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The Commercial Court No. 5 of Barcelona has declared the Supplementary Protection Certificate (“SPC”) of Merck Sharp & Dohme Corporation (“MSD”) null and void in a judgment dated 21 April 2021.
Background
As we reported in our previous article, MSD, along with its licensee in Spain, filed a lawsuit for infringement of its SPC on the combination of active ingredients ezetimibe + simvastatin against several companies that launched generic medicines based on this combination on the market.
The defendants counterclaimed that the holder’s SPC was null because it contravened various paragraphs of Art. 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 (“SPC Regulation”).
MSD also applied for injunctive relief against the defendants, but the Court dismissed the request on the grounds that the SPC was prima facie invalid because it contravened Arts. 3(c) and 3(a) of the SPC Regulation. In other words, it considered that ezetimibe + simvastatin (“the product”) had already been the subject of an earlier SPC (specifically, the SPC on ezetimibe) and, furthermore, that this combination was not protected by the basic patent, since the invention only referred to the family of compounds of which ezetimibe forms part. It is worth mentioning that the plaintiff appealed this decision, but there was no ruling from the Barcelona Court of Appeals because the SPC expired during the processing of the appeal.
Decision of the Court
The Commercial Court No. 5 of Barcelona has confirmed the nullity of MSD’s SPC on ezetimibe + simvastatin in the Judgment we are commenting on, on the grounds of a clear breach of Art. 3 (c) of the SPC Regulation.
In order to analyse whether “the product has not already been the subject of a certificate” for the purposes of this article, the Court assesses whether ezetimibe + simvastatin constitutes the core inventive advance of the basic patent or, on the contrary, only ezetimibe. The Court mentions that it is aware that the application of the “core inventive advance” has recently been ruled out by the CJEU for the analysis of Art. 3 (a) of the SPC Regulation, but not for Art. 3 (c).
Thus, it considers that, in the present case, the central inventive step of the patent relates only to ezetimibe (strictly speaking, the family of new compounds of which ezetimibe is a part), whereas simvastatin was already a known product in the prior art and was merely designated in one of the dependent claims of the patent.
According to the Court, this case does not differ from the factual scenarios in the CJEU judgments Actavis v Sanofi (C-443/12) and Actavis v Boehringer (C-577/13) on combinations of active ingredients irbesartan + hctz and telmisartan + hctz, respectively. In all three cases, SPCs were granted for a combination of the single active ingredient with another active ingredient previously known in the public domain, which in itself was not an independent subject matter of the respective basic patent.
Therefore, MSD having already enjoyed the exclusivity of an earlier SPC for ezetimibe, derived from the same patent and based on an earlier marketing authorisation, is not entitled to obtain a second SPC on the combination ezetimibe + simvastatin, derived from the same patent and based on a later marketing authorisation.
Having reached the conclusion on the breach of Art. 3 (c), the Court does not enter into an assessment of the breach of Art. 3 (a) and 3 (d) which had also been invoked in the defendants’ counterclaims.
MSD has lodged an appeal against the first instance judgment and, therefore, its rulings are not yet final.
The alleged lack of competence of the civil/commercial courts to declare the nullity of an SPC
In parallel to the ordinary proceedings, MSD requested the Spanish Patent and Trademark Office to bring a conflict of jurisdiction action against Commercial Court No. 5 of Barcelona in order to obtain a declaration that the latter lacked jurisdiction to rule on the invalidity of the SPC invoked. According to MSD, an SPC is merely an administrative title and, therefore, if its grant is not challenged through administrative channels, it is unassailable in civil proceedings.
MSD’s request gave rise to contentious-administrative proceedings which have ended before they even began, with the dismissal of the appeal by means of an Order dated 30 April 2021 issued by the Chamber for Contentious-Administrative Proceedings of the National High Court (4th Section). An appeal cannot be lodged against this Order, therefore, it is final.
It is worth mentioning that MSD had already filed declinatory plea before the Commercial Court No. 5 of Barcelona in the ordinary proceedings, which was also rejected.
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