Case C-567/16, Merck Sharp – SPC Lazarus law [judgment 2017, ECLI:EU:C:2017:948]

Drug companies can increase their profits by extending the life of their patents. In the EU, extensions can be granted with an ‘SPC’. However, these need to be applied for and their award is governed by the rules laid down in the EU’s ‘SPC’ Regulation 469/2009. In this case, a drug company applied for an SPC but it failed to provide a required document, and instead enclosed a different piece of paper. Does the omission kill the application? And if so, then is the application really dead? Can it be reanimated by dint of the fact that when the company had made its application the document did not exist but the company had offered to supply it at some point in the future?

Background
Merck Sharp & Dohme (MSD) is a company that makes pharmaceuticals. One of its products is Atozet. For years, this product had been protected by a European Patent (with a UK designation). However, the day before this patent was due to expire, MSD applied to the relevant UK body for an SPC certificate to extend the life of the patent.

Five days later, the UK body turned down MSD’s application. The reason was that MSD’s application lacked one specific obligatory document – a valid UK marketing authorisation for Atozet. This document was required by dint of Article 3 of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products, which stipulates:

3. A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
…
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;

MSD appealed the UK body’s decision to the High Court of England and Wales.

Its first argument was that in place of a valid UK marketing authorisation for Atozet, the relevant authority in Germany had already issued a document known as an ‘end of procedure notice’ in respect of the drug. According MSD, since the document came from Germany – the ‘reference Member State’ – this was therefore equivalent to a marketing authorisation for all national authorities. Mr Justice Arnold, who was hearing MSD’s case, did not know whether ‘an end of procedure notice’ could be relied upon in lieu of a valid UK marketing authorisation so that would be his first question to the CJEU.

If MSD would lose that argument, then MSD had raised a second one. MSD recalled that when it had made its application, there was no UK marketing authorisation; consequently, it had asked the UK body if it could supplement its application by supplying a copy of the UK valid marketing authorisation at a later date, namely, at the moment when the UK marketing authorisation was granted. The UK body had in effect said it could not do that. According to the UK body, the defect in MSD’s application arose from Article 3(b) of the Regulation and not Article 3(c) so the application could not be saved by Article 10(3) of the Regulation (which is limited to Article 3(c)). However, MSD sought to get around that literal understanding of the EU’s SPC Regulation. It cited a judgment from the Court of Appeal of England and Wales (E I du Pont de Nemours & Co [2009] EWCA Civ 966). In that judgment, the Court of Appeal had allowed a defect in an application to extend an SPC to be cured by Article 10(3) in circumstances where updated marketing authorisations had subsequently become available.

Mr Justice Arnold did not know if MSD’s application was still curable under Article 10(3) of the EU Regulation so he decided to ask the CJEU about this too.

Questions Referred
The official version of the questions has not yet been published on the Curia website. Fortunately, the Bailii website contains a copy of Mr Justice Arnold’s decision to make a preliminary ruling, and it concludes with these words:

50. I will hear counsel as to the precise wording of the questions, 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?