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.   

Belgian court’s judgment

The Enterprise Court in Brussels dismissed Amgen’s claims and arguments, and found that SB’s SPC manufacturing waiver notification complied with the Regulation. 

The Court came to its conclusion by interpreting the Regulation 2019/933 in view of its wording (including recitals), context, ratio legis and legislative history: 

1. According to the Belgian court, article 5(5) of the Regulation does not require a maker to hold a marketing authorisation in a third country to benefit from an SPC manufacturing waiver. The Court held that the text of the Regulation is clear and only provides that a marketing authorisation number must be communicated “as soon as it is publicly available”. The Court referred to the ratio legis of the Regulation (seeking a level playing field for EU makers), and noted that the Regulation also provides an opportunity to amend or update the notification. Similarly, the Court held that it is not required to include export countries in the waiver notification, and found support for this in the legislative history. According to the Court, while the recitals of a regulation can be used for interpretative purposes, they are not binding and cannot be used to deviate from the provisions of the regulation or to interpret them in a manner clearly contrary to their explicit wording. 
   
   
2. Amgen’s claim that an SPC manufacturing waiver for export to third countries could only apply insofar as no valid patent rights apply in the export countries, was also dismissed.  According to the Court, no such requirement could be identified in the law. Moreover, the Court held that if EU based drug makers would only be allowed to manufacture for export to third countries without valid patent rights, this would cause significant competitive disadvantage and be contrary to the ratio legis of the Regulation.
   
   
3. Finally, SB was allowed to keep the products in storage for export purposes. The Regulation foresees that the SPC manufacturing waiver also extends to related acts that are strictly necessary for the export, including temporary storage. The Court held that the exact duration thereof is not determined in the regulation and should therefore, in view of its ratio legis, amount to a duration that is common in the normal course of business, considering the nature of the manufacturing and supply chains at hand. 

Amgen’s claim of unfair competition was also dismissed for lack of current standing.

Comment

This decision by the Belgian court aligns with that of the district court of The Hague (Netherlands), which came to a similar conclusion in its judgment dated 23 January 2024. The Belgian court explicitly considered and rejected the stricter interpretation put forward by the regional court in Munich (Germany) in its judgment dated 20 October 2023.

As such, the Belgian court has applied a more lenient approach than the German court for manufacturers of generic and biosimilar products wishing to benefit from the SPC manufacturing waiver. 

The decision is subject to possible appeal.