Barcelona Commercial Court No. 5
Barcelona Court of Appeal
On 8 February 2022, the Barcelona Court of Appeal confirmed the invalidity of the Spanish supplementary protection certificate (SPC) covering the combination of ezetimibe and simvastatin, thus upholding a first-instance decision favourable to several generic competitors. This matter has been broadly followed in Europe since there is ongoing litigation in many jurisdictions.
Merck Sharp & Dohme (MSD) was the holder of SPC No. C200300018 (SPC'018) for ezetimibe and SPC No. C200500011 (SPC'011) for the combination of ezetimibe and simvastatin, both based on European patent EP0720599. The SPCs' expiry dates were 17 April 2018 and 2 April 2019, respectively.
The basic patent related to a family of compounds of formula I, including ezetimibe, which was specifically protected under claim 8. The patent also referred generally to the combination of the compounds of formula I with cholesterol biosynthesis inhibitor drugs.
MSD commercializes Ezetrol (ezetimibe) and Inegy (ezetimibe and simvastatin) for the treatment of atherosclerosis and the reduction of cholesterol.
In March 2018, MSD filed actions against several generics, together with ex parte preliminary injunction requests, for alleged imminent infringement of its SPC'011 for the combination of ezetimibe and simvastatin.
The court refused to grant any preliminary injunction ex parte due to lack of a justified extreme urgency. After a hearing, the court dismissed the preliminary injunction requests considering the prima facie invalidity of MSD's SPC based on article 15.1(a) of the EU SPC Regulation, in relation to articles 3(c) and 3(a) thereof and the applicable Court of Justice of the European Union (CJEU) case law.
In the main proceedings on the merits, MSD unsuccessfully attempted to challenge the jurisdiction of the commercial courts to judge the validity of an SPC on the grounds of articles 15.1(a) and 3 of the EU SPC Regulation.
With regard to invalidity, the defendants argued that SPC'011 did not comply with the requirements of article 3 of the EU SPC Regulation and the applicable CJEU case law for the following reasons:
- Ezetimibe had already been protected by a previous SPC (SPC'018), based on the same patent and a previous marketing authorisation, and therefore the grant of SPC'011 would be contrary to article 3(c).
- The basic patent did not protect the combination of ezetimibe and simvastatin in the sense of article 3(a).
- One of the defendants also argued that the marketing authorisation for Ezetrol (ezetimibe), and not that for Inegy (ezetimibe and simvastatin), was in fact the first relevant marketing authorisation, and therefore that the SPC would also be contrary to article 3(d).
MSD alleged that the defendants would be misinterpreting the CJEU case law concerning article 3(c) of the EU SPC Regulation. In this regard, MSD tried to rely on the CJEU judgments in Teva(1) and Royalty Pharma,(2) which in fact relate to the interpretation of article 3(a). MSD also maintained that the combination of ezetimibe and simvastatin was expressly mentioned in the claims of the basic patent in the sense of article 3(a), considering simvastatin was cited among a group of cholesterol biosynthesis inhibitors in claim 17. Ultimately, MSD argued that the marketing authorisation for Inegy would be the first for the combination product in the sense of article 3(d).
Barcelona Commercial Court No. 5
After the trial, which took place in April 2021, Barcelona Commercial Court No. 5 concluded that the SPC was invalid for being contrary to article 3(c) of the EU SPC Regulation.
The judge emphasised that the controversy and the facts of the case at stake were analogous to those in the Actavis I(3) and Actavis II(4) matters previously examined by the CJEU, and so the doctrine of its decisions was binding and directly applicable.
The first-instance judgment was issued right after MSD's last-minute request for a referral to the CJEU.
MSD appealed the decision, and the Barcelona Court of Appeal scheduled a second-instance hearing on 13 January 2022.
By means of its judgment dated 8 February 2022, the Barcelona Court of Appeal declared that MSD's SPC failed not only to meet the requirement of article 3(c) of the EU SPC Regulation, but also to comply with article 3(a), thus confirming the invalidity of SPC'011 for ezetimibe and simvastatin.
The judgment carefully reviewed the relevant CJEU case law. First, focusing on Actavis I, Georgetown II(5) and Actavis II, it explained that the holder of a basic patent cannot obtain further SPCs based on subsequent marketing authorisations – thus with an extended duration – every time that it commercialises an active ingredient protected by the basic patent combined with any other active ingredient. Secondly, as regards Teva and Royalty Pharma, while pointing out that they addressed cases where the facts at stake were essentially different, the Court posited that no SPC can be validly granted for a product developed after the priority/filing date of the basic patent.
In its decision, the Court acknowledged that the CJEU doctrine regarding the interpretation of articles 3(c) and 3(a) of the EU SPC Regulation in analogous cases is clear and unequivocal, and therefore refused MSD's request for a referral to the CJEU.
MSD has filed a further cassation appeal to the Spanish Supreme Court.
For further information on this topic please contact Núria Ribera at Grau & Angulo by telephone (+34 93 202 34 56) or email ([email protected]). The Grau & Angulo website can be accessed at www.ga-ip.com.
(3) C-443/12, irbesartan and hydrochlorothiazide.
(4) C-577/13, telmisartan and hydrochlorothiazide.