Case C-555/13 Merck v. Accord Healthcare

An arbitral tribunal such as the Portuguese ‘Tribunal Arbitral necessário’ may refer questions to the Court of Justice for a preliminary ruling

>> In order to avoid the period between the lodging of a patent application for a medicinal product and the marketing authorisation for that medicinal product reducing the duration of the protection conferred by the patent (20 years), Regulation 469/2009 created the supplementary protection certificate. This certificate can be granted for a maximum duration of five years, while the total duration of protection offered by the patent and by the certificate may not exceed 15 years from the first marketing authorisation in the European Union.

In November 2012, Merck ] brought an action before a Portuguese arbitral tribunal for the purpose of blocking the marketing of generic drugs containing the active ingredient at issue. Merck considers that these generic drugs could not be marketed in Portugal before 17 August 2014, the date on which, in its opinion, the certificate was due to expire. The generic drug manufacturers were of the view that the protection conferred by the patent and the certificate expired in August 2012, 15 years after the first marketing authorisation in the EU of a medicinal product containing the active ingredient. Seeking clarification on the subject, the Tribunal Arbitral necessário decided to refer a question to the Court of Justice for a preliminary ruling.

The Court however found that it was necessary to establish whether the Tribunal Arbitral necessário should be considered to be a court or tribunal for the purposes of Article 267 TFEU.

The Court reiterated that in order to determine whether a body making a reference was a ‘court or tribunal’ within the meaning of Article 267 TFEU, which was a question governed by EU law alone, the Court took account of a number of factors, such as whether the body is established by law, whether it was permanent, whether its jurisdiction was compulsory, whether its procedure is inter partes, whether it applies rules of law and whether it is independent (see C‑394/11 Belov [2013]).

The Court also reiterated that a conventional arbitration tribunal was not a ‘court or tribunal of a Member State’ within the meaning of Article 267 TFEU where the parties were under no obligation, in law or in fact, to refer their disputes to arbitration and the public authorities of the Member State concerned were not involved in the decision to opt for arbitration nor required to intervene of their own accord in the proceedings before the arbitrator (Case C‑125/04 Denuit and Cordenier [2005]).

However, the Court has held admissible preliminary questions referred to it by an arbitral tribunal, where that tribunal had been established by law, whose decisions were binding on the parties and whose jurisdiction did not depend on their agreement (see, to that effect, Case 109/88 Danfoss [1989]).

In the present case, the jurisdiction of the Tribunal Arbitral necessário did  not stem from the will of the parties, but from a Spanish law which conferred upon that tribunal compulsory jurisdiction to determine, at first instance, disputes involving industrial property rights pertaining to reference medicinal products and generic drugs. In addition, if the arbitral decision handed down by such a body was not subject to an appeal before the competent appellate court, it became definitive and had the same effects as a judgment handed down by an ordinary court.

The Member State at issue had therefore chosen, in the context of its procedure autonomy and with a view to implementing Regulation No 469/2009, to confer the jurisdiction for this type of dispute upon another body rather than an ordinary court (see Case 246/80 Broekmeulen v Huisarts Registratie Commissie).  Furthermore, according to the order for reference, the arbitrators were subject to the same obligations of independence and impartiality as judges belonging to the ordinary courts and the Tribunal Arbitral necessário observing the principle of equal treatment and the adversarial principle in the treatment of parties and gave its rulings on the basis of the Portuguese law on industrial property.

Taking all of those considerations into account, the Court  held that, in circumstances such as those of the main proceedings, the Tribunal Arbitral necessário fulfilled all of the conditions laid down by the case-law of the Court and must be considered to be a court or tribunal for the purposes of Article 267 TFEU.