000050156 000__ 02831nam\a2200409\i\4500 000050156 001__ 50156 000050156 003__ SzGeWIPO 000050156 005__ 20241024004426.0 000050156 006__ m eo d 000050156 007__ cr bn |||m|||a 000050156 008__ 241007s2024\\\\enk\\\\\ob\\\\000\0\eng\d 000050156 0247_ $$a10.1093/jiplp/jpae052$$2doi 000050156 035__ $$a(OCoLC)1463455133 000050156 040__ $$aSzGeWIPO$$beng$$erda$$cSzGeWIPO$$dCaBNVSL 000050156 041__ $$aeng 000050156 24500 $$aSPC manufacturing and stockpiling waiver—part 1. 000050156 264_1 $$aOxford, UK :$$bOxford University Press,$$c2024. 000050156 300__ $$a1 online resource (pages 695-704) 000050156 336__ $$atext$$2rdacontent 000050156 337__ $$acomputer$$2rdamedia 000050156 338__ $$aonline resource$$bcr$$2rdacarrier 000050156 4901_ $$aIntellectual Property Law & Practice,$$x1747-1540 ;$$v19, 9, 2024 000050156 520__ $$aThis two-part article analyzes and discusses the legal requirements of, as well as the opportunities and risks associated with the SPC Manufacturing and Stockpiling Waiver as introduced by EU Regulation 2019/933. The introduction of the SPC Manufacturing/Stockpiling Waiver on July 1, 2019 opened up opportunities for generics and biosimilars companies established in the EU to manufacture and stockpile medicinal products before expiry of the respective SPC, either for export to third countries or for timely Day-1 market entry in the EU. But unlike, for example, the bolar exemption, application of the SPC Waiver is dependent upon compliance with specific notification, due diligence and labeling obligations. Although introduced more than four years ago, there is still considerable legal uncertainty surrounding the application of the SPC Waiver, something recent court decisions in Germany and The Netherlands have exacerbated rather than clarified. In this first part, the policy background of the Regulation is explained and the territorial and temporal scope of the SPC Waiver is examined. In the second part of the article, to be published in the next edition of the Journal of Intellectual Property Law and Practice Vol.(…) Issue (…) I will take a close look at the material scope and core components of the waiver, particularly as it relates to privileged acts and the conditions under which the waiver is applicable 000050156 542__ $$fhttps://academic.oup.com/pages/using-the-content/citation 000050156 590__ $$aPublished online: 14-June-24 000050156 650_0 $$aPharmaceutical policy. 000050156 650_4 $$aPatents$$xLaw and legislation. 000050156 650_4 $$aIntellectual property$$xLaw and legislation. 000050156 650_0 $$aIntellectual property. 000050156 650_0 $$aPatents. 000050156 650_0 $$aCopyright. 000050156 7001_ $$aStief, Marco,$$eauthor. 000050156 7731_ $$tIntellectual Property Law & Practice,$$wJIPLP 000050156 830_0 $$aIntellectual Property Law & Practice,$$v19, 9, 2024. 000050156 85641 $$uhttps://doi.org/10.1093/jiplp/jpae052$$yJournal homepage 000050156 904__ $$aJournal Article 000050156 980__ $$aJIPLP