Merck Canada v Accord Healthcare (CJEU, C-555/13, 2014)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

By reasoned order under Article 99 of its Rules of Procedure, the Court held that Article 13 of Regulation 469/2009, read in the light of recital 9, precludes the holder of a patent and an SPC from relying on the entire period of validity of the certificate where it would thereby enjoy more than 15 years of exclusivity from the first marketing authorisation (MA) in the Union. It first held admissible the question referred by a Portuguese necessary arbitral tribunal. The order makes the 15-year cap enforceable against the holder, whatever the theoretical term of the certificate granted.

Facts and procedure

On 11 October 1991 Merck Canada applied in Portugal for a patent on montelukast sodium, the active ingredient of Singulair, granted on 2 October 1998 as No 99 213. The first MA in the Union for a medicinal product containing that ingredient was granted in Finland on 25 August 1997. SPC No 35, applied for on 3 February 1999, was granted on 10 January 2000 (paras 7 to 10). On 6 November 2012 Merck Canada brought proceedings before the necessary arbitral tribunal, which has jurisdiction under Portuguese Law No 62/2011 of 12 December 2011, to prevent the defendants from producing, importing or marketing generic montelukast in Portugal. It relied on the validity of the certificate until 17 August 2014, accepting that this might give it more than 15 years of exclusivity; the defendants argued that the Regulation caps that exclusivity at 15 years from the first MA in the Union (paras 11 and 12). The tribunal referred the question by decision of 17 October 2013 and requested the expedited procedure (para 13).

The applicable law

The question concerns Article 13 of Regulation 469/2009, read in the light of recital 9. On admissibility, the Court applied its usual criteria: establishment by law, permanence, compulsory jurisdiction, inter partes procedure, application of rules of law and independence (para 16). The necessary arbitral tribunal derives its jurisdiction from statute rather than from the parties’ agreement, and its decisions become final, which distinguishes it from a conventional arbitral tribunal (paras 17 to 19); its permanence was accepted despite its variable composition and its dissolution after each decision (para 24). It is therefore a court or tribunal within the meaning of Article 267 TFEU (para 25).

Question

Does Article 13 allow the holder of a patent and an SPC to enjoy, through the term of the certificate, more than 15 years of exclusivity from the first MA in the Union?

Decision

As the answer could clearly be deduced from existing case law, the Court ruled by reasoned order, without needing to decide on the request for the expedited procedure (para 26). A literal reading of Article 13, together with recital 9, rules out reliance on the full term of the certificate if it confers more than 15 years of exclusivity (paras 28 and 29), as the Court had already held in the AstraZeneca order (C-617/12) (para 30). The first MA in the Union means the first authorisation granted in any Member State, not in the State of application, which ensures that protection expires at the same time in all Member States (para 31, referring to Hässle). As the first MA was granted in Finland on 25 August 1997, the combined exclusivity conferred by the patent and the certificate cannot exceed 15 years from that date, whatever the grant date of the Portuguese patent or the theoretical term of the certificate (paras 32 and 33).

Key points for practice

• The cap of 15 years of exclusivity from the first MA in the Union binds the holder, whatever term is stated in the certificate granted (para 33 and operative part).
• The reference date is that of the first MA in any Member State, not that of the MA in the State where the certificate was granted (para 31).
• A Portuguese necessary arbitral tribunal, established by statute and with compulsory jurisdiction, may make a preliminary reference (paras 17 to 25).
• Practical point: a generic company may rely on the 15-year cap against a holder invoking the term of its certificate, which requires establishing the date of the first MA for the active ingredient in the Union.

Provisions applied

Regulation (EC) No 469/2009

Art. 13; recital 9

Treaty on the Functioning of the European Union

Art. 267

Other instruments

Rules of Procedure of the Court of Justice, Arts 99 and 105

National law

Portuguese Law No 62/2011 of 12 December 2011

Case law cited

Belov (C-394/11); Denuit and Cordenier (C-125/04); Danfoss (109/88); Broekmeulen (246/80); Saint-Gobain Glass Deutschland v Commission (C-503/07 P); AstraZeneca (C-617/12, order); Hässle (C-127/00)

Related decisions

• AstraZeneca, CJEU, 14 November 2013, order C-617/12 whose solution the Court follows (para 30).

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, English version), consulted on 11 October 2026. Only the official text is authoritative.