Astrazeneca v Comptroller General of Patents (CJEU, C-617/12, 2013)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

By a reasoned order under Article 99 of its Rules of Procedure, on a reference from the High Court (Patents Court), the Court held that, in the context of the European Economic Area, a marketing authorisation granted by Swissmedic and automatically recognised in Liechtenstein is the first authorisation in the EEA, within the meaning of Article 13(1) of Regulation 469/2009, where it predates the authorisations granted for the same product by the EMA, by the authorities of the Member States under Directive 2001/83, or by those of Iceland and Norway. It is irrelevant that the EMA found the clinical data insufficient, or that the Swiss authorisation was suspended and later reinstated (para 60 and operative part). What is at stake is the duration of the certificate, which an earlier Swiss authorisation may shorten considerably.

Facts and procedure

Astrazeneca holds a European patent covering gefitinib (Iressa), expiring on 22 April 2016 (para 20). Swissmedic granted a conditional fast-track authorisation on 2 March 2004 (para 21), automatically recognised in Liechtenstein, where indirect sales cannot be ruled out (para 22). It suspended the authorisation on 24 October 2005, leaving only supply to individually approved patients (para 23), and lifted the suspension on 8 December 2010 (para 26). Before the EMA, following an unfavourable view of the Committee for Medicinal Products for Human Use on the phase II data, Astrazeneca withdrew its application in January 2005 (para 24), before obtaining a European authorisation on 24 June 2009 (para 25). The UK Patent Office granted on 2 April 2012 the SPC applied for on 11 December 2009, treating the Swiss authorisation as the first authorisation, which gave a duration of two years and 314 days, whereas Astrazeneca claimed five years (paras 27 to 29). Noting divergent practices among national offices (para 32), the High Court referred three questions by decision of 11 December 2012.

The applicable law

Article 13(1) of Regulation 469/2009 sets the duration of the certificate by reference to the first authorisation in the Community, which, under Protocol 1 to the EEA Agreement, means the territory of the Contracting Parties (para 15). Annex II to the Agreement, as amended by Decision No 1/95, allows Liechtenstein to apply Swiss technical rules in parallel (para 17), and Liechtenstein grants no SPCs (para 18). The Court ruled by order because the answer follows clearly from Novartis and Others (C-207/03 and C-252/03) (paras 34 and 35).

Question

Can a Swiss authorisation automatically recognised in Liechtenstein be the first authorisation in the EEA, even though the EMA found the clinical data insufficient and the Swiss authorisation was suspended and later reinstated?

Decision

Under Novartis, the condition relating to the first authorisation in the EEA serves a temporal purpose (para 38). Two types of authorisation coexist in Liechtenstein, and a Swiss authorisation may be the first if it precedes the others (paras 39 to 41), which is consistent with recital 9 and the fifteen-year ceiling on exclusivity in the EEA (para 42). The lack of free movement for products authorised in Switzerland is irrelevant (para 43). Hässle, Synthon and Generics (UK), which require an authorisation under Directive 2001/83 or Regulation 726/2004, concerned Member States only and do not call Novartis into question (paras 47 to 51): the decisive factor is the EEA regime, which treats the Swiss authorisation as one granted under Directive 65/65 (paras 52 and 53). The EMA’s refusal (para 54), the fast-track procedure (para 55) and the suspension, actual marketing not being required (para 56), do not alter the outcome. Neurim, which had no EEA dimension, is of no relevance (para 59). The third question did not need answering (para 61).

Key points for practice

• A Swissmedic authorisation recognised in Liechtenstein may be the first authorisation in the EEA for calculating SPC duration (para 44).
• Neither the EMA’s refusal on comparable data nor the suspension of the Swiss authorisation deprives it of that effect (paras 54 to 56).
• Hässle, Synthon and Generics (UK) are confined to situations without an EEA dimension (paras 50 and 51).
• Practical point: calculating SPC duration requires checking for an earlier Swiss authorisation, which may shorten the certificate, here from five years to two years and 314 days (paras 28 and 29).

Provisions applied

Regulation (EC) No 469/2009

Arts 2, 3 and 13

Directive 2001/83/EC

referred to in the operative part

Agreement on the European Economic Area

Annex II; Annex XVII, point 6; Protocol 1, point 8

Other provisions

Regulation (EC) No 726/2004; Rules of Procedure of the Court of Justice, Art. 99

Case law cited

Novartis and Others (C-207/03 and C-252/03); Hässle (C-127/00); Synthon (C-195/09); Generics (UK) (C-427/09); Yamanouchi Pharmaceutical (C-110/95); Neurim Pharmaceuticals (1991) (C-130/11)

Related decisions

• Neurim, CJEU, 19 July 2012, relied on by the applicant and held irrelevant outside the EEA context (para 59).

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.