The (unsuccessful) challenge of the competence of the civil/commercial courts to decide on the validity of a Supplementary Protection Certificate
The Commercial Court No. 5 of Barcelona has recently needed to uphold that the civil/commercial courts are competent to decide on actions for invalidity of Supplementary Protection Certificates (hereinafter, SPCs).
Merck Sharp & Dohme Corporation, the holder of an SPC for a medicinal product based on a combination of the active ingredients ezetimibe + simvastatin, along with its licensee in Spain, filed a claim for infringement of their exclusive right against various companies that, at that time, had announced their intention to market generics of such medicinal product.
Both at the interim injunction hearing (such measures having been previously dismissed inaudita parte) and in the respective replies to the claim, the defendants sustained that the plaintiff’s SPC was invalid because it infringed various paragraphs of Article 3 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (hereinafter, the SPC Regulation).
In turn, the plaintiff argued (among other things) that the civil/commercial courts were not competent to decide on the validity of SPCs when it is only challenged based on Article 15.1(a) of the SPC Regulation, i.e. due to being issued by infringing the provisions in Article 3 of such Regulation.
Standpoints of the parties
According to the plaintiff, an SPC can never be challenged in the civil/commercial courts due to failing to comply with Article 3 of the SPC Regulation because it is a purely administrative title, granted in a regulated manner and because there is no rule assigning competence that states this. Nor would the defendants lack defence because the invalidity of an SPC can be claimed in administrative and contentious-administrative proceedings. Therefore, the only courts competent to decide on the validity of such titles are those in the contentious-administrative jurisdiction.
According to the defendants, some of whom were defended by this law firm, this interpretation is incorrect. Some of the reasons raised to justify this standpoint are outlined below.
Firstly, because an SPC is not a mere regulated administrative act but rather a real industrial property title.
Secondly, because the SPC Regulation expressly stipulates that an action for invalidity can be filed against an SPC through the same mechanisms provided in national legislation for its basic patent (Article 15.2 of such Regulation). In addition, the rules for assigning competence in Spain also confer competence to the civil/commercial courts to decide on the validity of SPCs (Articles 22(d) and 86 ter of the Spanish Judiciary Act 6/1985 of 1 July, hereinafter referred to by its initials in Spanish “LOPJ”).
Thirdly, because on several occasions the Spanish civil/commercial courts have already ruled on the validity of other SPCs challenged based on Article 3 of the SPC Regulation.
Finally, because the plaintiff’s approach would, in practice, lead to the SPCs that infringe Article 3 of the SPC Regulation being invoked against alleged infringing parties without the latter being able to even defend themselves by sustaining their invalidity, thus being trapped in a situation of lack of defence or a mandatory procedural crusade that would violate Article 24 of the Spanish Constitution.
Standpoint of the Commercial Court No. 5 of Barcelona
The first decision adopted by the Commercial Court No. 5 of Barcelona on this issue was the Order dismissing the interim injunctions on 12 September 2018.
In this Order, the Court referred to the provisions in Article 86 ter of the LOPJ, which precisely grants competence to the commercial courts to decide on actions related to industrial property. Since it was not disputed that the SPC was an industrial property title, an invalidity action against it would clearly fall within this provision.
The Court also highlighted the various case-law precedents in which commercial courts had already ruled on the validity of other SPCs when it had been challenged only due to infringing Article 3 of the SPC Regulation. For example, the Judgements of the Court of Appeals of Navarra of 20 May 2014, the Commercial Court No. 1 of Pamplona of 20 June 2012 and the Commercial Court No. 8 of Barcelona of 15 October 2012 (all these cases on the product telmisartan + hctz), the Judgement of the Commercial Court No. 1 of Pamplona of 26 April 2012 (on the product memantine) or, more recently, the Order of the Commercial Court No. 4 of Barcelona of 20 October 2017 (on the product tenofovir + emtricitabine).
Finally, the Court deemed that the defendants’ right to effective judicial protection could be seriously harmed if it were accepted that the SPC had the intangible or unchallengeable nature sustained by the plaintiff.
We should mention that the plaintiff lodged an appeal against this decision; however, there was no ruling on this case by the Court of Appeals of Barcelona because the SPC had expired while the appeal was being processed.
The plaintiff raised an objection to the jurisdiction, for the same reasons, in the ordinary proceedings on which the interim injunction proceedings depend, challenging the competence of the civil/commercial courts. The Commercial Court No. 5 of Barcelona dismissed the objection by virtue of an Order dated 30 May 2019, in which it basically referred to the grounds of the Order imposing the interim injunctions. The plaintiff lodged an appeal against this decision, but its approach was dismissed again by the Order of 15 November 2019.
Despite all the foregoing, the holder of the SPC has recently raised a conflict of jurisdiction to the Spanish Patent and Trademark Office (the authorities that granted the SPC) requesting, once again, that the civil/commercial courts are declared to lack competence to decide on the invalidity of the SPC when based on Article 15.1(a) of the SPC Regulation. For the time being, such authorities have ruled in line with the opinion already expressed by the Commercial Court No. 5 of Barcelona.