The European Research and Bolar Exemptions ‒ Background, Status Quo and a Look at the Agreement on a Unified Patent Court (UPCA) and the EU Commission’s New Draft Directive for the Reform of Pharmaceutical Legislation

Abstract A patent is a form of state monopoly granted to the owner of an invention. A patent rewards its owner with exclusive rights in exchange for innovation (‘quid pro quo’) for a limited period of time. These exclusive rights allow the patent holder to prohibit others from using the patented invention, helping to recover their research and development (R&D) costs and thereby create an incentive for further innovation. However, patents can hinder technical progress if no restrictions are imposed. Therefore, exceptions and restrictions exist to balance patent protection with the right to freedom of research under Art. 13 of the EU Charter. The most important exceptions are the so-called Bolar and research exemptions. The Bolar exemption allows generics manufacturers to seek authorization or approval under pharmaceutical law before a patent expires, enabling market entry immediately after patent expiration. The research exemption permits the use of patented inventions for research purposes. These two exceptions are increasingly important due to a shift in patent law favoring patent holders through simplified procedures and expanded rights. This article briefly outlines the history and application requirements of these two exemptions and the limits and restrictions to be observed. It also discusses the national differences in application of the Bolar and research exemptions within Europe and the new Art. 27 UPCA introduced in June 2023. Finally, the proposed amendments published in April 2023 as part of the new European pharmaceutical package will be discussed.