Safe Harbor Provision in European Patent LawThe Research & Bolar Exemptions, AIPLA Chemical Practice Chronicles Newsletter, Volume 13 Issue 1 2025

This article covers the most recent developments regarding the European Research Exemption, which permits the use of patented inventions for research purposes, as well as the European Bolar Exemption, which allows generics manufacturers to obtain authorization or approval under pharmaceutical law even before relevant patents expire. The article outlines and discusses the conditions for these two exemptions to apply and the limits and restrictions pertaining thereto. It also explains how the exemptions are applied in individual European countries. Finally, it reviews the proposed amendments published in April 2023 as part of the new European Pharmaceutical Package as well as the new Article 27 of the European Unified
Patent Court Agreement introduced in June 2023.