Life Sciences & Pharma IP Litigation 2025

A Global Overview of Life Sciences & Pharma IP Litigation

We are delighted to introduce the Life Sciences & Pharma IP Litigation 2025 edition of Chambers’ Global Practice Guides, 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.

Litigation in the life sciences and pharmaceutical industries continues to be prolific across all jurisdictions. With increasing complexity of the technologies involved, innovators have ever more avenues to consider when protecting their inventions. However, the socio-political environment companies are operating in is ever more challenging – governments in key manufacturing jurisdictions, including China and India, have been taking steps to make their countries more attractive for innovators. If manufacturing countries become more patentee friendly, we could see changes in global life-cycle management and enforcement strategies and litigation dynamics in this sector, with an increased focus on enforcement against manufacturers of active pharmaceutical ingredients (API) and finished products in jurisdictions where enforcement of patent rights had previously been regarded as challenging.

Biologics (and biosimilar versions of originator biologics) are now firmly established at the forefront of pharmaceutical litigation, and comprise the vast majority of the current generation of blockbuster medicines. Whilst small molecule generic litigation continues, the rise of biologics/biosimilars has had and continues to have an impact in terms of the dynamics of, and key regular players in, large-scale pharmaceutical patent litigation. Overall, the number of patent disputes in the sector has remained steady but the disputes are increasingly complex and high-stakes and are often fought in parallel across multiple forums. Other industry trends include the continued rise in the frequency of “innovator-on-innovator” disputes. At the tail end of the year, the US Court of Appeals for the Federal Circuit released an opinion that Orange Book patents must claim at least the active ingredient of a patent. It also addressed device patents specifically, holding that patents which only claim device components do not meet the listing requirement. Parties in the pharmaceutical space will also have a particular eye out for developments in the coming year regarding implications of the European Commission’s decision about the alleged misuse of divisional patents, where an innovator’s conduct of filing divisional patents to extend exclusivity on the market was found to be anti-competitive. This decision could have wide-ranging implications for life-cycle management throughout Europe.

New technologies on the rise

The focus on mRNA-based vaccines and treatment continues. The litigation related to the COVID-19 vaccines persists in some jurisdictions, while the parties have settled in others. Next generation technologies such as CRISPR gene editing and base editing remain on the forefront, and approvals of new CRISPR-based therapies are bound to lead to litigation in the area, including around licensing arrangements by the many players involved with the foundational CRISPR technology. With the rapid expansion of AI-based tools and technology, there has been continued focus on AI-based inventions. The UK courts continued to grapple with AI-based technology, and the UK Supreme Court is set to hear an appeal on the patentability of AI-based inventions in the coming year. The UK Court of Appeal had previously said obiter that AI-based inventions were not categorically unpatentable. Similarly, the US Patent and Trademark Office issued guidance stating that while AI-based inventions are not categorically unpatentable, the inventorship analysis should focus on human contributions.

Increased sophistication of AI-systems may lead to more prevalent use in drug discovery and platform technologies, and arguments about the patentability of such inventions are bound to arise before the courts and patent offices. Given the rapid uptake of AI-based inventions in areas such as healthcare and medical devices, we expect to see litigation in this area evolve in the coming year.

Approaches to enforcement

The ability to obtain a preliminary injunction to prevent the launch of a generic or biosimilar medicine is an all-important consideration in any business/legal strategy to protect the exclusivity of an originator product. However, there has been a recent trend in traditionally more preliminary injunction-friendly jurisdictions like the UK and Australia towards fewer injunctions being granted and greater scrutiny of claimants’ assertions of irreparable harm if the injunction they seek is denied. Perhaps relatedly, and with an increased awareness of the impact of public interest factors in the proportionality calculus, recently we have also seen greater forbearance on the part of claimants in seeking preliminary or final injunctive relief where critical medicines are concerned, although this continues to vary extensively from jurisdiction to jurisdiction, even across the EU where a single enforcement directive is in place. Each country guide includes an update on the steps required to obtain a preliminary injunction and the considerations for applicants.

The emergence of the Unified Patent Court (UPC) has also changed the injunction situation in Europe, with the Court granting a number of preliminary injunctions in the last year, but procedural requirements such as acceptable delay before bringing a request for an injunction have not quite crystallised between the different divisions. Given the wide-ranging scope of such injunctions, we expect to see increased interest in seeking them in parallel with other enforcement approaches.

Changing landscape in European litigation with the UPC

The UPC completed its first year of operation in June 2024, and has shaken up the patent litigation landscape in Europe, including the interplay with both national actions and the European Patent Office (EPO). As the Court matures, increasing numbers of unitary patents have been added to the register. The Court has seen a range of cases filed with it, with the number of pharmaceutical, medical devices and life sciences cases on the rise. Given the international nature of many disputes before the Court and the prevalence of UK-based firms co-ordinating the litigation, English has now become the most prevalent language in proceedings before the Court.

With the Court’s many local and central divisions and their different approaches and timelines, parties have, to a certain extent, been able to forum shop to achieve desired forum and outcomes. Given the Court’s infancy, many substantive and procedural issues are arising for the first time, and practitioners will eagerly await decisions from the UPC Court of Appeal regarding the proper approach to jurisdiction, bifurcated cases, and other procedural issues. These tactical opportunities also complicate considerations for both patentees and implementers, as the interplay between the UPC, the EPO and national rights and actions must all be taken into account in product life-cycle planning.

Litigation funding

In the medical devices, product liability and related fields, litigation funding has globally become an increasingly important factor in litigation strategies. While litigation funding has a long history in the USA, over the last year we have increasingly seen it utilised in the UK, where a proposal for reform of third-party litigation funding is expected this year. This enables parties that might historically not have been litigious, or able to undertake large scale litigation, to enter the litigation arena. While not prevalent in the medical devices or product liability space in the UK and EU as of yet, it is likely only a matter of time until the first funder-backed actions emerge.

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 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.