INTRODUCTION Contributed by: Daniel Lim, Steven Baldwin and Jin Ooi, Kirkland & Ellis International LLP
Conclusion Litigation in the pharmaceutical and life sciences industries is often highly complex and involves con ‑ current cross-border litigation in numerous jurisdic ‑ tions. As the snapshot of issues provided by this brief overview illustrates, the law and practice in the com ‑ bined 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 con ‑ tributing jurisdictions.
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 pro ‑ tection, 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 inno ‑ vative 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 deci ‑ sion 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 pric ‑ ing approval prior to expiry of patent exclusivity, and various measures to address medicine shortages and strengthen pharmaceutical supply chains.
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