Actavis v Sanofi (CJEU, C-443/12, 2013)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the High Court (Patents Court), the Court held that the proprietor of a patent protecting an innovative active ingredient, who has already obtained on that basis an SPC for that ingredient, may not obtain, on the same patent and a later marketing authorisation (MA), a second SPC for a combination of that ingredient with another active ingredient not protected as such by the patent. Article 3(c) bars that multiplication of certificates, since the SPC is meant to compensate for delay in marketing the core inventive advance that is the subject of the basic patent. The judgment closes off the extension of protection for one active ingredient through successive combinations.

Facts and procedure

Sanofi holds European patent EP 0 454 511, covering a family of compounds including irbesartan; claims 1 to 7 cover irbesartan alone or its salts, and claim 20 covers irbesartan with an unspecified diuretic. The patent, applied for on 20 March 1991 and granted on 17 June 1998, expired on 20 March 2011. On the basis of the MAs for Aprovel (irbesartan alone) of 27 August 1997, Sanofi obtained a first SPC, which expired on 14 August 2012; on the basis of the MAs for CoAprovel (irbesartan and hydrochlorothiazide) of 15 October 1998, it obtained a second SPC, expiring on 14 October 2013. Actavis, preparing generic versions of both products, challenged the validity of the second certificate. The High Court noted diverging national decisions, the Paris court having found hydrochlorothiazide not identified in claim 20, unlike the courts in Düsseldorf and The Hague, and referred two questions by decision of 21 September 2012.

The applicable law

The case concerns Articles 1, 3, 4, 5 and 13 of Regulation 469/2009, read in the light of recitals 4, 5, 9 and 10. The certificate is intended to re-establish a sufficient period of effective protection by granting an additional period of exclusivity that compensates for the time elapsed before the first MA in the Union (para 31); it confers on the product the same rights as the patent, for all authorised uses (paras 33 and 34).

Question

Does Article 3(c) allow the proprietor of a patent protecting an active ingredient, already covered by an SPC, to obtain on the same patent a second SPC for a combination of that ingredient with an unprotected active ingredient?

Decision

A patent protecting several distinct products may support several certificates, provided that each is protected as such (para 29). But even if Article 3(a) were satisfied, Article 3(c) precludes a new certificate each time the proprietor places on the market a combination of the core active ingredient with an unprotected one (para 30). Irbesartan is protected as such by the patent and has already been the subject of a certificate, whereas hydrochlorothiazide is protected neither by that patent nor by any other (para 32). The first certificate already allowed Sanofi to oppose the marketing of a CoAprovel-type product; once it expires, third parties must be free to market combinations containing irbesartan (paras 35 and 36). The aim of the Regulation is to compensate for delay in marketing the core inventive advance that is the subject of the basic patent, not to provide full compensation for that delay for every possible form of the invention; allowing multiple certificates for an unlimited number of combinations referred to only generically in the claims would upset the balance with public health (paras 39 to 41). A new basic patent covering a separate innovation could, however, support a certificate (para 42). The first question, on the criteria under Article 3(a), did not need answering (para 44).

Key points for practice

• Article 3(c) is assessed against the core inventive advance of the basic patent: only one certificate may be obtained for the innovative active ingredient on that patent (paras 41 and 42).
• A combination of the already certified active ingredient with an unprotected one cannot support a second certificate on the same patent (para 30 and operative part).
• The Court did not rule on the criteria under Article 3(a), which it left open in this case (para 44).
• Practical point: protecting a combination marketed after the active ingredient requires a new basic patent covering a separate innovation (para 42); a second certificate obtained on the original patent is exposed to an invalidity action.

Provisions applied

Regulation (EC) No 469/2009

Arts 1, 3, 4, 5 and 13; recitals 4, 5, 9 and 10

Case law cited

Medeva (C-322/10); Georgetown University and Others (C-422/10); Georgetown University (judgment of the same day); Yeda (C-518/10, order); University of Queensland and CSL (C-630/10, order); Daiichi Sankyo (C-6/11, order); Biogen (C-181/95); AHP Manufacturing (C-482/07); Neurim Pharmaceuticals (C-130/11); Hogan Lovells International (C-229/09); BASF (C-258/99); Novartis (C-442/11 and C-574/11, orders of 9 February 2012)

Related decisions

• Georgetown University, CJEU, 12 December 2013, delivered the same day, cited (paras 29 and 31).
• Medeva, CJEU, 24 November 2011, cited.
• Neurim, CJEU, 19 July 2012, cited (para 27).

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.