Brussels enterprise court clarifies requirements for SPC manufacturing waiver

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. In the EU, Amgen holds a SPC extending the protection initially provided to medicinal products containing denosumab as an active substance until November 2025.

During the SPC’s protection period, Samsung Bioepis submitted a notification to the Belgian Intellectual Property Rights Office, announcing its intention to manufacture its biosimilar version of denosumab in Belgium and to export to third countries under the SPC manufacturing waiver exception. In its notification, Samsung Bioepis committed to providing the reference number of the marketing authorisation, or its equivalent, once it became publicly available. 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

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. It does not require the manufacturer to have obtained a marketing authorisation in the export countries at the time of the notification. 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 January 23, 2024 but contradicts an earlier ruling from the Regional Court of Munich of October 20, 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

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 that the SPC Regulation does not include such requirement and imposing it would contradict the objective of the SPC Regulation. This reasoning is again in line with the ruling of the District Court of The Hague of January 23, 2024.

Long-term storage allowed

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

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. With this decision, Belgium has followed in the footsteps of the Netherlands¹ , adopting a more flexible interpretation compared to the approach taken earlier in Germany². This decision shows that an urgent need for an EU-wide harmonized approach regarding the scope of the SPC manufacturing waiver remains. 

Footnotes

1. District Court of The Hague January 23, 2024, Janssen Biotech Inc v. Samsung Bioepis

2. Regional Court of Munich October 20, 2023, Janssen Biotech Inc v. Formycon