New EU Legislative Proposal and the Bolar Exemption in the Winds of Change

Abstract On 26 April 2023, the European Commission presented a comprehensive legislative package aimed at revising and repealing the current EU general pharmaceutical legislation. This is arguably the most significant legislative effort in the field of general pharmaceutical legislation for a generation. One of the key objectives of the Proposal is to make Europe an attractive location for pharmaceutical manufacturers, including generic companies. In order to achieve this objective, the Proposal includes amendments to the Bolar exemption, which are designed to concretise and harmonise specific acts covered by it. Four aspects of the proposed amendments still raise questions. Will the proposed Bolar exemption cover acts done with the patented invention to obtain marketing authorisation in extra-EU jurisdictions? Under what circumstances will third party acts in relation to patented substances be covered by the Bolar exemption? Will innovative medicinal products be covered by the Bolar exemption? And how does the proposed Bolar exemption fit into the unitary patent system?