A&O Shearman
[co-author: Sofia Devroe]
In a judgment of 23 December 2024, the Dutch-speaking Enterprise Court of Brussels followed the reasoning of a Dutch court earlier in 2024, ruling that (i) manufacturers are not obliged to provide the reference number of their marketing authorisation or to specify the third countries to which they plan to export at the time of notification, and (ii) the SPC manufacturing waiver permits long-term storage of products intended for export.
The case concerned a dispute between Amgen Inc. and Amgen Fremont (“Amgen“), and Samsung Bioepis NL BV (“Samsung Bioepsis“), with respect to the manufacturing and storage of Samsung Bioepis’ biosimilar version of denosumab for export purposes under the SPC manufacturing waiver.
The SPC manufacturing waiver was introduced in 2019 in Regulation (EC) No 469/2009 concerning the supplementary protection for medicinal products (“SPC Regulation“), enabling the manufacturing of generic and biosimilar drugs for a limited number of purposes, while the innovator’s equivalent drugs are still protected by a supplementary protection certificate (“SPC“). The waiver aims to create a level playing field for generic and biosimilar manufacturers in the EU compared to non-EU manufacturers, according to the European Commission in an effort to preserve the competitiveness of the EU.
Background
The issue related to denosumab, which is the active ingredient in Amgen’s Prolia and XGEVA and used for the treatment of osteoporosis and bone loss. Amgen has a SPC in the EU that extends the protection initially granted to medicinal products that contain denosumab (as an active substance) until November 2025. Samsung Bioepis also informed Amgen of this notification on the same day. Samsung Bioepis also informed Amgen of this notification on the same day.
Amgen contended that Samsung Bioepis has failed to meet the notification requirements provided by the SPC Regulation and therefore could not lawfully invoke the SPC manufacturing waiver.
Dismissal by Brussels Court
The Brussels Court dismissed Amgen’s arguments across the entire line in favour of Samsung Bioepis:
No mandatory notification of market authorisation reference numbers and export countries
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Amgen argued that Samsung Bioepis had withheld critical information, as the reference number and the third countries of export were not explicitly mentioned in the notification.
The Brussels Court stated that the SPC Regulation is clear regarding the information that must be provided in a manufacturer’s notification. The manufacturer does not have to obtain a marketing authorization in the export country at the time the notification is made. Therefore, it is sufficient for the manufacturer to provide these authorisation’s reference numbers as soon as they become publicly available.
Moreover, the SPC Regulation does not imply that export countries must be mentioned in the notification, as – according to the Brussels Court – this allows manufacturers to maintain the confidential nature of business sensitive information, thereby avoiding a competitive disadvantage of EU-based manufacturers.
This reasoning follows the ruling of the District Court of The Hague of 23 January 2024 but contradicts an earlier ruling from the Regional Court of Munich of 20 October 2023, which adopted a more restrictive approach and held that the manufacturer must mention the reference number in its notification before it can invoke the waiver.
Export allowed to countries where no patents rights apply
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The Brussels Court rejected Amgen’s argument that the manufacturing waiver only applies if no relevant patent rights exist in the export countries. The court argued the SPC Regulation doesn’t include such a requirement and that imposing it would be contrary to the SPC Regulation. This reasoning is again in line with the ruling of the District Court of The Hague of 23 January 2024.
Long-term storage allowed
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The Brussels Court also rejected Amgen’s argument that long-term storage is not allowed under the manufacturing waiver. The Court emphasised that the waiver allows related actions such as possession or temporary storage, provided that these are solely aimed at and strictly necessary for the actual export to third countries.
As the SPC Regulation does not specify a particular term for storage (other than stipulating that it must be strictly necessary), the Court indicated, similar to the District Court of The Hague, that a storage period that is customary within normal business operations is acceptable according to the Brussels Court.
No proof of unfair market practices
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Amgen finally claimed that Samsung Bioepis’s infringement of its SPC and Samsung Bioepis’s threat to manufacture biosimilar drugs for export to countries where Amgen holds patent protection constitutes unfair market practices. The Court found this claim inadmissible, stating that Amgen failed to provide any evidence of an actual or imminent interest.
Impact
The Brussels Court’s decision is an important addition to a sparce, yet highly divergent body of case law in the EU. This decision follows the Netherlands1 in adopting a more liberal interpretation than the one adopted earlier by Germany2. This decision demonstrates that a harmonized EU-wide approach is still needed regarding the scope of SPC manufacturing waiver.
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1. District Court of The Hague, 23 January 2024. Janssen Biotech Inc. v. Samsung Bioepis
2. Regional Court of Munich, 20 October 2023. Janssen Biotech Inc. v. Formycon
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