By judgement of 14 March 2018, Case C-557/16, the European Court of Justice, at the instigation of Astellas, had to decide on the interpretation of Articles 28 and 29 of Directive 2001/83/EC within the framework of a decentralized procedure and Article 10 of this Directive in conjunction with Article 47 of the Charter of Fundamental Rights of the European Union.
In a decentralized procedure with Denmark as RMS and several CMS, the participating generic company was granted a generic approval for the reference drug Ribomustin, a drug with the active ingredient Bendamustin approved by the German Federal Institute for Drugs and Medical Devices on July 19, 2005 as part of a renewal procedure (Nachzulassung). Previously, on July 15, 2010, the Originator was granted approval for a drug Levact, also containing the active ingredient Bendamustin, for further indications in France. The Originator had not made use of the original approval of the drug Ribomustin for a long time and had finally waived the approval at that time.
The Originator brought an action against the granting of a generic approval in Finland (CMS) against the Finnish regulatory authority FIMEA on the ground that, on the one hand, the data protection period had not expired, since the approval for Levact was decisive and not that for Ribomustin and incidentally that Ribomustin would not be a suitable reference drug.
The first question referred by the Finnish court concerns whether Article 28 and Article 29(1) of Directive 2001/83 must be interpreted as meaning that, in a decentralised procedure for MAs in respect of a generic product, the competent authority of a Member State concerned by that procedure may itself determine the time from which the data exclusivity period for the reference medicinal product starts to run when it adopts, under Article 28(5) of that directive, its decision on the placing on the market of the generic medicinal product in that Member State.
The ECJ refused to do so on the ground that the decentralized authorisation procedure would end, when the general agreement of all Member States in which the application for authorisation to place the medicinal product on the market was acknowledged by the Reference Member State, and once this general agreement had been acknowledges, the competent authorities of those Member States may not, when making their decision on the placing on the market of that medicinal product in their territory, call into question the outcome of that procedure. In this procedure, an examination of the expiry of the data protection period for the reference medicinal product is included, so that the competent authorities of these Member States could not carry out such an examination again after the determination of this consent.
By the second question referred, the Finnish court then asked whether Article 10 of Directive 2001/83, read in conjunction with Article 47 of the Charter, must be interpreted as meaning that a court of a Member State concerned by the decentralized procedure for MAs, hearing an action brought by the holder of the MA for the reference medicinal product against the MA decision for a generic medicinal product in that Member State taken by that State’s competent authority, has jurisdiction to review the determination of the point in time from which the data exclusivity period for the reference medicinal product starts to run and to ascertain whether the initial MA for the reference medicinal product, granted in another Member State, was granted in accordance with that directive.
In this regard, the ECJ ruled that, in order to safeguard the rights of an originator, the originator must be recognised as having the right to appeal against the definition of the start of the data protection period in order to protect the documents relating to the reference medicinal product. It follows that effective judicial protection of the rights held by the holder of a MA for the reference medicinal product as regards the data exclusivity of that medicinal product can be ensured only if that holder can rely on those rights before a court of the Member State in which the competent authority adopted a MA decision for the generic medicinal product and if it can, inter alia, plead before that court an error relating to the determination of the point in time from which the exclusivity period, affected by that decision, starts to run. However, the Originator is not allowed to question this in other Member States.
Accordingly, the ECJ replied to the second question that Article 10 of Directive 2001/83, in conjunction with Article 47 of the Charter, must be interpreted as meaning that a court of a Member State concerned is empowered to review the determination of the date of commencement of the period protection data of the reference medicinal product.
However, that national court is not competent to review whether the initial MA for the reference medicinal product granted in another Member State was granted in accordance with that directive.