A reference has been made to the Court of Justice of the European Union (CJEU) by Mr Justice Arnold on the Supplementary Protection Certificate (SPC) Regulation in Merck Sharp & Dohme v Comptroller-General of Patents [2016] EWHC 1896. The main issue in question is whether a so-called “end of procedure notice” can be considered equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation.

Background

SPCs provide an additional period of protection for a product subject to a marketing authorisation having been granted at the date of the application (Article 3(b)). The product must also be protected by a patent in force at the date of the application (Article 3(a)).

In September 2013, Merck Sharp & Dohme Corp (MSD) filed applications for marketing authorisations for the medicinal product in question, Atozet, in a number of Member States using the decentralized procedure (DCP), which allows for applications for marketing authorisations to be made simultaneously in several Member States. One of these is designated by the applicant as the “reference member state” (RMS), which coordinates the process for approval of the marketing authorisation application.

With the patent protecting Atozet about to expire and no marketing authorisation yet granted, MSD filed an application for a SPC at the UKIPO. In the absence of a granted marketing authorization, MSD instead submitted the end of procedure notice from the German medicines agency stating that the DCP had ended with approval. In a covering letter MSD submitted that the end of procedure notice meant that the relevant Member States, including the UK, had agreed to grant marketing authorisations for Atozet.

The UKIPO examiner objected that the application did not comply with Article 3(b) of the SPC Regulation since MSD did not hold a valid UK marketing authorisation. Following grant of the UK marketing authorisation in October 2014, MSD submitted the UK authorisation, together with the first EU marketing authorisation (from France) to the UKIPO contending that this would meet any outstanding requirements for the application.

The examiner maintained the objections and at the resulting hearing the hearing officer agreed that the SPC application did not comply with Article 3(b) and that this could not be cured under Article 10(3) which allows for the rectification of irregularities in applications.

Appeal to the High Court

MSD appealed the UKIPO decision to the High Court. Mr Justice Arnold considered the UKIPO’s decision to be correct both in that the SPC application did not comply with Article 3(b) and that the absence of a marketing authorisation is not an irregularity that can be rectified under Article 10(3). Mr Justice Arnold considered the grant of marketing authorisation to be a focus of the SPC regulation and an end of procedure notice to have no legal effect.

However, Mr Justice Arnold noted that MSD’s applications in other member states had led to divergent decisions with applications being refused in Portugal and Sweden on the same grounds as in the UK but granted in Denmark, Greece, Italy and Luxembourg. Thus, Mr Justice Arnold concluded that only by referring the matter to the CJEU can an authoritative ruling be obtained.

The questions to be referred

The wording of the questions is yet to be finalised but in essence the questions are as follows:

  1. Is an end of procedure notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation?
  2. If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?

It remains to be seen whether the CJEU will opt for a strict literal interpretation of the Regulation or whether arguments relating to the purpose of the Regulation will prove persuasive, particularly in view of the huge investment of time and money taken to get Atozet to the point of applying for a marketing authorisation. On a practical level, careful planning is needed to ensure that marketing authorisation is sought in sufficient time before patent expiry and it is therefore hoped that such a situation should occur in practice relatively infrequently.