Teva v Merck Sharp & Dohme (CA Paris, RG 18/23642, 2020)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Paris Court of Appeal declared invalid Merck’s SPC FR05C0040 for the combination of ezetimibe and simvastatin (Inegy), the second certificate granted on the same basic patent after the one for ezetimibe alone (Ezetrol). Applying Actavis v Sanofi (C-443/12), it held that the combination was not a distinct product protected as such by the patent and that the first SPC already enabled the holder to oppose its marketing. It upheld, however, the rejection of the insufficiency attack on claims 9 to 18 of the patent and declined to make a preliminary reference. The judgment matters for holders seeking a second certificate on a combination expressly claimed.

Facts and procedure

Merck owned European patent EP 0 720 599, filed on 14 September 1994 and expired on 14 September 2014, covering a family of hydroxy-substituted azetidinones including ezetimibe (claim 8); claim 9 covers a composition combining those compounds with a cholesterol biosynthesis inhibitor and claim 17 names, among others, simvastatin. Two SPCs were granted: No 03C0028 for ezetimibe, expired on 17 April 2018, and No 05C0040 for the combination with simvastatin, expired on 2 April 2019. Teva, which launched its generics in April 2018, sued Merck on 3 November 2016 for invalidity of claims 9 to 18 and of SPC No 040. The Paris Tribunal de grande instance dismissed the claims on 25 October 2018 and Teva appealed. The judgment notes that foreign courts had reached differing outcomes on this certificate.

The applicable law

An SPC is granted if the product is protected by a basic patent in force and has not already been the subject of a certificate (Article 3(a) and (c) of Regulation 469/2009), the product being the active ingredient or combination of active ingredients (Article 1). The court construed those provisions in light of the CJEU rulings in Actavis v Sanofi and Georgetown University (C-484/12), and assessed protection from the standpoint of the skilled person, the description serving to interpret the claims under Article 69 EPC.

Question

Can a second SPC be obtained, on the same basic patent, for the combination of the active ingredient already certified with another active ingredient named in a dependent claim?

Decision

On validity of the patent, the court confirmed that the skilled person, a pharmacologist specialising in hypercholesterolaemia, could carry out the combination using the description’s guidance on preferred inhibitors and doses, without a research programme. On the SPC, it rejected the argument that Actavis v Sanofi did not apply to an expressly claimed combination: under point 30 of that ruling, Article 3(c) precludes a further certificate « even assuming » Article 3(a) is met. Gilead (C-121/17) and Royalty Pharma (C-650/17) concern functional definitions and a first certificate, so the notion of a distinct product was not at issue there. The description, which refers to the invention in the singular and presents the combination as « another aspect », attributes no specific therapeutic effect to it: the skilled person, aware of combining cholesterol lowering agents and of the routine use of statins, would not see it as a distinct product, any more than for the nine other active ingredients in claim 17. As the first SPC already allowed the combination to be opposed, the conditions of Article 3(a) and (c) were not met. The court declared SPC FR05C0040 invalid, refused publication and ordered Merck to pay EUR 150,000 under Article 700 of the Code of Civil Procedure.

Key points for practice

• Express mention of a combination in a dependent claim does not take a second SPC outside the Actavis v Sanofi rule.
• The court relied on the absence, in the description, of any therapeutic effect specific to the combination to deny that it was a distinct product.
• An insufficiency attack on a dependent combination claim fails where the description gives the preferred inhibitors and dosages.
• Practical point: a holder contemplating a combination SPC after a first SPC should check that the description attributes a specific contribution to the combination, a mere list of possible partner ingredients being insufficient.

Relevance before the UPC

As the UPC may hear invalidity actions against SPCs based on a European patent, this reading of Actavis v Sanofi, Georgetown University and Gilead may be debated before it.

Provisions applied

Regulation (EC) No 469/2009 (SPC)

Arts 1 and 3

European Patent Convention

Art. 69 and its Protocol on Interpretation

National law

French Code of Civil Procedure, Articles 699 and 700

Case law cited

CJEU, 12 December 2013, Actavis v Sanofi, C-443/12; CJEU, 12 December 2013, Georgetown University, C-484/12; CJEU, 25 July 2018, Teva v Gilead, C-121/17; CJEU, 30 April 2020, Royalty Pharma, C-650/17; Paris Court of Appeal, 14 February 2020 (parallel proceedings against Sandoz and Mylan)

Related decisions

• Actavis v Sanofi, CJEU, 12 December 2013, ruling applied under Article 3(c).
• Georgetown University, CJEU, 12 December 2013, distinct products covered by one patent.
• Teva v Gilead, CJEU, 25 July 2018, held not to address a second certificate.
• Royalty Pharma, CJEU, 30 April 2020, held not to address a second certificate.

Prepared by Dhenne Avocats from the text of the decision (PIBD, INPI), consulted on 11 October 2026. Only the official text is authoritative.