Life Sciences and Pharma IP Litigation 2025

INTRODUCTION  Contributed by: Nicola Dagg, Daniel Lim, Jin Ooi and Alex Magnusdottir, Kirkland & Ellis International LLP

that AI-based inventions were not categori - cally 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 exclusiv - ity of an originator product. However, there has been a recent trend in traditionally more prelimi - nary injunction-friendly jurisdictions like the UK and Australia towards fewer injunctions being granted and greater scrutiny of claimants’ asser - tions 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 direc - tive is in place. Each country guide includes an update on the steps required to obtain a pre - liminary 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 pro - cedural requirements such as acceptable delay before bringing a request for an injunction have not quite crystallised between the different divi - sions. Given the wide-ranging scope of such injunctions, we expect to see increased interest in seeking them in parallel with other enforce - ment 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 litiga - tion landscape in Europe, including the interplay with both national actions and the European Pat - ent Office (EPO). As the Court matures, increas - ing 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 pharma - ceutical, medical devices and life sciences cas - es on the rise. Given the international nature of many disputes before the Court and the preva - lence of UK-based firms co-ordinating the litiga - tion, English has now become the most preva - lent language in proceedings before the Court. With the Court’s many local and central divi - sions and their different approaches and time - lines, 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 imple - menters, as the interplay between the UPC, the

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