First decision on the SPC manufacturing waiver by the Belgian courts

Under the notification requirements, the Court found that an EU “maker” of generic or biosimilar medicinal products does not need to provide a marketing authorization number (before it is publicly available) nor the intended export countries to be able to benefit from the SPC waiver. Further, the Court held that (long-term) stockpiling of the manufactured medicinal product for export purposes may also be covered by the waiver.  

Background of the case

The SPC manufacturing waiver, introduced by Regulation 2019/933 amending Regulation 469/2009 (“Regulation”), entitles EU-based companies to manufacture a generic or biosimilar of a medicinal product protected by a third party supplementary protection certificate (“SPC”) before the expiry of the SPC, if the manufacture is done for the purpose of exporting to a non-EU market, or during the final 6 months of SPC exclusivity, if the manufacture is done for the purpose of storage in order to place the product on the EU market after the SPC expires. (For a more general introduction, see Manufacturing and stockpiling waiver set to limit rights of holders of SPCs for medicines.)

A manufacturer wishing to rely on such SPC manufacturing waiver must inter alia issue a notification to the competent patent office and to the holder of the SPC, in accordance with the conditions set forth in the Regulation. 

Several SPC waiver notifications have so far been made to patent offices around Europe, including in Belgium, some of which have triggered litigation. In this first case before the Belgian courts, SPC holder Amgen Inc. and Amgen Fremont ("Amgen") challenged the validity of the SPC manufacturing waiver notification made by Samsung Bioepis (“SB”) on 13 March 2024. The notification related to the manufacturing (or related acts) and storage of a biosimilar of denosumab (Prolia® and XGEVA®) for the purpose of exporting it from the EU. 

The SPC holder’s claims

Amgen argued that SB did not comply with the conditions set forth in article 5 of the Regulation to rely on the SPC manufacturing waiver, essentially because:

• SB’s waiver notification did not include in its notification any marketing authorization number for those countries to which SB would export the products, nor did it identify the countries of export; 
  
• Amgen held exclusive rights in countries outside the EU, notably the US and South Korea (on the active substance) and several other countries (on related manufacturing methods);
  
• According to Amgen, long-term storage of the product manufactured for export purposes is not allowed, since it is not strictly necessary for the export, 

On those bases, Amgen claimed that SB would in Belgium infringe or threaten to infringe upon their SPC rights and also act contrary to honest trade practices because of the (threat of) infringement it causes in third countries such as South Korea and the US. …