In a judgment handed down today, Mr Justice Arnold has said that he will refer two questions to the Court of Justice concerning the supplementary protection certificate regulation. This is one of the first post-Brexit references to the Court of Justice.
His judgment, Merck Sharp & Dohme v the Comptroller-General of Patents, Designs and Trade Marks  EWHC 1896 (Pat), concerned an application by Merck for a Supplementary Protection Certificate (SPC) in respect of its medicinal product Atozet. The application was filed on 12 September 2014, a single day before the patent protecting Atozet expired. Article 3 of the SPC Regulation provides (so far as relevant) that an SPC shall be granted if “in the Member State in which the application… is submitted and at the date of that application… a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with [the Medicinal Products Directive]”.
At the time of the application, Merck did not have a UK marketing authorisation for Atozet (although this was granted on 10 October 2014, within the timeframe prescribed by the Medicinal Products Directive). That being so, Merck could not provide any details of any UK marketing authorisation in its Application. Instead, Merck relied upon an email notification from the German National Competent Authority, the Bundesinstitut für Arzneimittel und Medizinprodukte (“BfArM”) – Germany having been designated by Merck as the “reference member state” for the purposes of its application for marketing authorisation pursuant to the decentralised procedure established by the Medicinal Products Directive. It was Merck’s case that the effect of this decision was that the UK was obliged by Article 28(5) to grant marketing authorisation, such that the grant of marketing authorisation was simply an administrative formality.
This was disputed by the Comptroller, who contended that the Medicinal Products Directive only harmonised the procedure for obtaining marketing authorisations. The actual grant of marketing authorisations remained a matter for the Member States acting in accordance with their national laws. Thus in the UK marketing authorisations are granted by the MHRA under the Human Medicines Regulations 2012.
In his judgment, Arnold J concluded that, for the reasons given by the Comptroller, Merck’s Application did not comply with the requirements of the SPC Regulation because, as at the date of the Application, no valid authorisation to place Atozet on the market had been granted in the UK, the notice issued by the BfArM was not equivalent to a marketing authorisation for this purpose, and that this was not an irregularity which could be rectified under Article 10(3) of the SPC Regulation.
However, Arnold J did not feel able to say that the answers he had given are acte clair. He noted that MSD’s applications for SPCs for Atozet had given rise to divergent decisions amongst the Member States as applications had been refused in Portugal and Sweden (on the same ground as in the United Kingdom) but that applications had been granted in Demark, Greece, Italy and Luxembourg.
The precise wording of the questions to be referred is yet to be settled, but the Judge indicated that the questions would (in essence) be 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 can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?
The judgment is here.
Nicholas Saunders and Malcolm Birdling acted for the Comptroller and were instructed by the Treasury Solicitor.