IP-Fälle und Artikel

EU SPCs: the question of valid marketing authorisation

There are a number of requirements which must be met in order to be granted a supplementary protection certificate (SPC) in a member state of the EU. One of these requirements is that, in the member state in which the application is made and at the date of that application, a valid marketing authorisation (MA) has been granted for the relevant product (Article 3(b) of the SPC Regulation). There must also be a basic patent still in force in that state which covers the product.

This case concerned the question of what constitutes a 'valid marketing authorisation' under the SPC Regulation.

Refusal by UKIPO in first instance

In the first instance, the UKIPO had refused Merck Sharpe & Dohme's (MSD) application for an SPC on the ground that MSD did not have a valid MA within the meaning of Article 3(b). MSD had contended that they did have a valid MA, and also contended that, if it were held that they did not have a valid MA at the date of the application, this was an irregularity which was capable of being rectified after filing the application, and which was rectified subsequently.

The SPC application in question was filed in respect of MSD's product Atozet. MSD had applied for MAs in a number of member states, including the UK, under the decentralised procedure in which an applicant applies simultaneously to the national competent authorities (NCAs) in multiple member states, with one state nominated as the reference member state (RMS). Upon agreement of the RMS and each of the other NCAs that the documents are approved, the RMS records the agreement and closes the procedure. The applicant then receives an end of procedure (EoP) notice, and each of the NCAs then have 30 days from this notice to grant the MA in that country.

MSD were the owner of the basic patent covering their product Atozet. The basic patent expired on 13 September 2014. MSD filed applications for MAs in a number of member states, designating Germany as the RMS, in early 2014.

The application for the SPC was filed on 12 September 2014, the day before expiry of the basic patent. At that time, MSD did not have a granted UK MA for Atozet. However, they had received an EoP notice from the German NCA. MSD contended that the effect of the EoP was that all affected member states, including the UK, had agreed to grant MAs for Atozet, and that each member state would now carry out the formal step of granting the MA.

The UKIPO did not agree, and refused the application.

The MA was granted in the UK on 10 October 2014, and MSD subsequently filed a copy of the MA at the UKIPO asserting that the submission of such documentation rectified any irregularities in the application. However, the UKIPO disagreed, noting that the fact that MSD had not had a valid MA at the time of filing the application was not an irregularity that could be rectified post-filing.

Decision of the UK court

Upon appeal, the UK court agreed with the UKIPO and held that the application did not comply with the requirement of Article 3(b). A number of reasons were provided for this decision, including that an EoP Notice has no legal effect – it remained for each member state to actually grant an MA – and that, since a product cannot be placed on the market until the MA was granted, it is the grant of the MA which is the key event. Indeed, the SPC Regulation repeatedly refers to the grant of an MA, and makes no reference to an EoP notice.

The UK court also agreed that the fact that MSD did not have a valid MA at the time of making the SPC application was not an irregularity that could be rectified after filing. The UK court held that, even if MSD were permitted belatedly to submit the MA, this could not cure the impossibility of satisfying a mandatory condition for the grant of an SPC.

Divergent decisions

The UK court noted, however, that MSD's SPC applications for Atozet have given rise to divergent decisions amongst the member states. Applications have been refused in Portugal and Sweden on the same grounds as in the UK. In contrast, applications have been granted in Denmark, Greece, Italy and Luxembourg.

The UK court has therefore referred the following two questions to the CJEU for a preliminary ruling:

  1. Is an end of procedure notice issued by the reference member state equivalent to a granted MA 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 MA at the date of the application for an SPC an irregularity which can be cured once the MA has been granted?

The CJEU decided that the end of procedure notice represented an intermediate stage in the procedure and that it did not have the same legal effects as a ‘valid’ marketing authorisation. Their reasoning for this decision essentially was that unlike a valid marketing authorisation, an end of procedure notice does not authorise the applicant to place the medicinal product on a particular market.

The answer of the CJEU to the question 1 was therefore “no”, with the result that an SPC may not be obtained on the basis of the end of procedure notice.

With regard to question 2, the CJEU decided that the absence of a marketing authorisation was not an irregularity which the applicant could rectify after the application date. This decision was based on the fact that a missing marketing authorisation constitutes an irregularity in connection with the product, as a medicinal product, not an irregularity in connection with the SPC application.

Although this decision from the CJEU makes legal sense, it seems unfair that an applicant be penalised because of timing. Nevertheless, when a patent is about to expire, an SPC application can only be made on the basis of a valid marketing authorisation, an end of procedure notice is not sufficient.

Case details at a glance

  • Court: High Court of Justice Chancery Division Patents Court
  • Parties: Merck Sharp & Dohme (applicant) and the Comptroller General of Patents, Designs annd Trade Marks (respondent)
  • Citation: [2016] EWHC 1896 (Pat)
  • Date: 29 July 2016
  • Full decision: http://dycip.com/ewhc1896pat