Author
Abstract
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.
Suggested Citation
Marco Stief, 2024.
"SPC Manufacturing and Stockpiling Waiver—part 2,"
Journal of Intellectual Property Law and Practice, Oxford University Press, vol. 19(10), pages 754-763.
Handle:
RePEc:oup:jiplap:v:19:y:2024:i:10:p:754-763.
Download full text from publisher
As the access to this document is restricted, you may want to search for a different version of it.
Corrections
All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:oup:jiplap:v:19:y:2024:i:10:p:754-763.. See general information about how to correct material in RePEc.
If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.
We have no bibliographic references for this item. You can help adding them by using this form .
If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.
For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Oxford University Press (email available below). General contact details of provider: https://academic.oup.com/jiplp .
Please note that corrections may take a couple of weeks to filter through
the various RePEc services.