Janssen Biotech v Samsung Bioepis (Gerechtshof Den Haag, 200.337.844/01, 2025)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

In summary proceedings, The Hague Court of Appeal upheld the dismissal of Janssen’s claims against Samsung Bioepis, which had been making an ustekinumab biosimilar in Denmark and Italy for export during the term of the SPCs. Interpreting the manufacturing for export waiver in Article 5(2)(a)(i) and (ii) of Regulation 469/2009, as amended by Regulation 2019/933, the court held that the maker need not hold a third country marketing authorisation at the time of notification or when manufacture starts, that the export country need not be free of rights, and that building up a stock for « Day-1 entry » on that market is permitted (paras 6.21, 6.29 and 6.42). This broad reading rests on the aim of a level playing field with makers in third countries.

Facts and procedure

Janssen held Danish and Italian SPCs for ustekinumab (Stelara), based on EP 1 309 692, which expired on 7 August 2021; the SPCs expired on 20 and 19 July 2024 (paras 3.2 to 3.4). On 24 October 2023 Samsung Bioepis notified the Danish and Italian authorities, and Janssen, of its intention to make and store its biosimilar SB17 for export, identifying on 30 October 2023 the target countries (the United Kingdom, Canada and South Korea); the authorisation numbers were to follow once public (paras 3.8 and 3.9). Manufacture began on 24 January 2024 and the authorisations were obtained between April and August 2024 (paras 3.13 and 3.14). Janssen argued that intellectual property rights still subsisted in those countries at the time of notification (para 4.2). The preliminary relief judge of The Hague District Court dismissed its claims on 23 January 2024 (para 4.3).

The applicable law

Article 5(2)(a) exempts making for the purpose of export to a third country and related acts strictly necessary for that making or for the actual export; the maker must notify, at least three months before manufacture starts, the information listed in Article 5(5), including under point (e) the reference number of the third country marketing authorisation as soon as it is publicly available (para 6.6). The court construed these provisions by reference to their wording, context, objectives and legislative history, recitals having no binding legal force (para 6.3).

Question

Does the manufacturing for export waiver require a marketing authorisation in the third country and the absence of rights there, and does it prohibit stockpiling for export?

Decision

As the SPCs had expired, the injunction claims could no longer succeed, but Janssen retained an interest in their review because of the costs order below, and an urgent interest in the moratorium it sought (para 6.1). The Regulation protects the SPC only on the EU market and does not serve to police rights in third countries (para 6.5). No provision requires a prior authorisation: Article 5(5)(e) merely requires the number to be supplied once public (paras 6.9 and 6.10). The legislative history shows that the legislature sought to keep export plans confidential, although export without the number remains excluded (paras 6.16 to 6.18). The risk of diversion to the EU is addressed by the logo and the absence of a unique identifier (para 6.13). A requirement that the export country be free of rights was discussed and not adopted, its assessment being left to third country courts; infringement there would arise only on import (paras 6.24, 6.25 and 6.27). Temporary storage under recital 9 covers a stock enabling entry into the export market as soon as rights expire, the first mover effect being essential (paras 6.34 to 6.36); neither recital 11 nor Article 52 of the Charter stands in the way (para 6.40). The judgment below was upheld, with EUR 3,404 in costs payable by Janssen (paras 6.46 and 7).

Key points for practice

• Notification may precede the grant of the third country authorisation; only export requires the reference number to have been supplied (paras 6.16 and 6.21).
• An SPC holder cannot rely, in an action within the EU, on patents in force in the export countries (paras 6.5 and 6.29).
• A stock intended for entry as soon as rights expire in the third country is covered by the waiver (para 6.42).
• Practical point: a holder wishing to act must show diversion to the EU market or a breach of the notification and labelling obligations, rather than the mere absence of an authorisation or the persistence of foreign rights (paras 6.13 and 6.43).

Relevance before the UPC

As the UPC hears actions concerning SPCs based on a European patent, this reading of Article 5(2) of Regulation 469/2009, a matter of EU law, may be debated before it.

Provisions applied

Regulation (EC) No 469/2009 (SPC), as amended by Regulation (EU) 2019/933

Art. 5(2), 5(4), 5(5), 5(7), 5(8) and 5(9)

EU law

Regulation (EU) 2019/933, recitals 3 to 5, 8, 9, 11, 15, 17, 18, 29 and 30; Delegated Regulation (EU) 2016/161; Charter of Fundamental Rights of the European Union, Article 52

National law

Dutch Code of Civil Procedure (Rv), Article 1019h; Dutch Civil Code, Article 6:119

Case law cited

CJEU, 20 December 2017, Acacia and D’Amato, C-397/16 and C-435/16; CJEU, 24 November 2005, Deutsches Milch-Kontor, C-136/04; Hoge Raad, 22 June 2012, ECLI:NL:HR:2012:BW5695; Hoge Raad, 28 September 2018, ECLI:NL:HR:2018:1782

Prepared by Dhenne Avocats from the text of the decision (rechtspraak.nl, official XML version from data.rechtspraak.nl), consulted on 11 October 2026. Only the official text is authoritative.