SPC Manufacturing and Stockpiling Waiver—part 2

This two-part article analyses and discusses the legal requirements of, as well as the opportunities and risks associated with the SPC Manufacturing and Stockpiling Waiver as introduced by EU Regulation 2019/933. The introduction of the SPC Manufacturing/Stockpiling Waiver on 1 July 2019 opened up opportunities for generics and biosimilars companies established in the EU to manufacture and stockpile medicinal products before expiry of the respective SPC, either for export to third countries or for timely Day-1 market entry in the EU. But unlike, for example, the bolar exemption, application of the SPC Waiver is dependent upon compliance with specific notification, due diligence and labelling obligations. Although introduced more than 4 years ago, there is still considerable legal uncertainty surrounding the application of the SPC Waiver, something recent court decisions in Germany and The Netherlands have exacerbated rather than clarified.The first part of the present article, published in the Journal of Intellectual Property Law and Practice, 2024, Vol.(…), issue (…) analysed and discussed the policy background of the Regulation and examined the SPC Waiver with particular focus on the territorial and temporal scope. This second part scrutinizes the material scope and core components of the waiver, with a particular focus on privileged acts and the conditions under which the waiver is applicable. It distinguishes between primary and closely related privileged acts, and dissects various elements, such as the timing, location, and purpose of these privileged acts.