@article{50156,
      author = {Stief, Marco,},
      url = {http://tind.wipo.int/record/50156},
      title = {SPC manufacturing and stockpiling waiver—part 1},
      abstract = {This 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},
      doi = {https://doi.org/10.1093/jiplp/jpae052},
      recid = {50156},
      pages = {1 online resource (pages 695-704)},
}