INTRODUCTION Contributed by: Daniel Lim, Steven Baldwin and Jin Ooi, Kirkland & Ellis International LLP
Kirkland & Ellis International LLP 40 Leadenhall Street London EC3A 2AA United Kingdom Tel: +44 20 7469 2000 Email: daniel.lim@kirkland.com Web: www.kirkland.com
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 devel ‑ opments expected in the coming year by leading law ‑ yers in each jurisdiction. Technological developments continue at pace in the life sciences and pharmaceutical sectors, driving liti ‑ gation 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 exclu ‑ sivity 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 land ‑ scape. 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 ubiq ‑ uitous consumer-facing wearable medical technol ‑ ogy including watches and glucose monitors have emerged over recent years, joining more typical medi ‑ cal 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 deci ‑ sion in BSH Hausgeräte v Electrolux in early 2025. This has further tied in with the contentious question of infringement of formulation patents under the doc ‑ trine of equivalents by biosimilars in litigation concern ‑ ing 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 formu ‑ lation 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 regula ‑ tory data protection and market exclusivity periods. All these developments may indicate increasing desire
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