliflozin proceedings following its own prior decision in the Apixaban proceedings which relied on the UK Supreme Court’s 2018 decision in Warner-Lambert. Thus, it appears that a technical contribution in the UK must be plausible ab initio, and post-filed evidence can be brought in only to confirm or reject an effect which is already rendered plausible by the patent.

Meanwhile, several other European jurisdictions have followed the lead of the Dutch Court of Appeal in interpreting G2/21 to mean that a threshold closer to ab initio implausibility is correct. This lower threshold for plausibility would make it easier for post-filed evidence of a technical effect to be brought in.

Meanwhile, the US approach continues to differ widely from both the UK and the rest of the EPC states. Rather than considering plausibility in relation to inventive step, the US primarily focuses on sufficiency in relation to enablement, as considered by the US Supreme Court more recently in Amgen. Though all agree that “armchair” inventions should be guarded against, these differing approaches emphasise the difficult balancing exercise for patent applicants when deciding whether to file early with limited data or wait for more evidence supporting an invention but with the risk of being scooped by keen competitors. It will be interesting to see to what extent these approaches will converge over the coming years.

Product life cycle management and exclusivity

While basic patents covering new products are incredibly important, complementing them with a suite of other secondary patents and regulatory exclusivities is a critical element of every life cycle management strategy for an important and commercially successful product. Plenty of cases over recent years demonstrate the powerful effect of a portfolio of patents consisting of dosing, formulation, second medical use, and other additional patents in protecting originator medicines from generic or biosimilar entry. Likewise, additional rights such as supplementary protection certificates (SPCs) and regulatory data exclusivity are critical tools for innovators in life cycle management. However, these additional protections are currently under the microscope in jurisdictions around the world, as governments increasingly seek to ensure that exclusivity periods are aligned with the investment required to develop innovative products, cracking down on perceived abusive practices and excessive exclusivity terms.

Further, the approaches to exclusivity may vary across different jurisdictions, as seen in recent cases considering the SPC manufacturing waiver notice provisions. While German courts have interpreted the requirements strictly, a more pragmatic approach has been taken in the Netherlands and the UK. This highlights that while the commercial value of exclusivity extensions can be immense, it is essential to consider carefully the optimal strategy associated with each relevant region and market over the life cycle of the product.

Finally, we look forward to considering the impact of the new EU pharma package following agreement by the EU institutions towards the end of 2025 (with the final text still pending). As part of these changes, the period of regulatory data protection will change from the familiar “8+2(+1)” to an “8+1(+1)(+1)” formula. That is, innovative medicines will continue to benefit from the existing eight years of regulatory data protection, but the subsequent market exclusivity period is reduced from two years to one, with the possibility for up to two further one-year extensions if certain conditions are met. This has the objective of limiting the maximum 11-year exclusivity period to truly innovative products which address unmet medical needs. It should also be noted that these requirements, and their application deadlines, may be interpreted very strictly as seen by the EU General Court’s recent decision denying an exclusivity extension for Tecfidera. Other parts of the package include changes to orphan drug exclusivity for products treating rare diseases, expansion of the Bolar Exemption allowing generics and biosimilars to obtain reimbursement and pricing approval prior to expiry of patent exclusivity, and various measures to address medicine shortages and strengthen pharmaceutical supply chains.

Conclusion

Litigation in the pharmaceutical and life sciences industries is often highly complex and involves concurrent cross-border litigation in numerous jurisdictions. As the snapshot of issues provided by this brief overview illustrates, the law and practice in the combined area is constantly developing and continues to evolve, such that in navigating life sciences and pharmaceutical patent disputes it is essential to have up-to-date advice and information from experienced practitioners in the field. It is hoped that this Guide is helpful to readers in providing a high-level overview of some of the essential features of life sciences and pharmaceutical IP litigation across the range of contributing jurisdictions.